Opmjune13 by Value-Based Cancer Care

Oncology Practice Management ™

PROCESS IMPROVEMENTS TO ENHANCE PATIENT CARE™

JUNE 2013

www.OncPracticeManagement.com

Managed Markets: Payers’ Perspectives on Transforming Care Delivery By Caroline Helwick

Hollywood, FL—At the Third Annual Conference of the Association for Value-Based Cancer Care, James Lang, PharmD, Vice President of Pharmacy Services at BlueCross BlueShield of Michigan (BCBSM), shared his company’s approach to new managed market challenges. Dr Lang noted that for each step across the managed market landscape, BCBSM built a “rigorous, intricate infrastructure.” The company has had incentive programs in place for more than a decade, having rolled out its first Collaborative Quality Initiative in 1997. In 2004, based on the chronic care model, BCBS implemented its Physician Group Incentive Program (PGIP). The program rewards physicians for improved

VOLUME 3 • NUMBER 4

AACR Issues New Policy on Tobacco Use

Oncology practices asked to educate patients on smoking cessation By Phoebe Starr

Washington, DC—Tobacco use among patients with cancer is an important, but often overlooked, issue that requires intervention by oncology practices. In recognition of the problem and the gap between the need for intervention and the services delivered, the American

Association for Cancer Research (AACR) issued a policy on tobacco use at its 2013 annual meeting. The genesis for the policy came from some surprising and disappointing survey results that revealed that many oncology practices do not routinely address tobacco Continued on page 10

Transitioning to ICD-10 By Susanne Talebian, CUA, CPC, CUC, CCS-P, CMOM, PCS, RMM Certified Healthcare Business Consultant, American Health Information Management Association–Certified ICD-10-CM/PCS Trainer

n October 1, 2014, the United States will adopt the International Classification of Diseases, Tenth Revision, Clinical Modification/Procedure Coding System (ICD-10-CM/PCS). The reprieve, although welcome to many, is

less than 16 months away, during which several phases of implementation must be completed. The timeline for implementing the code sets is divided into 4 phases: Phase 1: Impact Assessment, first quarter 2009 through second quarContinued on page 40

Continued on page 8 From the publishers of

of n it o s D ia ter VI ssocCen 1 O A r e .3 PR y thence f th ster. a o e D N ou bity C actequ A y T t to mun Impre S N h m e a TIE roug Co Thedic A B

INTEGRATING ONCOLOGISTS, PAYERS, AND THE ENTIRE CANCER CARE TEAM

In the newly metastatic CRPC patient who is asymptomatic or minimally symptomatic

STARTS THE FIGHT

AND HELPS HIS IMMUNE SYSTEM SUSTAIN* IT 1

• Targets and attacks prostate cancer cells • Statistically significant overall survival advantage1,2 • Sustained* immune response *A sustained immune response was seen out to 26 weeks in the pivotal study (the last time point measured).1 INDICATION: PROVENGE® (sipuleucel-T) is an autologous cellular immunotherapy indicated for the treatment of asymptomatic or minimally symptomatic metastatic castrate resistant (hormone refractory) prostate cancer. IMPORTANT SAFETY INFORMATION: PROVENGE is intended solely for autologous use and is not routinely tested for transmissible infectious diseases. In controlled clinical trials, serious adverse events reported in the PROVENGE group included acute infusion reactions (occurring within 1 day of infusion) and cerebrovascular events. Severe (Grade 3) acute infusion reactions were reported in 3.5% of patients in the PROVENGE group. Reactions included chills, fever, fatigue, asthenia, dyspnea, hypoxia, bronchospasm, dizziness, headache, hypertension, muscle ache, nausea, and vomiting. No Grade 4 or 5 acute infusion reactions were reported in patients in the PROVENGE group. The most common adverse events (incidence ≥15%) reported in the PROVENGE group were chills, fatigue, fever, back pain, nausea, joint ache, and headache. For more information on PROVENGE, please see Brief Summary of Prescribing Information on adjacent pages. www.PROVENGEHCP.com

PROVENGE® (sipuleucel-T) Suspension for Intravenous Infusion

Rx Only

BRIEF SUMMARY — See full Prescribing Information for complete product information

INDICATIONS AND USAGE: PROVENGE® (sipuleucel-T) is an autologous cellular immunotherapy indicated for the treatment of asymptomatic or minimally symptomatic metastatic castrate resistant (hormone refractory) prostate cancer. DOSAGE AND ADMINISTRATION • For Autologous Use Only. • The recommended course of therapy for PROVENGE is 3 complete doses, given at approximately 2-week intervals. • Premedicate patients with oral acetaminophen and an antihistamine such as diphenhydramine. • Before infusion, confirm that the patient’s identity matches the patient identifiers on the infusion bag. • Do Not Initiate Infusion of Expired Product. • Infuse PROVENGE intravenously over a period of approximately 60 minutes. Do Not Use a Cell Filter. • Interrupt or slow infusion as necessary for acute infusion reactions, depending on the severity of the reaction. (See Dosage and Administration [2] of full Prescribing Information.) CONTRAINDICATIONS: None. WARNINGS AND PRECAUTIONS • PROVENGE is intended solely for autologous use. • Acute infusion reactions (reported within 1 day of infusion) included, but were not limited to, fever, chills, respiratory events (dyspnea, hypoxia, and bronchospasm), nausea, vomiting, fatigue, hypertension, and tachycardia. In controlled clinical trials, 71.2% of patients in the PROVENGE group developed an acute infusion reaction. I n controlled clinical trials, severe (Grade 3) acute infusion reactions were reported in 3.5% of patients in the PROVENGE group. Reactions included chills, fever, fatigue, asthenia, dyspnea, hypoxia, bronchospasm, dizziness, headache, hypertension, muscle ache, nausea, and vomiting. The incidence of severe events was greater following the second infusion (2.1% vs 0.8% following the first infusion), and decreased to 1.3% following the third infusion. Some (1.2%) patients in the PROVENGE group were hospitalized within 1 day of infusion for management of acute infusion reactions. No Grade 4 or 5 acute infusion reactions were reported in patients in the PROVENGE group. Closely monitor patients with cardiac or pulmonary conditions. In the event of an acute infusion reaction, the infusion rate may be decreased, or the infusion stopped, depending on the severity of the reaction. Appropriate medical therapy should be administered as needed. • Handling Precautions for Control of Infectious Disease. PROVENGE is not routinely tested for transmissible infectious diseases. Therefore, patient leukapheresis material and PROVENGE may carry the risk of transmitting infectious diseases to health care professionals handling the product. Universal precautions should be followed. • Concomitant Chemotherapy or Immunosuppressive Therapy. Use of either chemotherapy or immunosuppressive agents (such as systemic corticosteroids) given concurrently with the leukapheresis procedure or PROVENGE has not been studied. PROVENGE is designed to stimulate the immune system, and concurrent use of immunosuppressive agents may alter the efficacy and/or safety of PROVENGE. Therefore, patients should be carefully evaluated to determine whether it is medically appropriate to reduce or discontinue immunosuppressive agents prior to treatment with PROVENGE. • Product Safety Testing. PROVENGE is released for infusion based on the microbial and sterility results from several tests: microbial contamination determination by Gram stain, endotoxin content, and in-process sterility with a 2-day incubation to determine absence of microbial growth. The final (7-day incubation) sterility test results are not available at the time of infusion. If the sterility results become positive for microbial contamination after PROVENGE has been approved for infusion, Dendreon will notify the treating physician. Dendreon will attempt to identify the microorganism, perform antibiotic sensitivity testing on recovered microorganisms, and communicate the results to the treating physician. Dendreon may request additional information from the physician in order to determine the source of contamination. (See Warnings and Precautions [5] of full Prescribing Information.) ADVERSE REACTIONS 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.

The safety evaluation of PROVENGE is based on 601 prostate cancer patients in the PROVENGE group who underwent at least 1 leukapheresis procedure in four randomized, controlled clinical trials. The control was non-activated autologous peripheral blood mononuclear cells. The most common adverse events, reported in patients in the PROVENGE group at a rate ≥15%, were chills, fatigue, fever, back pain, nausea, joint ache, and headache. Severe (Grade 3) and life-threatening (Grade 4) adverse events were reported in 23.6% and 4.0% of patients in the PROVENGE group compared with 25.1% and 3.3% of patients in the control group. Fatal (Grade 5) adverse events were reported in 3.3% of patients in the PROVENGE group compared with 3.6% of patients in the control group. Serious adverse events were reported in 24.0% of patients in the PROVENGE group and 25.1% of patients in the control group. Serious adverse events in the PROVENGE group included acute infusion reactions (see Warnings and Precautions), cerebrovascular events, and single case reports of eosinophilia, rhabdomyolysis, myasthenia gravis, myositis, and tumor flare. PROVENGE was discontinued in 1.5% of patients in Study 1 (PROVENGE group n=341; Control group n=171) due to adverse events. Some patients who required central venous catheters for treatment with PROVENGE developed infections, including sepsis. A small number of these patients discontinued treatment as a result. Monitoring for infectious sequelae in patients with central venous catheters is recommended. Each dose of PROVENGE requires a standard leukapheresis procedure approximately 3 days prior to the infusion. Adverse events that were reported ≤1 day following a leukapheresis procedure in ≥5% of patients in controlled clinical trials included citrate toxicity (14.2%), oral paresthesia (12.6%), paresthesia (11.4%), and fatigue (8.3%). Table 1 provides the frequency and severity of adverse events reported in ≥5% of patients in the PROVENGE group of randomized, controlled trials of men with prostate cancer. The population included 485 patients with metastatic castrate resistant prostate cancer and 116 patients with non-metastatic androgen dependent prostate cancer who were scheduled to receive 3 infusions of PROVENGE at approximately 2-week intervals. The population was age 40 to 91 years (median 70 years), and 90.6% of patients were Caucasian. Table 1 Incidence of Adverse Events Occurring in ≥5% of Patients Randomized to PROVENGE PROVENGE (N = 601)

Any Adverse Event Chills Fatigue Fever Back pain Nausea Joint ache Headache Citrate toxicity Paresthesia Vomiting Anemia Constipation Pain Paresthesia oral Pain in extremity Dizziness Muscle ache Asthenia Diarrhea Influenza-like illness Musculoskeletal pain Dyspnea Edema peripheral Hot flush Hematuria Muscle spasms

Control* (N = 303)

All Grades n (%)

Grade 3-5 n (%)

All Grades n (%)

591 (98.3) 319 (53.1) 247 (41.1) 188 (31.3) 178 (29.6) 129 (21.5) 118 (19.6) 109 (18.1) 89 (14.8) 85 (14.1) 80 (13.3) 75 (12.5) 74 (12.3) 74 (12.3) 74 (12.3) 73 (12.1) 71 (11.8) 71 (11.8) 65 (10.8) 60 (10.0) 58 (9.7) 54 (9.0) 52 (8.7) 50 (8.3) 49 (8.2) 46 (7.7) 46 (7.7)

186 (30.9) 13 (2.2) 6 (1.0) 6 (1.0) 18 (3.0) 3 (0.5) 11 (1.8) 4 (0.7) 0 (0.0) 1 (0.2) 2 (0.3) 11 (1.8) 1 (0.2) 7 (1.2) 0 (0.0) 5 (0.8) 2 (0.3) 3 (0.5) 6 (1.0) 1 (0.2) 0 (0.0) 3 (0.5) 11 (1.8) 1 (0.2) 2 (0.3) 6 (1.0) 2 (0.3)

291 (96.0) 33 (10.9) 105 (34.7) 29 (9.6) 87 (28.7) 45 (14.9) 62 (20.5) 20 (6.6) 43 (14.2) 43 (14.2) 23 (7.6) 34 (11.2) 40 (13.2) 20 (6.6) 43 (14.2) 40 (13.2) 34 (11.2) 17 (5.6) 20 (6.6) 34 (11.2) 11 (3.6) 31 (10.2) 14 (4.6) 31 (10.2) 29 (9.6) 18 (5.9) 17 (5.6)

Grade 3-5 n (%) 97 (32.0) 0 (0.0) 4 (1.3) 3 (1.0) 9 (3.0) 0 (0.0) 5 (1.7) 0 (0.0) 0 (0.0) 0 (0.0) 0 (0.0) 7 (2.3) 3 (1.0) 3 (1.0) 0 (0.0) 1 (0.3) 0 (0.0) 0 (0.0) 2 (0.7) 3 (1.0) 0 (0.0) 3 (1.0) 3 (1.0) 1 (0.3) 1 (0.3) 3 (1.0) 0 (0.0)

(Table 1 continued on next page.)

GBC_2013Conf_vertical_62512_Layout 1 7/11/12 11:38

Table 1 Incidence of Adverse Events Occurring in ≥5% of Patients Randomized to PROVENGE PROVENGE (N = 601)

Hypertension Anorexia Bone pain Upper respiratory tract infection Insomnia Musculoskeletal chest pain Cough Neck pain Weight decreased Urinary tract infection Rash Sweating Tremor

Control* (N = 303)

All Grades n (%)

Grade 3-5 n (%)

All Grades n (%)

Grade 3-5 n (%)

45 (7.5) 39 (6.5) 38 (6.3) 38 (6.3)

3 (0.5) 1 (0.2) 4 (0.7) 0 (0.0)

14 (4.6) 33 (10.9) 22 (7.3) 18 (5.9)

0 (0.0) 3 (1.0) 3 (1.0) 0 (0.0)

37 (6.2) 36 (6.0)

0 (0.0) 2 (0.3)

22 (7.3) 23 (7.6)

1 (0.3) 2 (0.7)

35 (5.8) 34 (5.7) 34 (5.7) 33 (5.5) 31 (5.2) 30 (5.0) 30 (5.0)

0 (0.0) 3 (0.5) 2 (0.3) 1 (0.2) 0 (0.0) 1 (0.2) 0 (0.0)

17 (5.6) 14 (4.6) 24 (7.9) 18 (5.9) 10 (3.3) 3 (1.0) 9 (3.0)

0 (0.0) 2 (0.7) 1 (0.3) 2 (0.7) 0 (0.0) 0 (0.0) 0 (0.0)

*Control was non-activated autologous peripheral blood mononuclear cells.

Cerebrovascular Events. In controlled clinical trials, cerebrovascular events, including hemorrhagic and ischemic strokes, were reported in 3.5% of patients in the PROVENGE group compared with 2.6% of patients in the control group. (See Adverse Reactions [6] of full Prescribing Information.) To report SUSPECTED ADVERSE REACTIONS, contact Dendreon Corporation at 1-877-336-3736 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Dendreon Corporation Seattle, Washington 98101

SECOND ANNUAL CONFERENCE

GLOBAL BIOMARKERS CONSORTIUM

™

Clinical Approaches to Targeted Technologies ™

October 4-6, 2013 The Seaport Boston Hotel 1 Seaport Lane Boston, MA 02210 REGISTER TODAY AT

GlobalBiomarkersConsortium.com WCMC_2013Conf_vertical_80612_Layout 1 11/13/12 2:4

SECOND ANNUAL CONFERENCE

2013 WORLD CUTANEOUS MALIGNANCIES CONGRESS TM

REFERENCES: 1. PROVENGE [package insert]. Dendreon Corporation; June 2011. 2. Kantoff PW, Higano CS, Shore ND, et al; for the IMPACT Study Investigators. Sipuleucel-T immunotherapy for castration-resistant prostate cancer. N Engl J Med. 2010;363:411-422.

Melanoma Basal Cell Carcinoma Cutaneous T-Cell Lymphoma Squamous Cell Carcinoma Merkel Cell Carcinoma

July 26-28, 2013 ©2013 Dendreon Corporation. All rights reserved. January 2013. Printed in the U.S.A. Dendreon, the Dendreon logo, and PROVENGE are registered trademarks of Dendreon Corporation. P-A-01.13-002.00

Hyatt Regency La Jolla at Aventine 3777 La Jolla Village Drive San Diego, California

To register, please visit www.CutaneousMalignancies.com

Introduction

The Festering Sequester By Lisa Neuman, Managing Editor

he statistics are startling. Initial survey results from the Association of Community Cancer Centers (ACCC) show that nearly 60% of the respondents say they’ve made significant changes in how they run their practices just in the past 3 months (see our story on page 31). A separate survey by the Com munity Oncology Alliance (COA) found that 49% of community oncology practices have been forced to send their Medicare patients elsewhere for treatment, a number that is projected to increase to 62% if the sequester is still in place on July 31.1 That same survey also revealed that 21% of oncology practices are already laying off staff, with that number also projected to rise to 38% if the sequester goes beyond July 31. The American Society of Clinical Oncology (ASCO) also found disturbing sequester-related data, reporting in its online survey that just 1 month later, an overwhelming 80% of the respondents were already being impacted by the mandatory 2% across-the-board budget cuts that went into effect on April 1, with 74% of oncology practices having enough difficulty paying for chemotherapy drugs that they were forced to turn patients away. Some practices and clinics were sending up to half of

their Medicare patients elsewhere, such as to expensive hospital-based infusion centers.2 Clearly, the effects of the sequester are being felt in oncology, and, in truth, they were felt early on. Barely 3 days after the sequester went into effect, The Washington Post reported that oncology clinics were already turning Medicare patients away. The chief executive of North Shore Hematology Oncology Associates in New York, Jeff Vacirca, was quoted as saying that if they treated their Medicare patients with the most expensive drugs, they’d “be out of business in six months to a year.” After looking at the math and holding an emergency meeting, North Shore made the difficult decision to no longer see 16,000 of their Medicare patients with cancer.3 It is no surprise, then, that cancer care providers, oncology practice managers, healthcare policymakers, and patients with cancer are all paying attention, and with great interest, to how a new bill progresses through Congress in the coming weeks and months. The Cancer Patient Protection Act of 2013 (H.R. 1416), which was introduced by Rep. Renee Ellmers, R-NC, in early April, was being cosponsored by 88 members of Congress (both Republicans and Democrats) as we went to press.

