OPM Dec 2014 | Vol 4 | No 9 | PSS Guide

DECEMBER 2014

www.OncPracticeManagement.com

VOLUME 4 • NUMBER 9 SPECIAL ISSUE

Oncology Practice Management ™

FOR ONCOLOGISTS, PRACTICE MANAGERS, FINANCIAL COUNSELORS, AND REIMBURSEMENT SPECIALISTS™

ONCOLOGY GUIDE to

PATIENT SUPPORT SERVICES

In Association with

© 2014 Engage Healthcare Communications, LLC

NEW PHASE 3 DATA

IMBRUVICA® demonstrated single-agent survival in previously treated CLL INDICATIONS: IMBRUVICA® is a first-in-class Bruton’s tyrosine kinase (BTK) inhibitor indicated for the treatment of patients with: • Chronic lymphocytic leukemia (CLL) who have received at least one prior therapy • CLL with 17p deletion

Significantly improved overall survival (OS)—secondary endpoint • 57% statistically significant reduction in the risk of death for patients in the IMBRUVICA® arm (HR=0.43; 95% CI: 0.24, 0.79) • Median OS not yet reached in either treatment arm • 29% of ofatumumab patients crossed over to receive IMBRUVICA® upon progression

Significantly extended progression-free survival (PFS)—primary endpoint 78% statistically significant reduction in the risk of death or progression (independent review) 100

PFS (%)

80 60 40 Hazard ratio (HR) for progression or death: 0.22 (95% CI: 0.15, 0.32) P<0.0001 by log-rank test

20 0

0

3

6

183 161

116 83

Number at risk IMBRUVICA® 195 Ofatumumab 196

Months

Ofatumumab 9

12

15

38 15

7 1

0 0

Results from the randomized, multicenter, open-label, Phase 3 RESONATE™ trial of IMBRUVICA® vs ofatumumab in patients with previously treated CLL. Patients (N=391) were randomized 1:1 to receive either IMBRUVICA® 420 mg orally daily until disease progression or unacceptable toxicity or IV ofatumumab at an initial dose of 300 mg, followed 1 week later by a dose of 2000 mg weekly for 7 doses, and then every 4 weeks for 4 additional doses. Fifty-seven patients randomized to ofatumumab crossed over following Independent Review Committee-confirmed progression to receive IMBRUVICA®.

Primary endpoint: PFS as assessed by an Independent Review Committee (IRC) according to modified International Workshop on CLL Criteria.

Significantly improved PFS in patients with previously treated del 17p CLL • 75% reduced risk of progression or death (HR=0.25; 95% CI: 0.14, 0.45) — Median PFS not reached with IMBRUVICA® vs 5.8 months with ofatumumab

In CLL studies, approximately 5% of patients discontinued due to adverse events Please review the Important Safety Information on adjacent page.

ORAL, ONCE-DAILY DOSING

IMPORTANT SAFETY INFORMATION WARNINGS AND PRECAUTIONS Hemorrhage - Grade 3 or higher bleeding events (subdural hematoma, gastrointestinal bleeding, hematuria, and post-procedural hemorrhage) have occurred in up to 6% of patients. Bleeding events of any grade, including bruising and petechiae, occurred in approximately half of patients treated with IMBRUVICA®.

The mechanism for the bleeding events is not well understood.

IMBRUVICA® may increase the risk of hemorrhage in patients receiving anti-platelet or anti-coagulant therapies. Consider the benefit-risk of withholding IMBRUVICA® for at least 3 to 7 days pre- and post-surgery depending upon the type of surgery and the risk of bleeding.

Infections - Fatal and non-fatal infections have occurred with IMBRUVICA®. Twenty-six percent of patients with CLL had infections Grade 3 or greater NCI Common Terminology Criteria for Adverse Events (CTCAE). Monitor patients for fever and infections and evaluate promptly.

Cytopenias - Treatment-emergent Grade 3 or 4 cytopenias including neutropenia (range, 23 to 29%), thrombocytopenia (range, 5 to 17%), and anemia (range, 0 to 9%) occurred in patients treated with IMBRUVICA®. Monitor complete blood counts monthly.

Atrial Fibrillation - Atrial fibrillation and atrial flutter (range, 6 to 9%) have occurred in patients treated with IMBRUVICA®, particularly in patients with cardiac risk factors, acute infections, and a previous history of atrial fibrillation.

Periodically monitor patients clinically for atrial fibrillation.

Patients who develop arrhythmic symptoms (eg, palpitations, lightheadedness) or new-onset dyspnea should have an ECG performed. If atrial fibrillation persists, consider the risks and benefits of IMBRUVICA® treatment and dose modification.

Second Primary Malignancies - Other malignancies (range, 5 to 10%) including carcinomas (range, 1 to 3%) have occurred in patients treated with IMBRUVICA®. The most frequent second primary malignancy was non-melanoma skin cancer (range, 4 to 8%).

© Pharmacyclics, Inc. 2014 © Janssen Biotech, Inc. 2014 08/14 PRC-00482

Embryo-Fetal Toxicity - Based on findings in animals, IMBRUVICA® can cause fetal harm when administered to a pregnant woman. Advise women to avoid becoming pregnant while taking IMBRUVICA®. If this drug is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus.

ADVERSE REACTIONS The most common adverse reactions (≥20%) in the clinical trials were thrombocytopenia (56%), neutropenia (51%), diarrhea (51%), anemia (37%), fatigue (28%), musculoskeletal pain (28%), upper respiratory tract infection (28%), rash (26%), nausea (25%), and pyrexia (24%). Approximately 5% of patients receiving IMBRUVICA® discontinued treatment due to adverse events. These included infections, subdural hematomas, and diarrhea. Adverse events leading to dose reduction occurred in approximately 6% of patients.

DRUG INTERACTIONS CYP3A Inhibitors - Avoid concomitant administration with strong or moderate inhibitors of CYP3A. If a moderate CYP3A inhibitor must be used, reduce the IMBRUVICA® dose.

CYP3A Inducers - Avoid co-administration with strong CYP3A inducers.

SPECIFIC POPULATIONS Hepatic Impairment - Avoid use in patients with baseline hepatic impairment.

Please review the Brief Summary of full Prescribing Information on the following page.

To learn more, visit us at

www.IMBRUVICA.com

Brief Summary of Prescribing Information for IMBRUVICA® (ibrutinib) IMBRUVICA® (ibrutinib) capsules, for oral use See package insert for Full Prescribing Information INDICATIONS AND USAGE Mantle Cell Lymphoma: IMBRUVICA is indicated for the treatment of patients with mantle cell lymphoma (MCL) who have received at least one prior therapy.

Accelerated approval was granted for this indication based on overall response rate. Improvements in survival or disease-related symptoms have not been established. Continued approval for this indication may be contingent upon verification of clinical benefit in confirmatory trials [see Clinical Studies (14.1) in full Prescribing Information].

Chronic Lymphocytic Leukemia: IMBRUVICA is indicated for the treatment of patients with chronic lymphocytic leukemia (CLL) who have received at least one prior therapy [see Clinical Studies (14.2) in full Prescribing Information].

Chronic Lymphocytic Leukemia with 17p deletion: IMBRUVICA is indicated for the treatment of patients with chronic lymphocytic leukemia (CLL) with 17p deletion [see Clinical Studies (14.2) in full Prescribing Information].

CONTRAINDICATIONS None WARNINGS AND PRECAUTIONS Hemorrhage: Grade 3 or higher bleeding events (subdural hematoma, gastrointestinal bleeding, hematuria and post procedural hemorrhage) have occurred in up to 6% of patients. Bleeding events of any grade, including bruising and petechiae, occurred in approximately half of patients treated with IMBRUVICA. The mechanism for the bleeding events is not well understood.

IMBRUVICA may increase the risk of hemorrhage in patients receiving antiplatelet or anticoagulant therapies.

Consider the benefit-risk of withholding IMBRUVICA for at least 3 to 7 days pre and post-surgery depending upon the type of surgery and the risk of bleeding [see Clinical Studies (14) in full Prescribing Information].

Infections: Fatal and non-fatal infections have occurred with IMBRUVICA therapy. Twenty-five percent of patients with MCL and 26% of patients with CLL had infections Grade 3 or greater NCI Common Terminology Criteria for Adverse Events (CTCAE) [See Adverse Reactions]. Monitor patients for fever and infections and evaluate promptly.

Cytopenias: Treatment-emergent Grade 3 or 4 cytopenias including neutropenia (range, 23 to 29%), thrombocytopenia (range, 5 to 17%), and anemia (range, 0 to 9%) occurred in patients treated with IMBRUVICA. Monitor complete blood counts monthly.

Atrial Fibrillation: Atrial fibrillation and atrial flutter (range, 6 to 9%) have occurred in patients treated with IMBRUVICA, particularly in patients with cardiac risk factors, acute infections, and a previous history of atrial fibrillation. Periodically monitor patients clinically for atrial fibrillation. Patients who develop arrhythmic symptoms (e.g., palpitations, lightheadedness) or new onset dyspnea should have an ECG performed.

If atrial fibrillation persists, consider the risks and benefits of IMBRUVICA treatment and dose modification [see Dosage and Administration (2.3) in full Prescribing Information].

Second Primary Malignancies: Other malignancies (range, 5 to 10%) including carcinomas (range, 1 to 3%) have occurred in patients treated with IMBRUVICA. The most frequent second primary malignancy was nonmelanoma skin cancer (range, 4 to 8%).

Embryo-Fetal Toxicity: Based on findings in animals, IMBRUVICA can cause fetal harm when administered to a pregnant woman. Ibrutinib caused malformations in rats at exposures 14 times those reported in patients with MCL and 20 times those reported in patients with CLL, receiving the ibrutinib dose of 560 mg per day and 420 mg per day, respectively. Reduced fetal weights were observed at lower exposures. Advise women to avoid becoming pregnant while taking IMBRUVICA. If this drug is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to a fetus [see Use in Specific Populations].

ADVERSE REACTIONS The following adverse reactions are discussed in more detail in other sections of the labeling: • Hemorrhage [see Warnings and Precautions] • Infections [see Warnings and Precautions] • Cytopenias [see Warnings and Precautions] • Atrial Fibrillation [see Warnings and Precautions] • Second Primary Malignancies [see Warnings and Precautions] Because clinical trials are conducted under widely variable conditions, adverse event rates observed in clinical trials of a drug cannot be directly compared with rates of clinical trials of another drug and may not reflect the rates observed in practice.

Mantle Cell Lymphoma: The data described below reflect exposure to IMBRUVICA in a clinical trial that included 111 patients with previously treated MCL treated with 560 mg daily with a median treatment duration of 8.3 months.

IMBRUVICA® (ibrutinib) capsules The most commonly occurring adverse reactions (≥ 20%) were thrombocytopenia, diarrhea, neutropenia, anemia, fatigue, musculoskeletal pain, peripheral edema, upper respiratory tract infection, nausea, bruising, dyspnea, constipation, rash, abdominal pain, vomiting and decreased appetite (see Tables 1 and 2).

The most common Grade 3 or 4 non-hematological adverse reactions (≥ 5%) were pneumonia, abdominal pain, atrial fibrillation, diarrhea, fatigue, and skin infections.

Fatal and serious cases of renal failure have occurred with IMBRUVICA therapy. Increases in creatinine 1.5 to 3 times the upper limit of normal occurred in 9% of patients.

Adverse reactions from the MCL trial (N=111) using single agent IMBRUVICA 560 mg daily occurring at a rate of ≥ 10% are presented in Table 1.

Table 1: Non-Hematologic Adverse Reactions in ≥ 10% of Patients with MCL (N=111) System Organ Class

Preferred Term

Diarrhea Nausea Constipation Abdominal pain Vomiting Stomatitis Dyspepsia Infections and Upper respiratory tract infestations infection Urinary tract infection Pneumonia Skin infections Sinusitis Fatigue General disorders Peripheral edema and administrative Pyrexia site conditions Asthenia Skin and Bruising subcutaneous Rash tissue disorders Petechiae Musculoskeletal and Musculoskeletal pain Muscle spasms connective tissue Arthralgia disorders Respiratory, thoracic Dyspnea and mediastinal Cough disorders Epistaxis Metabolism and Decreased appetite nutrition disorders Dehydration Nervous system Dizziness disorders Headache Gastrointestinal disorders

All Grades Grade 3 or 4 (%) (%) 5 51 0 31 0 25 5 24 0 23 1 17 0 11 34 14 14 14 13 41 35 18 14 30 25 11 37 14 11 27 19 11 21 12 14 13

0 3 7 5 1 5 3 1 3 0 3 0 1 0 0 4 0 0 2 4 0 0

Table 2: Treatment-Emergent* Decrease of Hemoglobin, Platelets, or Neutrophils in Patients with MCL (N=111)

Platelets Decreased Neutrophils Decreased Hemoglobin Decreased

Percent of Patients (N=111) All Grades Grade 3 or 4 (%) (%) 57 17 47 29 41 9

* Based on laboratory measurements and adverse reactions Ten patients (9%) discontinued treatment due to adverse reactions in the trial (N=111). The most frequent adverse reaction leading to treatment discontinuation was subdural hematoma (1.8%). Adverse reactions leading to dose reduction occurred in 14% of patients.

Patients with MCL who develop lymphocytosis greater than 400,000/mcL have developed intracranial hemorrhage, lethargy, gait instability, and headache. However, some of these cases were in the setting of disease progression.

Forty percent of patients had elevated uric acid levels on study including 13% with values above 10 mg/dL. Adverse reaction of hyperuricemia was reported for 15% of patients.

Chronic Lymphocytic Leukemia: The data described below reflect exposure to IMBRUVICA in an open label clinical trial (Study 1) that included

IMBRUVICA® (ibrutinib) capsules

IMBRUVICA® (ibrutinib) capsules

48 patients with previously treated CLL and a randomized clinical trial (Study 2) that included 391 randomized patients with previously treated CLL or SLL. The most commonly occurring adverse reactions in Study 1 and Study 2 (≥ 20%) were thrombocytopenia, neutropenia, diarrhea, anemia, fatigue, musculoskeletal pain, upper respiratory tract infection, rash, nausea, and pyrexia.

Approximately five percent of patients receiving IMBRUVICA in Study 1 and 2 discontinued treatment due to adverse events. These included infections, subdural hematomas and diarrhea. Adverse events leading to dose reduction occurred in approximately 6% of patients.

Study 1: Adverse reactions and laboratory abnormalities from the CLL trial (N=48) using single agent IMBRUVICA 420 mg daily occurring at a rate of ≥ 10% are presented in Tables 3 and 4.

Study 2: Adverse reactions and laboratory abnormalities described below in Tables 5 and 6 reflect exposure to IMBRUVICA with a median duration of 8.6 months and exposure to ofatumumab with a median of 5.3 months in Study 2.

Table 3: Non-Hematologic Adverse Reactions in ≥ 10% of Patients with CLL (N=48) in Study 1 System Organ Class Gastrointestinal disorders

Infections and infestations

General disorders and administrative site conditions Skin and subcutaneous tissue disorders Respiratory, thoracic and mediastinal disorders Musculoskeletal and connective tissue disorders Nervous system disorders

Preferred Term Diarrhea Constipation Nausea Stomatitis Vomiting Abdominal pain Dyspepsia Upper respiratory tract infection Sinusitis Skin infection Pneumonia Urinary tract infection Fatigue Pyrexia Peripheral edema Asthenia Chills Bruising Rash Petechiae Cough Oropharyngeal pain Dyspnea Musculoskeletal pain Arthralgia Muscle spasms Dizziness Headache Peripheral neuropathy Decreased appetite

Metabolism and nutrition disorders Neoplasms benign, Second malignancies* malignant, unspecified Injury, poisoning Laceration and procedural complications Psychiatric disorders Anxiety Insomnia Vascular disorders Hypertension

All Grades Grade 3 or 4 (%) (%) 63 4 23 2 21 2 21 0 19 2 15 0 13 0 48 21 17 10 10 31 25 23 13 13 54 27 17 19 15 10 27 23 19 21 19 10 17

2 6 6 8 0 4 2 0 4 0 2 0 0 0 0 0 6 0 2 0 2 0 2

10*

0

10

2

10 10 17

0 0 8

*One patient death due to histiocytic sarcoma.

Table 4: Treatment-Emergent* Decrease of Hemoglobin, Platelets, or Neutrophils in Patients with CLL (N=48) in Study 1

Platelets Decreased Neutrophils Decreased Hemoglobin Decreased

Percent of Patients (N=48) All Grades Grade 3 or 4 (%) (%) 71 10 54 27 44 0

* Based on laboratory measurements per IWCLL criteria and adverse reactions

Table 5: Non-Hematologic Adverse Reactions ≥ 10% Reported in Study 2

System Organ Class ADR Term Gastrointestinal disorders Diarrhea Nausea Stomatitis* Constipation Vomiting General disorders and administration site conditions Fatigue Pyrexia Infections and infestations Upper respiratory tract infection Pneumonia* Sinusitis* Urinary tract infection Skin and subcutaneous tissue disorders Rash* Petechiae Bruising* Musculoskeletal and connective tissue disorders Musculoskeletal Pain* Arthralgia Nervous system disorders Headache Dizziness Injury, poisoning and procedural complications Contusion Eye disorders Vision blurred

IMBRUVICA Ofatumumab (N=195) (N=191) All Grades Grade 3 or 4 All Grades Grade 3 or 4 (%) (%) (%) (%)

48 26 17 15 14

4 2 1 0 0

18 18 6 9 6

2 0 1 0 1

28 24

2 2

30 15

2 1

16 15 11 10

1 10 1 4

11 13 6 5

2 9 0 1

24 14 12

3 0 0

13 1 1

0 0 0

28

2

18

1

17

1

7

0

14 11

1 0

6 5

0 0

11

0

3

0

10

0

3

0

Subjects with multiple events for a given ADR term are counted once only for each ADR term.

The system organ class and individual ADR terms are sorted in descending frequency order in the IMBRUVICA arm. * Includes multiple ADR terms

IMBRUVICA® (ibrutinib) capsules Table 6: Treatment-Emergent* Decrease of Hemoglobin, Platelets, or Neutrophils in Study 2 IMBRUVICA Ofatumumab (N=195) (N=191) All Grades Grade 3 or 4 All Grades Grade 3 or 4 (%) (%) (%) (%) Neutrophils Decreased 51 23 57 26 Platelets Decreased 52 5 45 10 Hemoglobin Decreased 36 0 21 0 * Based on laboratory measurements per IWCLL criteria DRUG INTERACTIONS Ibrutinib is primarily metabolized by cytochrome P450 enzyme 3A. CYP3A Inhibitors: In healthy volunteers, co-administration of ketoconazole, a strong CYP3A inhibitor, increased Cmax and AUC of ibrutinib by 29- and 24-fold, respectively. The highest ibrutinib dose evaluated in clinical trials was 12.5 mg/kg (actual doses of 840 – 1400 mg) given for 28 days with single dose AUC values of 1445 ± 869 ng • hr/mL which is approximately 50% greater than steady state exposures seen at the highest indicated dose (560 mg).

Avoid concomitant administration of IMBRUVICA with strong or moderate inhibitors of CYP3A. For strong CYP3A inhibitors used short-term (e.g., antifungals and antibiotics for 7 days or less, e.g., ketoconazole, itraconazole, voriconazole, posaconazole, clarithromycin, telithromycin) consider interrupting IMBRUVICA therapy during the duration of inhibitor use. Avoid strong CYP3A inhibitors that are needed chronically. If a moderate CYP3A inhibitor must be used, reduce the IMBRUVICA dose.

Patients taking concomitant strong or moderate CYP3A4 inhibitors should be monitored more closely for signs of IMBRUVICA toxicity [see Dosage and Administration (2.4) in full Prescribing Information].

Avoid grapefruit and Seville oranges during IMBRUVICA treatment, as these contain moderate inhibitors of CYP3A [see Dosage and Administration (2.4), and Clinical Pharmacology (12.3) in full Prescribing Information].

CYP3A Inducers: Administration of IMBRUVICA with rifampin, a strong CYP3A inducer, decreased ibrutinib Cmax and AUC by approximately 13- and 10-fold, respectively.

Avoid concomitant use of strong CYP3A inducers (e.g., carbamazepine, rifampin, phenytoin and St. John’s Wort). Consider alternative agents with less CYP3A induction [see Clinical Pharmacology (12.3) in full Prescribing Information].

USE IN SPECIFIC POPULATIONS Pregnancy: Pregnancy Category D [see Warnings and Precautions].

Risk Summary: Based on findings in animals, IMBRUVICA can cause fetal harm when administered to a pregnant woman. If IMBRUVICA is used during pregnancy or if the patient becomes pregnant while taking IMBRUVICA, the patient should be apprised of the potential hazard to the fetus.

Animal Data: Ibrutinib was administered orally to pregnant rats during the period of organogenesis at oral doses of 10, 40 and 80 mg/kg/day. Ibrutinib at a dose of 80 mg/kg/day was associated with visceral malformations (heart and major vessels) and increased post-implantation loss. The dose of 80 mg/kg/day in animals is approximately 14 times the exposure (AUC) in patients with MCL and 20 times the exposure in patients with CLL administered the dose of 560 mg daily and 420 mg daily, respectively. Ibrutinib at doses of 40 mg/kg/day or greater was associated with decreased fetal weights. The dose of 40 mg/kg/day in animals is approximately 6 times the exposure (AUC) in patients with MCL administered the dose of 560 mg daily.

Nursing Mothers: It is not known whether ibrutinib is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from IMBRUVICA, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use: The safety and effectiveness of IMBRUVICA in pediatric patients has not been established.

Geriatric Use: Of the 111 patients treated for MCL, 63% were 65 years of age or older. No overall differences in effectiveness were observed between these patients and younger patients. Cardiac adverse events (atrial fibrillation and hypertension), infections (pneumonia and cellulitis) and gastrointestinal events (diarrhea and dehydration) occurred more frequently among elderly patients.

Of the 391 patients randomized in Study 2, 61% were ≥ 65 years of age. No overall differences in effectiveness were observed between age groups.

Grade 3 or higher adverse events occurred more frequently among elderly patients treated with IMBRUVICA (61% of patients age ≥ 65 versus 51% of younger patients) [see Clinical Studies (14.2) in full Prescribing Information].

IMBRUVICA® (ibrutinib) capsules Renal Impairment: Less than 1% of ibrutinib is excreted renally. Ibrutinib exposure is not altered in patients with Creatinine clearance (CLcr) > 25 mL/min. There are no data in patients with severe renal impairment (CLcr < 25 mL/min) or patients on dialysis [see Clinical Pharmacology (12.3) in full Prescribing Information].

Hepatic Impairment: Ibrutinib is metabolized in the liver and significant increases in exposure of ibrutinib are expected in patients with hepatic impairment. Patients with serum aspartate transaminase (AST/SGOT) or alanine transaminase (ALT/SGPT) ≥ 3.0 x upper limit of normal (ULN) were excluded from IMBRUVICA clinical trials. There is insufficient data to recommend a dose of IMBRUVICA in patients with baseline hepatic impairment [see Clinical Pharmacology (12.3) in full Prescribing Information].

Females and Males of Reproductive Potential: Advise women to avoid becoming pregnant while taking IMBRUVICA because IMBRUVICA can cause fetal harm [see Use in Specific Populations].

PATIENT COUNSELING INFORMATION See FDA-approved patient labeling (Patient Information) • Hemorrhage: Inform patients of the possibility of bleeding, and to report any signs or symptoms (blood in stools or urine, prolonged or uncontrolled bleeding).

Inform the patient that IMBRUVICA may need to be interrupted for medical or dental procedures [see Warnings and Precautions].

• Infections: Inform patients of the possibility of serious infection, and to report any signs or symptoms (fever, chills) suggestive of infection [see Warnings and Precautions].

• Atrial Fibrillation: Counsel patients to report any signs of palpitations, lightheadedness, dizziness, fainting, shortness of breath, and chest discomfort [see Warnings and Precautions].

• Second primary malignancies: Inform patients that other malignancies have occurred in patients who have been treated with IMBRUVICA, including skin cancers and other carcinomas [see Warnings and Precautions].

• Embryo-fetal toxicity: Advise women of the potential hazard to a fetus and to avoid becoming pregnant [see Warnings and Precautions].

• Inform patients to take IMBRUVICA orally once daily according to their physician’s instructions and that the capsules should be swallowed whole with a glass of water without being opened, broken, or chewed at approximately the same time each day [see Dosage and Administration (2.1) in full Prescribing Information].

• Advise patients that in the event of a missed daily dose of IMBRUVICA, it should be taken as soon as possible on the same day with a return to the normal schedule the following day. Patients should not take extra capsules to make up the missed dose [see Dosage and Administration (2.5) in full Prescribing Information].

• Advise patients of the common side effects associated with IMBRUVICA [see Adverse Reactions]. Direct the patient to a complete list of adverse drug reactions in PATIENT INFORMATION. • Advise patients to inform their health care providers of all concomitant medications, including prescription medicines, over-the-counter drugs, vitamins, and herbal products [see Drug Interactions].

• Advise patients that they may experience loose stools or diarrhea, and should contact their doctor if their diarrhea persists. Advise patients to maintain adequate hydration.

Active ingredient made in China.

Distributed and Marketed by: Pharmacyclics, Inc. Sunnyvale, CA USA 94085 and Marketed by: Janssen Biotech, Inc. Horsham, PA USA 19044 Patent http://www.imbruvica.com IMBRUVICA® is a registered trademark owned by Pharmacyclics, Inc. © Pharmacyclics, Inc. 2014 © Janssen Biotech, Inc. 2014 PRC-00524 07/14

Introduction

Welcome to the Inaugural Patient Support Services Guide

By Dawn Holcombe, MBA, FACMPE, ACHE; President, DGH Consulting, South Windsor, CT; Editor-in-Chief, Oncology Practice Management

T

he world for oncology patients and those who care for them is changing rapidly. Research and technology are offering an increasing potential to identify and treat cancer, bringing the promise and hope that this devastating disease can be reduced to a manageable chronic condition. New treatments, clinical trials, and dedicated care management teams are more accessible to a cancer patient. Resources and support have proliferated.

At the same time, however, patient financial stability and access to these advances in cancer treatment have been challenged. Insurance program changes, narrowing care and benefit structures, increasing financial obligations, and the impact of a cancer diagnosis on a patient’s personal financial situation have put many patients at risk of not being able to receive or complete the care or treatment indicated for their disease. Those who care for patients, including private practices, hospital-based cancer centers, and even specialty pharmacy entities, have

cancer treatment can be detrimental to their care and recovery.

Many resources have been created to help patients deal with these challenges. Some of these resources may be well known even to those in the general public not dealing with a cancer diagnosis. Others can be found by searching the Internet or visiting a local library. Practices and pharmacies have multiple files on different resources, which may be cataloged by disease or individual cancer treatment. But it takes time and effort to sift through all those different sources, at a time when rapid access to assistance may be essential.

This publication is intended for the use of practice managers; nurse and patient navigators; financial advocates, nurses, and physicians, and their staffs; cancer centers; and even the many patient assistance entities who work with those dealing with a cancer diagnosis. It will provide easy access to many of the resources now available.

In this guide, you will find information on tools to help you connect

Dawn Holcombe, MBA, FACMPE, ACHE

financial or treatment assistance programs. No patient facing cancer should miss any available opportunity for assistance or support, and we hope that this will speed the review process.

Oncology care teams should also find this guide to be a useful compilation of financial support programs as well as access to information on the growing disease support community. This will be a useful addition to the cancer center’s library, as well as that of clinical and business offices. It is intended to be an annual guide; please share with us your suggestions and feedback to incorporate in future installments.

The cancer community is united in battling this insidious disease, and we greatly appreciate the opportunity to offer a bridge between those who need support and assistance and those who have invested in building the resources and programs to bring a wide variety of help to those dealing with cancer. We hope you enjoy reading it, and that it serves as a resource for you and the patients you serve. l

The stress on patients as they work through both the cancer itself and the process of obtaining cancer treatment can be detrimental to their care and recovery. increased staff and facility resources to help patients navigate through the challenges and barriers that may arise before their treatment can proceed.

