Subject: Mektovi 2612-A SGM P2023a

Drug

MEKTOVI  (binimetinib)

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 Indications
               1.  Mektovi is indicated, in combination with encorafenib, for
                    the treatment of patients with unresectable or metastatic
                    melanoma with a BRAF V600E or V600K mutation, as
                    detected by an FDA-approved test.
               2.  Mektovi is indicated, in combination with encorafenib, for
                    the treatment of adults patients with metastatic non-
                    small cell lung cancer (NSCLC) with a BRAF V600E
                    mutation, as detected by an FDA-approved test.

          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
               5.  Langerhans cell histiocytosis

          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, where applicable.


  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 encorafenib (Braftovi).
               2.  Adjuvant treatment of resected stage III disease in
                    combination with encorafenib (Braftovi) 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 encorafenib (Braftovi) 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.  Non-Small Cell Lung Cancer (NSCLC)
               Authorization of 12 months may be granted for treatment of
               BRAF V600E mutation-positive metastatic NSCLC in
               combination with encorafenib (Braftovi).

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

          D.  Langerhans Cell Histiocytosis
               Authorization of 12 months may be granted as a single agent
               for treatment of Langerhans cell histiocytosis.


   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. Mektovi [package insert]. Boulder, CO: Array BioPharma, Inc.; October 2023.
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 BRAFV600EMutation 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 BRAFV600E 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.

November 09, 2023