Ronald Barkley, MS, JD President Cancer Center Business Development Group Bedford, NH Peggy Barton, RN Practice Manager Toledo Clinic, OH

Continued on page 13

Editorial Advisory Board

Editor-in-Chief Dawn Holcombe, MBA, FACMPE, ACHE President DGH Consulting South Windsor, CT

The bill would exempt Part B drugs, including cancer and supportive care drugs, from the 2% sequestration cut. However, a check of the bill on GovTrack (http://www.govtrack.us/ congress/bills/113/hr1416) shows it has only a 10% chance of making it past committee and a 6% chance of being enacted (as of press time). As the sequester wears on, these collective survey results indicate that every cancer care provider and patient with cancer will be, at some point and in some way, negatively impacted by the standstill in Washington. As a leading resource for information relating to all aspects of managing the business of an oncology practice, the editors, staff, and publishers of Oncology Practice Management will stay on the forefront of breaking news and developments that could impact your practice and your patients. With news and viewpoints from the ACCC, COA, ASCO, and other groups on the front line of shaping cancer care policy, we will keep you up to date on any legislative movements from Washington as well as offer valuable perspectives on how oncology practices everywhere are dealing with the impact. We invite you to join this national conversation by sharing your own experiences in your

Risë Marie Cleland President Oplinc, Inc Lawton, OK

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

Bruce A. Cutter, MD President Cutter HealthCare Consulting Spokane, WA

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

Craig K. Deligdish, MD Hematologist/Oncologist Oncology Resource Networks Orlando, FL

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

June 2013

Bonnie J. Miller, RN, BSN, OCN, FAAMA Administrative Director Women’s Cancer Center Fox Chase Cancer Center Philadelphia, PA Cindy C. Parman, CPC, CPC-H, RCC CSI Coding Strategies, Inc Powder Springs, GA Carla C. Wood, CPC, MS President Altos Solutions, Inc Los Altos, CA

www.OncPracticeManagement.com

In This Issue

PUBLISHING STAFF Senior Vice President/Group Publisher Nicholas Englezos nick@engagehc.com Vice President, Director of Sales & Marketing Joe Chanley joe@engagehc.com

By Caroline Helwick

AACR Issues New Policy on Tobacco Use............................................................1

By Phoebe Starr

Transitioning to ICD-10..............................................................................................1

Director, Client Services Lou Lesperance lou@greenhillhc.com

The Festering Sequester............................................................................................5

Managing Editor Lisa Neuman Associate Editor Lara J. Lorton Editorial Assistants Jennifer Brandt Cara Guglielmon Production Manager Marie RS Borrelli The Lynx Group President/CEO Brian Tyburski Chief Operating Officer Pam Rattanonont Ferris Vice President of Finance Andrea Kelly Director, Human Resources Blanche Marchitto Associate Editorial Director, Projects Division Terri Moore 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 Web Content Managers David Maldonado Anthony Travean Digital Programmer Michael Amundsen Senior Project Manager Andrea Boylston Project Coordinators Deanna Martinez Jackie Luma Executive Administrator 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

Managed Markets: Payers’ Perspectives on Transforming Care Delivery......................................................................................................1

Publisher Cristopher Pires cris@engagehc.com

Editorial Director Dalia Buffery dalia@engagehc.com

Features

By Susanne Talebian By Lisa Neuman

Expanding Patient Access to Compassionate-Use Drugs via Clinical Trials.......................................................................................................38 By Wayne Kuznar

Conference News

Penn Medicine Finds Support for Cancer Care Rationing............................. 13 University Hospitals Case Medical Center Experts Present Data Addressing Patient and Physician Barriers to Clinical Trials............................. 14 ASCO Completes Electronic Data Sharing–Standard for Breast Cancer Treatment..................................................................................... 19 News Briefs.............................................................................................................. 20

Departments

DRUG CODING FDA-Approved Medications Used for the Treatment of Lung Cancer....... 26 PATIENT AND PROVIDER ACCESS Brought to you by the Association of Community Cancer Centers

The Impact of the Medicare Sequester on Community Oncology….......…31 By Sydney Abbott, JD

PHYSICIAN WEALTH MANAGEMENT Don’t Leave Home Without Your Umbrella…...........................................................32 By Lawrence B. Keller, CFP®, CLU®, ChFC®, RHU®, LUTCF

MEDICAL LEGAL UPDATE Why the Time to Revisit Third-Party Relationships and Your Business Associate Agreements Is Now...........................................................................34 By Jennifer Kirschenbaum, Esq 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 cancer patients deserve, providers must master the ever-changing business of oncology. Oncology Practice Management will offer 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.

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 © 2013 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. 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 PRACTICE MANAGEMENT

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At Amgen, biologic medicines are rooted in

quality

and nurtured by

reliability.

Robust quality control and a reliable supply are every bit as important as scientific innovation. For more than 30 years, Amgen has poured commitment, passion, and a drive for perfection into every medicine we make. So you can turn to Amgen for the biologic medicines that matter so much to your patients’ treatment…for generations to come. To learn more about Amgen’s commitment to consistent quality and reliable supply, visit biotechnologybyamgen.com ©2013 Amgen Inc. All rights reserved. 73979-R1-V1

AVBCC Annual Meeting

Managed Markets: Payers’ Perspectives on…Continued from page 1 performance and efficiency and offers shared savings. “For providers, participation in the PGIP can mean 10% to 20% of the E&M [evaluation and management] code. It’s a substantial part of their reimbursement,” Dr Lang noted. This was followed by the patient-centered medical home (PCMH) program, a model of “primary care transformation.” The newest component of this is the PCMH “neighborhood concept,” which links to other specialties beyond oncology and includes medical management as a requirement. The company’s PCMH is the largest medical home in the country, encompassing 3000 physicians and impacting 2 million members. Most recently, under an organized system-of-care model, BCBSM added its accountable care organizations, which currently total 38. Hospital incentive contracts are now “bringing hospitals along on this same journey,” Dr Lang said. Three years ago, provider-delivered care management was implemented, and it now encompasses 400 practices, which are largely primary care. It is an extension of the Michigan Primary Care Transformation program, which is a collaborative effort with Medicare. Physicians receive trained nurse managers and can identify patients within their practices who warrant greater attention from these “embedded care managers.” Physician organizations report a positive impact on clinical indicators, but “it’s been a bit of a struggle, as practices do have to reengineer themselves,” Dr Lang acknowledged. Oncology practices will be added in 2014.

Channel Management The escalating cost of drugs led BCBSM to rethink the delivery of pharmacy services. Over the past 5 years, drugs administered under the medical benefit have been shifting from physicians’ offices to more costly outpatient facilities.

“For providers, participation in the PGIP can mean 10% to 20% of the E&M [evaluation and management] code. It’s a substantial part of their reimbursement.” —James Lang, PharmD

In 2008, the aggregate spending on drugs in the medical benefit (ie, outpatient setting) was $150 million; by 2012, this spending approached $300 million—a 20% rate of growth. Drug spending under the specialty phar-

ONCOLOGY PRACTICE MANAGEMENT

I June 2013

macy benefit rose from $250 million to $350 million, an 8% increase. By contrast, under the physician buy-and-bill model, drug spending increased only 1.5%, remaining essentially stable at around $325 million. “This trend caused me to reorganize how we deliver our services in pharmacy,” Dr Lang said. The result was a cross-functional “channel management” form of distribution.

Specialty Drug Management Dr Lang outlined BCBSM’s approach to managing specialty pharmacy. Among the techniques it implements are prior authorization, formulary tiers, off-label limitations, preferred specialty pharmacy, physician specialty treatment dashboard and data set, oncology pathways, pipeline monitoring, and more. In 2014, the company will also start implementing National Drug Code level pricing and National Drug Code level quantity required, ambulatory infusion benefits, channel efficiency reporting to physicians, global per-member per-month targets (which are currently in place), and specific specialty drug per-member per-month targets. “We will have the ability to split J code professional claims. We will know what drug is being prescribed,” he said. The challenges with specialty drug management will remain the obstacles of state and federal mandates, difficult provider contracts, the potential for fraud, problems with manufacturer copay cards, and physician buy-and-bill issues, Dr Lang added. l

*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 ÂŠ 2010, Millennium Pharmaceuticals, Inc. All rights reserved. Printed in USA

V-10-0196

11/10

AACR Annual Meeting

AACR Issues New Policy on Tobacco Use Continued from page 1 use and that many clinical trials do not document tobacco use at baseline and follow-up, although it is a confounding factor. In fact, tobacco use interferes with the efficacy of chemotherapy and radiation therapy, leads to worsened side effects from these therapies, increases the risk of developing a second cancer, and increases the risk of dying of heart disease. There is a strong rationale for creating infrastructure for delivery of evidence-based interventions to address tobacco use among patients with cancer. The AACR policy states that only 38% of National Cancer Institute (NCI)-designated cancer centers that responded to a survey document smoking status as a vital sign, and less than 50% of these centers have dedicated personnel for tobacco cessation; by contrast, 78% of centers have dedicated nutrition personnel. A different survey showed that whereas 90% of responding oncologists believe that tobacco use affects cancer outcomes and that tobacco cessation should be included as a standard of care, only 40% of these oncologists provide routine assistance for smoking cessation. Only 33% of lung cancer specialists considered themselves adequately trained in smoking cessation. A recent study of 155 NCI Clinical Trials Cooperative Group Program trials demonstrated that only 29% of registered trials assessed tobacco use during the study. Less than 5% of these trials included follow-up on subsequent tobacco use status. It is very difficult for people to quit smoking. Studies suggest that although approximately 50% of smokers try to quit, only between

4% and 7% are successful in doing so without evidence-based intervention. “Although lung cancer first comes to mind as associated with tobacco use, tobacco is implicated in 18 other cancers. A frequent assumption is that once cancer develops, it is fruitless to stop smoking. This is not true,” said Roy S. Herbst, MD, PhD, Chair of the AACR Tobacco and Cancer Subcommittee that pro-

“Although lung cancer first comes to mind as associated with tobacco use, tobacco is implicated in 18 other cancers. A frequent assumption is that once cancer develops, it is fruitless to stop smoking. This is not true.” —Roy S. Herbst, MD, PhD

duced the policy statement, and Chief of Medical Oncology, Yale Cancer Center and Smilow Cancer Hospital at Yale-New Haven, CT. Evidence-based approaches to stop smoking include pharmacotherapy and nicotine chewing gum, as well as the “5A” approach to smoking cessation—Ask about smoking status, Advise people to quit, Assess interest in quitting, Assist with pharmacotherapy and counseling, and Arrange follow-up.

ONCOLOGY PRACTICE MANAGEMENT

I June 2013

However, many cancer providers rarely advise patients on how to approach quitting. Concrete Steps The AACR’s policy statement endorses a number of recommendations to remedy this treatment gap. The statement notes that oncology practices should be responsible for providing assessment and intervention for patients with cancer who continue to smoke and for recent quitters. The recommendations call for: • Repeat documentation of tobacco use in all patients with cancer, so that the confounding effects of smoking on treatment, disease progression, and comorbidities can be tracked in clinical trials, starting at registration and continuing through follow-up • Tobacco use should also be documented in all clinical care settings; universal standardized measurements of tobacco use and of tobacco exposure are required to be able to make cross-center comparisons and to compile a meaningful database • Researchers and healthcare quality and accreditation bodies should incorporate evidence-based criteria • Healthcare systems, payers, and funding bodies should provide reimbursement for tobacco use interventions and should provide incentives for developing and for delivering interventions. The Affordable Care Act provides for reimbursement for smoking cessation interventions by insurance plans by 2014, but this will vary by state and will be evidence-based. Electronic medical records will also track smoking status. l

After 2 prior lines of MBC chemotherapy,

DISCOVER OVERALL SURVIVAL HALAVEN: The FIRST and ONLY single-agent therapy proven to significantly extend OVERALL SURVIVAL after 2 prior lines of MBC therapy1-9

UPDATED OVERALL SURVIVAL (OS) ANALYSIS (UNPLANNED): MEDIAN OS, MONTHS (95% CI)1,10,a

P R O P O R T I O N O F PAT I E N T S A L I V E

1.0

The updated OS analysis was consistent with the primary analysis1 The primary analysis, conducted when ~50% of events (deaths) had been observed, demonstrated a median OS for Halaven vs TPC of 13.1 months (95% CI: 11.8, 14.3) vs 10.6 months (95% CI: 9.3, 12.5), HR*=0.81 (95% CI: 0.66, 0.99) (P=0.041)1,10 Results from an updated, unplanned survival analysis of the Phase III, randomized, open-label, multicenter, multinational EMBRACE† trial of Halaven versus TPC in patients with metastatic breast cancer (MBC) (N=762), conducted when 77% of events (deaths) had been observed. The primary endpoint was OS. Patients were randomized (2:1) to receive either Halaven 1.4 mg/m2 IV for 2 to 5 minutes on Days 1 and 8 of a 21-day cycle, or any single-agent therapy, selected prior to randomization. At baseline, all patients had received ≥2 prior chemotherapeutic regimens for metastatic disease and demonstrated disease progression within 6 months of their last chemotherapeutic regimen. All patients received prior anthracycline- and taxane-based chemotherapy, unless contraindicated. Therapies in the TPC arm consisted of 97% chemotherapy (26% vinorelbine, 18% gemcitabine, 18% capecitabine, 16% taxanes [included paclitaxel, docetaxel, nab-paclitaxel, and ixabepilone], 9% anthracyclines, 10% other chemotherapy), and 3% hormonal therapy.

Indication Halaven is indicated for the treatment of patients with metastatic breast cancer who have previously received at least two chemotherapeutic regimens for the treatment of metastatic disease. Prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting.

Important Safety Information Neutropenia

• Monitor complete blood counts prior to each dose, and increase the frequency of monitoring in patients who develop Grade 3 or 4 cytopenias. Delay administration and reduce subsequent doses in patients who experience febrile neutropenia or Grade 4 neutropenia lasting longer than 7 days • Severe neutropenia (ANC <500/mm3) lasting more than 1 week occurred in 12% (62/503) of patients. Patients with elevated liver enzymes >3 × ULN and bilirubin >1.5 × ULN experienced a higher incidence of Grade 4 neutropenia and febrile neutropenia than patients with normal levels • Grade 3 and Grade 4 neutropenia occurred in 28% and 29%, respectively, of patients who received Halaven. Febrile neutropenia occurred in 5% of patients and two patients (0.4%) died from complications

Peripheral Neuropathy

• Patients should be monitored closely for signs of peripheral motor and sensory neuropathy • Grade 3 peripheral neuropathy occurred in 8% of patients, and Grade 4 in 0.4% of patients who received Halaven. Delay administration of Halaven until resolution to Grade 2 or less • Neuropathy lasting more than 1 year occurred in 5% of patients. Twenty-two percent of patients developed a new or worsening neuropathy that had not recovered within a median follow-up duration of 269 days (range 25-662 days) • Peripheral neuropathy (5%) was the most common adverse reaction resulting in discontinuation Please see accompanying brief summary of Halaven full Prescribing Information. To learn more about Halaven, visit www.halaven.com

0.9 0.8

Halaven

25% (2.6 month)

(n=508)

13.2

0.7

INCREASE

(12.1, 14.4)

0.6

IN MEDIAN OS

Deaths=386

0.5

Treatment of Physician’s Choice

0.4

(n=254)

0.3

10.6

0.2

(9.2, 12.0)

0.1

Deaths=203

0.0 0

54 26

11 5

0 Halaven 0 TPC

TIME (MONTHS) Number of patients at risk

508 254

406 178

274 106

142 61

CI=confidence interval; Treatment of Physician’s Choice (Control arm)=TPC. Conducted in the intent-to-treat (ITT) population.

Pregnancy Category D

• Halaven is expected to cause fetal harm when administered to a pregnant woman and patients should be advised of these risks

QT Prolongation

• In an uncontrolled ECG study in 26 patients, QT prolongation was observed on Day 8, independent of eribulin concentration, with no prolongation on Day 1. ECG monitoring is recommended for patients with congestive heart failure; bradyarrhythmias; concomitant use of drugs that prolong QT interval, including Class Ia and III antiarrhythmics; and electrolyte abnormalities • Correct hypokalemia or hypomagnesemia prior to initiating Halaven and monitor electrolytes periodically during therapy. Avoid in patients with congenital long QT syndrome

Hepatic and Renal Impairment

• For patients with mild (Child-Pugh A) or moderate (Child-Pugh B) hepatic and/or moderate (CrCl 30-50 mL/min) renal impairment, a reduction in starting dose is recommended

Most Common Adverse Reactions

• Most common adverse reactions (≥25%) reported in patients receiving Halaven were neutropenia (82%), anemia (58%), asthenia/fatigue (54%), alopecia (45%), peripheral neuropathy (35%), nausea (35%), and constipation (25%) • The most common serious adverse reactions reported in patients receiving Halaven were febrile neutropenia (4%) and neutropenia (2%) References: 1. Halaven [package insert]. Woodcliff Lake, NJ: Eisai Inc; 2012. 2. Saad ED et al. J Clin Oncol. 2010;28(11):1958-1962. 3. Slamon DJ et al. N Engl J Med. 2001;344(11):783-792. 4. Geyer CE et al. N Engl J Med. 2006;355(26):2733-2743. 5. von Minckwitz G et al. J Clin Oncol. 2009;27(12):1999-2006. 6. Miller K et al. N Engl J Med. 2007;357(26):2666-2676. 7. Robert NJ et al. J Clin Oncol. 2011;29(10):1252-1260. 8. Sparano JA et al. J Clin Oncol. 2010;28(20):3256-3263. 9. Jones SE et al. J Clin Oncol. 2005;23(24):55425551. 10. Cortes J et al. Lancet. 2011;377(9769):914-923. *HR=hazard ratio. † EMBRACE=Eisai Metastatic Breast Cancer Study Assessing Physician’s Choice versus E7389 (Eribulin).