The additional stress on patients as they work through both the cancer itself and the process of obtaining

patients with the support services available to them, whether offered through pharmaceutical companies, government organizations, nonprofit foundations, or somewhere in be­­ tween. You will find information on eligibility and enrollment in myriad

December 2014

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www.OncPracticeManagement.com

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Table of Contents

December 2014 • Volume 4, Number 9 • Special Issue

PUBLISHING STAFF Senior Vice President/Group Publisher Nicholas Englezos nenglezos@the-lynx-group.com Vice President/Group Publisher Russell Hennessy rhennessy@the-lynx-group.com Publisher Cristopher Pires cpires@the-lynx-group.com Vice President/Director of Sales & Marketing Joe Chanley jchanley@the-lynx-group.com Director, Client Services Zach Ceretelle zceretelle@the-lynx-group.com Editorial Directors Dalia Buffery dbuffery@the-lynx-group.com Anne Cooper acooper@the-lynx-group.com Associate Editor Lara J. Lorton Copyeditor Jessica Cheng Editorial Assistant Cara Guglielmon Production Manager Cara Nicolini The Lynx Group President/CEO Brian Tyburski Chief Operating Officer Pam Rattananont Ferris Vice President of Finance Andrea Kelly Human Resources Jennine Leale Associate Director, Content Strategy & Development John Welz Director, Quality Control Barbara Marino Quality Control Assistant Theresa Salerno Director, Production & Manufacturing Alaina Pede Director, Creative & Design Robyn Jacobs Creative & Design Assistant Lora LaRocca Director, Digital Media Anthony Romano Jr Digital Media Specialist Charles Easton IV Web Content Manager Anthony Trevean Digital Programmer Michael Amundsen Meeting & Events Planner Linda Sangenito Senior Project Managers Alyson Bruni Jini Gopalaswamy Project Manager Deanna Martinez Project Coordinator Mike Kodada IT Manager Kashif Javaid Administrative Services Team Leader Rachael Baranoski Office Coordinator Robert Sorensen Engage Healthcare Communications 1249 South River Road - Ste 202A Cranbury, NJ 08512 phone: 732-992-1880 fax: 732-992-1881

8

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Oncology Practice Management ™

FOR ONCOLOGISTS, PRACTICE MANAGERS, FINANCIAL COUNSELORS, AND REIMBURSEMENT SPECIALISTS™

Welcome to the Inaugural Patient Support Services Guide............7 Index by Drug......................................................................................... 11 Index by Company............................................................................... 12 Directory of Foundations, Nonprofit Organizations, Manufacturers, and Government Programs.................................... 18 Benefits of Patient Support Programs ................................................ 30

FEATURED PROFILES Amgen Inc.............................................................................................. 36 Astellas Pharma US, Inc/Medivation, Inc........................................... 37 AstraZeneca........................................................................................... 38 Bayer HealthCare Pharmaceuticals Inc............................................ 39 Boehringer Ingelheim Pharmaceuticals, Inc..................................... 40 Bristol-Myers Squibb Company............................................................ 41 Celgene Corporation........................................................................... 42 Dendreon Corporation......................................................................... 44 Eisai Inc.................................................................................................... 45 Eli Lilly and Company............................................................................ 46 Genentech, Inc...................................................................................... 48 Continued on page 10

MISSION STATEMENT Oncology healthcare requires providers to focus attention on financial concerns and strategic decisions that affect the bottom line. To continue to provide the high-quality care that patients with cancer deserve, providers must master the ever-changing business of oncology. Oncology Practice Management™ offers process solutions for members of the cancer care team—medical, surgical, and radiation oncologists, as well as executives, administrators, and coders/billers—to assist them in reimbursment, staffing, electronic health records, REMS, and compliance with state and federal regulations.

POSTMASTER: Correspondence regarding subscriptions or change of address should be directed to CIRCULATION DIRECTOR, Oncology Practice Management™, 1249 South River Road, Suite 202A, Cranbury, NJ 08512. Fax: 732-992-1881. Yearly subscription rates: 1 year: $99.00 USD; 2 years: $149.00 USD; 3 years: $199.00 USD.

ONCOLOGY GUIDE TO PATIENT SUPPORT SERVICES

I December 2014

New from Bayer HealthCare and Onyx

Introducing

*

$0

Co-Pay...

Up to $4,000 per month and up to $16,000 per year per patient for privately-insured patients

A new level of financial support for privately-insured oncology patients Available through

AND

A select network of specialty pharmacy providers (SPPs)

For more information, please visit

www.REACHPatientSupport.com *Patients who are enrolled in any type of government insurance or reimbursement programs are not eligible. As a condition precedent of the co-payment support provided under this program, e.g., co-pay refunds, participating patients and pharmacies are obligated to inform insurance companies and third-party payors of any benefits they receive and the value of this program, and may not participate if this program is prohibited by or conflicts with their private insurance policy, as required by contract or otherwise. Void where prohibited by law, taxed, or restricted. Patients enrolled in Bayerâ&#x20AC;&#x2122;s Patient Assistance Program are not eligible.

Bayer and Onyx may determine eligibility, monitor participation, equitably distribute product and modify or discontinue any aspect of the REACH program at any time, including but not limited to this commercial co-pay assistance program.

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REACH is a service mark of Bayer HealthCare Pharmaceuticals Inc. Š2014 Bayer HealthCare Pharmaceuticals Inc., Whippany, NJ PP-550-US-0009

249 E. Grand Avenue, South San Francisco, CA 94080 USA

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Printed in USA

Table of Contents

December 2014 • Volume 4, Number 9 • Special Issue

Oncology Practice Management™, ISSN 2164-4403 (print), is published 8 times a year by Engage Healthcare Communications, LLC, 1249 South River Road, Suite 202A, Cranbury, NJ 08512. Copyright © 2014 by Engage Healthcare Communications, LLC. All rights reserved. Oncology Practice Management™ is a registered trademark of Engage Healthcare Communications, LLC. No part of this publication may be reproduced or transmitted in any form or by any means now or hereafter known, electronic or mechanical, including photocopy, recording, or any informational storage and retrieval system, without written permission from the publisher. Printed in the United States of America.

The ideas and opinions expressed in Oncology Practice Management™ do not necessarily reflect those of the editorial board, the editors, or the publisher.

Publication of an advertisement or other product mentioned in Oncology Practice Management ™ should not be construed as an endorsement of the product or the manufacturer’s claims. Readers are encouraged to contact the manufacturers about any features or limitations of products mentioned. Neither the editors nor the publisher assume any responsibility for any injury and/or damage to persons or property arising out of or related to any use of the material mentioned in this publication.

Oncology Practice Management ™

FOR ONCOLOGISTS, PRACTICE MANAGERS, FINANCIAL COUNSELORS, AND REIMBURSEMENT SPECIALISTS™

Continued from page 9

FEATURED PROFILES Gilead Sciences, Inc............................................................................. 50 GlaxoSmithKline...................................................................................... 52 Incyte Corporation................................................................................ 53 Janssen Biotech, Inc.............................................................................. 56 Merck & Co., Inc.................................................................................... 58 Millennium: The Takeda Oncology Company................................. 59 Novartis Pharmaceuticals Corporation............................................. 60 Onyx Pharmaceuticals, Inc.................................................................. 62 Pfizer Inc................................................................................................... 64 Pharmacyclics, Inc................................................................................ 65 Teva Pharmaceuticals, Inc.................................................................. 66

EDITORIAL ADVISORY BOARD Editor-in-Chief Dawn Holcombe, MBA, FACMPE, ACHE President DGH Consulting South Windsor, CT Carla Balch CEO, Altos Solutions, a Division of Flatiron Health, Inc New York, NY Peggy Barton, RN Practice Manager Toledo, OH Risë Marie Cleland President Oplinc, Inc Portland, OR

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Ruth Linné Lander, FACMPE Practice Administrator Columbus Oncology & Hematology Associates, Inc Columbus, OH

Robert D. Orzechowski, MBA, SPHR Chief Operating Officer Lancaster Cancer Center Lancaster, PA

Teri U. Guidi, MBA, FAAMA President and CEO Oncology Management Consulting Group Pipersville, PA

Bonnie J. Miller, RN, BSN, OCN, FAAMA Administrative Director Women’s Cancer Center Fox Chase Cancer Center Philadelphia, PA

Sheryl A. Riley, RN, OCN, CMCN Director of Clinical Services SAI Systems Shelton, CT

Mariana Lamb, MS Executive Director Medical Oncology Association of Southern California Upland, CA

Karna W. Morrow, CPC, RCC, CCS-P, PCS Senior Consultant CSI Coding Strategies, Inc Powder Springs, GA

Patrick A. Grusenmeyer, ScD, FACHE President Christiana Care Health Initiatives Newark, DE

ONCOLOGY GUIDE TO PATIENT SUPPORT SERVICES

I December 2014

Mary Pat Whaley, FACMPE, CPC Physician Advocate and Consultant www.managemypractice.com Durham, NC

Index by Drug

Index by Drug Abraxane (paclitaxel protein-bound particles for injectable suspension) (albumin-bound)..................42 Adcetris (brentuximab vedotin).......................................28 Afinitor (everolimus) ...........................................................60 Akynzeo (netupitant/palonosetran)...............................45 Alimta (pemetrexed).........................................................46 Aloxi (palonosetron HCl injection) ..................................45 Aranesp (darbepoetin alfa).............................................36 Arimidex (anastrozole).......................................................38 Aromasin (exemestane tablets).......................................64 Arranon (nelarabine).........................................................52 Arzerra (ofatumumab).......................................................52 Avastin (bevacizumab).....................................................48 Bexxar (tositumomab)........................................................52 Bosulif (bosutinib).................................................................64 Camptosar (irinotecan hydrochloride injection).....................................................64 Caprelsa (vandetanib)......................................................38 Cyramza (ramucirumab)............................................24, 46 Doxil (doxorubicin HCl liposome injection)....................56 Droxia (hydroxyurea)..........................................................41 Elitek (rasburicase)..............................................................28 Ellence (epirubicin hydrochloride injection)..................64 Eloxatin (oxaliplatin)............................................................28 Emcyt (estramustine phosphate sodium)......................64 Emend (aprepitant)...........................................................58 Emend (fosaprepitant dimeglumine).............................58 Epogen (epoetin alfa).......................................................36 Erbitux (cetuximab)............................................................41 Erivedge (vismodegib).......................................................48 Etopophos (etoposide phosphate).................................41 Exjade (deferasirox)............................................................60 Fareston (toremifene citrate)............................................28 Faslodex (fulvestrant).........................................................38 Fentora (fentanyl buccal tablet) CII...............................66 Folotyn (pralatrexate injection)........................................28 Fusilev (levoleucovorin)......................................................28 Gazyva (obinutuzumab)...................................................48 Gelclair (bioadherent oral rinse gel)...............................24 Gemzar (gemcitabine hydrochloride)...........................46 Gilotrif (afatinib)..................................................................40 Gleevec (imatinib mesylate)............................................60 Granix (tbo-filgrastim).........................................................66 Halaven (eribulin mesylate) .............................................45 Herceptin (trastuzumab)...................................................48 Hexalen (altretamine)........................................................45 Hycamtin (topotecan) capsules.....................................52 Hycamtin (topotecan hydrochloride) for injection..........................................................................52 Iclusig (ponatinib)...............................................................20 Idamycin (idarubicin hydrochloride for injection).........................................................................64 Imbruvica (ibrutinib)...........................................................65 Inlyta (axitinib).....................................................................64 Intron A (interferon alfa-2b, recombinant).....................58

Istodax (romidepsin)...........................................................42 Ixempra (ixabepilone)........................................................41 Jakafi (ruxolitinib)................................................................53 Jevtana (cabazitaxel).......................................................28 Kadcyla (ado-trastuzumab emtansine).........................48 Keytruda (pembrolizumab)..............................................58 Kyprolis (carfilzomib)...........................................................62 Leukeran (chlorambucil)...................................................52 Leukine (sargramostim)......................................................28 Lupaneta Pack (leuprolide acetate and norethindrone acetate)............................................20 Lupron Depot (leuprolide acetate for depot suspension).........................................................20 Lysodren (mitotane)...........................................................41 Marqibo (vincristine sulfate liposome injection).............................................................28 Mekinist (trametinib)...........................................................52 Mozobil (plerixafor).............................................................28 Myleran (busulfan)..............................................................52 Neulasta (pegfilgrastim)....................................................36 Neumega (oprelvekin)......................................................64 Neupogen (filgrastim)........................................................36 Nexavar (sorafenib)............................................................39 Nilandron (nilutamide).......................................................24 Noxafil (posaconazole)...............................................27, 58 Nplate (romiplostim)...........................................................36 Oncaspar (pegaspargase)...............................................28 Oncotype DX test...............................................................26 Opdivo (nivolumab)...........................................................41 Perjeta (pertuzumab).........................................................48 Pomalyst (pomalidomide)................................................42 Procrit (epoetin alfa)..........................................................56 Proleukin (aldesleukin)........................................................28 Prolia (denosumab)............................................................36 Promacta (eltrombopag).................................................52 Provenge (sipuleucel-T) ....................................................44 Revlimid (lenalidomide).....................................................42 Rituxan (rituximab)..............................................................48 Sancuso (granisetron transdermal system)....................28 Sandostatin LAR Depot (octreotide acetate for injectable suspension)..................................60 Sensipar (cinacalcet).........................................................36 Soltamox (tamoxifen citrate)............................................24 Sprycel (dasatinib)..............................................................41 Stivarga (regorafenib)........................................................39 Sutent (sunitinib malate)....................................................64 Sylatron (peginterferon alfa-2b).......................................58 Synribo (omacetaxine mepesuccinate)........................66 Tafinlar (dabrafenib)..........................................................26 Tarceva (erlotinib)...............................................................48 Tasigna (nilotinib) ...............................................................60 Taxotere (docetaxel).........................................................28 Temodar (temozolomide) capsules................................58 Temodar (temozolomide) for injection...........................27 Thalomid (thalidomide).....................................................42

December 2014

Continued on page 12

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Index by Company

Index by Drug

(Continued from page 11)

Thymoglobulin (antithymocyte globulin [rabbit]).................................................................28 Torisel (temsirolimus)............................................................64 Treanda (bendamustine HCl)...........................................66 Trisenox (arsenic trioxide)...................................................66 Tykerb (lapatinib)................................................................52 Valstar (valrubicin)..............................................................24 Vantas (histrelin) implant...................................................24 Vectibix (panitumumab)...................................................36 Velcade (bortezomib).......................................................59 Vidaza (azacitidine)...........................................................42 Votrient (pazopanib)..........................................................52 Xalkori (crizotinib)................................................................64

Xgeva (denosumab).........................................................36 Xofigo (radium Ra 223 dichloride) ..................................22 Xtandi (enzalutamide) ......................................................37 Yervoy (ipilimumab)...........................................................41 Zaltrap (ziv-aflibercept)......................................................28 Zelboraf (vemurafenib)......................................................48 Zevalin (ibritumomab tiuxetan)........................................28 Zinecard (dexrazoxane for injection)........................28, 64 Zoladex (goserelin acetate implant)..............................38 Zometa (zoledronic acid).................................................60 Zydelig (idelalisib)................................................................50 Zykadia (ceritinib)...............................................................60 Zytiga (abiraterone acetate)...........................................56

Index by Company AbbVie Inc...........................................................................20 American Breast Cancer Foundation.............................18 American Cancer Society................................................18 American Childhood Cancer Organization..................18 Amgen Inc.....................................................................20, 36 Ariad Pharmaceuticals, Inc..............................................20 Assistance Fund...................................................................18 Astellas Pharma US, Inc/Medivation, Inc..................20, 37 AstraZeneca .................................................................20, 38 Avon Foundation for Women...........................................18 Bayer HealthCare Pharmaceuticals Inc...................20, 39 BenefitsCheckUp (National Council on Aging)............29 Boehringer Ingelheim Pharmaceuticals, Inc............22, 40 Bristol-Myers Squibb Company...................................22, 41 Cancer Financial Assistance Coalition...........................19 Cancer Support Community............................................19 CancerCare........................................................................18 Celgene Corporation..................................................22, 42 Chronic Disease Fund........................................................19 Compassionate Allowances (Social Security Administration)........................................29 Covis Pharmaceuticals Inc...............................................22 DARA BioSciences Inc........................................................24 Dendreon Corporation................................................24, 44 Eisai Inc...........................................................................24, 45 Eli Lilly and Company...................................................24, 46 Endo Pharmaceuticals Inc................................................24 Extra Help (Social Security Administration)........................................29 Genentech, Inc.............................................................24, 48 Genomic Health, Inc..........................................................26 Gilead Sciences, Inc....................................................26, 50 GlaxoSmithKline.............................................................26, 52 HealthWell Foundation......................................................19 Hill-Burton Free and Reduced-Cost Healthcare (Health Resources and Services Administration).....................................................29 Incyte Corporation.......................................................26, 53

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ONCOLOGY GUIDE TO PATIENT SUPPORT SERVICES

Janssen Biotech, Inc.....................................................26, 56 Johnson & Johnson Patient Assistance Foundation, Inc.............................................................27, 56 Leukemia & Lymphoma Society......................................19 Merck & Co., Inc...........................................................27, 58 Millennium: The Takeda Oncology Company........27, 59 National Childrenâ&#x20AC;&#x2122;s Cancer Society................................19 National Foundation for Transplants................................19 National Organization for Rare Disorders.......................19 NeedyMeds.........................................................................19 Novartis Pharmaceuticals Corporation....................27, 60 Onyx Pharmaceuticals, Inc.........................................27, 62 Partnership for Prescription Assistance............................19 Patient Access Network Foundation...............................19 Patient Advocate Foundation Co-pay Relief Program .....................................................19 Patient Services, Inc ..........................................................19 Patient Travel and Lodging Program (Office of Rare Diseases, National Institutes of Health).............................................................29 Pfizer Inc..........................................................................27, 64 Pharmacyclics, Inc.......................................................28, 65 Prometheus Therapeutics & Diagnostics........................28 ProStrakan USA....................................................................28 Resources for Financial Assistance for Cancer Patients and Their Families (National Cancer Institute)................................................29 Rx Outreach.........................................................................20 RxAssist .................................................................................20 RxHope.................................................................................20 Sanofi-Aventis US.................................................................28 Seattle Genetics ................................................................28 Sigma-Tau Pharmaceuticals, Inc.....................................28 Spectrum Pharmaceuticals, Inc.......................................28 Teva Pharmaceuticals, Inc.........................................28, 66 Understanding Prescription Assistance Programs (National Council on Patient Information and Education).............................................29

I December 2014

Our goal is to help make access to ZYTIGA®(abiraterone acetate) easy.

Support for you: 4-6

Support for your patients:

Rapid investigation and assessment of patient eligibility and coverage • Prior authorization support • Information on cost support options, including updates on independent foundation funding status • Electronic enrollment through an online portal • Identification of a Specialty Pharmacy Provider (SPP) • Access to medication order information • A personally-assigned Site Coordinator Business Hours

• Explanation of benefits from a personally-assigned Care Coordinator • Referral to cost support options, including the ZytigaOne® Instant Savings Program for eligible patients • Upon request, follow-up status calls to those referred for cost support • Coordination with SPP for processing and delivery of medication • Educational materials and personalized prescription reminders, if requested

Take advantage of ZytigaOne® Support today.

1-855-ZYTIGA-1 (998-4421) Monday–Friday, 8:00 AM–8:00 PM ET

ACCESS TO ZYTIGA® SIMPLIFIED FOR YOU AND YOUR PATIENTS More information at ZYTIGAHCP.com

Please see Important Safety Information on back, and Brief Summary of Prescribing Information on adjacent pages.

Patient insurance benefit investigation is provided as a service by The Lash Group, Inc., under contract for Janssen Biotech, Inc. In this regard, The Lash Group, lnc., assists healthcare professionals in the determination of whether treatment could be covered by the applicable third-party payer based on coverage guidelines provided by the payer and patient information provided by the healthcare provider under appropriate authorization following the provider’s exclusive determination of medical necessity. This reimbursement support service has no independent value to providers apart from the product and is included within the cost of the product.

Importantly, insurance verification is the ultimate responsibility of the provider. Third-party reimbursement is affected by many factors. This document is presented for informational purposes only and is not intended to provide reimbursement or legal advice and does not promise or guarantee coverage, levels of reimbursement, payment or charge. Similarly, all CPT and HCPCS codes are supplied for informational purposes only and represent no promise or guarantee that these codes will be appropriate or that reimbursement will be made. It is not intended to increase or maximize reimbursement by any payer. Laws, regulations and policies concerning reimbursement are complex and are updated frequently. While we have made an effort to be current as of the issue date of this document the information may not be as current or comprehensive when you view it. We strongly recommend you consult with your counsel, payer organization, or reimbursement specialist for any reimbursement or billing questions. While The Lash Group, Inc., attempts to provide correct information, they and Janssen Biotech, Inc., make no representations or warranties, expressed or implied, as to the accuracy of the information. In no event shall The Lash Group, Inc., Janssen Biotech, Inc., or its employees or agents be liable for any damages resulting from or relating to the services. All providers and other users of this information agree that they accept responsibility for the use of this service. © Janssen Biotech, Inc. 2014 11/14 006076-141015

INDICATION and IMPORTANT SAFETY INFORMATION about ZYTIGA® (abiraterone acetate) INDICATION ZYTIGA® (abiraterone acetate) in combination with prednisone is indicated for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC).

IMPORTANT SAFETY INFORMATION

003307-130924

Contraindications ZYTIGA® (abiraterone acetate) is not indicated for use in women. ZYTIGA® can cause fetal harm (Pregnancy Category X) when administered to a pregnant woman and is contraindicated in women who are or may become pregnant.

Hypertension, Hypokalemia and Fluid Retention Due to Mineralocorticoid Excess Use with caution in patients with a history of cardiovascular disease or with medical conditions that might be compromised by increases in blood pressure, hypokalemia, or fluid retention. ZYTIGA® may cause hypertension, hypokalemia, and fluid retention as a consequence of increased mineralocorticoid levels resulting from CYP17 inhibition. Safety has not been established in patients with LVEF <50% or New York Heart Association (NYHA) Class III or IV heart failure (in Study 1) or NYHA Class II to IV heart failure (in Study 2) because these patients were excluded from these randomized clinical trials. Control hypertension and correct hypokalemia before and during treatment. Monitor blood pressure, serum potassium, and symptoms of fluid retention at least monthly.

Adrenocortical Insufficiency (AI) AI was reported in patients receiving ZYTIGA® in combination with prednisone, after an interruption of daily steroids and/or with concurrent infection or stress. Use caution and monitor for symptoms and signs of AI if prednisone is stopped or withdrawn, if prednisone dose is reduced, or if the patient experiences unusual stress. Symptoms and signs of AI may be masked by adverse reactions associated with mineralocorticoid excess seen in patients treated with ZYTIGA®. Perform appropriate tests, if indicated, to confirm AI. Increased dosages of corticosteroids may be used before, during, and after stressful situations.

Hepatotoxicity Monitor liver function and modify, withhold, or discontinue ZYTIGA® dosing as recommended (see Prescribing Information for more information). Measure serum transaminases [alanine aminotransferase (ALT) and aspartate aminotransferase (AST)] and bilirubin levels prior to starting treatment with ZYTIGA®, every two weeks for the first three months of treatment, and monthly thereafter. Promptly measure serum total bilirubin, AST, and ALT if clinical symptoms or signs suggestive of hepatotoxicity develop. Elevations of AST, ALT, or bilirubin from the patient’s baseline should prompt more frequent monitoring. If at any time AST or ALT rise above five times the upper limit of normal (ULN) or the bilirubin rises above three times the ULN, interrupt ZYTIGA® treatment and closely monitor liver function.

Increased ZYTIGA® Exposures with Food ZYTIGA® must be taken on an empty stomach. No food should be eaten for at least two hours before the dose of ZYTIGA® is taken and for at least one hour after the dose of ZYTIGA® is taken. Abiraterone Cmax and AUC0-∞ (exposure) were increased up to 17- and 10- fold higher, respectively, when a single dose of abiraterone acetate was administered with a meal compared to a fasted state.

Adverse Reactions The most common adverse reactions (≥10%) are fatigue, joint swelling or discomfort, edema, hot flush, diarrhea, vomiting, cough, hypertension, dyspnea, urinary tract infection and contusion.

The most common laboratory abnormalities (>20%) are anemia, elevated alkaline phosphatase, hypertriglyceridemia, lymphopenia, hypercholesterolemia, hyperglycemia, elevated AST, hypophosphatemia, elevated ALT and hypokalemia.

Drug Interactions Based on in vitro data, ZYTIGA® is a substrate of CYP3A4. In a drug interaction trial, co-administration of rifampin, a strong CYP3A4 inducer, decreased exposure of abiraterone by 55%. Avoid concomitant strong CYP3A4 inducers during ZYTIGA® treatment. If a strong CYP3A4 inducer must be co-administered, increase the ZYTIGA® dosing frequency only during the co-administration period [see Dosage and Administration (2.3)]. In a dedicated drug interaction trial, co-administration of ketoconazole, a strong inhibitor of CYP3A4, had no clinically meaningful effect on the pharmacokinetics of abiraterone.

ZYTIGA® is an inhibitor of the hepatic drug-metabolizing enzyme CYP2D6. Avoid co-administration with CYP2D6 substrates with a narrow therapeutic index. If alternative treatments cannot be used, exercise caution and consider a dose reduction of the CYP2D6 substrate drug. In vitro, ZYTIGA® inhibits CYP2C8. There are no clinical data on the use of ZYTIGA® with drugs that are substrates of CYP2C8. Patients should be monitored closely for signs of toxicity related to the CYP2C8 substrate if used concomitantly with abiraterone acetate.

Use in Specific Populations Do not use ZYTIGA® in patients with baseline severe hepatic impairment (Child-Pugh Class C).

Please see Brief Summary of Prescribing Information on adjacent pages. © Janssen Biotech, Inc. 2014

11/14

006076-141015

ZYTIGA® (abiraterone acetate) Tablets

Brief Summary of Prescribing Information.

INDICATIONS AND USAGE ZYTIGA is a CYP17 inhibitor indicated in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer.

CONTRAINDICATIONS Pregnancy: ZYTIGA can cause fetal harm when administered to a pregnant woman. ZYTIGA is not indicated for use in women. ZYTIGA is contraindicated in women who are or may become pregnant. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, apprise the patient of the potential hazard to the fetus and the potential risk for pregnancy loss [see Use in Specific Populations].

WARNINGS AND PRECAUTIONS Hypertension, Hypokalemia and Fluid Retention Due to Mineralocorticoid Excess: ZYTIGA may cause hypertension, hypokalemia, and fluid retention as a consequence of increased mineralocorticoid levels resulting from CYP17 inhibition [see Clinical Pharmacology (12.1) in full Prescribing Information].

In the two randomized clinical trials, grade 3 to 4 hypertension occurred in 2% of patients, grade 3 to 4 hypokalemia in 4% of patients, and grade 3 to 4 edema in 1% of patients treated with ZYTIGA [see Adverse Reactions].

Co-administration of a corticosteroid suppresses adrenocorticotropic hormone (ACTH) drive, resulting in a reduction in the incidence and severity of these adverse reactions. Use caution when treating patients whose underlying medical conditions might be compromised by increases in blood pressure, hypokalemia or fluid retention, e.g., those with heart failure, recent myocardial infarction or ventricular arrhythmia. Use ZYTIGA with caution in patients with a history of cardiovascular disease. The safety of ZYTIGA in patients with left ventricular ejection fraction <50% or New York Heart Association (NYHA) Class III or IV heart failure (in Study 1) or NYHA Class II to IV heart failure (in Study 2) was not established because these patients were excluded from these randomized clinical trials [see Clinical Studies (14) in full Prescribing Information]. Monitor patients for hypertension, hypokalemia, and fluid retention at least once a month. Control hypertension and correct hypokalemia before and during treatment with ZYTIGA. Adrenocortical Insufficiency: Adrenal insufficiency occurred in the two randomized clinical studies in 0.5% of patients taking ZYTIGA and in 0.2% of patients taking placebo. Adrenocortical insufficiency was reported in patients receiving ZYTIGA in combination with prednisone, following interruption of daily steroids and/or with concurrent infection or stress. Use caution and monitor for symptoms and signs of adrenocortical insufficiency, particularly if patients are withdrawn from prednisone, have prednisone dose reductions, or experience unusual stress. Symptoms and signs of adrenocortical insufficiency may be masked by adverse reactions associated with mineralocorticoid excess seen in patients treated with ZYTIGA. If clinically indicated, perform appropriate tests to confirm the diagnosis of adrenocortical insufficiency. Increased dosage of corticosteroids may be indicated before, during and after stressful situations [see Warnings and Precautions].

Hepatotoxicity: In the two randomized clinical trials, grade 3 or 4 ALT or AST increases (at least 5X ULN) were reported in 4% of patients who received ZYTIGA, typically during the first 3 months after starting treatment. Patients whose baseline ALT or AST were elevated were more likely to experience liver test elevation than those beginning with normal values. Treatment discontinuation due to liver enzyme increases occurred in 1% of patients taking ZYTIGA. No deaths clearly related to ZYTIGA were reported due to hepatotoxicity events.

Measure serum transaminases (ALT and AST) and bilirubin levels prior to starting treatment with ZYTIGA, every two weeks for the first three months of treatment and monthly thereafter. In patients with baseline moderate hepatic impairment receiving a reduced ZYTIGA dose of 250 mg, measure ALT, AST, and bilirubin prior to the start of treatment, every week for the first month, every two weeks for the following two months of treatment and monthly thereafter. Promptly measure serum total bilirubin, AST, and ALT if clinical symptoms or signs suggestive of hepatotoxicity develop.

