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OCTOBER 2013

www.OncPracticeManagement.com

VOLUME 3 • NUMBER 6

Oncology Practice Management ™

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

Your Practice Management Software Is Only as Good as Your Practice Management By Mary Pat Whaley, FACMPE, CPC

A

colleague of mine has been part of a well-known practice management/ electronic medical record (EMR) company’s software support team for 10 years. She often tries to steer Mary Pat Whaley, FACMPE, CPC people to me when she cannot solve a client’s problems with a software solution. Even though she was once a practice administrator herself, she is a software support person now and the problems she sends to me cannot be solved with

Getting the Most Value from Manufacturer-Sponsored Reimbursement Support By Rhonda Greenapple, CEO, Reimbursement Intelligence

O

ne of the most vital roles of the oncology practice manager and financial assistance staff is managing patient affordability issues for oncologic therapies. Preventing patient sticker shock is essential to avoiding any disruption of therapy and the imposition of addi-

tional emotional burden on the patient and family. Unfortunately, studies show that acute sticker shock—manifesting as prescription abandonment or failure to fulfill a prescription—is increasingly common among patients who are prescribed expensive oral oncolytics, where copays Continued on page 12

Deadline for Approving SGR Reform Legislation Fast Approaching By Rosemary Frei, MSc

M

aybe it will really happen this time—but it’s best not to hold your breath. The December 31 deadline is rapidly approaching for the repeal of Medicare’s sustainable growth rate (SGR) formula

and avoiding an automatic 24.4% acrossthe-board reduction in physician payments in 2014. Legislators and physicians, including oncologists, are working at an increasingly fevered pace to set the groundwork for a fair and quality-based Continued on page 19

Continued on page 10 From the publishers of

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of n it o s D ia ter VI ssocCen the O Ar d 7 PR y thence ace ?…3 a F ” D N ou bity C ocs c Fix A y T t to munve D“Do N h m a st TIE roug Co H La A B

INTEGRATING ONCOLOGISTS, PAYERS, AND THE ENTIRE CANCER CARE TEAM

©2013 Engage Healthcare Communications, LLC

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A Critical Connection Between B-Cell Signaling and the Tumor Microenvironment* Until recently, research of B-cell malignancies has been focused primarily on the B cell itself.1 However, new insights have revealed that there are important interactions between the B cell and the extracellular microenvironment that are dependent on intracellular signaling pathways mediated by various kinases including Bruton’s tyrosine kinase (BTK).2,3 These interactions suggest an important role in B-cell homing, adhesion, and migration.4,5 Further elucidation of these processes could change how we view and approach B-cell malignancies.

BTK signaling pathways and the microenvironment*† FDC BCR TLR T cell MyD88

BTK

Lyn

CXCR4/5 PI3K

MSC

PIP3

Syk

BTK

G G

Nucleus

PLCγ2

B cell

BTK

DAG NF-κB

IP3

PKC Ca2+

*

Based on in vitro data. Illustrations not to scale.

Pharmacyclics, Inc., and Janssen Biotech, Inc., are currently investigating BTK in search of insights that could improve the lives of patients with B-cell malignancies. Visit us at www.BCellSignals.com.


BCR

CD79A CD79B

Prosurvival Signals Lyn

Syk

BTK PLCγ2

Nucleus

Normal and malignant B cells rely on multiple prosurvival pathways to avoid apoptosis.6-9 In B-cell malignancies, microenvironmental cues may inappropriately initiate signaling cascades through several kinases, including BTK, driving uncontrolled growth and survival of malignant B cells.5,10-13

NF-κB

B-Cell Homing Cells in the microenvironment secrete chemoattractant factors to promote the homing of B cells to lymphoid tissue.14 These factors act via signaling pathways involving BTK and other kinases.4,15

VCAM-1

Adhesion and Migration

VLA-4

The upregulation and increased migration of B cells may lead to retention of malignant cells in proliferative environments and the promotion of chemoresistance.16-18 BTK is an essential mediator of multiple adhesion and migration processes.4

References: 1. Burger JA. Nurture versus nature: the microenvironment in chronic lymphocytic leukemia. Hematology Am Soc Hematol Educ Program. 2011;2011:96-103. 2. Kil LP, de Bruijn MJW, van Hulst JA, Langerak AW, Yuvaraj S, Hendriks RW. Bruton’s tyrosine kinase mediated signaling enhances leukemogenesis in a mouse model for chronic lymphocytic leukemia. Am J Blood Res. 2013;3:71-83. 3. Pighi C, Gu T-L, Dalai I, et al. Phospho-proteomic analysis of mantle cell lymphoma cells suggests a pro-survival role of B-cell receptor signaling. Cell Oncol (Dordr). 2011;34:141-153. 4. de Gorter DJJ, Beuling EA, Kersseboom R, et al. Bruton’s tyrosine kinase and phospholipase C2 mediate chemokine-controlled B cell migration and homing. Immunity. 2007;26:93-104. 5. Burger JA, Ghia P, Rosenwald A, Caligaris-Cappio F. The microenvironment in mature B-cell malignancies: a target for new treatment strategies. Blood. 2009;114:3367-3375. 6. Woyach JA, Johnson AJ, Byrd JC. The B-cell receptor signaling pathway as a therapeutic target in CLL. Blood. 2012;120:1175-1184. 7. Rauch M, Tussiwand R, Bosco N, Rolink AG. Crucial role for BAFF-BAFF-R signaling in the survival and maintenance of mature B cells. PLoS One. 2009;4:e5456. 8. Gerondakis S, Grumont RJ, Banerjee A. Regulating B-cell activation and survival in response to TLR signals. Immunol Cell Biol. 2007;85:471-475. 9. Grumont RJ, Rourke IJ, O’Reilly LA, et al. B lymphocytes differentially use the Rel and nuclear factor B1 (NF-B1) transcription factors to regulate cell cycle progression and apoptosis in quiescent and mitogen-activated cells. J Exp Med. 1998;187:663-674. 10. Nishio M, Endo T, Tsukada N, et al. Nurselike cells express BAFF and APRIL, which can promote survival of chronic lymphocytic leukemia cells via a paracrine pathway distinct from that of SDF-1. Blood. 2005;106:1012-1020. 11. Wiestner A. Emerging role of kinase-targeted strategies in chronic lymphocytic leukemia. Blood. 2012;120:4684-4691. 12. Herishanu Y, Pérez-Galán P, Liu D, et al. The lymph node microenvironment promotes B-cell receptor signaling, NF-B activation, and tumor proliferation in chronic lymphocytic leukemia. Blood. 2011;117:563-574. 13. Davis RE, Ngo VN, Lenz G, et al. Chronic active B-cell-receptor signalling in diffuse large B-cell lymphoma. Nature. 2010;463:88-92. 14. Okada T, Ngo VN, Ekland EH, et al. Chemokine requirements for B cell entry to lymph nodes and Peyer’s patches. J Exp Med. 2002;196:65-75. 15. Burger JA, Burger M, Kipps TJ. Chronic lymphocytic leukemia B cells express functional CXCR4 chemokine receptors that mediate spontaneous migration beneath bone marrow stromal cells. Blood. 1999;94:3658-3667. 16. Kurtova AV, Tamayo AT, Ford RJ, Burger JA. Mantle cell lymphoma cells express high levels of CXCR4, CXCR5, and VLA-4 (CD49d): importance for interactions with the stromal microenvironment and specific targeting. Blood. 2009;113:4604-4613. 17. Binsky I, Lantner F, Grabovsky V, et al. TAp63 regulates VLA-4 expression and chronic lymphocytic leukemia cell migration to the bone marrow in a CD74-dependent manner. J Immunol. 2010;184:4761-4769. 18. Kurtova AV, Balakrishnan K, Chen R, et al. Diverse marrow stromal cells protect CLL cells from spontaneous and drug-induced apoptosis: development of a reliable and reproducible system to assess stromal cell adhesion-mediated drug resistance. Blood. 2009;114:4441-4450.

© Pharmacyclics, Inc. 2013 © Janssen Biotech, Inc. 2013 04/13 K08BR13002


In This Issue

PUBLISHING STAFF Senior Vice President/Group Publisher Nicholas Englezos nick@engagehc.com Vice President, Director of Sales & Marketing Joe Chanley joe@engagehc.com Publisher Cristopher Pires cris@engagehc.com Director, Client Services Lou Lesperance lou@engagehc.com Editorial Director Dalia Buffery dalia@engagehc.com Managing Editor Lisa Neuman lneuman@the-lynx-group.com Associate Editor Lara J. Lorton Editorial Assistants Jennifer Brandt Cara Guglielmon Production Manager Marie RS Borrelli The Lynx Group President/CEO Brian Tyburski Chief Operating Officer Pam Rattananont Ferris Vice President of Finance Andrea Kelly Director, Human Resources Blanche Marchitto Associate Editorial Director, Projects Division Terri Moore Director, Quality Control Barbara Marino Quality Control Assistant Theresa Salerno

FEATURES

Practice Management Your Practice Management Software Is Only as Good as Your Practice Management......................................................................................1 By Mary Pat Whaley, FACMPE, CPC

Reimbursement Getting the Most Value from Manufacturer-Sponsored Reimbursement Support.....................................................................................1 By Rhonda Greenapple

Legislation Deadline for Approving SGR Reform Legislation Fast Approaching...............1

COLUMN

From the Editor More than Leaves Are Dropping in the Fall—Are You Affected......................6 By Dawn Holcombe, MBA, FACMPE, ACHE

CONFERENCE COVERAGE

2013 Innovator Awards Shine “Spotlight on Success” at National Oncology Conference..........................................................................................23

DEPARTMENTS

FDA News FDA approval information for Xofigo, Tarceva, Kadcyla for injection, Pomalyst capsules, and more............................................................................25 Drug Coding FDA-Approved Medications Used for the Treatment of Breast Cancer..... 30 Patient and Provider Access

Brought to you by the Association of Community Cancer Centers

Have Docs Faced the Last “Doc Fix?”…........................................................…37 By Sydney Abbott, JD

Planning Ahead in Practice Management Find meetings and seminars to advance your skills and expertise..................38

Director, Production & Manufacturing Alaina Pede Director, Creative & Design Robyn Jacobs Creative & Design Assistant Lora LaRocca Director, Digital Media Anthony Romano Web Content Managers David Maldonado Anthony Travean Digital Programmer Michael Amundsen Senior Project Manager Andrea Boylston Project Coordinators Deanna Martinez Jackie Luma Executive Administrator Rachael Baranoski Office Coordinator Robert Sorensen Engage Healthcare Communications 1249 South River Road - Ste 202A Cranbury, NJ 08512 phone: 732-992-1880 fax: 732-992-1881

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

Oncology Practice Management™, ISSN 2164-4403 (print), is published 8 times a year by Engage Healthcare Communications, LLC, 1249 South River Road, Suite 202A, Cranbury, NJ 08512. Copyright © 2013 by Engage Healthcare Communications, LLC. All rights reserved. Oncology Practice Management™ is a registered trademark of Engage Healthcare Communications, LLC. No part of this publication may be reproduced or transmitted in any form or by any means now or hereafter known, electronic or mechanical, including photocopy, recording, or any informational storage and retrieval system, without written permission from the publisher. Printed in the United States of America. The ideas and opinions expressed in Oncology Practice Management™ do not necessarily reflect those of the editorial board, the editors, or the publisher. Publication of an advertisement or other product mentioned in Oncology Practice Management ™ should not be construed as an endorsement of the product or the manufacturer’s claims. Readers are encouraged to contact the manufacturers about any features or limitations of products mentioned. Neither the editors nor the publisher assume any responsibility for any injury and/or damage to persons or property arising out of or related to any use of the material mentioned in this publication. Postmaster: Correspondence regarding subscriptions or change of address should be directed to CIRCULATION DIRECTOR, Oncology Practice Management™, 1249 South River Road, Suite 202A, Cranbury, NJ 08512. Fax: 732-992-1881. Yearly subscription rates: 1 year: $99.00 USD; 2 years: $149.00 USD; 3 years: $199.00 USD.

ONCOLOGY PRACTICE MANAGEMENT

I October 2013


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


From the Editor

More than Leaves Are Dropping in the Fall—Are You Affected? By Dawn Holcombe, MBA, FACMPE, ACHE

I

n New England, Oc­t­ ober is prime leaf season. I was looking forward to that when I recently relocated to Connecticut from Florida, jumping back into consulting full bore. The first headline from the Hartford Business Journal that greeted me on my return was “United Healthcare drops thousands of CT Medicare Advantage docs.”1 The actual count was 2250; United claims that these physicians amounted to approximately 19% of their total physician network in Connecticut. The letters that were received by the physicians being let go noted that the cuts were being done “without cause,” and that United was “building a network of healthcare providers that we can collaborate with more closely to have the most positive impact on the quality of care for our members. This will encourage better health outcomes and ultimately lower costs.” This was matched with a recent headline out of Tennessee, report-

ed on local NBC affiliate WCYB, “Wellmont [Health System] drops some United Healthcare

Advantage plans as of January 2013.3 Headlines about dropped plans and dropped providers are likely to only increase as we move into 2014.

Patients who do not like the benefits packages presented by Medicare Advantage plans, experience restrictions, or encounter difficulties…have 2 very powerful tools at their disposal—they can walk or they can talk.

What’s at Stake for Medicare Advantage? The stakes are rising in the Medicare Advantage world. The Centers for Medicare & Medicaid Services (CMS) rates Medicare Advantage contractors using a complex system of measures that results in a ranking of up to 5 stars. There is big money attached to each star and half star. How much money varies each year, and in 2014 payments will drop to Medicare Advantage plans that do not achieve high enough ratings. The implementation process of these star ratings is an important driver of some of these market changes: • Beginning in 2012, a bonus payment was introduced for plans with 4 or more stars. The bonus payments have increased each year, and in 2014 Medicare

Medicare Plans.”2 The hospital system was dropping 4 United Medicare Advantage Plans. In the summer of 2012, the Texas Medical Association reported that Humana dropped about 200 physicians in Texas from their Medicare

Editorial Advisory Board

Editor-in-Chief Dawn Holcombe, MBA, FACMPE, ACHE President DGH Consulting South Windsor, CT Ronald Barkley, MS, JD President Cancer Center Business Development Group Bedford, NH Peggy Barton, RN Practice Manager Toledo Clinic, OH

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Continued on page 8

Risë Marie Cleland President Oplinc, Inc Portland, OR Craig K. Deligdish, MD Hematologist/Oncologist Oncology Resource Networks Orlando, FL Patrick A. Grusenmeyer, ScD, FACHE President Christiana Care Health Initiatives Newark, DE Teri U. Guidi, MBA, FAAMA President & CEO Oncology Management Consulting Group Pipersville, PA

ONCOLOGY PRACTICE MANAGEMENT

I October 2013

Marianna Lamb, MS Exceutive Director Medical Oncology Association of Southern California Upland, CA Ruth Linné Lander, FACMPE Practice Administrator Columbus Oncology & Hematology Associates, Inc Columbus, OH Bonnie J. Miller, RN, BSN, OCN, FAAMA Administrative Director Women’s Cancer Center Fox Chase Cancer Center Philadelphia, PA

Robert D. Orzechowski, MBA, SPHR CEO Lancaster Cancer Center Ltd. Lancaster, PA Karna W. Morrow, CPC, RCC, CCS-P, PCS Senior Consultant CSI Coding Strategies, Inc Powder Springs, GA Mary Pat Whaley, FACMPE, CPC Physician Advocate www.managemypractice.com Durham, North Carolina Carla C. Wood Balch, CPC, MS President Altos Solutions, Inc Los Altos, CA


Call for submissions

?

Do you have a practice management solution to share

In your background as an oncology practice manager, it’s likely there’s one business experience—and maybe more—that practice managers across the country would want to read about.

High-interest topics include: the solution you found to a practice management challenge, reimbursement, your experience with EMR, Medicare audits, a memorable encounter that shaped the way you now run your business and/or practice medicine, or how you successfully integrated ancillary products and services into your practice as a revenue generator.

Send us your ideas! Submit a 1000- to 2000-word original article, previously unpublished and submitted exclusively to Oncology Practice Management, that your fellow practice managers will want to read.