HALAVEN® (eribulin mesylate) Injection BRIEF SUMMARY – See package insert for full prescribing information. 2.2 Dose Modification Assess for peripheral neuropathy and obtain complete blood cell counts prior to each dose. Recommended dose delays • Do not administer HALAVEN on Day 1 or Day 8 for any of the following: – ANC <1,000/mm3 – Platelets <75,000/mm 3 – Grade 3 or 4 non-hematological toxicities. • The Day 8 dose may be delayed for a maximum of 1 week. – If toxicities do not resolve or improve to ≤ Grade 2 severity by Day 15, omit the dose. – If toxicities resolve or improve to ≤ Grade 2 severity by Day 15, administer HALAVEN at a reduced dose and initiate the next cycle no sooner than 2 weeks later. Recommended dose reductions • If a dose has been delayed for toxicity and toxicities have recovered to Grade 2 severity or less, resume HALAVEN at a reduced dose as set out in Table 1. • Do not re-escalate HALAVEN dose after it has been reduced. Table 1 Recommended Dose Reductions Recommended Event Description HALAVEN Dose Permanently reduce the 1.4 mg/m2 HALAVEN dose for any of the following: ANC <500/mm3 for >7 days ANC <1,000 /mm3 with fever or infection Platelets <25,000/mm3 1.1 mg/m2 Platelets <50,000/mm3 requiring transfusion Non-hematologic Grade 3 or 4 toxicities Omission or delay of Day 8 HALAVEN dose in previous cycle for toxicity Occurrence of any event requiring permanent dose reduction while receiving 1.1 mg/m2 0.7 mg/m2 Occurrence of any event requiring permanent dose reduction while receiving 0.7 mg/m2 Discontinue HALAVEN ANC = absolute neutrophil count. Toxicities graded in accordance with National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. 5 WARNINGS AND PRECAUTIONS 5.1 Neutropenia Severe neutropenia (ANC <500/mm3) lasting more than one week occurred in 12% (62/503) of patients in Study 1, leading to discontinuation in <1% of patients. Patients with alanine aminotransferase or aspartate aminotransferase >3 × ULN (upper limit of normal) experienced a higher incidence of Grade 4 neutropenia and febrile neutropenia than patients with normal aminotransferase levels. Patients with bilirubin >1.5 × ULN also had a higher incidence of Grade 4 neutropenia and febrile neutropenia. Monitor complete blood counts prior to each dose; increase the frequency of monitoring in patients who develop Grade 3 or 4 cytopenias. Delay administration of HALAVEN and reduce subsequent doses in patients who experience febrile neutropenia or Grade 4 neutropenia lasting longer than 7 days. Clinical studies of HALAVEN did not include patients with baseline neutrophil counts below 1,500/mm3. 5.2 Peripheral Neuropathy Grade 3 peripheral neuropathy occurred in 8% (40/503) of patients, and Grade 4 in 0.4% (2/503) of patients in Study 1. Peripheral neuropathy was the most common toxicity leading to discontinuation of HALAVEN (5% of patients; 24/503). Neuropathy lasting more than one year occurred in 5% (26/503) of patients. Twenty-two percent (109/503) of patients developed a new or worsening neuropathy that had not recovered within a median follow-up duration of 269 days (range 25-662 days). Monitor patients closely for signs of peripheral motor and sensory neuropathy. Withhold HALAVEN in patients who experience Grade 3 or 4 peripheral neuropathy until resolution to Grade 2 or less. 5.3 Embryo-Fetal Toxicity There are no adequate and well-controlled studies of HALAVEN in pregnant women. HALAVEN is a microtubule inhibitor; therefore, it is expected to cause fetal harm when administered to a pregnant woman. Embryo-fetal toxicity and teratogenicity occurred in rats that received eribulin mesylate at approximately half of the recommended human dose based on body surface area. If this drug is used during pregnancy, or if a patient becomes pregnant while taking this drug, she should be apprised of the potential hazard to the fetus. 5.4 QT Prolongation In an uncontrolled open-label ECG study in 26 patients, QT prolongation was observed on Day 8, independent of eribulin concentration, with no QT prolongation observed on Day 1. ECG monitoring is recommended if therapy is initiated in patients with congestive heart failure, bradyarrhythmias, drugs known to prolong the QT interval, including Class Ia and III antiarrhythmics, and electrolyte abnormalities. Correct hypokalemia or hypomagnesemia prior to initiating HALAVEN and monitor these electrolytes periodically during therapy. Avoid HALAVEN in patients with congenital long QT syndrome. 6 ADVERSE REACTIONS The following adverse reactions are discussed in detail in other sections of the labeling: • Neutropenia • Peripheral neuropathy • QT interval prolongation The most common adverse reactions (≥25%) reported in patients receiving HALAVEN were neutropenia, anemia, asthenia/fatigue, alopecia, peripheral neuropathy, nausea, and constipation. The most common serious adverse reactions reported in patients receiving HALAVEN were febrile neutropenia (4%) and neutropenia (2%). The most common adverse reaction resulting in discontinuation of HALAVEN was peripheral neuropathy (5%). Because clinical trials are conducted under widely varying conditions, the adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in other clinical trials and may not reflect the rates observed in clinical practice. In clinical trials, HALAVEN has been administered to 1,222 patients with multiple tumor types, including 240 patients exposed to HALAVEN for 6 months or longer. The majority of the 1,222 patients were women (82%) with a median age of 58 years (range: 26 to 91 years). The racial and ethnic distribution was Caucasian (83%), Black (5%), Asian (2%), and other (5%). The adverse reactions described in Table 2 were identified in 750 patients treated in Study 1. In Study 1, patients were randomized (2:1) to receive either HALAVEN (1.4 mg/m2 on Days 1 and 8 of a 21-day cycle) or single agent treatment chosen by their physician (control group). A total of 503 patients received HALAVEN, and 247 patients in the control group received therapy consisting of chemotherapy [total 97% (anthracyclines 10%, capecitabine 18%, gemcitabine 19%, taxanes 15%, vinorelbine 25%, other chemotherapies 10%)] or hormonal therapy (3%). The median duration of exposure was 118 days for patients receiving HALAVEN and 63 days for patients receiving control therapy. Table 2 reports the most common adverse reactions occurring in at least 10% of patients in either group. Table 2 Adverse Reactions with a Per-Patient Incidence of at Least 10% in Study 1 MedDRA ver 10.0 HALAVEN (n=503) Control Group (n=247) All Grades ≥ Grade 3 All Grades ≥ Grade 3 a Blood and Lymphatic System Disorders Neutropenia 82% 57% 53% 23% Anemia 58% 2% 55% 4% Nervous system disorders 35% 8% 16% 2% Peripheral neuropathyb Headache 19% <1% 12% <1% General disorders and administrative site conditions Asthenia/Fatigue 54% 10% 40% 11% Mucosal inflammation 9% 1% 10% 2% Pyrexia 21% <1% 13% <1% Gastrointestinal disorders Constipation 25% 1% 21% 1% Diarrhea 18% 0 18% 0 Nausea 35% 1% 28% 3% Vomiting 18% 1% 18% 1% Musculoskeletal and connective tissue disorders Arthralgia/Myalgia 22% <1% 12% 1% Back pain 16% 1% 7% 2% Bone pain 12% 2% 9% 2% Pain in extremity 11% 1% 10% 1% Investigations Weight decreased 21% 1% 14% <1% Metabolism and nutrition disorders Anorexia 20% 1% 13% 1% Respiratory, thoracic, and mediastinal disorders Cough 14% 0 9% 0 Dyspnea 16% 4% 13% 4% Skin and subcutaneous tissue disorders 10% NAc Alopecia 45% NAc

Table 2 (cont'd) MedDRA ver 10.0

HALAVEN (n=503) Control Group (n=247) All Grades ≥ Grade 3 All Grades ≥ Grade 3 Infections and Infestations Urinary Tract Infection 10% 1% 5% 0 a Based upon laboratory data. b Includes neuropathy peripheral, neuropathy, peripheral motor neuropathy, polyneuropathy, peripheral sensory neuropathy, and paraesthesia. c Not applicable; (grading system does not specify > Grade 2 for alopecia). Cytopenias: Grade 3 neutropenia occurred in 28% (143/503) of patients who received HALAVEN in Study 1, and 29% (144/503) of patients experienced Grade 4 neutropenia. Febrile neutropenia occurred in 5% (23/503) of patients; two patients (0.4%) died from complications of febrile neutropenia. Dose reduction due to neutropenia was required in 12% (62/503) of patients and discontinuation was required in <1% of patients. The mean time to nadir was 13 days and the mean time to recovery from severe neutropenia (<500/mm3) was 8 days. Grade 3 or greater thrombocytopenia occurred in 1% (7/503) of patients. G-CSF (granulocyte colony-stimulating factor) or GM-CSF (granulocyte–macrophage colony-stimulating factor) was used in 19% of patients who received HALAVEN. Peripheral Neuropathy: In Study 1, 17% of enrolled patients had Grade 1 peripheral neuropathy and 3% of patients had Grade 2 peripheral neuropathy at baseline. Dose reduction due to peripheral neuropathy was required by 3% (14/503) of patients who received HALAVEN. Four percent (20/503) of patients experienced peripheral motor neuropathy of any grade and 2% (8/503) of patients developed Grade 3 peripheral motor neuropathy. Liver Function Test Abnormalities: Among patients with Grade 0 or 1 ALT levels at baseline, 18% of HALAVEN-treated patients experienced Grade 2 or greater ALT elevation. One HALAVEN-treated patient without documented liver metastases had concomitant Grade 2 elevations in bilirubin and ALT; these abnormalities resolved and did not recur with re-exposure to HALAVEN. Less Common Adverse Reactions: The following additional adverse reactions were reported in ≥5% to <10% of the HALAVENtreated group: • Eye Disorders: increased lacrimation • Gastrointestinal Disorders: dyspepsia, abdominal pain, stomatitis, dry mouth • General Disorders and Administration Site Conditions: peripheral edema • Infections and Infestations: upper respiratory tract infection • Metabolism and Nutrition Disorders: hypokalemia • Musculoskeletal and Connective Tissue Disorders: muscle spasms, muscular weakness • Nervous System Disorders: dysgeusia, dizziness • Psychiatric Disorders: insomnia, depression • Skin and Subcutaneous Tissue Disorders: rash 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Category D There are no adequate and well-controlled studies with HALAVEN in pregnant women. HALAVEN is a microtubule inhibitor; therefore, it is expected to cause fetal harm when administered to a pregnant woman. Embryo-fetal toxicity and teratogenicity occurred in rats that received eribulin mesylate at approximately half of the recommended human dose based on body surface area. 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 the fetus. In a developmental toxicity study, pregnant rats received intravenous infusion of eribulin mesylate during organogenesis (Gestation Days 8, 10, and 12) at doses approximately 0.04, 0.13, 0.43 and 0.64 times the recommended human dose, based on body surface area (mg/m2). Increased abortion and severe external or soft tissue malformations were observed in offspring at doses 0.64 times the recommended human dose based on body surface area (mg/m2), including the absence of a lower jaw, tongue, stomach and spleen. Increased embryo-fetal death/resorption, reduced fetal weights, and minor skeletal anomalies consistent with developmental delay were also reported at or above doses of 0.43 times the recommended human dose. Maternal toxicity of eribulin mesylate was reported in rats at or above doses of 0.43 times the recommended human dose (mg/m²), and included enlarged spleen, reduced maternal weight gain and decreased food consumption. 8.3 Nursing Mothers It is not known whether HALAVEN is excreted into human milk. No studies in humans or animals were conducted to determine if HALAVEN is excreted into milk. Because many drugs are excreted into human milk and because of the potential for serious adverse reactions in human milk fed infants from HALAVEN, a decision should be made whether to discontinue nursing or to discontinue HALAVEN taking into account the importance of the drug to the mother. 8.4 Pediatric Use The safety and effectiveness of HALAVEN in pediatric patients below the age of 18 years have not been established. 8.6 Hepatic Impairment Administration of HALAVEN at a dose of 1.1 mg/m2 to patients with mild hepatic impairment and 0.7 mg/m2 to patients with moderate hepatic impairment resulted in similar exposure to eribulin as a dose of 1.4 mg/m2 to patients with normal hepatic function. Therefore, a lower starting dose of 1.1 mg/m2 is recommended for patients with mild hepatic impairment (Child-Pugh A) and of 0.7 mg/m2 is recommended for patients with moderate hepatic impairment (Child-Pugh B). HALAVEN was not studied in patients with severe hepatic impairment (Child-Pugh C). 8.7 Renal Impairment For patients with moderate renal impairment (CrCl 30-50 mL/min), the geometric mean dose-normalized systemic exposure increased 2-fold compared to patients with normal renal function. A lower starting dose of 1.1 mg/m2 is recommended for patients with moderate renal impairment. The safety of HALAVEN was not studied in patients with severe renal impairment (CrCl <30 mL/min). 10 OVERDOSAGE Overdosage of HALAVEN has been reported at approximately 4 times the recommended dose, which resulted in Grade 3 neutropenia lasting seven days and a Grade 3 hypersensitivity reaction lasting one day. There is no known antidote for HALAVEN overdose. 12 CLINICAL PHARMACOLOGY 12.3 Pharmacokinetics Specific Populations Hepatic Impairment A study evaluated the PK of eribulin in patients with mild (Child-Pugh A; n=7) and moderate (Child-Pugh B; n=5) hepatic impairment. Compared to patients with normal hepatic function (n=6), eribulin exposure increased 1.8-fold and 2.5-fold in patients with mild and moderate hepatic impairment, respectively. Administration of HALAVEN at a dose of 1.1 mg/m2 to patients with mild hepatic impairment and 0.7 mg/m2 to patients with moderate hepatic impairment resulted in similar exposure to eribulin as a dose of 1.4 mg/m2 to patients with normal hepatic function. Renal Impairment No formal PK trials were conducted with HALAVEN in patients with renal impairment. Available data suggests that geometric mean dose-normalized systemic exposure is similar for patients with mild renal impairment (CrCl 50-80 mL/min) relative to patients with normal renal function. However, for patients with moderate renal impairment (CrCl 30-50 mL/min), the geometric mean dosenormalized systemic exposure increased 2-fold compared to patients with normal renal function. 12.6 Cardiac Electrophysiology The effect of HALAVEN on the QTc interval was assessed in an open-label, uncontrolled, multicenter, single-arm dedicated QT trial. A total of 26 patients with solid tumors received 1.4 mg/m2 of HALAVEN on Days 1 and 8 of a 21-day cycle. A delayed QTc prolongation was observed on Day 8, with no prolongation observed on Day 1. The maximum mean QTcF change from baseline (95% upper confidence interval) was 11.4 (19.5) ms. 13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, mutagenesis, impairment of fertility Carcinogenicity studies have not been conducted with eribulin mesylate. Eribulin mesylate was not mutagenic in in vitro bacterial reverse mutation assays (Ames test). Eribulin mesylate was positive in mouse lymphoma mutagenesis assays, and was clastogenic in an in vivo rat bone marrow micronucleus assay. The effects of HALAVEN on human fertility are unknown. Fertility studies have not been conducted with eribulin mesylate in humans or animals. However, nonclinical findings in repeated-dose dog and rat toxicology studies suggest that male fertility may be compromised by treatment with eribulin mesylate. Rats exhibited testicular toxicity (hypocellularity of seminiferous epithelium with hypospermia/aspermia) following dosing with eribulin mesylate at or above 0.43 times the recommended human dose (mg/m2) given once weekly for 3 weeks, or at or above 0.21 times the recommended human dose (mg/m2) given once weekly for 3 out of 5 weeks, repeated for 6 cycles. Testicular toxicity was also observed in dogs given 0.64 times the recommended human dose (mg/m2) weekly for 3 out of 5 weeks, repeated for 6 cycles. 17 PATIENT COUNSELING INFORMATION See FDA-Approved Patient Labeling • Advise patients to contact their health care provider for a fever of 100.5°F or greater or other signs or symptoms of infection such as chills, cough, or burning or pain on urination. • Advise women of childbearing potential to avoid pregnancy and to use effective contraception during treatment with HALAVEN. –––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––––– HALAVEN® is a registered trademark used by Eisai Inc. under license from Eisai R&D Management Co., Ltd. © 2012 Eisai Inc. All rights reserved. Printed in USA / March 2012 ERI 346

ASCO Annual Meeting

Penn Medicine Finds Support for Cancer Care Rationing Philadelphia, PA—A majority of oncologists, patients with cancer, and members of the general public support cutting healthcare costs by refusing to pay for drugs that do not improve survival rates or quality of life. This is according to the results of a new study that were presented by researchers from the Perelman School of Medicine at the University of Pennsylvania during the annual meeting of the American Society of Clinical Oncology in Chicago. In 2012, the team from Penn Medicine surveyed 326 adult patients with cancer who were receiving treatment at Penn’s Abramson Cancer Center, a random sample of 891 adults in the general public, and 250 oncologists across the United States to ask their opinions about tactics for controlling the costs that are associated with cancer care. “We found that the majority of respondents considered Medicare spending a big or moderate problem, and many suggested that Medicare could spend less without causing harm,” said the study’s lead author, Keerthi Gogineni, MD, MSHP, an instructor in the division of Hematology-Oncology in Penn’s Abramson Cancer Center. “We know that cancer patients and their doctors face decisions every day

that stand to raise healthcare costs without conferring much benefit to patients, and our survey has identified some common themes in how these groups of stakeholders might propose to lower costs of care while still protecting patients.” More than 90% of all 3 groups attributed rising costs to drug companies charging too much, and more than 80% of each group cited insurance company profits as a driver of rising costs. Many of those surveyed (69% of the patients with cancer, 81% of the general public, and 70% of the oncologists) also thought that hospitals and doctors conducted unnecessary tests and provided unnecessary treatments. The research team, including senior author Ezekiel J. Emanuel, MD, PhD, Chairman of the Department of Medical Ethics and Health Policy at Penn, presented a variety of potential cost-lowering options to each group and asked whether they supported the idea. Patients with cancer, members of the general public, and oncologists tended to be in agreement with the idea that patients with cancer who can afford to pay more for care should be asked to pay more (56%, 58%, and 52%, respectively). Large numbers of all 3 groups also favored not paying for more

expensive drugs when cheaper alternatives are equally as effective (78% of the patients with cancer, 86% of the general public, and 90% of the oncologists). The majority of those surveyed also supported refusing to cover drugs that do not improve survival or quality of life, although the physicians were more likely to refuse payment under those circumstances (79% of oncologists compared with 52% of patients with cancer and 57% of the general public). However, drugs that confer only incremental gains in survival were found to be worth covering in the eyes of all of the groups surveyed— just 12% of the oncologists were willing to refuse payment for a drug that would extend life by 4 months, compared with 20% of the patients with cancer and 28% of the general public. “These results suggest that patients and the lay public prioritize quality of life, while oncologists appear focused on controlling disease and increasing length of life,” Dr Gogineni said. “Patients with cancer have a much broader set of concerns, from the cost of their doctor’s visits to the side effects of their treatment and the emotional toll of their illness.” (Source: Perelman School of Medicine, University of Pennsylvania, May 15, 2013.) l Introduction

The Festering Sequester Continued from page 5 own practices. If you have a story to share, please e-mail OPM’s Managing Editor, Lisa Neuman, at lneuman@ the-lynx-group.com. We plan to share some of your stories in future issues. Thank you for reading, and thank you

care-while-increasing-medicare-costs.html. Accessed June 13, 2013. 2. American Society of Clinical Oncology. ASCO sequestration impact survey: One month out, sequestration affecting care of Medicare cancer patients [press release]. May 9, 2013. 3. Kliff S. Cancer clinics are turning away thousands of Medicare patients. Blame the sequester. The Washington Post. April 3, 2013.

for your continued support of OPM.

