OPM Dec 2014 | Vol 4 | No 8 by Value-Based Cancer Care

www.OncPracticeManagement.com

DECEMBER 2014

VOLUME 4 • NUMBER 8

Oncology Practice Management ™

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

Leverage That Listserv with Caution By Karna Morrow, CPC, RCC, CCS-P, PCS

n an ideal prac tice manage ment world, every unique coding sit uation would be carefully explained within the Amer ican Medical Associ ation (AMA) Cur rent Procedural Term inology (CPT) codebook or within the CPT Changes: An Insider’s View manual. The rules for coding and compliance would be black and white, and they would be applied consistently from insurance payer to insurance payer. Unfortunately, we don’t live in an ideal world, and as such, Listservs that focus on coding, billing, compliance, practice management, and other rele vant topics have become familiar and helpful tools within the oncology coder’s

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

hose who care for patients with cancer are special. Clinical team and staff members come to work daily not just for a job, but because they care and want to be a part of helping their friends, neighbors,

and community battle an insidious dis ease. Most of us have loved ones who were touched by cancer, and we bring unique, appreciated, and caring atten tion to those who we serve. Continued on page 3

Sunrise, Sunset: Swiftly Go the Years By Peggy Barton, RN, BSBA; Sue Mahoney-Stombaugh, CNP; and Bahu Shaikh, MD, FACP; Toledo Clinic, OH

any experienced oncology nurses who are retiring or approaching retirement pos sess knowledge about oncology patient care that comes from years of experi ence. They have seen a transition from general oncology to specialties in bone marrow transplant, genetics, hematol ogy, medical oncology, palliative care and hospice, radiation oncology, as well

as site-specific and surgical oncology. What used to be a limited number of treatment resources has exploded to multiple new methodologies, many of which are based on specific tumor mark ers. How does a practice ensure that the knowledge, skills, and abilities of its senior nursing staff are transferred to newer nurses joining the practice? Continued on page 10

Continued on page 8 From the publishers of

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From the Editor

Setting the Bar for Oncology Practices Continued from the cover Even as we go to work every day to help our charges, there are new barriers and challenges to face. We see and address some of them, such as patient benefit coverage, support, and management; staffing conflicts; physician or staff shortages; and the daily reality of providing care for many patients, despite our dwindling resources and increasing demands. There are also unexpected challeng es in others who feel they—rather than medical oncologists—may have a better handle on how to manage oncology. I anticipate that 2015 will be a watershed year for the control of oncology care delivery. However, are we as practice managers, nurses, physicians, and oncology care teams ready to stand up and set the bar regarding appropriate management of those dealing with cancer? What can you do to help?

Voice of Oncology for Patients Oncology associations, such as the American Society of Clinical Oncology, Community Oncology Alliance, American Society of Hematology, and Association of Community Cancer Centers, have advocacy teams that keep us informed about trends and issues related to oncology in Congress. Legislatures at the state level, however, often are buried in a slew of proposed local bills, some of which may significant ly impact access to care for patients with cancer. Individual practices might not have the staff resources to monitor and react to local bills, but state associations are fantastic vehicles for such action. Pharmacy Activity and Intervention State boards of pharmacy, the Occupational Safety and Health Administration, the US Food and

Drug Administration, and other entities all have existing or pending legislation. If they are not vigilant, state oncology groups may find that new laws that affect them have already been passed. It does not matter if an oncology practice works under its medical license or its phar macy license; increased scrutiny on the risks and management of haz ardous drugs in any setting makes practices fair game for those who feel more oversight and control are needed. This is again a topic where many practices could work together through a local oncology associa tion to present testimony, advoca

levels of consensus and evidence, which are developed by hundreds of active practicing oncologists. The NCCN’s process of evaluating these guidelines is so rigorous and trans parent that their recommendations are designated by the Centers for Medicare & Medicaid Services as a federally approved compendium of appropriate treatments. Several other pathways and guidelines with strong academic rigor and the direct involvement of active treating oncologists are developed by academic medical centers and large groups of practicing oncolo gists. Pathways and guidelines that are not developed by the practic ing medical community might not follow the evidence supported by It does not matter this community, and patient access to standards of care may be com if an oncology promised. Part of our obligation to practice works under patients is to stand up and call out its medical license policies and programs that risk com promising patient access to those or its pharmacy standards. Do not hesitate to reach license; increased out to your state associations as well; chances are very good that scrutiny on the risks others will also have clinical or and management of quality concerns about a program hazardous drugs in promulgated in your region. No organization or entity under any setting makes stands the intimate process of man practices fair game. aging the cancer journey with a patient better than those who pro vide direct patient care. We owe cy, and a valuable perspective on it to our patients to stand up and the impact legislation can have on define appropriate care, parame patients with cancer as well as their ters, and the impact of oncolo access to care. gy management. Several entities have announced plans to grow and Evidence-Based Care expand their involvement in oncol The oncology medical com ogy care management in 2015. As munity has a strong tradition of we head into the new year, let’s rigorous academic review of peer- also stand together for our patients reviewed literature. The National where we need to. We owe it to Comprehensive Cancer Network them and to ourselves to set the bar (NCCN) publishes and updates for oncology management and not new treatment guidelines with to compromise on what is needed. l

December 2014

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Table of Contents

December 2014 • Volume 4 • Number 8

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

Oncology Practice Management ™

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

FROM THE EDITOR Setting the Bar for Oncology Practices................................................1 By Dawn Holcombe, MBA, FACMPE, ACHE

FEATURES Best Practices Leverage That Listserv with Caution......................................................1 By Karna Morrow, CPC, RCC, CCS-P, PCS

Sunrise, Sunset: Swiftly Go the Years..............................................................1 By Peggy Barton, RN, BSBA; Sue Mahoney-Stombaugh, CNP; and Bahu Shaikh, MD, FACP

DEPARTMENTS Patient and Provider Access 2014 Election Is in the Books: What Will It Mean for Healthcare in 2015?.............................................................................. 14 By Leah Ralph

Clinical Trial Tracker New Clinical Trials Under Way............................................................. 16 Wealth Management Ten Tips to Cut Your 2014 Taxes........................................................... 24

By Andrew D. Schwartz, CPA, and Lawrence B. Keller, CFP®, CLU®, ChFC®, RHU®, LUTCF Continued on page 6

MISSION STATEMENT Oncology healthcare requires providers to focus attention on financial concerns and strategic decisions that affect the bottom line. To continue to provide the high-quality care that patients with cancer deserve, providers must master the ever-changing business of oncology. Oncology Practice Management offers process solutions for members of the cancer care team—medical, surgical, and radiation oncologists, as well as executives, administrators, and coders/billers—to assist them in reimbursement, staffing, electronic health records, REMS, and compliance with state and federal regulations. POSTMASTER: Correspondence regarding subscriptions or change of address should be directed to CIRCULATION DIRECTOR, Oncology Practice Management™, 1249 South River Road, Suite 202A, Cranbury, NJ 08512. Fax: 732-992-1881. Yearly subscription rates: 1 year: $99.00 USD; 2 years: $149.00 USD; 3 years: $199.00 USD.

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I December 2014

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Table of Contents

December 2014 • Volume 4 • Number 8

Oncology Practice Management™, ISSN 2164-4403 (print), is published 8 times a year by Engage Healthcare Communications, LLC, 1249 South River Road, Suite 202A, Cranbury, NJ 08512. Copyright © 2014 by Engage Healthcare Communications, LLC. All rights reserved. Oncology Practice Management™ is a registered trademark of Engage Healthcare Communications, LLC. No part of this publication may be reproduced or transmitted in any form or by any means now or here after known, electronic or mechanical, including photocopy, recording, or any informational storage and retrieval system, without written permission from the publisher. Printed in the United States of America. The ideas and opinions expressed in Oncology Practice Management™ do not necessarily reflect those of the editorial board, the editors, or the publisher. Publication of an advertisement or other product mentioned in Oncology Practice Management ™ should not be construed as an endorsement of the product or the manufacturer’s claims. Readers are encouraged to contact the manufacturers about any features or limitations of products mentioned. Neither the editors nor the publisher assume any responsibility for any injury and/or damage to persons or property arising out of or related to any use of the material mentioned in this publication.

Oncology Practice Management ™

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

Continued from page 4

DEPARTMENTS Patient Assistance Programs Gilead Offers Patient Assistance Through AccessConnect........... 26 Drug Update Zydelig (Idelalisib): First-in-Class PI3 Kinase Inhibitor Approved by the FDA for the Treatment of 3 Hematologic Malignancies.............................................................. 28 By Lisa A. Raedler, PhD, RPh

Drug Coding FDA-Approved Medications Used for the Treatment of Melanoma...................................................................... 35

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

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

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

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

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

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

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

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

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

ONCOLOGY PRACTICE MANAGEMENT

I December 2014

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

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Best Practices

Leverage That Listserv with Caution Continued from the cover arsenal of reference materials. The network of experience provided on these Listservs is invaluable, and prac tice managers frequently turn to them for tips and best practices. Even when posting to a private forum though, it is important to keep in mind that the information provided or the question asked is, in fact, public. For most employees, an electronic sig nature on an e-mail is the equivalent of a business card, complete with the person’s position and contact informa tion. Here are several things to keep in mind when posting questions and/or answers in a public forum:

the question or response posted? Are you comfortable with the message being forwarded to someone else, to another Listserv, or to your super visor? Would you want the infor mation in the post linked to your organization and viewed by a payer representative, an investigator from the Office of Inspector General, or an FBI agent?

As a general rule, familiarize your self with each Listserv’s published guidelines, as well as the rules, reg ulations, and etiquette that govern use of a particular Listserv before you make any posts. In addition, all Internet communications should always have one more read-through before they are sent.

Who is getting the message? Do more than just confirm that the correct mailing list address shows in the “Send to” field. Even though you should never forward inquiries from other individuals to a Listserv without their permission, would you want anyone and everyone to see

Karna Morrow, CPC, RCC, CCS-P, PCS

Have you admitted in your post that current coding practices might not be consistent with com mon practices or established guide lines? Instead of asking about how to code something, consider asking

✓ Who is providing the service: the doctor, nonphysician practitioner, or clinical support staff? ✓ What is the setting of the service? ✓ Is it an inpatient office, freestanding center, or hospital-based outpatient department? ✓ Is there any contractual arrangement between the provider and the billing party (eg, employed provider, leased employee)? ✓ Who is the insurance payer? ✓ Does the situation involve state scope of practice or license issues? If so, identify the state where the service was rendered.

If you want solid guidance from a Listserv, you need to draft a solid question. Consider writing questions with sufficient information that will help you and others learn how to apply authoritative guidance for unusual situations. Resist the urge to cut and paste from a medical record and lead the subject line with the phrase, “Help Please.” See the Checklist for some questions to ask yourself before posting.

Checklist. Information to Provide When Posting a Question to a Listserv

about coding guidelines or reference tools for coding for a particular topic. The Listserv may not be the best place to say, “We always bill nonphysician provider services under the physician, even if the individuals are employed by the hospital. Is that ok?”

ONCOLOGY PRACTICE MANAGEMENT

I December 2014

Remove all information or data that are not relevant to the discus sion, as a courtesy to fellow readers and in consideration of Health Insurance Portability and Accountability Act guidelines. It is rarely necessary to include an entire progress note. Everyone will appreciate it if you jump right to the relevant parts, especially those who are reading on a smart phone or mobile device. One benefit to working in health care is the endless opportunity to learn. Although the saying “We’ve always done it that way” is a cliché, every year new codes, guidelines, and procedures encourage us to continue learning. As we approach 2015 with a fresh batch of new codes and guide lines, use Listservs to learn. If your questions require more detail than you are comfortable sharing online, or if the case requires sharing actual con tent from a medical record, consider privately e-mailing one of the mem bers of the Listserv or an administrator of the Listserv. If consulting advice is needed, an administrator can point you in the right direction. l

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Best Practices

Sunrise, Sunset: Swiftly Go the Years Continued from the cover Background The Toledo Clinic is a multispecial ty physician organization, of which oncology is one of its specialties. The practice was established in the 1960s, when the first medical oncologist was recruited to Toledo, and grew with the addition of new partners who specialized in both medical oncology and hematology. Today, the prac tice has 6 locations in Ohio and Michigan, with 8 physicians, 9 nurse practitioners, and approximately 79 employees—including 17 registered nurses—staffing the offices. Its founding members have retired, but the group continues to expand. Today, several senior part ners in the clinic are approaching retirement, some are in the middle of their careers, and new partners have joined. The practice recognizes a need to provide the new part ners with a mentoring process that provides historical perspective and practical knowledge. The mentor can help in the transition from student to practicing physician. As more experienced nurses and nurse practitioners prepared for retirement, the need for role develop

ment was identified. With an explo sion of new advances in diagnosis and treatment, newer nurses need a longer learning curve. We asked ourselves these questions: How does a practice ensure that its new nurses understand and appreciate the history of the practice, and how are ongoing learning opportunities provided for the nursing staff, especially in an era where there are competing priorities for nurses’ time?

