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.   

Coverage Criteria: 

1.    For diagnosis of melanoma: 

  • Dose does not exceed 450 mg (six 75 mg capsules) once daily; AND

  • Prescribed by or in consultation with an oncologist; AND

  • Patient has unresectable, 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

  • Documentation supporting Braftovi will be used in combination with Mektovi (binimetinib) tablets

2.    For diagnosis of colorectal cancer (CRC): 

  • Dose does not exceed 300 mg (four 75 mg capsules) once daily; AND 

  • Prescribed by or in consultation with an oncologist; AND

  • Patient has Colon cancer or rectal cancer; AND 

  • Cancer is either unresectable/advanced disease OR metastatic disease; 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 

  • Documentation supporting Braftovi will be used in combination with Erbitux (cetuximab); AND

  • Patient has received prior therapy (e.g., RAF, MEK, or EGFR inhibitor)

Reauthorization Criteria: 

1.    For diagnosis of melanoma: 

  • Dose does not exceed 450 mg (six 75 mg capsules) once daily; AND

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

2.    For diagnosis of colorectal cancer (CRC): 

  • Dose does not exceed 300 mg (four 75 mg capsules) once daily; AND 

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

Coverage Duration: 

1.    For diagnosis of melanoma and colorectal cancer (CRC):

  • Initial: 1 year

  • Reauthorization: 1 year

Additional Information: 

  • Strong or moderate CYP3A4 inhibitors: Avoid coadministration. If unavailable, reduce Braftovi dosage

  • Strong or moderate CYP3A4 inducers: Avoid coadministration with Braftovi

  • Avoid coadministration of Braftovi with hormonal contraceptives

Policy Updates:
  • 08/27/2019 - Initial review
  • 06/01/2023 - Updating policy to include new indication (CRC) and formatting
References:

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

  • 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. 

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

  • 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, 2023