Subject: Cotellic 1784-A SGM P2023

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 adult 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

          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 resected stage III disease in
                    combination with vemurafenib (Zelboraf) when the
                    member has had an unacceptable toxicity to dabrafenib
                    (Tafinlar) in combination with trametinib (Mekinist) or
                    dabrafenib/trametinib are less desirable based on side-
                    effect profiles.
               3.  Limited resectable local satellite/in-transit recurrent
                    disease in combination with vemurafenib (Zelboraf) when
                    the member has had an unacceptable toxicity to
                    dabrafenib (Tafinlar) in combination with trametinib
                    (Mekinist) or dabrafenib/trametinib are less desirable
                    based on side-effect profiles.

          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 2022 National Comprehensive Cancer Network, Inc. https://www.nccn.org. Accessed November 14, 2022.
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.

May 15, 2023