Clinical Policy: Sunitinib (Sutent) Reference Number: ERX.SPMN.118 Effective Date: 03/14 Coding Implications Last Review Date: 09/16 Revision Log See Important Reminder at the end of this policy for important regulatory and legal information. Policy/Criteria It is the policy of health plans affiliated with Envolve Pharmacy Solutions® that sunitinib (Sutent®) is medically necessary when one of the following criteria are met: I. Initial Approval Criteria A. Gastrointestinal Stromal Tumor (must meet all): 1. Diagnosis of gastrointestinal stromal tumor (GIST); 2. Member has demonstrated disease progression on or intolerance to imatinib mesylate; 3. Prescribed regimen of Sutent does not exceed 50 mg per day on a schedule of 4 weeks on treatment followed by 2 weeks off. Approval duration: 3 months B. Renal Cell Carcinoma (must meet all): 1. Diagnosis of renal cell carcinoma (RCC); 2. Member has relapsed or stage IV disease; 3. Prescribed regimen of Sutent does not exceed 50 mg per day on a schedule of 4 weeks on treatment followed by 2 weeks off. Approval duration: 3 months C. Pancreatic Neuroendocrine Tumors (must meet all): 1. Diagnosis of pancreatic neuroendocrine tumor (pNET); 2. pNET is unresectable locally advanced or metastatic; 3. Prescribed dose of Sutent does not exceed 50 mg per day. Approval duration: 3 months D. Other diagnoses/indications: Refer to ERX.SPMN.16 - Global Biopharm Policy. 1. Additional Sutent uses, as outlined in the NCCN compendium and meeting NCCN category 1, 2a, or 2b, are covered for the following indications per the ERX.SPMN.16 Global Biopharm Policy: a. Bone cancer- chordoma; b. Central nervous system cancers- meningiomas; c. Lung neuroendocrine tumors; d. Soft tissue sarcoma- alveolar soft part sarcoma (ASPS); e. Soft tissue sarcoma- angiosarcoma Page 1 of 4 CLINICAL POLICY Sunitinib f. Soft tissue sarcoma- solitary fibrous tumor/hemangiopericytoma; g. Thymomas and thymic carcinomas; h. Thyroid carcinoma- follicular carcinoma; i. Thyroid carcinoma- Hurthle cell carcinoma; j. Thyroid carcinoma- medullary carcinoma; k. Thyroid carcinoma- papillary carcinoma. II. Continued Approval A. All Indications (GIST, RCC, and pNET) (must meet all): 1. Currently receiving medication via health plan benefit or member has previously met all initial approval criteria; 2. Prescribed dosage regimen does not exceed the following: a. For GIST or RCC: 50 mg per day on a schedule of 4 weeks on treatment followed by 2 weeks off; b. For pNET: 50 mg per day. Approval duration: 6 months B. Other diagnoses/indications (must meet 1 or 2): 1. Currently receiving medication via health plan benefit and documentation supports positive response to therapy; or 2. Refer to ERX.SPMN.16 - Global Biopharm Policy. Background Description/Mechanism of Action: Sunitinib is a small molecule that inhibits multiple receptor tyrosine kinases (RTKs), some of which are implicated in tumor growth, pathologic angiogenesis, and metastatic progression of cancer. Sunitinib was evaluated for its inhibitory activity against a variety of kinases (>80 kinases) and was identified as an inhibitor of platelet-derived growth factor receptors (PDGFRα and PDGFRβ), vascular endothelial growth factor receptors (VEGFR1, VEGFR2 and VEGFR3), stem cell factor receptor (KIT), Fms-like tyrosine kinase-3 (FLT3), colony stimulating factor receptor Type 1 (CSF-1R), and the glial cell-line derived neurotrophic factor receptor (RET). Sunitinib inhibition of the activity of these RTKs has been demonstrated in biochemical and cellular assays, and inhibition of function has been demonstrated in cell proliferation assays. The primary metabolite exhibits similar potency compared to sunitinib in biochemical and cellular assays. Sunitinib inhibited the phosphorylation of multiple RTKs (PDGFRβ, VEGFR2, KIT) in tumor xenografts expressing RTK targets in vivo and demonstrated