Orientation The process of educating new nurs ing staff has evolved over time. Today, the orientation program has been revised and extended to a minimum of 6 months, and includes mentor ship and continuing education (CE) programs. Time is spent providing an orientation to the Toledo Clinic, as well as to overall practice oper ations. New registered nurses take a biotherapy/chemotherapy course online offered through the Oncology Nursing Society (ONS; www.ONS. org/online-courses). Because the practice is also very involved in clinical research, newly hired nurses complete a human protection course

Table Sample Nurse Orientation Checklist Front-desk operations

Yes

N/A

Yes

N/A

Schedule chemotherapy appointments utilizing appropriate cycle process Comments: Ensure appropriate laboratory tests/x-rays are ordered before upcoming visits, as required by treatment plan/protocol Comments: Chemotherapy orders Review order and demonstrate understanding of dosing and administration requirements; clarify with physician as necessary Comments: Complete dose calculations properly within 24 hours of receipt of order Comments: N/A indicates not applicable.

through the National Institutes of Health Office of Extramural Research (https://phrp.nihtraining.com). During the first few months, ori entation is designed around the practice’s policies and procedures, electronic medical record system, chemotherapy order writing process, and documentation of patient assess ment and treatment. Time is also spent with the practice administrator learning about the history of the prac tice. As with new physicians, under standing the practice’s goals, mission, and contributions to the community is important. Implementation of the new nurse training program has changed the schedule on the practice’s end. Formalized CE and pharmaceutical programs have been integrated into quarterly nursing meetings. In the past year, an event approved for nurses to earn CE units (CEUs) was also added.

Mentorship New nurses are assigned a men tor who is responsible for initiating an orientation checklist (Table) that includes activities from the office observation period to the respon sibilities related to chemotherapy administration and patient care in the infusion room. When the mentor completes the checklist, the nurse can begin taking patients inde pendently, but the mentor and other experienced nurses remain available to answer questions. As nurses transition from orien tation, they can continue their rela tionship with the mentor, or, if nec essary, another nurse in the office. Experienced nurses are paid a differ ential because of the importance of their role in the orientation of the newer staff. Mentors are active par ticipants in the initial orientation, and they complete the orientation checklist as well as a 90-day eval Continued on page 12

ONCOLOGY PRACTICE MANAGEMENT

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Evasion of apoptosis may be a question of balance Increased BCL-2 expression helps cancer cells to survive1

BCL-2

Displacement of pro-apoptotic proteins may trigger apoptosis1

Pro-apoptotic proteins sequestered by BCL-2

Free pro-apoptotic proteins

Increased expression of BCL-2 impairs the pathway to programmed cell death Like normal cells, cancer cells will often induce expression of pro-apoptotic proteins in response to stressors like limited metabolic resources, rapid cell division, or exposure to cytotoxic agents1. Cancer cells may increase expression of the anti-apoptotic protein, BCL-21. Pro-apoptotic proteins are bound and sequestered by BCL-2, helping the cancer cell to avoid programmed cell death2.

Mitochondria

Pro-apoptotic proteins—if displaced from BCL-2—have the potential to trigger apoptosis1.

To learn more about the BCL-2 pathway, visit BOOTH #1343 and #1909 at the ASH annual meeting

References: 1. Letai, A.G., Diagnosing and exploiting cancer’s addiction to blocks in apoptosis. Nat Rev Cancer, 2008. 8(2): p. 121-32. 2. Garcia-Saez, A.J., The secrets of the Bcl-2 family. Cell Death Differ, 2012. 19(11): p. 1733-40.

A3469581

Best Practices

Sunrise, Sunset: Swiftly Go the Years Continued from page 10 uation. Emphasis is also placed on chemotherapy safety, with mentors providing an assessment of skills and direct observation of performance in the mixing room.

Continuing Education Program The practice has nursing personnel from all of its locations, including nursing staff and licensed nursing practitioners, attend quarterly meet ings. Clinical topics are provided by one of the physicians, nurse practi tioners, or nurses who brings back information from the national ONS meeting. However, none of these meetings have provided approved CEUs, which was an identified need. The agenda also includes updates on new drugs, legislative and reimburse ment changes, as well as topics of interest, including practice updates, inventory management, safety topics, electronic medical record and docu mentation requirements, new drugs and updates from pharmaceutical representatives, as well as updates on quality initiatives, including depres sion screening. To become a provider of approved nursing CEUs in Ohio, the Ohio Nurses Association (ONA) requires the following: • A clearly defined unit or depart ment responsible for nursing CE • A nurse planner who meets the ONA’s specific qualifications • The organization to be functioning for at least 6 months, using accredi tation criteria and the Ohio Board of Nursing’s rules, during which time at least 3 separate activities of at least 60 minutes in length must have been planned, approved by the ONA, implemented, and evaluated • The practice to submit a form and the required fees showing intent to apply as an accredited CE provider. One of our nurse practitioners

accepted responsibility for the role of nurse planner, and the practice has now received a preliminary CEU pro vider designation. Our first planned activity was a review of oncology drugs of the past, present, and future, which was presented by an oncol ogy pharmacist. The objectives of the review were to state the mech anism, administration, and clinical pearls related to older, traditional chemotherapeutic agents, and to list a variety of targeted anticancer agents and explain their administration and common adverse effects.

In-house education programs should be customized to fit the needs of the nursing staff and the practice. The nurses who attended this ses sion and completed an evaluation received 1.0 contact hour of CEUs. The first program was well-received by the staff, and evaluations will be used to develop future presentations. Assessment of the evaluations showed that nurses appreciated the pharma cist’s knowledge of chemotherapy and presentation of the information in a manner that enhanced their under standing of oncology drugs. Several individuals requested that the phar macist attend the quarterly in-service meetings to review treatment regi mens on an ongoing basis. Based on the evaluations, programs are being developed on chronic lym phocytic leukemia, neuroendocrine tumors, genetic tests, and palliative care. A physician will provide clin ical information on the topic and a nurse practitioner will provide nurs ing care–specific information.

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Discussion Developing an in-house nursing CEU program is beneficial to the practice. It demonstrates the prac tice’s commitment to CE and to staff development. For individual nurses, the program provides neces sary information that is not readily available to them, and is an effective way for the practice to ensure nurs ing personnel have the information needed to care for patients. Other benefits include meeting the needs of busy nursing personnel, saving staff time, and minimizing travel time and expense. In-house education programs should be customized to fit the needs of the nursing staff and the practice, which will keep doctors and nurses in tune with each other. The programs should provide the staff with updated information as changes occur and should provide a forum for respond ing to problems, issues, regulations, and new trends in a timely manner. These programs can offer an oppor tunity for knowledge transfer from experienced nurses to newer nurses, and can provide potential recruits with a reason to join the practice. Conclusions Using the above approach, our practice has developed a program to prepare for the sunset of retiring nurs es and the sunrise of new nurses who will care for patients over the next decades. Orientation and mentorship programs allow newly hired nurses to learn about our clinic, including an overall understanding of process es, administrative procedures, the clinic’s role in the community, and expectations for the clinical care of patients. Educational programs and approved CE programs allow nurses to earn CEUs while maintaining clin ical competency and helping to meet the practice’s clinical standards. l

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Oncology

OCTOBER 2013

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Patient and Provider Access

2014 Election Is in the Books: What Will It Mean for Healthcare in 2015? By Leah Ralph, Manager, Provider Economics and Public Policy, Association of Community Cancer Centers

he 2014 elections are com plete, and we now know the makeup of the next US Congress. Even though Republicans picked up more than the 6 seats needed to take control of the Senate, it may not mean that significant healthcare changes are imminent. As the congressional landscape transforms, legislators will have to address the following issues. The Affordable Care Act (ACA): There is little chance of seeing this act repealed or replaced with President Barack Obama still in office, as it is one of his most signif icant legislative achievements. He will not have an interest in repeal ing it, and the Senate does not have the two-thirds majority to over come a presidential veto. We do know, however, that aspects of the law will be up for repeal or tweak ing, including the medical device excise tax (2.3% of the sales price on certain medical devices); the employer mandate to offer qualified, affordable health coverage; and the 30-hours-per-week definition for a full-time employee. The bottom line is that even if Republicans control Congress, it is expected the ACA will remain largely intact. The real future of the ACA likely lies with the US Supreme Court. Earlier this year, conflicting rulings came from the Appeals Courts on the legality of the ability of federal ly run exchanges to offer premium assistance, as the law only allows subsidies for citizens signing up for insurance through state-based exchanges. The Supreme Court’s ruling that is expected in June 2015 could have enormous implications for the success of the law with the

federal marketplace in 36 states. Another area that may see movement is the 21st Century Cures initiative: In 2014 the US House of Representatives Energy & Commerce Committee hosted hearings and roundtables to study issues that affect healthcare and innovation. In early 2015, the com mittee plans to introduce a bill that will address numerous issues, including one that touches on clin ical trials.

Bipartisan-Supported Legislation The following issues largely have bipartisan support, so the makeup of Congress is not as important for these issues as are the methods decided upon to pay for them. Both houses of Congress have indicated they will prioritize legislation that has bipartisan support; the chal lenge will be finding ways to offset the cost. • The Sustainable Growth Rate (SGR): The best opportuni ty to permanently repeal SGR occurred this year. A bipartisan bill on this matter had broad support, but Congress could not come together to determine how to pay for the cost of a fix ($130 billion). Instead, Congress passed another short-term patch that will expire in March 2015, which prevented roughly a 24% cut in Medicare physician reim bursement rates for 12 months. In keeping with previous fixes, Congress cut healthcare expendi tures to pay for the extension. It also extended Medicare seques tration-mandated cuts by 2 more years. If Congress is to try to

ONCOLOGY PRACTICE MANAGEMENT

I December 2014

pass another long-term SGR fix in 2015, they will still run into issues with cost. Although it is likely the new Congress will bring up a long-term fix, do not be surprised if another short-term fix is the solution. • Sequestration: For more than 18 months providers have faced sequester-mandated cuts to Medicare payments, and more than 10 years remain of the 2% Medicare claims reduction. This year, H.R. 1416, a bill that halts the cuts on reimbursement for cancer drugs, garnered some support, but not enough to pass in either chamber of Congress. Many advocacy organizations will push to have the bill rein troduced, but H.R. 1416 will be difficult to pass as part of any stand-alone healthcare bill. The best chance for a solution will be to attach some kind of fix to a larger bill, such as SGR reform. A number of other issues may come up during the year, includ ing oral parity and prompt pay discounts. These issues may be included in larger healthcarerelated vehicles. The Association of Community Cancer Centers will host a Capitol Hill Day for its members on March 16, 2015. We encourage all of our members to attend this annual event and educate elected officials on these important issues. l

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

Network with your oncology navigation team at the

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Best practices in navigation

Continuing education units

Oncology nurse navigators

Oncology social workers

Nuances in providing valuebased care in oncology

Psychosocial care for cancer patients

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Impact of prehabilitation and rehabilitation

Commission on Cancer case studies

Financial Counselors

Case managers

Survivorship

Networking opportunities

Patient or non-clinically licensed navigators

Oncology nurses and nurse practitioners

Visit AonnOnline.org to find out more and register today! NON-MEMBERS EARLY BIRD REGISTRATION (ends 1/31/15) $135 Clinically Licensed | $110 Non-Clinically Licensed MEMBERS (ends 5/18/15) $115 Clinically Licensed | $100 Non-Clinically Licensed

Clinical Trial Tracker

New Clinical Trials Under Way

he following clinical trials are currently re cruiting patients with acute myeloid leukemia (AML) for inclusion in several investiga tions. Each trial description in cludes the NLM Identifier to use as reference with ClinicalTrials.gov.

