Subject: Cotellic 1784-A SGM P2024a

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 BRAF V600 mutation-positive
               (e.g., BRAF V600E or V600K mutations) cutaneous melanoma in any of the following
               settings:
               1.  Unresectable or metastatic disease when used in combination with vemurafenib
                    (Zelboraf) with or without atezolizumab (Tecentriq).
               2.  Neoadjuvant therapy in combination with vemurafenib (Zelboraf) if immunotherapy is
                    contraindicated 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.  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.
               4.  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
               (Langerhans cell histiocytosis, Erdheim-Chester disease, Rosai-Dorfman disease) 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.; May 2023.
2. The NCCN Drugs & Biologics Compendium^® © 2024 National Comprehensive Cancer Network, Inc. https://www.nccn.org. Accessed April 30, 2024.
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.

June 08, 2024