Submit to: Lisa Neuman, Managing Editor E-Mail: lneuman@the-lynx-group.com OPM_73113


From the Editor

More than Leaves Are Dropping in the Fall…Continued from page 6 Advantage plans with more than 4 stars in the rating system can achieve a 5% bonus payment. • Rebates are also critical. Each year, Medicare Advantage plans bid to CMS for their costs to provide care in a given county. If the bid is below the county benchmark set by CMS, the plan also receives a rebate, which is a percentage of the savings off the benchmark. Depending on the star ratings, Medicare Advantage plans can receive rebates of 50% to 70% in 2014 in addition to the bonus payments achieved for higher star ratings. Costs of care delivered affect the ability of a Medicare Advantage plan to successfully bid under the county benchmarks, which is why these plans will be focusing more and more on cost containment, and even risk-based programs. However, there is a catch-22 for these plans. CMS has assigned the highest weight in the ratings process to outcomes, intermediate outcomes measures, patient experience/complaints, and then access measures. Patients who do not like the benefits packages presented by Medicare Advantage plans, experience re­ strictions in access, or encounter difficulties in working with their plan have 2 very powerful tools at their disposal—they can walk or they can talk. Neither is good for the Medicare Advantage plan. Each year, every patient enrolled in a Medicare Advantage plan has the ability to change plans; in 2013, that time period is from October 15 through December 7. When plans announce significant cuts in their physician panels just before the Medicare open enrollment period, they are taking a huge risk that patients will choose to remain with the plan rather than

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switch to another plan in which their doctor participates. Or, this could be part of a master plan to achieve a different patient mix, if physician panel cuts by Medicare Advantage plans lead to an exodus of members with costly or chronic disease who wish to stick with their physician. Ultimately, the plan could achieve a patient mix with more new enrollees who may have a less costly medical profile. Massive cuts in physician panels by plans, whether for public or private insurance, can also be part of a cost-cutting maneuver to encourage provider groups to offer cost savings and rate reductions to get back on the participating provider list. What does this mean for you? First, consider your strengths and vulnerabilities. Are you the only provider of your services in the area, or one of many? What does your “cost profile” look like to the plans with which you are contracted? Consider the Medicare Ad­ vantage plan strengths and vulnerabilities. What is happening with Medicare Advantage plans in your area? Are they encouraging primary care physicians or even specialists to accept risk contracts? What are their star ratings? Do you know the measures upon which these plans are being evaluated and how each of them stacks up against the others in your market? Understand clearly what you can and cannot do regarding Medicare open enrollment. Providers cannot recommend one plan versus another, but you can provide information to your patients and in your community about patient choices and resources. Patient complaints to CMS regarding access and choice of physician, as well as the volume of patients choosing to leave any one plan are very powerful and directly affect a Medicare Advantage plan’s star ratings.

ONCOLOGY PRACTICE MANAGEMENT

I October 2013

As we move into 2014, the number of Medicare Advantage plans is projected to decrease as plans with low star ratings find it more challenging to stay open. It is important for healthcare providers to know that these plans are driven by cost against benchmarks, and that even small percentage variations in dollars spent and patient satisfaction, in addition to performance on quality and outcomes measures, can lead to significant revenue impact for Medicare Advantage plans. We never used to worry much about the revenue profiles of insurance plans, but now those variations can directly affect our patient base, contract participation, and our own revenue streams. So, whether you get dropped or you are the dropper in this new game of health insurance, the more you understand the environment and goals of the Medicare Advantage insurers in your own area the better equipped you will be to react. Remember also that patient voices are increasingly important. Sometimes patients may need some help in understanding how to make their voices heard. Too often in the past, patient concerns had less sway when sweeping insurance changes were made. One advantage of the new CMS star ratings is that patients can indeed hit plans right in the pocketbook when the plans make sweeping changes that adversely affect patients—merely by making their voices heard and voting with their feet by exercising their option to leave the plans. l

References

1. United Healthcare drops thousands of CT Medicare Advantage docs. October 9, 2013. http:// www.hartfordbusiness.com/article/20131009/ NEWS01/131009898. Accessed October 14, 2013. 2. Wellmont drops some United Healthcare Medicare Plans. September 6, 2013. http://www. wcyb.com/news/wellmont-drops-united-healthcare/-/14590844/21814200/-/urj6ci/-/index.html. Accessed October 13, 2013. 3. Texas Medical Association. Humana Drops Medicare Advantage Physicians. June 15, 2012.


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Practice Management

Your Practice Management Software…Continued from page 1 software. “Mary Pat,” she asks me, “Why do they think I can solve their practice management issues? All I am empowered to do is to help them use the software.” Earlier in my career (before EMR) I heard someone call “practice management” software “billing” software and I remember being offended for some reason. I thought “billing” was such a narrow description of what practice management software did— but they were right. That software is meant to deal with everything billing. It all comes down to billing—whether it is the actual billing/ claims management itself, running reports to diagnose billing problems, or capturing recalls so patients get reminded to come in for a service and...get billed. Let me be clear that I am not saying that healthcare is all about billing. I am only saying that practice management software was developed to handle the financial side of the house. Practice management software cannot “do” practice management. It cannot figure out your workflow so you capture data in the most efficient way, and it cannot analyze your reports and tell you what to change to increase efficiency or decrease overhead. It certainly cannot tell you the best way to schedule, or how much to charge your self-pay patients. It is only a billing tool. I have worked in healthcare long enough to have helped practices go from manual billing (you typed or hand-wrote claim information on a 1500 form and mailed it in) to their first practice management system. I did a lot of practice management consulting even though that’s not what I was there to do. I had to get them in shape on paper so they could handle the software. I had to get their workflow optimized so the software would make

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things better—not worse.

What Your Practice Management Software Can and Cannot Do An implementation of practice management software is not intended to do anything but set up the system and train you to use it. Sometimes that perfectly rosy future the salesperson paints is nothing like

Practice management software cannot “do” practice management. It cannot figure out your workflow so you capture data in the most efficient way, and it cannot analyze your reports and tell you what to change to increase efficiency or decrease overhead. the painful first steps (and cash flow jam) of a new system. An implementation will not fix the issues that are existing in your practice that have nothing to do with the functionality of your billing system. Your practice management software can: Automate your registration process so patients can register and check-in online, or at a kiosk in the practice. But your practice management software cannot: Train staff to greet patients and make them feel welcome in the practice.

ONCOLOGY PRACTICE MANAGEMENT

I October 2013

Your practice management software can: Check the patient’s eligibility for active insurance coverage. But your practice management software cannot: Automatically choose the correct insurance company/payer to attach to each patient account (one of the biggest problems I hear about in the field!). Your practice management software can: Calculate the days since the patient’s last physical, the days left in a global period, or visits left in annual cap. But your practice management software cannot: Help the patient understand their benefit plans and understand their financial responsibility.

Conclusion Good practice management has a lot to do with attracting, training, coaching, and retaining the right staff, as well as providing them with the tools to do the job you hired them to do. Getting the software right is a must, but don’t expect your software trainers to be able to solve any of your staffing, communication, workflow, or cultural problems. That’s up to you, the practice manager! l Mary Pat Whaley, FACMPE, CPC, is the newest member of the Editorial Advisory Board for Oncology Practice Management. An expert physician advocate and consultant who blogs at Manage My Practice (www.mamagemypractice. com), Ms Whaley hosts her own LinkedIn group by the same name for those interested in healthcare management, and is a regular contributor to Oncology Practice Management’s LinkedIn group. You can contact Ms Whaley at marypat@manage mypractice.com.


Now enrolling Investigating ABT-199 (GDC-0199) in Chronic Lymphocytic Leukemia Phase II Open-Label Study of the Efficacy and Safety of ABT-199 in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia Harboring the 17p Deletion N=100

ABT-199 is an investigational agent that has not been approved by regulatory agencies for the use under investigation in this trial. Primary Endpoint

Secondary Endpoints

• Overall response rate

• • • • • • • •

Complete remission rate Partial remission rate Duration of response Progression-free survival Time to progression Overall survival Percentage of patients who move on to stem-cell transplant Safety and tolerability of ABT-199

Key Inclusion Criteria • Adult patients ≥18 years of age • Diagnosis of CLL that meets 2008 IWCLL NCI-WG criteria (relapsed/refractory after receiving ≥1 prior line of therapy and 17p deletion) • ECOG performance score of ≤2 • Adequate bone marrow function • Adequate coagulation, renal, and hepatic function, per laboratory reference range

NCT#01889186 Reference: ClinicalTrials.gov.

@ 2013 Genentech USA, Inc. All rights reserved. BIO0001961500 Printed in USA.

To learn more about this study, please visit www.ClinicalTrials.gov.


Reimbursement

Getting the Most Value from Manufacturer-…Continued from page 1 can amount to hundreds or even thousands of dollars per prescription.1 Prescription abandonment rates are particularly high among Medicare patients, who comprise approximately 50% of all patients being treated for cancer and whose out-of-pocket burden for medication costs are up to 3 times higher than those of commercially insured patients.2 For practice managers on the front line with patients worried about the affordability of their therapy, this aspect of the practice management role is becoming increasingly burdensome and difficult. In July 2012, Reimbursement Intelligence (RI) surveyed a national sample of oncology practice managers working in medium-to-large oncology practices. The goal of the survey was to identify the impact of patient financial issues in the selection of therapy, and the specific resources that may be needed by practice managers to assist them in managing these patient affordability

issues that are encountered on a day-to-day basis. Almost 70% of the

Practice managers and office financial staff are an essential touch-point for pharmaceutical representatives to provide information about programs and services that are available from the manufacturers to support access to and affordability of their products. practice managers surveyed agreed that a patient’s financial burden

70% of practice managers agree that patient financial burden can impact the choice of therapy 35% 30% 25% 20% 15% 10% 5% 0%

Never

1% to 10% 11% to 21% to 51% to 71% to of the time 20% of the 50% of the 70% of the 100% of time time time the time

Source: Reimbursement Intelligence Oncology RiQ Survey 2012. N=50 oncology practice managers

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ONCOLOGY PRACTICE MANAGEMENT

I October 2013

Manufacturer Reimbursement Services: No “Easy” Button for Practice Managers Although virtually all manufacturers offer and promote the availability of extensive reimbursement support services for oncology practice staff, the RI study showed that practice managers had widely varying experiences with the quality, timeliness, and value of these services. Practice managers, most of whom reported they typically spend 30% to 50% of their time on activities related to obtaining patient reimbursement, place the highest value on services that can save them time and actually streamline the process, such as information or assistance with all aspects of precertification or information about the breadth of a company’s offerings for copayment assistance. In actuality, a majority of practice managers reported that manufacturer reimbursement support hotlines or online portals often fall short of expectations. Wrote one practice manager, “Either you can get the forms for the right plans, or they’re not in the format I need to be able to file them online.” Company Continued on page 14

Figure. Impact of acute sticker shock on choice of therapy.

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can impact the choice of therapy (Figure). More than half of the practice managers (52%) said that they have experienced physicians writing 2 or more different prescriptions for a patient, with the final treatment selection made after insurance coverage and out-of-pocket costs have been determined. These findings suggest that practice managers and office financial staff are an essential touch-point for pharmaceutical representatives to provide information about programs and services that are available from the manufacturers to support access to and affordability of their products.


A Global Collaboration dedicated to improving the lives of patients with B-Cell Malignancies

Š Pharmacyclics, Inc. 2013 Š Janssen Biotech, Inc. 2013 08/13 K08BR13002C


Reimbursement

Getting the Most Value from Manufacturer-…Continued from page 12 KEY POINTS • “Sticker shock” is a major contributing factor to drug therapy noncompliance • Prescription abandonment rates are particularly high among Medicare patients • The out-of-pocket burden for oncology medications is up to 3 times higher for Medicare patients than it is for patients with commercial insurance • Practice managers report experiencing physicians writing 2 or more different prescriptions for a patient, with the final treatment selection made after insurance coverage and out-of-pocket costs have been determined • A majority of practice managers report that manufacturer reimbursement support hotlines or online portals sales representatives who call on practice managers and financial assistance staff were described as “well-intentioned” but were not able to provide detailed or accurate information about key reimbursement support services, such as copayment assistance programs for

underinsured patients. Practice managers were sometimes frustrated by their interactions with company support services, and more than half of the practice managers surveyed reported that they had shared negative experiences with a manufacturer’s patient assistance program with a physician or other practice staff.

Manufacturers Striving to Better Support Oncology Office Staff Oncology product manufacturers are becoming increasingly aware of the importance of expedient and effective reimbursement support as a key component of their overall customer service offerings to patients and practices. As a result, manufacturers are investing in research and training to enhance the support capabilities of their field sales representatives as well as the representatives that staff their toll-free assistance hotlines for practice staff. Practice managers can support the manufacturers’ efforts by providing regular feed-

back to company representatives about their reimbursement support needs and wants, as well as share their personal experience with the manufacturers’ support services. When difficult reimbursement situations are encountered, practice managers should ask for support from a manufacturer’s reimbursement specialist, who is specifically trained in resolving problems and expediting support. By becoming vocal self-advocates for their professional needs—and for the needs of patients—practice managers can better access optimal support from pharmaceutical manufacturers. l

About the Author Rhonda Greenapple is the founder and CEO of Reimbursement Intelligence, a research and consulting firm based in Madison, New Jersey. References

1. Streeter SB, Schwartzberg L, Husain N, Johnsrud M. Patient and plan characteristics affecting abandonment of oral oncolytic prescriptions. Am J Manag Care. 2011;17(Suppl 5):38-44. 2. Clinical Oncology News. http://www.clinicalon cology.com/ViewArticle.aspx?d=Solid+Tumors&d_ id=148&i=April+2011&i_id=720&a_id=16928. Accessed July 10, 2013.

CALL FOR SUBMISSIONS! Do you have a practice management solution to share? An answer to a problem with reimbursement, EMR implementation, medicare audits, or navigating the rules of the ACA? SEND US YOUR SOLUTION! Submit a 1,000-2,000 word original, previously unpublished article to Lisa Neuman, Managing Editor, at lneuman@the-lynx-group.com 14

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SHOULDN’T A PATIENT SUPPORT PROGRAM BE EASY TO NAVIGATE?

•REIMBURSEMENT SERVICES

•EDUCATIONAND SUPPORT SERVICES

•BENEFIT VERIFICATIONS

•PATIENT ASSISTANCE

•DELIVERY COORDINATION

•CO-PAY ASSISTANCE

An uncommon condition requires a common solution— IncyteCARES IncyteCARES helps connect your patients with intermediate or high-risk myelofibrosis (MF), who qualify for the program, to ongoing support and resources during their treatment with Jakafi® (ruxolitinib). Indications and Usage Jakafi is indicated for treatment of patients with intermediate or high-risk MF, including primary MF, post–polycythemia vera MF and post–essential thrombocythemia MF. Important Safety Information

•Treatment with Jakafi can cause thrombocytopenia, anemia and neutropenia, which are

each dose-related effects, with the most frequent being thrombocytopenia and anemia •Monitor CBCs, and in patients with cytopenias, consider dose reductions, temporarily withholding Jakafi, or transfusions, as clinically indicated PleaseseeadditionalImportantSafetyInformationandtheBriefSummaryofFull Prescribing Information within this ad.


HELPING PATIENTS RECEIVING JAKAFI (ruxolitinib) STAY CONNECTED TO CARE ®

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

IncyteCARESHELPSPEOPLEBEINGTREATEDWITHJAKAFI ACCESS AND REIMBURSEMENT SERVICES

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

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

PATIENT EDUCATION AND SUPPORT

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

•

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


IncyteCARES: ASSISTING PROVIDERS AND PATIENTS INOBTAININGACCESSTOJAKAFI Enrollment sent to

95% of patients had insurance coverage for

Patients without insurance coverage were screened for patient assistance eligibility

94% of prior authorizations were approved for

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

Information is basedupon1421 patients enrolled in IncyteCARES betweenApril1,2012 andApril1,2013.