Elevations of AST, ALT, or bilirubin from the patient’s baseline should prompt more frequent monitoring. If at any time AST or ALT rise above five times the ULN, or the bilirubin rises above three times the ULN, interrupt ZYTIGA treatment and closely monitor liver function.

Re-treatment with ZYTIGA at a reduced dose level may take place only after return of liver function tests to the patient’s baseline or to AST and ALT less than or equal to 2.5X ULN and total bilirubin less than or equal to 1.5X ULN [see Dosage and Administration (2.2) in full Prescribing Information].

The safety of ZYTIGA re-treatment of patients who develop AST or ALT greater than or equal to 20X ULN and/or bilirubin greater than or equal to 10X ULN is unknown.

Increased ZYTIGA Exposures with Food: ZYTIGA must be taken on an empty stomach. No food should be consumed for at least two hours before the dose of ZYTIGA is taken and for at least one hour after the dose of ZYTIGA is taken. Abiraterone Cmax and AUC0-∞ (exposure) were increased up to 17and 10-fold higher, respectively, when a single dose of abiraterone acetate was administered with a meal compared to a fasted state. The safety of these increased exposures when multiple doses of abiraterone acetate are taken with food has not been assessed [see Dosage and Administration (2.1) and Clinical Pharmacology (12.3) in full Prescribing Information].

ZYTIGA® (abiraterone acetate) Tablets ADVERSE REACTIONS The following are discussed in more detail in other sections of the labeling: • Hypertension, Hypokalemia, and Fluid Retention due to Mineralocorticoid Excess [see Warnings and Precautions].

• Adrenocortical Insufficiency [see Warnings and Precautions].

• Hepatotoxicity [see Warnings and Precautions].

• Increased ZYTIGA Exposures with Food [see Warnings and Precautions].

Clinical Trial Experience: Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

Two randomized placebo-controlled, multicenter clinical trials enrolled patients who had metastatic castration-resistant prostate cancer who were using a gonadotropin-releasing hormone (GnRH) agonist or were previously treated with orchiectomy. In both Study 1 and Study 2 ZYTIGA was administered at a dose of 1,000 mg daily in combination with prednisone 5 mg twice daily in the active treatment arms. Placebo plus prednisone 5 mg twice daily was given to control patients.

The most common adverse drug reactions (≥10%) reported in the two randomized clinical trials that occurred more commonly (>2%) in the abiraterone acetate arm were fatigue, joint swelling or discomfort, edema, hot flush, diarrhea, vomiting, cough, hypertension, dyspnea, urinary tract infection and contusion.

The most common laboratory abnormalities (>20%) reported in the two randomized clinical trials that occurred more commonly (≥2%) in the abiraterone acetate arm were anemia, elevated alkaline phosphatase, hypertriglyceridemia, lymphopenia, hypercholesterolemia, hyperglycemia, elevated AST, hypophosphatemia, elevated ALT and hypokalemia.

Study 1: Metastatic CRPC Following Chemotherapy: Study 1 enrolled 1195 patients with metastatic CRPC who had received prior docetaxel chemotherapy. Patients were not eligible if AST and/or ALT ≥2.5X ULN in the absence of liver metastases. Patients with liver metastases were excluded if AST and/or ALT >5X ULN. Table 1 shows adverse reactions on the ZYTIGA arm in Study 1 that occurred with a ≥2% absolute increase in frequency compared to placebo or were events of special interest. The median duration of treatment with ZYTIGA was 8 months.

Table 1: Adverse Reactions due to ZYTIGA in Study 1 ZYTIGA with Placebo with Prednisone (N=791) Prednisone (N=394) System/Organ Class All Grades1 Grade 3-4 All Grades Grade 3-4 Adverse reaction % % % % Musculoskeletal and connective tissue disorders Joint swelling/ discomfort2 29.5 4.2 23.4 4.1 Muscle discomfort3 26.2 3.0 23.1 2.3 General disorders Edema4 26.7 1.9 18.3 0.8 Vascular disorders Hot flush 19.0 0.3 16.8 0.3 Hypertension 8.5 1.3 6.9 0.3 Gastrointestinal disorders Diarrhea 17.6 0.6 13.5 1.3 Dyspepsia 6.1 0 3.3 0 Infections and infestations Urinary tract infection 11.5 2.1 7.1 0.5 Upper respiratory tract infection 5.4 0 2.5 0 Respiratory, thoracic and mediastinal disorders Cough 10.6 0 7.6 0 Renal and urinary disorders Urinary frequency 7.2 0.3 5.1 0.3 Nocturia 6.2 0 4.1 0 Injury, poisoning and procedural complications Fractures5 5.9 1.4 2.3 0 Cardiac disorders Arrhythmia6 7.2 1.1 4.6 1.0 Chest pain or chest discomfort7 3.8 0.5 2.8 0 Cardiac failure8 2.3 1.9 1.0 0.3

ZYTIGA® (abiraterone acetate) Tablets

ZYTIGA® (abiraterone acetate) Tablets

1 Adverse events graded according to CTCAE version 3.0 2 Includes terms Arthritis, Arthralgia, Joint swelling, and Joint stiffness 3 Includes terms Muscle spasms, Musculoskeletal pain, Myalgia,

Table 3: Adverse Reactions in ≥5% of Patients on the ZYTIGA Arm in Study 2 (continued) ZYTIGA with Placebo with Prednisone (N=542) Prednisone (N=540) 1 System/Organ Class All Grades Grade 3-4 All Grades Grade 3-4 Adverse reaction % % % % Renal and urinary disorders Hematuria 10.3 1.3 5.6 0.6 Skin and subcutaneous tissue disorders Rash 8.1 0.0 3.7 0.0 1 Adverse events graded according to CTCAE version 3.0 2 Includes terms Edema peripheral, Pitting edema, and Generalized edema 3 Includes terms Arthritis, Arthralgia, Joint swelling, and Joint stiffness

Musculoskeletal discomfort, and Musculoskeletal stiffness terms Edema, Edema peripheral, Pitting edema, and Generalized edema 5 Includes all fractures with the exception of pathological fracture 6 Includes terms Arrhythmia, Tachycardia, Atrial fibrillation, Supraventricular tachycardia, Atrial tachycardia, Ventricular tachycardia, Atrial flutter, Bradycardia, Atrioventricular block complete, Conduction disorder, and Bradyarrhythmia 7 Includes terms Angina pectoris, Chest pain, and Angina unstable.

Myocardial infarction or ischemia occurred more commonly in the placebo arm than in the ZYTIGA arm (1.3% vs. 1.1% respectively).

8 Includes terms Cardiac failure, Cardiac failure congestive, Left ventricular dysfunction, Cardiogenic shock, Cardiomegaly, Cardiomyopathy, and Ejection fraction decreased 4 Includes

Table 2 shows laboratory abnormalities of interest from Study 1. Grade 3-4 low serum phosphorus (7%) and low potassium (5%) occurred at a greater than or equal to 5% rate in the ZYTIGA arm.

Table 2: Laboratory Abnormalities of Interest in Study 1 Abiraterone (N=791) Placebo (N=394) Laboratory All Grades Grade 3-4 All Grades Grade 3-4 Abnormality (%) (%) (%) (%) Hypertriglyceridemia 62.5 0.4 53.0 0 High AST 30.6 2.1 36.3 1.5 Hypokalemia 28.3 5.3 19.8 1.0 Hypophosphatemia 23.8 7.2 15.7 5.8 High ALT 11.1 1.4 10.4 0.8 High Total Bilirubin 6.6 0.1 4.6 0 Study 2: Metastatic CRPC Prior to Chemotherapy: Study 2 enrolled 1088 patients with metastatic CRPC who had not received prior cytotoxic chemotherapy. Patients were ineligible if AST and/or ALT ≥2.5X ULN and patients were excluded if they had liver metastases.

Table 3 shows adverse reactions on the ZYTIGA arm in Study 2 that occurred with a ≥2% absolute increase in frequency compared to placebo.

The median duration of treatment with ZYTIGA was 13.8 months.

Table 3: Adverse Reactions in ≥5% of Patients on the ZYTIGA Arm in Study 2 ZYTIGA with Placebo with Prednisone (N=542) Prednisone (N=540) System/Organ Class All Grades1 Grade 3-4 All Grades Grade 3-4 Adverse reaction % % % % General disorders Fatigue 39.1 2.2 34.3 1.7 Edema2 25.1 0.4 20.7 1.1 Pyrexia 8.7 0.6 5.9 0.2 Musculoskeletal and connective tissue disorders Joint swelling/ discomfort3 30.3 2.0 25.2 2.0 Groin pain 6.6 0.4 4.1 0.7 Gastrointestinal disorders Constipation 23.1 0.4 19.1 0.6 Diarrhea 21.6 0.9 17.8 0.9 Dyspepsia 11.1 0.0 5.0 0.2 Vascular disorders Hot flush 22.3 0.2 18.1 0.0 Hypertension 21.6 3.9 13.1 3.0 Respiratory, thoracic and mediastinal disorders Cough 17.3 0.0 13.5 0.2 Dyspnea 11.8 2.4 9.6 0.9 Psychiatric disorders Insomnia 13.5 0.2 11.3 0.0 Injury, poisoning and procedural complications Contusion 13.3 0.0 9.1 0.0 Falls 5.9 0.0 3.3 0.0 Infections and infestations Upper respiratory tract infection 12.7 0.0 8.0 0.0 Nasopharyngitis 10.7 0.0 8.1 0.0

Table 4 shows laboratory abnormalities that occurred in greater than 15% of patients, and more frequently (>5%) in the ZYTIGA arm compared to placebo in Study 2. Grade 3-4 lymphopenia (9%), hyperglycemia (7%) and high alanine aminotransferase (6%) occurred at a greater than 5% rate in the ZYTIGA arm.

Table 4: Laboratory Abnormalities in >15% of Patients in the ZYTIGA Arm of Study 2 Abiraterone (N=542) Placebo (N=540) Laboratory Grade 1-4 Grade 3-4 Grade 1-4 Grade 3-4 Abnormality % % % % Hematology Lymphopenia 38.2 8.7 31.7 7.4 Chemistry Hyperglycemia1 56.6 6.5 50.9 5.2 High ALT 41.9 6.1 29.1 0.7 High AST 37.3 3.1 28.7 1.1 Hypernatremia 32.8 0.4 25.0 0.2 Hypokalemia 17.2 2.8 10.2 1.7 1Based on non-fasting blood draws Cardiovascular Adverse Reactions: In the combined data for studies 1 and 2, cardiac failure occurred more commonly in patients treated with ZYTIGA compared to patients on the placebo arm (2.1% versus 0.7%).

Grade 3-4 cardiac failure occurred in 1.6% of patients taking ZYTIGA and led to 5 treatment discontinuations and 2 deaths. Grade 3-4 cardiac failure occurred in 0.2% of patients taking placebo. There were no treatment discontinuations and one death due to cardiac failure in the placebo group.

In Study 1 and 2, the majority of arrhythmias were grade 1 or 2. There was one death associated with arrhythmia and one patient with sudden death in the ZYTIGA arms and no deaths in the placebo arms. There were 7 (0.5%) deaths due to cardiorespiratory arrest in the ZYTIGA arms and 3 (0.3%) deaths in the placebo arms. Myocardial ischemia or myocardial infarction led to death in 3 patients in the placebo arms and 2 deaths in the ZYTIGA arms.

Post Marketing Experience The following additional adverse reactions have been identified during post approval use of ZYTIGA. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Respiratory, Thoracic and Mediastinal Disorders: non-infectious pneumonitis.

DRUG INTERACTIONS Drugs that Inhibit or Induce CYP3A4 Enzymes: Based on in vitro data, ZYTIGA is a substrate of CYP3A4.

In a dedicated drug interaction trial, co-administration of rifampin, a strong CYP3A4 inducer, decreased exposure of abiraterone by 55%. Avoid concomitant strong CYP3A4 inducers during ZYTIGA treatment. If a strong CYP3A4 inducer must be co-administered, increase the ZYTIGA dosing frequency [see Dosage and Administration (2.3) and Clinical Pharmacology (12.3) in full Prescribing Information].

In a dedicated drug interaction trial, co-administration of ketoconazole, a strong inhibitor of CYP3A4, had no clinically meaningful effect on the pharmacokinetics of abiraterone [see Clinical Pharmacology (12.3) in full Prescribing Information].

Effects of Abiraterone on Drug Metabolizing Enzymes: ZYTIGA is an inhibitor of the hepatic drug-metabolizing enzyme CYP2D6. In a CYP2D6 drug-drug interaction trial, the Cmax and AUC of dextromethorphan (CYP2D6 substrate) were increased 2.8- and 2.9-fold, respectively, when

ZYTIGA® (abiraterone acetate) Tablets

ZYTIGA® (abiraterone acetate) Tablets

dextromethorphan was given with abiraterone acetate 1,000 mg daily and prednisone 5 mg twice daily. Avoid co-administration of abiraterone acetate with substrates of CYP2D6 with a narrow therapeutic index (e.g., thioridazine).

If alternative treatments cannot be used, exercise caution and consider a dose reduction of the concomitant CYP2D6 substrate drug [see Clinical Pharmacology (12.3) in full Prescribing Information].

In vitro, ZYTIGA inhibits CYP2C8. There are no clinical data on the use of ZYTIGA with drugs that are substrates of CYP2C8. However, patients should be monitored closely for signs of toxicity related to the CYP2C8 substrate if used concomitantly with abiraterone acetate.

Patients with Renal Impairment: In a dedicated renal impairment trial, the mean PK parameters were comparable between healthy subjects with normal renal function (N=8) and those with end stage renal disease (ESRD) on hemodialysis (N=8) after a single oral 1,000 mg dose of ZYTIGA. No dosage adjustment is necessary for patients with renal impairment [see Dosage and Administration (2.1) and Clinical Pharmacology (12.3) in full Prescribing Information].

OVERDOSAGE Human experience of overdose with ZYTIGA is limited.

There is no specific antidote. In the event of an overdose, stop ZYTIGA, undertake general supportive measures, including monitoring for arrhythmias and cardiac failure and assess liver function.

Storage and Handling: Store at 20°C to 25°C (68°F to 77°F); excursions permitted in the range from 15°C to 30°C (59°F to 86°F) [see USP controlled room temperature].

Based on its mechanism of action, ZYTIGA may harm a developing fetus.

Therefore, women who are pregnant or women who may be pregnant should not handle ZYTIGA without protection, e.g., gloves [see Use in Specific Populations].

PATIENT COUNSELING INFORMATION See FDA-approved patient labeling (Patient Information) • Patients should be informed that ZYTIGA and prednisone are used together and that they should not interrupt or stop either of these medications without consulting their physician.

• Patients receiving GnRH agonists should be informed that they need to maintain this treatment during the course of treatment with ZYTIGA and prednisone.

• Patients should be informed that ZYTIGA must not be taken with food and that no food should be consumed for at least two hours before the dose of ZYTIGA is taken and for at least one hour after the dose of ZYTIGA is taken. They should be informed that the tablets should be swallowed whole with water without crushing or chewing. Patients should be informed that taking ZYTIGA with food causes increased exposure and this may result in adverse reactions.

• Patients should be informed that ZYTIGA is taken once daily and prednisone is taken twice daily according to their physician’s instructions.

• Patients should be informed that in the event of a missed daily dose of ZYTIGA or prednisone, they should take their normal dose the following day. If more than one daily dose is skipped, patients should be told to inform their physician.

• Patients should be apprised of the common side effects associated with ZYTIGA, including peripheral edema, hypokalemia, hypertension, elevated liver function tests, and urinary tract infection. Direct the patient to a complete list of adverse drug reactions in PATIENT INFORMATION. • Patients should be advised that their liver function will be monitored using blood tests.

• Patients should be informed that ZYTIGA may harm a developing fetus; thus, women who are pregnant or women who may be pregnant should not handle ZYTIGA without protection, e.g., gloves. Patients should also be informed that it is not known whether abiraterone or its metabolites are present in semen and they should use a condom if having sex with a pregnant woman. The patient should use a condom and another effective method of birth control if he is having sex with a woman of child-bearing potential. These measures are required during and for one week after treatment with ZYTIGA.

USE IN SPECIFIC POPULATIONS Pregnancy: Pregnancy Category X [see Contraindications].: ZYTIGA can cause fetal harm when administered to a pregnant woman based on its mechanism of action and findings in animals. While there are no adequate and well-controlled studies with ZYTIGA in pregnant women and ZYTIGA is not indicated for use in women, it is important to know that maternal use of a CYP17 inhibitor could affect development of the fetus. Abiraterone acetate caused developmental toxicity in pregnant rats at exposures that were lower than in patients receiving the recommended dose. ZYTIGA is contraindicated in women who are or may become pregnant while receiving the drug. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, apprise the patient of the potential hazard to the fetus and the potential risk for pregnancy loss. Advise females of reproductive potential to avoid becoming pregnant during treatment with ZYTIGA. In an embryo-fetal developmental toxicity study in rats, abiraterone acetate caused developmental toxicity when administered at oral doses of 10, 30 or 100 mg/kg/day throughout the period of organogenesis (gestational days 6-17). Findings included embryo-fetal lethality (increased post implantation loss and resorptions and decreased number of live fetuses), fetal developmental delay (skeletal effects) and urogenital effects (bilateral ureter dilation) at doses ≥10 mg/kg/day, decreased fetal ano-genital distance at ≥30 mg/kg/day, and decreased fetal body weight at 100 mg/kg/day. Doses ≥10 mg/kg/day caused maternal toxicity. The doses tested in rats resulted in systemic exposures (AUC) approximately 0.03, 0.1 and 0.3 times, respectively, the AUC in patients.

Nursing Mothers: ZYTIGA is not indicated for use in women. It is not known if abiraterone acetate is excreted in human milk. Because many drugs are excreted in human milk, and because of the potential for serious adverse reactions in nursing infants from ZYTIGA, a decision should be made to either discontinue nursing, or discontinue the drug taking into account the importance of the drug to the mother.

Pediatric Use: Safety and effectiveness of ZYTIGA in pediatric patients have not been established.

Geriatric Use: Of the total number of patients receiving ZYTIGA in phase 3 trials, 73% of patients were 65 years and over and 30% were 75 years and over. No overall differences in safety or effectiveness were observed between these elderly patients and younger patients. Other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

Patients with Hepatic Impairment: The pharmacokinetics of abiraterone were examined in subjects with baseline mild (n=8) or moderate (n=8) hepatic impairment (Child-Pugh Class A and B, respectively) and in 8 healthy control subjects with normal hepatic function. The systemic exposure (AUC) of abiraterone after a single oral 1,000 mg dose of ZYTIGA increased by approximately 1.1-fold and 3.6-fold in subjects with mild and moderate baseline hepatic impairment, respectively compared to subjects with normal hepatic function.

In another trial, the pharmacokinetics of abiraterone were examined in subjects with baseline severe (n=8) hepatic impairment (Child-Pugh Class C) and in 8 healthy control subjects with normal hepatic function. The systemic exposure (AUC) of abiraterone increased by approximately 7-fold and the fraction of free drug increased 2-fold in subjects with severe baseline hepatic impairment compared to subjects with normal hepatic function.

No dosage adjustment is necessary for patients with baseline mild hepatic impairment. In patients with baseline moderate hepatic impairment (ChildPugh Class B), reduce the recommended dose of ZYTIGA to 250 mg once daily. Do not use ZYTIGA in patients with baseline severe hepatic impairment (Child-Pugh Class C). If elevations in ALT or AST >5X ULN or total bilirubin >3X ULN occur in patients with baseline moderate hepatic impairment, discontinue ZYTIGA treatment [see Dosage and Administration (2.1) and Clinical Pharmacology (12.3) in full Prescribing Information].

For patients who develop hepatotoxicity during treatment, interruption of treatment and dosage adjustment may be required [see Dosage and Administration (2.2) in full Prescribing Information, Warnings and Precautions, and Clinical Pharmacology (12.3)] in full Prescribing Information.

Manufactured by: Patheon Inc. Mississauga, Canada Manufactured for: Janssen Biotech, Inc. Horsham, PA 19044 © Janssen Biotech, Inc. 2012 Revised: May 2014 015924-140528

Patient Support Services

Patient Support Services Directory of Foundations, Nonprofit Organizations, Manufacturers, and Government Programs Cancer research has significantly improved patient care, survival, and quality of life. Since the 1990s, the mortality rate has declined 21% and 12%, respectively, among men and women with cancer, and more than 13 million cancer survivors are alive in the United States today.1 A better understanding of the cancer genome has facilitated the development of new and more targeted therapeutic strategies, ushering in an era of increasing potential for personalized medicine.2 Despite these advances in cancer diagnostics and therapeutics, there is also a considerable cost associated with cancer treatment. A tremendous amount of research is required to develop breakthrough therapies and technologies in cancer, and it is expensive to perform the clinical trials required to gain approval and move new compounds from the bench to the bedside.3,4 According to Express Scripts’ 2013 Drug Trend Report, the average cost per prescription for a cancer drug was

Foundations and Nonprofit Organizations AMERICAN BREAST CANCER FOUNDATION Phone: (410) 825-9388 www.abcf.org

The American Breast Cancer Foundation provides direct financial assistance to uninsured and underserved women and men of all ages for breast cancer screening and diagnostic tests through the Key to Life Breast Cancer Assistance Program.

The program includes annual screenings and support services.

AMERICAN CANCER SOCIETY Phone: (800) 227-2345 www.cancer.org

The American Cancer Society has programs and services to help patients with cancer and their loved ones understand cancer, manage their lives through treatment and recovery, and identify resources for patients who need financial assistance.

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$4023 in 2013,5 and it is estimated that 40% of Americans of all ages,6 and two-thirds of the elderly population, report difficulty paying for medications.7 As a result, more than one-quarter of patients have not filled a prescription or have reduced a prescribed dosage because they cannot afford to pay its out-of-pocket cost.8 Furthermore, despite Medicaid program expansion and the Accountable Care Act mandate requiring eligible individuals to purchase health insurance, many adult Americans remain uninsured.9 Cost-related medication nonadherence has important implications for healthcare, and paradoxically may increase overall healthcare costs, because care for conditions that are potentially preventable with the use of effective medications could cost more than the drugs themselves.10-12 A number of options are available for patients with cancer who are in need. This directory intends to provide a broad overview of the patient support services that are available to eligible patients with cancer.

AMERICAN CHILDHOOD CANCER ORGANIZATION Phone: (855) 858-2226 www.acco.org

through the Avon Breast Health Outreach Program, links medically underserved women to breast health education and screening services.

Low-income, underinsured, and other marginalized populations often need targeted, customized approaches to help them obtain regular mammograms and clinical breast exams.

The American Childhood Cancer Organization provides programs, information, and awareness for children and adolescents with cancer and their families, to advocate for their needs, and to support research so every child survives and leads a long and healthy life.

CANCERCARE

ASSISTANCE FUND

Phone: (800) 813-4673 www.cancercarecopay.org

Phone: (855) 845-3663 www.theassistancefund.org

The Assistance Fund is a leading 501(c)(3) nonprofit organization that is established to provide ad­­ vanced biotech therapies to the underinsured population.

AVON FOUNDATION ­­ FOR WOMEN Phone: (212) 244-5368 www.avonbhop.org

The Avon Foundation for Women,

ONCOLOGY GUIDE TO PATIENT SUPPORT SERVICES

I December 2014

CancerCare is a national nonprofit organization that provides free professional support services to patients with cancer and their caregivers, children, loved ones, and the bereaved. CancerCare programs, which include counseling, education, financial assistance, and practical help, are provided by trained oncology social workers. CancerCare’s financial assistance programs provide limited financial assistance for cancer-related costs.

Patient Support Services

CANCER FINANCIAL ASSISTANCE COALITION www.cancerfac.org

The Cancer Financial Assistance Coalition (CFAC) is a group of national organizations that provide financial help to patients with cancer; CFAC provides a searchable database of financial resources available to patients in need.

CANCER SUPPORT COMMUNITY Phone: (888) 793-9355 www.cancersupportcommunity.org

The Cancer Support Community (CSC) is an international nonprofit organization that is dedicated to providing support, education, and hope to individuals affected by cancer. CSC offers a menu of personalized services and education. These support services are available through a network of professionally led, community-based centers, hospitals, community oncology practices, and online resources, so that no one has to face cancer alone.

CHRONIC DISEASE FUND Phone: (877) 968-7233 www.cdfund.org/Copay-Assistance. aspx

The Chronic Disease Fund provides assistance to underinsured patients who are diagnosed with chronic or life-altering diseases (including cancer) that require the use of expensive, specialty therapeutics.

HEALTHWELL FOUNDATION Phone: (800) 675-8416 www.healthwellfoundation.org

The HealthWell Foundation is an independent, nonprofit organization that provides financial assistance to eligible individuals to cover coinsurance, copayments, healthcare premiums, and deductibles for certain medications and therapies.

LEUKEMIA & LYMPHOMA SOCIETY Phone: (800) 955-4572 www.lls.org/copay

The Leukemia & Lymphoma Society’s patient financial aid program provides limited financial assistance to patients diagnosed with a blood cancer (eg, leukemia, lymphoma, or multiple myeloma) and with significant financial needs to help defray treatment-related expenses.

is an information source on companies that offer patient assistance programs. These programs help patients obtain medications at no cost or low cost through the manufacturer.

PARTNERSHIP FOR PRESCRIPTION ASSISTANCE Phone: (888) 477-2669 www.pparx.org

NATIONAL CHILDREN’S CANCER SOCIETY

The National Children’s Cancer Society seeks to improve the quality of life for children with cancer and their families by providing financial and in-kind assistance, advocacy, support services, and education.

The Partnership for Prescription Assistance helps qualifying patients without prescription drug coverage get the medication they need for free or nearly free. This organization offers access to more than 475 public and private programs, in­ cluding 200 pharmaceutical company programs.

NATIONAL FOUNDATION FOR TRANSPLANTS

PATIENT ACCESS NETWORK FOUNDATION

Phone: (800) 489-3863 www.transplants.org

Phone: (866) 316-7263 www.panfoundation.org

NATIONAL ORGANIZATION FOR RARE DISORDERS

PATIENT ADVOCATE FOUNDATION CO-PAY RELIEF PROGRAM

Phone: (203) 744-0100 www.rarediseases.org

Phone: (866) 512-3861 www.copays.org

Phone: (800) 532-6459 www.thenccs.org

The National Foundation for Transplants provides fundraising assistance for patients needing transplants, including bone marrow and stemcell transplants.

The Patient Access Network Foundation provides financial support for outof-pocket costs associated with a wide range of medications to treat a number of conditions, including cancer.

The National Organization for Rare Disorders (NORD) is a federation of voluntary health organizations that are dedicated to helping patients with rare orphan diseases and assisting the organizations that serve them. NORD is committed to the identification, treatment, and cure of rare disorders through programs of education, advocacy, research, and service.

The Patient Advocate Foundation Co-Pay Relief (PAF CPR) program currently provides direct financial support to insured patients, including Medicare Part D beneficiaries, who must financially and medically qualify to access pharmaceutical copayment assistance.

PATIENT SERVICES, INC Phone: (800) 366-7741 www.patientservices.org

NEEDYMEDS

Patient Services, Inc is a nonprofit organization dedicated to providing health insurance premium assistance, pharmacy copayment assistance, and copayment waiver assistance for patients with specific expensive chronic illnesses.

Phone: (800) 503-6897 www.needymeds.org

NeedyMeds is a 501(c)(3) nonprofit organization that helps individuals who cannot afford medications or other healthcare costs. NeedyMeds

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Patient Support Services

RX OUTREACH

AMGEN INC

Phone: (800) 769-3880 www.rxoutreach.org

Amgen Assist

Rx Outreach is a nonprofit charity that provides affordable medicines to patients who are in need. Rx Outreach offers more than 500 medications through their mail-­ order pharmacy to all 50 states, Puerto Rico, and the Virgin Islands.

RXASSIST Phone: (800) 808-1213 www.rxassist.org

Using their online Patient Assistance Program Center, RxAssist helps patients find information about free and low-cost medicine programs, as well as other ways to manage their medication costs.

RXHOPE

Phone: (888) 762-6436 www.amgenassist.com

Amgen Assist provides support options for insured, uninsured, and underinsured patients through a variety of programs.

• Aranesp (darbepoetin alfa) • Epogen (epoetin alfa) • Neulasta (pegfilgrastim) • Neupogen (filgrastim) • Nplate (romiplostim) • Prolia (denosumab) • Sensipar (cinacalcet) • Vectibix (panitumumab) • Xgeva (denosumab) Safety Net Foundation Phone: (888) 762-6436 www.safetynetfoundation.com

AbbVie Patient Assistance Foundation

The Safety Net Foundation is a nonprofit patient assistance program designed to assist patients who are uninsured, with limited ­or no financial resources. Program eligibility is based on US residen­­cy, insurance status, and income requirements.

