Clinical Policy: (Tasigna) Reference Number: CP.CPA.162 Effective Date: 11.16.16 Last Review Date: 11.17 Line of Business: Commercial Revision Log See Important Reminder at the end of this policy for important regulatory and legal information. Description (Tasigna ) is a kinase inhibitor. FDA approved indication Tasigna is indicated: For the treatment of newly diagnosed adult patients with Philadelphia chromosome positive chronic myelogenous leukemia (Ph+ CML) in chronic phase For the treatment of chronic phase and accelerated phase Ph+ CML in adult patients resistant to or intolerant to prior therapy that included imatinib (Gleevec ) Policy/Criteria Provider must submit documentation (which may include office chart notes and lab results) supporting that member has met all approval criteria It is the policy of health plans affiliated with Centene Corporation that Tasigna is medically necessary when the following criteria are met: I. Initial Approval Criteria A. Newly Diagnosed Philadelphia Chromosome Positive Chronic Myeloid Leukemia (Ph+ CML) (must meet all): 1. Patient is newly diagnosed with Ph+ CML in chronic phase; 2. Dose does not exceed 600 mg/day. B. Resistant or Intolerant Ph+ CML (must meet all): 1. Diagnosis of resistant or intolerant chronic or accelerated phase (AP) Ph+ CML 2. Failure of imatinib (Gleevec ) unless contraindicated or clinically significant adverse effects are experienced; 3. Dose does not exceed. C. Soft Tissue Sarcoma-Gastrointestinal Stromal Tumor (GIST) (off-label) (must meet all): 1. Diagnosis of GIST; 2. Failure of imatinib (Gleevec ), Sutent, or Stivarga unless contraindicated or clinically significant adverse effects are experienced; Page 1 of 6
3. Dose does not exceed. D. Acute Lymphoblastic Leukemia (ALL) (off-label) (must meet all): 1. Diagnosis of ALL according to the NCCN guidelines (Class 2A recommendation); 2. Dose does not exceed. E. Other diagnoses/indications 1. Refer to CP.CPA.09 if diagnosis is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) II. Continued Therapy A. All Indications in Section I (must meet all): 1. Currently receiving medication via Centene benefit or member has previously met initial approval criteria; 2. Member is responding positively to therapy; 3. Dose does not exceed (600 mg/day for newly diagnosed CML). B. Other diagnoses/indications (must meet 1 or 2): 1. Currently receiving medication via Centene benefit and documentation supports positive response to therapy. Approval duration: Duration of request or 12 months (whichever is less); or 2. Refer to CP.CPA.09 if diagnosis is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) III. Diagnoses/Indications for which coverage is NOT authorized: A. Non-FDA approved indications, which are not addressed in this policy, unless there is sufficient documentation of efficacy and safety according to the off label use policy CP.CPA.09 or evidence of coverage documents; B. Patients with hypokalemia, hypomagnesemia, or long QT syndrome. IV. Appendices/General Information Appendix A: Abbreviation/Acronym Key Ph+ CML: Philadelphia chromosome positive chronic myelogenous leukemia CP: Chronic phase AP: Accelerated phase GIST: Soft tissue sarcoma-gastrointestinal stromal tumor ALL: Acute Lymphoblastic Leukemia Appendix B: General Information Tasigna prolongs the QT interval. It has a black box warning reporting sudden deaths in patients receiving Tasigna and it should not be used in patients with hypokalemia, hypomagnesemia, or long QT syndrome. ECGs should be obtained to monitor the QTc at baseline, seven days after initiation, and periodically thereafter, as well as following any dose adjustments. Page 2 of 6
Tasigna is the only protein tyrosine kinase inhibitor that is not approved for blast crisis of CML. CML is a myeloproliferative disorder that arises from genetic defects in hematopoietic stem cells, and is associated with an increased production of mature and immature blood cells, which progresses through three "phases". Most patients present in chronic phase, progress through an accelerated phase (although some patients skip this phase), and then die after entering a brief phase, blast crisis. Per NCCN Drugs and Biologics Compendium, Tasigna has a category 2A rating for GIST for progressive disease after patient is no longer receiving benefit from imatinib, Sutent, or Stivarga. Fetal harm can occur when administered to a pregnant woman. Sexually active female patients should use effective contraception during treatment and should be advised not to become pregnant when taking Tasigna. Appendix C: Therapeutic Alternatives Drug Dosing Regimen Dose Limit/ Imatinib (Gleevec ) Newly diagnosed Ph+ CML in chronic phase: 400 mg PO QD Maximum Dose Sprycel (dasatinib)* Ph+ CML blast or accelerated phase: 600 mg PO QD GIST: 400 mg PO QD Newly diagnosed Ph+ CML in chronic phase: 100 mg PO QD 180 mg/day Ph+ CML blast or accelerated phase: 140 mg PO QD Sutent (sunitinib) GIST: 50 mg PO QD 87.5 mg/day Therapeutic alternatives are listed as Brand name (generic) when the drug is available by brand name only and generic (Brand name ) when the drug is available by both brand and generic *Requires Prior Authorization V. Dosage and Administration Drug Dosing Regimen Dose Limit/ Maximum Dose Tasigna (nilotinib) Newly diagnosed Ph+ CML: 300 mg PO BID Newly diagnosed Ph+ CML: 600 mg/day Resistant or intolerant Ph+ CML chronic or accelerated phase: 400 mg PO BID GIST: 400 mg PO BID Resistant or intolerant Ph+ CML chronic or accelerated phase: GIST: ALL: Page 3 of 6
