Subject: Braftovi 2616-A SGM P2024a

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 Indications
               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.
               3.  Braftovi is indicated, in combination with binimetinib, for the treatment of adult patients
                    with metastatic non-small cell lunch cancer (NSCLC) with a BRAF V600E mutation, as
                    detected by an FDA-approved test.

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

          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

          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 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 either:
                     i.     in combination with binimetinib (Mektovi), or
                     ii.    as a single agent, if BRAF/MEK inhibitor combination therapy is contraindicated
               2.  Neoadjuvant therapy in combination with binimetinib (Mektovi) 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 binimetinib
                    (Mektovi) 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
                    binimetinib (Mektovi) 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) gliomas, meningiomas, or astrocytomas.

          C.  Colorectal Cancer
               Authorization of 12 months may be granted for treatment of colorectal cancer (including
               appendiceal adenocarcinoma and anal adenocarcinoma) 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
                         the member has received FOLFOX (fluorouracil, leucovorin, and oxaliplatin) or
                         CapeOX (capecitabine and oxaliplatin) within the past 12 months

          D.  Non-Small Cell Lung Cancer (NSCLC)

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


   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.; October 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 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.
7. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines): Anal Carcinoma. Version 3.2023. Accessed November 15, 2023. https://www.nccn.org/professionals/physician_gls/pdf/anal.pdf
8. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines): Colon Cancer. Version 3.2023. Accessed November 15, 2023. https://www.nccn.org/professionals/physician_gls/pdf/colon.pdf

 

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