• Aranesp (darbepoetin alfa) • Epogen (epoetin alfa) • Neulasta (pegfilgrastim) • Neupogen (filgrastim) • Nplate (romiplostim) • Prolia (denosumab) • Sensipar (cinacalcet) • Vectibix (panitumumab) • Xgeva (denosumab)

Phone: (800) 222-6885 www.abbviepaf.org

ARIAD PHARMACEUTICALS, INC

Phone: (877) 267-0517 www.rxhope.com

RxHope helps patients obtain free or low-cost prescription medications. RxHope has program descriptions and downloadable applications for prescription assistance programs for specific medications.

Manufacturer Patient Assistance Programs ABBVIE INC

The AbbVie Patient Assistance Foundation provides AbbVie medications at no cost to patients experiencing financial difficulty who may or may not have or qualify for prescription medication benefits through private insurance or government-­funded programs.

• Lupaneta Pack (leuprolide acetate and norethindrone acetate) • Lupron Depot (leuprolide acetate for depot suspension)

ARIAD PASS Phone: (855) 447-7277 www.ariadpass.com

ARIAD PASS (Patient Access and Support Services) program helps providers and patients afford treatment.

• Iclusig (ponatinib) ASTELLAS PHARMA US, INC/ MEDIVATION, INC

Xtandi Support Solutions helps providers and patients understand patients’ cost-sharing obligations and the mechanisms that are available to reduce the cost of Xtandi (enzalutamide) for eligible patients. Xtandi is indicated for metastatic castration-­ resistant prostate cancer.

• Xtandi (enzalutamide) Astellas Access Program Phone: (855) 982-6341 www.astellasaccess.com

This program is designed for patients who have no health insurance. The program provides free Xtandi to patients who qualify for enrollment based on their insurance status and household income.

• Xtandi (enzalutamide) ASTRAZENECA AZ&Me Prescription Savings Program Phone: (800) 292-6363 www.azandmeapp.com

The AZ&Me Prescription Savings Program provides AstraZeneca medications at no cost to individuals without health insurance and to Medicare Part D beneficiaries. This program provides AstraZeneca medications to low-income patients through qualifying facilities, such as disproportionate-­ share hospitals, community health centers, community free clinics, central-fill pharmacies, and charitable pharmacy programs.

• Arimidex (anastrozole) • Caprelsa (vandetanib) • Faslodex (fulvestrant) • Zoladex (goserelin acetate implant) BAYER HEALTHCARE PHARMACEUTICALS INC Resources for Expert Assistance and Care Helpline (REACH) Phone: (866) 639-2827 www.reachpatientsupport.com

This program is designed to reduce the monthly copays of patients with private insurance. Through the REACH $0 Co-Pay Program, private-

Xtandi Support Solutions Phone: (855) 898-2634 www.astellasaccess.com/home/ hcp/xtandi

Continued on page 22

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ONCOLOGY GUIDE TO PATIENT SUPPORT SERVICES

I December 2014

Christine Celgene Patient Support ® Specialist

Your single source for personal support

Celgene Patient Support® offers you and your patients financial assistance and insurance-related services from a single Specialist assigned to your area. Co-pays for Celgene medications are reduced to $25 or less for eligible patients.

Celgene Commercial Co-pay Programa

Financial assistance through third-party organizations

Celgene Free Medication Programa

Help with locating transportation assistance

Call Celgene Patient Support® at 1-800-931-8691 Monday – Friday, 8 AM – 7 PM ET

Online enrollment now available at www.celgenepatientsupport.com Or e-mail us: patientsupport@celgene.com a

Subject to eligibility requirements.

Celgene Patient Support® is a registered trademark of Celgene Corporation. © 2014 Celgene Corporation

08/14

US-CELG140179

Patient Support Services

ly insured patients may qualify for a $0 copay, up to $4000 per month and up to $16,000 per year in assistance.

• Nexavar (sorafenib) • Stivarga (regorafenib) Xofigo Access Services

• Erbitux (cetuximab) • Etopophos (etoposide phosphate) • Lysodren (mitotane) • Ixempra (ixabepilone) • Opdivo (nivolumab) • Sprycel (dasatinib) • Yervoy (ipilimumab)

Phone: (855) 696-3446 www.xofigo-us.com/hcp/ patient-support

Bristol-Myers Squibb Patient Assistance Foundation

Xofigo Access Services provides Xofigo (radium Ra 223 dichloride) free of charge to eligible patients who are un­ insured or who are insured but do not have coverage for Xofigo. Patients with private commercial insurance may also be eligible for copay assistance.

• Xofigo (radium Ra 223 dichloride) BOEHRINGER INGELHEIM PHARMACEUTICALS, INC Boehringer Ingelheim Cares Foundation Phone: (800) 556-8317 www.bipatientassistance.com

This program helps US residents in need obtain medications free of charge.

Patients must meet certain financial criteria to be eligible for assistance.

Solutions Plus Phone: (877) 814-3915 www.gilotrif.com/patients_and_ caregivers/support_program/ support_program.html

Solutions Plus provides financial assistance for medicine to patients who meet income requirements.

• Gilotrif (afatinib) BRISTOL-MYERS SQUIBB COMPANY Bristol-Myers Squibb Access Support Phone: (800) 861-0048 www.bmsaccesssupport.com

Through its Access Support Program, Bristol-Myers Squibb offers a variety of oncology support options for patients receiving outpatient treatment in the United States and Puerto Rico, and, in certain circumstances, the Virgin Islands.

• Droxia (hydroxyurea)

and reimbursement assistance from a single specialist assigned to each doctor’s office. No matter what the insurance situation, Celgene Patient Support is committed to helping patients access their Celgene medication.

Celgene Commercial Co-pay Program

Phone: (800) 736-0003 www.bmspaf.org

This foundation assists patients who need temporary help paying for the medications listed below. To receive temporary help, patients must prove financial hardship and meet other eligibility criteria.

• Erbitux (cetuximab) • Ixempra (ixabepilone) • Sprycel (dasatinib) • Yervoy (ipilimumab) Bristol-Myers Squibb Oncology Copay Program Phone: (855) 302-7557 www.bmsaccesssupport.bms customerconnect.com/oncology/ services/patient-financial-assistance/­ copay

This program is designed to assist with out-of-pocket copays or coinsurance requirements for eligible, commercially insured patients prescribed the below Bristol-Myers Squibb medications, per US Food and Drug Administration (FDA)-approved indications.

• Droxia (hydroxyurea) • Erbitux (cetuximab) • Etopophos (etoposide phosphate) • Lysodren (mitotane) • Ixempra (ixabepilone) • Opdivo (nivolumab) • Sprycel (dasatinib) • Yervoy (ipilimumab) CELGENE CORPORATION Celgene Patient Support

Phone: (800) 931-8691 www.celgenepatientsupport.com/ commercial_insurance.aspx

This program provides up to $10,000 annually to help meet deductible and copay/coinsurance costs. For qualified patients in the program, their cost will be $25 or less, depending on which Celgene drug they are prescribed (assistance not to exceed $10,000).

To qualify, patients must have commercial/private insurance and a household income of $100,000 or less.

• Abraxane (paclitaxel protein-­ bound particles for injectable suspension) (albumin-bound) • Pomalyst (pomalidomide) • Revlimid (lenalidomide) • Thalomid (thalidomide) Free Medication Program Phone: (800) 931-8691 www.celgenepatientsupport.com/ uninsured_patients.aspx

Patients who do not have insurance coverage for a Celgene medication prescribed by their physicians may be eligible for this program. Patients must meet financial criteria to be eligible for assistance. Program eligibility is based on household income and assets.

• Abraxane (paclitaxel protein-­ bound particles for injectable suspension) (albumin-bound) • Istodax (romidepsin) • Pomalyst (pomalidomide) • Revlimid (lenalidomide) • Thalomid (thalidomide) • Vidaza (azacitidine) COVIS PHARMACEUTICALS INC

Phone: (800) 931-8691 www.celgenepatientsupport.com

Celgene Patient Support offers health­ care professionals and patients access

Covis Patient Assistance Program Phone: (877) 438-9759 www.covispharma.com Continued on page 24

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ONCOLOGY GUIDE TO PATIENT SUPPORT SERVICES

I December 2014

ts and Providers with the Reimburse n e i t a P ment ng Proc Helpi ess 1-888-587-3263 www.TevaCORE.com

Our C RE Commitment CORE Hotline Offers Assistance Related to: • Benefit verification and coverage determination • Precertifications / prior authorization support • Coverage guidelines and claim requirements of payers • Support through the claims and appeals process • Templates for letters of medical necessity • Teva Cares Foundation Patient Assistance Program

To enroll in CORE • Phone 1-888-587-3263 Monday through Friday, 9 AM to 8 PM (ET), fax 1-866-676-4073, or visit www.TevaCORE.com

Supporting Teva Oncology Products Reimbursement Assistance and Support through CORE - the Comprehensive Oncology Reimbursement Expertise Program

Teva Cares Foundation offers a Patient Assistance Program to provide FDA-approved products free of charge for patients who qualify.

Teva Oncology also supports patient advocacy organizations, such as the Leukemia & Lymphoma Society, and others that have programs designed to help patients access the treatment they need.

Use of CORE services is not a guarantee of payment. Payments are based on medical necessity at the time a claim is received.

Oncology

©2013 CEPHALON, INC., A WHOLLY-OWNED SUBSIDIARY OF TEVA PHARMACEUTICAL INDUSTRIES LTD. ALL RIGHTS RESERVED. ONC-40298

OCTOBER 2013

PRINTED IN USA.

Patient Support Services

The Covis Patient Assistance Pro­ gram helps US citizens or residents who do not have a healthcare plan or have been denied coverage for treatment.

• Nilandron (nilutamide) DARA BIOSCIENCES INC No Coupon, No Copay, No Hassles Program Phone: (919) 872-5578 www.onco360.com/Gelclair/ Default.aspx www.soltamox.com/co-pay-support

This program is intended to reduce or eliminate financial outlays by offsetting patient out-of-pocket copay expenses, and will be applied automatically to qualified prescriptions at more than 43,000 pharmacies nationwide. Additional paperwork, coupons, or electronic input is not required by patients, healthcare providers, or pharmacists.

• Gelclair (bioadherent oral rinse gel) • Soltamox (tamoxifen citrate) DENDREON CORPORATION Dendreon ON Call Phone: (877) 336-3736 www.DendreonONCall.com

Dendreon is committed to help­­ ing patients who are eligible for treatment gain access to patient assistance through Dendreon ON Call. Pa­ tients may be eligible to access PROvide—the Provenge (sipuleucel-T) commercial copay program that provides financial assistance for copays, coinsurance, and de­ductible costs.

For eligible pa­tients who do not have coverage for Pro­venge, Dendreon also provides Pro­venge free of charge.

•P rovenge (sipuleucel-T) EISAI INC Eisai Reimbursement Resources Phone: (866) 613-4724 www.eisaireimbursement.com

Through Eisai Reimbursement Re­ sources, patients who are prescribed

Eisai products can find product-specific resources related to coding, coverage, and reimbursement of select products, as well as a variety of pa­ tient assistance services.

•A kynzeo (netupitant/palonosetron) • Aloxi (palonosetron hydrochloride injection) • Halaven (eribulin mesylate) • Hexalen (altretamine) ELI LILLY AND COMPANY Lilly PatientOne Phone: (866) 472-8663 www.lillypatientone.com

PatientOne addresses financial and coverage issues for qualified uninsured, underinsured, and insured patients who are prescribed a Lilly oncology drug. PatientOne can help provide replacement vials for ongoing therapy to qualified uninsured patients who earn up to 500% of the federal poverty level. In addition, Patient­ One provides assistance to insured patients whose claims for a Lilly oncology drug have been denied by their insurer.

Certain eligibility requirements apply. Ap­­proved drug re­­quests are conveniently shipped to the physician’s office.

• Alimta (pemetrexed) • Gemzar (gemcitabine hydro­ chloride) • Cyramza (ramucirumab) Lilly TruAssist Phone: (855) 559-8783 www.lillytruassist.com

Lilly TruAssist is a platform that provides a description of Lilly’s pa­ tient assistance programs. Patients can browse programs using the Program Tool Finder.

Cyramza Co-Pay Program Phone: (866) 472-8663 www.cyramzahcp.com/resources/ copay_program.html

Patients who have been prescribed Cyramza (ramucirumab) may qualify for the Cyramza Co-pay Program,

in which eligible patients pay ≤$50 per infusion.

• Cyramza (ramucirumab injection) ENDO PHARMACEUTICALS INC Endo Patient Assistance Program Phone: (800) 462-3636 www.endo.com/endopharma/ about-us/u-s-patient-assistance

The Endo Pharmaceuticals Inc patient assistance program offers free medications to patients who otherwise cannot afford them. Patients must meet financial and other program-specific criteria to be eligible for assistance.

• Valstar (valrubicin) • Vantas (histrelin) implant GENENTECH, INC Genentech Access Solutions Phone: (888) 249-4918 www.genentech-access.com

Genentech Access So­­ lutions provides programs and services to help facilitate access to Genentech BioOncology medicines for eligible patients and healthcare professionals.

Services include benefits investigations, financial assistance options, and resource support, and vary depending on patients’ insurance status.

• Avastin (bevacizumab) • Erivedge (vismodegib) • Gazyva (obinutuzumab) • Herceptin (trastuzumab) • Kadcyla (ado-trastuzumab emtansine) • Perjeta (pertuzumab) • Rituxan (rituximab) • Tarceva (erlotinib) • Zelboraf (vemurafenib) Genentech Access to Care Foundation Phone: (888) 249-4918 www.genentech-access.com/hcp/ find-patient-assistance/co-pay-­ foundation

The Genentech Access to Care Foundation helps patients receive medications for free if they do not have a healthcare plan or have been denied coverage for treatment. Patients must Continued on page 26

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*The VELCADE Reimbursement Assistance Program does not file claims or appeal claims for callers, nor can it guarantee that you will be successful in obtaining reimbursement

VELCADE and Millennium are registered trademarks of Millennium Pharmaceuticals, Inc. Other trademarks are property of their respective owners.

Millennium Pharmaceuticals, Inc., Cambridge, MA 02139 Copyright Š 2010, Millennium Pharmaceuticals, Inc. All rights reserved.

Printed in USA

V-10-0196

11/10

Patient Support Services

have a household-­adjusted income of $100,000 or less annually.

• Avastin (bevacizumab) • Erivedge (vismodegib) • Gazyva (obinutuzumab) • Herceptin (trastuzumab) • Kadcyla (ado-trastuzumab emtansine) • Perjeta (pertuzumab) • Rituxan (rituximab) • Tarceva (erlotinib) • Zelboraf (vemurafenib) Genentech BioOncology Copay Card Phone: (855) 692-6729 www.genentech-access.com/­ biooncology/hcp

The Genentech BioOncology Co-­ pay­Card helps qualified patients with their out-of-pocket prescription costs. Eligible patients must be aged ≥18 years and must be covered by commercial insurance.

• Avastin (bevacizumab) • Erivedge (vismodegib) • Gazyva (obinutuzumab) • Herceptin (trastuzumab) • Kadcyla (ado-trastuzumab emtansine) • Perjeta (pertuzumab) • Rituxan (rituximab) • Tarceva (erlotinib) • Zelboraf (vemurafenib)

Zydelig Copay Coupon Program Phone: (844) 622-2377 www.activatethecard.com/zydelig

The Zydelig Copay Coupon Program provides copay assistance for eligible patients with private insurance who need assistance paying for their out-of-pocket medication costs. Most patients will pay no more than $5 per monthly copay.

• Zydelig (idelalisib) Zydelig QuickStart Program Phone: (844) 622-2377 www.zydeligaccessconnect.com/ hcp/access/zydelig-quickstart-­ program

The Zydelig QuickStart Program gives eligible patients who have an insurance-coverage delay of >5 business days rapid access to a free, 1-time, 30-day supply of Zy­­delig.

• Zydelig (idelalisib) GLAXOSMITHKLINE Commitment to Access Program Phone: (866) 265-6491 www.gskcta.com

Zydelig AccessConnect Phone: (844) 622-2377 www.zydeligaccessconnect.com

Copay Assistance Program

Genomic Access Program (GAP) Phone: (866) 662-6897 www.oncotypedx.com

The Genomic Access Program assists patients throughout the process of determining coverage and billing insurance. The program is designed for uninsured and underinsured pa­ tients based on financial eligibility.

• Oncotype DX test GILEAD SCIENCES, INC

The Zydelig AccessConnect program provides Zydelig (idelalisib) at

I

Phone: (866) 265-6491 www.gsk-access.com

ONCOLOGY GUIDE TO PATIENT SUPPORT SERVICES

I December 2014

The GSK Copay Assistance Program is available to those individ­ uals with commercial prescription coverage who satisfy income and other eligibility requirements.

• Arranon (nelarabine) • Arzerra (ofatumumab) • Bexxar (tositumomab) • Hycamtin (topotecan) capsules • Hycamtin (topotecan hydrochloride) for injection • Leukeran (chlorambucil) • Mekinist (trametinib) • Myleran (busulfan) • Promacta (eltrombopag) • Tafinlar (dabrafenib) • Tykerb (lapatinib) • Votrient (pazopanib) INCYTE CORPORATION

GlaxoSmithKline (GSK)’s patient assistance program supports access to GSK’s oncology and certain specialty pharmacy drugs at little or no cost to qualified patients.

• Arranon (nelarabine) • Arzerra (ofatumumab) • Bexxar (tositumomab) • Hycamtin (topotecan) capsules • Hycamtin (topotecan hydrochloride) for injection • Leukeran (chlorambucil) • Mekinist (trametinib) • Myleran (busulfan) • Promacta (eltrombopag) • Tykerb (lapatinib) • Votrient (pazopanib)

GENOMIC HEALTH, INC

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no charge to eligible patients with no other insurance options.

• Zydelig (idelalisib)

IncyteCARES Patient Assistance Program Phone: (855) 452-5234 www.jakafi.com/incytecares.com

The IncyteCARES (Connecting to Access, Reimbursement, Education, and Support) Patient Assistance Program helps individuals who do not have a healthcare plan.

The program can also help pa­ tients whose plans have turned them down for Jakafi (ruxolitinib) treatment. Patients with private or commercial prescription insurance may be eligible to receive Jakafi for no more than $50 monthly, depending on their income.

• Jakafi (ruxolitinib) JANSSEN BIOTECH, INC Janssen Prescription Assistance Phone: (800) 526-7736 www.janssenprescription assistance.com

By visiting www.JanssenPrescription Assistance.com, patients can use the Janssen Prescription Assistance tool to search different types of prescription assistance programs. The site allows patients to search for up-todate, product-relevant programs, and is open to insured, uninsured, and underinsured patients.

Patient Support Services

Johnson & Johnson Patient Assistance Foundation, Inc Phone: (800) 652-6227 www.jjpaf.org/index.html

The Johnson & Johnson Patient Assistance Foundation, Inc assists patients without adequate financial resources and prescription drug coverage in obtaining free medications donated by the operating companies of Johnson & Johnson. There is 1 application for all agents, and patients may receive free medicines for up to 1 year.

AccessOne www.janssenaccessone.com

Information about reimburse­­ment support programs for eligible patients is accessible through the AccessOne portal, available at www.janssen accessone.com. Reim­burse­ment programs are product-­specific.

•D oxil (doxorubicin hydrochloride liposome injection) •P rocrit (epoetin alfa) •Z ytiga (abiraterone acetate) ZytigaONE Phone: (855) 998-4421 www.janssen­accessone.com/ assets/zytiga/instant_savings.pdf

Patients who have been prescribed Zytiga may be able to save on copays, deductibles, and coinsurance costs through the ZytigaOne Instant Sav­ings Program.

MERCK & CO., INC ACT and MAP Programs Phone: (866) 363-6379 www.merck.com/merckhelps

The ACT and MAP programs provide free reimbursement support services to help answer questions related to insurance coverage and re­imbursement. The ACT Program also refers patients to the patient assistance program, which provides certain Merck medicines free of charge to eligible patients who do not have insurance coverage. Many Merck medications are included in this program.

• Emend (aprepitant)

• Sandostatin LAR Depot (octreotide acetate for injectable suspension) • Tasigna (nilotinib) • Zometa (zoledronic acid) • Zykadia (ceritinib)

• Emend (fosaprepitant dimeglumine) • Intron A (interferon alfa-2b, recombinant) • Keytruda (pembrolizumab) • Noxafil (posaconazole) • Sylatron (peginterferon alfa-2b) Merck Patient Assistance Program

Patient Assistance NOW Oncology Program

Phone: (800) 727-5400 www.merck.com/merckhelps

Phone: (800) 282-7630 www.oncologyaccessnow.com

The Merck Patient Assistance Program is available to eligible, uninsured patients who may qualify to receive medicine at no cost.

• Temodar (temozolomide)

The Novartis Patient Assistance NOW Oncology program offers quick and easy access to information about the many reimbursement and support programs available to patients. Pa­ tients with private in­surance or without prescription coverage may be eligible to receive copay discount cards on certain medications.

• Afinitor (everolimus) tablets • Exjade (deferasirox) • Gleevec (imatinib mesylate) tablets • Sandostatin LAR Depot (octreotide acetate) for injectable suspension • Tasigna (nilotinib) • Zometa (zoledronic acid) • Zykadia (ceritinib)

MILLENNIUM: THE TAKEDA ONCOLOGY COMPANY Velcade Reimbursement Assistance Program Phone: (866) 835-2233 www.velcade-hcp.com/­ reimbursement

Millennium: The Takeda Oncology Company offers eligible patients receiving treatment with Velcade (bortezomib) assistance through the Velcade Reimbursement Assis­ tance Program (VRAP). Support and resources are available for the in­sured, uninsured, and underinsured.

Eligibility-­dependent support services include financial assistance, navigation through reimbursement processes and concerns, as well as referrals to independent copay foundations.

• Velcade (bortezomib)

ONYX PHARMACEUTICALS, INC Onyx 360 Phone: (855) 669-9360 www.kyprolis.com/support-­duringtreatment

This comprehensive, personalized program is designed to support providers and patients (who meet certain eligibility criteria) with free medication assistance for uninsured patients or those rendered uninsured through payer denial.

• Kyprolis (carfilzomib)

NOVARTIS PHARMACEUTICALS CORPORATION Novartis Oncology Patient Assistance Foundation, Inc

PFIZER INC

Phone: (800) 277-2254 www.patientassistancenow.com

Pfizer RxPathways

The Novartis Oncology Patient Assistance Foundation, Inc provides assistance to patients who experience financial hardship and who have no third-party insurance coverage for their medications.

• Afinitor (everolimus) • Exjade (deferasirox) • Gleevec (imatinib mesylate)

Phone: (866) 706-2400 www.pfizerrxpathways.com

To improve accessibility of services and respond to patients’ needs, Pfizer has combined its existing p­ rograms into Pfizer RxPathways, formerly known as Pfizer Helpful Answers. A comprehensive assistance program, Pfizer RxPathways provides eligible Continued on page 28

December 2014

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Patient Support Services

pa­tients with a range of support services, including insurance counseling, copay assistance, and access to medicines at no cost or at a savings.

• Aromasin (exemestane) tablets • Bosulif (bosutinib) • Camptosar (irinotecan hydrochloride) • Ellence (epirubicin hydrochloride) • Emcyt (estramustine phosphate sodium) • Idamycin (idarubicin hydrochloride for injection) • Inlyta (axitinib) • Neumega (oprelvekin) • Sutent (sunitinib malate) • Torisel (temsirolimus) • Xalkori (crizotinib) •Z inecard (dexrazoxane for injection) PHARMACYCLICS, INC Imbruvica YOU&i Support Program Phone: (877) 877-3536 www.youandisupport.com

Patients with commercial insurance and who meet certain eligibility requirements pay no more than $10 monthly for Imbruvica (ibrutinib).

Eligible patients prescribed Imbruvica for an FDA-approved indication, and who are experiencing an insurance coverage delay greater than 5 business days, can receive a free, 30-day supply of Imbruvica. Under appropriate circumstances, an additional free, 30-day supply of Imbruvica may be provided.

• Imbruvica (ibrutinib) PROMETHEUS THERAPEUTICS & DIAGNOSTICS Prometheus IV Bolus Proleukin Inpatient Reimbursement Hotline Phone: (877) 776-5385 www.proleukin.com/health-­careprofessional/resources

As part of their commitment to ensure that all eligible patients have access to Proleukin (aldesleukin), the Prometheus IV Bolus Proleukin Inpatient Reimbursement Hotline is staffed

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with specialists who can help resolve specific access and reimbursement issues for patients and physicians.

• Proleukin (aldesleukin) PROSTRAKAN USA Patient Rx Solutions Phone: (866) 676-5884 www.patientrxsolutions.com

Patient Rx Solutions is designed to assist uninsured individuals and those who have no public or private prescription coverage. ProStrakan also offers copay assistance to eligible individuals with private insurance.

• Fareston (toremifene citrate) • Sancuso (granisetron transdermal system) SANOFI-AVENTIS US

SIGMA-TAU PHARMACEUTICALS, INC SOS Copay Assistance Program Phone: (855) 497-3366 www.sigmatau.com/support/­ support_oncaspar.asp

Sigma-Tau Pharmaceuticals, Inc is offering the SOS (Sigma-Tau Outreach Services) Copay Assistance Program for patients taking Oncaspar (pegaspargase) to reduce the out-ofpocket costs of Oncaspar. Eligible patients who enroll in this program may obtain copay assistance through the electronic benefit cards or checks.

• Oncaspar (pegaspargase) SPECTRUM PHARMACEUTICALS, INC STAR

Sanofi Patient Connection

Phone: (888) 537-8277 www.getasapinfo.com

SEATTLE GENETICS

Spectrum Pharmaceuticals, Inc is committed to providing appropriate patient access to care. STAR (Spectrum Therapy Access Resources) includes a copay assistance program to assist privately insured patients (who meet the STAR eligibility criteria) with copay and coinsurance responsibilities related to ­certain Spectrum medications. In addition, the STAR program in­ cludes a patient assistance pro­­ gram that ­provides Spectrum medications free of charge to enrolled patients who meet the income, insurance, and citizenship/ residency eligibility c­ riteria.

• Folotyn (pralatrexate injection) • Fusilev (levoleucovorin) • Marqibo (vincristine sulfate liposome injection) • Zevalin (ibritumomab tiuxetan)

SeaGen Secure Patient Assistance Program

TEVA PHARMACEUTICALS, INC

Phone: (855) 473-2436 www.seagensecure.com

Comprehensive Oncology Reimbursement Expertise (CORE)

Phone: (888) 847-4877 www.visitspconline.com

Through the Sanofi Foundation of North America, Sanofi Patient Connection provides medications free of charge to patients who have no insurance coverage or who are con­sidered to be functionally un­­ insured.

• Elitek (rasburicase) • Eloxatin (oxaliplatin) • Jevtana (cabazitaxel) • Leukine (sargramostim) • Mozobil (plerixafor) • Taxotere (docetaxel) • Thymoglobulin (antithymocyte globulin [rabbit]) • Zaltrap (ziv-aflibercept)

SeaGen Secure is a comprehensive assistance program for uninsured and underinsured patients who have been prescribed Adcetris (brentuximab vedotin).

• Adcetris (brentuximab vedotin)

ONCOLOGY GUIDE TO PATIENT SUPPORT SERVICES

I December 2014

Phone: (888) 587-3263 www.tevacore.com

Comprehensive Oncology Reimbursement Expertise supports pa­ tients and providers through programs for eligible patients treated in the United States who do not have

Patient Support Services

insurance, cannot afford their outof-pocket copay costs, or need assistance with reimbursement issues.

• Granix (tbo-filgrastim) • Synribo (omacetaxine mepesuccinate) • Treanda (bendamustine HCl) • Trisenox (arsenic trioxide) Teva Cares Foundation www.tevacares.org

The foundation offers some medications at no cost to eligible patients who meet certain income and insurance criteria. The following are oncology and oncology-supportive drugs cov­­ ered by the Teva Cares Foundation: • Fentora (fentanyl citrate) buccal tablet, CII • Granix (tbo-filgrastim) • Synribo (omacetaxine mepesuccinate) • Treanda (bendamustine HCl) • Trisenox (arsenic trioxide)

Government Assistance Programs BENEFITSCHECKUP (NATIONAL COUNCIL ON AGING) Phone: (202) 479-1200 www.benefitscheckup.org

BenefitsCheckUp helps individuals aged ≥55 years find programs that may cover some of their prescription drug costs, healthcare expenses, and other services.

COMPASSIONATE ALLOWANCES (SOCIAL SECURITY ADMINISTRATION) Phone: (800) 772-1213 www.ssa.gov/compassionate allowances

Compassionate Allowances are a way of quickly identifying diseases and other medical conditions that invariably qualify under the Listing of Impairments based on minimal objective medical information. Compassionate Allowances allow Social Security to quickly target the most obviously disabled individuals for allowances.

EXTRA HELP (SOCIAL SECURITY ADMINISTRATION)

organizations that provide financial assistance to patients with cancer and their families. In addition, it provides information about patient assistance programs.

