Subject: Mekinist 1681-A SGM P2022a
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. Mekinist is indicated, as a single agent in BRAF-inhibitor
treatment-naïve patients or in combination with
dabrafenib, for the treatment of patients with
unresectable or metastatic melanoma with BRAF V600E
or V600K mutations as detected by an FDA-approved
test.
2. Mekinist is indicated, in combination with dabrafenib, for
the treatment of patients with metastatic non-small cell
lung cancer (NSCLC) with BRAF V600E mutation as
detected by an FDA-approved test.
3. Mekinist is indicated, in combination with dabrafenib, for
the adjuvant treatment of patients with melanoma with
BRAF V600E or V600K mutations as detected by an
FDA-approved test, and involvement of lymph node(s),
following complete resection.
4. Mekinist is indicated, in combination with dabrafenib, for
the treatment of patients with locally advanced or
metastatic anaplastic thyroid cancer (ATC) with BRAF
V600E mutation and no satisfactory locoregional
treatment options.
5. Mekinist is indicated, in combination with dabrafenib, for
the treatment of adult and pediatric patients 6 years of
age and older with unresectable or metastatic solid
tumors with BRAF V600E mutation who have progressed
following prior treatment and have no satisfactory
alternative treatment options.
Limitations of Use: Mekinist is not indicated for
treatment of patients with colorectal cancer because of
known intrinsic resistance to BRAF inhibition.
B. Compendial Uses
1. Melanoma (including brain metastases), BRAF V600
activating mutation-positive
2. Glioma, BRAF V600 activating mutation-positive
3. Meningioma, BRAF V600 activating mutation-positive
4. Astrocytoma, BRAF V600 activating mutation-positive
5. Uveal melanoma as a single agent
6. Brain cancer and neurofibromatosis type 1
7. Non-small cell lung cancer (NSCLC)
8. Low grade serous ovarian carcinoma/ ovarian borderline
epithelial tumors (low malignant potential) with invasive
implants
9. Hepatobiliary Cancers
i. Gallbladder Cancer
ii. Extrahepatic Cholangiocarcinoma
iii. Intrahepatic Cholangiocarcinoma
10. Histiocytic Neoplasms
i. Erdheim-Chester Disease
ii. Langerhans Cell Histiocytosis
iii. Rosai-Dorfman Disease
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 for applicable indications
as outlined in section III.
III. CRITERIA FOR INITIAL APPROVAL
A. Melanoma
Authorization of 12 months may be granted for treatment
of melanoma in any of the following settings:
1. Unresectable or metastatic cutaneous melanoma with a
BRAF V600 activating mutation as a single agent or in
combination with dabrafenib (Tafinlar).
2. Brain metastases from melanoma with a BRAF V600E
activating mutation in combination with dabrafenib
(Tafinlar).
3. Adjuvant treatment of stage III cutaneous melanoma
with a BRAF V600 activating mutation in combination
with dabrafenib (Tafinlar) following complete resection
or no evidence of disease.
4. Uveal melanoma as a single agent for distant metastatic
disease.
B. 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 dabrafenib (Tafinlar).
C. Anaplastic Thyroid Cancer (ATC)
Authorization of 12 months may be granted for treatment
of locally advanced or metastatic BRAF V600E mutation-
positive ATC in combination with dabrafenib (Tafinlar).
D. Central Nervous System Cancer
Authorization of 12 months may be granted for treatment
of central nervous system cancer in a member with either
of the following:
1. BRAF V600 mutation-positive gliomas, meningiomas, or
astrocytomas
2. Brain cancer and neurofibromatosis type 1
E. Low Grade Serous Ovarian Carcinoma/ Ovarian
Borderline Epithelial Tumors (Low Malignant
Potential) with invasive implants
Authorization of 12 months may be granted for treatment
of persistent disease or recurrence of low-grade serous
ovarian carcinoma/ ovarian borderline epithelial tumors
(low malignant potential) with invasive implants.
F. Hepatobiliary Cancers
Authorization of 12 months may be granted for subsequent
treatment of progressive BRAF-V600E mutated
unresectable or metastatic gallbladder cancer, extrahepatic
cholangiocarcinoma, or intrahepatic cholangiocarcinoma in
combination with dabrafenib (Tafinlar).
G. Histiocytic Neoplasms
Authorization of 12 months may be granted for treatment
of Erdheim-Chester disease, Langerhans cell histiocytosis,
or Rosai-Dorfman disease as a single agent.
H. Solid Tumors
Authorization of 12 months may be granted for treatment
of unresectable or metastatic solid tumors when all of the
following criteria are met:
1. The tumors are BRAF V600E mutation positive.
2. The disease has progressed following prior treatment
and there are no satisfactory alternative treatment
options.
3. The member is 6 years of age or older.
4. The requested medication will not be used for the
treatment of colorectal cancer.
5. The requested medication will be used in combination
with dabrafenib (Tafinlar).
IV. CONTINUATION OF THERAPY
Authorization of 12 months may be granted for continuation of
therapy for an indication outlined in section III when there is
no evidence of unacceptable toxicity or disease progression or
recurrence while on the current regimen. For patients using
Mekinist for adjuvant treatment of cutaneous melanoma, only
12 months of therapy total will be approved.
Place of Service:
Outpatient
The above policy is based on the following references:
- Mekinist [package insert]. East Hanover, NJ: Novartis Pharmaceutical Corporation; June 2022.
- The NCCN Drugs & Biologics Compendium 2021 National Comprehensive Cancer Network, Inc. Available at: https://www.nccn.org. Accessed November 5, 2021.
- 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. J Neuropathol Exp Neurol. 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. Pediatr Hematol Oncol. 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.
- Meletath 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. J Natl Compr Canc Netw. 2016;14(11):1345-1350.
- Knight T, Shatara M, Carvalho L, et al. Dramatic response to trametinib in a male child with neurofibromatosis type 1 and refractory astrocytoma. Pediatr Blood Cancer. 2019; 66(1):e27474.
- See WL, Tan IL, Mukherjee J, et al. Sensitivity of Glioblastomas to Clinically Available MEK Inhibitors Is Defined by Neurofibromin 1 Deficiency. Cancer Res. 2012;72(13):3350.
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.
August 06, 2022
