Market Applicability Market GA KY MD NJ NY WA Applicable X NA X X X X

Cotellic (cobimetinib)

Override(s) Approval Duration Prior Authorization 1 year Quantity Limit

Medications Quantity Limit Cotellic (cobimetinib) May be subject to quantity limit

APPROVAL CRITERIA

Requests for Cotellic (cobimetinib) may be approved if the following criteria are met:

I. Individual has a diagnosis of unresectable or metastatic Melanoma (Label, NCCN 1, 2A); AND A. Individual has BRAF V600E or V600K mutation (or BRAF V600 activating mutation), with test results confirmed; AND B. Individual is using in combination with vemurafenib with or without atezolizumab (Tecentriq 2020);

OR II. Individual has a diagnosis of Central Nervous System cancer (NCCN 2A); AND A. Individual is using in combination with vemurafenib; AND B. Individual is using as adjuvant therapy for primary CNS cancer; AND C. Individual has BRAF V600E mutation with test result confirmed.

Key References:

1. Clinical Pharmacology [database online]. Tampa, FL: Gold Standard, Inc.: 2020. URL: http://w w w.clinicalpharmacology.com. Updated periodically. 2. DailyMed. Package inserts. U.S. National Library of Medicine, National Institutes of Health w ebsite. http://dailymed.nlm.nih.gov/daily med/about.cfm. Accessed: August 7, 2020. 3. DrugPoints® System [electronic version]. Truven Health Analytics, Greenw ood Village, CO. Updated periodically. 4. Lexi-Comp ONLINE™ w ith AHFS™, Hudson, Ohio: Lexi-Comp, Inc.; 2020; Updated periodically. 5. NCCN Clinical Practice Guidelines in Oncology™. © 2020 National Comprehensive Cancer Netw ork, Inc. For additional information visit the NCCN w ebsite: http://w w w.nccn.org/index.asp. Accessed on September 10, 2020.

a. Central Nervous System Cancers. V2.2020. Revised April 20, 2020.

b. Cutaneous Melanoma. V4.2020. Revised September 1, 2020.

PAGE 1 of 2 11/23/2020 CRX-ALL-0627-20 This policy does not apply to health plans or member categories that do not have pharmacy benefits, nor does it apply to Medicare. Note that market specific restrictions or transition-of-care benefit limitations may apply. Market Applicability Market GA KY MD NJ NY WA Applicable X NA X X X X

6. Tecentriq (atezolizumab). 2016. Revised 7/2020. Drugs@FDA: FDA-Approved Drugs. U.S. Food & Drug Administration, U.S. Department of Health and Human Services. Available at https://w ww.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview .process&ApplNo=761034. Accessed August 7, 2020.

Federal and state law s or requirements, contract language, and Plan utilization management programs or polices may take precedence over the application of this clinical criteria.

No part of this publication may be reproduced, stored in a retrieval system or transmitted, in any form or by any means, electronic, mechanical, photocopying, or otherw ise, w ithout permission from the health plan.

PAGE 2 of 2 11/23/2020

This policy does not apply to health plans or member categories that do not have pharmacy benefits, nor does it apply to Medicare. Note that market specific restrictions or transition-of-care benefit limitations may apply.