Phone: (800) 772-1213 www.ssa.gov/medicare/­ prescriptionhelp

Medicare beneficiaries may qualify for Extra Help with their Medicare prescription drug plan costs. Extra Help is estimated to be worth about $4000 annually. To qualify for Extra Help, an individual must receive Medicare, have limited resources and income, and reside in 1 of the 50 states or in the District of Columbia.

UNDERSTANDING PRESCRIPTION ASSISTANCE PROGRAMS (NATIONAL COUNCIL ON PATIENT INFORMATION AND EDUCATION) Phone: (301) 340-3940 www.talkaboutrx.org/paps.jsp

This website provides resources for getting the right information about prescription assistance programs.

HILL-BURTON FREE AND REDUCED-COST HEALTHCARE (HEALTH RESOURCES AND SERVICES ADMINISTRATION)

REFERENCES

1. Patel JD, Krilov L, Adams S, et al. Clinical cancer advances 2013: annual report on progress against cancer from the American Society of Clinical Oncology.

J Clin Oncol. 2014;32:129-160.

2. National Cancer Institute. Managing the nation’s cancer research portfolio: professional judgment budget 2013. www.cancer.gov/aboutnci/budget_plan ning_leg/plan-2013. Accessed August 20, 2014.

3. IMS Institute for Healthcare Informatics. In­­ novation in cancer care and implications for health systems: global oncology trend report. www.imshealth. com/portal/site/imshealth/menuitem.762a961826aad 98f53c753c71ad8c22a/?vgnextoid=f8d4df7a5e8b5410 VgnVCM10000076192ca2RCRD. Published May 2014. Accessed August 19, 2014.

4. McKee AE, Farrell AT, Pazdur R, Woodcock J. The role of the U.S. Food and Drug Administration review process: clinical trial endpoints in oncology.

Oncologist. 2010;15:13-18.

5. Express Scripts. The 2013 Drug Trend Report.

April 2014. http://lab.express-scripts.com/~/media/ pdfs/drug%20trend%20report/express%20scripts%20 2013%20drug%20trend%20report.ashx. Accessed August 19, 2014.

6. Harvard School of Public Health. Four in 10 Americans say they have trouble paying for drugs or skip prescriptions or cut pills due to cost. www.hsph. harvard.edu/news/press-releases/poll-usa-today-kaiserharvard-prescription-drugs/. Published March 4, 2008.

Accessed August 20, 2014.

7. Tseng CW, Dudley RA, Brook RH, et al. Elderly patients’ preferences and experiences with providers in managing their drug costs. J Am Geriatr Soc. 2007;55:1974-1980.

8. Kaiser Family Foundation. Kaiser health tracking poll: public opinion on health care issues. http://kaiser familyfoundation.files.wordpress.com/2013/01/7990. pdf. Published September 2009. Accessed August 21, 2014.

9. Levy J. In U.S., uninsured rate lowest since 2008: uninsured rate declines most among blacks and lower-income Americans. Gallup. www.gallup. com/poll/168248/uninsured-rate-lowest-2008.aspx.

Published April 7, 2014. Accessed August 20, 2014.

10. Cubanski J, Neuman P. Status report on Medicare Part D enrollment in 2006: analysis of plan-specific market share and coverage. Health Aff (Millwood).

2007;26:w1-w12.

11. Goldman DP, Joyce GF, Zheng Y. Prescription drug cost sharing: associations with medication and medical utilization and spending and health. JAMA. 2007;298:61-69.

12. Hsu J, Price M, Huang J, et al. Unintended consequences of caps on Medicare drug benefits. N Engl J Med. 2006;354:2349-2359.

Phone: (800) 638-0742 www.hrsa.gov/gethealthcare/ affordable/hillburton

More than 160 healthcare facilities nationwide provide free or reducedcost care as mandated by the Hill-Burton Act. Patients are eligible to apply for Hill-Burton free care if their income is at or below the current Health & Human Services Poverty Guidelines.

PATIENT TRAVEL AND LODGING PROGRAM (OFFICE OF RARE DISEASES, NATIONAL INSTITUTES OF HEALTH) Phone: (301) 402-4336 http://rarediseases.info.nih.gov/ resources/5#category17

This resource provides links to charitable or special fare flights to research and treatment sites, hospitality houses for patients and their families, and fee-for-service ambulance services.

RESOURCES FOR FINANCIAL ASSISTANCE FOR CANCER PATIENTS AND THEIR FAMILIES (NATIONAL CANCER INSTITUTE) Phone: (800) 422-6237 www.cancer.gov/cancertopics/ coping/financial-legal

This resource contains a database of government agencies and national

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SPOTLIGHT

on Celgene Patient Support

Benefits of Patient Support Programs Interview with Jeffry Gype, Senior Director of Patient Support, Celgene Corporation

P

atient assistance programs play a key role in helping patients with cancer afford their prescribed treatments and therapeutic regimens. As the healthcare and cancer care landscapes evolve, these programs, coupled with increased awareness and utilization, have the potential to continue to connect patients with existing and emerging therapies. In the following interview, Jeffry Gype, Senior Director of Patient Support, Celgene, shares his thoughts on patient support programs, awareness and utilization of these programs, meeting the needs of patients with cancer, and Celgene’s efforts to connect patients with their medications.

of innovation and what these newer therapies actually provide for patients, not necessarily in the short term, but in the long term as well.

Q: The patient’s share of cost continues to rise for both treatment and medications. What can pharmaceutical companies do to ensure that patients and caregivers have access to the prescriptions they need during the course of their care?

JG: It is really important that manufacturers provide continuous education to all stakeholders, such as office practice managers, specialty pharmacies, and social workers, regarding the type of services that we Q: What do you feel are some of the more pressing offer, whether it is commercial copayment assistance needs among patients with cancer today? or help through foundations. More and more hospitals Jeffry Gype (JG): There are a number of things. are acquiring practices, and I am not so sure hospitals Assessing the financial assistance that patients have totally understand all the resources that patients had needed is key, especially in the access to in the community setting. past couple of years; during diffiThey need to tap into those resources cult economic times, fewer patients to help control some of the cost that were insured, and thus more help the patient incurs. Ongoing educawas needed. It is only now that we tion—not only for those stakeholders are starting to see a change in that. but also for support groups and advoIn addition, there also is a need cacy groups—is important. Having for integrated continuum of care online enrollment into programs is services that meet many patients’ another key capability. As our society physical and psychosocial needs. It gravitates more toward the Internet is something that needs to be done for information, it is more important in addition to assessing financial than ever to have enrollment into needs. some of these programs done via the On a grander scale, some private Internet. practices, community-based practicAlso, it is crucial that a patient or es, hospitals, and health systems are a caregiver has a single point of conusing a multidisciplinary approach tact with the manufacturer so as to to cancer care. This needs to tie limit the burden of them attempting Jeffry Gype into the financial issues affecting to search for every type of assistance the patient. Patients are interactthat is available for each product that ing with any number of specialists, the patient might be on. Somebody maybe a surgeon, medical oncologist, radiation oncol- from the manufacturer—such as a navigator or case ogist, and other specialists, to receive the best, most manager—should be available to help patients navigate comprehensive treatment, but we also need to find all through the process. the financial assistance that is out there available for patients in conjunction with this type of approach. We Q: Is there adequate awareness of patient support need to integrate the financial picture into the contin- programs in the oncology community? What can be uum of care. done to increase the awareness of these programs?

There is one other area where the industry needs to JG: It depends on the practice. There is an oppordo a good job: helping everybody understand the value tunity for continuous education. Practices sometimes

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ONCOLOGY GUIDE TO PATIENT SUPPORT SERVICES

I December 2014

Celgene Patient Support

have high turnover, so ongoing education is required to ensure that not only the healthcare practitioners are aware of financial resources, but also the ancillary staff within the office, because one of them more than likely will be the one who is going to help connect the patient with support programs. Also, there are many opportunities in the hospital setting. Hospitals usually are big institutions with lots of different layers, and right now, I see them absorbing a lot of costs. By tapping into some of these assistance programs, they could mitigate their costs as well as patients’ out-of-pocket expenses.

Q: Are there barriers that prevent patients and caregivers from receiving financial support? If so, what can be done to overcome these barriers?

JG: One of the main barriers is a limited awareness of some of these assistance programs. The information is out there, but here’s the issue: practices deal with hundreds of products, and multiple manufacturers are involved. They need to have a really good understanding of what is out there, but currently there is limited awareness in some places. Specialty pharmacies play a very important role in this, and they need to be very proactive in asking the patient if that patient needs any financial assistance. That is a key piece, because many times the patient’s prescription goes to a specialty pharmacy, and the specialty pharmacy needs to understand what assistance is available for a given product. Some of the patients who are being treated are very proud; we need to facilitate that understanding, and empower and educate them to seek financial help.

Q: Are patient support programs meeting the needs of oncology patients? Are there ways to improve the programs that are in place? If so, what is the formula for success when developing a patient support program?

JG: If there is an awareness of the assistance programs—and the programs are being utilized—I truly believe they are meeting patients’ needs. It becomes an issue when the programs are not being utilized. When support programs are in place, there are plenty of opportunities and plenty of resources for patients to use.

Ways to improve programs would be to implement a single point of contact with the manufacturer rather than multiple points of contact. The true formula for success is building a strong relationship between the manufacturer and the patient, the caregiver, or the practice, or a combination of those. The way this can be done is with a highly competent case manager who is very familiar, perhaps with regional payers, as well

as the landscape that a given geography has for that patient, practice, or caregiver.

Q: How has the Affordable Care Act changed the way patients access and pay for medications?

JG: The concept is extremely good; the Affordable Care Act has provided additional options for many patients. Unfortunately, we are finding that the outof-pocket costs associated with these plans are very prohibitive for many individuals. Because of that, they might not be viewed as that affordable. What we have to do is look at those patients who have purchased plans through the Affordable Care Act—so that we can help them with copayment assistance and the ability to access the drugs that their physician has prescribed them.

Q: Who are the patients that Celgene’s Patient Support Program helps?

JG: We help the commercially insured patient, the underinsured patient, the patient who has no insurance. We also help the Medicare/Medicaid patient by directing them to third-party foundations. We help all those patient groups. To date, more than 80% of the patients who are opted into our program receive some type of help (commercial copay, nonprofit foundation assistance, or free drugs).

Q: There is a section on Celgene’s website for healthcare providers. Why is it important to include information for healthcare providers on a page that is dedicated to patient assistance?

JG: When you go onto that website and click on Healthcare Providers, you will find a sort of cheat sheet. The primary source of opt-ins are from healthcare providers, so it is an opportunity for an office to see what services we provide and how we can help to facilitate the process for their patients. It shows them that we do it with a single point of contact, by using a case manager who is dedicated to that patient, that office, or that caregiver. We then can help them navigate through difficult issues that they might have with a given situation.

Q: Is there anything else that you would like to discuss or questions that are important to address?

JG: The bottom line is that there are a number of resources available. Everyone needs to explore all opportunities, and no one should stop at any point if they have been denied or turned away. It is about finding the right option that works for the patient. l

December 2014

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www.OncPracticeManagement.com

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31

Your Patients, Your Practice…

Helping Your Practice This comprehensive financial assistance program offers ongoing support across the reimbursement spectrum to help you help your patients.

Complete Provider Assistance Benefits verification Prior authorization tracking Regionally dedicated case managers Local access and reimbursement specialists Denied claims assistance Indication XTANDI (enzalutamide) capsules is indicated for the treatment of patients with metastatic castration-resistant prostate cancer (CRPC).

Important Safety Information Contraindications XTANDI (enzalutamide) capsules can cause fetal harm when administered to a pregnant woman based on its mechanism of action and findings in animals. XTANDI is not indicated for use in women. XTANDI is contraindicated in women who are or may become pregnant.

Warnings and Precautions In Study 1, conducted in patients with metastatic castration-resistant prostate cancer (CRPC) who previously received docetaxel, seizure occurred in 0.9% of patients who were treated with XTANDI and 0% treated with placebo. In Study 2, conducted in patients with chemotherapy-naïve metastatic CRPC, seizure occurred in 0.1% of patients who were treated with XTANDI and 0.1% treated with placebo. Patients experiencing a seizure were permanently discontinued from therapy and all seizure events resolved. There is no clinical trial experience re-administering XTANDI to patients who experienced a seizure, and limited clinical trial experience in patients with predisposing factors for seizure. Study 1 excluded the use of concomitant medications that may lower threshold, whereas Study 2 permitted the use of these medications.

Because of the risk of seizure associated with XTANDI use, patients should be advised of the risk of engaging in any activity during which sudden loss of consciousness could cause serious harm to themselves or others. Permanently discontinue XTANDI in patients who develop a seizure during treatment.

Adverse Reactions The most common adverse reactions (≥ 10%) reported from the two combined clinical trials that occurred more commonly (≥ 2% over placebo) in the XTANDI-treated patients were asthenia/fatigue, back pain, decreased appetite, constipation, arthralgia, diarrhea, hot flush, upper respiratory tract infection, peripheral edema, dyspnea, musculoskeletal pain, weight decreased, headache, hypertension, and dizziness/ vertigo.

Other Adverse Reactions include: • Laboratory Abnormalities: In the two studies, Grade 1-4 neutropenia occurred in 15% of patients treated with XTANDI (1% Grade 3-4) and in 6% of patients treated with placebo (0.5% Grade 3-4). The incidence of Grade 1-4 thrombocytopenia was 6% of patients treated with XTANDI (0.3% Grade 3-4) and 5% of patients on placebo (0.5% Grade 3-4). Grade 1-4 elevations in ALT occurred in 10% of patients treated with XTANDI (0.2% Grade 3-4) and 16% of patients treated with placebo (0.2% Grade 3-4). Grade 1-4 elevations in bilirubin occurred in 3% of patients treated with XTANDI

We’ve Got You Covered Helping Your Patients Financial assistance is available for patients.* Private Insurance $5000/month copay assistance, up to $12,000/year

Medicare/Medicaid Referrals to Independent Copay Foundations†

Uninsured or Underinsured Free XTANDI® (enzalutamide) capsules

New Patients Awaiting Coverage Decision Free XTANDI through XTANDI Quick Start+™ Program

*Subject to eligibility. Void where prohibited by law. Restrictions may apply. † XTANDI Support SolutionsSM has no control over the decisions made by and does not guarantee support by these independent copay foundations.

To learn more about XTANDI Support Solutions or enroll your patients today:

1-855-8XTANDI (855-898-2634) 8 AM – 8 PM ET

(0.1% Grade 3-4) and 2% of patients treated with placebo (no Grade 3-4).

• Infections: In Study 1, 1% of XTANDI versus 0.3% of placebo patients and in Study 2, 1 patient in each treatment group (0.1%) had an infection resulting in death.

• Falls: In the two studies, falls including fall-related injuries occurred in 9% of XTANDI patients vs 4% treated with placebo. Falls were not associated with loss of consciousness or seizure. Fall-related injuries were more severe in XTANDI patients and included non-pathologic fractures, joint injuries, and hematomas.

• Hypertension: In the two studies, hypertension was reported in 11% of patients receiving XTANDI and 4% of patients receiving placebo. No patients experienced hypertensive crisis. Medical history of hypertension was balanced between arms. Hypertension led to study discontinuation in < 1% of XTANDI or placebo treated patients.

Drug Interactions • Effect of Other Drugs on XTANDI – Administration of strong CYP2C8 inhibitors can increase the plasma exposure to XTANDI. Co-administration of XTANDI with strong CYP2C8 inhibitors should be avoided if possible.

If co-administration of XTANDI cannot be avoided,

XTANDISupportSolutions.com

reduce the dose of XTANDI. Co-administration of XTANDI with strong or moderate CYP3A4 and CYP2C8 inducers may alter the plasma exposure of XTANDI and should be avoided if possible.

• Effect of XTANDI on Other Drugs – XTANDI is a strong CYP3A4 inducer and a moderate CYP2C9 and CYP2C19 inducer in humans. Avoid CYP3A4, CYP2C9 and CYP2C19 substrates with a narrow therapeutic index, as XTANDI may decrease the plasma exposures of these drugs. If XTANDI is co-administered with warfarin (CYP2C9 substrate), conduct additional INR monitoring.

PLEASE SEE BRIEF SUMMARY OF COMPLETE PRESCRIBING INFORMATION ON FOLLOWING PAGES.

XTANDI Support SolutionsSM, a component of Astellas Access ServicesSM 1-855-8XTANDI (1-855-898-2634); Fax 1-855-982-6341; XTANDISupportSolutions.com ©2014 Astellas Pharma US, Inc. All rights reserved. 076-0329-PM 9/14 Printed in USA XTANDI, Astellas, and the flying star logo are trademarks of Astellas Pharma, Inc.

XTANDI® (enzalutamide) capsules for oral use Initial U.S. Approval: 2012 BRIEF SUMMARY OF PRESCRIBING INFORMATION The following is a brief summary. Please see the package insert for full prescribing information.

INDICATIONS AND USAGE

Grade 3 and higher adverse reactions were reported among 47% of XTANDI-treated patients and 53% of placebo-treated patients. Discontinuations due to adverse events were reported for 16% of XTANDI-treated patients and 18% of placebo-treated patients. The most common adverse reaction leading to treatment discontinuation was seizure, which occurred in 0.9% of the XTANDI-treated patients compared to none (0%) of the placebo-treated patients. Table 1 shows adverse reactions reported in Study 1 that occurred at a ≥ 2% higher frequency in the XTANDI arm compared to the placebo arm.

Table 1. Adverse Reactions in Study 1 (cont.)

Respiratory Disorders

Table 1. Adverse Reactions in Study 1

Study 2: Chemotherapy-naive Metastatic CastrationResistant Prostate Cancer Study 2 enrolled 1717 patients with metastatic CRPC who had not received prior cytotoxic chemotherapy, of whom 1715 received at least one dose of study drug. The median duration of treatment was 17.5 months with XTANDI and 4.6 months with placebo. Grade 3-4 adverse reactions were reported in 44% of XTANDItreated patients and 37% of placebo-treated patients.

Discontinuations due to adverse events were reported for 6% of XTANDI-treated patients and 6% of placebo-treated patients. The most common adverse reaction leading to treatment discontinuation was fatigue/asthenia, which occurred in 1% of patients on each treatment arm. Table 2 includes adverse reactions reported in Study 2 that occurred at a ≥ 2% higher frequency in the XTANDI arm compared to the placebo arm.

XTANDI N = 800

XTANDI is indicated for the treatment of patients with metastatic castration-resistant prostate cancer (CRPC).

Grade 1-4a (%)

CONTRAINDICATIONS Pregnancy XTANDI can cause fetal harm when administered to a pregnant woman based on its mechanism of action and findings in animals. XTANDI is not indicated for use in women. XTANDI is contraindicated in women who are or may become pregnant. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, apprise the patient of the potential hazard to the fetus and the potential risk for pregnancy loss [see Use in Specific Populations (8.1)].

WARNINGS AND PRECAUTIONS Seizure In Study 1, which enrolled patients who previously received docetaxel, 7 of 800 (0.9%) patients treated with XTANDI experienced a seizure and no patients treated with placebo experienced a seizure. Seizure occurred from 31 to 603 days after initiation of XTANDI. In Study 2, 1 of 871 (0.1%) chemotherapy-naive patients treated with XTANDI and 1 of 844 (0.1%) patients treated with placebo experienced a seizure. Patients experiencing seizure were permanently discontinued from therapy and all seizure events resolved. There is no clinical trial experience readministering XTANDI to patients who experienced seizure.

Limited safety data are available in patients with predisposing factors for seizure because these patients were generally excluded from the trials. These exclusion criteria included a history of seizure, underlying brain injury with loss of consciousness, transient ischemic attack within the past 12 months, cerebral vascular accident, brain metastases, and brain arteriovenous malformation. Study 1 excluded the use of concomitant medications that may lower the seizure threshold, whereas Study 2 permitted the use of these medications.

Because of the risk of seizure associated with XTANDI use, patients should be advised of the risk of engaging in any activity where sudden loss of consciousness could cause serious harm to themselves or others. Permanently discontinue XTANDI in patients who develop a seizure during treatment.

ADVERSE REACTIONS Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Two randomized clinical trials enrolled patients with metastatic prostate cancer that has progressed on androgen deprivation therapy (GnRH therapy or bilateral orchiectomy), a disease setting that is also defined as metastatic CRPC. In both studies, patients received XTANDI 160 mg orally once daily in the active treatment arm or placebo in the control arm. All patients continued androgen deprivation therapy. Patients were allowed, but not required, to take glucocorticoids.

The most common adverse reactions (≥ 10%) that occurred more commonly (≥ 2% over placebo) in the XTANDI-treated patients from the two randomized clinical trials were asthenia/fatigue, back pain, decreased appetite, constipation, arthralgia, diarrhea, hot flush, upper respiratory tract infection, peripheral edema, dyspnea, musculoskeletal pain, weight decreased, headache, hypertension, and dizziness/vertigo.

Study 1: Metastatic Castration-Resistant Prostate Cancer Following Chemotherapy Study 1 enrolled 1199 patients with metastatic CRPC who had previously received docetaxel. The median duration of treatment was 8.3 months with XTANDI and 3.0 months with placebo. During the trial, 48% of patients on the XTANDI arm and 46% of patients on the placebo arm received glucocorticoids.

General Disorders Asthenic Conditionsb Peripheral Edema

Placebo N = 399

Grade Grade Grade 3-4 1-4 3-4 (%) (%) (%)

50.6

9.0

44.4

9.3

15.4

1.0

13.3

0.8

Musculoskeletal And Connective Tissue Disorders Back Pain

26.4

5.3

24.3

4.0

Arthralgia 20.5 Musculoskeletal 15.0 Pain Muscular 9.8 Weakness Musculoskeletal 2.6 Stiffness Gastrointestinal Disorders

2.5

17.3

1.8

1.3

11.5

0.3

1.5

6.8

1.8

0.3

0.3

0.0

21.8

1.1

17.5

0.3

Hot Flush

20.3

0.0

10.3

0.0

Hypertension

6.4

2.1

2.8

1.3

Diarrhea Vascular Disorders

Nervous System Disorders Headache

12.1

0.9

5.5

0.0

Dizzinessc Spinal Cord Compression and Cauda Equina Syndrome Paresthesia Mental Impairment Disordersd Hypoesthesia

9.5

0.5

7.5

0.5

Epistaxis

3.3

0.1

1.3

0.3

a CTCAE v4 b Includes asthenia and fatigue. c Includes dizziness and vertigo. d Includes amnesia, memory impairment, cognitive disorder, and disturbance in attention. e Includes nasopharyngitis, upper respiratory tract infection, sinusitis, rhinitis, pharyngitis, and laryngitis. f Includes pneumonia, lower respiratory tract infection, bronchitis, and lung infection.

Table 2. Adverse Reactions in Study 2 XTANDI N = 871 Grade 1-4a (%)

Grade 3-4 (%)

Placebo N = 844 Grade 1-4 (%)

Grade 3-4 (%)

General Disorders Asthenic 46.9 3.4 33.0 2.8 Conditionsb Peripheral 11.5 0.2 8.2 0.4 Edema Musculoskeletal And Connective Tissue Disorders Back Pain

28.6

2.5

22.4

3.0

Arthralgia

21.4

1.6

16.1

1.1

Gastrointestinal Disorders 7.4

6.6

4.5

3.8

6.6

0.0

4.5

0.0

4.3

0.3

1.8

0.0

4.0

0.3

1.8

0.0

0.0

6.5

0.3

Infections And Infestations Upper Respiratory Tract 10.9 Infectione Lower Respiratory 8.5 Tract And Lung Infectionf Psychiatric Disorders

2.4

4.8

1.3

Insomnia

8.8

0.0

6.0

0.5

Anxiety

6.5

0.3

4.0

0.0

Renal And Urinary Disorders Hematuria

6.9

1.8

4.5

1.0

Pollakiuria

4.8

0.0

2.5

0.0

Injury, Poisoning And Procedural Complications Fall 4.6 0.3 1.3 Non-pathologic 4.0 1.4 0.8 Fractures Skin And Subcutaneous Tissue Disorders

0.0 0.3

Pruritus

3.8

0.0

1.3

0.0

Dry Skin

3.5

0.0

1.3

0.0

Constipation

23.2

0.7

17.3

0.4

Diarrhea

16.8

0.3

14.3

0.4

Vascular Disorders Hot Flush

18.0

0.1

7.8

0.0

Hypertension

14.2

7.2

4.1

2.3

Nervous System Disorders Dizzinessc

11.3

0.3

7.1

0.0

Headache

11.0

0.2

7.0

0.4

Dysgeusia

7.6

0.1

3.7

0.0

5.7

0.0

1.3

0.1

2.1

0.1

0.4

0.0

0.6

8.5

0.6

0.0

10.5

0.0

1.5

4.7

1.1

0.1

5.7

0.0

Mental Impairment Disordersd Restless Legs Syndrome

Respiratory Disorders Dyspneae

11.0

Infections And Infestations Upper Respiratory 16.4 Tract Infectionf Lower Respiratory Tract And 7.9 Lung g Infection Psychiatric Disorders Insomnia

8.2

Table 2. Adverse Reactions in Study 2 (cont.)

Renal And Urinary Disorders Hematuria

8.8

1.3

5.8

1.3

Injury, Poisoning And Procedural Complications Fall

12.7

1.6

NonPathological 8.8 2.1 Fracture Metabolism and Nutrition Disorders Decreased 18.9 0.3 Appetite

5.3

0.7

3.0

1.1

16.4

0.7

8.5

0.2

Investigations Weight Decreased

12.4

0.8

Reproductive System and Breast Disorders Gynecomastia

3.4

0.0

1.4

0.0

a b c d

CTCAE v4 Includes asthenia and fatigue.

Includes dizziness and vertigo.

Includes amnesia, memory impairment, cognitive disorder, and disturbance in attention. e Includes dyspnea, exertional dyspnea, and dyspnea at rest. f Includes nasopharyngitis, upper respiratory tract infection, sinusitis, rhinitis, pharyngitis, and laryngitis. g Includes pneumonia, lower respiratory tract infection, bronchitis, and lung infection.

Laboratory Abnormalities In the two randomized clinical trials, Grade 1-4 neutropenia occurred in 15% of patients treated with XTANDI (1% Grade 3-4) and in 6% of patients treated with placebo (0.5% Grade 3-4).

The incidence of Grade 1-4 thrombocytopenia was 6% of patients treated with XTANDI (0.3% Grade 3-4) and 5% of patients treated with placebo (0.5% Grade 3-4). Grade 1-4 elevations in ALT occurred in 10% of patients treated with XTANDI (0.2% Grade 3-4) and 16% of patients treated with placebo (0.2% Grade 3-4). Grade 1-4 elevations in bilirubin occurred in 3% of patients treated with XTANDI (0.1% Grade 3-4) and 2% of patients treated with placebo (no Grade 3-4).

Infections In Study 1, 1% of patients treated with XTANDI compared to 0.3% of patients treated with placebo died from infections or sepsis. In Study 2, 1 patient in each treatment group (0.1%) had an infection resulting in death.

Falls and Fall-related Injuries In the two randomized clinical trials, falls including fall-related injuries, occurred in 9% of patients treated with XTANDI compared to 4% of patients treated with placebo. Falls were not associated with loss of consciousness or seizure. Fall-related injuries were more severe in patients treated with XTANDI and included non-pathologic fractures, joint injuries, and hematomas.

Hypertension In the two randomized trials, hypertension was reported in 11% of patients receiving XTANDI and 4% of patients receiving placebo. No patients experienced hypertensive crisis. Medical history of hypertension was balanced between arms. Hypertension led to study discontinuation in < 1% of patients in each arm.

DRUG INTERACTIONS Drugs that Inhibit or Induce CYP2C8 Co-administration of a strong CYP2C8 inhibitor (gemfibrozil) increased the composite area under the plasma concentration-time curve (AUC) of enzalutamide plus N-desmethyl enzalutamide by 2.2-fold in healthy volunteers. Co-administration of XTANDI with strong CYP2C8 inhibitors should be avoided if possible. If co-administration of XTANDI with a strong CYP2C8 inhibitor cannot be avoided, reduce the dose of XTANDI [see Dosage and Administration (2.2) and Clinical Pharmacology (12.3)].

The effects of CYP2C8 inducers on the pharmacokinetics of enzalutamide have not been evaluated in vivo.

Co-administration of XTANDI with strong or moderate CYP2C8 inducers (e.g., rifampin) may alter the plasma exposure of XTANDI and should be avoided if possible.

Selection of a concomitant medication with no or minimal CYP2C8 induction potential is recommended [see Clinical Pharmacology (12.3)].

Drugs that Inhibit or Induce CYP3A4 Co-administration of a strong CYP3A4 inhibitor (itraconazole) increased the composite AUC of enzalutamide plus N-desmethyl

enzalutamide by 1.3-fold in healthy volunteers [see Clinical Pharmacology (12.3)].