References

1. Community Oncology Alliance. Sequestration cuts threaten seniors’ cancer care while increasing Medicare costs. Available at http://www.commu nityoncology.org/site/blog/detail/2013/05/09/may-92013-sequestration-cuts-threaten-seniors-au-cancer-

June 2013

www.OncPracticeManagement.com

ASCO Annual Meeting

University Hospitals Case Medical Center Experts Present Data Addressing Patient and Physician Barriers to Clinical Trials Chicago, IL—Researchers from University Hospitals Case Medical Center (UHCMC)’s Seidman Can cer Center presented findings from 2 studies evaluating new technologies designed to address common barriers to patient enrollment in clinical trials at the annual meeting of the American Society of Clinical Oncology (ASCO) in Chicago. Results from a large-scale, randomized trial demonstrated that the use of tailored, web-based videos delivering educational information to patients before an oncologist visit can significantly improve knowledge and reduce attitudinal barriers that impact enrollment in clinical trials. A second, preliminary study showed that a new automated technology created by UHCMC researchers helped oncologists to identify clinical trials for individual patients in a busy outpatient oncology clinic. “Although clinical trials are the key to developing new, better cancer treatments, less than 10% of cancer patients participate in them,” said Neal J. Meropol, MD, study author, Chief of the Division of Hematology and Oncology at UHCMC and Case Western Reserve University School of Medicine and member of the ASCO Board of Directors. “We know there are multiple barriers to clinical trials for both patients and oncologists, and the new technologies being evaluated at UHCMC Seidman Cancer Center are designed to break down those obstacles by providing individualized education for patients and new technology to help oncologists to efficiently identify appropriate trials for their patients.”

Common barriers to patient en rollment in clinical trials include fear of side effects, receiving placebo instead of treatment, financial concerns, and the misperception that clinical trials should only be considered as a “last resort” option. For oncologists, a common obstacle is

“Although clinical trials are the key to developing new, better cancer treatments, less than 10% of cancer patients participate in them.” —Neal J. Meropol, MD

the time needed to help identify appropriate clinical trials—thousands of which are currently in progress across the country—for their patients. At the UHCMC Seidman Cancer Center alone, there are currently more than 300 ongoing clinical trials focused on cancer. About the Studies Randomized Trial of a Web-Based Intervention to Address Barriers to Clinical Trials (Abstract 6500) Dr Meropol presented the findings from a trial examining the use of PRE-ACT (Preparatory Edu cation About Clinical Trials), a tailored, interactive, web-based intervention to address patient barriers and improve preparation for consideration of clinical trials as a

ONCOLOGY PRACTICE MANAGEMENT

I June 2013

treatment option. The prospective, randomized, multicenter, phase 3 clinical trial evaluated 1255 patients and utilized baseline assessments to determine their top clinical trial barriers. Patients in the PRE-ACT group were presented with a video library of 30- to 90-second clips that addressed their individual barriers, as indicated by their assessment results. Patients in the control group received online, text-based information that was not tailored to their individual barriers. A follow-up survey was conducted to reassess patient knowledge and attitudes. The results showed that PREACT significantly improved patient understanding and attitudes toward clinical trials when viewed before a visit to an oncologist. The control group also had improved knowledge, reduced attitudinal barriers, and improved preparation, but the PRE-ACT group was more satisfied with the amount and format of information presented to them and felt more prepared to consider enrollment in clinical trials when compared with patients who received written information. Trial Prospector: An Automated Clinical Trials Eligibility Matching Program (Abstract 6538) Co-authors Andrew Parchman, MD, Hematology and Oncology Fellow at UHCMC, and Dr Meropol presented findings examining the use of Trial Prospector, an automated, HIPAA-compliant program pioneered by UHCMC that matches patients to clinical trials based on information extracted from their electronic medical records (EMRs). Continued on page 20

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Patients living with intermediate or high-risk MF face many challenges. IncyteCARES is a program created by Incyte to connect patients who qualify for the program to ongoing support and resources during their treatment with Jakafi.

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•Benefit verification •Prior authorization •Appeal support • Delivery coordination of Jakafi

•Co-pay assistance •Free medication programs • Referrals and assistance with independent not-for-profit organizations

PATIENT EDUCATION AND SUPPORT

• Access to trained nurses • Educational information to help teach your patients about their condition and Jakafi Patient packet

•

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.

IncyteCARES: ASSISTING PROVIDERS AND PATIENTS IN OBTAINING ACCESS TO JAKAFI Enrollment sent to

95% of patients had insurance coverage for

Patients without insurance coverage were screened for patient assistance eligibility

94% of prior authorizations were approved for

86% of commercially insured patients had co-pays of less than $100/month

Information is based upon 1421 patients enrolled in IncyteCARES between April 1, 2012 and April 1, 2013.

91% of patients referred to the IncyteCARES commercial co-pay assistance program were eligible for assistance Important Safety Information (continued)

•Patients should be assessed for the risk of developing serious bacterial, mycobacterial, fungal and viral infections

• The three most frequent non-hematologic adverse reactions were bruising, dizziness and headache

Please see additional Important Safety Information and the Brief Summary of Full Prescribing Information within this ad. Jakaﬁ is a registered trademark of Incyte Corporation. © 2013, Incyte Corporation. All rights reserved. RUX-1227 04/13

Table 2: Worst Hematology Laboratory Abnormalities in the Placebo-controlled Studya Jakafi Placebo (N=155) (N=151) Laboratory All All b Grade 3 Grade 4 Grades Grade 3 Grade 4 Parameter Grades BRIEF SUMMARY: For Full Prescribing Information, see package insert. (%) (%) (%) (%) (%) (%) INDICATIONS AND USAGE Jakafi is indicated for treatment of patients with intermediate or high-risk Thrombocytopenia 69.7 9.0 3.9 30.5 1.3 0 myelofibrosis, including primary myelofibrosis, post-polycythemia vera myelofibrosis and post-essential Anemia 96.1 34.2 11.0 86.8 15.9 3.3 thrombocythemia myelofibrosis. Neutropenia 18.7 5.2 1.9 4.0 0.7 1.3 CONTRAINDICATIONS None. WARNINGS AND PRECAUTIONS Thrombocytopenia, Anemia and Neutropenia Treatment a Presented values are worst Grade values regardless of baseline b National Cancer Institute Common Terminology Criteria for Adverse Events, version 3.0 with Jakafi can cause hematologic adverse reactions, including thrombocytopenia, anemia and neutropenia. A complete blood count must be performed before initiating therapy with Jakafi [see Dosage and Additional Data from the Placebo-controlled Study 25.2% of patients treated with Jakafi and 7.3% of Administration (2.1) in Full Prescribing Information]. Patients with platelet counts of less than 200 X 109/L patients treated with placebo developed newly occurring or worsening Grade 1 abnormalities in alanine transat the start of therapy are more likely to develop thrombocytopenia during treatment. Thrombocytopenia was aminase (ALT). The incidence of greater than or equal to Grade 2 elevations was 1.9% for Jakafi with 1.3% Grade 3 and no Grade 4 ALT elevations. 17.4% of patients treated with Jakafi and 6.0% of patients treated generally reversible and was usually managed by reducing the dose or temporarily withholding Jakafi. If with placebo developed newly occurring or worsening Grade 1 abnormalities in aspartate transaminase clinically indicated, platelet transfusions may be administered [see Dosage and Administration (2.2) in Full (AST). The incidence of Grade 2 AST elevations was 0.6% for Jakafi with no Grade 3 or 4 AST elevations. Prescribing Information, and Adverse Reactions]. Patients developing anemia may require blood trans16.8% of patients treated with Jakafi and 0.7% of patients treated with placebo developed newly occurring or fusions. Dose modifications of Jakafi for patients developing anemia may also be considered. Neutropenia worsening Grade 1 elevations in cholesterol. The incidence of Grade 2 cholesterol elevations was 0.6% for (ANC less than 0.5 X 109/L) was generally reversible and was managed by temporarily withholding Jakafi Jakafi with no Grade 3 or 4 cholesterol elevations. [see Adverse Reactions]. Complete blood counts should be monitored as clinically indicated and dosing DRUG INTERACTIONS Drugs That Inhibit or Induce Cytochrome P450 Enzymes Ruxolitinib adjusted as required [see Dosage and Administration (2.2) in Full Prescribing Information, and Adverse is predominantly metabolized by CYP3A4. Strong CYP3A4 inhibitors: The C max and AUC of ruxolitinib Reactions]. Infections Patients should be assessed for the risk of developing serious bacterial, mycobac- increased 33% and 91%, respectively, with Jakafi administration (10 mg single dose) following ketoconazole terial, fungal and viral infections. Active serious infections should have resolved before starting therapy with 200 mg twice daily for four days, compared to receiving Jakafi alone in healthy subjects. The half-life was also Jakafi. Physicians should carefully observe patients receiving Jakafi for signs and symptoms of infection and prolonged from 3.7 to 6.0 hours with concurrent use of ketoconazole. The change in the pharmacodynamic initiate appropriate treatment promptly. Herpes Zoster Physicians should inform patients about early signs marker, pSTAT3 inhibition, was consistent with the corresponding ruxolitinib AUC following concurrent adminand symptoms of herpes zoster and advise patients to seek treatment as early as possible [see Adverse istration with ketoconazole. When administering Jakafi with strong CYP3A4 inhibitors a dose reduction is Reactions]. recommended [see Dosage and Administration (2.4) in Full Prescribing Information]. Patients should be ADVERSE REACTIONS Clinical Trials Experience Because clinical trials are conducted under closely monitored and the dose titrated based on safety and efficacy. Mild or moderate CYP3A4 inhibitors: widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly There was an 8% and 27% increase in the Cmax and AUC of ruxolitinib, respectively, with Jakafi administration compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The (10 mg single dose) following erythromycin, a moderate CYP3A4 inhibitor, at 500 mg twice daily for 4 days, safety of Jakafi was assessed in 617 patients in six clinical studies with a median duration of follow-up of 10.9 compared to receiving Jakafi alone in healthy subjects. The change in the pharmacodynamic marker, pSTAT3 months, including 301 patients with myelofibrosis in two Phase 3 studies. In these two Phase 3 studies, inhibition was consistent with the corresponding exposure information. No dose adjustment is recommended patients had a median duration of exposure to Jakafi of 9.5 months (range 0.5 to 17 months), with 88.7% of when Jakafi is coadministered with mild or moderate CYP3A4 inhibitors (eg, erythromycin). CYP3A4 patients treated for more than 6 months and 24.6% treated for more than 12 months. One hundred and inducers: The Cmax and AUC of ruxolitinib decreased 32% and 61%, respectively, with Jakafi administration eleven (111) patients started treatment at 15 mg twice daily and 190 patients started at 20 mg twice daily. In (50 mg single dose) following rifampin 600 mg once daily for 10 days, compared to receiving Jakafi alone in a double-blind, randomized, placebo-controlled study of Jakafi, 155 patients were treated with Jakafi. The healthy subjects. In addition, the relative exposure to ruxolitinib’s active metabolites increased approximately most frequent adverse drug reactions were thrombocytopenia and anemia [see Table 2]. Thrombocytopenia, 100%. This increase may partially explain the reported disproportionate 10% reduction in the pharmacoanemia and neutropenia are dose related effects. The three most frequent non-hematologic adverse reactions dynamic marker pSTAT3 inhibition. No dose adjustment is recommended when Jakafi is coadministered with were bruising, dizziness and headache [see Table 1]. Discontinuation for adverse events, regardless of a CYP3A4 inducer. Patients should be closely monitored and the dose titrated based on safety and efficacy. causality, was observed in 11.0% of patients treated with Jakafi and 10.6% of patients treated with placebo. USE IN SPECIFIC POPULATIONS Pregnancy Pregnancy Category C: There are no adequate Following interruption or discontinuation of Jakafi, symptoms of myelofibrosis generally return to and well-controlled studies of Jakafi in pregnant women. In embryofetal toxicity studies, treatment with pretreatment levels over a period of approximately 1 week. There have been isolated cases of patients discon- ruxolitinib resulted in an increase in late resorptions and reduced fetal weights at maternally toxic doses. tinuing Jakafi during acute intercurrent illnesses after which the patient’s clinical course continued to worsen; Jakafi should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. however, it has not been established whether discontinuation of therapy contributed to the clinical course in Ruxolitinib was administered orally to pregnant rats or rabbits during the period of organogenesis, at doses these patients. When discontinuing therapy for reasons other than thrombocytopenia, gradual tapering of the of 15, 30 or 60 mg/kg/day in rats and 10, 30 or 60 mg/kg/day in rabbits. There was no evidence of teratodose of Jakafi may be considered [see Dosage and Administration (2.6) in Full Prescribing Information]. genicity. However, decreases of approximately 9% in fetal weights were noted in rats at the highest and maternally toxic dose of 60 mg/kg/day. This dose results in an exposure (AUC) that is approximately 2 times Table 1 presents the most common adverse reactions occurring in patients who received Jakafi in the doublethe clinical exposure at the maximum recommended dose of 25 mg twice daily. In rabbits, lower fetal weights blind, placebo-controlled study during randomized treatment. of approximately 8% and increased late resorptions were noted at the highest and maternally toxic dose of Table 1: Adverse Reactions Occurring in Patients on Jakafi in the Double-blind, Placebo-controlled 60 mg/kg/day. This dose is approximately 7% the clinical exposure at the maximum recommended dose. In Study During Randomized Treatment a pre- and post-natal development study in rats, pregnant animals were dosed with ruxolitinib from implanJakafi Placebo tation through lactation at doses up to 30 mg/kg/day. There were no drug-related adverse findings in pups for (N=155) (N=151) fertility indices or for maternal or embryofetal survival, growth and development parameters at the highest Adverse All All dose evaluated (34% the clinical exposure at the maximum recommended dose of 25 mg twice daily). a Reactions Grades Grade 3 Grade 4 Grades Grade 3 Grade 4 Nursing Mothers It is not known whether ruxolitinib is excreted in human milk. Ruxolitinib and/or its metabolites were excreted in the milk of lactating rats with a concentration that was 13-fold the maternal (%) (%) (%) (%) (%) (%) plasma. Because many drugs are excreted in human milk and because of the potential for serious adverse b Bruising 23.2 0.6 0 14.6 0 0 reactions in nursing infants from Jakafi, a decision should be made to discontinue nursing or to discontinue Dizzinessc 18.1 0.6 0 7.3 0 0 the drug, taking into account the importance of the drug to the mother. Pediatric Use The safety and effecHeadache 14.8 0 0 5.3 0 0 tiveness of Jakafi in pediatric patients have not been established. Geriatric Use Of the total number of Urinary Tract Infectionsd 9.0 0 0 5.3 0.7 0.7 myelofibrosis patients in clinical studies with Jakafi, 51.9% were 65 years of age and older. No overall differWeight Gaine 7.1 0.6 0 1.3 0.7 0 ences in safety or effectiveness of Jakafi were observed between these patients and younger patients. Renal Impairment The safety and pharmacokinetics of single dose Jakafi (25 mg) were evaluated in a study in Flatulence 5.2 0 0 0.7 0 0 healthy subjects [CrCl 72-164 mL/min (N=8)] and in subjects with mild [CrCl 53-83 mL/min (N=8)], Herpes Zosterf 1.9 0 0 0.7 0 0 moderate [CrCl 38-57 mL/min (N=8)], or severe renal impairment [CrCl 15-51 mL/min (N=8)]. Eight (8) a National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), version 3.0 b includes contusion, ecchymosis, hematoma, injection site hematoma, periorbital hematoma, vessel puncture site additional subjects with end stage renal disease requiring hemodialysis were also enrolled. The pharmacokinetics of ruxolitinib was similar in subjects with various degrees of renal impairment and in those with hematoma, increased tendency to bruise, petechiae, purpura c includes dizziness, postural dizziness, vertigo, balance disorder, Meniere’s Disease, labyrinthitis normal renal function. However, plasma AUC values of ruxolitinib metabolites increased with increasing d includes urinary tract infection, cystitis, urosepsis, urinary tract infection bacterial, kidney infection, pyuria, bacteria severity of renal impairment. This was most marked in the subjects with end stage renal disease requiring urine, bacteria urine identified, nitrite urine present hemodialysis. The change in the pharmacodynamic marker, pSTAT3 inhibition, was consistent with the e includes weight increased, abnormal weight gain corresponding increase in metabolite exposure. Ruxolitinib is not removed by dialysis; however, the removal f includes herpes zoster and post-herpetic neuralgia of some active metabolites by dialysis cannot be ruled out. When administering Jakafi to patients with Description of Selected Adverse Drug Reactions Anemia In the two Phase 3 clinical studies, median moderate (CrCl 30-59 mL/min) or severe renal impairment (CrCl 15-29 mL/min) with a platelet count time to onset of first CTCAE Grade 2 or higher anemia was approximately 6 weeks. One patient (0.3%) between 100 X 109/L and 150 X 109/L and patients with end stage renal disease on dialysis a dose reduction discontinued treatment because of anemia. In patients receiving Jakafi, mean decreases in hemoglobin is recommended [see Dosage and Administration (2.5) in Full Prescribing Information]. Hepatic reached a nadir of approximately 1.5 to 2.0 g/dL below baseline after 8 to 12 weeks of therapy and then Impairment The safety and pharmacokinetics of single dose Jakafi (25 mg) were evaluated in a study in gradually recovered to reach a new steady state that was approximately 1.0 g/dL below baseline. This pattern healthy subjects (N=8) and in subjects with mild [Child-Pugh A (N=8)], moderate [Child-Pugh B (N=8)], or was observed in patients regardless of whether they had received transfusions during therapy. In the severe hepatic impairment [Child-Pugh C (N=8)]. The mean AUC for ruxolitinib was increased by 87%, 28% randomized, placebo-controlled study, 60% of patients treated with Jakafi and 38% of patients receiving and 65%, respectively, in patients with mild, moderate and severe hepatic impairment compared to patients placebo received red blood cell transfusions during randomized treatment. Among transfused patients, the with normal hepatic function. The terminal elimination half-life was prolonged in patients with hepatic median number of units transfused per month was 1.2 in patients treated with Jakafi and 1.7 in placebo impairment compared to healthy controls (4.1-5.0 hours versus 2.8 hours). The change in the pharmacotreated patients. Thrombocytopenia In the two Phase 3 clinical studies, in patients who developed Grade 3 dynamic marker, pSTAT3 inhibition, was consistent with the corresponding increase in ruxolitinib exposure or 4 thrombocytopenia, the median time to onset was approximately 8 weeks. Thrombocytopenia was except in the severe (Child-Pugh C) hepatic impairment cohort where the pharmacodynamic activity was generally reversible with dose reduction or dose interruption. The median time to recovery of platelet counts more prolonged in some subjects than expected based on plasma concentrations of ruxolitinib. When above 50 X 109/L was 14 days. Platelet transfusions were administered to 4.7% of patients receiving Jakafi administering Jakafi to patients with any degree of hepatic impairment and with a platelet count between and to 4.0% of patients receiving control regimens. Discontinuation of treatment because of thrombo- 100 X 109/L and 150 X 109/L, a dose reduction is recommended [see Dosage and Administration (2.5) in cytopenia occurred in 0.7% of patients receiving Jakafi and 0.9% of patients receiving control regimens. Full Prescribing Information]. Patients with a platelet count of 100 X 109/L to 200 X 109/L before starting Jakafi had a higher frequency of Grade 3 or 4 thrombocytopenia compared to patients with a platelet count greater than 200 X 109/L (16.5% Jakafi is a registered trademark of Incyte Corporation. All rights reserved. versus 7.2%). Neutropenia In the two Phase 3 clinical studies, 1.0% of patients reduced or stopped Jakafi U.S. Patent No. 7,598,257 because of neutropenia. Table 2 provides the frequency and severity of clinical hematology abnormalities © 2011-2012 Incyte Corporation. All rights reserved. reported for patients receiving treatment with Jakafi or placebo in the placebo-controlled study. Issued: June 2012 RUX-1040a

