Subject: Tafinlar 1683-A SGM P2024a
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 1 year 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.
7. Tafinlar is indicated, in combination with trametinib, for the treatment of pediatric patients
1 year of age and older with low-grade glioma (LGG) with a BRAF V600E mutation who
require systemic therapy.
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. Anaplastic thyroid carcinoma
8. Biliary tract 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
11. Gastrointestinal stromal tumor
12. Pancreatic adenocarcinoma
13. Salivary gland tumor
14. Gastric adenocarcinoma
15. Esophageal and esophageal junction cancer
16. Hairy cell leukemia
17. Small bowel adenocarcinoma
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 BRAF V600 mutation-positive
(e.g., BRAF V600E or V600K mutations) melanoma in any of the following settings:
1. Unresectable or metastatic disease when used either:
i. as a single agent if BRAF/MEK inhibitor combination therapy is contraindicated, or
ii. in combination with trametinib (Mekinist) with or without pembrolizumab (Keytruda)
2. Brain metastases from melanoma in combination with trametinib (Mekinist).
3. Neoadjuvant therapy in combination with trametinib (Mekinist) if immunotherapy is
contraindicated.
4. Adjuvant treatment of resected stage III cutaneous melanoma in combination with
trametinib (Mekinist).
5. 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
recurrent, advanced, or metastatic NSCLC when the member has not experienced disease
progression on BRAF-targeted therapy and the requested drug will be used either:
1. as a single agent, if the combination of dabrafenib plus trametinib is not tolerated, or
2. 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. Anaplastic Thyroid Cancer
Authorization of 12 months may be granted for treatment of BRAF V600E mutation-positive
locally advanced or stage IV anaplastic thyroid carcinoma in combination with trametinib
(Mekinist).
E. Biliary Tract Cancers
Authorization of 12 months may be granted for subsequent treatment of progressive BRAF
V600E mutation-positive unresectable, resected gross residual (R2), 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 1 year 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 mutation-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).
I. Gastrointestinal Stromal Tumor (GIST)
Authorization of 12 months may be granted for treatment of BRAF V600E mutation-positive
GIST in combination with trametinib (Mekinist) when used as either of the following:
1. Neoadjuvant therapy
2. First-line therapy for gross residual disease (R2 resection), unresectable primary
disease, tumor rupture or recurrent/metastatic disease
J. Pancreatic Adenocarcinoma
Authorization of 12 months may be granted for treatment of BRAF V600E mutation-positive
recurrent, locally advanced, or metastatic disease in combination with trametinib (Mekinist).
K. Salivary Gland Tumors
Authorization of 12 months may be granted for treatment of BRAF V600E mutation-positive
recurrent salivary gland tumor in combination with trametinib (Mekinist).
L. Gastric, Esophageal and Esophagogastric Junction Cancer
Authorization of 12 months may be granted for subsequent treatment of BRAF V600E
mutation-positive unresectable locally advanced, recurrent, or metastatic disease or for
members who are not surgical candidates, in combination with trametinib (Mekinist).
M. Hairy Cell Leukemia
Authorization of 12 months may be granted for treatment of relapsed/refractory hairy cell
leukemia in combination with trametinib (Mekinist) if not previously treated with BRAF
inhibitor therapy.
N. Small Bowel Adenocarcinoma
Authorization of 12 months may be granted for treatment of BRAF V600E mutation-positive
advanced or metastatic small bowel adenocarcinoma 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; August 2023.
- The NCCN Drugs & Biologics Compendium® © 2024 National Comprehensive Cancer Network, Inc. Available at: https://www.nccn.org. Accessed April 30, 2024.
- Micromedex Solutions [database online]. Ann Arbor, MI: Truven Health Analytics Inc. Updated periodically. www.micromedexsolutions.com [available with subscription]. Accessed November 15, 2023.
- 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:10.1002/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.
June 08, 2024