Safety Study of SGN-CD33A The objective of this phase 1 , nonrandomized, open-label study is to find the maximum toler ated dose of SGN-CD33A, admin istered as a single agent and in combination with a hypomethylat ing agent (HMA) in patients with AML. Patients aged ≥18 years who are positive for CD33 and have an Eastern Cooperative Oncology Group performance status of 0 or 1 as well as adequate baseline renal and hepatic function may enroll if other criteria are met. Patients are given the experimental drug intravenously on day 1 or days 1 and 4 every 3 weeks with or with out an HMA. The primary outcome measure is the incidence of adverse events and laboratory abnormalities. The anti leukemia activity and pharmacoki netic profile of the drug will be exam ined. Secondary outcomes include blood concentrations of SGNCD33A and metabolites, incidence of antitherapeutic antibodies, and remission and survival data. This study is expected to enroll 225 patients in many locations across the United States. For more information, contact Terri Lowe at 866-333-7436 or clinicaltrials@seagen.com. The NLM Identifier is NCT01902329.

Decitabine, Cytarabine, and Daunorubicin Hydrochloride This phase 2, randomized, open-label trial assesses the efficacy of decitabine when given in combi

nation with daunorubicin hydro chloride and cytarabine. Patients aged 18 to 65 years who are diag nosed with AML, have specific karyotypes, and have adequate cardi ac function may enroll if other crite ria are met. Patients will receive 1-hour intravenous daunorubicin hydrochloride and cytarabine with or without intravenous decitabine 5 days prior to induction of chemo therapy. Patients who do not achieve complete remission after the first cycle will receive a second, identical induction course. Primary and secondary outcome measures are complete remission rates after 1 and 2 courses of decit abine-primed induction of chemo therapy, respectively. Survival is mea sured for overall, relapse-free, and event-free rates. This trial is expected to enroll 180 patients and is conduct ed at academic hospitals in Maine, New York, and Ohio. For more infor mation, contact Joseph Scandura, MD, at 212-746-1848 or jms2003@ med.cornell.edu. The NLM Identifier is NCT01627041.

Phase 1 Study of IGN523 The main purpose of this phase 1 study is to determine the maximum tolerated dose of intravenous IGN523 in patients with AML. A recommended dose for the phase 2 trial will be identi fied based on the resulting safety, pharmacokinetic, and clinical data. Patients aged ≥18 years with relapsed or refractory disease, East ern Cooperative Oncology Group performance status of 0 to 2, life expectancy of ≥12 weeks, and ade quate baseline renal and hepatic function may qualify for enrollment if other criteria are met. Patients will receive the experimental drug intravenously every week for 8 weeks. Patients who meet the crite ria for ongoing clinical benefit and

acceptable safety will be permitted to receive dosing beyond 8 weeks. The primary outcome is the inci dence of adverse events throughout 1 month after the last dose. The sec ondary outcomes measure the inci dence of antidrug antibodies to IGN523, the concentration of the drug in the blood, and IGN523’s anti leukemic activity. Preliminary assess ments for biological markers of anti leukemic activity are collected. This study is expected to enroll 50 patients in California, Georgia, Indiana, Michigan, Texas, and Washington. For more information, contact Wil liam Ho, MD, PhD, at c linicaltrials@ igenica.com. The NLM Identifier is NCT02040506.

Oral Sapacitabine in Elderly Patients The purpose of this random ized, open-label, phase 3 study is to assess the efficacy of 2 initial treat ment regimens in elderly patients who are not recommended to receive the standard treatment. Patients aged ≥70 years with adequate renal and liver function who are newly diag nosed with AML may qualify if other criteria are met, and are randomized to receive decitabine alone or in alter nating cycles with sapacitabine. The primary outcome is overall survival, and the secondary out comes measure various remission sta tuses, hematologic improvement, and disease duration. Patients are fol lowed for up to 43 months. This study plans to enroll 485 patients in many locations across the United States. For more information, contact Judy H. Chiao, MD, at 908-517-7330 or jchiao@cyclacel.com. The NLM Identifier is NCT01303796.

S0919 Idarubicin, Cytarabine, and Pravastatin This phase 2, open-label, single- group assignment trial studies the effi Continued on page 18

ONCOLOGY PRACTICE MANAGEMENT

I December 2014

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Clinical Trial Tracker

New Clinical Trials…Continued from page 16 cacy of the combination of idarubicin and cytarabine with pravastatin in treating patients with relapsed AML. Patients aged ≥18 years who have relapsed ≥3 months after receiving ≥1 previous chemotherapy regimens for AML, with an ejection fraction ≥45% by echocardiogram or MUGA scan, and AST, ALT, and total bilirubin within the required range may qualify if other study criteria are met. Concur rent enrollment in the research study SWOG-9007 is required. The primary objectives include complete remission rate, relapsefree survival, and overall survival. A toxicity profile and association between prestudy cytogenetic fea tures and response are studied. The study plans to enroll 110 patients at multiple locations across the United States. For more information, call 210-614-8808 to reach Sandi J. Fredette at extension 1002 or sfredette@swog.org, or Dana Sparks, MAT, at extension 1004 or dsparks@ swog.org. The NLM Identifier is NCT00840177.

Oral Azacitidine Plus Best Supportive Care The objective of this phase 3, randomized, double-blind study is to compare the efficacy and safety of best supportive care with or without oral azacitidine as maintenance ther apy in patients with AML. Patients aged ≥55 years who have achieved their first complete remission—or complete remission with incomplete blood count recovery—within 90 days of receiving their induction chemotherapy may enroll if other criteria are met. Oral azacitidine 300 mg or placebo will be given for the first 14 days of each 28-day treat ment cycle. The results are collected over the course of 60 months. The primary outcome is the over all survival rate, measured as the number of patients who survive. The

secondary outcomes include relapsefree survival, complete remission, and the safety and tolerability of the treatment. Healthcare resource utili zation and health-related quality-oflife data are also collected. The study is expected to enroll 460 patients in multiple locations across the United States. For more infor mation, contact Andrew Dorman at 908-673-2076 or adorman@ celgene.com. The NLM Identifier is NCT01757535.

Phase 1b Study of AMG 232 ± Trametinib This is a phase 1b, open-label, sequential dose escalation and ex pansion study of AMG 232. Patients aged ≥18 years with AML that is relapsed or refractory to standard therapy, and who have adequate hematologic, renal, hepatic, and coagulation laboratory assessments are eligible if other criteria are met. Patients will receive oral AMG 232 in escalating doses with or without a fixed dose of oral trametinib. The primary outcome measures are to evaluate the safety and toler ability, characterize the pharmaco kinetics, and determine the maxi mum tolerated dose of AMG 232 with or without trametinib. Treat ment response, measured as com plete response, complete response with incomplete recovery, and duration response are the secondary outcome measures. This study is expected to enroll 130 patients in Alabama, New York, Utah, and Washington. For more information, contact the Amgen Call Center at 866-572-6436 or www.amgentrials. com/amgen/study.aspx. The NLM Identifier is NCT02016729.

Clofarabine with Cytarabine Versus Conventional Induction Therapy and NK Cell Transplantation

ONCOLOGY PRACTICE MANAGEMENT

I December 2014

The objective of this phase 3, randomized, open-label study is to assess the feasibility and efficacy of haploidentical natural killer (NK) cell transplantation in patients with standard-risk AML, examine the efficacy of clofarabine and cytara bine (Clo/AraC) in patients newly diagnosed with AML, and use min imum residual disease–adapted therapy and further improvements in supportive care to optimize ther apy. Patients aged ≤21 years who were previously untreated except for hyperleukocytosis may enroll if other criteria are met. Patients will be randomized to receive a regimen of cytarabine, daunorubicin, and etoposide, or Clo/AraC. The primary outcome measure is to compare the immunologic com plete response rate after 1 course of therapy. The secondary outcome measures evaluate the event-free survival of standard-risk patients who receive chemotherapy alone versus chemotherapy followed by NK cell transplantation, and results are collected for 3 years after the patient completes therapy. This study is expected to enroll 270 patients in multiple sites across the United States. For more informa tion, contact Jeffrey Rubnitz, MD, at 866-278-5833 or info@stjude.org. The NLM Identifier is NCT00703820.

Selinexor in Older Patients This phase 2, randomized, open-label study compares oral Selinexor to a physician’s choice of 3 conventional-care regimens. Patients aged ≥60 years with relapsed or refractory AML of any type except for M3, an Eastern Cooperative Oncology Group per formance status of ≤2, and only 1 line of previous chemotherapy given at standard doses may qualify if other criteria are met. Patients will receive the experimental drug twice

Clinical Trial Tracker

weekly, with doses based on the patient’s body surface area. The patients randomized to the physi cian’s choice group will receive 1 of the following: (1) best supportive care, (2) best supportive care and a subcutaneous injection of cytara bine 20 mg, or (3) best supportive care with a subcutaneous injection of azacitidine or decitabine. Treat ment will continue until the occur rence of disease progression, patient death, or treatment intolerance. The primary outcome is overall survival, from randomization date until the participant’s death or when the study ends (after about 104 weeks). The secondary outcome is the patient’s survival status 3 months after randomization. This study is

their first-line AML therapy may enroll if other eligibility criteria are met. Patients will be randomized to receive either quizartinib 20 or 30 mg, or a cytarabine-based salvage chemotherapy regimen, and are fol lowed for 2 years. The primary outcome is overall survival rate in each group. Second ary outcomes measure event-free survival rates between the 2 treatment groups. This study is expected to enroll 326 patients in locations across the United States. For more informa tion, contact Guy Gammon, MBBS, at 858-334-2165 or ggammon@ ambitbio.com, or Marianne Man cini, MBA, at 858-334-2170 or mmancini@ambitbio.com. The NLM Identifier is NCT02039726. l

expected to enroll 150 patients in multiple locations across the United States. For more information, contact the primary investigators for each site listed at ClinicalTrials.gov. The NLM Identifier is NCT02088541.

Quizartinib Monotherapy Versus Salvage Chemotherapy The primary objective of this phase 3, open-label, parallel assign ment study is to determine whether quizartinib monotherapy extends overall survival when compared with salvage chemotherapy. Patients aged ≥18 years with FMS-like tyrosine kinase 3–Internal Tandem Duplica tion–positive AML who are refracto ry to or relapsed within 6 months of

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Your Patients, Your Practice… Helping Your Practice This comprehensive financial assistance program offers ongoing support across the reimbursement spectrum to help you help your patients. Complete Provider Assistance Benefits verification Prior authorization tracking Regionally dedicated case managers Local access and reimbursement specialists Denied claims assistance Indication XTANDI (enzalutamide) capsules is indicated for the treatment of patients with metastatic castration-resistant prostate cancer (CRPC). Important Safety Information Contraindications XTANDI (enzalutamide) capsules can cause fetal harm when administered to a pregnant woman based on its mechanism of action and findings in animals. XTANDI is not indicated for use in women. XTANDI is contraindicated in women who are or may become pregnant. Warnings and Precautions In Study 1, conducted in patients with metastatic castration-resistant prostate cancer (CRPC) who previously received docetaxel, seizure occurred in 0.9% of patients who were treated with XTANDI and 0% treated with placebo. In Study 2, conducted in patients with chemotherapy-naïve metastatic CRPC, seizure occurred in 0.1% of patients who were treated with XTANDI and 0.1% treated with placebo. Patients experiencing a seizure were permanently discontinued from therapy and all seizure events resolved. There is no clinical trial experience re-administering XTANDI to patients who experienced a seizure, and limited clinical trial experience in patients with predisposing factors for seizure. Study 1 excluded the use of concomitant medications that may lower threshold, whereas Study 2 permitted the use of these medications.