ASCO Annual Meeting

ASCO Completes Electronic Data Sharing– Standard for Breast Cancer Treatment Chicago, IL—The American Society of Clinical Oncology (ASCO) has completed the first phase in developing several sets of interoperability standards for cancer care data and overcoming the widespread inconsistencies that currently limit secure sharing of information between providers, patients, and researchers. The first standard, the Breast Cancer Treatment Plan and Summary Standard and Implementation Guide, was announced at ASCO’s annual meeting and will be published later this summer. The standard was discussed at a briefing where the Society also demonstrated the prototype of CancerLinQ™, ASCO’s health information technology (HIT) initiative to achieve higher-quality, higher-value cancer care with better outcomes for patients. “This data standard will allow oncologists to share data during care, but also provide a summary for primary care physicians and patients after treatment ends. ASCO and other oncology organizations can and will use it as a foundation for creating additional standards,” said ASCO Immediate Past President, President, Sandra M. Swain, MD, FACP. ASCO’s work in CancerLinQ, data standards, and other HIT initiatives are based on the fact that future cancer care will depend on the ability to electronically share clinical information between practitioners. However, electronic health records often contain data that cannot easily be shared among physicians or contributed to quality improvement, public health reporting, or analytics. In addition, the current exchange standards do not include disease-specific templates needed for the continuity of cancer care. ASCO hosted a Data Inter operability Standards Summit in

February 2013 to encourage collaboration in developing standards that will overcome these barriers. The Society selected adjuvant treatment for breast cancer as the focus for the first oncology standard. The draft standard was approved in May by open ballot through Health Level Seven International (HL7®), an

development of CancerLinQ, a learning computer network that will collect and analyze cancer care data from millions of patient visits, together with expert guidelines and other evidence, to generate real-time, personalized guidance and quality feedback for physicians. ASCO recently completed a breast cancer–specific prototype that demonstrates the feasibility of a HIT-based learning health system, which the Institute of Medicine has defined as critical to the future of the nation’s healthcare system. “CancerLinQ is being designed to improve cancer care even before approved standards are in place, although we recognize their necessity in ensuring that future oncology care keeps pace with technology,” said ASCO President Clifford A. Hudis, MD. “ASCO has taken a leadership role in this area, and we hope to encourage even more collaboration and participation from additional organizations in this effort.” Future areas of focus for ASCO’s data standards initiative will include developing standards for other specific cancers, for additional types of data such as patient-entered information, or for additional cancer care priorities, such as survivorship. As there are advances in molecular data and biomarkers, ASCO hopes to collaborate with other specialty stakeholder organizations to develop standards that will include the complete oncologic treatment history for a patient diagnosed with cancer. CancerLinQ is supported by the Conquer Cancer Foundation of ASCO. CancerLinQ is a project of ASCO’s Institute for Clinical Excellence. For more information, please visit: www. asco.org/cancerlinq. (Copyright © American Society of Clinical Oncology, June 1, 2013. Used with Permission)

“This...standard will allow oncologists to share data during care, but also provide a summary for primary care physicians and patients after treatment ends. —Sandra M. Swain, MD

accredited Standards Developing Organization (SDO) and the leading global SDO focused solely on healthcare, and the standard is expected to be published by HL7 and ready for implementation in the summer of 2013. Major elements covered with the standard include: • Diagnosis (site, histology, and stage) • Pertinent patient health and comorbidity information • Surgical history and pathology • Goals of therapy • Chemotherapy regimen and dosage • Duration of treatment and number of cycles • Major chemotherapy side effects. The Society’s work in data standards is in conjunction with the

June 2013

www.OncPracticeManagement.com

News Briefs

Patients Unwilling to Let Costs Influence Their Treatment The issue of cost in clinical decision-making is increasingly becoming necessary in the face of growing healthcare costs, limited resources, and often limited access to care. Involving patients in the cost discussion has been suggested as a way to begin to curb the rising costs of care. A new study investigated the inclination of Americans with health insurance to discuss their willingness to have cost as part of the decision-making in their care (Sommers R, et al. Health Aff [Millwood]. 2013;32:338-346). The study population included 22 focus groups of Americans with health insurance from 2 geographically distinct metropolitan areas—Santa Monica, CA, and Washington, DC. Although all of the participants had insurance, they varied by age, race, education, and income levels. At least 50% had incomes <300% of the federal poverty level and 43% had incomes <$40,000. “We found that the majority of participants were unwilling to consider cost when deciding between nearly comparable options and generally resisted the less expensive, marginally inferior option,” the authors wrote.

The 4 barriers to participants’ willingness to consider cost in treatment decisions included: • Preference for the best therapeutic option, regardless of cost • Inexperience in making tradeoff decisions between health and money • Lack of concern for money spent by society and health insurance • No sense of personal responsibility for the cost of care • Noncooperation because of prioritizing self-interest concerns. Overall, participants wanted the best care and were not interested in considering limited resources and making trade-offs between their health and money, holding physicians responsible to provide them with the best care available, regardless of cost. Based on their findings, the investigators concluded that “for cost to be an explicitly recognized and discussed factor in clinical decisions, public attitudes about healthcare costs must first undergo a significant shift.” Patients with Cancer at Risk for Bankruptcy Being diagnosed with cancer in creases a person’s risk for bankruptcy, according to results of a new study analyzing data from the National

Cancer Institute (NCI)’s SEER (Surveillance, Epidemiology and End Results) program (Ramsey S, et al. Health Aff. May 15, 2013 [E-pub ahead of print]). A team of researchers led by Scott Ramsey, MD, PhD, Health Economist at Fred Hutchinson Cancer Research Center (FHCRC) and Director of the Hutchinson Institute for Cancer Outcomes, analyzed data from the Cancer Surveillance System of Western Washington, a populationbased cancer registry at FHCRC, which is NCI’s SEER program. The team compared the data of patients with cancer with people without cancer and matched them with bankruptcy records for those populations between 1995 and 2009. The results showed “strong evidence of a link between cancer diagnosis and increased risk of bankruptcy,” the investigators wrote. “Our study thus raises important questions about the factors underlying the relationship between cancer and financial hardship.” During the study period, 197,840 people in Western Washington were diagnosed with cancer and met the inclusion criteria for this study. These patients were matched for age, sex, and zip code with a Continued on page 22

ASCO Annual Meeting

University Hospitals Case Medical Center…Continued from page 14 Its user-friendly interface allows for physician perusal of relevant clinical trials and eligibility checklists at the point of care without requiring manual data entry. For this study, pilot testing was performed in a gastrointestinal oncology subspecialty clinic. Eleven oncologists completed sur-

veys after each patient visit to assess the usability and impact of Trial Prospector. The results showed that the Trial Prospector matching algorithm was 100% accurate and saved time identifying potential clinical trials. Physicians generally found it to be easy to use, and 90.9% said they would recommend its use for

ONCOLOGY PRACTICE MANAGEMENT

I June 2013

clinical trial eligibility screening. Based on these preliminary findings, Dr Parchman and his team intend to expand data elements to increase the precision of trial matching and expand to other disease specialties and practice locations. (Source: University Hospitals Case Medical Center, May 15, 2013.) l

We Will

exhaust all possibilities.

We will…because patients are our priority. Celgene Patient Support® provides free and personalized assistance with patients’ access and reimbursement needs. With continual communication and consistent follow-through, your dedicated Celgene Patient Support® Specialist will streamline access to Celgene products by helping you and your patients with: • Benefits investigation

To Contact Celgene Patient Support®:

• Prior authorization

Call: 1-800-931-8691

• Appeal support

E-mail: patientsupport@celgene.com

• Medicare

Fax: 1-800-822-2496

• Co-pay assistance – Celgene Commercial Co-pay Program – Co-pay assistance through third-party organizations

Visit: www.CelgenePatientSupport.com Monday through Friday, 8:00 am to 7:00 pm ET

• Prescription status • Celgene free medication program • Celgene products and restricted distribution programs

4 out of 5 patients who requested assistance from Celgene Patient Support ® received their medication.

News Briefs Continued from page 20

control group of people without cancer. Of the patients with cancer, 4408 (2.2%) filed for bankruptcy protection after diagnosis compared with 2291 (1.1%) of the matched controls who filed for bankruptcy during the same period. “This is the strongest evidence we have between a disease and risk for severe financial distress,” said Dr Ramsey. “I’ve not seen other studies that linked databases of this quality.” Generic Name Linked to Medication Errors The US Food and Drug Admin istration (FDA) has warned healthcare professionals about potential medication errors resulting from confusion with the nonproprietary name for the recently approved breast cancer drug ado-trastuzumab emtansine (Kadcyla; also known as T-DM1). The FDA noted that in various online publications and in different medical electronic systems the drug is sometimes referred to incorrectly as trastuzumab, which is the active ingredient in the older breast cancer drug Herceptin, which had a different dosing and a different treatment schedule. The FDA-approved nonproprietary name for Kadcyla is “ado-trastuzumab emtansine” but the prefix “ado-” is often dropped, which may lead to the confusion with trastuzumab (ie, Herceptin). The FDA notes that it is, therefore, important to keep the prefix with the nonproprietary name when referring to Kadcyla, when prescribing the medication, and in electronic medical records (EMRs) or any online or other publications. The FDA noted that some third-party publications, compendia references, health information systems (ie, EMR systems and other systems used for pharmacy prescription processing, wholesaler ordering, and pharmacy ordering), and various websites are incorrectly

using “trastuzumab emtansine” and omitting the “ado-” prefix. Although no medication errors related to confusion between Kadcyla and Herceptin have been reported since the approval of Kadcyla on February 22, 2013, such errors did occur during the clinical trials that evaluated the safety and efficacy of the drug before its approval, according to the FDA. The agency advises health plans, pharmacists, and prescribers to implement strategies to warn against and look for any confusion between the 2 drugs in electronic systems, and, when needed, to correct the error. Furthermore, the FDA insists that ado-trastuzumab emtansine should not be substituted for or used with trastuzumab. The recommended dose of Kadcyla is 3.6 mg/kg, administered by intravenous infusion every 3 weeks for a total of 21 days. This drug should not be prescribed at higher doses. By contrast, the recommended dose of Herceptin is significantly higher, up to 8 mg/ kg per loading dose, followed by a maintenance dose of 6 mg/kg every 3 weeks. These drugs may not be used concomitantly. (May 6, 2013) FDA Puts High Priority on Social Media Guidance for Drugs and Devices One of the FDA’s highest priorities at the moment is providing guidance on drugs and medical devices to drug and device companies on their use of social media, according to Tom Abrams, head of the FDA’s Office of Prescription Drug Promotion. The FDA hopes to meet its designated deadline of July 2014 for issuing that guidance. In the interim, the FDA had a virtual conference on May 30 to advise drugand device-makers on how to take advantage of social media, including Facebook, Twitter, and YouTube,

ONCOLOGY PRACTICE MANAGEMENT

I June 2013

for disseminating their news and breakthroughs via online marketing within the FDA regulatory limits. The virtual conference spelled out what companies can and cannot do regarding the marketing of their drugs and devices in social media—the latest channel for influencing policymakers, patients, payers, and healthcare providers. (May 14, 2013.) Participation in ASCO’s Quality Practice Program Improves Performance Scores Oncology practices that participate in the American Society of Clin ical Oncology (ASCO)’s Quality Oncology Practice Initiative (QOPI)—a program of self-reported metrics on performance measures— demonstrate improved performance scores on several measures, including: • Providing adjuvant chemotherapy (which has shown to improve survival) for breast, colorectal, and non–small-cell lung cancers: ≥90% of participating practices perform as recommended • Improved uptake of new clinical practice (following new guidelines or clinical evidence): from 5% to 69% in the past 4 years. “This study further shows that participation in quality assessment programs like QOPI should provide reassurance to people living with cancer that they are receiving high-quality care,” said Sandra M. Swain, MD, FACP, ASCO President. “Nearly 600 practices in the United States are already participating in QOPI, in part because it provides a systematic process, a library of diverse quality measures, a collection tool, and reliable information to assess the care they provide. QOPI is also the gateway to QOPI Certification, which recognizes practices that demonstrate performance on designated QOPI measures and meet certification standards for quality and safe care.” (ASCO in Action; March 12, 2013.) l

AVBCC wishes to acknowledge the organizations listed below that graciously gave their support on behalf of AVBCCâ&#x20AC;&#x2122;s Third Annual Conference, held May 3-5, 2013, in Hollywood, Florida.

