TAFINLAR (dabrafenib)

TAFINLAR (dabrafenib)

Self-Administration – oral

Diagnosis considered for coverage:

• BRAF V600E Mutation-Positive Unresectable or Metastatic Melanoma - 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.
• BRAF V600E or V600K Mutation-Positive Unresectable or Metastatic Melanoma - 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.
• Adjuvant Treatment of BRAF V600E or V600K Mutation-Positive Melanoma - 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.
• BRAF V600E Mutation-Positive Metastatic NSCLC - 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.
• BRAF V600E Mutation-Positive Locally Advanced or Metastatic Anaplastic Thyroid Cancer - indicated, in combination with trametinib, for the treatment of patients with locally advanced or metastatic anaplastic thyroid cancer (ATC) with BRAF V600E mutation and with no satisfactory locoregional treatment options.
• BRAF V600E Mutation-Positive Unresectable or Metastatic Solid Tumors - 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. This indication is approved under accelerated approval based on overall response rate and duration of response. 
  • Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
• BRAF V600E Mutation-Positive Low-Grade Glioma - 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.

Coverage Criteria:

For diagnosis of unresectable or metastatic melanoma:

• Dose does not exceed 150 mg twice daily, AND
• Prescribed by or in consultation with an oncologist, AND
• Patient is 18 years of age or older, AND
• One of the following diagnoses:
  • Unresectable melanoma 
  • Metastatic melanoma, AND
• One of the following (A or B): 
  • A. Cancer is BRAFV600E mutant type as detected by an FDA-approved test (THxID-BRAF Kit) or a test performed at a facility approved by Clinical Laboratory Improvement Amendments (CLIA), or
  • B. Both of the following (I and II):
    • I. Cancer is BRAFV600E or V600K mutant type as detected by an FDA-approved test (THxID-BRAF Kit) or a test performed at a facility approved by Clinical Laboratory Improvement Amendments (CLIA), and
    • II. Medication is used in combination with Mekinist (trametinib)

For diagnosis of adjunctive treatment of melanoma:

• Dose does not exceed 150 mg (two 75 mg capsules) twice daily, AND
• Prescribed by or in consultation with an oncologist, AND
• Patient is 18 years of age or older, AND
• Diagnoses of melanoma, AND
• Cancer is BRAF V600E mutation or V600K mutation type as detected by an FDA-approved test (THxID-BRAF Kit) or a test performed at a facility approved by Clinical Laboratory Improvement Amendments (CLIA), AND
• Involvement of lymph nodes following complete resection, AND
• Used as adjunctive therapy, AND
• Medication is used in combination with Mekinist (trametinib), AND
• Used until disease recurrence or unacceptable toxicity for up to 1 year

For diagnosis of non-small cell lung cancer:

• Dose does not exceed 150 mg (two 75 mg capsules) twice daily, AND
• Prescribed by or in consultation with an oncologist, AND
• Patient is 18 years of age or older, AND
• Diagnoses of metastatic non-small cell lung cancer, AND
• Cancer is BRAF V600E mutant type as detected by an FDA-approved test (THxID-BRAF Kit) or a test performed at a facility approved by Clinical Laboratory Improvement Amendments (CLIA), AND
• Medication is used in combination with Mekinist (trametinib)

For diagnosis of anaplastic thyroid cancer (ATC):

• Dose does not exceed 150 mg (two 75 mg capsules) twice daily, AND
• Prescribed by or in consultation with an oncologist, AND
• Patient is 18 years of age or older, AND
• Diagnosis of locally advanced or metastatic anaplastic thyroid cancer (ATC), AND
• Cancer is BRAF V600E mutation type as detected by an FDA-approved test (THxID-BRAF Kit) or a test performed at a facility approved by Clinical Laboratory Improvement Amendments (CLIA), AND
• Cancer may not be treated with standard locoregional treatment options, AND
• Medication is used in combination with Mekinist (trametinib)

For diagnosis of unresectable or metastatic solid tumors:

• Dose does not exceed 150 mg twice daily (see Additional Information section for more information) AND
• Prescribed by or in consultation with an oncologist, AND
• Patient is 6 years of age or older, AND
• Diagnosis of solid tumors, AND
• Disease is one of the following:
  • Unresectable 
  • Metastatic, AND
• Cancer is BRAF V600E mutation type as detected by an FDA-approved test (THxID-BRAF Kit) or a test performed at a facility approved by Clinical Laboratory Improvement Amendments (CLIA), AND
• Patient has progressed on or following prior treatment and have no satisfactory alternative treatment options, AND
• Medication is used in combination with Mekinist (trametinib)

For diagnosis of low-grade glioma (LGG):

• Dose does not exceed 150 mg twice daily (see Dosing section for more information), AND
• Patient is 1 year of age or older, AND
• Diagnosis of low-grade glioma (LGG), AND
• Cancer is BRAF V600E mutation type as detected by an FDA-approved test (THxID-BRAF Kit) or a test performed at a facility approved by Clinical Laboratory Improvement Amendments (CLIA), AND
• Patient requires systemic therapy, AND
• Medication is used in combination with Mekinist (trametinib)

Reauthorization Criteria:

For diagnosis of unresectable or metastatic melanoma, non-small cell lung cancer, anaplastic thyroid cancer (ATC), or unresectable or metastatic solid tumors, or low-grade glioma (LGG):

• Dose does not exceed 150mg twice daily (see Dosing section for more information AND
• Patient does not show evidence of progressive disease while on therapy, AND
• Adjunctive melanoma: Used until disease recurrence or unacceptable toxicity for up to 1 year 

Coverage Duration: 

• Initial: 1 year
• Reauthorization: 
  • Adjunctive melanoma: 1 year total treatment
  • All other indications: 1 year

Authorization is not covered for the following:
The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics (P&T) Committee.
 

Dosing: 

• Capsules (for patient’s weighing at least 26 kg): 
• Adults: 150 mg twice daily
• Pediatrics:
  • 26 to 37 kg: 75 mg twice daily
  • 38 to 50 kg: 100 mg twice daily,
  • 51 kg or greater: 150 mg twice daily 
• Tablets for Oral Suspension (see table):

Additional Information: 

• The recommended duration of treatment for patients with unresectable or metastatic melanoma or solid tumors, metastatic NSCLC, or locally advanced or metastatic anaplastic thyroid cancer is until disease progression or unacceptable toxicity.
• The recommended duration of treatment in the adjuvant melanoma setting is until disease recurrence or unacceptable toxicity for up to 1 year.
• A recommended dose has not been established in patients who weigh less than 26 kg.

Policy Updates:

• 11/15/2022 – New policy approved by P&T.
• 12/1/2023 (policy effective date) – New policy approved by WHA P&T Committee. (P&T, 11/14/2023) (P&T meeting date) 

References:
1.    Tafinlar Prescribing Information. Novartis Pharmaceuticals Corporation. East Hanover, NJ. May 2023. 
2.    National Comprehensive Cancer (NCCN) Drugs & Biologics Compendium [internet database]. Updated periodically. Available at: http://www.nccn.org/professionals/drug_compendium/content/contents.asp. Accessed February 14, 2022