CurrentUnitedHealthcarePolicy N/A

Braftovi (encorafenib) prior authorization — coverage criteria

Prior authorization and notification criteria for coverage of Braftovi (encorafenib) for melanoma, colorectal cancer, and non-small cell lung cancer, including combination therapy requirements and reauthorization rules for UnitedHealthcare members.

Policy Summary

PayerUnitedHealthcare

PolicyBraftovi (encorafenib) prior authorization — coverage criteria

Policy CodePolicy N/A

Change TypeMaterial updates (added NSCLC, clarified CRC combinations)

Effective DateSep 1, 2025

Next Review DateN/A

Key ActionSubmit prior authorization showing diagnosis, BRAF V600 mutation status, and required combination therapy to obtain 12‑month approval.

SourceLink

POLICY UPDATE CHANGES

Added coverage for advanced and recurrent NSCLC per NCCN Compendium and requires Braftovi be used in combination with Mektovi for NSCLC reauthorization.

Updated initial and reauthorization criteria for colon and rectal cancer; combined criteria sections for colon and rectal cancer.

Updated background to include new FDA-approved use of Braftovi in combination with Erbitux and mFOLFOX6 for BRAF V600E mutated colorectal cancer.

12 monthsstandard authorization duration

BRAF V600E/V600Kmutation requirement

Requiredcombination therapy

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Coverage Criteria for Braftovi (encorafenib)

Indication-specific coverage criteria

Covered when the following indication-specific criteria are met

Melanoma initial: Diagnosis of melanoma AND presence of BRAF V600E mutation AND disease is unresectable OR metastatic AND used in combination with Mektovi (binimetinib)

Melanoma reauthorization: Patient does not show evidence of progressive disease while on Braftovi therapy AND used in combination with Mektovi (binimetinib)

Colorectal cancer initial: Diagnosis of colon or rectal cancer AND presence of BRAF V600E mutation AND disease is advanced OR metastatic AND one of the following: (a) prior therapy with an oxaliplatin-based regimen AND used in combination with Erbitux (cetuximab) or Vectibix (panitumumab); OR (b) no prior oxaliplatin-based regimen AND used in combination with Erbitux (cetuximab) or Vectibix (panitumumab) AND used with FOLFOX (fluorouracil, leucovorin, and oxaliplatin)

Colorectal cancer reauthorization: Patient does not show evidence of progressive disease while on Braftovi therapy AND used in combination with one of the following: Erbitux (cetuximab)

NSCLC initial: Diagnosis of non-small cell lung cancer (NSCLC) AND presence of BRAFV600 mutation AND disease is advanced OR recurrent OR metastatic AND used in combination with Mektovi (binimetinib)

NSCLC reauthorization: Patient does not show evidence of progressive disease while on Braftovi therapy AND used in combination with Mektovi (binimetinib)

Patients <19: Patient is less than 19 years of age (prescription processes without coverage review)

Braftovi (encorafenib) is not indicated for the treatment of patients with wild-type BRAF disease states, including melanoma, colorectal cancer (CRC), and non‑small cell lung cancer (NSCLC).

Use of Braftovi in patients who do not harbor the specified BRAF activating mutations (i.e., patients with wild-type BRAF) is outside the drug's indicated uses and is considered not medically necessary per the policy.

Initial Authorization Criteria

Initial therapy criteria

Initial authorization requires diagnosis, mutation confirmation, disease stage, and specified combination therapy.

Melanoma initial: Diagnosis of melanoma AND presence of BRAF V600E mutation AND disease is unresectable OR metastatic AND used in combination with Mektovi (binimetinib)

CRC initial - prior oxaliplatin: Diagnosis of colon or rectal cancer AND presence of BRAF V600E mutation AND disease is advanced OR metastatic AND patient has received prior therapy with an oxaliplatin-based regimen (e.g., FOLFOX, CAPEOX) AND used in combination with Erbitux (cetuximab) or Vectibix (panitumumab)

CRC initial - no prior oxaliplatin: Diagnosis of colon or rectal cancer AND presence of BRAF V600E mutation AND disease is advanced OR metastatic AND patient has not received prior therapy with an oxaliplatin-based regimen (e.g., FOLFOX, CAPEOX) AND used in combination with Erbitux (cetuximab) or Vectibix (panitumumab) AND used with FOLFOX (fluorouracil, leucovorin, and oxaliplatin)

Reauthorization and Continuation Criteria

Reauthorization/Continuation criteria

Reauthorization (continuation) rules require lack of disease progression and continued use in specified combinations.

Melanoma continuation: Patient does not show evidence of progressive disease while on Braftovi therapy AND used in combination with Mektovi (binimetinib)

Authorization will be issued for 12 months.

Colorectal continuation: Patient does not show evidence of progressive disease while on Braftovi therapy AND used in combination with one of the following: Erbitux (cetuximab)

Authorization will be issued for 12 months.

NSCLC continuation: Patient does not show evidence of progressive disease while on Braftovi therapy AND used in combination with Mektovi (binimetinib)

Authorization will be issued for 12 months.

Provider Actions, Authorization & Documentation

Prior Authorization

Prior Authorization Required

Prior authorization required — approval issued for 12 months when diagnosis, mutation status, stage, and combination therapy criteria are met.

Authorization duration: 12 months when criteria are met
Applies to initial authorization and reauthorization where specified

Denial Risk

Denial Risk — Clinical Criteria Not Met

Coverage may be denied if the member does not meet the listed clinical criteria. Note: state mandates may supersede these criteria.

Members must meet all applicable clinical criteria for coverage
For members under 19 years of age, prescriptions will automatically process without a coverage review unless otherwise specified by state mandate

Background and Definitions

Braftovi (encorafenib) is a kinase inhibitor indicated for specific BRAF V600–mutant cancers when used in defined combination regimens. Indications include use with Mektovi (binimetinib) for unresectable or metastatic melanoma with a BRAF V600E or V600K mutation; use with Erbitux (cetuximab) and mFOLFOX6 for metastatic colorectal cancer with a BRAF V600E mutation; and use with Erbitux (cetuximab) for metastatic CRC with BRAF V600E after prior therapy. The NCCN Compendium also recommends Braftovi in combination with Erbitux or Vectibix (panitumumab) for advanced or metastatic CRC with BRAF V600E. Additionally, Braftovi in combination with Mektovi is indicated for adult patients with metastatic or recurrent NSCLC harboring a BRAF V600E mutation. Braftovi is not indicated for tumors with wild-type BRAF.

Limitations of Use

Non-indicated tumor typesBraftovi is not indicated for treatment of patients with wild-type BRAF melanoma.

Non-indicated colorectal cancerBraftovi is not indicated for treatment of patients with wild-type BRAF colorectal cancer (CRC).

Non-indicated NSCLCBraftovi is not indicated for treatment of patients with wild-type BRAF non-small cell lung cancer (NSCLC).

Step Therapy / Prior Treatment Pathways

Prior therapy pathway	Required prior therapy	Required combination regimen
Post-oxaliplatin pathway (colorectal cancer)	Patient has received prior therapy with an oxaliplatin‑based regimen (e.g., FOLFOX, CAPEOX)	Used in combination with Erbitux (cetuximab) or Vectibix (panitumumab)
No prior oxaliplatin pathway (colorectal cancer)	Patient has not received prior therapy with an oxaliplatin‑based regimen (e.g., FOLFOX, CAPEOX)	Used in combination with Erbitux (cetuximab) or Vectibix (panitumumab) AND used with FOLFOX (fluorouracil, leucovorin, and oxaliplatin)