Because of the risk of seizure associated with XTANDI use, patients should be advised of the risk of engaging in any activity during which sudden loss of consciousness could cause serious harm to themselves or others. Permanently discontinue XTANDI in patients who develop a seizure during treatment. Adverse Reactions The most common adverse reactions (≥ 10%) reported from the two combined clinical trials that occurred more commonly (≥ 2% over placebo) in the XTANDI-treated patients were asthenia/fatigue, back pain, decreased appetite, constipation, arthralgia, diarrhea, hot flush, upper respiratory tract infection, peripheral edema, dyspnea, musculoskeletal pain, weight decreased, headache, hypertension, and dizziness/ vertigo. Other Adverse Reactions include: • Laboratory Abnormalities: In the two studies, Grade 1-4 neutropenia occurred in 15% of patients treated with XTANDI (1% Grade 3-4) and in 6% of patients treated with placebo (0.5% Grade 3-4). The incidence of Grade 1-4 thrombocytopenia was 6% of patients treated with XTANDI (0.3% Grade 3-4) and 5% of patients on placebo (0.5% Grade 3-4). Grade 1-4 elevations in ALT occurred in 10% of patients treated with XTANDI (0.2% Grade 3-4) and 16% of patients treated with placebo (0.2% Grade 3-4). Grade 1-4 elevations in bilirubin occurred in 3% of patients treated with XTANDI

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(0.1% Grade 3-4) and 2% of patients treated with placebo (no Grade 3-4). • Infections: In Study 1, 1% of XTANDI versus 0.3% of placebo patients and in Study 2, 1 patient in each treatment group (0.1%) had an infection resulting in death. • Falls: In the two studies, falls including fall-related injuries occurred in 9% of XTANDI patients vs 4% treated with placebo. Falls were not associated with loss of consciousness or seizure. Fall-related injuries were more severe in XTANDI patients and included non-pathologic fractures, joint injuries, and hematomas. • Hypertension: In the two studies, hypertension was reported in 11% of patients receiving XTANDI and 4% of patients receiving placebo. No patients experienced hypertensive crisis. Medical history of hypertension was balanced between arms. Hypertension led to study discontinuation in < 1% of XTANDI or placebo treated patients. Drug Interactions • Effect of Other Drugs on XTANDI – Administration of strong CYP2C8 inhibitors can increase the plasma exposure to XTANDI. Co-administration of XTANDI with strong CYP2C8 inhibitors should be avoided if possible. If co-administration of XTANDI cannot be avoided,

XTANDISupportSolutions.com

reduce the dose of XTANDI. Co-administration of XTANDI with strong or moderate CYP3A4 and CYP2C8 inducers may alter the plasma exposure of XTANDI and should be avoided if possible. • Effect of XTANDI on Other Drugs – XTANDI is a strong CYP3A4 inducer and a moderate CYP2C9 and CYP2C19 inducer in humans. Avoid CYP3A4, CYP2C9 and CYP2C19 substrates with a narrow therapeutic index, as XTANDI may decrease the plasma exposures of these drugs. If XTANDI is co-administered with warfarin (CYP2C9 substrate), conduct additional INR monitoring. PLEASE SEE BRIEF SUMMARY OF COMPLETE PRESCRIBING INFORMATION ON FOLLOWING PAGES.

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

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

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

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

Table 1. Adverse Reactions in Study 1

Study 2: Chemotherapy-naive Metastatic CastrationResistant Prostate Cancer Study 2 enrolled 1717 patients with metastatic CRPC who had not received prior cytotoxic chemotherapy, of whom 1715 received at least one dose of study drug. The median duration of treatment was 17.5 months with XTANDI and 4.6 months with placebo. Grade 3-4 adverse reactions were reported in 44% of XTANDItreated patients and 37% of placebo-treated patients. Discontinuations due to adverse events were reported for 6% of XTANDI-treated patients and 6% of placebo-treated patients. The most common adverse reaction leading to treatment discontinuation was fatigue/asthenia, which occurred in 1% of patients on each treatment arm. Table 2 includes adverse reactions reported in Study 2 that occurred at a ≥ 2% higher frequency in the XTANDI arm compared to the placebo arm.

XTANDI N = 800

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

Grade 1-4a (%)

CONTRAINDICATIONS Pregnancy XTANDI can cause fetal harm when administered to a pregnant woman based on its mechanism of action and findings in animals. XTANDI is not indicated for use in women. XTANDI is contraindicated in women who are or may become pregnant. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, apprise the patient of the potential hazard to the fetus and the potential risk for pregnancy loss [see Use in Specific Populations (8.1)]. WARNINGS AND PRECAUTIONS Seizure In Study 1, which enrolled patients who previously received docetaxel, 7 of 800 (0.9%) patients treated with XTANDI experienced a seizure and no patients treated with placebo experienced a seizure. Seizure occurred from 31 to 603 days after initiation of XTANDI. In Study 2, 1 of 871 (0.1%) chemotherapy-naive patients treated with XTANDI and 1 of 844 (0.1%) patients treated with placebo experienced a seizure. Patients experiencing seizure were permanently discontinued from therapy and all seizure events resolved. There is no clinical trial experience readministering XTANDI to patients who experienced seizure. Limited safety data are available in patients with predisposing factors for seizure because these patients were generally excluded from the trials. These exclusion criteria included a history of seizure, underlying brain injury with loss of consciousness, transient ischemic attack within the past 12 months, cerebral vascular accident, brain metastases, and brain arteriovenous malformation. Study 1 excluded the use of concomitant medications that may lower the seizure threshold, whereas Study 2 permitted the use of these medications. Because of the risk of seizure associated with XTANDI use, patients should be advised of the risk of engaging in any activity where sudden loss of consciousness could cause serious harm to themselves or others. Permanently discontinue XTANDI in patients who develop a seizure during treatment. ADVERSE REACTIONS Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Two randomized clinical trials enrolled patients with metastatic prostate cancer that has progressed on androgen deprivation therapy (GnRH therapy or bilateral orchiectomy), a disease setting that is also defined as metastatic CRPC. In both studies, patients received XTANDI 160 mg orally once daily in the active treatment arm or placebo in the control arm. All patients continued androgen deprivation therapy. Patients were allowed, but not required, to take glucocorticoids. The most common adverse reactions (≥ 10%) that occurred more commonly (≥ 2% over placebo) in the XTANDI-treated patients from the two randomized clinical trials were asthenia/fatigue, back pain, decreased appetite, constipation, arthralgia, diarrhea, hot flush, upper respiratory tract infection, peripheral edema, dyspnea, musculoskeletal pain, weight decreased, headache, hypertension, and dizziness/vertigo. Study 1: Metastatic Castration-Resistant Prostate Cancer Following Chemotherapy Study 1 enrolled 1199 patients with metastatic CRPC who had previously received docetaxel. The median duration of treatment was 8.3 months with XTANDI and 3.0 months with placebo. During the trial, 48% of patients on the XTANDI arm and 46% of patients on the placebo arm received glucocorticoids.

General Disorders Asthenic Conditionsb Peripheral Edema

Placebo N = 399

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

50.6

9.0

44.4

9.3

15.4

1.0

13.3

0.8

Musculoskeletal And Connective Tissue Disorders Back Pain

26.4

5.3

24.3

4.0

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

2.5

17.3

1.8

1.3

11.5

0.3

1.5

6.8

1.8

0.3

0.0

21.8

1.1

17.5

0.3

Hot Flush

20.3

0.0

10.3

0.0

Hypertension

6.4

2.1

2.8

1.3

Diarrhea Vascular Disorders

Nervous System Disorders Headache

12.1

0.9

5.5

0.0

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

9.5

0.5

7.5

0.5

Epistaxis

3.3

0.1

1.3

0.3

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

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

Grade 3-4 (%)

Placebo N = 844 Grade 1-4 (%)

Grade 3-4 (%)

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

28.6

2.5

22.4

3.0

Arthralgia

21.4

1.6

16.1

1.1

Gastrointestinal Disorders 7.4

6.6

4.5

3.8

6.6

0.0

4.5

0.0

4.3

0.3

1.8

0.0

4.0

0.3

1.8

0.0

6.5

0.3

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

2.4

4.8

1.3

Insomnia

8.8

0.0

6.0

0.5

Anxiety

6.5

0.3

4.0

0.0

Renal And Urinary Disorders Hematuria

6.9

1.8

4.5

1.0

Pollakiuria

4.8

0.0

2.5

0.0

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

0.0 0.3

Pruritus

3.8

0.0

1.3

0.0

Dry Skin

3.5

0.0

1.3

0.0

Constipation

23.2

0.7

17.3

0.4

Diarrhea

16.8

0.3

14.3

0.4

Vascular Disorders Hot Flush

18.0

0.1

7.8

0.0

Hypertension

14.2

7.2

4.1

2.3

Nervous System Disorders Dizzinessc

11.3

0.3

7.1

0.0

Headache

11.0

0.2

7.0

0.4

Dysgeusia

7.6

0.1

3.7

0.0

5.7

0.0

1.3

0.1

2.1

0.1

0.4

0.0

0.6

8.5

0.6

0.0

10.5

0.0

1.5

4.7

1.1

0.1

5.7

0.0

Mental Impairment Disordersd Restless Legs Syndrome

Respiratory Disorders Dyspneae

11.0

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

8.2

Table 2. Adverse Reactions in Study 2 (cont.) Renal And Urinary Disorders Hematuria

8.8

1.3

5.8

1.3

Injury, Poisoning And Procedural Complications Fall

12.7

1.6

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

5.3

0.7

3.0

1.1

16.4

0.7

8.5

0.2

Investigations Weight Decreased

12.4

0.8

Reproductive System and Breast Disorders Gynecomastia

3.4

0.0

1.4

0.0

a b c d

CTCAE v4 Includes asthenia and fatigue. Includes dizziness and vertigo. Includes amnesia, memory impairment, cognitive disorder, and disturbance in attention. e Includes dyspnea, exertional dyspnea, and dyspnea at rest. f Includes nasopharyngitis, upper respiratory tract infection, sinusitis, rhinitis, pharyngitis, and laryngitis. g Includes pneumonia, lower respiratory tract infection, bronchitis, and lung infection.

Laboratory Abnormalities In the two randomized clinical trials, Grade 1-4 neutropenia occurred in 15% of patients treated with XTANDI (1% Grade 3-4) and in 6% of patients treated with placebo (0.5% Grade 3-4). The incidence of Grade 1-4 thrombocytopenia was 6% of patients treated with XTANDI (0.3% Grade 3-4) and 5% of patients treated with placebo (0.5% Grade 3-4). Grade 1-4 elevations in ALT occurred in 10% of patients treated with XTANDI (0.2% Grade 3-4) and 16% of patients treated with placebo (0.2% Grade 3-4). Grade 1-4 elevations in bilirubin occurred in 3% of patients treated with XTANDI (0.1% Grade 3-4) and 2% of patients treated with placebo (no Grade 3-4). Infections In Study 1, 1% of patients treated with XTANDI compared to 0.3% of patients treated with placebo died from infections or sepsis. In Study 2, 1 patient in each treatment group (0.1%) had an infection resulting in death. Falls and Fall-related Injuries In the two randomized clinical trials, falls including fall-related injuries, occurred in 9% of patients treated with XTANDI compared to 4% of patients treated with placebo. Falls were not associated with loss of consciousness or seizure. Fall-related injuries were more severe in patients treated with XTANDI and included non-pathologic fractures, joint injuries, and hematomas. Hypertension In the two randomized trials, hypertension was reported in 11% of patients receiving XTANDI and 4% of patients receiving placebo. No patients experienced hypertensive crisis. Medical history of hypertension was balanced between arms. Hypertension led to study discontinuation in < 1% of patients in each arm. DRUG INTERACTIONS Drugs that Inhibit or Induce CYP2C8 Co-administration of a strong CYP2C8 inhibitor (gemfibrozil) increased the composite area under the plasma concentration-time curve (AUC) of enzalutamide plus N-desmethyl enzalutamide by 2.2-fold in healthy volunteers. Co-administration of XTANDI with strong CYP2C8 inhibitors should be avoided if possible. If co-administration of XTANDI with a strong CYP2C8 inhibitor cannot be avoided, reduce the dose of XTANDI [see Dosage and Administration (2.2) and Clinical Pharmacology (12.3)]. The effects of CYP2C8 inducers on the pharmacokinetics of enzalutamide have not been evaluated in vivo. Co-administration of XTANDI with strong or moderate CYP2C8 inducers (e.g., rifampin) may alter the plasma exposure of XTANDI and should be avoided if possible. Selection of a concomitant medication with no or minimal CYP2C8 induction potential is recommended [see Clinical Pharmacology (12.3)]. Drugs that Inhibit or Induce CYP3A4 Co-administration of a strong CYP3A4 inhibitor (itraconazole) increased the composite AUC of enzalutamide plus N-desmethyl