The effects of CYP3A4 inducers on the pharmacokinetics of enzalutamide have not been evaluated in vivo.

Co-administration of XTANDI with strong CYP3A4 inducers (e.g., carbamazepine, phenobarbital, phenytoin, rifabutin, rifampin, rifapentine) may decrease the plasma exposure of XTANDI and should be avoided if possible.

Selection of a concomitant medication with no or minimal CYP3A4 induction potential is recommended. Moderate CYP3A4 inducers (e.g., bosentan, efavirenz, etravirine, modafinil, nafcillin) and St. John’s Wort may also reduce the plasma exposure of XTANDI and should be avoided if possible [see Clinical Pharmacology (12.3)].

Effect of XTANDI on Drug Metabolizing Enzymes Enzalutamide is a strong CYP3A4 inducer and a moderate CYP2C9 and CYP2C19 inducer in humans. At steady state, XTANDI reduced the plasma exposure to midazolam (CYP3A4 substrate), warfarin (CYP2C9 substrate), and omeprazole (CYP2C19 substrate). Concomitant use of XTANDI with narrow therapeutic index drugs that are metabolized by CYP3A4 (e.g., alfentanil, cyclosporine, dihydroergotamine, ergotamine, fentanyl, pimozide, quinidine, sirolimus and tacrolimus), CYP2C9 (e.g., phenytoin, warfarin) and CYP2C19 (e.g., S-mephenytoin) should be avoided, as enzalutamide may decrease their exposure. If co-administration with warfarin cannot be avoided, conduct additional INR monitoring [see Clinical Pharmacology (12.3)].

USE IN SPECIFIC POPULATIONS Pregnancy - Pregnancy Category X [see Contraindications (4)].

Risk Summary XTANDI can cause fetal harm when administered to a pregnant woman based on its mechanism of action and findings in animals. While there are no human data on the use of XTANDI in pregnancy and XTANDI is not indicated for use in women, it is important to know that maternal use of an androgen receptor inhibitor could affect development of the fetus. Enzalutamide caused embryofetal toxicity in mice at exposures that were lower than in patients receiving the recommended dose. XTANDI is contraindicated in women who are or may become pregnant while receiving the drug. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, apprise the patient of the potential hazard to the fetus and the potential risk for pregnancy loss. Advise females of reproductive potential to avoid becoming pregnant during treatment with XTANDI. Animal Data In an embryo-fetal developmental toxicity study in mice, enzalutamide caused developmental toxicity when administered at oral doses of 10 or 30 mg/kg/day throughout the period of organogenesis (gestational days 6-15). Findings included embryo-fetal lethality (increased post-implantation loss and resorptions) and decreased anogenital distance at ≥ 10 mg/kg/day, and cleft palate and absent palatine bone at 30 mg/kg/day. Doses of 30 mg/kg/day caused maternal toxicity. The doses tested in mice (1, 10 and 30 mg/kg/day) resulted in systemic exposures (AUC) approximately 0.04, 0.4 and 1.1 times, respectively, the exposures in patients. Enzalutamide did not cause developmental toxicity in rabbits when administered throughout the period of organogenesis (gestational days 6-18) at dose levels up to 10 mg/kg/day (approximately 0.4 times the exposures in patients based on AUC).

Nursing Mothers XTANDI is not indicated for use in women. It is not known if enzalutamide is excreted in human milk. Because many drugs are excreted in human milk, and because of the potential for serious adverse reactions in nursing infants from XTANDI, a decision should be made to either discontinue nursing, or discontinue the drug taking into account the importance of the drug to the mother.

Pediatric Use Safety and effectiveness of XTANDI in pediatric patients have not been established.

Geriatric Use Of 1671 patients who received XTANDI in the two randomized clinical trials, 75% were 65 and over, while 31% were 75 and over. No overall differences in safety or effectiveness were observed between these patients and younger patients. Other reported clinical

experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

Patients with Renal Impairment A dedicated renal impairment trial for XTANDI has not been conducted.

Based on the population pharmacokinetic analysis using data from clinical trials in patients with metastatic CRPC and healthy volunteers, no significant difference in enzalutamide clearance was observed in patients with pre-existing mild to moderate renal impairment (30 mL/min ≤ creatinine clearance [CrCL] ≤ 89 mL/min) compared to patients and volunteers with baseline normal renal function (CrCL ≥ 90 mL/min). No initial dosage adjustment is necessary for patients with mild to moderate renal impairment. Severe renal impairment (CrCL < 30 mL/min) and end-stage renal disease have not been assessed [see Clinical Pharmacology (12.3)].

Patients with Hepatic Impairment A dedicated hepatic impairment trial compared the composite systemic exposure of enzalutamide plus N-desmethyl enzalutamide in volunteers with baseline mild or moderate hepatic impairment (Child-Pugh Class A and B, respectively) versus healthy controls with normal hepatic function.

The composite AUC of enzalutamide plus N-desmethyl enzalutamide was similar in volunteers with mild or moderate baseline hepatic impairment compared to volunteers with normal hepatic function. No initial dosage adjustment is necessary for patients with baseline mild or moderate hepatic impairment. Baseline severe hepatic impairment (Child-Pugh Class C) has not been assessed [see Clinical Pharmacology (12.3)].

OVERDOSAGE In the event of an overdose, stop treatment with XTANDI and initiate general supportive measures taking into consideration the half-life of 5.8 days. In a dose escalation study, no seizures were reported at < 240 mg daily, whereas 3 seizures were reported, 1 each at 360 mg, 480 mg, and 600 mg daily. Patients may be at increased risk of seizure following an overdose.

NONCLINICAL TOXICOLOGY Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term animal studies have not been conducted to evaluate the carcinogenic potential of enzalutamide.

Enzalutamide did not induce mutations in the bacterial reverse mutation (Ames) assay and was not genotoxic in either the in vitro mouse lymphoma thymidine kinase (Tk) gene mutation assay or the in vivo mouse micronucleus assay.

Based on nonclinical findings in repeat-dose toxicology studies, which were consistent with the pharmacological activity of enzalutamide, male fertility may be impaired by treatment with XTANDI. In a 26-week study in rats, atrophy of the prostate and seminal vesicles was observed at ≥ 30 mg/kg/day (equal to the human exposure based on AUC). In 4-, 13-, and 39-week studies in dogs, hypospermatogenesis and atrophy of the prostate and epididymides were observed at ≥ 4 mg/kg/day (0.3 times the human exposure based on AUC).

Manufactured by: Catalent Pharma Solutions, LLC, St. Petersburg, FL 33716 Manufactured for and Distributed by: Astellas Pharma US, Inc., Northbrook, IL 60062 Marketed by: Astellas Pharma US, Inc., Northbrook, IL 60062 Medivation, Inc., San Francisco, CA 94105 Revised: September 2014 14B006-XTA-BRFS Rx Only © 2014 Astellas Pharma US, Inc. XTANDI® is a registered trademark of Astellas Pharma Inc.

076-0472-PM

Featured Profile

Amgen Inc

(888) 762-6436 www.amgenassist.com Amgen Assist provides support options for insured, uninsured, and underinsured patients: the Amgen FIRST STEP program assists eligible, commercially insured patients with the cost of their deductibles, coinsurance, and copays. The Safety Net Foundation, a nonprofit assistance program supported by Amgen, provides qualifying uninsured or underinsured patients with Amgen products free of charge. Amgen Assist also helps eligible patients with Medicare or Medicaid by providing referrals to independent copay foundations. A complete list of medications and potential support options are provided in the Table.

Amgen FIRST STEP The Amgen FIRST STEP medical benefit copay coupon program helps qualified, commercially insured patients with deductible, coinsurance, and copay requirements to pay their share of out-of-pocket costs. In order to qualify for this program, the patient

must be prescribed a covered drug; have private commercial health insurance that covers medication costs for these drugs under a medical benefit plan; must not participate in any federally funded, state-funded, or government-funded healthcare program; and must not be a resident of Massachusetts or any other state where coupons or copay programs are invalid.

Out-of-pocket costs must be associated with medications purchased and administered at a participating clinic or institution; the clinic or institution must be enrolled in the program before its patients can participate.

For the first dose of covered medication, 100% of the patients’ combined copayment, coinsurance, or deductible will be covered; for all subsequent doses, Amgen will pay the patient’s combined out-of-pocket copayment, coinsurance, or deductible in excess of $25 per dose. The total benefit for Prolia is ≤$1500 per patient, per 6-month coverage period. Total program benefits for all other covered

Table Potential Support Options for Covered Drugsa Potential support options Amgen FIRST STEP Program

Oncology drug Aranesp (darbepoetin alfa) Epogen (epoetin alfa)

Safety Net Foundation

Referral to independent copay foundation

X

X

X

X

Neulasta (pegfilgrastim)

X

X

X

Neupogen (filgrastim)

X

X

X

Nplate (romiplostim)

X

X

X

Prolia (denosumab)

X

X

X

X

X

X

X

X

X

Sensipar (cinacalcet)

b

Vectibix (panitumumab) Xgeva (denosumab)

X

Patients must meet eligibility criteria.

Patients who are prescribed Sensipar may also qualify for the Sensipar Pharmacy Card Program. Call (855) 553-7345 for more information. b

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Safety Net Foundation The Safety Net Foundation provides assistance to patients in medical need who are uninsured and have limited financial resources, and who reside in the United States or its territories. In certain cases, patients who are underinsured or who have Medicare Part D may qualify to receive support. To qualify, patients must complete an application and satisfy eligibility requirements.

Prospective Model Amgen products included in this model are Prolia and Sensipar.

Products in this model (for patients seeking assistance) can be shipped to the patient or provider. Patients can apply directly to the Foundation to get access to Amgen products. Pro­ viders applying for prospective products do not need to be enrolled in the Foundation, but must fill out the Foundation’s product prescription form or submit an original prescription in order to request products.

Product Replacement Model This model allows providers to order Amgen products to replace medications that have been administered to qualifying Foundation patients from existing stock. Multiple product replacements can be requested for a variety of patients on a single form.

Covered Amgen products include Aranesp, Epogen (for dialysis only), Neulasta, Neupogen, Nplate, Prolia, Vectibix injection, and Xgeva.

Replacements may be requested for treatments up to 6 months before the patient’s enrollment date. l

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drugs are ≤$5000 per patient, per 6-month coverage period. Six-month periods run from January 1 to June 30, and from July 1 to December 31.

Featured Profile

Astellas Pharma US, Inc/Medivation, Inc (855) 898-2634 www.astellasaccess.com/home/hcp/xtandi Xtandi Support Solutions helps providers and patients understand patients’ cost-sharing obligations and the mechanisms that are available to reduce the cost of Xtandi (enzalutamide) for eligible patients. Xtandi is indicated for metastatic castration-­ resistant prostate cancer.

Eligibility Xtandi Patient Savings Program This program is designed for patients who have private health insurance but may not be able to pay for out-ofpocket costs. The Xtandi copay card covers up to $5000 per prescription and up to $12,000 each calendar year.

Patients are not eligible for the program if they have prescription-drug cov­erage in part or in full from any state-funded or federally funded programs; there also are other rules and restrictions. Each drug refill will cost patients $20 or less out of pocket.

Referral to Independent Copay Foundation Third-party foundations provide patients, including those who are privately insured or those who have Medicare or Medicaid, who cannot afford out-of-pocket costs with assistance for copayments associated with Xtandi. Xtandi Support Solutions staff can help determine whether this option is appropriate for individual pa­tients and connect patients with foundations that may be able to help them. Each foundation has its own eligibility criteria and enrollment process.

Astellas Access Program This program is for patients without health insurance—although some Medicare Part D patients may be eli­ gible—and provides Xtandi free of charge to patients who meet certain

criteria. Patients must meet the following eligibility guidelines: • Have a prescription for Xtandi for an FDA-approved indication or in accordance with an authorized compendia listing • Be without insurance, waiting on determination of their eligibility for public assistance such as Medicaid, or denied Xtandi coverage by their health insurance plan • Have an annual household adjusted gross income <$100,000 • Have a verifiable shipping address within the United States.

A 30-day supply of the medication is mailed directly to the patient’s home after he or she has been enrolled in the program.

most recent W-2 form is required as proof of your patient’s income.

Receiving Medication Astellas notifies patients and their prescriber regarding enrollment in the Astellas Access Program. The patient will receive a 30-day supply of Xtandi shipped directly to their home; 30-day refills are sent automatically to the patient’s home for the duration of the approval period, which may be up to 1 year. Forty-five days before the end of the approval period a representative will contact the patient and his or her healthcare provider to discuss re-enrollment. The healthcare provider then can reapply on the patient’s behalf.

Xtandi prescriptions can only be filled at specialty pharmacies participating in the Xtandi network; a list of participating pharmacies is available online.

A 14-day supply of Xtandi is offered to eligible patients who have a delay in obtaining approval for coverage of Xtandi by their insurance provider.

Astellas’s QuickStart+ program is for patients who are beginning use of Xtandi. The program can be initiated by a physi­­cian, pharmacy, or Xtandi Support Solutions staff after the prescriber completes the QuickStart+ por­ ­tion of the Xtandi Support Solu­tions patient enrollment application. l

Application/Enrollment Process To determine whether a patient qualifies for payment assistance, his or her healthcare provider should fill out the enrollment form at www. astellasaccess.com and fax it to (855) 982-6341. The provider can call Xtandi Support Solutions or access Astellas eService to verify benefits and cost-­ sharing requirements and obtain more information about assistance options. Docu­ mentation such as a copy of the patient’s most recent tax return or

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Featured Profile

AstraZeneca (800) 292-6363 www.azandmeapp.com

AstraZeneca has offered patient assistance programs for the past 35 years, and is committed to helping eligible patients gain access to their medications. Its AZ&Me Prescription Savings Program aims to assist a variety of patient populations.

AZ&Me Prescription Savings Program AstraZeneca’s AZ&Me Prescrip­ tion Savings Program is designed to help 3 patient groups: (1) uninsured patients, (2) beneficiaries of Medicare Part D, and (3) those who receive their medications through participating healthcare facilities (eg, community health centers and charitable pharmacies). For a complete list of oncology drugs covered through this program as well as their indications, see the Table.

Eligibility Uninsured patients and those who are beneficiaries of Medicare Part D may qualify for enrollment in the program if they meet the following eligibility requirements: • They must reside in the United States, or have a Green Card or US work visa • The patient does not have prescription drug coverage through private or government insurance programs and is not receiving any other assistance to pay for medicine • They meet the program’s annual income requirements (ie, at or below $35,000 for a single person; $48,000 for a family of 2; $60,000 for a family of 3; $70,000 for a family of 4; and $80,000 for a family of 5) • Medicare Part D beneficiaries cannot be enrolled in or eligible for Limited Income Subsidiary for Medicare Part D. More information is available at

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Table Oncology Drugs and Disease State Oncology drug

Disease state/condition

Arimidex (anastrozole)

Postmenopausal women with certain types of breast cancer

Caprelsa (vandetanib)

Symptomatic or progressive medullary thyroid cancer

Faslodex (fulvestrant)

Hormone receptor–positive metastatic breast cancer in postmenopausal women

Zoladex (goserelin acetate implant)

Locally confined prostate cancer (in combination with flutamide); palliative treatment of advanced prostate cancer; palliative treatment of advanced breast cancer in premenopausal and perimenopausal women

www.azandmeapp.com/requirements.

In order to qualify for enrollment, healthcare facilities must meet several requirements, including the following: • There must be a licensed, outpatient pharmacy or dispensary onsite • They must have policies and procedures in place that are robust • They must hold their patients to eligibility requirements that are consistent with the program guidelines for patient eligibility (eg, patients have the necessary income requirements and are uninsured).

This program is designed to help provide AstraZeneca medicines to low-income patients through qualifying facilities, such as disproportionate share hospitals, free clinics, and charitable pharmacies. For more information, call (866) 325-8198.

Enrollment A prescreening program is available for uninsured patients and beneficiaries of Medicare Part D at www.azand meapp.com/eligibility/patient/medica tions, which determines whether the patient fulfills the basic requirements.

Eligible candidates will be prompted to complete an application form, which is available at www.azandme app.com/assets/app.pdf. Patients are also welcome to enroll by calling (800) 292-6363 to speak with an assis-

ONCOLOGY GUIDE TO PATIENT SUPPORT SERVICES

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tance specialist. Enrollment is valid for 1 year, after which eligible patients may re-enroll. Completed enrollment forms can be faxed by a physician to (800) 961-8323 or mailed directly to the program’s PO Box. For information about how to enroll as a healthcare facility, call (866) 325-8198. Enrollment for eligible facilities lasts 2 years, after which the establishment may re-enroll.

What Patients Will Receive Uninsured patients/beneficiaries of Medicare Part D: Once the patient is enrolled, he or she may receive up to a 90-day supply of medication, the quantity of which is determined by the prescriber. Medications are sent to the patient’s home or to his or her physician’s office.

Refill requests can be made by calling (800) 292-6363; once the patient is enrolled in the AZ&Me Prescription Savings Program, prescriptions can be filled via this automated phone line 24 hours a day, 7 days a week.

Healthcare facilities: Eligible facilities will be able to distribute Astra­Zeneca medications to qualifying patients free of charge or for a nominal, facility-assessed fee from their outpatient pharmacy or dispensary, and may become part of a bulk replacement program. l

Featured Profile

Bayer HealthCare Pharmaceuticals Inc (866) 639-2827 www.reachpatientsupport.com Bayer HealthCare Pharmaceuticals provides a variety of support servic­­ es for eligible patients, including REACH (Resources for Expert Assistance and Care Helpline) nurse counselors, who are available to provide patient education and support, such as Patient Starter Kits, and answer questions about therapy.

In addition, service counselors are available to provide benefit verification and specialty pharmacy provider identification, prior authorizations, denials and appeals information, help or assistance with copays for commercial insurance, as well as a patient assistance program for qualified pa­ tients who are uninsured or underinsured, and information for alternative programs to help eligible patients pay for their medications. Through the REACH $0 Co-Pay Program, privately insured patients may qualify for a $0 copay, up to $4000 per month and up to $16,000 per year in assistance.

Oncology drugs supported by the program are Nexavar (sorafenib), which is indicated for the treatment of unresectable hepatocellular carcinoma, advanced renal cell carcinoma, and locally recurrent or metastatic, progressive, differentiated thyroid carcinoma, and Stivarga (regorafenib), which is indicated for the treatment of patients with metastatic colorectal cancer who have received previous therapy, and unresectable or metastatic gastrointestinal stromal tumors who have been treated previously with certain therapies.

Eligibility Criteria Patients may be eligible to enroll in the Patient Assistance Program provided by Bayer HealthCare Pharma­ ceuticals if they are financially uninsured or underinsured.

For the $0 Co-Pay Program, only

privately insured patients who were not previously enrolled in the REACH Commercial Co-Pay Assistance Program are eligible for this Program. Patients enrolled in Medi­care, Medicaid, or any government-funded programs are also not eligible for $0 copay assistance.

In addition, patients may have access to Temporary Patient Assistance Programs, which offer help to qualified patients so that they may receive the medication if they are waiting for insurance approval.

reminders and information re­­ garding adverse events.

Receiving Medication The Patient Assistance Program provides eligible patients with a month’s supply of the medication shipped to their home. Patients who meet eligibility requirements for the program will receive assistance for a year, after which they must reapply.

Other Services In addition to the Patient Assistance Program, the $0 Co-Pay Program, and the Temporary Patient Assistance Program, the following programs are also available for patients: • The State Pharmaceutical Assis­tance Programs provide prescription coverage and payment assistance for the disabled and low-­­income seniors who qualify. Patients can ask a REACH counselor for more information about this program in their respective states.

• The Commercial Co-Pay Assistance Program can help privately insured patients with their copay or coinsurance. A REACH counselor can provide details and further information on patient eligibility.

• Other sources of assistance include referrals to independent charitable foundations or support groups that may assist patients with their copay or other related medical expenses.

Patients can ask a REACH counselor to help them. l

Enrollment Eligible patients can turn to REACH and call (866) 639-2827 to speak to a specially trained REACH counselor who will assist with the following: • Communicate with insurance companies and help patients obtain coverage for their medication— from obtaining authorization of coverage to following through if coverage is denied • Help to determine if you qualify for financial assistance and assist with the application process • Identify and electronically submit prescriptions to the specialty pharmacy provider that will fill the prescription and send it directly to your home • Provide you with the patient education and support you need while on therapy, such as refill

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Featured Profile

Boehringer Ingelheim Pharmaceuticals, Inc (877) 814-3915 www.bisolutionsplus.com

Boehringer Ingelheim offers a variety of support programs to patients with cancer in the United States.

Through Solutions Plus, the Gilotrif (afatinib) Expanded Access Program, and the Boehringer Ingelheim Cares Foundation Patient Assistance Pro­ gram, patients prescribed Gilotrif, which is used in the treatment of metastatic non–small-cell lung cancer, may have access to free medicine, reimbursement support, or copay assistance. The programs differ in structure for insured, privately insured, and uninsured patients.

Solutions Plus

(877) 814-3915 www.gilotrif.com/patients_and_ caregivers/support_program/ support_program.html

Solutions Plus provides eligible patients receiving treatment with Gilotrif a wide range of access, reimbursement, and clinical solutions by which they can swiftly and affordably get access to their medication.

Patients learn more about eligibility criteria by calling (800) 859-9673.

What Patients Will Receive Clinical support solutions: • Patients will receive a Patient Support Kit. • Patients enrolled in Solutions Plus can sign up for a Nurse Support Program, which provides dedicated oncology nurses who speak to patients and offer help during their first few weeks.

• Solutions Plus partners with Accredo for specialty pharmacy services to offer patients consistent, efficient, and reliable support.

Access and reimbursement solutions: • Eligible patients can receive assistance with prior authorizations, benefit verifications, denials, and appeals.

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• Alternative funding and copay assistance are available for eligible patients seeking financial support.

• Patients and insurers will receive a refund if treatment is discontinued before the first prescription refill if certain criteria are met.

Enrollment Interested applicants can call Solutions Plus at (877) 814-3915.

Enrollment forms are also available online by visiting www.gilotrif.com, then clicking on Solutions Plus, followed by Enrollment. Applications must be faxed to (866) 240-4556 or mailed directly to the program’s PO Box. Prescriptions must be submitted for processing with enrollment and patient authorization forms.

Distribution Solutions Plus works closely with Accredo to ensure timely distribution, transition from enrollment to filling the prescription, and consistent patient support. Gilotrif is also available at select onsite pharmacies, including certain group practices and hospitals with outpatient clinics.

Afatinib Expanded Access Program

(877) 814-3915 http://us.boehringer-ingelheim. com/eap.html

The afatinib Expanded Access Program is an investigational, multicenter, open-label trial. To qualify for enrollment, patients must meet the following criteria: •R eside in the United States • Have locally advanced or metastatic non–small-cell lung cancer • Test positive for epidermal growth factor receptor mutations • Meet other inclusion and exclusion criteria.

ONCOLOGY GUIDE TO PATIENT SUPPORT SERVICES

I December 2014

Patients can learn more about the afatinib Expanded Access Program at www.clinicaltrials.gov using the NLM Identifier NCT01649284, or by calling (855) 327-2474.

Boehringer Ingelheim Cares Foundation Patient Assistance Program

(800) 556-8317 http://us.boehringer-ingelheim.­ com/our_responsibility/patients-­ families/patient_­assistance_­ program.html

The Boehringer Ingelheim Cares Foundation Patient Assistance Program offers medications free of charge to eligible patients in the United States who meet income and other eligibility criteria. Candidates cannot be eligible for prescription drug assistance through Medicare, Medicaid, Medicare Part D, or private insurance. Patients under Medicare Part D who cannot afford their medication costs may be eligible to enroll, as long as they meet other eligibility criteria and do not have any other prescription drug coverage.

What Patients Will Receive Boehringer Ingelheim drugs are shipped in a 90-day supply to qualifying patients. Most medications can be delivered to the patient’s home or to the prescribing physician’s office.

Enrollment Applications must be faxed to (866) 851-2827 from a prescriber’s facility or mailed directly to the program’s PO Box. Prescriptions must be submitted for processing with the application form, along with proof of income. Interested applicants should call the Boehringer Ingelheim Cares Foundation Patient Assistance Program for more information. l

Featured Profile

Bristol-Myers Squibb Company (855) 302-7557 www.bmsaccesssupport.com | www.bmspaf.org Through its Access Support Program, Bristol-Myers Squibb (BMS) offers a variety of oncology support options for patients receiving outpatient treatment in the United States and Puerto Rico, and, in certain circumstances, the Virgin Islands. See the Table for ­a listing of covered oncology and oncology-­supportive drugs as well as their indications. Oral drugs may be shipped to the provider or the patient.

Programs/Eligibility Criteria • Access Support. This program is available to insured patients with reimbursement needs for certain BMS oncology medications, and provides resources such as benefits investigations as well as prior authorization and appeals support.

Support representatives may also assist patients with referrals to the following programs: • BMS Oncology Co-Pay Program.

This program is available for patients who have been prescribed Ixempra

(ixabepilone) and Yervoy (ipilimumab). Commercially in­ sured pa­ tients who need financial assistance with out-of-pocket de­ductibles, co­­ pays, or coinsurance may be eligible.

• BMS Patient Assistance Founda­tion (BMSPAF). Patients may be re­ ferred to this independent, nonprofit organization if they meet the income limits for the requested medication and other insurance criteria. Patients may also be eligible if they are uninsured, have been denied coverage for the requested medication, or are enrolled in a Medicare Part D plan that covers the medication and have spent at least 3% of their yearly household income on out-of-pocket costs for prescription medications this year.

For more information on these programs, visit www.bmsaccess support.com.

patient-specific and plan-specific benefits investigations, comprehensive coverage research, claims appeals, prior authorization, and specialty pharmacy coordination services.

• BMS Oncology Co-Pay Program.

Eligible patients pay the first $25 of their copay per infusion. BMS will cover all medication-related expenses, up to $25,000 per year per product.

• BMSPAF. Eligible patients may qualify to receive medications free of charge; the supply of medication provided depends upon the type of medication and route of administration (oral or infusion).

Enrollment Completion of an enrollment form is required for Access Support. Patients or providers should indicate the Access to Care Services in which the patient wishes to enroll, such as the BMS Oncology Co-Pay Program, Comprehensive Coverage Research, or the Specialty Pharmacy Services.

Forms are available at www.bms customerconnect.com/bmsaccesssup port/oncology/forms-and-­documents.

To enroll in the BMS Oncology Co-Pay Program, patient name, address, insurance carrier, member identification, and provider office identification number are required.

Enrollment forms specific to each oncology drug are available at www. bmsaccesssupport.com.

An application is required to enroll in BMSPAF. Proof of income should be submitted with the application. The healthcare provider should sign the application and return it to the foundation by mail or fax to (866) 694-2545. The enrollment form is available at www.rx hope.com/PAP/pdf/2011_Oncology ­%20Application.pdf. l

What Patients Will Receive • Access Support. Access Support will assist the oncology practice with

Table O ncology and Oncology-Supportive Drugs and Indications Oncology drug

Indications

Droxia (hydroxyurea)

Melanoma Chronic myeloid leukemia Carcinoma of the ovary Primary squamous cell carcinoma of the head and neck

Erbitux (cetuximab)

Advanced squamous cell carcinoma of the head and neck

Etopophos (etoposide phosphate) Refractory testicular tumors Small-cell lung cancer Lysodren (mitotane)

Adrenal cortical carcinoma of functional and nonfunctional types

Ixempra (ixabepilone)

Metastatic or locally advanced breast cancer

Opdivo (nivolumab)

Unresectable or metastatic melanoma

Sprycel (dasatinib)

Newly diagnosed Ph+ CML; in chronic phase; chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to therapy; Ph+ acute lymphoblastic leukemia

Yervoy (ipilimumab)

Unresectable or metastatic melanoma

Ph+ indicates Philadelphia chromosome-positive; CML, chronic myeloid leukemia.

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Featured Profile

Celgene Corporation

(800) 931-8691 www.celgenepatientsupport.com/commercial_insurance.aspx Celgene Patient Support offers healthcare professionals and patients access and reimbursement assistance from a single specialist assigned to each doctor’s office. Regardless of the insurance situation, Celgene Patient Support helps patients access their Celgene medication. Through Celgene’s support programs, patients prescribed Celgene medications potentially have access to free medicine, reimbursement support, and copay or travel assistance.

The Celgene Commercial Co-Pay Program helps eligible patients receiving Celgene medications reduce their out-of-pocket costs. The program provides up to $10,000 annually to assist with deductibles and copay or coinsurance costs. Depending on the Celgene medication prescribed, qualified pa­ tients can lower their out-of-pocket costs to $25 or less. For a complete list of oncology drugs covered through this program, see the Table.

Uninsured or underinsured pa­ tients who meet required financial criteria may qualify to receive Celgene products free of charge through the Celgene Free Medication Program. For a complete list of oncology drugs covered through this program, see the Table.