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

•Risk of Infection: Assess patients for signs and symptoms of infection and initiate

appropriate treatment promptly. Serious infections should have resolved before starting therapy with Jakafi •The three most frequent non-hematologic adverse reactions were bruising, dizziness and headache PleaseseeadditionalImportantSafetyInformationandtheBriefSummaryofFull Prescribing Information within this ad. Jakafi is a registered trademark of Incyte Corporation. © 2013, Incyte Corporation. All rights reserved. RUX-1227f 07/13


Table 2: Worst Hematology Laboratory Abnormalities in the Placebo-controlled Studya Jakafi Placebo (N=155) (N=151) Laboratory All All b Grade 3 Grade 4 Grades Grade 3 Parameter Grades BRIEF SUMMARY: For Full Prescribing Information, see package insert. (%) (%) (%) (%) (%) INDICATIONS AND USAGE Jakafi is indicated for treatment of patients with intermediate or high-risk Thrombocytopenia 69.7 9.0 3.9 30.5 1.3 myelofibrosis, including primary myelofibrosis, post-polycythemia vera myelofibrosis and post-essential Anemia 96.1 34.2 11.0 86.8 15.9 thrombocythemia myelofibrosis. Neutropenia 18.7 5.2 1.9 4.0 0.7 CONTRAINDICATIONS None.

WARNINGS AND PRECAUTIONS Thrombocytopenia, Anemia and Neutropenia Treatment with Jakafi can cause thrombocytopenia, anemia and neutropenia. [see Dosage and Administration (2.1) in Full Prescribing Information]. Thrombocytopenia was generally reversible and was usually managed by reducing the dose or temporarily interrupting Jakafi. Platelet transfusions may be necessary [see Dosage and Administration (2.2) in Full Prescribing Information, and Adverse Reactions]. Patients developing anemia may require blood transfusions and/or dose modifications of Jakafi. Severe neutropenia (ANC less than 0.5 X 109/L) was generally reversible. Withhold Jakafi until recovery [see Adverse Reactions]. Perform a pretreatment complete blood count (CBC) and monitor CBCs every 2 to 4 weeks until doses are stabilized, and then as clinically indicated [see Dosage and Administration (2.2) in Full Prescribing Information, and Adverse Reactions]. Risk of Infection Serious bacterial, mycobacterial, fungal and viral infections may occur. Active serious infections should have resolved before starting therapy with Jakafi. Observe patients receiving Jakafi for signs and symptoms of infection and initiate appropriate treatment promptly. PML Progressive multifocal leukoencephalopathy (PML) has been reported with ruxolitinib treatment for myelofibrosis. If PML is suspected, stop Jakafi and evaluate. Herpes Zoster Advise patients about early signs and symptoms of herpes zoster and to seek treatment as early as possible if suspected [see Adverse Reactions]. ADVERSE REACTIONS The following serious adverse reactions are discussed in greater detail in other sections of the labeling: • Myelosuppression [see Warnings and Precautions]; • Risk of Infection [see Warnings and Precautions] Clinical Trials 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. The safety of Jakafi was assessed in 617 patients in six clinical studies with a median duration of follow-up of 10.9 months, including 301 patients with myelofibrosis in two Phase 3 studies. In these two Phase 3 studies, patients had a median duration of exposure to Jakafi of 9.5 months (range 0.5 to 17 months), with 88.7% of patients treated for more than 6 months and 24.6% treated for more than 12 months. One hundred and eleven (111) patients started treatment at 15 mg twice daily and 190 patients started at 20 mg twice daily. In a double-blind, randomized, placebo-controlled study of Jakafi, 155 patients were treated with Jakafi. The most frequent adverse drug reactions were thrombocytopenia and anemia [see Table 2]. Thrombocytopenia, anemia and neutropenia are dose related effects. The three most frequent non-hematologic adverse reactions were bruising, dizziness and headache [see Table 1]. Discontinuation for adverse events, regardless of causality, was observed in 11.0% of patients treated with Jakafi and 10.6% of patients treated with placebo. Following interruption or discontinuation of Jakafi, symptoms of myelofibrosis generally return to pretreatment levels over a period of approximately 1 week. There have been isolated cases of patients discontinuing Jakafi during acute intercurrent illnesses after which the patient’s clinical course continued to worsen; however, it has not been established whether discontinuation of therapy contributed to the clinical course in these patients. When discontinuing therapy for reasons other than thrombocytopenia, gradual tapering of the dose of Jakafi may be considered [see Dosage and Administration (2.9) in Full Prescribing Information]. Table 1 presents the most common adverse reactions occurring in patients who received Jakafi in the double-blind, placebo-controlled study during randomized treatment. Table 1: Adverse Reactions Occurring in Patients on Jakafi in the Double-blind, Placebo-controlled Study During Randomized Treatment Jakafi Placebo (N=155) (N=151) Adverse All All Grade 3 Grade 4 Grades Grade 3 Grade 4 Reactions Gradesa (%) (%) (%) (%) (%) (%) Bruisingb 23.2 0.6 0 14.6 0 0 Dizzinessc 18.1 0.6 0 7.3 0 0 Headache 14.8 0 0 5.3 0 0 Urinary Tract Infectionsd 9.0 0 0 5.3 0.7 0.7 Weight Gaine 7.1 0.6 0 1.3 0.7 0 Flatulence 5.2 0 0 0.7 0 0 Herpes Zosterf 1.9 0 0 0.7 0 0 a National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), version 3.0 b includes contusion, ecchymosis, hematoma, injection site hematoma, periorbital hematoma, vessel puncture site hematoma, increased tendency to bruise, petechiae, purpura c includes dizziness, postural dizziness, vertigo, balance disorder, Meniere’s Disease, labyrinthitis d includes urinary tract infection, cystitis, urosepsis, urinary tract infection bacterial, kidney infection, pyuria, bacteria urine, bacteria urine identified, nitrite urine present e includes weight increased, abnormal weight gain f includes herpes zoster and post-herpetic neuralgia

Description of Selected Adverse Drug Reactions Anemia In the two Phase 3 clinical studies, median time to onset of first CTCAE Grade 2 or higher anemia was approximately 6 weeks. One patient (0.3%) discontinued treatment because of anemia. In patients receiving Jakafi, mean decreases in hemoglobin reached a nadir of approximately 1.5 to 2.0 g/dL below baseline after 8 to 12 weeks of therapy and then gradually recovered to reach a new steady state that was approximately 1.0 g/dL below baseline. This pattern was observed in patients regardless of whether they had received transfusions during therapy. In the randomized, placebo-controlled study, 60% of patients treated with Jakafi and 38% of patients receiving placebo received red blood cell transfusions during randomized treatment. Among transfused patients, the median number of units transfused per month was 1.2 in patients treated with Jakafi and 1.7 in placebo treated patients. Thrombocytopenia In the two Phase 3 clinical studies, in patients who developed Grade 3 or 4 thrombocytopenia, the median time to onset was approximately 8 weeks. Thrombocytopenia was generally reversible with dose reduction or dose interruption. The median time to recovery of platelet counts above 50 X 109/L was 14 days. Platelet transfusions were administered to 4.7% of patients receiving Jakafi and to 4.0% of patients receiving control regimens. Discontinuation of treatment because of thrombocytopenia occurred in 0.7% of patients receiving Jakafi and 0.9% of patients receiving control regimens. Patients with a platelet count of 100 X 109/L to 200 X 109/L before starting Jakafi had a higher frequency of Grade 3 or 4 thrombocytopenia compared to patients with a platelet count greater than 200 X 109/L (16.5% versus 7.2%). Neutropenia In the two Phase 3 clinical studies, 1.0% of patients reduced or stopped Jakafi because of neutropenia. Table 2 provides the frequency and severity of clinical hematology abnormalities reported for patients receiving treatment with Jakafi or placebo in the placebo-controlled study.

Grade 4 (%) 0 3.3 1.3

a Presented values are worst Grade values regardless of baseline b National Cancer Institute Common Terminology Criteria for Adverse Events, version 3.0

Additional Data from the Placebo-controlled Study 25.2% of patients treated with Jakafi and 7.3% of patients treated with placebo developed newly occurring or worsening Grade 1 abnormalities in alanine transaminase (ALT). The incidence of greater than or equal to Grade 2 elevations was 1.9% for Jakafi with 1.3% Grade 3 and no Grade 4 ALT elevations. 17.4% of patients treated with Jakafi and 6.0% of patients treated with placebo developed newly occurring or worsening Grade 1 abnormalities in aspartate transaminase (AST). The incidence of Grade 2 AST elevations was 0.6% for Jakafi with no Grade 3 or 4 AST elevations. 16.8% of patients treated with Jakafi and 0.7% of patients treated with placebo developed newly occurring or worsening Grade 1 elevations in cholesterol. The incidence of Grade 2 cholesterol elevations was 0.6% for Jakafi with no Grade 3 or 4 cholesterol elevations. DRUG INTERACTIONS Drugs That Inhibit or Induce Cytochrome P450 Enzymes Ruxolitinib is predominantly metabolized by CYP3A4. Strong CYP3A4 inhibitors: The Cmax and AUC of ruxolitinib increased 33% and 91%, respectively, with Jakafi administration (10 mg single dose) following ketoconazole 200 mg twice daily for four days, compared to receiving Jakafi alone in healthy subjects. The half-life was also prolonged from 3.7 to 6.0 hours with concurrent use of ketoconazole. The change in the pharmacodynamic marker, pSTAT3 inhibition, was consistent with the corresponding ruxolitinib AUC following concurrent administration with ketoconazole. When administering Jakafi with strong CYP3A4 inhibitors a dose reduction is recommended [see Dosage and Administration (2.7) in Full Prescribing Information]. Patients should be closely monitored and the dose titrated based on safety and efficacy. Mild or moderate CYP3A4 inhibitors: There was an 8% and 27% increase in the Cmax and AUC of ruxolitinib, respectively, with Jakafi administration (10 mg single dose) following erythromycin, a moderate CYP3A4 inhibitor, at 500 mg twice daily for 4 days, compared to receiving Jakafi alone in healthy subjects. The change in the pharmacodynamic marker, pSTAT3 inhibition was consistent with the corresponding exposure information. No dose adjustment is recommended when Jakafi is coadministered with mild or moderate CYP3A4 inhibitors (eg, erythromycin). CYP3A4 inducers: The Cmax and AUC of ruxolitinib decreased 32% and 61%, respectively, with Jakafi administration (50 mg single dose) following rifampin 600 mg once daily for 10 days, compared to receiving Jakafi alone in healthy subjects. In addition, the relative exposure to ruxolitinib’s active metabolites increased approximately 100%. This increase may partially explain the reported disproportionate 10% reduction in the pharmacodynamic marker pSTAT3 inhibition. No dose adjustment is recommended when Jakafi is coadministered with a CYP3A4 inducer. Patients should be closely monitored and the dose titrated based on safety and efficacy. USE IN SPECIFIC POPULATIONS Pregnancy Pregnancy Category C: There are no adequate and well-controlled studies of Jakafi in pregnant women. In embryofetal toxicity studies, treatment with ruxolitinib resulted in an increase in late resorptions and reduced fetal weights at maternally toxic doses. Jakafi should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Ruxolitinib was administered orally to pregnant rats or rabbits during the period of organogenesis, at doses of 15, 30 or 60 mg/kg/day in rats and 10, 30 or 60 mg/kg/day in rabbits. There was no evidence of teratogenicity. However, decreases of approximately 9% in fetal weights were noted in rats at the highest and maternally toxic dose of 60 mg/kg/day. This dose results in an exposure (AUC) that is approximately 2 times the clinical exposure at the maximum recommended dose of 25 mg twice daily. In rabbits, lower fetal weights of approximately 8% and increased late resorptions were noted at the highest and maternally toxic dose of 60 mg/kg/day. This dose is approximately 7% the clinical exposure at the maximum recommended dose. In a pre- and post-natal development study in rats, pregnant animals were dosed with ruxolitinib from implantation through lactation at doses up to 30 mg/kg/day. There were no drug-related adverse findings in pups for fertility indices or for maternal or embryofetal survival, growth and development parameters at the highest dose evaluated (34% the clinical exposure at the maximum recommended dose of 25 mg twice daily). Nursing Mothers It is not known whether ruxolitinib is excreted in human milk. Ruxolitinib and/or its metabolites were excreted in the milk of lactating rats with a concentration that was 13-fold the maternal plasma. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from Jakafi, a decision should be made to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. Pediatric Use The safety and effectiveness of Jakafi in pediatric patients have not been established. Geriatric Use Of the total number of myelofibrosis patients in clinical studies with Jakafi, 51.9% were 65 years of age and older. No overall differences in safety or effectiveness of Jakafi were observed between these patients and younger patients. Renal Impairment The safety and pharmacokinetics of single dose Jakafi (25 mg) were evaluated in a study in healthy subjects [CrCl 72-164 mL/min (N=8)] and in subjects with mild [CrCl 53-83 mL/min (N=8)], moderate [CrCl 38-57 mL/min (N=8)], or severe renal impairment [CrCl 15-51 mL/min (N=8)]. Eight (8) additional subjects with end stage renal disease requiring hemodialysis were also enrolled. The pharmacokinetics of ruxolitinib was similar in subjects with various degrees of renal impairment and in those with normal renal function. However, plasma AUC values of ruxolitinib metabolites increased with increasing severity of renal impairment. This was most marked in the subjects with end stage renal disease requiring hemodialysis. The change in the pharmacodynamic marker, pSTAT3 inhibition, was consistent with the corresponding increase in metabolite exposure. Ruxolitinib is not removed by dialysis; however, the removal of some active metabolites by dialysis cannot be ruled out. When administering Jakafi to patients with moderate (CrCl 30-59 mL/min) or severe renal impairment (CrCl 15-29 mL/min) with a platelet count between 100 X 109/L and 150 X 109/L and patients with end stage renal disease on dialysis a dose reduction is recommended [see Dosage and Administration (2.8) in Full Prescribing Information]. Hepatic Impairment The safety and pharmacokinetics of single dose Jakafi (25 mg) were evaluated in a study in healthy subjects (N=8) and in subjects with mild [Child-Pugh A (N=8)], moderate [Child-Pugh B (N=8)], or severe hepatic impairment [Child-Pugh C (N=8)]. The mean AUC for ruxolitinib was increased by 87%, 28% and 65%, respectively, in patients with mild, moderate and severe hepatic impairment compared to patients with normal hepatic function. The terminal elimination half-life was prolonged in patients with hepatic impairment compared to healthy controls (4.1-5.0 hours versus 2.8 hours). The change in the pharmacodynamic marker, pSTAT3 inhibition, was consistent with the corresponding increase in ruxolitinib exposure except in the severe (Child-Pugh C) hepatic impairment cohort where the pharmacodynamic activity was more prolonged in some subjects than expected based on plasma concentrations of ruxolitinib. When administering Jakafi to patients with any degree of hepatic impairment and with a platelet count between 100 X 109/L and 150 X 109/L, a dose reduction is recommended [see Dosage and Administration (2.8) in Full Prescribing Information]. Jakafi is a registered trademark of Incyte Corporation. All rights reserved. U.S. Patent No. 7,598,257 © 2011-2013 Incyte Corporation. All rights reserved. Issued: June 2013 RUX-1216


Legislation

Deadline for Approving SGR Reform…Continued from page 1 payment system to replace the SGR. A positive sign was the House Energy and Commerce Committee’s unanimous approval in August of the Medicare Patient Access and Quality Improvement Act of 2013, which is meant to replace the SGR formula. The next steps are House of Representatives and then Senate approval of the Act. This would allow for 5 or 10 years of stable Medicare payments starting next year, with reimbursement rates increasing by 0.5% every year. Subsequently, physicians would be able to choose the quality measures to which they will adhere, and have their payments adjusted based on how well they perform on those measures. “We’ve been watching efforts toward SGR reform for almost 10 years now, and every time a deadline has come Congress has just punted it a little farther down the road,” said Jeffery Ward, MD, an oncologist practicing at the Swedish Cancer Institute, Edmonds, Washington, and immediate past chair of the Clinical Practice Committee of the American Society of Clinical Oncology (ASCO). “But the stars seem to be aligning such that reform may take place this time—they’ve actually been working within Congress and back and forth with medical societies and providers since March. So there is a desire and effort by Congress to fix this that we haven’t seen before.” ASCO president Clifford Hudis, MD, is also cautiously optimistic that the SGR reform will move forward and remove the specter hanging over oncologists of a potentially huge income cut. “This appears to be the best chance we’ve had in years to get some agreement and move forward,” Dr Hudis said in a telephone interview with Oncology Practice Management. “But it’s very complex. The legislation has to be approved by both the House

and the Senate, where there are many competing views on it. And it’s also not clear which payment model for replacing fee-for-service is favored

ment to the unwieldiness of finding a replacement that satisfies most stakeholders. Ironically, the very complexity of the reform process may ultimately be an asset in moving the ball through the goalposts this time, Dr Hudis noted. “Because it’s such a very detailed policy, most people in the general public, and even many physicians, don’t completely understand it and so don’t care about it much—which may make it easier for lawmakers to come to agreement and pass the reform legislation,” he said. Indeed, it is hard for anyone but a legal beagle to discern the most relevant details in the draft SGR bill released on May 28, 2013, by the House Committee on Ways and Means’ Subcommittee on Health and the Energy and Commerce Committee. The draft was based on an SGR reform framework released in early February (Overview of SGR Repeal and Reform Proposal. Available at http://waysandmeans. house.gov/uploadedfiles/sgr_reform_ short_summary_2013.pdf). The legislators’ vision is that the reform would take place in 3 phases. The first step would be the repeal of the SGR and the freezing of physician reimbursement for several years. The intention is to allow doctors to ramp up their participation in quality-based payment programs by the time it fully goes into effect sometime between 2019 and 2024. In the second phase, according to the framework document, “physician fee schedule payment updates will be based on performance on meaningful, physician-endorsed measures of care quality and participation in clinical improvement activities.” During this period, quality measures and clinical improvement programs that medical societies have

“We’ve been watching efforts toward SGR reform for almost 10 years now, and every time a deadline has come Congress has just punted it a little farther down the road. But the stars seem to be aligning such that reform may take place this time—they’ve actually been working within Congress and back and forth with medical societies and providers since March. So there is a desire and effort by Congress to fix this that we haven’t seen before.” —Jeffery Ward, MD by the majority of oncologists. That’s why we’re testing several models in small pilot projects.”