enzalutamide by 1.3-fold in healthy volunteers [see Clinical Pharmacology (12.3)]. The effects of CYP3A4 inducers on the pharmacokinetics of enzalutamide have not been evaluated in vivo. Co-administration of XTANDI with strong CYP3A4 inducers (e.g., carbamazepine, phenobarbital, phenytoin, rifabutin, rifampin, rifapentine) may decrease the plasma exposure of XTANDI and should be avoided if possible. Selection of a concomitant medication with no or minimal CYP3A4 induction potential is recommended. Moderate CYP3A4 inducers (e.g., bosentan, efavirenz, etravirine, modafinil, nafcillin) and St. John’s Wort may also reduce the plasma exposure of XTANDI and should be avoided if possible [see Clinical Pharmacology (12.3)]. Effect of XTANDI on Drug Metabolizing Enzymes Enzalutamide is a strong CYP3A4 inducer and a moderate CYP2C9 and CYP2C19 inducer in humans. At steady state, XTANDI reduced the plasma exposure to midazolam (CYP3A4 substrate), warfarin (CYP2C9 substrate), and omeprazole (CYP2C19 substrate). Concomitant use of XTANDI with narrow therapeutic index drugs that are metabolized by CYP3A4 (e.g., alfentanil, cyclosporine, dihydroergotamine, ergotamine, fentanyl, pimozide, quinidine, sirolimus and tacrolimus), CYP2C9 (e.g., phenytoin, warfarin) and CYP2C19 (e.g., S-mephenytoin) should be avoided, as enzalutamide may decrease their exposure. If co-administration with warfarin cannot be avoided, conduct additional INR monitoring [see Clinical Pharmacology (12.3)]. USE IN SPECIFIC POPULATIONS Pregnancy - Pregnancy Category X [see Contraindications (4)]. Risk Summary XTANDI can cause fetal harm when administered to a pregnant woman based on its mechanism of action and findings in animals. While there are no human data on the use of XTANDI in pregnancy and XTANDI is not indicated for use in women, it is important to know that maternal use of an androgen receptor inhibitor could affect development of the fetus. Enzalutamide caused embryofetal toxicity in mice at exposures that were lower than in patients receiving the recommended dose. XTANDI is contraindicated in women who are or may become pregnant while receiving the drug. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, apprise the patient of the potential hazard to the fetus and the potential risk for pregnancy loss. Advise females of reproductive potential to avoid becoming pregnant during treatment with XTANDI. Animal Data In an embryo-fetal developmental toxicity study in mice, enzalutamide caused developmental toxicity when administered at oral doses of 10 or 30 mg/kg/day throughout the period of organogenesis (gestational days 6-15). Findings included embryo-fetal lethality (increased post-implantation loss and resorptions) and decreased anogenital distance at ≥ 10 mg/kg/day, and cleft palate and absent palatine bone at 30 mg/kg/day. Doses of 30 mg/kg/day caused maternal toxicity. The doses tested in mice (1, 10 and 30 mg/kg/day) resulted in systemic exposures (AUC) approximately 0.04, 0.4 and 1.1 times, respectively, the exposures in patients. Enzalutamide did not cause developmental toxicity in rabbits when administered throughout the period of organogenesis (gestational days 6-18) at dose levels up to 10 mg/kg/day (approximately 0.4 times the exposures in patients based on AUC). Nursing Mothers XTANDI is not indicated for use in women. It is not known if enzalutamide is excreted in human milk. Because many drugs are excreted in human milk, and because of the potential for serious adverse reactions in nursing infants from XTANDI, a decision should be made to either discontinue nursing, or discontinue the drug taking into account the importance of the drug to the mother. Pediatric Use Safety and effectiveness of XTANDI in pediatric patients have not been established. Geriatric Use Of 1671 patients who received XTANDI in the two randomized clinical trials, 75% were 65 and over, while 31% were 75 and over. No overall differences in safety or effectiveness were observed between these patients and younger patients. Other reported clinical

experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Patients with Renal Impairment A dedicated renal impairment trial for XTANDI has not been conducted. Based on the population pharmacokinetic analysis using data from clinical trials in patients with metastatic CRPC and healthy volunteers, no significant difference in enzalutamide clearance was observed in patients with pre-existing mild to moderate renal impairment (30 mL/min ≤ creatinine clearance [CrCL] ≤ 89 mL/min) compared to patients and volunteers with baseline normal renal function (CrCL ≥ 90 mL/min). No initial dosage adjustment is necessary for patients with mild to moderate renal impairment. Severe renal impairment (CrCL < 30 mL/min) and end-stage renal disease have not been assessed [see Clinical Pharmacology (12.3)]. Patients with Hepatic Impairment A dedicated hepatic impairment trial compared the composite systemic exposure of enzalutamide plus N-desmethyl enzalutamide in volunteers with baseline mild or moderate hepatic impairment (Child-Pugh Class A and B, respectively) versus healthy controls with normal hepatic function. The composite AUC of enzalutamide plus N-desmethyl enzalutamide was similar in volunteers with mild or moderate baseline hepatic impairment compared to volunteers with normal hepatic function. No initial dosage adjustment is necessary for patients with baseline mild or moderate hepatic impairment. Baseline severe hepatic impairment (Child-Pugh Class C) has not been assessed [see Clinical Pharmacology (12.3)]. OVERDOSAGE In the event of an overdose, stop treatment with XTANDI and initiate general supportive measures taking into consideration the half-life of 5.8 days. In a dose escalation study, no seizures were reported at < 240 mg daily, whereas 3 seizures were reported, 1 each at 360 mg, 480 mg, and 600 mg daily. Patients may be at increased risk of seizure following an overdose. NONCLINICAL TOXICOLOGY Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term animal studies have not been conducted to evaluate the carcinogenic potential of enzalutamide. Enzalutamide did not induce mutations in the bacterial reverse mutation (Ames) assay and was not genotoxic in either the in vitro mouse lymphoma thymidine kinase (Tk) gene mutation assay or the in vivo mouse micronucleus assay. Based on nonclinical findings in repeat-dose toxicology studies, which were consistent with the pharmacological activity of enzalutamide, male fertility may be impaired by treatment with XTANDI. In a 26-week study in rats, atrophy of the prostate and seminal vesicles was observed at ≥ 30 mg/kg/day (equal to the human exposure based on AUC). In 4-, 13-, and 39-week studies in dogs, hypospermatogenesis and atrophy of the prostate and epididymides were observed at ≥ 4 mg/kg/day (0.3 times the human exposure based on AUC). Manufactured by: Catalent Pharma Solutions, LLC, St. Petersburg, FL 33716 Manufactured for and Distributed by: Astellas Pharma US, Inc., Northbrook, IL 60062 Marketed by: Astellas Pharma US, Inc., Northbrook, IL 60062 Medivation, Inc., San Francisco, CA 94105 Revised: September 2014 14B006-XTA-BRFS Rx Only © 2014 Astellas Pharma US, Inc. XTANDI® is a registered trademark of Astellas Pharma Inc.

076-0472-PM

Wealth Management

Ten Tips to Cut Your 2014 Taxes By Andrew D. Schwartz, CPA, and Lawrence B. Keller, CFP®, CLU®, ChFC®, RHU®, LUTCF

er to withhold additional taxes if you have not had enough taxes withheld during the year. The IRS Withholding Calculator for 2015 is available at www.irs.gov/Individuals/ IRS-Withholding-Calculator. Andrew D. Schwartz

Lawrence B. Keller

ost people are familiar with the old adage about life’s 2 certainties: taxes, like death, are inevitable. But why pay more in taxes than you have to? This article provides 10 potential tax-saving oppor tunities for 2014. The key is to take the time to evaluate which of these concepts, if any, may work in your situ ation. There is still time to take advan tage of these 10 tax-saving opportuni ties before December 31, 2014.

If you have not been contributing to your 401(k) and 403(b) plans at the maximum rate all year, increase your contributions. This year, you can put up to $17,500 into your 401(k) or 403(b) plan. Anyone aged ≥50 years by December 31, 2014, can put away an additional $5500 (for a total of $23,000). Contributing to a 401(k) or 403(b) plan at work is one of the best tax shelters available to you during your working years.

If you are self-employed, consider setting up a Solo 401(k) by December 31, 2014. A Solo 401(k) plan allows a self-employed person to reach the $52,000 retirement plan maximum with less income than a SEP-IRA. It also allows people aged ≥50 years to put away an additional $5500 (for a total of $57,500) into a retirement plan for 2014.

To avoid an underpayment penalty, review your withholdings and instruct your employ-

Consider selling your investments held in nonretirement accounts that have depreciated. Since your capital losses can offset other capital gains realized during the year (including those from your mutual funds), excess losses can then be used to offset up to $3000 of wages and other income. However, wait at least 31 days before buying back secu rity sold at a loss, or the IRS will not allow the loss under “wash sale” rules.

If you are in the lowest tax bracket, consider selling your investments that have increased in value. Since the capital gains rate will be 0%, those securities can be bought back, and the “cost-basis” will be the higher amount. This strategy will save you taxes when you sell these securities in the future. Ensure that the capital gains realized don’t push you out of the 15% tax bracket, or you will be taxed on gains that fall outside that range.

Send in your January 2015 mortgage payment early enough for processing before December 31, 2014. You can deduct the interest portion of that payment a year earlier by sending in your pay ment a few weeks early.

Clean out your closets; donate your clothing and household items to a charitable organization, since itemized “noncash” contributions are tax deductible. Remember to get a receipt. Make an itemized list that includes condi tion of the donated items, and take

ONCOLOGY PRACTICE MANAGEMENT

I December 2014

a few pictures of the items as well. Only donations of clothing and household items in “good condition or better” qualify for a deduction.

Making monetary donations by credit card before December 31, 2014, allows you to deduct the donation on this year’s return, even if you don’t pay your credit card bill until 2015. You always have the option of donating to charities any investments that have appreciated. You can claim your donation based on the value of the donated assets without paying capital gains taxes on the appreciation.

Prepay your projected state tax shortfall if you will be itemizing your deductions and you will not be subject to the alternative minimum tax.

Prepay and pay off your medical bills if your total medical expenses exceed 10% of your income and you itemize. The threshold increased from 7.5% to 10% in 2013, except for people aged >65 years, for whom the threshold remains at 7.5%. This month, evaluate whether you will save taxes by postpon ing 2014 income or deductions into 2015 or by accelerating 2015 income or deductions into 2014. l

Andrew D. Schwartz, CPA, is a partner in the Boston CPA firm Schwartz & Schwartz, PC, and is also the founder of the MDTAXES Network (www. mdtaxes.com). He can be reached at 800-471-0045 or by e-mail to Andrew@ mdtaxes.com. Lawrence B. Keller, CFP®, CLU®, ChFC®, RHU®, LUTCF, is the found er of Physician Financial Services. He can be reached at 800-481-6447 or by e-mail to Lkeller@physicianfinancial services.com.

Innovations in Oncology Management A newsletter series for oncology practice administrators, administrative staff, advanced practice clinicians, and oncology pharmacists. The series will provide concise, up-to-date information on current issues that are impacting the business of oncology.

Good Manufacturing Process

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

innovationsinoncologymanagement.com Supported by funding from Celgene Corporation and Celgene Patient Support. Manufacturer did not influence content. EHC388 Innovations A-Size_111314

Patient Assistance Programs

Gilead Offers Patient Assistance Through AccessConnect

ilead offers eligible patients receiving treatment with Zydelig (idelalisib) ease of access, affordability, and adherence support through its patient assistance program, Zydelig AccessConnect. Zydelig is a kinase inhibitor approved for the treatment of relapsed follicu lar B-cell non-Hodgkin lymphoma, relapsed small lymphocytic lympho ma, and in combination with ritux imab in the treatment of relapsed chronic lymphocytic leukemia.

