Subject: Mektovi SGM 2612-A P2025

Drug

MEKTOVI  (binimetinib)

Policy:

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.

FDA-approved Indications¹

• 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.
• Mektovi is indicated, in combination with encorafenib, for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation, as detected by an FDA-approved test.

Compendial Uses^2-7

• NRAS-mutant melanoma
• Recurrent, advanced NSCLC
• Glioma, BRAF V600 activating mutation-positive
• Meningioma, BRAF V600 activating mutation-positive
• Astrocytoma, BRAF V600 activating mutation-positive
• Cutaneous melanoma
• Langerhans cell histiocytosis

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

Documentation

Submission of BRAF or NRAS mutation documentation is necessary to initiate the prior authorization review, where applicable.

Coverage Criteria

Cutaneous Melanoma^1-3

Authorization of 12 months may be granted for treatment of cutaneous melanoma in any of the following settings:

• Unresectable or metastatic disease with a BRAF V600 activating mutation (e.g., V600E or V600K) when used in combination with encorafenib (Braftovi).
• Neoadjuvant treatment of BRAF V600 mutation-positive cutaneous melanoma in combination with encorafenib (Braftovi) 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.
• Adjuvant treatment of resected stage III disease with a BRAF V600 activating mutation (e.g., V600E or V600K) 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.
• Limited resectable local satellite/in-transit recurrent disease with a BRAF V600 activating mutation (e.g., V600E or V600K) 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.
• Locally advanced unresectable or metastatic NRAS-mutant melanoma, as a single agent, when the member is previously untreated or has experienced disease progression on or after prior immunotherapy.

Non-Small Cell Lung Cancer (NSCLC)^1,2

Authorization of 12 months may be granted for treatment of BRAF V600E mutation-positive recurrent, advanced, or metastatic NSCLC in combination with encorafenib (Braftovi) when the member has not experienced disease progression on BRAF-targeted therapy.

Central Nervous System Cancer^4-6

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

Langerhans Cell Histiocytosis²

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

Continuation of Therapy

Authorization of 12 months may be granted for continued treatment in members requesting reauthorization for an indication listed in the coverage criteria section 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.; September 2024.
2. The NCCN Drugs & Biologics Compendium® © 2024 National Comprehensive Cancer Network, Inc. https://www.nccn.org. Accessed November 8, 2024.
3. Lexi-Drugs. UpToDate Lexidrug. UpToDate Inc. https://online.lexi.com. Accessed November 8, 2024.
4. 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.
5. 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: 10.3109/08880018.2014.936058.
6. 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:10.1002/pbc.26086.
7. 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 18, 2025