Subject: Braftovi 2616-A SGM P2023a
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
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 either:
i. in combination with binimetinib (Mektovi), or
ii. as a single agent if BRAF/MEK inhibitor combination
therapy is contraindicated
2. 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.
3. 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)
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
D. 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 binimetinib (Mektovi).
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:
- Braftovi [package insert]. Boulder, CO: Array BioPharma, Inc.; October 2023.
- The NCCN Drugs & Biologics Compendium® © 2022 National Comprehensive Cancer Network, Inc. https://www.nccn.org. Accessed November 11, 2022.
- 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.
- 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
- 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.
- 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