inhibition of tumor growth or tumor regression and/or inhibited metastases in some experimental models of cancer. Sunitinib demonstrated the ability to inhibit growth of tumor cells expressing dysregulated target RTKs (PDGFR, RET, or KIT) in vitro and to inhibit PDGFRβ- and VEGFR2-dependent tumor angiogenesis in vivo. Page 2 of 4 CLINICAL POLICY Sunitinib Formulations: Sutent is available in 12.5 mg, 25 mg, 37.5 mg, and 50 mg capsules for oral administration. FDA Approved Indications: Sutent is a multi-kinase inhibitor/oral capsule formulation indicated for the treatment of patients with: Gastrointestinal stromal tumor (GIST) after disease progression on or intolerance to imatinib mesylate. Advanced renal cell carcinoma (RCC). Progressive, well-differentiated pancreatic neuroendocrine tumors (pNET) in patients with unresectable locally advanced or metastatic disease. Appendices Appendix A: Abbreviation Key ASPS: alveolar soft part sarcoma CSF-1R: colony stimulating factor receptor Type 1 FLT3: Fms-like tyrosine kinase-3 GIST: gastrointestinal stromal tumor KIT: stem cell factor receptor PDGFR: platelet-derived growth factor receptors pNET: pancreatic neuroendocrine tumor RCC: renal cell carcinoma RET: glial cell-line derived neurotrophic factor receptor RTKs: receptor tyrosine kinases VEGFR: vascular endothelial growth factor receptors Coding Implications Codes referenced in this clinical policy are for informational purposes only. Inclusion or exclusion of any codes does not guarantee coverage. Providers should reference the most up-to-date sources of professional coding guidance prior to the submission of claims for reimbursement of covered services. HCPCS Description Codes Reviews, Revisions, and Approvals Date Approval Date Policy created. 02/1 03/14 4 Policy converted to new template. 08/1 09/16 Removed all safety criteria. Added dosing criteria per PI. Modified 6 approval duration to 3 months for initial and 6 months for re-auth. Page 3 of 4 CLINICAL POLICY Sunitinib Reviews, Revisions, and Approvals Date Approval Date Added NCCN compendial uses that are approvable via global biopharm policy. RCC: clarified “advanced disease” as “relapsed or stage IV”. pNET: removed requirement for disease to be progressive. References 1. Sutent Prescribing Information. New York, NY: Pfizer Inc.; April 2015. Available at: http://www.sutent.com/. Accessed July 21, 2016. 2. Sunitinib malate. In: National Comprehensive Cancer Network Drugs and Biologics Compendium. Available at www.NCCN.org. Accessed July 21, 2016. 3. Kidney Cancer (Version 3.2016). In: National Comprehensive Cancer Network Guidelines. Available at www.NCCN.org. Accessed July 25, 2016. 4. Neuroendocrine Tumors (Version 2.2016). In: National Comprehensive Cancer Network Guidelines. Available at www.NCCN.org. Accessed July 25, 2016. 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. This Clinical Policy is not intended to dictate to providers how to practice medicine, nor does it constitute a contract or guarantee regarding payment or results. 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 policy is the property of Envolve Pharmacy Solutions. Unauthorized copying, use, and distribution of this Policy or any information contained herein is strictly prohibited. By accessing this policy, you agree to be bound by the foregoing terms and conditions, in addition to the Site Use Agreement for Health Plans associated with Envolve Pharmacy Solutions. ©2016 Envolve Pharmacy Solutions. All rights reserved. All materials are exclusively owned by Envolve Pharmacy Solutions 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 retrieval system, transmitted in any form or by any means, or otherwise published without the prior written permission of Envolve Pharmacy Solutions. You may not alter or remove any trademark, copyright or other notice contained herein. Page 4 of 4 .