SGR Reform Complexity a Two-Edged Sword SGR was put in place in 1997. Its longevity is at least partially a testa-

October 2013

Continued on page 20

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Legislation

Deadline for Approving SGR Reform…Continued from page 19 already been assiduously assembling will be segued into full and official use. “This proposal will reduce the reporting burden on physician practices, override the current ineffective CMS [Centers for Medicare & Medicaid Services] quality-measurement programs, and align Medicare payment initiatives with private-payer initiatives,” the reform document posits. In the third and final phase, doctors will earn additional reimbursement for increased efficiency.

Keeping Oncology Ahead of the Curve In July, Dr Hudis provided the Energy and Commerce Committee with a detailed response to a series of questions posed by the committee. The committee’s goal was to determine what the various American medical societies believe is the way forward. Dr Hudis said that ASCO strongly supports using benchmarks to determine how well individual physicians are performing and, therefore, how much reimbursement they should receive. ASCO does not support a peer-to-peer system of comparison. Dr Hudis also noted that ASCO’s Quality Oncology Practice Initiative (QOPI®) has a high uptake rate among oncologists and is, therefore, well positioned to be a centerpiece of oncologists’ involvement in the second phase of the payment-reform process. QOPI was first offered to ASCO members in 2006; today, 850 prac-

tices and 1200 individual practice sites participate. In addition, the QOPI Certification Program was launched in 2010 to set a standard for acceptably high-quality care in oncology. Dr Hudis told Oncology Practice Management that officials at CMS have indicated that the QOPI and the QOPI Certification Program would be acceptable to them as quality measures in the second phase. “So that means QOPI, which a lot of oncologists are already participating in, would serve double duty for them: as a means of satisfying both ASCO’s and CMS’ thresholds for acceptably high quality of care,” Dr Hudis stated. Another leader consulted by Oncology Practice Management said the new payment system also should reward oncologists for participating in clinical trials designed to increase progression-free and overall survival, including phase 3 studies that are part of the National Cancer Institute’s Clinical Trials Cooperative Group Program. “These changes in the metrics for payment would offer a unique opportunity to raise the bar on clinical trial enrollment—and also push insurers to pay for these trials since they are known to be associated with improved quality practices and improved outcomes,” said Sagar Lonial, MD, Professor and Vice Chair of Clinical Affairs, Department of Hematology and Medical Oncology, Winship Cancer Institute, Emory University, Atlanta, Georgia.

For his part, Dr Ward emphasized the importance of integrating QOPI into the electronic medical record of pilot programs for optimizing the value/cost/efficiency equation in oncology. “You have to be able to measure quality seamlessly and robustly, incentivize physicians and patients to reduce resource use without compromising quality or care, and then incentivize them further to provide the most efficient use of resources,” Dr Ward said. He points to a program being road-tested by oncologist-hematol­ ogist and American Medical Assoc­ iation Trustee Barbara McAneny, MD, Texas oncologist Ray Page, MD, and others. Armed with a $19.8-million grant from CMS, the team is exploring a way for private oncology practices to provide patients with cancer better care at lower cost. Dr Hudis and Dr Ward have an intense and candid demeanor when discussing payment reform. This reflects the huge amount of time they and their colleagues have devoted to exploring the best options for the path forward—which, if chosen poorly, will mean years of continued uncertainty and, if selected wisely, will put oncology on solid footing for the foreseeable future. “We spend a lot of time on this because central to our mission is the need to maintain access to the highest quality care for all patients—and payment reform has to support this key goal,” concluded Dr Hudis. l

JOIN THE CONVERSATION!

Oncology Practice Management is now on LinkedIn… see page 24 for details!

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Coming soon

Another option in short-acting G-CSF therapy

»

FDA approved

Brought to you by Teva—a global leader experienced in developing and manufacturing biologics. Teva has a substantial portfolio of more than 50 oncology products in the US.

Learn more at GRANIXhcp.com Indication

» GRANIXTM is a leukocyte growth factor indicated for reduction in the duration of severe neutropenia in patients with nonmyeloid malignancies receiving myelosuppressive anticancer drugs associated with a clinically significant incidence of febrile neutropenia.

Important Safety Information

» Splenic rupture: Splenic rupture, including fatal cases, can occur following the administration of human granulocyte colony-stimulating factors (hG-CSFs). Discontinue GRANIX and evaluate for an enlarged spleen or splenic rupture in patients who report upper abdominal or shoulder pain after receiving GRANIX. » Acute respiratory distress syndrome (ARDS): ARDS can occur in patients receiving hG-CSFs. Evaluate patients who develop fever and lung infiltrates or respiratory distress after receiving GRANIX, for ARDS. Discontinue GRANIX in patients with ARDS. » Allergic reactions: Serious allergic reactions, including anaphylaxis, can occur in patients receiving hG-CSFs. Reactions can occur on initial exposure. Permanently discontinue GRANIX in patients with serious allergic reactions. Do not administer GRANIX to patients with a history of serious allergic reactions to filgrastim or pegfilgrastim. » Use in patients with sickle cell disease: Severe and sometimes fatal sickle cell crises can occur in patients with sickle cell disease receiving hG-CSFs. Consider the potential risks and benefits prior to the administration of GRANIX in patients with sickle cell disease. Discontinue GRANIX in patients undergoing a sickle cell crisis. » Potential for tumor growth stimulatory effects on malignant cells: The granulocyte colony-stimulating factor (G-CSF) receptor, through which GRANIX acts, has been found on tumor cell lines. The possibility that GRANIX acts as a growth factor for any tumor type, including myeloid malignancies and myelodysplasia, diseases for which GRANIX is not approved, cannot be excluded. » Most common treatment-emergent adverse reaction: The most common treatmentemergent adverse reaction that occurred in patients treated with GRANIX at the recommended dose with an incidence of at least 1% or greater and two times more frequent than in the placebo group was bone pain. Please see brief summary of Prescribing Information on adjacent page.

©2013 Cephalon, Inc., a wholly owned subsidiary of Teva Pharmaceutical Industries Ltd. GRANIX is a trademark of Teva Pharmaceutical Industries Ltd. All rights reserved. FIL-40098 August 2013.


BRIEF SUMMARY OF PRESCRIBING INFORMATION FOR GRANIX™ (tbo-filgrastim) Injection, for subcutaneous use SEE PACKAGE INSERT FOR FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE GRANIX is indicated to reduce the duration of severe neutropenia in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. 4 CONTRAINDICATIONS None. 5 WARNINGS AND PRECAUTIONS 5.1 Splenic Rupture Splenic rupture, including fatal cases, can occur following administration of human granulocyte colony-stimulating factors. In patients who report upper abdominal or shoulder pain after receiving GRANIX, discontinue GRANIX and evaluate for an enlarged spleen or splenic rupture. 5.2 Acute Respiratory Distress Syndrome (ARDS) Acute respiratory distress syndrome (ARDS) can occur in patients receiving human granulocyte colony-stimulating factors. Evaluate patients who develop fever and lung infiltrates or respiratory distress after receiving GRANIX, for ARDS. Discontinue GRANIX in patients with ARDS. 5.3 Allergic Reactions Serious allergic reactions including anaphylaxis can occur in patients receiving human granulocyte colony-stimulating factors. Reactions can occur on initial exposure. The administration of antihistamines‚ steroids‚ bronchodilators‚ and/or epinephrine may reduce the severity of the reactions. Permanently discontinue GRANIX in patients with serious allergic reactions. Do not administer GRANIX to patients with a history of serious allergic reactions to filgrastim or pegfilgrastim. 5.4 Use in Patients with Sickle Cell Disease Severe and sometimes fatal sickle cell crises can occur in patients with sickle cell disease receiving human granulocyte colony-stimulating factors. Consider the potential risks and benefits prior to the administration of human granulocyte colony-stimulating factors in patients with sickle cell disease. Discontinue GRANIX in patients undergoing a sickle cell crisis. 5.5 Potential for Tumor Growth Stimulatory Effects on Malignant Cells The granulocyte colony-stimulating factor (G-CSF) receptor through which GRANIX acts has been found on tumor cell lines. The possibility that GRANIX acts as a growth factor for any tumor type, including myeloid malignancies and myelodysplasia, diseases for which GRANIX is not approved, cannot be excluded. 6 ADVERSE REACTIONS The following potential serious adverse reactions are discussed in greater detail in other sections of the labeling: • Splenic Rupture [see Warnings and Precautions (5.1)] • Acute Respiratory Distress Syndrome [see Warnings and Precautions (5.2)] • Serious Allergic Reactions [see Warnings and Precautions (5.3)] • Use in Patients with Sickle Cell Disease [see Warnings and Precautions (5.4)] • Potential for Tumor Growth Stimulatory Effects on Malignant Cells [see Warnings and Precautions (5.5)] The most common treatment-emergent adverse reaction that occurred at an incidence of at least 1% or greater in patients treated with GRANIX at the recommended dose and was numerically two times more frequent than in the placebo group was bone pain. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. GRANIX clinical trials safety data are based upon the results of three randomized clinical trials in patients receiving myeloablative chemotherapy for breast cancer (N=348), lung cancer (N=240) and non-Hodgkin’s lymphoma (N=92). In the breast cancer study, 99% of patients were female, the median age was 50 years, and 86% of patients were Caucasian. In the lung cancer study, 80% of patients were male, the median age was 58 years, and 95% of patients were Caucasian. In the non-Hodgkin’s lymphoma study, 52% of patients were male, the median age was 55 years, and 88% of patients were Caucasian. In all three studies a placebo (Cycle 1 of the breast cancer study only) or a nonUS-approved filgrastim product were used as controls. Both GRANIX and the non-US-approved filgrastim product were administered at 5 mcg/kg subcutaneously once daily beginning one day after chemotherapy for at least five days and continued to a maximum of 14 days or until an ANC of ≥10,000 x 106/L after nadir was reached. Bone pain was the most frequent treatment-emergent adverse reaction that occurred in at least 1% or greater in patients treated with GRANIX at the

recommended dose and was numerically two times more frequent than in the placebo group. The overall incidence of bone pain in Cycle 1 of treatment was 3.4% (3.4% GRANIX, 1.4% placebo, 7.5% non-US-approved filgrastim product). Leukocytosis In clinical studies, leukocytosis (WBC counts > 100,000 x 106/L) was observed in less than 1% patients with non-myeloid malignancies receiving GRANIX. No complications attributable to leukocytosis were reported in clinical studies. 6.2 Immunogenicity As with all therapeutic proteins, there is a potential for immunogenicity. The incidence of antibody development in patients receiving GRANIX has not been adequately determined. 7 DRUG INTERACTIONS No formal drug interaction studies between GRANIX and other drugs have been performed. Drugs which may potentiate the release of neutrophils‚ such as lithium‚ should be used with caution. Increased hematopoietic activity of the bone marrow in response to growth factor therapy has been associated with transient positive bone imaging changes. This should be considered when interpreting bone-imaging results. 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Pregnancy Category C There are no adequate and well-controlled studies of GRANIX in pregnant women. In an embryofetal developmental study, treatment of pregnant rabbits with tbo-filgrastim resulted in adverse embryofetal findings, including increased spontaneous abortion and fetal malformations at a maternally toxic dose. GRANIX should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. In the embryofetal developmental study, pregnant rabbits were administered subcutaneous doses of tbo-filgrastim during the period of organogenesis at 1, 10 and 100 mcg/kg/day. Increased abortions were evident in rabbits treated with tbo-filgrastim at 100 mcg/kg/day. This dose was maternally toxic as demonstrated by reduced body weight. Other embryofetal findings at this dose level consisted of post-implantation loss‚ decrease in mean live litter size and fetal weight, and fetal malformations such as malformed hindlimbs and cleft palate. The dose of 100 mcg/kg/day corresponds to a systemic exposure (AUC0-24) of approximately 50-90 times the exposures observed in patients treated with the clinical tbo-filgrastim dose of 5 mcg/kg/day. 8.3 Nursing Mothers It is not known whether tbo-filgrastim is secreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when GRANIX is administered to a nursing woman. Other recombinant G-CSF products are poorly secreted in breast milk and G-CSF is not orally absorbed by neonates. 8.4 Pediatric Use The safety and effectiveness of GRANIX in pediatric patients have not been established. 8.5 Geriatric Use Among 677 cancer patients enrolled in clinical trials of GRANIX, a total of 111 patients were 65 years of age and older. No overall differences in safety or effectiveness were observed between patients age 65 and older and younger patients. 8.6 Renal Impairment The safety and efficacy of GRANIX have not been studied in patients with moderate or severe renal impairment. No dose adjustment is recommended for patients with mild renal impairment. 8.7 Hepatic Impairment The safety and efficacy of GRANIX have not been studied in patients with hepatic impairment. 10 OVERDOSAGE No case of overdose has been reported.

©2013 Cephalon, Inc., a wholly owned subsidiary of Teva Pharmaceutical Industries Ltd. All rights reserved. GRANIX is a trademark of Teva Pharmaceutical Industries Ltd. Manufactured by: Sicor Biotech UAB Vilnius, Lithuania U.S. License No. 1803 Distributed by: Teva Pharmaceuticals USA, Inc. North Wales, PA 19454 Product of Israel FIL-40045 July 2013 This brief summary is based on TBO-003 GRANIX full Prescribing Information.