What Patients Will Receive Qualified patients enrolled in Zydelig AccessConnect will receive access, financial, and adherence sup port, including the following: • Access Support. Case Specialists at Zydelig AccessConnect can help eligible patients and their provid ers by ensuring timely delivery of their medications, explaining the benefits of Medicare Part D, and providing a better understanding of the details and requirements of their insurance coverage with regard to Zydelig. • Financial Support. Uninsured patients may be eligible to receive Zydelig free of charge through the Zydelig AccessConnect Patient Assistance Program, and patients with commercial or private insur ance may qualify for copay cou pon assistance. Referrals to inde pendent foundations capable of offering financial support may be available for patients with Medicare. • Adherence Support. With the help of Zydelig AccessConnect’s Patient Support Nurses, eligible

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

Copay Coupon Card Eligibility To qualify for the Copay Coupon Card, patients must meet the follow ing eligibility requirements: • They must have a valid prescrip tion for Zydelig • The patient must reside in the United States, Puerto Rico, Guam, or the Virgin Islands • They cannot be enrolled in any state-funded or federally funded health insurance programs (eg, Medicaid, Medicare, or Medigap) Enrollment Using the online enrollment form available at www.activatethecard. com/zydelig/, eligible patients can sign up for the Copay Coupon Card themselves and, right after doing so, can print out a copy of their card. The card is valid for 1 year following the date of receipt, or for 15 fills within that 12-month time span. What Patients Will Receive The Zydelig AccessConnect Copay Coupon Card will cover outof-pocket costs for Zydelig after the first $5 of each prescription fill, for up to a maximum of 25% of the catalog price of a 1-year supply of Zydelig. Government Insurance Support Patients who are enrolled in gov ernment health insurance programs

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

Patient Assistance Program Patients who do not have insur ance coverage for Zydelig may be eligible to receive the medication free of charge through the Zydelig AccessConnect Patient Assistance Program. To qualify they must reside in the United States, be enrolled in Zydelig AccessConnect, and be receiving care from a US physician. Additionally, they cannot have insurance coverage for the requested medication. For more information about the Patient Assistance Pro gram, call (844) 622-2377. Zydelig QuickStart Program The Zydelig QuickStart Program gives eligible patients who have an insurance-coverage delay of >5 busi ness days rapid access to a free, 1-time, 30-day supply of Zydelig. The purchase of Zydelig is not com pulsory for participation in the pro gram, but certain restrictions may apply. Patients can enroll in the Zydelig QuickStart Program by fill ing out section 8 of the Zydelig AccessConnect enrollment form. Section 8 of the enrollment form also includes detailed information about eligibility criteria and what patients can expect to receive from the Zydelig QuickStart Program. l

Oncology Practice Management is now available online at: www.OncPracticeManagement.com 26

ONCOLOGY PRACTICE MANAGEMENT

I December 2014

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

Network with your oncology navigation team at the

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

“

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

Special Session in Partnership with the Association for Oncology Practice Management

Value-Based Strategies for Navigation

with:

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

Meeting Topics Include:

Who Should Attend:

Best practices in navigation

Continuing education units

Oncology nurse navigators

Oncology social workers

Nuances in providing valuebased care in oncology

Psychosocial care for cancer patients

Practice managers

Administrators

Impact of prehabilitation and rehabilitation

Commission on Cancer case studies

Financial Counselors

Case managers

Survivorship

Networking opportunities

Patient or non-clinically licensed navigators

Oncology nurses and nurse practitioners

Drug Update

Zydelig (Idelalisib): First-in-Class PI3 Kinase Inhibitor Approved by the FDA for the Treatment of 3 Hematologic Malignancies By Lisa A. Raedler, PhD, RPh

hronic lymphocytic leukemia (CLL), a cancer of B-cell lym phocytes, is the most common type of leukemia in Western adult patients.1 According to the Leukemia & Lymphoma Society, more than 15,600 Americans were diagnosed with CLL in 2013.2 CLL is a disease of the elderly.3 The incidence of CLL increases sig nificantly among individuals aged ≥50 years, with only a small fraction of patients diagnosed in their 30s and 40s.2 The majority of patients with CLL are diagnosed without symptoms, and typically learn that they have CLL after routine blood work.4 As it advances, CLL can cause severe fatigue, swollen lymph nodes, enlarged spleen, shortness of breath, and infections.4 The clinical course of CLL is hetero geneous. Although some patients with CLL live for decades with no treat ment, others have disease that is rapid ly aggressive.3 The survival of patients with CLL ranges from approximately 1 year to more than 20 years.5 According to the American Society of Clinical Oncology, the 5-year overall survival (OS) rate for patients with CLL of all stages is approximately 79%.5 The cost burden associated with CLL is significant. Based on a recent cost analysis conducted in Germany, the total per-patient costs for patients with CLL is €9753 (approximate ly $12,202) annually compared with €4807 (approximately $6014) annu ally for individuals in a control group of the same age and sex.6 In this study, Copyright © 2014 American Health & Drug Benefits. All rights reserved.

the economic burden of CLL was pri marily driven by inpatient costs and by drug costs. From a societal perspec tive, productivity loss was the highest cost associated with a CLL diagnosis.6

Small Lymphocytic Lymphoma According to the World Health Organization, CLL and small lympho cytic lymphoma (SLL) are different clinical manifestations of the same disease.7 The term CLL is used when there is a leukemic component in peripheral blood, whereas SLL is used when lymph nodes or other tissues are infiltrated by CLL cells that appear to be without the leukemic compo nent.2,7 Only 5% of patients present with clinical features of SLL.2 CLL and SLL affect people of the same agegroups, have common signs and symp toms, and are generally slow-growing conditions.8 The treatment for both malignancies is also similar.8 Follicular Lymphoma Follicular lymphoma is the sec ond most common subtype of non-Hodg kin lymphoma (NHL), comprising approximately 20% of all NHL cases.8 Follicular lympho ma is characterized by a translo cation between chromosome 14 and chromosome 18, which causes the overexpression of BCL-2 and increased resistance to treatment.8 Although an indolent NHL, follic ular lymphoma can transform into an aggressive phenotype, at which point it should be managed using therapies that are appropriate for aggressive forms of NHL, including combinations of chemotherapy and anti-CD20 monoclonal antibodies.9

ONCOLOGY PRACTICE MANAGEMENT

I December 2014

Evolving Treatments for Chronic Lymphocytic Leukemia In the past several years, major advances have been made in under standing the pathophysiology of CLL, including biologic factors that influence its clinical course. As a result, treatment approaches have evolved to target the underlying dis ease pathology.3 The International Workshop on CLL recommends treating CLL if patients present with active pro gressive disease manifested as bulky progressive adenopathy or bone mar row failure.2,10 Initial treatment of patients with symptomatic CLL typ ically includes chemotherapy com bined with a targeted drug––either rituximab or another CD20-targeted monoclonal antibody.2,11 Medications that can be used for the treatment of patients with relapsed and/or refractory CLL in clude alem tuzumab, bendamustine, chlorambucil, fludarabine, ibrutinib, lenalidomide, obinutuzumab (in com bination with chlorambucil), ofatu mumab, and rituximab.12 Several of these are new therapies that were approved in 2013 and 2014 for use in patients with previously untreated CLL and in relapsed or refractory CLL; these include ibrutinib, obinu tuzumab, and ofatumumab.13-15 Idelalisib: First-in-Class PI3 Kinase Inhibitor Approved by the FDA On July 23, 2014, the US Food and Drug Administration (FDA) approved idelalisib (Zydelig; Gilead Sciences), an oral phosphatidyl inositol 3-kinase delta (PI3Kδ)

Drug Update

inhibitor, for the treatment of 3 types of hematologic malignancies, including patients with relapsed CLL, to be used in combination with rituximab when rituximab can be used alone because of the presence of comorbidities, as well as patients with relapsed follic ular lymphoma or patients with relapsed SLL after 2 previous sys temic therapies.16 The FDA approved idelalisib for the treatment of CLL under the pre scheduled review process, and used its accelerated approval program to approve the indications for the treatment of patients with relapsed follicular lymphoma and for patients with relapsed SLL, based on the sur rogate end points of tumor response rate and duration of response. An improvement in survival or dis ease-related symptoms has not been established for idelalisib in these 2 malignancies.16 Idelalisib was approved with a Risk Evaluation and Mitigation Strategy program to ensure that healthcare providers who prescribe idelalisib are informed of the risk for fatal and serious toxicities associated with idelalisib.16

Mechanism of Action Idelalisib is a potent and selec tive inhibitor of the PI3Kδ, an enzyme that is expressed in normal and malignant B-cells.17,18 Idelalisib inhibits several cell-signaling path ways, including B-cell receptor sig naling and CXCR4 and CXCR5 signaling, which are involved in trafficking and homing of B-cells to the lymph nodes and to the bone marrow.18 In cell lines derived from malig nant B-cells and in primary tumor cells, idelalisib induced apopto sis and inhibited proliferation. Inhibition of chemotaxis and adhe sion, and reduced cell viability have been observed in lymphoma cells that were treated with idelalisib.18

Table 1 I delalisib versus Placebo: Survival and Response Results in Patients with Relapsed CLL in Study 116 Idelalisib plus rituximab Placebo plus rituximab Efficacy parameter (N = 110) (N = 110) P value Median PFS, months

NR (95% CI, 10.7-NR)

5.5 (95% CI, 3.8-7.1)

P <.001

PFS, %

P <.001

Overall survival, %

P = .02

Overall response, %

P <.001

CI indicates confidence interval; CLL, chronic lymphocytic leukemia; NR, not reached; PFS, progression-free survival. Sources: Zydelig (idelalisib) tablets prescribing information; 2014. Furman RR, et al. N Engl J Med. 2014;370:997-1007.

Dosing and Administration The recommended dosage of idelalisib for all 3 indications is 150 mg administered orally twice daily. Idelalisib tablets can be taken with or without food and should be swal lowed whole.18 Treatment with idelalisib should be continued until disease progres sion or unacceptable toxicity. The optimal and safe dosing regimen for patients who take idelalisib for more than several months is unknown.18

arms received 8 doses of rituximab (first dose, 375 mg/m2; subsequent doses, 500 mg/m2 every 2 weeks for 4 infusions, and every 4 weeks for 4 infusions). The median dura tion of exposure to idelalisib was 5 months.17,18 The primary end point was pro gression-free survival (PFS), which was defined as the interval from randomization to disease pro gression or death from any cause (whichever came first), using the Kaplan-Meier method.17 The pri mary end point was assessed by an Independent Review Committee. The secondary end points included overall response rate (ORR) and complete response rates, lymphnode response, and OS. Study 116 was stopped for efficacy following the first prespecified interim anal ysis.17,18 Patient population. The patients’ median age was 71 years, with 78% of patients aged ≥65 years. The majority of patients were male (66%), and Caucasian (90%). The median time since CLL diagnosis was 8.5 years.17,18 Overall, 40% of patients in Study 116 had moderate-to-severe renal dysfunction, defined as creatinine clearance <60 mL per minute, and 35% of patients had poor bone mar row function, defined as grade ≥3 anemia, thrombocytopenia, or neu tropenia. Almost two-thirds of the

Key Clinical Trials Study 116: Phase 3 Clinical Trial in Relapsed CLL The approval of idelalisib in com bination with rituximab for the treat ment of patients with relapsed CLL was based on Study 116, a random ized, double-blind, placebo-controlled phase 3 clinical trial.17 This clini cal trial enrolled 220 patients with relapsed CLL who required treatment and were unable to tolerate standard chemoimmunotherapy as a result of coexisting medical conditions, re duced renal function, or significant neutropenia or thrombocytopenia resulting from previous therapy with cytotoxic agents.17,18 Patients received idelalisib plus ri tuximab or placebo plus ritux imab until disease progression or unacceptable toxicity. Idelalisib was administered orally at 150 mg twice daily.17,18 Patients in both

Continued on page 30

December 2014

www.OncPracticeManagement.com

Drug Update

Zydelig (Idelalisib): First-in-Class Inhibitor…Continued from page 29 patients had advanced-stage CLL, and more than 40% had 17p dele tion or TP53 gene mutations.17,18 Patients in both arms had received a median of 3 previous therapies, including regimens containing ri tuximab, fludarabine, cyclophos phamide, and bendamustine.17,18 Efficacy. At 24 weeks, the PFS rate was 93% in patients receiving idelalisib plus rituximab compared with 46% in patients receiving pla cebo plus ri tuximab (Table 1).17 The adjusted hazard ratio (HR) for progression or death in the idelalisib plus rituximab group was 0.15 (95% confidence interval [CI], 0.08-0.28; unadjusted P <.001).17,18 Study 116 was stopped for efficacy following the first prespecified inter im analysis.17,18 Results of a second interim analysis continued to show a significant PFS improvement for idelalisib plus rituximab over place bo plus rituximab (HR, 0.18; 95% CI, 0.10-0.32; P <.001; Table 1). In the idelalisib plus rituximab group, the median duration of PFS was not reached; in the placebo plus ritux imab group, the median duration of PFS was 5.5 months. The PFS benefit for idelalisib and rituximab was similarly favorable in all pre specified subgroups, including those

that were stratified according to the presence or absence of the 17p deletion or TP53 gene mutation and immunoglobulin heavy chain variable mutational status.17,18 At 12 months, the OS rate in the idelalisib plus rituximab group (92%) was significantly higher than the OS rate in the placebo plus ri tuximab group (80%; HR for death, 0.28; 95% CI, 0.09-0.86; P = .02). In the idelalisib plus rituximab group, the ORR was 81% (95% CI, 71%-88%) compared with 13% (95% CI, 6%-21%) in the placebo plus rituximab group (P <.001). All responses were partial responses (Table 1).17

DELTA Study: Phase 2 Clinical Trial in Relapsed Follicular Lymphoma The safety and efficacy of idel alisib in patients with relapsed follicular lymphoma were evaluat ed in the DELTA clinical trial, a single-arm, multicenter clinical trial that included 72 patients with relapsed follicular lymphoma.18,19 In this clinical trial, idelalisib was administered orally at 150 mg twice daily until evidence of disease pro gression or unacceptable toxicity. The study’s primary end point was

ELTA Trial: Response Rate in Patients with Relapsed FL or SLL Table 2 D Receiving Idelalisib Response

Idelalisib 150 mg twice daily, N (%)

Relapsed FL (N = 72) Overall response

39 (54)

Complete response

42 (8)

Partial response

33 (46)

Relapsed SLL (N = 26) Overall response

15 (58)

Complete response

Partial response

15 (58)

FL indicates follicular lymphoma; SLL, small lymphocytic lymphoma. Source: Zydelig (idelalisib) tablets prescribing information; 2014.