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Drug Coding Supplied by RJ Health Systems

FDA-Approved Medications Used for the Treatment of Lung Cancer The following sections will assist healthcare professionals and payers by providing appropriate coding and billing information associated with the treatment of lung cancer. The following sections include: • Associated ICD-9-CM codes used for the classification of lung cancer • Drugs that have been FDA-approved for the treatment of lung cancer • Drugs that are Compendia listed for off-label use for lung cancer based on clinical studies that suggest bene ficial use in some cases. Please note: If a check mark appears in the FDA column it will NOT appear in the Compendia off-label use column • Corresponding HCPCS/CPT® codes and code descriptions

Associated ICD-9-CM codes for the treatment of lung cancer: 162 Malignant neoplasm of trachea, bronchus, and lung 162.0 Trachea Cartilage of trachea Mucosa of trachea 162.2 Main bronchus Carina Hilus of lung 162.3 Upper lobe, bronchus or lung 162.4 Middle lobe, bronchus or lung 162.5 Lower lobe, bronchus or lung 162.8 Other parts of bronchus or lung Malignant neoplasm of contiguous or overlapping sites of bronchus or lung whose point of origin cannot be determined 162.9 Bronchus and lung, unspecified

Compendia listed FDA-approved off-label uses for Possible CPT® for lung cancer lung cancer administration codes

Generic (brand) name

HCPCS code: code description

amifostine (Ethyol)

J0207: Injection, amifostine, 500 mg

√

96374

Bacillus Calmette-Guerin (BCG vaccine)

90585: Bacillus Calmette-Guerin vaccine (BCG) for tuberculosis, live, for percutaneous use

√

90471, 90472

Bacillus Calmette-Guerin (Theracys, Tice BCG)

90586: Bacillus Calmette-Guerin vaccine (BCG) for bladder cancer, live, for intravesical use

√

51720

Bacillus Calmette-Guerin (Theracys, Tice BCG)

J9031: BCG (intravesical), per installation

√

51720

bevacizumab (Avastin)

J9035: Injection, bevacizumab, 10 mg

bleomycin (Blenoxane)

J9040: Injection, bleomycin sulfate, 15 units

ONCOLOGY PRACTICE MANAGEMENT

I June 2013

96413, 96415

√ √

96401, 96409

Drug Coding

Compendia listed FDA-approved off-label uses for Possible CPT® for lung cancer lung cancer administration codes

Generic (brand) name

HCPCS code: code description

carboplatin (Paraplatin)

J9045: Injection, carboplatin, 50 mg

√

96409, 96413, 96415

cetuximab (Erbitux)

J9055: Injection, cetuximab, 10 mg

√

96413, 96415

cisplatin (Platinol-AQ)

J9060: Injection, cisplatin, powder or solution, per 10 mg

√

96409, 96413, 96415

crizotinib (Xalkori)

C9399*: Unclassified drugs or biological (hospital outpatient use ONLY)

√

N/A

crizotinib (Xalkori)

J8999*: Prescription drug, oral, chemotherapeutic, not otherwise specified

√

N/A

cyclophosphamide (Cytoxan)

J8530: Cyclophosphamide, oral, 25 mg

√

N/A

cyclophosphamide (Cytoxan)

J9070: Cyclophosphamide, 100 mg

√

96409, 96413, 96415

docetaxel (Taxotere)

J9171: Injection, docetaxel, 1 mg

√

96413

doxorubicin HCl (Adriamycin)

J9000: Injection, doxorubicin hydrochloride, 10 mg

√

96409

doxorubicin (Doxil)

J9002: Injection, doxorubicin hydrochloride, liposomal, doxil, 10 mg

√

96413

epirubicin (Ellence)

J9178: Injection, epirubicin hydrochloride, 2 mg

√

96409, 96413

erlotinib (Tarceva)

C9399*: Unclassified drugs or biological (hospital outpatient use ONLY)

√

N/A

erlotinib (Tarceva)

J8999*: Prescription drug, oral, chemotherapeutic, not otherwise specified

√

N/A

etoposide (VePesid)

J8560: Etoposide, oral, 50 mg

√

N/A

etoposide (Etopophos, Toposar)

J9181: Injection, etoposide, 10 mg

√

96413, 96415

fluorouracil (Adrucil)

J9190: Injection, fluorouracil, 500 mg

gefitinib (Iressa)

J8565: Gefitinib, oral, 250 mg

√

N/A

gemcitabine (Gemzar)

J9201: Injection, gemcitabine hydrochloride, 200 mg

√

96413

ifosfamide (Ifex)

J9208: Injection, ifosfamide, 1 g

√

June 2013

96409

96413, 96415

www.OncPracticeManagement.com

Drug Coding

Compendia listed FDA-approved off-label uses for Possible CPT® for lung cancer lung cancer administration codes

Generic (brand) name

HCPCS code: code description

irinotecan (Camptosar)

J9206: Injection, irinotecan, 20 mg

√

96413, 96415

lomustine (CeeNu)

J8999*: Prescription drug, oral, chemotherapeutic, not otherwise specified

√

N/A

lomustine (CeeNu)

S0178: Lomustine, oral, 10 mg

√

N/A

mechlorethamine HCl (Mustargen)

J9230: Injection, mechlorethamine hydrochloride (nitrogen mustard), 10 mg

√

96409

methotrexate (Trexall)

J8610: Methotrexate, oral, 2.5 mg

√

N/A

methotrexate

J9250: Methotrexate sodium, 5 mg

√

96372, 96374, 96401, 96409, 96450

methotrexate

J9260: Methotrexate sodium, 50 mg

√

96372, 96374, 96401, 96409, 96450

mitomycin (Mutamycin)

J9280: Injection, mitomycin, 5 mg

√

96409

oxaliplatin (Eloxatin)

J9263: Injection, oxaliplatin, 0.5 mg

√

96413, 96415

paclitaxel protein-bound particles (Abraxane)

J9264: Injection, paclitaxel protein-bound particles, 1 mg

√

96413

paclitaxel (Taxol)

J9265: Injection, paclitaxel, 30 mg

√

96413, 96415

panitumumab (Vectibix)

J9303: Injection, panitumumab, 10 mg

pemetrexed (Alimta)

J9305: Injection, pemetrexed, 10 mg

√

96409

porfimer sodium (Photofrin)

J9600: Injection, porfimer sodium, 75 mg

√

96409

tamoxifen (Nolvadex)

J8999*: Prescription drug, oral, chemotherapeutic, not otherwise specified

√

N/A

tamoxifen (Nolvadex)

S0187: Tamoxifen citrate, oral, 10 mg

√

N/A

temozolomide (Temodar)

J8700: Temozolomide, oral, 5 mg

√

N/A

vinBLAStine (Velban)

J9360: Injection, vinblastine sulfate, 1 mg

√

96409

vinCRIStine (Vincasar PFS)

J9370: Vincristine sulfate, 1 mg

√

96409

vinorelbine (Navelbine)

J9390: Injection, vinorelbine tartrate, 10 mg

ONCOLOGY PRACTICE MANAGEMENT

I June 2013

√

96413, 96415

96409

Drug Coding

*When billing a nonclassified medication using a CMS 1500 claim form, you must include both the HCPCS code (ie, J8999 for Xalkori) in Column 24D and the drug name, strength, and NDC (National Drug Code) in Box 19 or 24A to ensure appropriate reimbursement. Please note: Check with payer regarding correct placement of Medication Information in Box 19 or 24A. References HCPCS Level II Expert 2013 • Current Procedural Terminology (CPT®) 2013 (copyright 2013 American Medical Association. All rights reserved. CPT® is a registered trademark of the American Medical Association) • ICD-9-CM for Professionals Volumes 1, 2, 2013 • FDA-approved indication (from product prescribing information) • Compendia references available upon request • www.ReimbursementCodes.com powered by RJ Health Systems International, LLC, Rocky Hill, Connecticut • CMS (Centers for Medicare and Medicaid Services) CPT® indicates Current Procedural Terminology; HCPCS, Healthcare Common Procedure Coding System.

This information was supplied by:

30 Cold Spring Road, Rocky Hill, CT 06067 T: (860) 563-1223 • F: (860) 563-1650 • www.RJHealthSystems.com

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SECOND ANNUAL CONFERENCE

GLOBAL BIOMARKERS CONSORTIUM

™

Clinical Approaches to Targeted Technologies

™

October 4-6, 2013 • The Seaport Boston Hotel • 1 Seaport Lane • Boston, MA 02210

June 2013

www.OncPracticeManagement.com

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. Please visit www.rjhealthsystems.com to learn more about our products and services listed below:

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Patient and Provider Access Brought to you by the Association of Community Cancer Centers

The Impact of the Medicare Sequester on Community Oncology By Sydney Abbott, JD, Manager of Provider Economics and Public Policy, Association of Community Cancer Centers

ecause of failed debt negotiation talks back in 2011, on April 1, 2013, an automatic 2% reduction in payment took place across the board on all claims submitted for Medicare reimbursement. The “sequester,” as it has become known, impacts Medicare providers by reducing all of the payments submitted to Medicare by 2%, and, in combination with other cuts and reductions in Medicare reimbursement, further decreases providers’ ability to cover the cost of providing care to Medicare patients. This is not about making a profit; many providers are already losing money by caring for Medicare patients. Rather, this payment reduction could even further reduce the number of Medicare patients a cancer center is able to treat. Because of how Part B drugs are reimbursed, the 2% sequester disproportionately reduces the payments for critical cancer drugs. Provider reimbursement should be at average sales price (ASP) plus 6%. However, after accounting for the patient copay component, the sequester actually makes provider reimbursement ASP plus 4.3%. This translates to a 28% reduction for Part B drugs. The president’s budget for 2014 proposes to reduce Medicare reimbursement to ASP plus 3%. Both the Centers for Medicare & Medicaid Services and the Department of Health and Human Services have declared that they have no power to adjust the sequester cuts.

The Sequester Is Felt in Community Cancer Care The Association of Community Cancer Centers (ACCC) is currently surveying its members on the impact of the Medicare sequester. While the results are not yet final, a snapshot of the results submitted to date show that responses are split almost evenly among hospital-based cancer centers and private physician oncology practices. Nearly 60% of the respondents have made changes as a result of the 2% across-the-board sequester cuts on Medicare reimbursement. Of those providers that are making changes, more than 80% have reduced their general operating expenses, including making reductions in staff. In fact, some facilities are freezing wages, postponing large capital purchases, and canceling travel and meetings to offset some of the sequester cuts. According to the survey results so far, all service areas have been impacted, including survivorship, patient navigation, clinical trials, and nutrition services. However, it is chemotherapy infusion that has been hit the hardest, with nearly 75% of the respondents saying it has been impacted. Of the 40% of private practices and hospitals that stated that they have not yet made changes as a result of the sequester, 66% plan to make changes within the next 6 months. Of the results compiled so far, less than 15% do not plan to make any changes as a result of the 2% Medicare sequester. Again, the survey is not yet complete, and

June 2013

ACCC encourages all members to submit their responses. We will have a full report once the survey is closed and the data are reviewed. In general, ACCC members are trying to make responsible changes that allow them to continue to care for all of their patients in the same way as they have in the past. However, the sequester’s impact is taking its toll, and many members are barely breaking even—or worse yet, are now under water—on their Medicare reimbursement. One way to alleviate the pain of the sequester is to eliminate the cost of cancer drugs from the 2% cut in reimbursement. US Representative Renee Ellmers, R-NC, recently introduced a bill that would do just this. ACCC supports H.R. 1416: Cancer Patient Protection Act of 2013, which is legislation that would eliminate the 2% sequester from Part B drugs. This legislation does not remove the sequester cuts from services provided to cancer patients, only the fixed costs that are associated with Part B drugs. Support for this bill is growing, and there are currently 75 cosponsors in the House of Representatives. ACCC will continue to push for a reasonable solution to the Medicare sequester. As always, we will keep members up to date on changes to this important issue. l

www.OncPracticeManagement.com

Physician Wealth Management With Lawrence B. Keller

Don’t Leave Home without Your Umbrella By Lawrence B. Keller, CFP®, CLU®, ChFC®, RHU®, LUTCF

n today’s litigious society, no one is immune from potential lawsuits. Injured parties are commonly awarded judgments in excess of $1 million. If your assets are insufficient to pay these claims, your future earnings can be attached to satisfy the debt. Personal liability insurance protects your assets if you injure another person or damage someone else’s property. If you are found legally responsible for causing an injury or property damage, your personal liability insurance will provide a legal defense, if necessary, and pay the claim up to the limits of the policy. This added protection can generally be purchased in amounts ranging from $1 million to $10 million or more. Personal Liability (Umbrella) Insurance The liability coverage under your homeowners and auto insurance policies is your primary layer of protection. However, if you need additional protection, you will need to purchase an excess liability or “umbrella” policy. Personal umbrella liability protection is secondary coverage that works in conjunction with your primary policy. However, your insurer will require that you have underlying basic liability coverage (usually an automobile or homeowners policy, or both) before you can purchase an umbrella liability policy. When the liability limit of your primary policy is exhausted, the umbrella policy pays the balance of a liability claim against you up to the umbrella policy’s limit.

An umbrella liability policy may also protect you from losses that are not covered under basic liability insurance. It covers you against damages for unusual occurrences, including personal injury losses due to libel, slander, wrongful eviction, false arrest, and invasion of privacy. Your umbrella liability policy might also pay for damages incurred worldwide. In addition, an umbrella

An umbrella liability policy…covers you against damages for unusual occurrences, including personal injury losses due to libel, slander, wrongful eviction, false arrest, and invasion of privacy.

policy might pay a proportionate share of a claim even if your basic liability insurance policy cannot pay its portion, either because you failed to comply with the conditions of the policy or because the company itself has become insolvent. Let’s say you are found liable for a bodily injury claim totaling $1.5 million as a result of an automobile accident. If your automobile policy’s liability limit was $500,000 and you did not have an umbrella policy, the balance of the claim ($1 million) would likely be paid out of your pocket. However, if you had a $1 million umbrella policy,

ONCOLOGY PRACTICE MANAGEMENT

I June 2013

you would be adequately protected. Your automobile policy would pay the first $500,000 and your umbrella policy would cover the balance of the claim. Structure Your Automobile and Homeowners Insurance Policies Properly Avoid structuring your automobile and homeowners policies with low deductibles. Low deductibles will cause your premium rates to rise substantially. It is best to increase your deductibles and allocate the premium savings toward increasing your liability limits and purchasing or increasing your excess liability or “umbrella” policy’s limits. After all, you do not need the coverage for the first $250 or $500; you need it on the back end where a judgment could be financially devastating to you and/or your family. Unfortunately, most Property & Casualty agents will automatically structure your policies to have the minimum amount of liability coverage that is required before your umbrella policy will go into effect. However, the liability limits on your homeowners and automobile policies should be the same. For example, if you have a $500,000 liability limit on your car and a $300,000 liability limit on your home, you might find yourself “out of pocket” for $200,000 if something happens in the “wrong place.” Suppose you go home after a long day at the office and find the mailman collapsed on your front lawn, looking like a snow angel, with letters everywhere. Because this would fall under your homeowners policy, you would be liable for the $200,000 difference between that policy and your automobile policy.

Physician Wealth Management

The same example could go the opposite way. If you have a $500,000 liability limit on your home and a $300,000 liability limit on your car, you again might find yourself “out of pocket” for $200,000 if something happens in the “wrong place.” This time, let’s assume that you are driving home from the office and hit a pedestrian. Your automobile policy would be affected, but because it carries $200,000 less coverage than your homeowners policy, in this example you would also be liable for that difference. What Personal Liability Insurance Does Not Cover Although a personal umbrella liability policy covers more types of hazards than basic personal liability policies, no personal liability insurance policy will protect you against every loss you might face. All types of personal liability insurance generally exclude the following: • Intentional damage caused by you or a member of your family or household • Damages arising out of business or professional pursuits, including malpractice claims • Liability that you accept under the terms of a contract or agreement

• Liability related to the ownership, maintenance, and use of aircrafts, nontraditional watercrafts (like jet skis), and most recreational vehicles • Damage to property owned, used, or maintained by you (the insured) • Damage covered under a workers’ compensation policy • Liability arising as a result of war or insurrection

should also consider factors such as how often you have guests in your home, how much you drive, and whether you have teenage drivers at home. Of course, as a physician, you already know that you are viewed as having “deep pockets.” Summary If you need more liability protection than your homeowners and/or automobile policies offer, consider purchasing a personal umbrella liability policy. This type of policy can significantly expand your liability coverage by providing a liability limit above that contained in your homeowners and/or automobile policies. Without adequate liability protection, a large judgment against you could put your practice in jeopardy by costing you your assets as well as your potential future earnings and inheritances. l

Other common exclusions under a homeowners policy are damage caused by communicable diseases and acts of war. An automobile policy might exclude accidents and losses that occur overseas or while a vehicle is in transport. Umbrella policies often exclude liability losses related to aircraft, damages caused by watercraft not covered under your homeowners policy, or injuries suffered by someone covered by workers’ compensation.

Lawrence B. Keller, CFP®, CLU®, ChFC®, RHU®, LUTCF is the founder of Physician Financial Services, a New York –based firm specializing in income protection and wealth accumulation strategies for physicians. He can be reached at 516-677-6211 or by e-mail at Lkeller@physicianfinancialser vices.com with comments or questions.

How Much of an Umbrella Should You Have? Determining how much liability coverage you need is not an exact science. While a general rule is that you need only enough liability insurance to protect your assets, you

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FOURTH ANNUAL NAVIGATION AND SURVIVORSHIP CONFERENCE NOVEMBER 15-17, 2013 The Peabody Memphis • Memphis, Tennessee

June 2013

www.OncPracticeManagement.com

Medical Legal Update

Why the Time to Revisit Third-Party Relationships and Your Business Associate Agreements Is Now By Jennifer Kirschenbaum, Esq

he Final Rule modifying 45 CFR Parts 160 and 164, commonly known as the “HIPAA Rules,” which was promulgated on January 25, 2013, and be comes effective on September 23, 2013, is replete with changes that are required for the maintenance, use, and disclosure of protected patient health information, which includes individually identifiable patient health information that is electronically transmitted or maintained. This article will address changes to the HIPAA Rules that impact your relationships with third parties. A significant change to the HIPAA Rules is the direct extension of liability for breaches of the rules by agents of the practice, meaning that, prior to the Final Rule, third parties with access to protected health information that are responsible for the misuse or any breach of the HIPAA Rules would not necessarily open the practice up to potential liability, as long as the agent was a business associate and relevant contract requirements had been met. In addition, for the practice to be protected from such an agent’s exposure, the practice would not have known that a pattern or practice of the business associate was in violation of the contract and, therefore, the practice would not have failed to act as required under the HIPAA Rules with respect to any such violation. However, the Final Rule has clearly modified this premise so that liability by an agent of the practice will result in exposure

and potential fines for the practice. At the crux of whether liability will be charged to a practice based on an agency relationship is whether an agency relationship actually exists. The fact that an individual works directly for the practice or is a known business associate of the practice does not impact whether or not that person is an agent of the practice. Whether an agency relationship exists is fact-specific, taking into

Once you have determined that you may, in fact, have an agency relationship, it is important to ensure that the agent is aware of and adheres to the HIPAA Rules with regard to protected health information. account the totality of the circumstances in the ongoing relationship. The essential factor in determining agency is the right or authority that the practice has to control the conduct of the agent in the performance of a service for the practice. One relevant question in such an inquiry includes whether the practice has the authority to give interim instructions or directions to the agent. For example, the practice would not be in an agency relationship if it enters into a business associate agreement with a third party that sets the terms

ONCOLOGY PRACTICE MANAGEMENT

I June 2013

and conditions of the relationship between the parties, and the only avenue of control is for the practice to amend the terms of that contract or sue for breach of contract. In a circumstance where the practice has no authority over the third party, the practice is simply engaging a third party to perform a specific service; because the third party determines the best course of action, it is likely that no agency relationship would be found. A typical example of a nonagency relationship is most practices’ relationships with their billing companies. Typically, a practice contracting with a billing company is not aware of, nor does it have the authority to control, the billing company’s operations and services. The contract governs the relationship, and if the relationship deviates from the agreement, the recourse for either party is to initiate a breach of contract lawsuit. Another example of a nonagency relationship is where the practice engages an accreditation consultant. Under most circumstances, accreditation functions performed by a third party cannot be performed by the practice, because a practice cannot perform an accreditation survey or award accreditation and, as such, functions performed by a third party do not constitute an agency relationship. Once you have determined that you may, in fact, have an agency relationship, it is important to ensure that the agent is aware of and adheres to the HIPAA Rules with regard to protected health information. From a practical standpoint, any agent of the practice should be held—at a minimum—to the same Continued on page 36

VISIT THE NEW ONLINE RESOURCE FOR NURSES AND THE ENTIRE MULTIPLE MYELOMA CARE TEAM

“Quality care is everyone’s business.” Beth Faiman, RN, MSN, APRN, BC, AOCN Nurse Practitioner, Multiple Myeloma Program Cleveland Clinic Taussig Cancer Institute Cleveland, OH

Value-BasedCare IN Myeloma

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RESOURCE CENTER FOR PAYERS, PROVIDERS, AND THE ENTIRE CANCER CARE TEAM

Value-Based Care in Myeloma delivers exclusive interviews and perspectives related to cost, quality, and access issues. Special sections for VA-based clinicians, advanced practice nurses, and pharmacists will also focus on the unique challenges in the management of multiple myeloma.

