Subject: Cotellic 1784-A SGM P2022a

Drug

COTELLIC  (cobimetinib)

Policy:

      I.  INDICATIONS

           The indications below including FDA-approved indications and
           compendial uses are considered a covered benefit provided that all the
           approval criteria are met, and the member has no exclusions to the
           prescribed therapy.

           A.  FDA-Approved Indication
                1. Cotellic is indicated for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or
                    V600K mutation, in combination with vemurafenib.
                2. Cotellic is indicated as a single agent for the treatment of adult patients with histiocytic neoplasms.

           B.  Compendial Uses
                1.  Glioma, BRAF V600 activating mutation-positive
                2.  Meningioma, BRAF V600 activating mutation-positive
                3.  Astrocytoma, BRAF V600 activating mutation-positive
                4.  Cutaneous melanoma, adjuvant systemic therapy

           All other indications are considered experimental/investigational and
           not medically necessary.

 

    II.  DOCUMENTATION

           Submission of BRAF mutation documentation is necessary to initiate the
          prior authorization review for applicable indications as outlined in section
          III.

 

   III.  CRITERIA FOR INITIAL APPROVAL

           A.  Cutaneous Melanoma
                Authorization of 12 months may be granted for treatment of
                cutaneous melanoma with a BRAF V600 activating mutation (e.g.,
                V600E or V600K) in any of the following settings:
                1.  Unresectable or metastatic disease when used in combination
                     with vemurafenib (Zelboraf) with or without atezolizumab
                     (Tecentriq).
                2.  Adjuvant treatment of stage III disease in combination with
                     vemurafenib (Zelboraf) following complete resection or no
                     evidence of disease, when the member has had an unacceptable
                     toxicity to dabrafenib (Tafinlar) in combination with trametinib
                     (Mekinist)

           B.  Central Nervous System Cancer
                Authorization of 12 months may be granted for treatment of BRAF
                V600 mutation-positive (e.g., BRAF V600E or V600K mutations)
                gliomas, meningiomas, or astrocytomas.

           C.  Histiocytic Neoplasms
                Authorization of 12 months may be granted for treatment of histiocytic neoplasms as a single agent.

 

     IV.  CONTINUATION OF THERAPY

            Authorization of 12 months may be granted for continued treatment in
            members requesting reauthorization for an indication listed in Section
            III when there is no evidence of unacceptable toxicity or disease
            progression while on the current regimen.

Place of Service:

Outpatient

The above policy is based on the following references:

1. Cotellic [package insert]. South San Francisco, CA: Genentech USA, Inc.; October 2022.
2. The NCCN Drugs & Biologics Compendium 2021 National Comprehensive Cancer Network, Inc. http://www.nccn.org. Accessed November 3, 2021.
3. Usubalieva A, Pierson CR, Kavran CA, et al. Primary Meningeal Pleomorphic Xanthoastrocytoma With Anaplastic Features: A Report of 2 Cases, One With BRAFV600E Mutation and Clinical Response to the BRAF Inhibitor Dabrafenib. Journal of neuropathology and experimental neurology. 2015;74(10):960-969. doi:10.1097/NEN.0000000000000240.
4. Mordechai O, Postovsky S, Vlodavsky E, et al. Metastatic Rhabdoid Meningioma with BRAF V600E Mutation and Good Response to Personalized Therapy: Case Report and Review of the Literature. Pediatric Hematology and Oncology. 2015; 32:3, 207-211, DOI: 3109/08880018.2014.936058
5. Lassaletta, A, Guerreiro Stucklin, A, Ramaswamy, V, et al. Profound clinical and radiological response to BRAF inhibition in a 2‐month‐old diencephalic child with hypothalamic/chiasmatic glioma. Pediatric Blood and Cancer. 2016; 63: 2038-2041. doi:1002/pbc.26086.
6. Meletah SK, Pavlick D, Brennan T, et al. Personalized Treatment for a Patient with a BRAF V600E Mutation using Dabrafenib and a Tumor Treatment Fields Device in a High-Grade Glioma Arising from Ganglioglioma. Journal of the National Comprehensive Cancer Network. 2016; 14(11): 1345-1350.

Copyright Aetna Inc. All rights reserved. Pharmacy Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.

December 17, 2022