Pharmacy Prior Authorization Criteria

Braftovi (encorafenib)

Indications for Prior Authorization

Braftovi (encorafenib)

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

  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.

• For diagnosis of BRAF V600E Mutation-Positive Metastatic Colorectal Cancer (CRC)
  1) Indicated in combination with cetuximab and mFOLFOX6, for the treatment of patients with metastatic colorectal cancer (mCRC) with a BRAF V600E mutation, as detected by an FDA‑approved test. This indication is approved under accelerated approval based on response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). 2) Indicated in combination with Erbitux (cetuximab) for the treatment of adult patients with metastatic colorectal cancer with a BRAF V600E mutation, as detected by an FDA-approved test, after prior therapy. 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.

• For diagnosis of BRAF V600E Mutation-Positive Metastatic 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, 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

• One of the following diagnoses: [2]
• Unresectable melanoma
• Metastatic melanoma
AND
• Cancer is BRAF V600E 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
• 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

• One of the following diagnoses:
• Colon Cancer
• Rectal Cancer
AND
• One of the following [3,4]:
• Unresectable or advanced disease
• Metastatic disease
AND
• 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)
AND
• Both of the following:
• Used in combination with Erbitux (cetuximab)
AND
• One of the following:
• Patient has received prior therapy
OR
• Used in combination with mFOLFOX6

Braftovi

Prior Authorization (Initial Authorization)

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

• 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)

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

P & T Revisions

2025-02-05, 2024-07-29, 2023-12-01, 2023-06-27, 2023-06-05, 2022-06-01, 2021-06-07, 2020-06-02

References

1. Braftovi Prescribing Information. Array Biopharma Inc. Boulder, CO. December 2024.
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 5.2024. Available at: https://www.nccn.org/professionals/physician_gls/pdf/colon.pdf Accessed January 16, 2025.
4. National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology: Rectal Cancer. Version 6.2024. Available at: http://www.nccn.org/professionals/physician_gls/PDF/rectal.pdf. Accessed January 21, 2025

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Revision History

• 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

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