ACCC National Oncology Conference

2013 Innovator Awards Shine “Spotlight on Success” at National Oncology Conference

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t the Association of Com­ munity Cancer Centers (ACCC) 30th National Oncology Conference, which was held October 2-5, 2013, in Boston before an audience of more than 500 cancer care providers from across the country, 10 cancer programs that developed pioneering solutions to address the challenges of treating patients with cancer received the ACCC’s 2013 Innovator Awards. In keeping with the meeting’s theme, “Spotlight on Success,” the award-winning innovations included creating a portable, secure electronic medical record (EMR) that can travel with a patient in the wake of a natural disaster; a process to streamline cancer patients’ evaluation and management in the emergency room; expanding essential cancer and health screenings through mobile clinics; and improving access to genetic counseling for patients and their family members. Established in 2011, the In­­ novator Awards are sponsored by GE Healthcare to honor ex­­ ceptional cancer programs that ex­­hibit forward-thinking strategic planning and have developed pioneering, replicable programs for cancer care delivery. “Both ACCC and GE Healthcare are proud to honor programs that are enhancing community cancer care through progressive, patient-focused tools and strategies,” said Virginia T. Vaitones, MSW, OSW-C, ACCC’s president and an oncology social worker at Pen Bay Medical Center in Rockport, Maine. “They will provide inspiration and spark new innovations for all of us working in cancer care.” l

The Award Winners Avera McKennan Hospital and University Health Center, Avera Cancer Institute, Sioux Falls, South Dakota. As part of its mission to ensure consistent access to quality care for patients in rural areas, Avera Cancer Institute created a process to unify chemotherapy administration standards across 45 sites by establishing guidelines and standards of practice. Within 9 months of launching the initiative, compliance across all sites that administer chemotherapy was achieved. Baton Rouge General Medical Center, Pennington Cancer Center, Baton Rouge, Louisiana. Hurricane Katrina left patients with cancer displaced and their treatments disrupted. Just outside of New Orleans, the Pennington Cancer Center received patients with no records. To complicate matters, phone and fax lines were down and treating physicians were unreachable. Taking lessons learned from that experience, the radiation oncology treatment team developed an emergency chart system—a portable EMR that provides patients with their “must-have” documents in a universal jump drive format so that they may quickly resume care if they are displaced by a disaster. The George Washington University, GW Cancer Institute, Washington, DC. The GW Cancer Institute’s Citywide Patient Navigation Network developed a program that helps patients in vulnerable and underserved populations navigate their cancer treatment. Lay navigators work with a social worker and nurse navigators to guide patients from screening through treatment and into survivorship care. The network served 2840 DC-area residents in 2012—of whom 86% were minority and nearly 30% were uninsured. Gibbs Cancer Center & Research Institute, Spartanburg, South Carolina. Patient-centered care requires a holistic approach to patient needs, including palliative care. However, palliative care

October 2013

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services are often only available in an inpatient setting, while much of cancer care is delivered in the outpatient setting. This quality improvement initiative integrated a half-day supportive care clinic into the medical oncology practice, expanding palliative care services beyond the inpatient setting. Program successes include increased patient satisfaction and reduced distress symptoms. Methodist Healthcare System, Methodist Cancer Center, San Antonio, Texas. A multidisciplinary team at the Methodist Cancer Center designed and developed a process for rapid assessment and management of patients with cancer with a low white blood cell count presenting to the emergency department (ED) with symptoms of febrile neutropenia, a potentially catastrophic adverse effect for a patient with cancer who is receiving chemotherapy. The Very Immunocompromised Patient (VIP) Program quickly evaluates and treats oncology patients in the ED. A “VIP Kit” educates patients on when to report to the ED and improves coordination of care with community-based physicians and treating oncologists. St. Luke’s Mountain States Tumor Institute (MSTI), Boise, Idaho. Many accreditation bodies, including the Commission on Cancer, are including the provision of genetic risk assessment in their standards. Providing those living in rural communities access to these services is challenging. MSTI addressed 2 barriers, access to qualified genetic specialists and patient identification, through a 2-pronged approach—telehealth and weekly chart review. The result is improved convenience and access, cost savings, and improved quality of care. Temple University Hospital, Temple Cancer Program, Philadelphia, Pennsylvania. Treatment plan delays led to decreased patient satisfaction, care deContinued on page 24

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ACCC National Oncology Conference

The Award Winners…Continued from page 23 lays, low employee morale, and potential lost revenue. To solve this challenge, an electronic dosimetry “whiteboard” that centrally displays the status of every case increased transparency and communication and identified potential bottlenecks, allowing the staff to make process changes. The whiteboard led to improved patient satisfaction and employee morale as well as increased accountability. Texas Health Harris Methodist Hospital, Fort Worth, Klabzuba Cancer Center, Fort Worth, Texas. When Klabzuba Cancer Center discovered that patients using mobile mammography services had unmet healthcare needs beyond mammograms, they adapted their mobile clinics to provide additional services including can-

cer, cardiovascular, and bone density screenings, pelvic and clinical breast examinations, and education for each service. By bringing care to work sites and rural locations, the mobile units remove barriers to care access. Partnerships with businesses, government agencies, and other local organizations enable them to provide services to a diverse and widespread population. University of Texas Southwestern Medical Center, Harold C. Simmons Comprehensive Cancer Center, Dallas, Texas. The Simmons Cancer Center developed CancerGene Connect, a patient-driven online genetic risk assessment program. Patients complete an online family and medical history that allows genetic counselors to calculate their risk before their visit. Using Can-

cerGene Connect cut evaluation and documentation time in half, and expanded the program without increasing staff or compromising patient care. Winship Cancer Institute, Emory University, Atlanta, Georgia. Winship Cancer Institute implemented the community-based “Winship at the Y” program in collaboration with the YMCA of Metro Atlanta’s THE COACH APPROACH©. In the first 9 months of the program, almost 100 survivors and caregivers were referred for enrollment. In collaboration with the American Cancer Society, the program also offers cancer awareness and screening activities around Atlanta. Source: Association of Community Cancer Centers, October 7, 2013

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FDA News

New Drug Update

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s oncology practice managers assume higher levels of assistance to the medical oncology staff, it becomes critically important to stay abreast of the latest news and updates concerning the drug agents used in cancer treatment. The following drugs have been approved by the US Food and Drug Administration (FDA) since January 1, 2013, for the treatment of various cancers. For more information on any of these agents visit the FDA’s website at www.fda. gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm279174.htm.

New Drug for Advanced Prostate Cancer Xofigo approved 3 months ahead of schedule under priority review program.

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he US Food and Drug Administration (FDA) has approved Xofigo (radium Ra 223 dichloride) to treat men with symptomatic late-stage (metastatic) castration-resistant prostate cancer that has spread to bones but not to other organs. It is intended for men whose cancer has spread after receiving medical or surgical therapy to lower testosterone. According to the National Cancer Institute, an estimated 238,590 men will be diagnosed with prostate cancer and 29,720 will die from the disease in 2013. Xofigo was approved more than 3 months ahead of the product’s prescription drug user fee goal date of August 14, 2013, the date the agency was scheduled to complete review of the drug application. The FDA reviewed Xofigo under the agency’s priority review program,

which provides for an expedited review of drugs that appear to provide safe and effective therapy when no satisfactory alternative therapy exists, or offer significant improvement compared with marketed products. In August 2012, the FDA approved Xtandi to treat men with metastatic castration-resistant prostate cancer that has spread or recurred, even with medical or surgical therapy to minimize testosterone. Xtandi is approved for patients who have previously been treated with the chemotherapy drug docetaxel. Xofigo’s safety and effectiveness were evaluated in a single clinical trial of 809 men with symptomatic castration-resistant prostate cancer that spread to bones but not to other organs. Patients were randomly assigned to receive Xofigo or a placebo plus best standard of care.

The study was designed to measure overall survival. Results from a preplanned interim analysis showed that men who received Xofigo lived a median of 14 months compared with a median of 11.2 months for men who received placebo. An exploratory updated analysis conducted later in the trial confirmed Xofigo’s ability to extend overall survival. The most common side effects reported during the clinical trials in men receiving Xofigo were nausea, diarrhea, vomiting, and swelling of the leg, ankle, or foot. The most common abnormalities detected during blood testing included low levels of red blood cells (anemia), lymphocytes (lymphocytopenia), white blood cells (leukopenia), platelets (thrombocytopenia), and infection-fighting white blood cells (neutropenia). l Source: US Food and Drug Administration

First Companion Diagnostic to Detect Gene Mutation Associated with a Type of Lung Cancer New indication for Tarceva also approved.

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he US Food and Drug Ad­­ ministration (FDA) approved the cobas EGFR Mutation Test, a companion diagnostic for the cancer drug erlotinib (Tarceva). This

is the first FDA-approved companion diagnostic that detects epidermal growth factor receptor (EGFR) gene mutations, which are present in approximately 10% of non–small-

October 2013

cell lung cancers (NSCLCs). The test was approved with an expanded use for Tarceva as a first-line treatment for patients with NSCLC that has spread to other parts of the

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FDA News

body (metastasized) and who have certain mutations in the EGFR gene. Lung cancer is the leading cause of cancer-related death among both men and women. According to the National Cancer Institute, there will be an estimated 228,190 new cases of lung cancer this year, and 159,480 deaths. About 85% of lung cancers are NSCLC, making it the most common type of lung cancer. The safety and effectiveness of the cobas EGFR Mutation Test was established with clinical data show-

ing that, on average, patients with NSCLC with specific types of EGFR mutations (exon 19 deletions or exon 21 L858R substitution mutations) lived without their disease progressing for 10.4 months when they received Tarceva treatment, compared with 5.4 months for those who received a standard 2-drug chemotherapy regimen. Investigators used tumor samples from the clinical trial to validate the test’s use in this patient population. The approval is Tarceva’s fourth

indication and the third use for lung cancer. The FDA approved Tarceva in April 2010 for maintenance treatment of patients with locally advanced or metastatic NSCLC whose disease had not progressed after 4 cycles of platinum-based firstline chemotherapy. Tarceva was originally approved in November 2004 for the treatment of patients with locally advanced or metastatic NSCLC after failure of at least 1 prior chemotherapy regimen. l Source: US Food and Drug Administration

Single-Agent Injection for HER2-Positive Metastatic Breast Cancer Ado-trastuzumab emtansine showed longer progression-free survival and overall survival in clinical trials.

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n February, the US Food and Drug Administration approved ado-trastuzumab emtansine (Kadcyla for injection), for use as a single agent for the treatment of patients with HER2-positive metastatic breast cancer who previously received trastuzumab and a taxane, separately or in combination. Patients should have either received prior therapy for metastatic disease or developed disease recurrence during or within 6 months of completing adjuvant therapy. The approval is based on a randomized, multicenter, open-label trial enrolling 991 patients with HER2-positive metastatic breast cancer. Patients must have received prior taxane and trastuzumab-based therapy before enrollment. Patients who received these therapies only in the adjuvant setting were required to have disease recurrence during or within 6 months of completing this therapy. Breast tumor specimens were required to show HER2 overexpression defined as 3+ immunohistochemistry or fluorscence in

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situ hybridization amplification ratio ≥2 determined at a central laboratory. Patients were randomly allocated (1:1) to receive ado-trastuzumab emtansine 3.6 mg/kg by intravenous infusion on day 1 every 21 days or lapatinib 1250 mg/day orally once daily for 21 days plus capecitabine 1000 mg/m2 orally twice daily for 14 days. Treatment continued until disease progression, unacceptable toxicity, or consent withdrawal. The coprimary efficacy endpoints were progression-free survival (PFS), based on tumor response assessments by an independent review committee, and overall survival (OS). The median PFS was 9.6 and 6.4 months for patients in the ado-trastuzumab emtansine and lapatinib plus capecitabine arms, respectively. The median OS was 30.9 and 25.1 months in the ado-trastuzumab emtansine and the lapatinib plus capecitabine arms, respectively. The most common (>25%) ad­­ verse reactions observed in patients receiving ado-trastuzumab emtansine were fatigue, nausea, muscu-

ONCOLOGY PRACTICE MANAGEMENT

I October 2013

loskeletal pain, thrombocytopenia, headache, increased transaminases, and constipation. The most common adverse events leading to ado-trastuzumab emtansine withdrawal were thrombocytopenia and increased transaminases. The most common (>2%) grade 3 or 4 adverse reactions were thrombocytopenia, increased transaminases, anemia, hypokalemia, peripheral neuropathy, and fatigue. Serious hepatobiliary disorders, including at least 2 fatal cases of severe drug-induced liver injury and associated hepatic encephalopathy, have been reported in clinical trials with ado-trastuzumab emtansine. Other significant adverse reactions include left ventricular dysfunction, interstitial lung disease, and infusion-associated reactions. A Boxed Warning in product labeling describes the risk of hepatotoxicity, reduction in left ventricular ejection fraction, embryo-fetal toxicity and birth defects, and the need for effective contraception prior to Continued on page 28


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FDA News

Single-Agent Injection Approved…Continued from page 26 starting ado-trastuzumab emtansine. The recommended dose and schedule for ado-trastuzumab emtansine is 3.6 mg/kg administered as an intra-

venous infusion every 3 weeks (a 21-day cycle) until disease progression or unacceptable toxicity. Adotrastuzumab emtansine should not be

administered at doses greater than 3.6 mg/kg and should not be substituted for or with trastuzumab. l Source: US Food and Drug Administration

Pomalidomide Capules Approved for Multiple Myeloma FDA granted accelerated approval for treatment of patients who have received at least 2 prior therapies.

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n February, the US Food and Drug Administration (FDA) granted accelerated approval to pomalidomide (Pomalyst capsules) for the treatment of patients with multiple myeloma (MM) who have received at least 2 prior therapies, including lenalidomide and bortezomib, and have demonstrated disease progression on or within 60 days of completion of the last therapy. The approval was based on the results of clinical trial CC-4047MM-002; a multicenter, randomized, open-label study in 221 pa­ tients with relapsed and refractory MM who had previously received lenalidomide and bortezomib and were refractory to the last myeloma therapy. The treatment arms were pomalidomide alone or pomalidomide plus low-dose dexamethasone. The efficacy results demonstrated an overall response rate of 7% in patients treated with pomalidomide alone, and 29% in those treated with pomalidomide plus low-dose dexa-

methasone. The median response duration was not evaluable in the pomalidomide alone arm and was 7.4 months in the pomalidomide plus low-dose dexamethasone arm. The most common side effects reported in the clinical trial included fatigue and asthenia, neutropenia, anemia, constipation, nausea, diarrhea, dyspnea, upper respiratory tract infections, back pain, and pyrexia. Pomalidomide carries a Boxed Warning alerting patients and healthcare professionals that the drug can cause embryo-fetal toxicity and venous thromboembolism. Because of this embryo-fetal risk, pomalidomide is available only through a restricted distribution program called the Pomalyst Risk Evaluation and Mitigation Strategy (REMS) Program. Pres­ cribers must be certified with the Pomalyst REMS program by enrolling and complying with the REMS requirements. Patients must sign a Patient–Physician Agreement Form and comply with the REMS

requirements. Female patients of reproductive potential who are not pregnant must comply with the pregnancy testing and contraception requirements. Males must comply with contraception requirements. Pharmacies must be certified with the Pomalyst REMS program, must only dispense to patients who are authorized to receive pomalidomide, and comply with REMS requirements. As a condition of this accelerated approval, the FDA will require submission of the results of clinical trial CC-4047-MM-007, a randomized clinical trial of pomalidomide added to bortezomib and low-dose dexamethasone compared with bortezomib plus low-dose dexamethasone in patients with previously treated MM. The recommended dose and schedule for pomalidomide is 4 mg taken orally on days 1 to 21 of repeated 28-day cycles. Cycles are repeated until disease progression. l Source: US Food and Drug Administration

WEB POLL QUESTION

Have your cancer patients experienced any “side effects” from the Afforadable Care Act yet? What are you and your patients concerned about as the ACA goes into effect? Log onto www.oncpracticemanagement.com to make your voice heard! 28

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FDA News

Doxorubicin Hydrochloride Liposome Injection FDA expedited review of generic application due to drug shortage.

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n February 2013, the US Food and Drug Administration (FDA) approved doxorubicin hydrochloride liposome injection, a generic version of Doxil Injection (doxorubicin hydrochloride liposome) for the treatment of patients with ovarian cancer whose disease has progressed or recurred after platinum-based chemotherapy and for AIDS-related Kaposi’s sarcoma after the failure of prior systemic chemotherapy or intolerance to such therapy.

The FDA’s Office of Generic Drugs expedited the review of this generic application because of the drug shortage for Doxil. As of April, Doxil was still under drug shortage because of manufacturing issues. The FDA has been exercising regulatory discretion for alternative doxorubicin hydrochloride injection products to meet patient needs. Upon approval of the generic product, the FDA will stop enforcement discretion once approved product

supply is sufficient to meet patient demand. The FDA will closely monitor the drug supply situation and continue to use enforcement discretion to allow importation of additional Lipodox or the release of additional lots of unapproved Doxil until supplies of commercially marketed lots of doxorubicin hydrochloride liposome injection in the United States are sufficient to meet patient demand. l Source: US Food and Drug Administration

Bevacizumab for Use in Combination with Fluoropyrimidine-Based Chemotherapy for Metastatic Colorectal Cancer Drug will be used to treat patients whose disease progresses on a first-line bevacizumab-containing regimen.