United States or Puerto Rico who have commercial or private insurance and a household income of ≤$100,000 may qualify for copay assistance. A random audit may be required to verify the applicant’s household income.

For patients with Medicare, Medicaid, or any other type of government-sponsored insurance, Celgene Patient Support offers information about funding through independent organizations. For more information about options for patients with government-­ sponsored insurance, call Celgene Patient Support at (800) 931-8691.

Eligibility for the Celgene Free Medication Program is based on the applicant’s household income and assets. Income is determined based on a patient’s salary as well as earnings from dividends, disability compensation, pension, Social Security, and rental properties. Assets are determined based on a patient’s savings, checking, and money market Eligibility Criteria accounts; credit default swap; and For the Celgene Commercial Co-­ the estimated market values of their Pay Program, patients residing in the Individual Retirement Accounts, Table Covered Oncology Drugs Celgene Commercial Co-Pay Program

Celgene Free Medication Program

Abraxane (paclitaxel protein-bound particles for injectable suspension) (albumin-bound)

Abraxane (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) Istodax (romidepsin) Pomalyst (pomalidomide) Revlimid (lenalidomide) Thalomid (thalidomide) Vidaza (azacitidine)

Pomalyst (pomalidomide) Revlimid (lenalidomide) Thalomid (thalidomide)

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stocks, mutual funds, and bonds.

Patients can learn more about eligibility requirements for the Celgene Free Medication Program at www.celgenepatientsupport.com/ uninsured_patients.aspx, or by calling (800) 931-8691 to speak with a dedicated Celgene Patient Support Specialist.

Enrollment Enrollment forms are available at http://celgenepatientsupport.com/ pdf/PAA-form.pdf. Applications must be faxed to (800) 822-2496 or e-mailed to patientsupport@celgene. com. Applicants can also call (800) 931-8691 to speak with a dedicated Celgene Patient Support Specialist and enroll by phone.

Distribution and Travel Assistance Because of the risks associated with certain medications, a selection of Celgene products are only available through restricted distribution programs. Prescriptions for drugs that require restricted distribution must be filled at select pharmacies.

Celgene Patient Support can also help locate options to assist patients with the costs of traveling to doctors’ appointments. Patients can call Celgene Patient Support at (800) 931-8691 to learn more about attaining restricted distribution products or to get more information on travel assistance. l

Your One Source for Patient Support IncyteCARES connects eligible patients taking Jakafi® (ruxolitinib) to ongoing support and resources during their treatment.

Reimbursement Assistance • Benefit verification • Prior authorization • Appeal support

Access

Education & Support

• Co-pay assistance

• Access to trained nurses

• Free medication program

• Educational information to help teach your patients about their condition

• Referrals and assistance with independent not-for-profit organizations

• Patient education packet

Connect Today Visit www.IncyteCARES.com or call 1-855-4-JAKAFI (1-855-452-5234) Monday–Friday, 8 AM–8 PM ET, to learn more about how to connect your patients to IncyteCARES.

Jakafi is a registered trademark of Incyte Corporation. © 2014, Incyte Corporation. All rights reserved. RUX-1378 04/14

Featured Profile

Dendreon Corporation (877) 336-3736 www.DendreonOnCall.com Dendreon is committed to helping patients who are eligible for treatment with Provenge (sipu­leucel-­­T) gain access to payment assistance if needed.

Through Dendreon ON Call, patients who have been prescribed Provenge may be eligible for a variety of services: patient assistance programs, referrals ­­to independent foundations for financial assistance, and reimbursement or financial support. An autologous ­cellular im­munotherapy, Provenge is ­indicated for the treatment of asymptomatic or minimally symptomatic met­astatic castrate-resistant (hormone-­ resistant) prostate cancer.

Application/Enrollment Process To determine whether a patient qualifies for payment assistance, healthcare providers can fill out an enrollment form at www.provenge ­reimbursement.com/pdf/writeable-­ approved-pap-enrollment-150k.pdf and fax it to (877) 556-3737. Pa­­ tients can determine their eligibility directly by filling out the second page of the enrollment form and/or calling a patient care representative at (877) 336-3736.

Support for Patients with Government Insurance A reimbursement coordinator can refer patients to an independent foundation that can help patients with assistance in paying copayments, coinsurance, and de­ductibles.

Each foundation makes independent decisions of who is eligible, based on financial need and other criteria.

Dendreon cannot guarantee that

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patients will be eligible for or receive assistance after referral; it does not have influence on the foundations.

Support for Patients with Commercial Health Plans PROvide offers eligible patients financial assistance with any combination of cost—copays, coinsurance, and deductibles—up to a max­­imum of $6000 during the 3 Pro­venge treatments. To be eligible, patients must be aged ≥18 years ­­and a US resident, and have private, commercial health insurance (patients with government-funded insurance including Medicare, Medi­care Part D, Medicaid, or TRICARE are not eligible); a household adjusted gross annual income ≤$150,000; and an on-label prescription for Provenge.

The participating physician must attest that by participating in the program he or she will not submit any third-party claims for patient cost-sharing expenses that are covered by the PROvide commercial copay program and agree to disclose his or her participation in the commercial copay program to third-party payers when required to do so. The participating patient must at­­test that he or she meets residency and household income requirements.

Dendreon reserves the right to modify the eligibility requirements or discontinue the program at any time.

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Support for Patients Without Coverage for Provenge Adult patients with an annual household adjusted gross income of ≤$150,000, who are US residents, and who have an on-label prescription for Provenge may be eligible to receive the drug at no cost to them if (1) their claim to their payer—along with all appeals—is denied, or (2) if they have no health insurance or do not have drug coverage. Note that Dendreon can change the eligibility criteria for or discontinue PROvide and the Uninsured Patient Program at any time at its sole discretion.

Support for Travel Expenses Dendreon can help patients with travel expenses associated with Dendreon treatments through independent travel-assistance foun­­ dations. A Dendreon ON Call case manager can refer patients to ­an independent foundation to determine if they are eligible for help with these costs. The foundations’ decisions are based on the patient’s financial need and other eligibility criteria. Dendreon cannot guarantee that patients will either be eligible for or receive financial help after referral to a travel-assistance foundation; it does not have influence on the foundations. l

Featured Profile

Eisai Inc

(866) 612-4724 www.eisaireimbursement.com Through Eisai Reimbursement Resources, patients who are prescribed Eisai products can find product-specific resources related to coding, coverage, and reimbursement of select products, as well as a variety of patient assistance services. For a list of oncology and oncology-supportive drugs covered through Eisai reimbursement and/or patient assistance services, see the Table.

Table Oncology and Oncology-Supportive Drugs and Indications Oncology/oncologysupportive drugs

Indications

Akynzeo (netupitant/palonosetron)

Prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of cancer chemotherapy, including highly emetogenic chemotherapy

Aloxi (palonosetron HCl injection) Prevention of acute and delayed nausea and vomiting in adults associated with initial and repeat courses of moderately emetogenic chemotherapy; prevention of acute nausea and vomiting associated with initial and repeat courses of highly emetogenic chemotherapy

Eisai Reimbursement Services Eisai Reimbursement Services are product-specific; patients and providers are encouraged to visit www. eisaireimbursement.com and select their prescribed medication or medication of interest for more information on programs specific to the selected treatment. Resources such as product information, general coding and billing information for each treatment, billing forms, and coverage policies for patients in a variety of care settings with Medicare, Medicaid, and commercial insurance are available. Links to relevant forms and codes, documents to help patients and providers who are appealing a denied claim, coverage scenario flowcharts, and checklists for claims submissions are among the resources available online. Patients and providers who are in need of other reimbursement support or who have additional reimbursement questions can call (866) 613-4724.

nancially needy patients who meet program eligibility criteria, including US residency as well as financial parameters, clinical status, and site-ofservice specifications. Coverage and payment depend on patients’ insurance plans; services and resources offered are also dependent upon the prescribed medication. Reimbursement information, insurance verification processing, prior authorization information, and guidance regarding denied claims may also be available. Patients and providers can learn more information by calling the following phone numbers: • Akynzeo: (855) 347-2448 • Aloxi and Halaven: (866) 613-4724 • Hexalen: (800) 769-3880

Patient Assistance Programs (PAPs) Assistance is available for patients who have been prescribed Eisai products and are having difficulty covering the cost of care. Through the PAP, certain medications may be available at no cost or low cost to fi-

Enrollment Completed PAP enrollment forms should be faxed with a valid prescription to (866) 573-4724 or mailed to the program’s PO Box; forms are available at www.eisaireimbursement.com/ Halaven/downloads/Eisai_Oncology %20PAP%20App_ALv.pdf.

Halaven (eribulin mesylate)

Treatment of patients with metastatic breast cancer who have previously received at least 2 chemotherapy regimens for the treatment of metastatic disease with an anthracycline and a taxane in adjuvant or metastatic settings

Hexalen (altretamine)

Palliative treatment of patients with persistent or re­­­­ current ovarian cancer following first-line therapy with a cisplatin and/or alkylating agent–based combination

December 2014

A copy of the patient’s insurance card as well as financial documentation should be attached. Accepted financial documents include a federal tax return, a Social Security benefit statement, 1 month of paycheck stubs, unemployment statements, or disability statements.

Copay Programs Commercially insured patients who have been prescribed Akynzeo may be eligible for the Akynzeo Savings Card Program. Through this program, most patients will pay the first $25 of their monthly outof-pocket prescription cost, and Eisai will pay up to $100 per month per prescription, to a maximum of $1200 per year. Benefits may differ for patients paying cash. The savings card cannot be used in combination with other coupons or offers, and is not available to patients with state or federal healthcare programs.

For more information, call (855) 347-2448 or visit www.akynzeo. com/savingscard. l

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Featured Profile

Eli Lilly and Company (866) 472-8663 www.lillypatientone.com

Eli Lilly and Company (Lilly) offers assistance to patients in the United States and Puerto Rico who are unable to afford their medications.

TruAssist Lilly TruAssist, available at www. lillytruassist.com, is a platform that provides a description of Lilly’s patient assistance programs. Patients can browse the programs using the Pro­ gram Tool Finder, available at www. lillytruassist.com/findprogram.aspx.

PatientOne Through the PatientOne program, patients who are uninsured, under­ insured, insured, denied a claim, or have difficulty affording their copay or coinsurance may be eligible to receive financial assistance, reimbursement assistance, or Lilly Oncolo­ gy products at no cost. The two programs fall under the umbrella of the Lilly PatientOne program: the Patient Assistance Program and the Patient Reimbursement Assistance Program.

PatientOne covered drugs include: • Alimta (pemetrexed) • Gemzar (gemcitabine hydrochloride) Eligibility Criteria Patients who are uninsured, underinsured, or insured may qualify for the Reimbursement Assistance Program if they meet the following requirements: • Provide proof of residency within the United States or Puerto Rico • Receive administration of a qualified Lilly Oncology drug within the United States.

Patients who are uninsured, underinsured, or insured may qualify for en­­ rollment in the Patient Assistance Pro­­ gram if they meet the following criteria: • Meet the requirements for patients seeking reimbursement assistance • Currently receiving ongoing therapy

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• Do not have insurance, or have in­ surance that does not cover therapy • Service date must be within 180 days from the date PatientOne receives a patient’s application • Patient will be given treatment in an outpatient setting • Patient meets the financial requirements of the program.

Enrollment Authorization forms for patients interested in enrolling in the Pa­­ tientOne program are available at http://lillypatientone.com. Qualified patients can apply for the Patient Assistance Program or for the Patient Reimbursement Assistance Program.

Uninsured patients who meet eligibility requirements and are earn­­ing up to 500% of the federal poverty level can apply to the PatientOne Patient Assis­ tance Program using the enrollment application form, available at www.lillypatientone.com/ documents/application.pdf.

Underinsured patients who are unable to afford their copays and deductibles may be able to receive assistance from PatientOne in the form of referrals to programs that can help them cover their out-of-pocket expenses. Patients who meet the eligibility requirements available in detail at www.lillypatientone.com/lilly-patient one-eligibility.aspx may qualify to enroll in the PatientOne Patient As­­

ONCOLOGY GUIDE TO PATIENT SUPPORT SERVICES

I December 2014

sistance Program.

Insured patients who are receiving eligible Lilly Oncology products but facing a denied claim can apply for re­ source support from the Reim­ bursement Assistance Program. The Re­­ imbursement Assistance Applica­ tion form is available at www.lillypatient one.com/_Assets/new_pdf/Patient_ Reimbursement_Patient_Auth.pdf.

What Patients Will Receive Uninsured patients may be eligible to receive Lilly Oncology products at no cost. Once patients are enrolled in the Patient Assistance Program, ap­proved dates of service will be determined, and product replacement vials may be sent directly to the provider’s office.

Underinsured patients can call the PatientOne hotline. Representatives can assess the patient’s needs, provide further information, and provide an ap­­plication for enrollment in the Pa­­ tient Assistance Program, if applicable.

Insured patients who receive an eligible Lilly Oncology product and are facing a denied claim can receive support by completing the Reimburse­ ­ment Assistance Application.

Patients who have been prescribed Cyramza (ramucirumab) may qualify for the Cyramza Co-pay Program, in which eligible patients pay ≤$50 per infusion. More information is available at http://cyramzahcp.com/resourc es/copay.aspx. l

Promote the value of oncology navigation to your organization and bottom line

Network with your oncology navigation team at the

AONN+ West Coast Regional Meeting May 18 – 20, 2015 in Seattle, Washington

“

Financial Navigators a new buzz word is circling cancer centers right now. Navigators and patient advocates need to make sure that there is a clear understanding on the part of the patient what the cost of care means for them. Start talking with your oncology navigation team and see what the plans are for obtaining cost information for patients going forward, and get to know the financial navigator who will be involved in your clinic by attending the AONN+ West Coast Regional Meeting.”

Lillie Shockney, RN, BS, MAS, CBPN-IC, Program Director, Academy of Oncology Nurse & Patient Navigators (AONN+)

TUESDAY | MAY 19, 2015 10:45 AM - 11:45 AM

Special Session in Partnership with the Association for Oncology Practice Management

Value-Based Strategies for Navigation

with:

LINDA BOSSERMAN, MD, FACP Assistant Clinical Professor Community Medical Oncologist Breast Cancer and Oncology Medical Home Specialist City of Hope Medical Group

Meeting Topics Include:

Who Should Attend:

Best practices in navigation

Continuing education units

Oncology nurse navigators

Oncology social workers

Nuances in providing valuebased care in oncology

Psychosocial care for cancer patients

Practice managers

Administrators

Impact of prehabilitation and rehabilitation

Commission on Cancer case studies

Financial Counselors

Case managers

Survivorship

Networking opportunities

Patient or non-clinically licensed navigators

Oncology nurses and nurse practitioners

Visit AonnOnline.org to find out more and register today!

NON-MEMBERS EARLY BIRD REGISTRATION (ends 1/31/15) $135 Clinically Licensed | $110 Non-Clinically Licensed MEMBERS (ends 5/18/15) $115 Clinically Licensed | $100 Non-Clinically Licensed

Featured Profile

Genentech, Inc (888) 249-4918 www.genentech-access.com Genentech Access Solutions provides programs and services to help facilitate access to Genentech BioOncology medicines for eligible patients and healthcare professionals.

Services include benefits investigations, financial assistance options, and resource support, and vary depending on patients’ insurance status. For a list of medicines covered by Genentech Access Solutions programs, see the Table.

Access Solutions What Patients Will Receive Access Solutions can conduct a benefits investigation to facilitate an understanding of patients’ health in­ surance coverage and potential costs associated with treatment; each investigation is medication-specific. The in­­ vestigation may determine whether the treatment is covered, requires prior au­­ thorization, or is denied. If treatment is denied, an Access Solutions representative can help determine next steps.

The program also offers resource support for questions related to billing and coding, as well as appeals for denied claims. If a patient’s coverage for a Genentech BioOncology medicine is denied, it is important to first understand the reason(s) for the denial, which should be explained in a letter from the insurer or the patient’s explanation of benefits. An Access Solutions representative can then provide guidance during the develop-

ment of an appeal; tips and checklists are available for appeals processes.

Additional services and resources may be available, dependent upon the prescribed medication’s route of administration (infusion or oral), distribution, and/or site of service. For more information, call (888) 249-4918.

Enrollment Patients who wish to enroll in Access Solutions should complete the Statement of Medical Necessity form with their physicians, as well as a Patient Authorization and Notice of Release of Information form. These forms can be used to initiate a benefits investigation as well as help identify the need for prior authorization.

Access Solutions representatives can assist the patient and provider in completing these forms. For more information, call (888) 249-4918.

Genentech Access to Care Foundation (GATCF) Eligibility Uninsured patients, insured pa­ tients, as well as those who have been denied coverage for a prescribed Gen­ entech product(s) may qualify for the GATCF program if they meet eligibility criteria. Those without coverage must have a household adjusted ­gross income (AGI) of ≤$100,000, or >$100,000 to ≤$150,000 if their Genentech medicines account for at least 10% of their annual household

Table Infusion and Oral Oncology Drugs

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Infusion oncology drugs

Oral oncology drugs

Avastin (bevacizumab) Gazyva (obinutuzumab) Herceptin (trastuzumab) Kadcyla (ado-trastuzumab emtansine) Perjeta (pertuzumab) Rituxan (rituximab)

Erivedge (vismodegib) Tarceva (erlotinib) Zelboraf (vemurafenib)

ONCOLOGY GUIDE TO PATIENT SUPPORT SERVICES

I December 2014

AGI and they have exhausted all other assistance options. Patients whose insurance covers Genentech medicines may qualify if their household AGI is ≤$150,000, their Genen­ tech medicines account for at least 10% of their annual household AGI, and they have exhausted all other assistance options. Patients must also meet medical eligibility criteria set out by a GATCF Clinical Advisory Board.

Enrollment Patients who wish to enroll should complete the Statement of Medical Necessity form with their physicians, as well as a Patient Authorization and Notice of Release of Information form. In addition, uninsured patients must complete an insurance attestation form; all applicants should complete a confirmation of infusion or injection for office-administered products. Eligible patients who meet specified insurance, financial, and medical criteria may qualify to receive their Genentech medication at no cost. For more information, contact a GATCF specialist at (866) 422-2377.

Copay Card Program Genentech also offers assistance options to help patients cover out-ofpocket costs associated with their medications. Visit www.genentech-­ access.com/biooncology/hcp and click Genentech BioOncology Co-pay Card, or call (855) 692-6729, to learn more about copay assistance for specific medications.

Copay Foundations Genentech Access Solutions staff also can connect patients to independent copay assistance foundations. A list is available at www.genentech-­ access.com/hcp/find-patient-assistance/ co-pay-foundation. l

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The Academy of Oncology Nurse & Patient Navigators (AONN+) invites you to share your story of how cancer has affected you or a loved one. These stories will serve as a forum to build awareness and be a source of inspiration and reassurance to others. Select stories will be featured on the AONN+ website and in future issues of the Journal of Oncology Navigation & SurvivorshipÂŽ.

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Featured Profile

Gilead Sciences, Inc (844) 622-2377 www.zydeligaccessconnect.com Gilead offers eligible patients receiving treatment with Zydelig (idelalisib) ease of access, affordability, and adherence support through its patient assistance program, Zydelig AccessConnect. Zydelig is a kinase inhibitor approved for the treatment of relapsed follicular B-cell non-Hodgkin lymphoma, relapsed small lymphocytic lymphoma, and in combination with rituximab in the treatment of relapsed chronic lymphocytic leukemia.

What Patients Will Receive Qualified patients enrolled in Zydelig AccessConnect will receive access, financial, and adherence support, including the following: • Access Support. Case Specialists at Zydelig AccessConnect can help eligible patients and their providers by ensuring timely delivery of their medications, explaining the benefits of Medicare Part D, and providing a better understanding of the details and requirements ­­of their insurance coverage with regard to Zydelig.

• Financial Support. Uninsured patients may be eligible to receive Zydelig free of charge through the Zydelig AccessConnect Patient Assistance Program, and patients with commercial or private insurance may qualify for copay coupon assistance. Referrals to independent foundations capable of offering financial support may ­­be available for patients with Medicare.

• Adherence Support. With the help of Zydelig AccessConnect’s Patient Support Nurses, eligible

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patients can receive tips on how to join support networks, take their prescribed medication as advised, and communicate with their provider regarding their treatment.

Copay Coupon Card Eligibility To qualify for the Copay Coupon Card, patients must meet the following eligibility requirements: • They must have a valid prescription for Zydelig • The patient must reside in the United States, Puerto Rico, Guam, or the Virgin Islands • They cannot be enrolled in any state-funded or federally funded health insurance programs (eg, Medicaid, Medicare, or Medigap).

Enrollment Using the online enrollment form available at www.activatethecard. com/zydelig, eligible patients can sign up for the Copay Coupon Card themselves and, right after doing so, can print out a copy of their card.

The card is valid for 1 year following the date of receipt, or for 15 fills within that 12-month time span.

What Patients Will Receive The Zydelig AccessConnect Copay Coupon Card will cover outof-pocket costs for Zydelig after the first $5 of each prescription fill, for up to a maximum of 25% of the catalog price of a year’s supply of Zydelig.

Government Insurance Support Patients who are enrolled in government health insurance programs

ONCOLOGY GUIDE TO PATIENT SUPPORT SERVICES

I December 2014

(eg, Medicare) but cannot afford the full out-of-pocket costs for the copays and coinsurance may be eligible for assistance from independent foundations. Information about independent assistance foundations and referrals is available at www.zydeligaccessconnect.com/ hcp/afford/government-­insurancesupport.

Patient Assistance Program Patients who do not have insurance coverage for Zydelig may be eligible to receive the medication free of charge through the Zydelig AccessConnect Patient Assistance Program. To qualify they must reside in the United States, be enrolled in Zydelig AccessConnect, and be receiving care from a US physician.

Additionally, they cannot have insurance coverage for the requested medication. For more information about the Patient Assistance Pro­ gram, call (844) 622-2377.

Zydelig QuickStart Program The Zydelig QuickStart Program gives eligible patients who have an insurance-coverage delay of >5 business days rapid access to a free, 1-time, 30-day supply of Zy­­ delig.

The purchase of Zydelig is not compulsory for participation in the program, but certain restrictions may apply. Patients can enroll in the Zydelig QuickStart Program by filling out section 8 of the Zydelig AccessConnect enrollment form.

Section 8 of the en­­rollment form also includes de­­ tailed information about eligibility criteria and what patients can expect to receive from the Zydelig QuickStart Program. l

Innovations in Oncology Management A newsletter series for oncology practice administrators, administrative staff, advanced practice clinicians, and oncology pharmacists.

The series will provide concise, up-to-date information on current issues that are impacting the business of oncology.

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Good Manufacturing Process

Topics include: Part 1: Patient Support Services Part 2: Oral Parity Legislation Part 3: Emerging Payment and Delivery Models Part 4: Working Collaboratively with Local Payers TO VIEW THE SERIES ONLINE PLEASE LOG ON TO:

innovationsinoncologymanagement.com Supported by funding from Celgene Corporation and Celgene Patient Support. Manufacturer did not influence content.

EHC388 Innovations A-Size_111314

Featured Profile

GlaxoSmithKline (866) 265-6491 www.gskcta.com

GlaxoSmithKline (GSK) offers support programs to patients with cancer in the United States or Puerto Rico. Through its Commitment to Access (CTA) program, patients prescribed GSK medications potentially have access to free medicine, reimbursement support, or copay assistance. The programs differ in structure for federally insured, privately insured, and uninsured patients. For a complete list of oncology and oncology-­ supportive drugs covered through these programs as well as their indications, see the Table.

Eligibility Criteria Patients with a household income of ≤500% of the federal poverty level (FPL) may qualify for the following programs if other criteria are met: • Patient Assistance. GSK offers cancer medicines free of charge to eligible patients in the United States and Puerto Rico who meet income and other eligibility criteria. Can­ didates cannot be eligible for Medi­ caid or Puerto Rico’s Govern­ment Health Plan or have coverage for brand name prescription drug benefits. Patients under Medicare Part D who spend ≥$600 on prescription medicines during the current calendar year are eligible to enroll.

• Reimbursement Support. Patients who have private prescription drug coverage, and are in a health plan that permits member participation in copay assistance programs may be eligible if other criteria are met. Financial assistance will vary depending on the FPL percentage range at the time of enrollment and specific commercial insurance coverage.

• Copayment Assistance. This program is available to patients with commercial insurance coverage, in­

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Table Oncology and Oncology-Supportive Drugs and Indications Drug name

Indications

Arranon (nelarabine)

T-cell acute lymphoblastic leukemia T-cell lymphoblastic lymphoma

Arzerra (ofatumumab)

Chronic lymphocytic leukemia

Bexxar (tositumomab)

CD20-positive, relapsed or refractory, low-grade, follicular, or transferred non-Hodgkin lymphoma

Hycamtin (topotecan) capsules

Relapsed small-cell lung cancer

Hycamtin (topotecan hydrochloride) for injection

Metastatic carcinoma of the ovary Small-cell lung cancer Recurrent or persistent carcinoma of the cervix

Leukeran (chlorambucil)

Chronic lymphatic (lymphocytic) leukemia Malignant lymphomas, including lymphosarcoma Giant follicular lymphoma Hodgkin disease

Mekinist (trametinib)

Unresectable metastatic melanoma with BRAF V600E or V600K mutations

Myleran (busulfan)

Chronic myelogenous leukemia

Tafinlar (dabrafenib)

Unresectable metastatic melanoma with BRAF V600E or V600K mutations

Tykerb (lapatinib)

HER2/neu advanced or metastatic breast cancer

Votrient (pazopanib)

Advanced renal-cell carcinoma Advanced soft tissue sarcoma

Oncology-supportive drug Promacta (eltrombopag)

Chronic immune (idiopathic) thrombocytopenia

Source: GlaxoSmithKline Commitment to Access. www.gskcta.com.

cluding those who are enrolled in a Health Insurance Marketplace plan or exchange. Eligibility and proportion of coverage is based on income.

What Patients Will Receive • All medicines are mailed to the prescriber or pa­tient based on program guidelines per medication.

• To receive the medicine by mail, send in the application, income documentation, and a prescription for the requested medicine.

How to Obtain Refills •C all (866) 265-6491 (8ON­COL­OGY1).

• Order refills ≥2 weeks before the pa­ tient runs out of medicine or 7 to 10 days before the next treatment.

• Refills are sent at no cost for up ­to 12 months after enrollment in

ONCOLOGY GUIDE TO PATIENT SUPPORT SERVICES

I December 2014

CTA. (Refills for eligible Medicare Part D patients are sent through the end of the current calendar year.)

• Refills can be sent to the prescriber’s office or patient’s home.

Enrollment An enrollment form is available at www.gskcta.com/enrollment/phone­application.html. Applications must be­­­ faxed to (800) 750-9832 from a pre­­­ scrib­er’s facility or mailed to the program’s PO Box along with the prescription. Up to 13 refills, if med­­ically appropriate, can be requested at the time the prescription is submitted.

A patient who is enrolling for the first time for Patient Assistance must also register a healthcare worker in­volved in the patient’s care as his or her patient advocate. l

Featured Profile

Incyte Corporation (855) 452-5234 www.incytecares.com

IncyteCARES (Connecting to Access, Reimbursement, Education, and Support) is a service for patients receiving treatment with Jakafi (ruxolitinib). In addition to patient education, resource support, and help overcoming potential insurance barriers, Incyte­CARES also offers a free medication program, as well as the reimbursement and financial assistance options that are presented below. For more information, call (855) 452-5234 or visit www.Incyte CARES.com.

Enrollment Enrollment forms are available at www.incytecares.com/pdf/jakafi-­ enrollment-form.pdf; fax completed forms to (855) 525-7207 or mail them directly to the program’s PO Box. Enrollment in IncyteCARES is an­­ nual. Every year, patients and their pro­­viders will need to submit a new en­rollment form. IncyteCARES will then per­form benefit verification and screen the patient’s need for financial assistance. Patients and their providers will be informed about when their participation in the program is ending and when they need to complete re-enrollment.

Patients should contact Incyte­ CARES if they are currently enrolled in the program and have experienced an event such as loss of employment, change in income, and loss of or change in prescription drug insurance coverage. Incyte­ CARES will then verify the patient’s benefits and may provide additional financial assistance.

Eligibility IncyteCARES Patient Assistance Patients who are insured through Med­icaid, Medicare, TRICARE, and healthcare exchange plans are not eligible; however, others may qualify

to enroll for IncyteCARES patient assistance if they meet these and other requirements: • They reside in the United States or Puerto Rico • They do not have prescription drug coverage for Jakafi, or their plans have turned them down for Jakafi treatment • Their yearly income and household size meet certain criteria (ie, an annual income of <$125,000 or <600% of the federal poverty level).

The specialty pharmacy will then contact the patient to arrange delivery.

IncyteCARES will also determine whether the patient qualifies for copay assistance or cost-free products.