Medical Legal Update

Third-Party Relationships…Continued from page 34 standards as practice employees, and should be made aware of any and all existing HIPAA policies at the practice and be subject to any and all HIPAA training employed by the practice. Holding your agents to a high standard is essential, as you may very well be held responsible for any improper use or disclosure of protected health information by those agents, which is not the case for business associates of the practice as long as certain requirements are followed. Prior to the Final Rule, a business associate was defined as any person who performed activities or services on behalf of a practice that involved the use of or disclosure of protected health information. With the implementation of the Final Rule, the definition of a business associate has expanded to include any person who creates, receives, maintains, or transmits protected health information for any number of purposes, including claims processing or administration, data analysis, processing or administration, utilization review, quality assurance, patient safety activities, billing, benefit management, practice management, and repricing. The definition of a business associate also includes individuals providing management, administrative, accreditation, or financial services where the provision of such services involves the disclosure of protected health information. In accordance with the Final Rule, any individual with more than “routine access” to protected health information qualifies as a business associate, except for a practice employee, healthcare provider, other practice, government agency, or a plan sponsor. Determining if an individual has more than “routine access” is a fact determination that requires looking at whether the individual serves as a

mere conduit. Pursuant to the Final Rule, a conduit transports information but does not access it other than on a random or infrequent basis as necessary to perform the transportation service as required by law. For example, an Internet service provider would qualify as having only “routine access” and would not qualify as a

Holding your agents to a high standard is essential, as you may very well be held responsible for any improper use or disclosure of protected health information by those agents, which is not the case for business associates of the practice as long as certain requirements are followed.

business associate. Similarly, a financial institution likely does not qualify as a business associate when conducting payment processing. For each business associate of the practice, a duly executed business associate agreement is required. Each business associate agreement must comply with certain parameters, including being in writing and detailing the services to be provided by the business associate and the access needed by the business associate to the practice’s protected health information. In addition, each business associate agreement

ONCOLOGY PRACTICE MANAGEMENT

I June 2013

should also contain required protections against the improper use of protected health information as well as such assurances as determined necessary for protecting that health information. Another element of a business associate agreement that every provider should incorporate is a contractual shifting of risk and exposure upon the improper use or disclosure of protected health information to the business associate. If the business associate is the responsible party for an improper use or disclosure of protected health information, it should be clear in the business associate agreement that the business associate will bear the cost of such exposure, including legal fees, costs, fines, and expenses. Failure to comply with the HIPAA Rules—including the requirement for proper business associate agreements and proper use and disclosures of protected health information by agents of the practice—may result in exposure that would cause the imposition of civil monetary penalties. To ensure compliance, all practices should review their relationships with third parties to ensure that they are operating with proper business associate agreements, as well as properly protecting all patient health information. l Jennifer Kirschenbaum, Esq, manages Kirschenbaum & Kirschenbaum’s healthcare department, which specializes in representing healthcare practitioners in regulatory compliance, audit defense, licensure, and transactional matters. To ensure that your practice is in compliance with the HIPAA Rules before September 23, 2013, read the available HIPAA policies at www.healthcarepracticecompliance. com or contact Jennifer at 516-7476700 x302 or by e-mail at Jennifer@ kirschenbaumesq.com.

Fourth Annual Navigation and Survivorship Conference Memphis, Tennessee â&#x20AC;˘ The Peabody Memphis

NOVEMBER 15-17, 2013 CONFERENCE CO-CHAIRS Lillie D. Shockney, RN, BS, MAS AONN Program Director University Distinguished Service Associate Professor of Breast Cancer Departments of Surgery and Oncology Administrative Director, Johns Hopkins Clinical Breast Programs Administrative Director, Johns Hopkins Cancer Survivorship Programs Department of Surgery and Oncology Associate Professor, JHU School of Medicine Departments of Surgery, Oncology, and Gynecology Associate Professor, JHU School of Nursing Johns Hopkins Avon Foundation Breast Center Baltimore, MD

Sharon Gentry, RN, MSN, AOCN, CBCN Breast Health Navigator Derrick L. Davis Forsyth Regional Cancer Center Winston-Salem, NC

www.AONNonline.org AONNAsize31413

HOPA Annual Meeting

Expanding Patient Access to CompassionateUse Drugs via Clinical Trials By Wayne Kuznar

Los Angeles, CA—Pharmacists can serve as an important information portal for access to investigational drugs through clinical trials or via expanded-access mechanisms, according to Kim Redic, PharmD, BCPS, Manager, Research Pharmacy, University of Michigan Health System, Ann Arbor. “Fewer than 1% of patients say that they learn about clinical trials from pharmacists, with most relying on the media or on their physicians,” Dr Redic said at the 2013 Hematology/Oncology Pharmacy Association Annual Conference. Most patients, however, indicate that they are willing to hear about clinical trials from their pharmacists. Clinical trials may take longer than expected to complete, because of recruitment delays. “This is an area where we can play a part,” said Dr Redic. Only 6% of clinical trials are completed on schedule, with 75% running over schedule by more than 1 month. Nearly 25% of National Cancer Institute (NCI) Cooperative Group phase 3 trials fail to attain at least 90% of their recruitment goal.

Enrolling Patients in Clinical Trials Clinical trials can provide an opportunity for access to a treatment. Government sources for open clinical trials include the National Institutes of Health (NIH) and the NCI. Disease and foundation websites are another source of clinical trial information. Many institutions have websites that identify clinical trials that are open at that particular institution. The institutions that are not formally a research site can sometimes arrange to become a second insti-

tution; in these cases, the patient is enrolled at another institution but receives doses at their home institution. “The patients may start at NIH but get their doses closer to home,” Dr Redic said. Guidance on criteria

“These will only be the treatment INDs [investigational new drugs], the ones which are available and open for large numbers of patients. If you don’t find anything, you can contact individual sponsors or individual companies that have these drugs in development and see if they are making them available for single patient access.” —Kim Redic, PharmD, BCPS

for becoming a second institution is available from the US Food and Drug Administration (FDA) at www. fda.gov/RegulatoryInformation/ Guidances/ucm126432.htm. Regulations for expanded access to investigational new drugs (INDs) were revised in 2009. The new

ONCOLOGY PRACTICE MANAGEMENT

I June 2013

regulations have a provision for charging for INDs, which must be approved by the FDA at the time of the IND’s submission. To qualify for expanded access, the patient must not have any other treatment options, and there cannot be any clinical trials open for which the patient qualifies. In addition, the risks of treatment with the investigational drug must outweigh the risk of the disease or of the condition, and expanded access must not create an adverse impact on the development of the drug. There is an advanced search field on www.clinicaltrials.gov to search for available expanded-access programs. “These will only be the treatment INDs, the ones which are available and open for large numbers of patients,” said Dr Redic. “If you don’t find anything, you can contact individual sponsors or individual companies that have these drugs in development and see if they are making them available for single patient access.” Expanded access to a drug may be denied if the supply of the drug is limited, the regulatory work may be deemed too costly, safety problems that may arise could jeopardize the FDA’s approval process, or the expanded-access program may hinder enrollment in other clinical trials. Dr Redic pointed out that pharmacists must consider that providing a drug outside of a clinical trial in a patient population that it has not been tested in may leave the patient worse off. “This is worth thinking about and reminding your team about, as you are wrestling with this idea of compassionate use,” she advised. l

ANNUAL CONFERENCE

"! ! !

! Professor Rob Coleman, MBBS, MD, FRCP Yorkshire Cancer Research Professor of Medical Oncology Director, Sheffield Cancer Research Centre Associate Director, National Institute for Health Research Cancer Research Network Department of Oncology, Weston Park Hospital Sheffield, United Kingdom

* 3:00 pm - 7:00 pm

Registration

5:30 pm - 7:30 pm

Welcome Reception and Exhibits

7:00 am - 8:00 am

Symposium/Product Theater

8:15 am - 8:30 am

Welcome to the Second Annual Conference of the Global Biomarkers Consortiumâ&#x20AC;&#x201D;Setting the Stage for the Meeting Professor Rob Coleman, MBBS, MD, FRCP

8:15 am - 11:45 am

General Session I â&#x20AC;˘ Personalized Medicine in Oncology: Evolution of Cancer Therapy from Nonspecific Cytotoxic Drugs to Targeted Therapies â&#x20AC;˘ Taking Stock of Molecular Oncology Biomarkers â&#x20AC;˘ Genomics â&#x20AC;˘ Bioinformatics â&#x20AC;˘ Validating Biomarkers for Clinical Use in Solid Tumors - Professor Rob Coleman, MBBS, MD, FRCP â&#x20AC;˘ Validating Biomarkers for Clinical Use in Hematologic Malignancies Jorge E. Cortes, MD â&#x20AC;˘ The Challenges of Biomarker-Based Clinical Trials â&#x20AC;˘ Keynote Lecture: Understanding Cancer at the Molecular Level

12:00 pm - 1:00 pm

Symposium/Product Theater/Exhibits

1:15 pm - 4:30 pm

This activity is jointly sponsored by Medical Learning Institute Inc, Center of Excellence Media, LLC, and Core Principle Solutions, LLC.

General Session II â&#x20AC;˘ Introduction to Case Studies - Jorge E. Cortes, MD â&#x20AC;˘ Case Studies: Optimal, Value-Based Use of Molecular Biomarkers in Oncology: The Expertâ&#x20AC;&#x2122;s Perspective on How I Treat My Patients, Part I â&#x20AC;˘ Lung Cancer â&#x20AC;˘ Breast Cancer â&#x20AC;˘ Multiple Myeloma â&#x20AC;˘ Prostate Cancer â&#x20AC;˘ Leukemia â&#x20AC;˘ Lymphoma â&#x20AC;˘ Panel Discussion: Management Controversies and Accepted Guidelines for the Personalized Management of Solid Tumors and Hematologic Malignancies â&#x20AC;˘ Keynote Lecture: The Medical-Legal Issues Surrounding the Use of Biomarkers in Oncology

4:30 pm - 6:30 pm

Meet the Experts/Networking/Exhibits

Jorge E. Cortes, MD Chair, CML and AML Sections D.B. Lane Cancer Research Distinguished Professor for Leukemia Research Department of Leukemia, Division of Cancer Medicine The University of Texas MD Anderson Cancer Center Houston, TX

The only global meeting dedicated to advancing the understanding of value and clinical impact of biomarker research in oncology. Guided by the expertise of leaders in this field, participants will receive a thorough understanding of the current and future landscape of the relevance of tumor biomarkers and how to effectively personalize cancer care in the clinical setting.

This meeting will be directed toward medical oncologists and hematologists, pathologists, geneticists, advanced practice oncology nurses, research nurses, clinical oncology pharmacists, and genetic counselors involved in the management of patients with solid tumors or hematologic malignancies, and interested in the use of molecular tumor biomarkers to help optimize patient care.

Upon completion of this activity, the participant will be able to: â&#x20AC;˘ Assess emerging data and recent advances in the discovery of molecular biomarkers and their impact on the treatment of patients with solid tumors or hematologic malignancies â&#x20AC;˘ Discuss the role of molecular biomarkers in designing personalized therapy for patients with solid tumors or hematologic malignancies â&#x20AC;˘ Outline the practical aspects of integrating molecular biomarkers into everyday clinical practice in the treatment of patients with cancer

Grant requests are currently being reviewed by numerous supporters. Support will be acknowledged prior to the start of the educational activities.

7:00 am - 8:00 am

Symposium/Product Theater

8:15 am - 11:45 am

General Session III â&#x20AC;˘ Review of Saturdayâ&#x20AC;&#x2122;s Presentations and Preview of Today - Jorge E. Cortes, MD â&#x20AC;˘ Case Studies: Optimal, Value-Based Use of Molecular Biomarkers in Oncology: The Expertâ&#x20AC;&#x2122;s Perspective on How I Treat My Patients, Part II â&#x20AC;˘ Melanoma â&#x20AC;˘ Colorectal Cancer and Other GI Malignancies â&#x20AC;˘ MDS â&#x20AC;˘ Myeloproliferative Neoplasms â&#x20AC;˘ Keynote Lecture: Promises and Challenges of Personalized Medicine in Improving Cancer Care â&#x20AC;˘ Tumor Board: Challenging Cases in the Use of Biomarkers in Managing Solid Tumors (attendee-contributed cases) â&#x20AC;˘ Tumor Board: Challenging Cases in the Use of Biomarkers in Managing Hematologic Malignancies (attendee-contributed cases)

12:00 pm - 1:00 pm

Symposium/Product Theater/Exhibits

1:15 pm - 3:00 pm

General Session IV â&#x20AC;˘ Keynote Lecture: Making Personalized Medicine a Reality: The Realization of Genomic Medicine â&#x20AC;˘ The Future of Personalized Medicine: Measuring Clinical Outcomes â&#x20AC;˘ Cost-Effective Technologies That Can Drive Therapeutic Decision Making â&#x20AC;˘ Regulatory Perspectives on PMO â&#x20AC;˘ PMO: The Payerâ&#x20AC;&#x2122;s Perspective â&#x20AC;˘ Panel Discussion: Can We Afford PMO? A Value-Based Analysis â&#x20AC;˘ Practical Considerations in Incorporating PMO into Everyday Cinical Management â&#x20AC;˘ Reimbursement Challenges â&#x20AC;˘ Closing Remarks

3:00 pm

Departures

The Medical Learning Institute Inc designates this live activity for a maximum of 12.5 AMA PRA Category 1 Creditsâ&#x201E;˘. Physicians should claim only the credit commensurate with the extent of their participation in the activity. This activity has been planned and implemented in accordance with the Essential Areas and policies of the Accreditation Council for Continuing Medical Education through the joint sponsorship of the Medical Learning Institute Inc and the Center of Excellence Media, LLC. The Medical Learning Institute Inc is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.

Medical Learning Institute Inc Provider approved by the California Board of Registered Nursing, Provider Number 15106, for 12.5 contact hours.

The Medical Learning Institute Inc is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Completion of this knowledge-based activity provides for 12.5 contact hours (1.25 CEUs) of continuing pharmacy education credit. The Universal Activity Number for this activity is (To be determined).

CONFERENCE REGISTRATION

EARLY BIRD REGISTRATION NOW OPEN! $175.00 until June 30, 2013

www.globalbiomarkersconsortium.com

*Agenda is subject to change.

P O

PERSONALIZED MMEDICINE IN ONCOLOGY

ICD-10 Update

Transitioning to ICD-10…Continued from page 1 ter 2012; Phase 2: Preparing for Implementation, first quarter 2012 through second quarter 2014; Phase 3: Go Live Preparation, first quarter 2013 through third quarter 2014; and Phase 4: Postimplementation, fourth quarter 2014 through fourth quarter 2015.

Phase 1: Impact Assessment Your practice should already have completed the impact assessment. If you are behind schedule, you need to work hard now to catch up. The shift from International Classification of Diseases, Ninth Revision (ICD-9) involves serious challenges, including transitioning from a system of 13,000 codes to a system of more than 68,000 codes in ICD-10-CM. You may recall that the implementation of a new generation of the 9 electronic standards for the Health Insurance Portability and

Accountability Act (HIPAA), known as the American National Standards Institute (ANSI)

The shift from ICD-9 involves serious challenges, including transitioning from a system of 13,000 codes to a system of more than 68,000 codes in ICD-10-CM. Version 5010 (v5010), is a part of this process. ANSI v5010 replaced the electronic transaction standards ANSI v4010/v4010A. Once

Table 1. Structural Differences between ICD-9-CM and ICD-10-CM Diagnostic Codes ICD-9-CM

ICD-10-CM

3 to 5 digits

3 to 7 digits

Digit 1, numeric

Digit 1, alpha

Digits 2 to 5, numeric

Digit 2, numeric Digits 3 to 7, alpha or numeric

ICD-9-CM indicates International Classification of Diseases, Ninth Revision, Clinical Modification; ICD-10-CM, International Classification of Diseases, Tenth Revision, Clinical Modification. Table 2. Structural Differences between ICD-9-CM and ICD-10-CM Procedure Codes ICD-9-CM

ICD-10-CM

3 to 4 digits

7 digits

All digits, numeric

Each digit, either alpha or numeric

ICD-9-CM indicates International Classification of Diseases, Ninth Revision, Clinical Modification; ICD-10-CM, International Classification of Diseases, Tenth Revision, Clinical Modification.