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n January 2013, the US Food and Drug Administration (FDA) approved bevacizumab (Avastin) for use in combination with fluor­opyrimidine-irinotecan or fluoro­pyrimidine-oxaliplatin– based chemo­ therapy for the treatment of patients with metastatic colorectal cancer (mCRC) whose disease has progressed on a firstline bevacizumab-containing regimen. Bevacizumab is a recombinant humanized monoclonal immunoglobulin G1 antibody that binds to human vascular endothelial growth factor (VEGF), preventing the interaction of VEGF to its receptors on the surface of endothelial cells. This approval is based on the results of a randomized, open-label, multinational trial enrolling patients with mCRC that progressed during or within 3 months of discontinuation of bevacizumabbased combination chemotherapy

with fluoropyrimidine-oxaliplatin or fluoropyrimidine-irinotecan in the first line. The primary efficacy end point was overall survival (OS). Treatment assignment was stratified by firstline treatment (irinotecan-based vs oxaliplatin-based), first-line progression-free survival (PFS) (>9 months vs ≤9 months), time from last bevacizumab dose (>42 days vs ≤42 days), and Eastern Cooperative Oncology Group (ECOG) performance status (0-1 vs 2). The median age of the study population was 63 years, 64% were men, and 96% had an ECOG performance status of 0 or 1. A statistically significant OS improvement was observed in patients receiving crossover chemotherapy plus bevacizumab compared with those receiving crossover chemotherapy alone. Median OS was 11.2 and 9.8 months for patients on

October 2013

the crossover chemotherapy plus bevacizumab and crossover chemotherapy arms, respectively. PFS was also significantly improved in patients receiving crossover chemotherapy plus bevacizumab compared with those receiving chemotherapy alone. The median PFS times were 5.7 and 4 months, respectively. No new safety signals were ob­ served in this trial. The safety data were consistent with the known safety profile established in previously approved indications. The recommended dose and schedule in patients receiving bevacizumab in combination with fluoropyrimidine-irinotecan– or fluoropyrimidine-oxaliplatin– based chemotherapy after progression on a first-line bevacizumab-containing regimen is 5 mg/kg administered every 2 weeks or 7.5 mg/kg administered every 3 weeks as a 60-minute intravenous infusion. l Source: US Food and Drug Administration

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Drug Coding Supplied by RJ Health Systems

FDA-Approved Medications Used for the Treatment of Breast Cancer The following sections will assist healthcare professionals and payers by providing appropriate coding and billing information associated with the treatment of breast cancer. The following sections include: • Associated ICD-9-CM codes used for the classification of breast cancer • Drugs that have been FDA approved in the treatment of breast cancer • Drugs that are Compendia-listed for off-label use for breast cancer based on clinical studies that suggest beneficial 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 breast cancer. However, drugs in the FDA-approved section are FDA approved for at least 1 of the breast cancer ICD-9-CM codes but may also have Compendia-listed uses as well

Associated ICD-9-CM codes for the treatment of breast cancer: 174 Malignant neoplasm of female breast Includes: breast (female) connective tissue soft parts Paget’s disease of: breast nipple Use additional code to identify estrogen receptor status (V86.0, V86.1) Excludes: skin of breast (172.5, 173.5) 174.0 Nipple and areola 174.1 Central portion 174.2 Upper-inner quadrant 174.3 Lower-inner quadrant 174.4 Upper-outer quadrant 174.5 Lower-outer quadrant 174.6 Axillary tail 174.8 Other specified sites of female breast Ectopic sites Inner breast Lower breast Malignant neoplasm of contiguous or overlapping Sites of breast whose point of origin cannot be determined Midline of breast Outer breast Upper breast 174.9 Breast (female), unspecified 175 Malignant neoplasm of male breast Use additional code to identify estrogen receptor status (V86.0, V86.1) Excludes: skin of breast (172.5, 173.5) 175.0 Nipple and areola 175.9 Other and unspecified sites of male breast Ectopic breast tissue, male

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Drug Coding

FDA approved for breast cancer

Compendia listed off-label uses for breast cancer

Possible CPT ® administration codes

Generic (brand) name

HCPCS code: Code description

ado-trastuzumab emtansine (Kadcyla)

C9131: Injection, ado-trastuzumab emtansine, 1 mg

ado-trastuzumab emtansine (Kadcyla)

J9999*: Not otherwise classified, antineoplastic drugs

anastrozole (Arimidex)

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

N/A

anastrozole (Arimidex)

S0170: Anastrozole, oral, 1 mg

N/A

Bacillus Calmette-Guérin (Tice BCG, TheraCys)

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

51720

Bacillus Calmette-Guérin (Tice BCG, TheraCys)

J9031: BCG (intravesical), per installation

51720

bevacizumab (Avastin)

C9257: Injection, bevacizumab, 0.25 mg

67028

bevacizumab (Avastin)

J9035: Injection, bevacizumab, 10 mg

96413, 96415

capecitabine (Xeloda)

J8520: Capecitabine, oral, 150 mg

N/A

capecitabine (Xeloda)

J8521: Capecitabine, oral, 500 mg

N/A

carboplatin (Paraplatin)

J9045: Injection, carboplatin, 50 mg

96409, 96413, 96415

cisplatin (Platinol AQ)

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

96409, 96413, 96415

cyclophosphamide (Cytoxan)

J8530: Cyclophosphamide, oral, 25 mg

N/A

cyclophosphamide (Cytoxan)

J9070: Cyclophosphamide, 100 mg

96409, 96413, 96415

dexamethasone (Decadron)

J1100: Injection, dexamethasone sodium phosphate, 1 mg

11900, 11901, 20600, 20605, 20610, 96372, 96374

dexamethasone (Decadron)

J8540: Dexamethasone, oral, 0.25 mg

N/A

docetaxel (Taxotere)

J9171: Injection, docetaxel, 1 mg

96413

doxorubicin HCl (Adriamycin)

J9000: Injection, doxorubicin hydrochloride, 10 mg

96409

doxorubicin HCl liposome (Doxil)

J9002: Injection, doxorubicin hydrochloride, liposomal, not otherwise specified, 10 mg (code no longer payable by Medicare effective 7/1/13)

96413, 96415

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96413

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Drug Coding

32

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FDA approved for breast cancer

Compendia listed off-label uses for breast cancer

Possible CPT ® administration codes

Generic (brand) name

HCPCS code: Code description

doxorubicin HCl liposome (Doxil)

Q2050: Injection, doxorubicin hydrochloride, liposomal, not otherwise specified, 10 mg

epirubicin (Ellence)

J9178: Injection, epirubicin hydrochloride, 2 mg

96409, 96413

eribulin (Halaven)

J9179: Injection, eribulin mesylate, 0.1 mg

96409

estradiol (Estrace)

J8499*: Prescription drug, oral, nonchemotherapeutic, not otherwise specified

N/A

etoposide (VePesid)

J8560: Etoposide, oral, 50 mg

N/A

etoposide (Etopophos, Toposar)

J9181: Injection, etoposide, 10 mg

96413, 96415

everolimus (Afinitor)

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

N/A

everolimus (Afinitor)

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

N/A

exemestane (Aromasin)

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

N/A

exemestane (Aromasin)

S0156: Exemestane, 25 mg

N/A

fluorouracil (Adrucil)

J9190: Injection, fluorouracil, 500 mg

96409

fluoxymesterone (Androxy)

J8499*: Prescription drug, oral, nonchemotherapeutic, not otherwise specified

N/A

fulvestrant (Faslodex)

J9395: Injection, fulvestrant, 25 mg

96402

gemcitabine (Gemzar)

J9201: Injection, gemcitabine hydrochloride, 200 mg

96413

goserelin acetate (Zoladex 3.6 mg ONLY)

J9202: Goserelin acetate implant, per 3.6 mg

96372, 96402

hydrocortisone sodium (Solu-Cortef)

J1720: Injection, hydrocortisone sodium succinate, up to 100 mg

96365, 96366, 96372, 96374

hydroxyurea (Hydrea)

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

N/A

hydroxyurea (Hydrea)

S0176: Hydroxyurea, oral, 500 mg

N/A

ONCOLOGY PRACTICE MANAGEMENT

I October 2013

96413


Drug Coding

FDA approved for breast cancer

Compendia listed off-label uses for breast cancer

Possible CPT ® administration codes

Generic (brand) name

HCPCS code: Code description

ifosfamide (Ifex)

J9208: Injection, ifosfamide, 1g

96413, 96415

irinotecan (Camptosar)

J9206: Injection, irinotecan, 20 mg

96413, 96415

ixabepilone (Ixempra)

J9207: Injection, ixabepilone, 1 mg

96413, 96415

lapatinib (Tykerb)

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

N/A

letrozole (Femara)

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

N/A

leucovorin calcium (Wellcovorin)

J0640: Injection, leucovorin calcium, per 50 mg

96372, 96374, 96409

leuprolide (Eligard, Lupron Depot)

J9217: Leuprolide acetate (for depot suspension), 7.5 mg

96402

leuprolide (Lupron)

J9218: Leuprolide acetate, per 1 mg

96402

lomustine (CeeNu)

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

N/A

lomustine (CeeNU)

S0178: Lomustine, oral, 10 mg

N/A

medroxyprogesterone (Depo-Provera)

J1050: Injection, medroxyprogesterone acetate, 1 mg

96402

megestrol (Megace)

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

N/A

megestrol (Megace)

S0179: Megestrol acetate, oral, 20 mg

N/A

melphalan (Alkeran)

J8600: Melphalan, oral, 2 mg

N/A

melphalan (Alkeran)

J9245: Injection, melphalan hydrochloride, 50 mg

96409, 96413

methotrexate (Trexall)

J8610: Methotrexate, oral, 2.5 mg

N/A

methotrexate sodium

J9250: Methotrexate sodium, 5 mg

96372, 96374, 96401, 96409, 96450

methotrexate sodium

J9260: Methotrexate sodium, 50 mg

96372, 96374, 96401, 96409, 96450

methylprednisolone (Depo-Medrol)

J1020: Injection, methylprednisolone acetate, 20 mg

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11900, 11901, 20600, 20605, 20610, 96372, 96374

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Drug Coding

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FDA approved for breast cancer

Compendia listed off-label uses for breast cancer

Possible CPT ® administration codes

Generic (brand) name

HCPCS code: Code description

methylprednisolone (Depo-Medrol)

J1030: Injection, methylprednisolone acetate, 40 mg

11900, 11901, 20600, 20605, 20610, 96372, 96374

methylprednisolone (Depo-Medrol)

J1040: Injection, methylprednisolone acetate, 80 mg

11900, 11901, 20600, 20605, 20610, 96372, 96374

methylprednisolone (Solu-Medrol)

J2920: Injection, methylprednisolone sodium succinate, up to 40 mg

11900, 11901, 20600, 20605, 20610, 96372, 96374

methylprednisolone (Medrol)

J7509: Methylprednisolone, oral, per 4 mg

N/A

mitomycin (Mutamycin)

J9280: Mitomycin, 5 mg

96409

mitoxantrone (Novantrone)

J9293: Injection, mitoxantrone hydrochloride, per 5 mg

96409, 96413

oxaliplatin (Eloxatin)

J9263: Injection, oxaliplatin, 0.5 mg

96413, 96415

paclitaxel protein-bound particles (Abraxane)

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

96413

paclitaxel (Taxol)

J9265: Injection, paclitaxel, 30 mg

96413, 96415

pemetrexed (Alimta)

J9305: Injection, pemetrexed, 10 mg

pertuzumab (Perjeta)

C9292: Injection, pertuzumab, 10 mg

96413

pertuzumab (Perjeta)

J9999*: Not otherwise classified, antineoplastic drugs

96413

prednisolone (eg, Orapred, Millipred)

J7510: Prednisolone, oral, per 5 mg

N/A

prednisone (eg, Deltasone, Orasone)

J7506: Prednisone, oral, per 5 mg

N/A

tamoxifen (Nolvadex)

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

N/A

tamoxifen (Nolvadex)

S0187: Tamoxifen citrate, oral, 10 mg

N/A

thiotepa (Thiotepa)

J9340: Injection, thiotepa, 15 mg

51720, 96409

topotecan (Hycamtin)

J8705: Topotecan, oral, 0.25 mg

N/A

topotecan (Hycamtin)

J9351: Injection, topotecan, 0.1 mg

96413

ONCOLOGY PRACTICE MANAGEMENT

I October 2013

96409


Drug Coding

FDA approved for breast cancer

Compendia listed off-label uses for breast cancer

Possible CPT ® administration codes

Generic (brand) name

HCPCS code: Code description

toremifene (Fareston)

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

N/A

trastuzumab (Herceptin)

J9355: Injection, trastuzumab, 10 mg

96413, 96415

triptorelin (Trelstar)

J3315: Injection, triptorelin pamoate, 3.75 mg

vinblastine (Velban)

J9360: Injection, vinblastine sulfate, 1 mg

vincristine (Vincasar PFS)

J9370: Vincristine sulfate, 1 mg

96409

vinorelbine (Navelbine)

J9390: Injection, vinorelbine tartrate, per 10 mg

96409

zoledronic acid (Zometa)

J3487: Injection, zoledronic acid (Zometa), 1 mg (code no longer payable by Medicare effective 7/1/13)

96365, 96413

zoledronic acid (Reclast)

J3488: Injection, zoledronic acid (Reclast), 1 mg (code no longer payable by Medicare effective 7/1/13)

96365, 96374

zoledronic acid (Reclast, Zometa)

Q2051: Injection, zoledronic acid, not otherwise specified, 1 mg

96365, 96374, 96413

96372, 96402 96409

*When billing a nonclassified medication using a CMS 1500 claim form you must include both the HCPCS code (eg, J9999 Kadcyla) in Column 24D and the drug name, strength, and NDC (National Drug Code) in Box 19 or 24A to ensure appropriate reimbursement. Please note: Check with payer regarding correct placement of medication information. References HCPCS Level II Expert 2013 • Current Procedural Terminology (CPT ®) 2013 (copyright 2013 American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association) • ICD-9-CM for Professionals Volumes 1, 2, 2013 • FDA-approved indication (from product prescribing information) • Compendia references available upon request • www.ReimbursementCodes.com powered by RJ Health Systems International, LLC, Rocky Hill, Connecticut • CMS (Centers for Medicare & Medicaid Services) CPT ® indicates Current Procedural Terminology; HCPCS, Healthcare Common Procedure Coding System.

This information was supplied by:

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

October 2013

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RJ Health Systems The Creators of ReimbursementCodes.com

RJ Health Systems — 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 drug’s NDC and brand/generic name. Please visit www.rjhealthsystems.com to learn more about our products and services listed below:

>> >> >> >> >> >> >> >> >>

ReimbursementCodes.com Drug Diagnosis Coding CMAC PartBorPartD.com NDC Conversion Database Min/Max Dosing Advisories Notations Clinical Consulting

rjhealthsystems.com


Patient Provider Access

Have Docs Faced the Last “Doc Fix”? By Sydney Abbott, JD, Manager, Provider Economics and Public Policy, Association of Community Cancer Centers

C

ontinually a barrier to future planning, the annual threat of cuts to Medicare reimbursement in the range of 25% to 30% may be on the way out. Most people would agree that the sustainable growth rate formula—which is used by the Centers for Medicare & Medicaid Services (CMS) to determine provider reimbursement rates for services provided to Medicare beneficiaries—is fundamentally flawed. Because the formula is designed to ensure that the annual increase in the expense per Medicare beneficiary does not exceed gross domestic product growth, when healthcare spending outpaces spending in other sectors of the economy the conversion factor kicks in to bring the following year’s reimbursement back in line. For 2014, the conversion factor would result in a 25% reduction in payment for providers. The threat of such a significant reduction in reimbursement leaves physicians unable to plan for future investments in technology, staff, and equipment. Historically, Congress has stepped in at the last minute each year to avoid such enormous cuts (ie, the “doc fix”), but this year congressional action is not guaranteed. The ongoing problem with fixing the SGR is the cost. In recent years, the expected cost to fix the Medicare reimbursement system has grown, making legislation to correct the formula less politically palatable. This year, however, the SGR may finally be eliminated. In February, in its annual report on the federal budget and economy, the Congressional Budget Office (CBO) drastically reduced the estimated cost to repeal the SGR formula from $245 billion to less

than $140 billion over 10 years—a relative bargain in congressional terms. The score reduction can be attributed to a slowing of Medicare spending in relation to historical trends and an expected decline in the growth of future spending for physician services. The lower score—in combination with the

SGR formula and replaces it with a 2-phase approach to physician reimbursement. Phase 1 stabilizes reimbursement with a 0.5% update to the Medicare fee schedule conversion factor annually for 5 years. Starting in 2019, phase 2 begins with 0.5% updates to the conversion factor. In phase 2, these updates could be positive or negative, depending on the ability of an individual provider or group of providers to reach predetermined quality measures or clinical improvement activities. While this is certainly a step toward solving the problem, HR 2810 is not the full solution. First,

For 2014, the conversion factor would result in a 25% reduction in payment for providers. The threat of such a significant reduction in reimbursement leaves physicians unable to plan for future investments in technology, staff, and equipment.

