WHA

BRAFTOVI (encorafenib)

SELF-ADMINISTRATION - ORAL

Indications for Prior Authorization: 

  • Melanoma: Indicated in combination with Mektovi (binimetinib tablets), for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-approved test

  • Colorectal Cancer (CRC): 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.   

  • Non-Small Cell Lung Cancer (NSCLC): Indicated in combination with Mektovi (binimetinib) for the treatment of adult patients with metastatic non-small cell lung 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 or wild-type BRAF CRC.

 

Coverage Criteria: 

For diagnosis of melanoma: 

  • Patient has unresectable melanoma, advanced, or metastatic melanoma; AND
  • Cancer is BRAF V600E or V600K mutant type as detected by an FDA-approved test (i.e., THxID-BRAF assay) or a test performed at a facility approved by the Clinical Laboratory Improvement Amendments (CLIA); AND
  • Used in combination with Mektovi (binimetinib) tablets AND
  • One of the following: 
    • Trial and failure, contraindication, or intolerance to one of the following:
      • Zelboraf
      • Tafinlar OR
    • For continuation of therapy 

 

For diagnosis of colorectal cancer (CRC): 

  • Patient has Colon cancer or rectal cancer; AND 
  • Cancer is either unresectable/advanced disease OR metastatic disease; AND
  • Cancer is BRAF V600E mutant type as detected by an FDA-approved test (i.e., THxID-BRAF assay) or a test performed at a facility approved by the Clinical Laboratory Improvement Amendments (CLIA); AND 
  • Used in combination with Erbitux (cetuximab); AND
  • Patient has received prior therapy (e.g., RAF, MEK, or EGFR inhibitor)

 

For diagnosis of Non-Small Cell Lung Cancer (NSCLC): 

  • Diagnosis of metastatic non-small cell lung cancer (NSCLC) 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
  • Used in combination with Mektovi (binimetinib)

 

Reauthorization Criteria: 

For diagnosis of all indications listed above: 

  • Patient does not show evidence of progressive disease while on therapy

 

Coverage Duration: 

For diagnosis of all indications listed above:

  • Initial: 1 year

  • Reauthorization: 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.

 

Policy Updates:
  • 08/27/2019 - Initial review
  • 06/01/2023 - Updating policy to include new indication (CRC) and formatting
  • 06/1/2024 (policy effective date)- Added Added trial and failure criteria of Zelboraf or Tafinlar for melanoma diagnosis. Removed BRAF V600K mutant type from colorectal cancer criteria. Removal of  Oncologist and dosing requirements. Addition of CRC (P&T 5/20/2024) (P&T Meeting May)

 

References:

  1. Braftovi Prescribing Information. Array BioPharma Inc. Boulder, Colorado. February 2022.

  2. National Comprehensive Cancer Network. Clinical practice guidelines in oncology: melanoma cutaneous v.3.2022. Available at: https://www.nccn.org/professionals/physician_gls/pdf/cutaneous_melanoma.pdf. Accessed June 1, 2022. 

  3. National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology: Colon Cancer. Version 1.2022. Accessed June 1, 2022. 

  4. National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology: Rectal Cancer. Version 1.2022. http://www.nccn.org/professionals/physician_gls/PDF/rectal.pdf. Accessed June 1, 2022

Last review date: June 1, 2024