ONCOLOGY PRACTICE MANAGEMENT

I June 2013

ICD-10-CM goes into effect, any transactions that are not compliant with HIPAA (ie, not using ANSI v5010) will be rejected. The new codes will be structurally different from the ICD-9 codes (Table 1 and Table 2). By now, you should have a steering committee in place or have devised a communication schedule involving everyone in your practice who will play a role in implementing the new coding system. If you have not already done so, you should take the following steps as soon as possible: • Begin operational processes • Evaluate workflow (data and staff) • Identify how to improve workflow • Conduct a gap analysis • Modify your software and upgrade your hardware • Educate your staff

Phase 2: Preparing for Implementation Now is also the time for the staff to review the practice’s current procedures and improve upon them, making them more efficient and cost-effective. The newly provided codes were designed to ensure that the collected data reflect patients’ conditions more precisely, decrease claims rejections, and improve the benchmarking of data and public health records. Examine the systems, vendor contracts, and costs for both your electronic health records (EHRs) and practice management systems. Use the following questions as a guide through this process. Are your contracts with payers ready for the move? You may need to review and update these contracts to pave the way for the move to ICD-10. Will your current practice management system accommodate the change, or will you require a new Continued on page 42

2013 WORLD CUTANEOUS MALIGNANCIES CONGRESS

• Melanoma • Basal Cell Carcinoma • Cutaneous T-Cell Lymphoma • Squamous Cell Carcinoma • Merkel Cell Carcinoma

July 26-28, 2013

Hyatt Regency La Jolla • San Diego, California PROGRAM OVERVIEW

CONFERENCE CO-CHAIRS

A 2-day congress dedicated to informing, educating, and fostering the exchange of clinically relevant information in the field of cutaneous malignancies on topics in melanoma, basal cell carcinoma, cutaneous T-cell lymphoma, squamous cell carcinoma, and Merkel cell carcinoma, including: • Epidemiology and genetic/environmental factors • Molecular biology and cytogenetics related to the pathogenesis of cutaneous malignancies • Risk stratification based on patient and tumor characteristics • Principles of cancer prevention of melanoma and basal cell carcinoma • Current treatment guidelines • Emerging treatment options for personalized therapy • Future strategies in management based on translational data from current clinical trials and basic research

LEARNING OBJECTIVES

Sanjiv S. Agarwala, MD Professor of Medicine Temple University School of Medicine Chief, Oncology & Hematology St. Luke’s Cancer Center Bethlehem, Pennsylvania

Upon completion of this activity, the participant will be able to: • Review the molecular biology and pathogenesis of cutaneous malignancies as they relate to the treatment of cutaneous T-cell lymphoma, basal cell carcinoma, Merkel cell tumors, and malignant melanoma • Compare risk stratification of patients with cutaneous malignancies, and how to tailor treatment based on patient and tumor characteristics • Summarize a personalized treatment strategy that incorporates current standards of care and emerging treatment options for therapy of patients with cutaneous malignancies

TARGET AUDIENCE This activity was developed for medical and surgical oncologists, dermatologists, radiation oncologists, and pathologists actively involved in the treatment of cutaneous malignancies. Advanced practice oncology or dermatololgy nurses, oncology pharmacists, and researchers interested in the molecular biology and management of cutaneous malignancies are also encouraged to participate.

DESIGNATION OF CREDIT STATEMENTS SPONSORS

FRIDAY, JULY 26, 2013 3:00 pm – 7:00 pm

Registration

5:30 pm – 7:30 pm

Welcome Reception/Exhibits

SATURDAY, JULY 27, 2013 7:00 am – 8:00 am

Symposium/Product Theater/Exhibits (non–CME-certified activity)

8:00 am – 8:15 am

BREAK

8:15 am – 8:30 am

Welcome to the Second Annual World Cutaneous Malignancies Congress — Setting the Stage for the Meeting - Sanjiv S. Agarwala, MD

8:30 am – 11:45 am General Session I: A Clinician’s Primer on the Molecular Biology of Cutaneous Malignancies • Keynote Lecture Understanding the Basic Biology and Clinical Implications of the Hedgehog Pathway • Keynote Lecture Pathogenesis of Merkel Cell Carcinoma: An Infectious Etiology? - Paul Nghiem, MD, PhD 12:00 pm – 1:00 pm Lunch Symposium/Product Theater/Exhibits (non–CME-certified activity) 1:00 pm – 1:15 pm

BREAK

1:15 pm – 4:30 pm

General Session II: Current Treatment Guidelines in Cutaneous Malignancies • Case Studies Optimal, Value-Based Therapy of Cutaneous Malignancies: The Expert’s Perspective on How I Treat My Patients • Panel Discussion Management Controversies and Accepted Guidelines for the Personalized Management of Cutaneous Malignancies • Keynote Lecture New Combinations in Melanoma: A Role for MEK + BRAF and Anti–PD-1

4:30 pm – 6:30 pm

Meet the Experts/Networking/Exhibits

COMMERCIAL SUPPORT ACKNOWLEDGMENT Grant requests are currently being reviewed by numerous supporters. Support will be acknowledged prior to the start of the educational activities.

The Medical Learning Institute Inc designates this live activity for a maximum of 13.0 AMA PRA Category 1 Credits ™. Physicians should claim only the credit commensurate with the extent of their participation in the activity. This activity has been planned and implemented in accordance with the Essential Areas and policies of the Accreditation Council for Continuing Medical Education through the joint sponsorship of the Medical Learning Institute Inc and the Center of Excellence Media, LLC. The Medical Learning Institute Inc is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.

www.CutaneousMalignancies.com WCMC2013ConferenceA_Ad_60313

Professor Dr. Med. Axel Hauschild Professor, Department of Dermatology University of Kiel Kiel, Germany

AGENDA*

This activity is jointly sponsored by Medical Learning Institute Inc, Center of Excellence Media, LLC, and Core Principle Solutions, LLC.

PHYSICIAN CREDIT DESIGNATION

Steven J. O’Day, MD Hematology/Oncology Director of Clinical Research Director of Los Angeles Skin Cancer Institute at Beverly Hills Cancer Center Clinical Associate Professor of Medicine USC Keck School of Medicine Los Angeles, California

SUNDAY, JULY 28, 2013 7:00 am – 8:00 am

Breakfast Symposium/Product Theater/Exhibits (non–CME-certified activity)

8:00 am – 8:15 am

BREAK

8:15 am – 8:30 am

Review of Saturday’s Presentations and Preview of Today’s Sessions

8:30 am – 11:45 am General Session III: Review of Emerging Treatment Options for Cutaneous Malignancies General Session IV: Challenges for the Cutaneous Malignancies Clinician • Panel Discussion How Can the Healthcare Team Work Best Together to Deliver Value-Based Care in Cutaneous Malignancies? 12:00 pm – 1:00 pm Lunch Symposium/Product Theater/Exhibits (non–CME-certified activity) 1:00 pm – 1:15 pm

BREAK

1:15 pm – 2:45 pm

General Session V: “Hot Data” — What I Learned at Recent Meetings: Focus on Cutaneous Malignancies

2:45 pm – 3:00 pm

Closing Remarks - Steven J. O’Day, MD

*Agenda is subject to change.

For complete agenda please visit www.CutaneousMalignancies.com

ICD-10 Update

Transitioning to ICD-10…Continued from page 40 system? Choose a software package that will accommodate the necessary changes. Review the problems your practice has experienced in the past 2 years and how they affected your practice and cash flow. Ask yourself what responses and issues you faced with your current practice management software vendor/customer support. How difficult was it to resolve any problems? What did it cost you in time, lost productivity, staffing, and overtime to “catch up” from having your system down for maintenance and upgrades? Will the upgrade to the new system involve a fee? If so, how much will that cost? Will your vendor(s) provide the codes at no cost? What is your vendor(s’) timeline for implementation, and when will they allow you to test your system? You will need to know when the upgrade to your existing system will be complete or when the entirely new system will be available. When it is complete, you then need to know whether your vendor(s) will provide training for your practice, and if so, what the training will cost. Have you begun to modify your templates? Remember to update your forms and superbills. The newer forms will, by necessity, be far more comprehensive and complex than the older forms. Will your vendor(s) load your specialty specifically, or will all of the specialties be included in your system? Will diagnoses be searchable by partial terms, and will they include the coding guidelines, rules, and exceptions to the guidelines that your practice may encounter? For example, when coding for malignancies, the malignancy will remain the principal diagnosis when the treatment is directed at the malignancy. However, if a patient is admitted for anemia associated with the malignancy and the treatment

is exclusively for anemia, the code for the malignancy will be listed as the principal or first-listed diagnosis, followed by the code D63.0, Anemia in neoplastic disease.

implementation • Develop a communications plan in preparation for going live • Regularly update your senior executives

Next Steps: • Contract with a consulting service • Redesign and reprint paper forms • Convert your data • Maintain a dual system until all of the problems with the new system have been worked out

Phase 3: Go Live Preparation Before you “go live,” be sure that any systems that are not working properly are corrected. Again, make sure you know what your vendor(s) will be able to do to help you with the transition. If you do not know for sure, ask your vendor(s) whether a mapping program will be provided. General Equivalence Mappings (GEMs) were developed to help you with the conversion, because ICD10 is more specific than ICD-9.1 GEMs are basically translation tools for not only payers and providers, but anyone working with coded data. Remember, the diagnostic codes have increased from 14,025 to 68,069. Procedural codes have increased from 3824 to 72,589. The GEMs can be used to convert your data from ICD-9 to ICD-10-CM/ PCS and back again (ie, forward and backward mappings, also known as crosswalks). The GEMs will allow you to translate data for tracking quality, recording morbidity and mortality, calculating reimbursement, or converting an ICD-9-CM–based application to ICD-10-CM/PCS. They also can be used to help your practice convert payment systems, payment and coverage edits, risk adjustment logic, quality measures, and research applications germane to trend data. In cases where there is no translation between an ICD9-CM code and an ICD-10 code, a flag will indicate “No Map.” One such example is ICD-9-CM Procedure Code 89.8—Autopsy, for which there is no translation in ICD-10-CM/PCS.

Looking at the positive side of the ICD-10-CM/ PCS transition, once we are prepared, trained, and on our way, the higher level of specificity with which this coding system will allow us to code will paint a very clear picture for the insurance carriers and will clearly identify patients’ medical problems to justify the medical services performed.

• Purchase software, seek educational resources, and use mapping tools as needed to help with the transition • Anticipate decreased coding accuracy and work to solve those associated issues • Monitor coding from the point of

ONCOLOGY PRACTICE MANAGEMENT

I June 2013

ICD-10 Update

Next Steps: • Confirm with your vendor(s) that the needed upgrades are in place • Finalize all system changes from January through September 2014 • Complete testing • Conduct claims testing • Make any necessary modifications and reassign testing • Have a contingency plan in place

Phase 4: Postimplementation Reeducate your staff as necessary and continue to monitor all of your systems—cash flow, productivity, revenue, and coding accuracy. Exceptions to the Rule As one would expect, there are several exceptions to the rule. One occurs in the etiology/manifestation convention regarding placement of the code, as well as the placement of the notes “use additional code” and “diseases classified elsewhere.” Certain conditions have both an underlying etiology and multiple body system manifestations owing to the underlying etiology. For such conditions, the ICD-9 coding convention requires that the underlying condition be sequenced first, followed by the systemic manifestation(s). Wherever such a combination exists, there is a “use additional code” note at the etiology code, and a “code first” note at the manifestation code. These instructional notes indicate the proper sequencing order of the codes—etiology followed by manifestation.2

Another exception to the rule occurs with regard to syndromes. When coding syndromes, it is important to follow the alphabetical index guidance. When there is no index guidance, assign codes for the documented manifestations of the syndrome.2 Looking at the positive side of the ICD-10-CM/PCS transition, once we are prepared, trained, and on our way, the higher level of specificity with which this coding system will allow us to code will paint a very clear picture for the insurance carriers and will clearly identify patients’ medical problems to justify the medical services performed. All of this assumes, of course, that the provider is well educated on this system and is utilizing it to its fullest potential. The level of detail required should result in decreased requests from insurance carriers for medical records which, in turn, will allow the staff to work on other tasks that are critical to the daily operations of your medical practice.

• Monitor your case mix • Resolve payment issues • Communicate with payers

Conclusion A significant amount of concern and resistance remains in accepting ICD-10-CM/PCS. However, it is coming, and time is ticking away. It is better to take a look at things now, to take the first step and have the first meeting to see who in your organization knows anything about ICD-10-CM/PCS. Your first step may be to send someone to a seminar or assign someone to spend the time to research the basics online. To fully participate in this system, it is highly recommended that you fully understand the coding guidelines. Although some of the guidelines have been retained, there are exceptions—particularly with the new combination codes. It is important to remember that the ICD-10-CM codes will be used by all medical providers. The ICD10-CM/PCS codes are only for inpatient hospital procedures and are used only by the hospitals. You must provide a full description of a procedure or diagnosis. It would be a grave error to truncate these codes, as we are attempting to seek the highest level of specificity. If your vendors download only partial codes, the data will not serve its purpose.l l

Next Steps: • Monitor the impact of ICD-10 on reimbursement • Meet with your staff regularly to share information • Monitor the functionality of your practice management and EHRs systems • Monitor coding accuracy and productivity • Train or retrain your staff as required

References

1. General Equivalence Mappings. www.cms.gov/ Medicare/Coding/ICD10/downloads/GEMS-Cross walksBasicFAQ.pdf. Accessed April 17, 2013. 2. American Medical Association. CPT® 2013 Professional Edition. 2013; American Medical Association. Last modified May 2, 2013.

Do you have a practice management tip to share? We are accepting articles from our readers for future issues of Oncology Practice Management. If you are interested in submitting an article, e-mail Lisa Neuman, Managing Editor, at: lneuman@the-lynx-group.com for more information and author guidelines.

June 2013

www.OncPracticeManagement.com

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) 1 System/Organ Class All Grades 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 7 discomfort 3.8 0.5 2.8 0 Cardiac failure8 2.3 1.9 1.0 0.3 1 Adverse

events graded according to CTCAE version 3.0 terms Arthritis, Arthralgia, Joint swelling, and Joint stiffness terms Muscle spasms, Musculoskeletal pain, Myalgia, Musculoskeletal discomfort, and Musculoskeletal stiffness

2 Includes 3 Includes

ZYTIGA® (abiraterone acetate) Tablets

4 Includes

1 Adverse

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 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) 1 System/Organ Class All Grades 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 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

2 Includes 3 Includes

events graded according to CTCAE version 3.0 terms Edema peripheral, Pitting edema, and Generalized edema terms Arthritis, Arthralgia, Joint swelling, and Joint stiffness

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) Grade 1-4 Grade 3-4 Grade 1-4 Grade 3-4 Laboratory 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. DRUG INTERACTIONS 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 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. Drugs that Inhibit or Induce CYP3A4 Enzymes: Based on in vitro data, ZYTIGA is a substrate of CYP3A4. The effects of strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, atazanavir, nefazodone, saquinavir, telithromycin, ritonavir, indinavir, nelﬁnavir, voriconazole) or inducers (e.g., phenytoin, carbamazepine, rifampin, rifabutin, rifapentine, phenobarbital) on the pharmacokinetics of abiraterone have not been evaluated, in vivo. Avoid or use with caution, strong inhibitors and inducers of CYP3A4 during ZYTIGA treatment [see Clinical Pharmacology (12.3) in full Prescribing Information]. 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.

ZYTIGA® (abiraterone acetate) Tablets

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. 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. 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]. The safety of ZYTIGA in patients with baseline severe hepatic impairment has not been studied. These patients should not receive ZYTIGA. 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]. 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 There have been no reports of overdose of ZYTIGA during clinical studies. 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 20oC to 25oC (68oF to 77oF); excursions permitted in the range from 15oC to 30oC (59oF 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].

• 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.

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.

Manufactured by: Patheon Inc. Mississauga, Canada Manufactured for: Janssen Biotech, Inc. Horsham, PA 19044 © Janssen Biotech, Inc. 2012 Revised: December 2012 2000005445 K08Z121174A

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

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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 ZYTIGA® is an inhibitor of the hepatic drug-metabolizing enzyme CYP2D6. Avoid co-administration with CYP2D6 substrates that have a narrow therapeutic index. If an alternative cannot be used, exercise caution and consider a dose reduction of the CYP2D6 substrate. In vitro, ZYTIGA® inhibits CYP2C8. There are no clinical data on its use 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. Based on in vitro data, ZYTIGA® is a substrate of CYP3A4. The effects of strong CYP3A4 inhibitors or inducers on the pharmacokinetics of abiraterone have not been evaluated, in vivo. Strong inhibitors and inducers of CYP3A4 should be avoided or used with caution during treatment with ZYTIGA®. 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.

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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 TheraCom, LLC and The Lash Group, Inc., under contract for Janssen Biotech, Inc. In this regard, TheraCom, LLC, and The Lash Group, Inc., assist 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. Importantly, insurance verification is the ultimate responsibility of the provider. Third-party reimbursement is affected by many factors. Therefore, TheraCom, LLC, The Lash Group, Inc., and Janssen Biotech make no representation or guarantee that full or partial insurance reimbursement or any other payment will be available. This information is provided as an information service only. While TheraCom, LLC, and The Lash Group, Inc., try to provide correct information, they and Janssen Biotech make no representations or warranties, expressed or implied, as to the accuracy of the information. In no event shall TheraCom, LLC, The Lash Group, Inc., or Janssen Biotech 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 assumes no responsibility for, and does not guarantee the quality, scope, or availability of the services including but not limited to reimbursement support services, patient education, and other support services. Each provider, not Janssen Biotech, is responsible for the services they provide. These support services have no independent value to providers apart from the product and are included within the cost of the product. © Janssen Biotech, Inc. 2013

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