KEY POINTS • The sustainable growth rate that CMS uses to determine provider reimbursement rates is fundamentally flawed • In February the CEO reduced the estimated cost to repeal the SGR formula from $245 billion to less than $140 billion over 10 years • The Medicare Patient Access and Quality Improvement Act of 2013 (HR 2810) eliminates the current SGR formula and replaces it with a 2-phase approach to physician reimbursement • Even if budget offsets are identified and agreed to by congress, as written HR 2810 is expected to cost significantly more than the CBO predicted earlier this year, as much as 40% more by some estimates • The bill awaits a full floor vote as of press time

steady drumbeat of support from the Association of Community Cancer Centers (ACCC) and other stakeholders—prompted Congress to take action. The House Energy and Commerce Committee has been working with the House Committee on Ways and Means to develop legislation to replace the SGR formula. On July 31, the House Energy and Commerce Committee voted unanimously in favor of a bill that would do just that. The Medicare Patient Access and Quality Improvement Act of 2013 (HR 2810) eliminates the current

October 2013

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Patient Provider Access

Have Docs Faced the Last…Continued from page 37 HR 2810 does not replenish the pool of available funds with savings realized annually by CMS. The bill requires CMS to identify the services it overpays and reduce those payments by 1% each year from 2016 to 2018. However, the bill contains no language calling for CMS to redirect that money back into services it designates as undervalued. Without this direction, it could mean that the total payment pool would be smaller and planned reimbursement increas-

es might never materialize. Second, the CBO has reduced the expected total cost to replace the SGR, and not eliminated it entirely. There has yet to be a mechanism identified to “pay for” such a repeal, and many in Congress believe that offsets will not be identified anytime soon. Third, even if budget offsets are identified and agreed to by Congress—a tall order, no doubt— HR 2810, as written, is expected to cost significantly more than

the CBO scored earlier this year. In fact, some estimates peg the SGR legislation to cost about 40% more than the current CBO score. Because of this, the CBO is revisiting the issue and a new score is expected this fall. In the meantime, HR 2810 awaits a full floor vote with 40 bipartisan cosponsors. The ACCC continues to work with legislators to help ensure that the legislation passed will appropriately reimburse physician services. l

Planning Ahead in Practice Management

M

eet colleagues, share ideas, and find solutions to common practice management challenges by attending a meeting or seminar to further your skills, expertise, and professional network. Here are a few of the upcoming events that every practice manager should put on his or her calendar.

2013

Association of Community Cancer Centers Regional Oncology and Management Meetings November 7, 2013—St. Louis, Missouri December 10, 2013—Atlanta, Georgia Visit www.accc-cancer.org/meetings/RegionalMeetings. asp for more information and to register.

American Academy of Professional Coders National Conference April 1-4, 2014—Las Vegas, Nevada Visit www.aapc.com/medical-coding-education/confer ences/national/index.aspx for more information and to register.

Practice Management Institute (PMI®) PMI 9th Annual Las Vegas Conference November 13-15, 2013—Las Vegas, Nevada Visit www.pmimd.com/lasvegas13/default.asp for more information and to register.

Association for Value-Based Cancer Care/Association of Oncology Practice Management 4th Annual Conference May 6-9, 2014—Los Angeles, California Visit www.AVBCConline.org/conference for more information and to register.

American Academy of Medical Administrators 2013 Annual Conference November 19-22, 2013—Las Vegas, Nevada Visit aameda.org/Conference/Annual/AnnualMain.html for more information and to register.

Physician Office Managers Association of America 2014 Annual National Educational Conference September 18-21, 2014—Baltimore, Maryland Visit www.pomaa.com for more information and to register.

2014

Association of Community Cancer Centers 31st National Oncology Conference October 8-11, 2014—San Diego, California Visit accc-cancer.org/meetings/Calendar.asp for more information and to register.

Medical Group Management Association 2014 Financial Management and Payer Contracting Conference March 2-4, 2014—Orlando, Florida Visit www.mgma.com for more information and to register.

Medical Group Management Association 2014 Annual Conference October 26-29, 2014—Las Vegas, Nevada Visit www.mgma.com for more information and to register.

Association of Community Cancer Centers 40th Annual National Meeting March 31–April 2, 2014—Arlington, Virginia Visit accc-cancer.org/meetings/AM2014.asp for more information and to register.

38

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ONCOLOGY PRACTICE MANAGEMENT

I October 2013


Fourth Annual Navigation and Survivorship Conference Memphis, Tennessee • The Peabody Memphis

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

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

REGISTER TODAY

www.AONNonline.org AONNAsize31413


ZYTIGA® (abiraterone acetate) Tablets Brief Summary of Prescribing Information. INDICATIONS AND USAGE ZYTIGA is a CYP17 inhibitor indicated in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer. CONTRAINDICATIONS Pregnancy: ZYTIGA can cause fetal harm when administered to a pregnant woman. ZYTIGA is not indicated for use in women. ZYTIGA is contraindicated in women who are or may become pregnant. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, apprise the patient of the potential hazard to the fetus and the potential risk for pregnancy loss [see Use in Specific Populations]. WARNINGS AND PRECAUTIONS Hypertension, Hypokalemia and Fluid Retention Due to Mineralocorticoid Excess: ZYTIGA may cause hypertension, hypokalemia, and fluid retention as a consequence of increased mineralocorticoid levels resulting from CYP17 inhibition [see Clinical Pharmacology (12.1) in full Prescribing Information]. In the two randomized clinical trials, grade 3 to 4 hypertension occurred in 2% of patients, grade 3 to 4 hypokalemia in 4% of patients, and grade 3 to 4 edema in 1% of patients treated with ZYTIGA [see Adverse Reactions]. Co-administration of a corticosteroid suppresses adrenocorticotropic hormone (ACTH) drive, resulting in a reduction in the incidence and severity of these adverse reactions. Use caution when treating patients whose underlying medical conditions might be compromised by increases in blood pressure, hypokalemia or fluid retention, e.g., those with heart failure, recent myocardial infarction or ventricular arrhythmia. Use ZYTIGA with caution in patients with a history of cardiovascular disease. The safety of ZYTIGA in patients with left ventricular ejection fraction < 50% or New York Heart Association (NYHA) Class III or IV heart failure (in Study 1) or NYHA Class II to IV heart failure (in Study 2) was not established because these patients were excluded from these randomized clinical trials [see Clinical Studies (14) in full Prescribing Information]. Monitor patients for hypertension, hypokalemia, and fluid retention at least once a month. Control hypertension and correct hypokalemia before and during treatment with ZYTIGA. Adrenocortical Insufficiency: Adrenal insufficiency occurred in the two randomized clinical studies in 0.5% of patients taking ZYTIGA and in 0.2% of patients taking placebo. Adrenocortical insufficiency was reported in patients receiving ZYTIGA in combination with prednisone, following interruption of daily steroids and/or with concurrent infection or stress. Use caution and monitor for symptoms and signs of adrenocortical insufficiency, particularly if patients are withdrawn from prednisone, have prednisone dose reductions, or experience unusual stress. Symptoms and signs of adrenocortical insufficiency may be masked by adverse reactions associated with mineralocorticoid excess seen in patients treated with ZYTIGA. If clinically indicated, perform appropriate tests to confirm the diagnosis of adrenocortical insufficiency. Increased dosage of corticosteroids may be indicated before, during and after stressful situations [see Warnings and Precautions]. Hepatotoxicity: In the two randomized clinical trials, grade 3 or 4 ALT or AST increases (at least  5X ULN) were reported in 4% of patients who received ZYTIGA, typically during the first 3 months after starting treatment. Patients whose baseline ALT or AST were elevated were more likely to experience liver test elevation than those beginning with normal values. Treatment discontinuation due to liver enzyme increases occurred in 1% of patients taking ZYTIGA. No deaths clearly related to ZYTIGA were reported due to hepatotoxicity events. Measure serum transaminases (ALT and AST) and bilirubin levels prior to starting treatment with ZYTIGA, every two weeks for the first three months of treatment and monthly thereafter. In patients with baseline moderate hepatic impairment receiving a reduced ZYTIGA dose of 250 mg, measure ALT, AST, and bilirubin prior to the start of treatment, every week for the first month, every two weeks for the following two months of treatment and monthly thereafter. Promptly measure serum total bilirubin, AST, and ALT if clinical symptoms or signs suggestive of hepatotoxicity develop. Elevations of AST, ALT, or bilirubin from the patient’s baseline should prompt more frequent monitoring. If at any time AST or ALT rise above five times the ULN, or the bilirubin rises above three times the ULN, interrupt ZYTIGA treatment and closely monitor liver function. Re-treatment with ZYTIGA at a reduced dose level may take place only after return of liver function tests to the patient’s baseline or to AST and ALT less than or equal to 2.5X ULN and total bilirubin less than or equal to 1.5X ULN [see Dosage and Administration (2.2) in full Prescribing Information]. The safety of ZYTIGA re-treatment of patients who develop AST or ALT greater than or equal to 20X ULN and/or bilirubin greater than or equal to 10X ULN is unknown. Increased ZYTIGA Exposures with Food: ZYTIGA must be taken on an empty stomach. No food should be consumed for at least two hours before the dose of ZYTIGA is taken and for at least one hour after the dose of ZYTIGA is taken. Abiraterone Cmax and AUC0-∞ (exposure) were increased up to 17and 10-fold higher, respectively, when a single dose of abiraterone acetate was administered with a meal compared to a fasted state. The safety of these increased exposures when multiple doses of abiraterone acetate are taken with food has not been assessed [see Dosage and Administration (2.1) and Clinical Pharmacology (12.3) in full Prescribing Information].

ZYTIGA® (abiraterone acetate) Tablets ADVERSE REACTIONS The following are discussed in more detail in other sections of the labeling: • Hypertension, Hypokalemia, and Fluid Retention due to Mineralocorticoid Excess [see Warnings and Precautions]. • Adrenocortical Insufficiency [see Warnings and Precautions]. • Hepatotoxicity [see Warnings and Precautions]. • Increased ZYTIGA Exposures with Food [see Warnings and Precautions]. Clinical Trial Experience: Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. Two randomized placebo-controlled, multicenter clinical trials enrolled patients who had metastatic castration-resistant prostate cancer who were using a gonadotropin-releasing hormone (GnRH) agonist or were previously treated with orchiectomy. In both Study 1 and Study 2 ZYTIGA was administered at a dose of 1,000 mg daily in combination with prednisone 5 mg twice daily in the active treatment arms. Placebo plus prednisone 5 mg twice daily was given to control patients. The most common adverse drug reactions (≥10%) reported in the two randomized clinical trials that occurred more commonly (>2%) in the abiraterone acetate arm were fatigue, joint swelling or discomfort, edema, hot flush, diarrhea, vomiting, cough, hypertension, dyspnea, urinary tract infection and contusion. The most common laboratory abnormalities (>20%) reported in the two randomized clinical trials that occurred more commonly (≥2%) in the abiraterone acetate arm were anemia, elevated alkaline phosphatase, hypertriglyceridemia, lymphopenia, hypercholesterolemia, hyperglycemia, elevated AST, hypophosphatemia, elevated ALT and hypokalemia. Study 1: Metastatic CRPC Following Chemotherapy: Study 1 enrolled 1195 patients with metastatic CRPC who had received prior docetaxel chemotherapy. Patients were not eligible if AST and/or ALT ≥ 2.5X ULN in the absence of liver metastases. Patients with liver metastases were excluded if AST and/or ALT > 5X ULN. Table  1 shows adverse reactions on the ZYTIGA arm in Study 1 that occurred with a ≥2% absolute increase in frequency compared to placebo or were events of special interest. The median duration of treatment with ZYTIGA was 8 months. Table 1: Adverse Reactions due to ZYTIGA in Study 1 ZYTIGA with Placebo with Prednisone (N=791) Prednisone (N=394) System/Organ Class All Grades1 Grade 3-4 All Grades Grade 3-4 Adverse reaction % % % % Musculoskeletal and connective tissue disorders 29.5 4.2 23.4 4.1 Joint swelling/discomfort2 Muscle discomfort3 26.2 3.0 23.1 2.3 General disorders Edema4 26.7 1.9 18.3 0.8 Vascular disorders Hot flush 19.0 0.3 16.8 0.3 Hypertension 8.5 1.3 6.9 0.3 Gastrointestinal disorders Diarrhea 17.6 0.6 13.5 1.3 Dyspepsia 6.1 0 3.3 0 Infections and infestations Urinary tract infection 11.5 2.1 7.1 0.5 Upper respiratory tract infection 5.4 0 2.5 0 Respiratory, thoracic and mediastinal disorders Cough 10.6 0 7.6 0 Renal and urinary disorders Urinary frequency 7.2 0.3 5.1 0.3 Nocturia 6.2 0 4.1 0 Injury, poisoning and procedural complications Fractures5 5.9 1.4 2.3 0 Cardiac disorders Arrhythmia6 7.2 1.1 4.6 1.0 Chest pain or chest discomfort7 3.8 0.5 2.8 0 Cardiac failure8 2.3 1.9 1.0 0.3 1 Adverse

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


ZYTIGA® (abiraterone acetate) Tablets

ZYTIGA® (abiraterone acetate) Tablets

4 Includes

1 Adverse

terms Edema, Edema peripheral, Pitting edema, and Generalized edema 5 Includes all fractures with the exception of pathological fracture 6 Includes terms Arrhythmia, Tachycardia, Atrial fibrillation, Supraventricular tachycardia, Atrial tachycardia, Ventricular tachycardia, Atrial flutter, Bradycardia, Atrioventricular block complete, Conduction disorder, and Bradyarrhythmia 7 Includes terms Angina pectoris, Chest pain, and Angina unstable. Myocardial infarction or ischemia occurred more commonly in the placebo arm than in the ZYTIGA arm (1.3% vs. 1.1% respectively). 8 Includes terms Cardiac failure, Cardiac failure congestive, Left ventricular dysfunction, Cardiogenic shock, Cardiomegaly, Cardiomyopathy, and Ejection fraction decreased Table 2 shows laboratory abnormalities of interest from Study 1. Grade 3-4 low serum phosphorus (7%) and low potassium (5%) occurred at a greater than or equal to 5% rate in the ZYTIGA arm. Table 2: Laboratory Abnormalities of Interest in Study 1 Abiraterone (N=791) Placebo (N=394) Laboratory All Grades Grade 3-4 All Grades Grade 3-4 Abnormality (%) (%) (%) (%) Hypertriglyceridemia 62.5 0.4 53.0 0 High AST 30.6 2.1 36.3 1.5 Hypokalemia 28.3 5.3 19.8 1.0 Hypophosphatemia 23.8 7.2 15.7 5.8 High ALT 11.1 1.4 10.4 0.8 High Total Bilirubin 6.6 0.1 4.6 0 Study 2: Metastatic CRPC Prior to Chemotherapy Study 2 enrolled 1088 patients with metastatic CRPC who had not received prior cytotoxic chemotherapy. Patients were ineligible if AST and/or ALT ≥ 2.5X ULN and patients were excluded if they had liver metastases. Table  3 shows adverse reactions on the ZYTIGA arm in Study 2 that occurred with a ≥ 2% absolute increase in frequency compared to placebo. The median duration of treatment with ZYTIGA was 13.8 months. Table 3: Adverse Reactions in ≥5% of Patients on the ZYTIGA Arm in Study 2 ZYTIGA with Placebo with Prednisone (N=542) Prednisone (N=540) System/Organ Class All Grades1 Grade 3-4 All Grades Grade 3-4 Adverse reaction % % % % General disorders Fatigue 39.1 2.2 34.3 1.7 Edema2 25.1 0.4 20.7 1.1 Pyrexia 8.7 0.6 5.9 0.2 Musculoskeletal and connective tissue disorders Joint swelling/ discomfort3 30.3 2.0 25.2 2.0 Groin pain 6.6 0.4 4.1 0.7 Gastrointestinal disorders Constipation 23.1 0.4 19.1 0.6 Diarrhea 21.6 0.9 17.8 0.9 Dyspepsia 11.1 0.0 5.0 0.2 Vascular disorders Hot flush 22.3 0.2 18.1 0.0 Hypertension 21.6 3.9 13.1 3.0 Respiratory, thoracic and mediastinal disorders Cough 17.3 0.0 13.5 0.2 Dyspnea 11.8 2.4 9.6 0.9 Psychiatric disorders Insomnia 13.5 0.2 11.3 0.0 Injury, poisoning and procedural complications Contusion 13.3 0.0 9.1 0.0 Falls 5.9 0.0 3.3 0.0 Infections and infestations Upper respiratory tract infection 12.7 0.0 8.0 0.0 Nasopharyngitis 10.7 0.0 8.1 0.0 Renal and urinary disorders Hematuria 10.3 1.3 5.6 0.6 Skin and subcutaneous tissue disorders Rash 8.1 0.0 3.7 0.0

events graded according to CTCAE version 3.0 terms Edema peripheral, Pitting edema, and Generalized edema 3 Includes terms Arthritis, Arthralgia, Joint swelling, and Joint stiffness 2 Includes