Drug Dosing Regimen Dose Limit/ Maximum Dose ALL: 400 mg PO BID VI. Product Availability Capsules: 150 mg and 200 mg VII. References 1. Tasigna [Prescribing Information] East Hanover, NJ: Novartis Pharmaceuticals; September 2016. 2. National Comprehensive Cancer Network. Chronic Myelogenous Leukemia Version 1.2015. Available at http://www.nccn.org. Accessed January 2017. 3. National Comprehensive Cancer Network Drugs and Biologics Compendium. Available at http://www.nccn.org/professionals/drug_compendium. Accessed January 2017. 4. Micromedex Healthcare Series [Internet database]. Greenwood Village, Colo: Thomson Healthcare. Updated periodically. Accessed January 2017. 5. Tasigna. American Hospital Formulary Service Drug Information. AHFS Web site. Available at: http://www.medicinescomplete.com/. Accessed January 2017.National Comprehensive Cancer Network. Soft Tissue Sarcoma. Version.1.2015. Available at http://www.nccn.org. Accessed January 2017. 6. Tasigna Clinical Pharmacology Web site. Available at: http://www.clinicalpharmacology-ip.com/. Accessed January 2017. 7. Kantarjian H, Giles, F, Wunderle L, et al. in Imatinib-Resistant CML and Philadelphia Chromosome Positive ALL. N Engl J Med 2006; 354:2542-2551 8. Montemurro M, Schoffski P, Reichardt P, et al. in the treatment of advanced gastrointestinal stromal tumours resistant to both imatinib and sunitinib. Eur J Cancer 2009 Sep; 45(13):2293-2297 9. Sawaki A, Nishida T, Doi T, et al. Phase 2 study of nilotinib as third-line therapy for patients with gastrointestinal stromal tumor. Cancer. 2011 Oct 15; 117(20):4633-4641. Reviews, Revisions, and Approvals Date P&T Approval Date Converted to new template. Minor changes to verbiage and grammar. References updated. 01.11.17 11.17 Important Reminder This clinical policy has been developed by appropriately experienced and licensed health care professionals based on a review and consideration of currently available generally accepted standards of medical practice; peer-reviewed medical literature; government agency/program approval status; evidence-based guidelines and positions of leading national health professional organizations; views of physicians practicing in relevant clinical areas affected by this clinical policy; and other available clinical information. The Health Plan makes no representations and accepts no liability with respect to the content of any external information used or relied upon in developing this clinical policy. This clinical policy is consistent with standards of medical practice Page 4 of 6
current at the time that this clinical policy was approved. Health Plan means a health plan that has adopted this clinical policy and that is operated or administered, in whole or in part, by Centene Management Company, LLC, or any of such health plan s affiliates, as applicable. The purpose of this clinical policy is to provide a guide to medical necessity, which is a component of the guidelines used to assist in making coverage decisions and administering benefits. It does not constitute a contract or guarantee regarding payment or results. Coverage decisions and the administration of benefits are subject to all terms, conditions, exclusions and limitations of the coverage documents (e.g., evidence of coverage, certificate of coverage, policy, contract of insurance, etc.), as well as to state and federal requirements and applicable Health Plan-level administrative policies and procedures. This clinical policy is effective as of the date determined by the Health Plan. The date of posting may not be the effective date of this clinical policy. This clinical policy may be subject to applicable legal and regulatory requirements relating to provider notification. If there is a discrepancy between the effective date of this clinical policy and any applicable legal or regulatory requirement, the requirements of law and regulation shall govern. The Health Plan retains the right to change, amend or withdraw this clinical policy, and additional clinical policies may be developed and adopted as needed, at any time. This clinical policy does not constitute medical advice, medical treatment or medical care. It is not intended to dictate to providers how to practice medicine. Providers are expected to exercise professional medical judgment in providing the most appropriate care, and are solely responsible for the medical advice and treatment of members. This clinical policy is not intended to recommend treatment for members. Members should consult with their treating physician in connection with diagnosis and treatment decisions. Providers referred to in this clinical policy are independent contractors who exercise independent judgment and over whom the Health Plan has no control or right of control. Providers are not agents or employees of the Health Plan. This clinical policy is the property of the Health Plan. Unauthorized copying, use, and distribution of this clinical policy or any information contained herein are strictly prohibited. Providers, members and their representatives are bound to the terms and conditions expressed herein through the terms of their contracts. Where no such contract exists, providers, members and their representatives agree to be bound by such terms and conditions by providing services to members and/or submitting claims for payment for such services. Note: For Medicaid members, when state Medicaid coverage provisions conflict with the coverage provisions in this clinical policy, state Medicaid coverage provisions take precedence. Please refer to the state Medicaid manual for any coverage provisions pertaining to this clinical policy. 2016 Centene Corporation. All rights reserved. All materials are exclusively owned by Centene Corporation and are protected by United States copyright law and international copyright law. No part of this publication may be reproduced, copied, modified, distributed, displayed, stored in a Page 5 of 6
retrieval system, transmitted in any form or by any means, or otherwise published without the prior written permission of Centene Corporation. You may not alter or remove any trademark, copyright or other notice contained herein. Centene and Centene Corporation are registered trademarks exclusively owned by Centene Corporation. Page 6 of 6