WHA
 

Braftovi (encorafenib)

Indications for Prior Authorization

Braftovi (encorafenib)
  • For diagnosis of Melanoma
    Indicated in combination with binimetinib for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-authorized test.

  • For diagnosis of Colorectal Cancer (CRC)
    Indicated in combination with cetuximab and fluorouracil-based chemotherapy, for the treatment of patients with metastatic colorectal cancer (mCRC) with a BRAF V600E mutation, as detected by an FDA‑authorized test; and indicated in combination with cetuximab for the treatment of adult patients with metastatic colorectal cancer with a BRAF V600E mutation, as detected by an FDA-authorized test, after prior therapy.

  • For diagnosis of Non-Small Cell Lung Cancer (NSCLC)
    Indicated in combination with 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-authorized test.

  • For diagnosis of Limitations of Use:
    BRAFTOVI is not indicated for treatment of patients with wild-type BRAF melanoma, wild-type BRAF CRC, or wild-type BRAF NSCLC.

Criteria

Braftovi

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Melanoma

  • Diagnosis of melanoma
    • AND
  • Disease is one of the following:
    • Unresectable
    • Metastatic
    AND
  • One of the following:
    • Presence of BRAF V600E mutation as detected by an FDA-approved test or a test performed at a facility approved by Clinical Laboratory Improvement Amendments (CLIA)
    • Presence of BRAF V600K mutation as detected by an FDA-approved test or a test performed at a facility approved by Clinical Laboratory Improvement Amendments (CLIA)
    AND
  • Used in combination with Mektovi (binimetinib)
    • AND
  • One of the following:
    • Trial and failure, contraindication, or intolerance to one of the following:
      • Zelboraf (vemurafenib)
      • Tafinlar (dabrafenib)
      OR
    • For continuation of prior therapy
Braftovi

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Colorectal Cancer

  • Diagnosis of one of the following:
    • Colon cancer
    • Rectal cancer
    AND
  • Disease is metastatic
    • AND
  • Presence of BRAF V600E mutation as detected by an FDA-approved test or a test performed at a facility approved by Clinical Laboratory Improvement Amendments (CLIA)
    • AND
  • Both of the following:
    • Used in combination with Erbitux (cetuximab)
      • AND
    • One of the following: [2]
      • Patient has received prior therapy (e.g., chemotherapy)
        • OR
      • Used in combination with fluorouracil-based chemotherapy (e.g., mFOLFOX6, FOLFIRI)
Braftovi

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Non-Small Cell Lung Cancer

  • Diagnosis of non-small cell lung cancer (NSCLC)
    • AND
  • Disease is metastatic
    • AND
  • Presence of BRAF V600E mutation as detected by an FDA-approved test or a test performed at a facility approved by Clinical Laboratory Improvement Amendments (CLIA)
    • AND
  • Used in combination with Mektovi (binimetinib)
Braftovi

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of All indications listed above

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

  • Guideline ID
    GL-601201

  • Formulary
    Premium

  • Effective date
    Aug 1, 2026

  • P&T approval date
    Aug 16, 2018

P & T Revisions

2026-05-06, 2026-03-31, 2025-12-18, 2025-08-06, 2025-02-05, 2024-07-29, 2023-12-01, 2023-06-27, 2023-06-05, 2022-06-01, 2021-06-07, 2020-06-02

  1. Braftovi Prescribing Information. Array Biopharma Inc. Boulder, CO. February 2026.
  2. National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology: Colon Cancer. Version 2.2026. Available at: https://www.nccn.org/professionals/physician_gls/pdf/colon.pdf Accessed May 6, 2026.
  • 2026-05-06: Annual Review 2026 - Removed unresectable and advanced disease options from CRC criteria, in alignment with FDA indication. Added chemotherapy as example of prior therapy for CRC. Throughout guideline, the following updates were made without change to clinical intent: updated criteria for standard dx verbiage (i.e., Dx of xyz) & updated criteria to standard format to limit the number of requirements that need to be met within a single criterion (e.g., separated out Dx check & disease is metastatic, unresectable). Background updates.
  • 2026-03-31: Updated criteria for colorectal cancer to use in combination with fluorouracil-based chemotherapy
  • 2025-12-18: no criteria changes, added IL statute operational note
  • 2025-08-06: 2025 Annual Review. Updated language in genetic mutation criteria with no changes to clinical content. Updated references.
  • 2025-02-05: Update to reflect expanded indication in metastatic colorectal cancer (mCRC).
  • 2024-07-29: Annual review: Updated existing trial and failure requirement options formatting to include generic names of listed products - no change to clinical intent. Background updates.
  • 2023-12-01: Addition of new indication for NSCLC. Updated background and references.
  • 2023-06-27: update guideline
  • 2023-06-05: Annual Review: No criteria changes. Updated references and GPI.
  • 2022-06-01: Annual review: no criteria changes, updated references
  • 2021-06-07: Annual Review
  • 2020-06-02: Update Program