Table 4 shows laboratory abnormalities that occurred in greater than 15% of patients, and more frequently (>5%) in the ZYTIGA arm compared to placebo in Study 2. Grade 3-4 lymphopenia (9%), hyperglycemia (7%) and high alanine aminotransferase (6%) occurred at a greater than 5% rate in the ZYTIGA arm. Table 4: Laboratory Abnormalities in > 15% of Patients in the ZYTIGA Arm of Study 2 Abiraterone (N = 542) Placebo (N = 540) 1-4 Grade 3-4 Grade 1-4 Grade 3-4 Laboratory Abnormality Grade % % % % Hematology Lymphopenia 38.2 8.7 31.7 7.4 Chemistry Hyperglycemia1 56.6 6.5 50.9 5.2 High ALT 41.9 6.1 29.1 0.7 High AST 37.3 3.1 28.7 1.1 Hypernatremia 32.8 0.4 25.0 0.2 Hypokalemia 17.2 2.8 10.2 1.7 1Based on non-fasting blood draws Cardiovascular Adverse Reactions: In the combined data for studies 1 and 2, cardiac failure occurred more commonly in patients treated with ZYTIGA compared to patients on the placebo arm (2.1% versus 0.7%). Grade 3-4 cardiac failure occurred in 1.6% of patients taking ZYTIGA and led to 5 treatment discontinuations and 2 deaths. Grade 3-4 cardiac failure occurred in 0.2% of patients taking placebo. There were no treatment discontinuations and one death due to cardiac failure in the placebo group. In Study 1 and 2, the majority of arrhythmias were grade 1 or 2. There was one death associated with arrhythmia and one patient with sudden death in the ZYTIGA arms and no deaths in the placebo arms. There were 7 (0.5%) deaths due to cardiorespiratory arrest in the ZYTIGA arms and 3 (0.3%) deaths in the placebo arms. Myocardial ischemia or myocardial infarction led to death in 3 patients in the placebo arms and 2 deaths in the ZYTIGA arms. DRUG INTERACTIONS Effects of Abiraterone on Drug Metabolizing Enzymes: ZYTIGA is an inhibitor of the hepatic drug-metabolizing enzyme CYP2D6. In a CYP2D6 drug-drug interaction trial, the Cmax and AUC of dextromethorphan (CYP2D6 substrate) were increased 2.8- and 2.9-fold, respectively, when dextromethorphan was given with abiraterone acetate 1,000 mg daily and prednisone 5 mg twice daily. Avoid co-administration of abiraterone acetate with substrates of CYP2D6 with a narrow therapeutic index (e.g., thioridazine). If alternative treatments cannot be used, exercise caution and consider a dose reduction of the concomitant CYP2D6 substrate drug [see Clinical Pharmacology (12.3) in full Prescribing Information]. In vitro, ZYTIGA inhibits CYP2C8. There are no clinical data on the use of ZYTIGA with drugs that are substrates of CYP2C8. However, patients should be monitored closely for signs of toxicity related to the CYP2C8 substrate if used concomitantly with abiraterone acetate.  Drugs that Inhibit or Induce CYP3A4 Enzymes: Based on in vitro data, ZYTIGA is a substrate of CYP3A4. The effects of strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, atazanavir, nefazodone, saquinavir, telithromycin, ritonavir, indinavir, nelfinavir, voriconazole) or inducers (e.g.,  phenytoin, carbamazepine, rifampin, rifabutin, rifapentine, phenobarbital) on the pharmacokinetics of abiraterone have not been evaluated, in vivo. Avoid or use with caution, strong inhibitors and inducers of CYP3A4 during ZYTIGA treatment [see Clinical Pharmacology (12.3) in full Prescribing Information]. USE IN SPECIFIC POPULATIONS Pregnancy: Pregnancy Category X [see Contraindications].: ZYTIGA can cause fetal harm when administered to a pregnant woman based on its mechanism of action and findings in animals. While there are no adequate and well-controlled studies with ZYTIGA in pregnant women and ZYTIGA is not indicated for use in women, it is important to know that maternal use of a CYP17 inhibitor could affect development of the fetus. Abiraterone acetate caused developmental toxicity in pregnant rats at exposures that were lower than in patients receiving the recommended dose. ZYTIGA is contraindicated in women who are or may become pregnant while receiving the drug. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, apprise the patient of the potential hazard to the fetus and the potential risk for pregnancy loss. Advise females of reproductive potential to avoid becoming pregnant during treatment with ZYTIGA.


ZYTIGA® (abiraterone acetate) Tablets

ZYTIGA® (abiraterone acetate) Tablets

In an embryo-fetal developmental toxicity study in rats, abiraterone acetate caused developmental toxicity when administered at oral doses of 10, 30 or 100 mg/kg/day throughout the period of organogenesis (gestational days 6-17). Findings included embryo-fetal lethality (increased post implantation loss and resorptions and decreased number of live fetuses), fetal developmental delay (skeletal effects) and urogenital effects (bilateral ureter dilation) at doses ≥10 mg/kg/day, decreased fetal ano-genital distance at ≥30 mg/kg/day, and decreased fetal body weight at 100 mg/kg/ day. Doses ≥10 mg/kg/day caused maternal toxicity. The doses tested in rats resulted in systemic exposures (AUC) approximately 0.03, 0.1 and 0.3 times, respectively, the AUC in patients. Nursing Mothers: ZYTIGA is not indicated for use in women. It is not known if abiraterone acetate is excreted in human milk. Because many drugs are excreted in human milk, and because of the potential for serious adverse reactions in nursing infants from ZYTIGA, a decision should be made to either discontinue nursing, or discontinue the drug taking into account the importance of the drug to the mother. Pediatric Use: Safety and effectiveness of ZYTIGA in pediatric patients have not been established. Geriatric Use: Of the total number of patients receiving ZYTIGA in phase 3 trials, 73% of patients were 65 years and over and 30% were 75  years and over. No overall differences in safety or effectiveness were observed between these elderly patients and younger patients. Other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Patients with Hepatic Impairment: The pharmacokinetics of abiraterone were examined in subjects with baseline mild (n  =  8) or moderate (n  =  8) hepatic impairment (Child-Pugh Class A and B, respectively) and in 8 healthy control subjects with normal hepatic function. The systemic exposure (AUC) of abiraterone after a single oral 1,000 mg dose of ZYTIGA increased by approximately 1.1-fold and 3.6-fold in subjects with mild and moderate baseline hepatic impairment, respectively compared to subjects with normal hepatic function. No dosage adjustment is necessary for patients with baseline mild hepatic impairment. In patients with baseline moderate hepatic impairment (ChildPugh Class B), reduce the recommended dose of ZYTIGA to 250 mg once daily. If elevations in ALT or AST >5X ULN or total bilirubin >3X ULN occur in patients with baseline moderate hepatic impairment, discontinue ZYTIGA treatment [see Dosage and Administration (2.1) and Clinical Pharmacology (12.3) in full Prescribing Information]. The safety of ZYTIGA in patients with baseline severe hepatic impairment has not been studied. These patients should not receive ZYTIGA. For patients who develop hepatotoxicity during treatment, interruption of treatment and dosage adjustment may be required [see Dosage and Administration (2.2) in full Prescribing Information, Warnings and Precautions, and Clinical Pharmacology (12.3) in full Prescribing Information]. Patients with Renal Impairment: In a dedicated renal impairment trial, the mean PK parameters were comparable between healthy subjects with normal renal function (N=8) and those with end stage renal disease (ESRD) on hemodialysis (N=8) after a single oral 1,000 mg dose of ZYTIGA. No dosage adjustment is necessary for patients with renal impairment [see Dosage and Administration (2.1) and Clinical Pharmacology (12.3) in full Prescribing Information]. OVERDOSAGE There have been no reports of overdose of ZYTIGA during clinical studies. There is no specific antidote. In the event of an overdose, stop ZYTIGA, undertake general supportive measures, including monitoring for arrhythmias and cardiac failure and assess liver function. Storage and Handling: Store at 20oC to 25oC (68oF to 77oF); excursions permitted in the range from 15oC to 30oC (59oF to 86°F) [see USP controlled room temperature]. Based on its mechanism of action, ZYTIGA may harm a developing fetus. Therefore, women who are pregnant or women who may be pregnant should not handle ZYTIGA without protection, e.g., gloves [see Use in Specific Populations].

• Patients receiving GnRH agonists should be informed that they need to maintain this treatment during the course of treatment with ZYTIGA and prednisone. • Patients should be informed that ZYTIGA must not be taken with food and that no food should be consumed for at least two hours before the dose of ZYTIGA is taken and for at least one hour after the dose of ZYTIGA is taken. They should be informed that the tablets should be swallowed whole with water without crushing or chewing. Patients should be informed that taking ZYTIGA with food causes increased exposure and this may result in adverse reactions. • Patients should be informed that ZYTIGA is taken once daily and prednisone is taken twice daily according to their physician’s instructions. • Patients should be informed that in the event of a missed daily dose of ZYTIGA or prednisone, they should take their normal dose the following day. If more than one daily dose is skipped, patients should be told to inform their physician. • Patients should be apprised of the common side effects associated with ZYTIGA, including peripheral edema, hypokalemia, hypertension, elevated liver function tests, and urinary tract infection. Direct the patient to a complete list of adverse drug reactions in PATIENT INFORMATION. • Patients should be advised that their liver function will be monitored using blood tests. • Patients should be informed that ZYTIGA may harm a developing fetus; thus, women who are pregnant or women who may be pregnant should not handle ZYTIGA without protection, e.g., gloves. Patients should also be informed that it is not known whether abiraterone or its metabolites are present in semen and they should use a condom if having sex with a pregnant woman. The patient should use a condom and another effective method of birth control if he is having sex with a woman of child-bearing potential. These measures are required during and for one week after treatment with ZYTIGA.

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

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


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

K08Z121176

Contraindications ZYTIGA® (abiraterone acetate) is not indicated for use in women. ZYTIGA® can cause fetal harm (Pregnancy Category X) when administered to a pregnant woman and is contraindicated in women who are or may become pregnant. Hypertension, Hypokalemia and Fluid Retention Due to Mineralocorticoid Excess Use with caution in patients with a history of cardiovascular disease or with medical conditions that might be compromised by increases in blood pressure, hypokalemia, or fluid retention. ZYTIGA® may cause hypertension, hypokalemia, and fluid retention as a consequence of increased mineralocorticoid levels resulting from CYP17 inhibition. Safety has not been established in patients with LVEF <50% or New York Heart Association (NYHA) Class III or IV heart failure (in study 1) or NYHA Class II to IV heart failure (in study 2) because these patients were excluded from these randomized clinical trials. Control hypertension and correct hypokalemia before and during treatment. Monitor blood pressure, serum potassium, and symptoms of fluid retention at least monthly. Adrenocortical Insufficiency (AI) AI was reported in patients receiving ZYTIGA® in combination with prednisone, after an interruption of daily steroids and/or with concurrent infection or stress. Use caution and monitor for symptoms and signs of AI if prednisone is stopped or withdrawn, if prednisone dose is reduced, or if the patient experiences unusual stress. Symptoms and signs of AI may be masked by adverse reactions associated with mineralocorticoid excess seen in patients treated with ZYTIGA®. Perform appropriate tests, if indicated, to confirm AI. Increased dosages of corticosteroids may be used before, during, and after stressful situations. Hepatotoxicity Monitor liver function and modify, withhold, or discontinue ZYTIGA® dosing as recommended (see Prescribing Information for more information). Measure serum transaminases [alanine aminotransferase (ALT) and aspartate aminotransferase (AST)] and bilirubin levels prior to starting treatment with ZYTIGA®, every two weeks for the first three months of treatment, and monthly thereafter. Promptly measure serum total bilirubin, AST, and ALT if clinical symptoms or signs suggestive of hepatotoxicity develop. Elevations of AST, ALT, or bilirubin from the patient’s baseline should prompt more frequent monitoring. If at any time AST or ALT rise above five times the upper limit of normal (ULN) or the bilirubin rises above three times the ULN, interrupt ZYTIGA® treatment and closely monitor liver function. Increased ZYTIGA® Exposures with Food ZYTIGA® must be taken on an empty stomach. No food should be eaten for at least two hours before the dose of ZYTIGA® is taken and for at least one hour after the dose of ZYTIGA® is taken. Abiraterone Cmax and AUC0-∞ (exposure) were increased up to 17- and 10-fold higher, respectively, when a single dose of abiraterone acetate was administered with a meal compared to a fasted state. Adverse Reactions The most common adverse reactions (≥10%) are fatigue, joint swelling or discomfort, edema, hot flush, diarrhea, vomiting, cough, hypertension, dyspnea, urinary tract infection and contusion. The most common laboratory abnormalities (>20%) are anemia, elevated alkaline phosphatase, hypertriglyceridemia, lymphopenia, hypercholesterolemia, hyperglycemia, elevated AST, hypophosphatemia, elevated ALT and hypokalemia. Drug Interactions ZYTIGA® is an inhibitor of the hepatic drug-metabolizing enzyme CYP2D6. Avoid co-administration with CYP2D6 substrates that have a narrow therapeutic index. If an alternative cannot be used, exercise caution and consider a dose reduction of the CYP2D6 substrate. In vitro, ZYTIGA® inhibits CYP2C8. There are no clinical data on its use with drugs that are substrates of CYP2C8. Patients should be monitored closely for signs of toxicity related to the CYP2C8 substrate if used concomitantly with abiraterone acetate. Based on in vitro data, ZYTIGA® is a substrate of CYP3A4. The effects of strong CYP3A4 inhibitors or inducers on the pharmacokinetics of abiraterone have not been evaluated, in vivo. Strong inhibitors and inducers of CYP3A4 should be avoided or used with caution during treatment with ZYTIGA®. Use in Specific Populations Do not use ZYTIGA® in patients with baseline severe hepatic impairment (Child-Pugh Class C). Please see Brief Summary of Prescribing Information on adjacent pages.

© Janssen Biotech, Inc. 2013

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Please see Important Safety Information on back, and Brief Summary of Prescribing Information on adjacent pages. Patient insurance benefit investigation is provided as a service by TheraCom, LLC and The Lash Group, Inc., under contract for Janssen Biotech, Inc. In this regard, TheraCom, LLC, and The Lash Group, Inc., assist healthcare professionals in the determination of whether treatment could be covered by the applicable third-party payer based on coverage guidelines provided by the payer and patient information provided by the healthcare provider under appropriate authorization following the provider’s exclusive determination of medical necessity. Importantly, insurance verification is the ultimate responsibility of the provider. Third-party reimbursement is affected by many factors. Therefore, TheraCom, LLC, The Lash Group, Inc., and Janssen Biotech make no representation or guarantee that full or partial insurance reimbursement or any other payment will be available. This information is provided as an information service only. While TheraCom, LLC, and The Lash Group, Inc., try to provide correct information, they and Janssen Biotech make no representations or warranties, expressed or implied, as to the accuracy of the information. In no event shall TheraCom, LLC, The Lash Group, Inc., or Janssen Biotech or its employees or agents be liable for any damages resulting from or relating to the services. All providers and other users of this information agree that they accept responsibility for the use of this service. Janssen Biotech assumes no responsibility for, and does not guarantee the quality, scope, or availability of the services including but not limited to reimbursement support services, patient education, and other support services. Each provider, not Janssen Biotech, is responsible for the services they provide. These support services have no independent value to providers apart from the product and are included within the cost of the product. © Janssen Biotech, Inc. 2013

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