IncyteCARES Copayment Assistance Program The IncyteCARES copay assistance program may help lower patients’ monthly copayments to no more than $25. Patients are responsible for reporting receipt of program rewards to their private insurer that pays for or reimburses them for any part of the prescriptions filled under the program.

Patients, pharmacists, and prescribers must not seek reimbursement for any or all of the benefit received by the patients through the IncyteCARES copay assistance program.

IncyteCARES Copayment Assistance Program Patients may qualify for enrollment in the IncyteCARES copay assistance program (eligible patients will receive assistance of up to $8300/ month or $25,000/year) if they meet these and other requirements: • They reside in the United States or Puerto Rico • The patient has commercial or private insurance • They have a valid prescription for Jakafi for treatment of an indication approved by the FDA • The patient is not covered under state-funded or federally funded healthcare programs.

Alternative Referrals IncyteCARES may refer patients who are not eligible for other forms ­­of assistance, or who have Medicare Part D and cannot afford Jakafi, to independent, nonprofit organizations and co­­ payment assistance foundations. To ap­­ply, patients need to create an infor­­mative list consisting of details such as all of their medical conditions and treatments, their doctor’s contact information, their copay amount, their household income, and information about their healthcare plan or plans. If a patient is not accepted by one foundation, then IncyteCARES may be able to refer him or her to another organization. l

What Patients Will Receive IncyteCARES Patient Assistance Once IncyteCARES receives an enrollment form, staff members will verify the patient’s prescription drug coverage and coordinate with a specialty pharmacy to fill the prescription.

December 2014

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An online resource addressing your oncol

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Featured Profile

Janssen Biotech, Inc

(800) 652-6227 | www.jjpaf.org (732) 562-3000 | www.janssenaccessone.com Janssen Biotech, Inc, offers support to patients through product-specific reimbursement programs, patient assistance information, and resource services that facilitate patients’ access to medications.

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Janssen Biotech, Inc Prescription Assistance By visiting www.JanssenPrescrip tionAssistance.com, patients can use the Janssen Prescription Assistance tool to search different types of prescription assistance programs. The site allows patients to search for up-to-date, product-relevant programs, and is open to insured, uninsured, and underinsured patients.

What Patients Will Receive Patients who qualify may be eligible to receive their medications at no cost for up to 1 year. Methods of distribution are product-specific; a distribution guide is available on the en­­ rollment form or at www. jjpaf.org/resources/distribution-­ guide.html.

Johnson & Johnson Patient Assistance Foundation, Inc Johnson & Johnson Patient Assis­ tance Foundation (JJPAF), Inc helps patients without adequate financial resources and prescription coverage obtain free medications.

Enrollment Enrollment forms are available at www.jjpaf.org/resources/jjpaf-appli cation.pdf. Applications, along with any required documentation, can be faxed to (888) 526-5168 or mailed to the program’s PO Box.

Eligibility Criteria Patients may qualify for enrollment if the following criteria are met: • They reside in the United States or its territories • They receive outpatient treatment from a licensed US healthcare provider • They lack prescription drug coverage • Income eligibil­­­ity requirements, available at www.jjpaf.org/eligibility/­ index.html.

AccessOne Information about reimbursement support programs for eligible patients is accessible through the AccessOne portal, available at www.janssenaccessone.com. Reim­ burse­ ment programs are product-­ specific. The reimbursement pro- Doxil and Procrit DOXILine offers Doxil-specific re­­ grams pertaining to on­ cology and oncology-­ supportive drugs are as imbursement support, resources, and tools for patients and providers. follows: More information can be found at www.janssenaccessone.com/pages/ doxil, or by calling (800) 609-1083.

PROCRITline offers Procritspecific reimbursement support, re­ sources, and tools for patients and providers. More information can be found at www.janssenaccessone. com/pages/procrit, or by calling (800) 553-3851. l

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Zytiga Patients who have been prescribed Zytiga may be able to save on copays, deductibles, and coinsurance costs through the ZytigaOne Instant Sav­ings Program. Eligibil­­ ity criteria are available at www. janssen­accessone.com/assets/zytiga/ instant_savings.pdf. Patients en­­ rolled in this pro­gram will receive an Instant Savings ­­Card that qualifies them to pay ≤$10 per month for their prescription, ­­ up to a $12,000 annual benefit, 12 months after card activation or after 12 doses, whichever comes first. Other benefits include personalized re­ minders for prescriptions, explanations of insurance benefits, and access to e­ducational resources about Zytiga. Digital en­ rollment and re-­enrollment forms are available at http://webrebate.­trialcard. com/Coupon/ZytigaPortal.

RJ Health Systems The Creators of ReimbursementCodes.com

RJ Health Systems â&#x20AC;&#x201D; the pharmaceutical specialists that healthcare professionals have turned to since 1983 for their drug information.

We work with over 170 Payor organizations that touch approximately 110 million lives.

RJ Health Systems has established and continuously maintains a Library of Drug Intelligence that provides the most comprehensive, trusted, and up-to-date coding and reimbursement information in the industry.

ReimbursementCodes.com incorporates the CMS HCPCS and AMA CPT Drug codes into a system that crosswalks each drug code with the drugâ&#x20AC;&#x2122;s NDC and brand/generic name.

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Featured Profile

Merck & Co., Inc

PAP: (800) 727-5400 | ACT Program: (866) 363-6379 | MAP: (855) 257-3932 www.merckhelps.com | www.merckaccessprogram.com Merck offers a number of programs that provide free medications and reimbursement assistance to eligible patients who are uninsured or underinsured. Merck Helps serves as the hub for all of Merck’s patient assistance programs, including the Merck Patient Assistance Program, the ACT Program, and the Merck Access Program. Visit Merck Helps at www. merckhelps.com for more information on Merck’s various patient assistance programs.

Merck Patient Assistance Program Through the Merck Patient Assistance Program (MPAP), eligible uninsured patients or those facing financial or medical hardship may qualify to receive medications free of charge. The Merck oncology drug included in MPAP is Temodar (temozolomide) capsules, an oncology drug used in the treatment of patients with glioblastoma multiforme or refractory anaplastic astrocytoma.

Eligibility Criteria Patients may qualify for MPAP if they meet the following requirements: • They are legal residents of the United States or its territories • They have a prescription for a Merck medication from a licensed US healthcare provider • They are uninsured and/or do not have other forms of coverage for their prescription medicines • They are unable to afford their medication; income eligibility criteria

are available at www.merckhelps. com/MPAP/WhoQualifies.aspx.

Exceptions may be made in certain circumstances for patients who do not meet the criteria for prescription drug coverage and if they face extraordinary medical and financial hardships.

Patients who qualify for this program are eligible to receive medications at no cost; a completed application may allow for up to 1 year of medications.

Enrollment Enrollment forms are available at www.merckhelps.com/docs/MPAP_ Enrollment_Form_English.pdf. Once the patient completes the form, he or she must then take it to the physician or prescriber, who should complete Sections 2 and 3. Up to 3 Merck medications may be included in a single application. Individual prescriptions have a supply cap of 90 days, with 3 refills maximum.

Applications must be signed by both the patient and his or her physician/prescriber, and mailed directly to the program’s PO Box. Enrollment is valid for up to 12 months, at which point patients who wish to continue must reapply by completing a new application. Patients may apply as many times as necessary; in certain situations, enrollment may not exceed a calendar year. For more information on this program, call (800) 727-5400.

ACT Program/Merck Access Program (MAP) The ACT Program and MAP provide eligible patients with free

Table O ncology and Oncology-Supportive Drugs Covered Through MAP

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Oncology drug

Oncology-supportive drug

Intron A (interferon alfa-2b, recombinant) Keytruda (pembrolizumab) Sylatron (peginterferon alfa-2b)

Emend (aprepitant) Emend (fosaprepitant dimeglumine)

ONCOLOGY GUIDE TO PATIENT SUPPORT SERVICES

I December 2014

re­­imbursement support services, and in some cases refer patients to other Merck patient assistance programs. The ACT Program covers Noxafil (posaconazole), an oncology-­ supportive drug used to prevent invasive Aspergillus and Candida infections in patients with hematologic malignancies or in certain patients who have undergone stem cell transplantation. For a complete list of oncology and oncology-­ supportive drugs covered through MAP, see the Table.

Eligibility Criteria Patients may qualify for the ACT Program or MAP if they meet the following requirements: • They are a resident of the United States or its territories • They have a prescription for a Merck medication from a licensed US healthcare provider • They are uninsured and do not have other forms of coverage for their prescription medicines • They cannot afford their medication; income eligibility requirements are available for the ACT Program at www.merckhelps.com/ACT/Who ­­Qualifies.aspx, and for MAP at www.merckhelps.com/MAP/Who Qualifies.aspx. Excep­ tions may be made in certain circumstances.

Enrollment Enrollment forms must be filled out and signed by both the patients and their providers. Forms are available at www.merckhelps.com/docs/ ACT_Enrollment_Form_English.pdf for the ACT Program, and at www. merckhelps.com/docs/MAP_En rollment_Form_English.pdf for MAP. For more information, call (866) 3636379 for the ACT Program, or (855) 257-3932 for MAP. l

Featured Profile

Millennium: The Takeda Oncology Company (866) 835-2233, option 2 www.velcade-hcp.com/reimbursement Millennium: The Takeda Oncology Company offers eligible patients re­ ceiving treatment with Velcade (bortezomib) assistance through the Vel­cade Reimbursement Assis­tance Pro­gram (VRAP). Support and resources are available for the in­ sured, uninsured, and underinsured. Eligibility-­ depend­ ent support services include fi­­nancial assistance, navigation through reimbursement processes and concerns, as well as referrals to independent copay foundations. Vel­cade is indicated for the treatment o­ f multiple myeloma and relapsed mantle cell lymphoma.

Velcade Reimbursement Assistance Program Eligibility Insured patients are encouraged ­­to speak with a case manager about VRAP, a free program available to all patients who are receiving Velcade, regardless of their financial situation.

Case managers can share support options as well as resources to facilitate access to therapy. More information is available at www.velcade.com/ paying-­for-treatment.

Enrollment Patients can enroll by calling (866) 835-2233 to speak with a case manager, or by working with their physician to complete the enrollment form available at www.­velcade.com/files/ pdfs/VELCADE_VRAP_Enrollment_­ Form.pdf. When­completing the ap­­ plication, the healthcare professional should indicate the patient’s diagnosis (including code); route of administration; the patient’s previous therapies; and the clinical service setting. Pa­­ tient health insurance information and verification of income are also required.

What Patients Will Receive Patients who are enrolled in VRAP

or call the VRAP hotline can speak with a case manager about insurance or coverage questions, or seek help navigating the reimbursement process. Caregivers, physicians, and other healthcare professionals are also welcome to call the hotline. Additional services include the following: • Information on insurance verification, the claims appeal process, alternate and supplemental insurance coverage options, and referrals to copayment foundations • Screening and enrollment of ­eligible patients into the Velcade Patient Assistance Program • Treatment support that connects patients with other patients and caregivers; disease state and therapy planning guides (available at www. velcade.com/Support-and-resources/­ Tools-and-downloads); and live tele­ ­phone support at (866) 835-2233.

Case managers can also connect patients with various social services, and/or provide a resource guide to independent copayment foun­dations.

For more information, visit www.­ velcade.com/files/PDFs/Co-pay_ Resource.pdf.

coverage for Velcade may be eligible to participate in the Velcade Patient Assistance Program. Eligibility is based on treatment setting, household income, and prescription information.

Enrollment Patients who do not have insurance coverage for Velcade must apply for assistance through their healthcare professional. Enrollment forms are available at www.velcade. com/files/pdfs/VELCADE_VRAP_ Enrollment_­Form­.pdf or by calling the VRAP hotline. Com­ pleted forms must be submitted with income documentation as well as health insurance information. Phy­ sicians are encouraged to enroll patients into the Patient Assis­tance Program before initiating therapy; forms must be submitted within 6 months of the first treatment.

What Patients Will Receive Patients who qualify for the Patient Assistance Program will have their medication delivered to their prescribing physician’s office at no cost to the patient or provider. Patients are eligible to participate in Velcade’s Patient Assistance Program for 1 year, as long as they continue to meet program qualifications, and can re-enroll after 12 months if they are still receiving treatment at that time. l

Velcade Patient Assistance Program Eligibility Patients residing in the United States who do not have insurance

December 2014

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Featured Profile

Novartis Pharmaceuticals Corporation (800) 277-2254 www.patientassistancenow.com | www.oncologyaccessnow.com Novartis seeks to improve patients’ lives by developing the medicines they need, educating patients about their disease, and connecting pa­tients with assistance to help pay for Novartis medicines.

Through its Patient Assistance Foundation (PAF) and Patient Assistance Now Oncology (PANO), Novartis provides resources and assistance to eligible patients. PAF alone provided 100,000 patients in the United States with $500 million in free medication in 2013. For a complete list of oncology and oncology-­ supportive drugs covered through these programs, see the Table.

Novartis Patient Assistance Foundation Eligibility and Enrollment To be eligible for PAF, patients must meet the following requirements: • A resident of the United States • Provide proof of income and meet income criteria, which varies by medication • They cannot have private or public prescription insurance.

Depending on which Novartis medication is prescribed, financial eligibility requirements for PAF are 250% to 500% of the federal poverty level.

A PAF enrollment form is available at www.pharma.us.novartis.com/ assets/pdf/PAP-GenMed-OncologyEnglish.pdf. The enrollment process varies by medication, and patients can

learn more about the application process for their specific prescribed medication by visiting www.pharma.us. novartis.com/info/patient-assistance/ patient-assistance-enrollment.jsp. By simply selecting their medication from the drop-down menu, applicants can access enrollment information that is specific to their particular product.

Patients, caregivers, and physi­­ cians can learn more about the program and the PAF enrollment process by registering at www.npcpapportal. com/login.aspx, or by calling (800) 277-2254 to speak with a representative. Patients must re-enroll for the Patient Assistance Program annually.

What Patients Will Receive Patients who qualify for PAF are eligible to receive assistance for up to 1 year, or until they become eligible to receive a prescription drug benefit.

Up to a 1-year supply of medications are shipped to the patient or prescribing physician, and may be available at no cost. For more information, call (800) 277-2254 to speak with a representative.

Table O ncology and Oncology-Supportive Drugs Oncology drug

Oncology-supportive drug

Afinitor (everolimus)

Exjade (deferasirox)

Gleevec (imatinib mesylate)

Sandostatin LAR Depot (octreotide acetate for injectable suspension)

Tasigna (nilotinib) Zometa (zoledronic acid)

Zometa (zoledronic acid)

Zykadia (ceritinib)

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ONCOLOGY GUIDE TO PATIENT SUPPORT SERVICES

I December 2014

Patient Assistance Now Oncology Novartis offers the Patient Assis­ tance Now platform, which is a comprehensive resource for patients to learn about opportunities for assistance, disease management, and health­ ­care reform to take an active part in managing their health. The oncology branch of Patient Assistance Now— PANO—provides patients with quick and easy access to information about the many reimbursement and support programs. Support options include insurance verification, Medicare education, and information about financial assistance and free medication.

Patients can access more informa­­tion about PANO at www.oncologyac cessnow.com.

Novartis Oncology Reimbursement Hotline The Reimbursement Hotline provides assistance with questions or concerns about the reimbursement process for Novartis Oncology products.

Services include insurance benefits and coverage verification, co­­payment clarifications, assistance with coding and billing questions, denials and appeals support, as well as alternative funding searches and referrals to Novartis Oncology brand-specific copay card programs and independent assistance programs for low-income, uninsured patients. Patients and providers can reach the Reimbursement Hotline by calling (800) 282-7630. l

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Featured Profile

Onyx Pharmaceuticals, Inc (855) 669-9360 www.kyprolis.com/support-during-treatment Onyx Pharmaceuticals, Inc offers assistance through its Onyx 360 program to patients who are receiving Ky­prolis (carfilzomib) for injection for the treatment of refractory multiple mye­loma. Patients who have experienced disease progression within 60 days of the last day of treatment with bortezomib and an immunomodulatory agent (ie, lenalidomide or thalidomide) may qualify for this drug. Ky­prolis is administered at a physician’s office, allowing for administration of proper care throughout treatment.

Onyx 360 Onyx 360 provides eligible patients with clinical, social, and reimbursement and payment support. This includes support for insurance verification, copay and free product assistance, and referrals for assistance with transportation costs and patient support services.

As part of the program, oncology nurse advocates provide personalized, one-on-one financial, clinical, and social support tailored to the individual needs of each patient.

Reimbursement of indirect medical costs may also be provided to eligible patients, improving the patient’s access to therapy.

Eligibility Criteria Patients who have experienced disease progression within 60 days of the last day of treatment with bortezomib and an immunomodulatory agent (ie, lenalidomide, thalidomide) may qualify to receive treatment with Kyprolis. For more information on eligibility criteria for Onyx 360, call (855) 669-9360 to speak with an oncology nurse advocate.

Enrollment Patient and physician signatures

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are required on all applications. An enrollment form is available at ­w ww.kyprolis.com/content/pdfs/ Onyx360EnrollmentForm.pdf.

Completed forms must be faxed to (855) 669-9329.

What Patients Will Receive Medication Reimbursement and Payment Support This facet of the Onyx 360 program will help eligible patients receive financial support, assistance with copays and coinsurance, and help to verify a patient’s insurance benefits. Qualified patients will also have access to information regarding appeals processes and prior authorizations. Patients who are uninsured or who were rendered uninsured because of payer denial may receive free product assistance if other criteria are met.

Social Support Onyx 360 also provides social support to patients who qualify for assistance with indirect healthcare expenses through referrals for transportation assistance services:

ONCOLOGY GUIDE TO PATIENT SUPPORT SERVICES

I December 2014

gas, lodging, tolls, and parking costs related to therapy. Referrals for patient support groups and caretaker or family support networks are available, as are referrals to services that provide product information and local transportation to appointments.

Clinical Support Intended to provide guidance to a patient throughout the course of their therapy, Onyx 360 provides clinical support in the form of information about multiple myeloma and treatment of the disease.

Information on side effect management, nutritional requirements, and other needs pertaining to disease state are available through Onyx 360. Patients and caregivers can request informational resources from an oncology nurse advocate by calling (855) 669-9360.

How to Obtain Refills For more information about how to obtain refills through Onyx 360, call (855) 669-9360 to speak with an oncology nurse advocate. l

Featured Profile

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Featured Profile

Pfizer Inc

(866) 706-2400 www.pfizerrxpathways.com To improve accessibility of services and respond to patients’ needs, Pfizer has combined its existing programs into Pfizer RxPathways, ­ formerly known as Pfizer Helpful Answers. A comprehensive assistance program, Pfizer RxPathways provides eligible pa­ tients with a range of support services, including insurance counseling, copay assistance, and access to medicines at no cost or at a savings.

Pfizer RxPathways may be able to help eligible uninsured and underinsured patients get their Pfizer medications for free. Insured patients who have prescription coverage but still cannot afford their medications may also qualify to receive them at no cost if they meet certain requirements. For a complete list of oncol­ ogy and oncology-supportive drugs covered through this program, see the Table.

• They are receiving treatment as an outpatient • The patient does not have prescription coverage, or does not have enough prescription coverage to afford his or her medication • They meet income requirements.

For more information, patients and their prescribers can call (877) 744-5675 to speak with a Pfizer Rx­­ Pathways counselor.

Enrollment Applications are grouped based on the type of medication the patient is seeking (ie, those typically prescribed by a specialist or by a primary care provider). Uninsured patients and insured patients who lack prescription coverage or re­­ quire assistance to pay for their oncology and oncology-supportive Pfizer drugs need to complete the Enrollment Form for Group B Medicines (Pfizer specialty medicaEligibility Criteria tions). The form is available at Patients may qualify for enrollment www.pfizerrxpathways.com/sites/ in the Pfizer RxPathways Patient default/files/attachment/GroupB Assistance Program, and may be eligi- Form_Aug2014.pdf. ble to receive free medications if they Enrollment forms must be filled meet the following criteria: out by the patient and his or her • They reside in the United States, prescriber. Completed application Puerto Rico, or US Virgin Islands forms, along with any other neces• The patient has been prescribed sary paperwork, can be faxed by ­a Pfizer oncology or oncology-­ ­the prescriber to (800) 708-3430 or supportive drug mailed to the program’s PO Box. Table Oncology and Oncology-Supportive Drugs

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Oncology drug

Oncology-supportive drug

Aromasin (exemestane tablets) Bosulif (bosutinib) Camptosar (irinotecan hydrochloride injection) Idamycin (idarubicin hydrochloride for injection) Inlyta (axitinib) Sutent (sunitinib malate) Torisel (temsirolimus) Xalkori (crizotinib)

Ellence (epirubicin hydrochloride injection) Emcyt (estramustine phosphate sodium) Neumega (oprelvekin) Zinecard (dexrazoxane for injection)

ONCOLOGY GUIDE TO PATIENT SUPPORT SERVICES

I December 2014

What Patients Will Receive Patients will receive a call with an update on the status of their enrollment within 2 business days.

• Uninsured patients. Patients will first receive assistance from an Rx­­ Pathways counselor, who will help them identify and apply for insurance coverage options (eg, Medi­ caid, Medicare Part D) that can facilitate access to their medicine.

Throughout this period, patients who are eligible can receive a free, 90-day supply of their medication.

Eligible patients who are unable to secure insurance coverage can ­continue receiving free medication ­for up to 12 months through Pfizer RxPathways.

• Insured patients. Patients will first receive assistance from an Rx­­ Pathways counselor, who will help them locate and apply for alternative forms of copay assistance (Medicare Part D, independent foundations, copay card programs).

Insured pa­tients who qualify for free medication can have their products shipped directly to their homes or to their prescriber’s office.

Some patients with private insurance who have applied for free medicine may be eligible to receive copay assistance through Pfizer Rx­­Pathways via a copay card. These patients will not have medications sent to them, but they can use a copay card at their pharmacy to cover the entire copay for their ­medication.

Other Options Uninsured patients who do not qualify to receive free medicine may be eligible to save on the cost of specific medications with the Pfizer RxPathways Savings Card. To find out more information about the Pfizer RxPathways Savings Card, call (866) 706-2400. l

Featured Profile

Pharmacyclics, Inc (877) 877-3536 www.youandisupport.com

When Pharmacyclics and Janssen Biotech set out to launch Imbruvica in the United States, they prioritized one goal above all others: providing access support to patients who are prescribed Imbruvica.

Improving access for patients is challenging due to the complicated nature of the reimbursement landscape. What might help improve access for a patient with commercial insurance may not be available or allowed for a patient with government-funded insurance. Patients may have high­ er out-of-pocket costs in certain months versus others. To help make access to ­ Imbruvica simple, convenient, and easy for a variety of patients, Pharmacyclics and Janssen Biotech created a unique set of patient support programs called YOU&i Support programs.

Eligibility Criteria Commercially Insured Patients For commercially insured pa­ tients, Phar­ macyclics and Janssen Biotech offer the YOU&i Instant Savings Program to help with outof-pocket expenses for Imbruvica.

This program enables eligible patients with commercial insurance to pay a copay of $10 per month,a regardless of income level. The patient can use as much or as little as they need in each month.

For patients experiencing insurance coverage decision delays, Pharmacyclics and Janssen Biotech

(income requirement of 600% of the federal poverty level).

offer the YOU&i Start Program.

This program offers eligible patients who have been prescribed Imbruvica for a US Food and Drug Ad­­ ministration–approved indication, and who are experiencing an insurance coverage decision delay of more than 5 business days, a free 30-day supply of Imbruvica. Under appropriate circumstances, an additional 30-day supply may be provided. The free product is offered to eligible patients without any purchase contingencies or other obligations.

Third-Party Copay Assistance Lastly, for all patients with chronic lymphocytic leukemia (CLL) and mantle-cell lymphoma (MCL), Pharmacyclics and Janssen Biotech support third-party copay assistance foundations, organizations, and other efforts to help any patients gain access to appropriate care and therapies. Pharmacyclics and Janssen Biotech have supported and continue to support third-party foundations to assist patients living with CLL or MCL. For more information, visit www.youandiaccess.com or call ­(877) 877-3536. l

Uninsured Patients For uninsured patients, the Johnson & Johnson Patient As­­ sistance Foundation, an independent, nonprofit organization, may offer assistance with accessing Imbruvica to eligible patients who qualify based on financial need

December 2014

Month refers to a 30-day supply subject to a maximum benefit, 12 months after activation or 12 monthly fills (1-year supply), whichever comes first, unless the maximum dollar benefit has been reached. Not valid for patients enrolled in Medicare or Medicaid.

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Featured Profile

Teva Pharmaceuticals, Inc (877) 237-4881 www.tevacares.org/ | www.TevaCORE.com Through the Teva Cares Foun­ dation and Teva CORE, Teva provides medications at no cost to eligible patients in the United States who are unable to afford their oncology and oncology-supportive drugs.

The Teva Cares Foundation The foundation offers some medications at no cost to eligible patients who meet certain income and insurance criteria. The following are oncology and oncology-­ supportive drugs cov­­ ered by the Teva Cares Foundation: • Fentora (fentanyl buccal tablet), CII • Granix (tbo-filgrastim) • Synribo (omacetaxine mepesuccinate) • Treanda (bendamustine HCl) • Trisenox (arsenic trioxide) Teva CORE The Comprehensive Oncology Reimbursement Expertise (CORE) service provided by Teva Oncology is designed to answer questions from patients and providers and offer guidance throughout the reimbursement process. CORE can provide assistance with benefit verification, coverage determination, and prior authorizations, and offer personalized support throughout the claims and appeals processes. For uninsured patients, CORE can identify additional resources that assist patients with costs of treatment.

Eligibility Criteria Patients may qualify for the Teva Cares Foundation Patient Assistance Program if they meet the following eligibility requirements: • They have been prescribed a ­­­­Teva oncology or oncology-­ supportive drug

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• They lack prescription drug coverage • They meet annual household in­­ come requirements (Table).

More information about eligibility requirements is available at www. cephaloncares.com/DoIQualify.aspx.

Patients may qualify for assistance through Teva CORE if they meet the following eligibility requirements: • They have been prescribed Granix, Synribo, Treanda, or Trisenox • They meet annual household in­­ come requirements.

For more information about eligibility requirements, call (888) 587-3263 to speak with a CORE representative.

Income Guidelines for the Table Teva Cares Foundation Patient Assistance Program Total Household annual size (persons) income,a $

Total annual income,b $

1

57,450

34,470

2

77,550

46,530

3

97,650

58,590

4

117,750

70,650

5

137,850

82,710

Applies to all above-listed oncology and oncology-supportive drugs, except Fentora. b Applies to Fentora only. a

Prescribers enrolling in CORE can fill out a standard application form or submit one digitally through Enrollment iAssist at https://eprescribe.iassist.

Patients applying to the Teva com/?style=tevaoncology. iAssist is Cares Foundation can find drug-­ a tool to register patients who are specific application forms at www. taking Teva Oncology medications, cephaloncares.com/Download­ and for applying for financial supApplication.aspx. Applications port. Directions on how to enroll should be faxed to the number listed patients in Teva CORE through on the enrollment form or shipped iAssist are available at https://epre directly to the program’s PO Box. scribe.iassist.com/files/tevaoncology/­ For patients applying to the Teva Teva_CORE_Enrollment.pdf.

CORE program, an application is available at www.tevacore.com/ How to Obtain Refills For information about how to PDF/Enrollment%20Form.pdf.

Ap­pli­­cations should be faxed to the obtain refills, call (877) 237-4881 to number listed on the enrollment speak with a representative at the form or ship­ped directly to the pro- Teva Cares Foundation, or (888) 5873263 to reach the CORE Hotline. l gram’s PO Box.

ONCOLOGY GUIDE TO PATIENT SUPPORT SERVICES

I December 2014

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CONQUER ™ magazine is the premier forum for patients with cancer featuring articles written by and for patients, survivors, nurse navigators, and other oncology team members initiated by the Academy of Oncology Nurse & Patient Navigators (AONN+).

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Navigating the path to medication access Novartis Oncology is committed to helping patients living with cancer receive the medicines they need. Patient Assistance Now Oncology (PANO) offers quick and easy access to information about our wide range of resources.

SUPPORT FOR PATIENTS INCLUDES: • Support with insurance verification • Medicare education • Alternative assistance searches and referrals to federal or state assistance programs • Support for Novartis Oncology medication

• Patients prequalified via phone screening for the Patient Assistance Program (PAP) will be sent a 30-day supply of their needed medication while completing the application

• Information about financial or co-pay assistance that may be available via independent charitable foundations • Convenient provider portal to access program support or check the status of patients enrolled

GET ACCESS NOW Visit www.OncologyAccessNow.com, or call 1-800-282-7630, to speak with a member of our knowledgeable staff dedicated to making access to therapy as simple and convenient as possible.

Novartis Pharmaceuticals Corporation East Hanover, New Jersey 07936-1080

© 2014 Novartis

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