Subject: Braftovi 2616-A SGM P2022

Drug

BRAFTOVI  (encorafenib)

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.   Braftovi is indicated, in combination with binimetinib, 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.   Braftovi is indicated, in combination with cetuximab, for the treatment of adult patients with metastatic
            colorectal cancer (CRC) with a BRAF V600E mutation, as detected by an FDA-approved test, after prior therapy. 

      Limitations of use: Braftovi is not indicated for treatment of patients with wild-type BRAF melanoma or wild-type BRAF CRC.

 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.   Colorectal cancer, advanced disease
       5.   Colorectal cancer, unresectable metachronous metastases
       6.   Cutaneous melanoma, adjuvant systemic therapy 

 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 binimetinib (Mektovi).
      2.   Adjuvant treatment of stage III disease in combination with binimetinib (Mektovi) 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.   Colorectal Cancer
      Authorization of 12 months may be granted for treatment of colorectal cancer when the following criteria are met:
      1.   Braftovi is used in combination with either cetuximab (Erbitux) or panitumumab (Vectibix).
      2.   Tumor is positive for BRAF V600E mutation.
      3.   Either of the following:
            a.   Will be used as subsequent therapy for advanced or metastatic disease
            b.   Will be used as primary treatment for unresectable metachronous metastases and previous
                  adjuvant FOLFOX (fluorouracil, leucovorin, and oxaliplatin) or CapeOX (capecitabine and oxaliplatin)
                  within the past 12 months 

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. Braftovi [package insert]. Boulder, CO: Array BioPharma, Inc.; April 2020.
2. The NCCN Drugs & Biologics Compendium 2021 National Comprehensive Cancer Network, Inc. http://www.nccn.org. Accessed November 3, 2021.
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.

April 16, 2022