Subject: Mektovi 2612-A SGM P2022a

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 Indication
      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.

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
      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.

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 stage III disease in combination with encorafenib (Braftovi) 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) gliomas, meningiomas, or astrocytomas. 

C.   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 2020.
2. The NCCN Drugs & Biologics Compendium 2022 National Comprehensive Cancer Network, Inc. http://www.nccn.org. Accessed June 2, 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.

July 15, 2022