ONCOLOGY PRACTICE MANAGEMENT

I December 2014

Independent Review Committee– assessed ORR. Tumor response was assessed using revised response cri teria for malignant lymphoma, as recommended by the International Working Group.18,19 Patient population. The patients’ median age was 62 years.18,19 The majority of the patients were male (54%), Caucasian (90%), and had a baseline Eastern Cooperative Oncology Group (ECOG) perfor mance status of 0 or 1 (92%). The patients’ median time since diag nosis was 4.7 years. The patients had received at least 2 previous treatments and experienced disease relapse within 6 months after treat ment with rituximab and an alkylat ing agent. The median number of previous treatments was 4 (range, 2-12) and included rituximab plus cyclophosphamide, doxorubicin, vin cristine, and prednisone (R-CHOP); bendamustine and rituximab; and rituximab plus cyclophosphamide, vincristine, and prednisone. At base line, 33% of patients had extranodal disease, and 26% of patients had bone marrow involvement.18,19 Efficacy. Among the 72 patients with relapsed follicular lymphoma who received idelalisib, the ORR was 54% (95% CI, 42%-66%), including 6 complete respons es (8%) and 33 partial responses (46%) (Table 2). The median dura tion of response was not evaluable (range, 0+ to 14.8+ months). The median time to response was 1.9 months (range, 1.6-8.3 months).18 An improvement in survival or disease-related symptoms has not been established for idelalisib in patients with relapsed follicular lym phoma.16,18 The continued approv al of idelalisib for the treatment of patients with relapsed follicular lymphoma may be contingent on the verification of clinical benefit in confirmatory clinical trials.18

Drug Update

DELTA Study: Phase 2 Clinical Trial in Relapsed Small Lymphocytic Lymphoma The safety and efficacy of idela lisib in patients with relapsed SLL were also evaluated in the DELTA clinical trial.18,19 Overall, 26 patients with relapsed SLL received 150 mg of idelalisib orally twice daily until evidence of disease progression or unacceptable toxicity. The primary end point was Independent Review Committee–assessed ORR. Tumor response was assessed using revised response criteria for malignant lym phoma, as recommended by the International Working Group.18,19 Patient population. The patients’ median age was 65 years.18 The majority of patients were male (73%), Caucasian (81%), and had a baseline ECOG performance status of 0 or 1 (96%). The patients had received at least 2 previous treat ments, and their disease had relapsed within 6 months after treatment with rituximab and an alkylating agent. The patients’ median time since SLL diagnosis was 6.7 years. The median number of previous treatments was 4 (range, 2-9) and included benda mustine plus rituximab; fludarabine, cyclophosphamide, and rituximab; and R-CHOP. At baseline, 27% of patients had extranodal disease.18,19 Efficacy. Among the 26 patients with relapsed SLL who received idelalisib, the ORR was 58% (95% CI, 37%-77%), and all responses were partial responses (Table 2). The median duration of response was 11.9 months (range, 0+ to 14.7+ months). The median time to response was 1.9 months (range, 1.6-8.3 months).18,19 An improvement in survival or dis ease-related symptoms has not been established for idelalisib in relapsed SLL. The continued approval of idel alisib for the treatment of patients with relapsed SLL may be contingent on the verification of clinical benefit in confirmatory clinical trials.16,19

Table 3 Grade ≥3 Adverse Reactions Reported with Idelalisib versus Placebo in Patients with CLL Idelalisib plus rituximab, N (%) (N = 110)

Placebo plus rituximab, N (%) (N = 108)

18 (16)

14 (13)

Sepsis

8 (7)

4 (4)

Diarrhea

6 (5)

Rash

4 (4)

1 (1)

Pyrexia

3 (3)

1 (1)

Chills

2 (2)

Stomatitis

2 (2)

Bronchitis

1 (1)

Headache

1 (1)

Adverse event Pneumonia

CLL indicates chronic lymphocytic leukemia. Source: Zydelig (idelalisib) tablets prescribing information; July 2014.

Adverse Events The majority of adverse events among patients receiving idelalis ib plus rituximab were consistent with those expected for patients with relapsed CLL who had received extensive previous therapy.17 In Study 116, serious adverse events were reported in 49% of the patients who received idelalisib plus rituximab.17,18 The most frequent serious adverse events included pneumonia, pyrexia, sepsis, febrile neutropenia, and diarrhea (Table 3). Adverse reactions leading to the discontinuation of idelalisib therapy occurred in 10% of the patients; the most common of these reactions included hepatotoxicity and diarrhea or colitis.17,18 Dose interruption of idelalisib was required in 35% of patients with relapsed CLL.18 Overall, 15% of the patients needed dose reductions as a result of adverse events or laborato ry abnormalities; the most common reasons for dose reductions included elevated transaminase levels, diar rhea or colitis, and rash.18 The safety data for idelalisib also reflect drug exposure in 146 adult patients with indolent NHL who received idelalisib 150 mg twice daily in clinical trials. The patients’

median duration of exposure to idel alisib was 6.1 months (range, 0.326.4 months). Overall, 50% of these patients experienced serious adverse events, including pneumonia, diar rhea, and pyrexia.18 In addition, dose interruption or discontinuation of idelalisib occurred in 53% of the patients with indolent NHL; the most common reasons for interruption or discontinuation of idel alisib included diarrhea, pneumonia, and elevated transaminase levels.18

Contraindications Idelalisib is contraindicated in patients with a history of seri ous allergic reactions, including anaphylaxis and toxic epidermal necrolysis.18 Warnings and Precautions Boxed warning. Idelalisib carries a boxed warning indicating that the drug may cause fatal and/or serious intestinal perforation, hepatoxicity, diarrhea or colitis, and pneumonitis. Patients should be monitored for the development of these adverse events, and idelalisib therapy should be discontinued if intestinal perfora tion is suspected.18 Hepatotoxicity. In clinical trials, 14% of patients who received idela Continued on page 32

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Drug Update

Zydelig (Idelalisib): First-in-Class Inhibitor…Continued from page 31 lisib experienced fatal and/or serious hepatotoxicity. In addition, eleva tions in transaminase levels greater than 5 times the upper limit of nor mal have been observed. These find ings were typically noted within the first 12 weeks of treatment with idel alisib and were reversible with dose interruption.18 After resuming idelalisib treatment at a lower dose, 26% of patients expe rienced recurrence of alanine ami notransferase (ALT) and aspartate aminotransferase (AST) elevations. Idelalisib treatment should be dis continued if recurrent hepatotoxicity occurs.18 The use of idelalisib concurrently with other drugs that may cause liver toxicity is not recommended.18 Transaminase levels should be monitored in all idelalisib recip ients according to the following schedule18: • Every 2 weeks for months 1 to 3 • Every 4 weeks for months 4 to 6 • Every 1 to 3 months thereafter. Weekly monitoring is appropriate if ALT or AST levels rise above 3 times the upper limit of normal until liver toxicity resolves. Idelalisib should be withheld if ALT or AST levels are greater than 5 times the upper limit of normal. Total biliru bin, AST, and ALT levels should be monitored weekly until abnormali ties resolve.18 Severe diarrhea or colitis. Across clinical trials, severe diarrhea or colitis (grade ≥3) occurred in 14% of patients receiving idelalis ib. Diarrhea can occur at any time and responds poorly to antimotility agents. Concurrent use of idelalisib and other medications that cause diarrhea should be avoided.18 After interruption of idelalisib therapy and, in some instances, the use of corticosteroids, the median time to resolution of diarrhea ranged

from 1 week to 4 weeks.18 Pneumonitis. Patients taking idelalisib have experienced fatal and serious pneumonitis. Pneumonitis should be suspected in patients who are taking idelalisib and present with pulmonary symptoms, including cough, dyspnea, hypoxia, interstitial infiltrates on a radiologic examina tion, or a decline of >5% in oxygen saturation.18 For patients with possible pneu monitis, idelalisib should be inter rupted until an etiology for lung symptoms has been determined. Patients with pneumonitis that is believed to be caused by idelalisib have discontinued idelalisib ther apy and received corticosteroids.18 Intestinal perforation. In clinical trials, fatal and serious intestinal per forations have occurred in patients taking idelalisib. Some patients had moderate-to-severe diarrhea at the time of perforation. Patients should immediately report new or worsening abdominal pain, chills, fever, nausea, or vomiting. Idelalisib should be permanently discontinued in patients who experience intesti nal perforation.18 Severe cutaneous reactions. Over all, 1 case of toxic epidermal necroly sis was reported in a study of idelalisib plus bendamustine and rituximab. Patients receiving idelalisib have also reported other severe or life-threaten ing (grade ≥3) cutaneous reactions, including exfoliative dermatitis, rash, rash erythematous, rash generalized, rash macular, rash maculopapular, rash papular, rash pruritic, exfolia tive rash, and skin disorders. Patients should be monitored for the develop ment of severe cutaneous reactions, and idelalisib should be discontinued if they occur.18 Anaphylaxis. Serious allergic reactions, including anaphylaxis, have been reported in patients tak

ONCOLOGY PRACTICE MANAGEMENT

I December 2014

ing idel alisib. Idelalisib should be permanently discontinued if this occurs, and appropriate supportive measures should be instituted.18 Neutropenia. Across clinical tri als, 31% of patients receiving idel alisib experienced treatment-emer gent grade 3 or 4 neutropenia. Blood counts should be monitored a min imum of every 2 weeks for the first 3 months of therapy and at least weekly in patients whose neutrophil counts are <1.0 Gi/L.18 Embryofetal toxicity. Idelalisib may cause fetal harm when admin istered to a pregnant woman.18 If idelalisib is used during pregnancy, or if a patient becomes pregnant while taking this drug, she should be made aware of the potential hazard to the fetus. While taking idelalis ib, women of reproductive potential should avoid becoming pregnant. Effective contraception can be used during idelalisib treatment and for at least 1 month after the last dose.18

Use in Specific Populations Pregnancy. Idelalisib is a preg nancy category D teratogen and may cause teratogenicity and/or embryo fetal lethality. Women should avoid becoming pregnant while taking idelalisib.18 Nursing mothers. Because many drugs are excreted in human milk and because of the potential for idelalisib- related adverse events in nursing infants from idelalisib, nursing or idel alisib should be discontinued based on the importance of the drug to the mother.18 Pediatric use. The safety and effi cacy of idelalisib in pediatric patients have not been established.18 Geriatric use. In clinical trials of idelalisib for relapsed CLL, relapsed follicular lymphoma, and relapsed SLL, 63% of patients receiving the agent (131 of 208) were aged ≥65

Drug Update

years. No meaningful differences in efficacy were observed among age cohorts.18 When patients aged ≥65 years with relpased CLL were compared with younger patients, older patients had a higher incidence of discontin uation as a result of an adverse reac tion (11% vs 5%), higher incidence of serious adverse events (51% vs 43%), and higher incidence of death (3% vs 0%).18 When patients aged ≥65 years with indolent NHL were compared with younger patients, older patients had a higher incidence of discontin uation as a result of an adverse event (28% vs 20%). In addition, older patients had a higher incidence of serious adverse reactions (64% vs 37%) and a higher incidence of death (11% vs 5%).18 Hepatic impairment. Safety and efficacy data are not available in patients with baseline ALT or AST values greater than 2.5 times the upper limit of normal, or bilirubin values greater than 1.5 times the upper limit of normal. Patients with baseline hepatic impairment should be monitored for signs of idelalisib toxicity.18

Conclusion Idelalisib, the first FDA-approved PI3Kδ inhibitor, is an effective and safe treatment option for patients with relapsed CLL, relapsed follic ular lymphoma, or relapsed SLL.

