Subject: Tafinlar 1683-A SGM P2023
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TAFINLAR
(dabrafenib)
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| Note: |
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. Tafinlar is indicated as a single agent for the treatment of
patients with unresectable or metastatic melanoma with
BRAF V600E mutation as detected by an FDA-approved
test.
2. Tafinlar is indicated, in combination with trametinib, for
the treatment of patients with unresectable or metastatic
melanoma with BRAF V600E or V600K mutations as
detected by an FDA-approved test.
3. Tafinlar is indicated, in combination with trametinib, 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. Tafinlar is indicated, in combination with trametinib, for
the treatment of patients with metastatic non-small cell
lung cancer (NSCLC) with BRAF V600E mutation as
detected by an FDA-approved test.
5. Tafinlar is indicated, in combination with trametinib, for
the treatment of patients with locally advanced or
metastatic anaplastic thyroid cancer (ATC) with BRAF
V600E mutation and no satisfactory locoregional
treatment options.
6. Tafinlar is indicated, in combination with trametinib, 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: Tafinlar is not indicated for treatment
of patients with colorectal cancer because of known
intrinsic resistance to BRAF inhibition. Tafinlar is not
indicated for treatment of patients with wild-type BRAF
solid tumors.
B. Compendial Uses
1. Melanoma, BRAF V600 activating mutation-positive
2. Brain metastases from melanoma
3. NSCLC, BRAF V600E
4. Glioma, BRAF V600 activating mutation-positive
5. Meningioma, BRAF V600 activating mutation-positive
6. Astrocytoma, BRAF V600 activating mutation-positive
7. Thyroid Carcinoma
a. Anaplastic carcinoma
b. Papillary carcinoma
c. Follicular carcinoma
d. Hűrthle cell carcinoma
8. Hepatobiliary Cancers
a. Gallbladder Cancer
b. Extrahepatic Cholangiocarcinoma
c. Intrahepatic Cholangiocarcinoma
9. Histiocytic Neoplasms
a. Erdheim-Chester Disease
b. Langerhans Cell Histiocytosis
10. Ovarian cancer/fallopian tube cancer/primary peritoneal
cancer
All other indications are considered experimental/investigational
and not medically necessary.
II. DOCUMENTATION
Submission of BRAF mutation documentation is necessary to
initiate prior authorization review.
III. CRITERIA FOR INITIAL APPROVAL
A. Cutaneous melanoma
Authorization of 12 months may be granted for treatment of
melanoma with a BRAF V600 activating mutation (e.g.,
V600E or V600K) in any of the following settings:
1. Unresectable or metastatic cutaneous melanoma as a
single agent or in combination with trametinib (Mekinist).
2. Brain metastases from melanoma in combination with
trametinib (Mekinist).
3. Adjuvant treatment of resected stage III cutaneous
melanoma in combination with trametinib (Mekinist).
4. Limited resectable local satellite/in-transit recurrent
disease in combination with trametinib (Mekinist).
B. Non-Small Cell Lung Cancer (NSCLC)
Authorization of 12 months may be granted for treatment
of BRAF V600E mutation-positive advanced or metastatic
NSCLC as a single agent or in combination with trametinib
(Mekinist).
C. Central Nervous System Cancer
Authorization of 12 months may be granted for treatment
of BRAF V600 mutation-positive gliomas, meningiomas, or astrocytomas.
D. Thyroid Cancer
Authorization of 12 months may be granted for treatment of
thyroid carcinoma when any of the following criteria are met:
1. Member has progressive and/or symptomatic BRAF-
positive follicular, Hürthle cell, or papillary thyroid
carcinoma that is not amenable to radioactive iodine
(RAI) therapy.
2. Member has BRAF V600E mutation positive locally
advanced, metastatic, or borderline resectable anaplastic
thyroid carcinoma and the requested medication will be
used in combination with trametinib (Mekinist).
E. 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 trametinib (Mekinist).
F. Histiocytic Neoplasms
Authorization of 12 months may be granted for treatment of
BRAF V600E mutation-positive Erdheim-Chester disease or
Langerhans cell histiocytosis as a single agent.
G. 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
trametinib (Mekinist).
H. Ovarian Cancer, Fallopian Tube Cancer, and Primary
Peritoneal Cancer
Authorization of 12 months may be granted for treatment of
persistent or recurrent BRAF-V600E positive epithelial
ovarian cancer, fallopian tube cancer, primary peritoneal
cancer, carcinosarcoma (malignant mixed Mullerian tumors),
clear cell carcinoma of the ovary, grade 1 endometrioid
carcinoma, low-grade serious carcinoma/ovarian borderline
epithelial tumor (low malignant potential), or mucinous
carcinoma of the ovary, in combination with trametinib
(Mekinist).
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 or recurrence
while on the current regimen. For patients using Tafinlar 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:
- Tafinlar [package insert]. East Hanover, NJ: Novartis Pharmaceutical Corporation; June 2022.
- The NCCN Drugs & Biologics Compendium® © 2022 National Comprehensive Cancer Network, Inc. Available at: https://www.nccn.org. Accessed November 17, 2022.
- Micromedex Solutions [database online]. Ann Arbor, MI: Truven Health Analytics Inc. Updated periodically. www.micromedexsolutions.com [available with subscription]. Accessed November 17, 2022.
- 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.
- 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: 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. 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 15, 2023