Based on a significant PFS bene fit, idelalisib joins ibrutinib as an FDA-approved oral agent for use in patients with relapsed CLL. In relapsed follicular lymphoma and relapsed SLL, idelalisib was approved under the accelerated approval pro gram based on ORR data. Clinical trials to collect data verifying the clinical benefit of idelalisib in these 2 indolent lymphomas are under way.20 Additional clinical trials are evaluating the combination of idel alisib plus ofatumumab and idel alisib plus obinutuzumab for the treatment of patients with previ ously untreated CLL. Idelalisib is also being studied in combination with bendamustine and rituximab for the treatment of patients with previously untreated and relapsed hematologic malignancies.20 l

Organization classification of neoplastic diseases of the hematopoietic and lymphoid tissues: report of the Clinical Advisory Committee meeting—Airlie House, Virginia, November 1997. J Clin Oncol. 1999;17:3835-3849. 8. Leukemia & Lymphoma Society. Non-Hodgkin lymphoma: treating specific indolent subtypes. www. lls.org/#/diseaseinformation/lymphoma/nonhodgkin lymphoma/treatment/indolentnhlsubtypes/specific indolentsubtypes/. Accessed September 11, 2014. 9. Leukemia & Lymphoma Society. Treatment for aggres sive NHL subtypes. www.lls.org/#/diseaseinformation/ lymphoma/nonhodgkinlymphoma/treatment/aggressive nhlsubtypes/. Accessed September 11, 2014. 10. Hallek M, Cheson BD, Catovsky D, et al. Guidelines for the diagnosis and treatment of chronic lymphocytic leukemia: a report from the International Workshop on Chronic Lymphocytic Leukemia updat ing the National Cancer Institute–Working Group 1996 guidelines. Blood. 2008;111:5446-5456. Erratum in: Blood. 2008;112:5259. 11. Leukemia & Lymphoma Society. Chronic lym phocytic leukemia: treatment: chemotherapy and drug therapy. www.lls.org/#/diseaseinformation/leukemia/ chroniclymphocyticleukemia/treatment/chemotherapy drugtherapy/. Accessed September 11, 2014. 12. National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®): non-Hodgkin’s lymphomas. Version 4.2014. August 22, 2014. www.nccn.org/ professionals/physician_gls/pdf/nhl.pdf. Accessed October 3, 2014. 13. Gazyva (obinutuzumab) injection [prescribing information]. South San Francisco, CA: Genentech, Inc; June 2014. 14. Imbruvica (ibrutinib) capsules [prescribing infor mation]. Sunnyvale, CA: Pharmacyclics, Inc; July 2014. 15. Arzerra (ofatumumab) injection [prescribing information]. Research Triangle Park, NC: Glaxo SmithKline; April 2014. 16. US Food and Drug Administration. FDA approves Zydelig for three types of blood cancers. Press release. July 23, 2014. www.fda.gov/newsevents/ newsroom/pressannouncements/ucm406387.htm. Accessed September 11, 2014. 17. Furman RR, Sharman JP, Coutre SE, et al. Idelalisib and rituximab in relapsed chronic lympho cytic leukemia. N Engl J Med. 2014;370:997-1007. 18. Zydelig (idelalisib) tablets [prescribing informa tion]. Foster City, CA: Gilead Sciences, Inc; July 2014. 19. Gopal AK, Kahl BS, de Vos S, et al. PI3Kδ inhi bition by idelalisib in patients with relapsed indolent lymphoma. N Engl J Med. 2014;370:1008-1018. 20. ClinicalTrials.gov. Idelalisib. Search results. http:// clinicaltrials.gov/ct2/results?term=idelalisib&Search= Search. Accessed September 11, 2014.

References

1. Leukemia & Lymphoma Society. Chronic lym phocytic leukemia. www.lls.org/#/diseaseinformation/ leukemia/chroniclymphocyticleukemia/. Accessed Sep tember 11, 2014. 2. Leukemia & Lymphoma Society. Chronic lymphocyt ic leukemia: incidence. www.lls.org/#/diseaseinforma tion/leukemia/chroniclymphocyticleukemia/incidence/. Accessed September 11, 2014. 3. Gribben JG. How I treat CLL up front. Blood. 2010; 115:187-197. 4. Leukemia & Lymphoma Society. Chronic lympho cytic leukemia: signs and symptoms. www.lls.org/#/ diseaseinformation/leukemia/chroniclymphocyticleu kemia/signssymptoms/. Accessed September 11, 2014. 5. Cancer.net. Leukemia—chronic lymphocytic— CLL: statistics. Reviewed July 2014. www.cancer. net/cancer-types/leukemia-chronic-lymphocytic-cll/ statistics. Accessed September 11, 2014. 6. Blankart CR, Koch T, Linder R, et al. Cost of illness and economic burden of chronic lymphocytic leukemia. Orphanet J Rare Dis. 2013;8:32. 7. Harris NL, Jaffe ES, Diebold J, et al. World Health

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Drug Coding Supplied by RJ Health Systems

FDA-Approved Medications Used for the Treatment of Melanoma The following sections will assist healthcare professionals and payers by providing appropriate coding and billing information associated with the treatment of melanoma. The following sections include: • Associated ICD-9-CM codes used for the classification of melanoma • Drugs that have been FDA approved in the treatment of melanoma • Drugs that are Compendia-listed for off-label use for melanoma based on clinical studies that suggest benefi cial 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 • Drugs listed in the Compendia section have no FDA-approved uses for melanoma. However, drugs in the FDA-approved section are FDA approved for at least 1 of the melanoma ICD-9-CM codes but may also have Compendia-listed uses as well.

Associated ICD-9-CM codes for the treatment of melanoma: 172

Malignant melanoma of skin Includes: melanocarcinoma melanoma (skin), not otherwise specified melanoma in situ of skin Excludes: s kin of genital organs (184.0-184.9, 187.1-187.9) sites other than skin-code to malignant neoplasm of the site 172.0 Lip Excludes: vermilion border of lip (140.0-140.1, 140.9) 172.1 Eyelid, including canthus 172.2 Ear and external auditory canal Auricle (ear) Auricular canal, external External [acoustic] meatus Pinna 172.3 Other and unspecified parts of the face Cheek (external) Chin Eyebrow Forehead Nose, external Temple 172.4 Scalp and neck 172.5 Trunk, except scrotum Axilla Breast Buttock Groin Perianal skin Perineum Umbilicus Excludes: a nal canal (154.2) anus, not otherwise specified (154.3) scrotum (187.7)

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Drug Coding

172.6 Upper limb, including shoulder Arm Finger Forearm Hand 172.7 Lower limb, including hip Ankle Foot Heel Knee Leg Popliteal area Thigh Toe 172.8 Other specified sites of skin Malignant melanoma of contiguous or overlapping sites of skin whose point of origin cannot be determined 172.9 Melanoma of skin, site unspecified

FDA approved for melanoma

Compendia off-label uses for melanoma

CPT ® administration codes

Generic (brand) name

HCPCS code – code description

aldesleukin (Proleukin)

J9015 – Injection, aldesleukin, per single-use vial

amifostine (Ethyol)

J0207 – Injection, amifostine, 500 mg

√

96374

Bacillus CalmetteGuerin (Tice BCG, TheraCys)

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

√

51720

Bacillus CalmetteGuerin (Tice BCG, TheraCys)

J9031 – BCG (intravesical), per installation

√

51720

Bacillus CalmetteGuerin (BCG Vaccine)

90585 – BCG for tuberculosis, live, for percutaneous use

√

90471, 90472

bleomycin (Blenoxane)

J9040 – Injection, bleomycin sulfate, 15 units

√

96401, 96409

carboplatin (Paraplatin)

J9045 – Injection, carboplatin, 50 mg

√

96409, 96413, 96415

carmustine (BiCNU)

J9050 – Injection, carmustine, 100 mg

√

96413, 96415

cisplatin (Platinol-AQ)

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

√

96409, 96413, 96415

dabrafenib (Tafinlar)

C9399* – Unclassified drugs or biologicals (hospital outpatient use ONLY)

√

N/A

dabrafenib (Tafinlar)

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

√

N/A

ONCOLOGY PRACTICE MANAGEMENT

I December 2014

96409

√

Drug Coding

FDA approved for melanoma

Compendia off-label uses for melanoma

CPT ® administration codes

Generic (brand) name

HCPCS code – code description

dacarbazine (DTIC-Dome)

J9130 – Dacarbazine, 100 mg

dactinomycin (Cosmegen)

J9120 – Injection, dactinomycin, 0.5 mg

√

96409

docetaxel (Taxotere)

J9171 – Injection, docetaxel, 1 mg

√

96413

hydroxyurea (Hydrea)

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

√

N/A

interferon alfa-2b (Intron A)

J9214 – Injection, interferon alfa2b, recombinant, 1 million units

√

96372, 96401

ipilimumab (Yervoy)

J9228 – Injection, ipilimumab, 1 mg

√

96413, 96415

lomustine (CeeNU)

S0178 – Lomustine, oral, 10 mg

√

N/A

melphalan (Alkeran)

J9245 – Injection, melphalan hydrochloride, 50 mg

√

96409, 96413

paclitaxel (Taxol)

J9265 – Injection, paclitaxel, 30 mg (Code deleted effective January 1, 2015; see J9267 for new code)

√

96413, 96415

paclitaxel (Taxol)

J9267 – Injection, paclitaxel, 1 mg (Code effective for Medicare billing January 1, 2015)

√

96413, 96415

peginterferon alfa-2b (Sylatron)

C9399* – Unclassified drugs or biologicals (hospital outpatient use ONLY)

√

96372, 96401

peginterferon alfa-2b (Sylatron)

J9999* – Not otherwise classified, antineoplastic drugs

√

96372, 96401

peginterferon alfa-2b (PegIntron)

J3590* – Unclassified biologics

√

96372

peginterferon alfa-2b (PegIntron)

S0148 – Injection, pegylated interferon alfa-2b, 10 mcg

√

96372

pembrolizumab (Keytruda)

C9399* – Unclassified drugs or biologicals (hospital outpatient use ONLY) (see C9027 for OPPS billing, effective January 1, 2015)

√

96413

pembrolizumab (Keytruda)

C9027 – Injection, pembrolizumab, 1 mg (Code effective for OPPS billing January 1, 2015; see also J9999)

√

96413

pembrolizumab (Keytruda)

J9999* – Not otherwise classified, antineoplastic drugs

√

96413

sargramostim (Leukine)

J2820 – Injection, sargramostim (GM-CSF), 50 mcg

96409, 96413

√

December 2014

96365, 96366, 96372

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Drug Coding

FDA approved for melanoma

Compendia off-label uses for melanoma

CPT ® administration codes

Generic (brand) name

HCPCS code – code description

temozolomide (Temodar)

J8700 – Temozolomide, oral, 5 mg

trametinib (Mekinist)

C9399* – Unclassified drugs or biologicals (hospital outpatient use ONLY)

√

N/A

trametinib (Mekinist)

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

√

N/A

vemurafenib (Zelboraf)

C9399* – Unclassified drugs or biologicals (hospital outpatient use ONLY)

√

N/A

vemurafenib (Zelboraf)

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

√

N/A

vinBLAStine (Velban)

J9360 – Injection, vinblastine sulfate, 1 mg

√

96409

vinCRIStine (Vincasar PFS)

J9370 – Vincristine sulfate, 1 mg

√

96409

√

N/A

*When billing a nonclassified medication using a CMS 1500 claim form, you must include both the HCPCS code (eg, J8999 Zelboraf) in Item 24D and the drug name, strength, and NDC (National Drug Code) in Item 19 or Item 24A (shaded area) in order to ensure appropriate reimbursement. Please note: Check with payer regarding correct placement of medication information. References • HCPCS Level II Expert 2014 • Current Procedural Terminology (CPT ®) 2014 • CPT copyright 2014 American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association • ICD-9-CM for Professionals Volumes 1 & 2, 2014 • FDA-approved indication (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) GM-CSF indicates granulocyte macrophage colony-stimulating factor; OPPS, Outpatient Prospective Payment System.

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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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