CurrentCignaPolicy N/A

Oncology (Oral - BRAF Inhibitor) - Braftovi PA Policy

Cigna prior authorization policy for oral BRAF inhibitor Braftovi (encorafenib capsules) describing coverage criteria for FDA-approved indications and selected other uses with supportive evidence, approval durations, and non-covered conditions.

Policy Summary

PayerCigna

PolicyOncology (Oral - BRAF Inhibitor) - Braftovi PA Policy

Policy CodePolicy N/A

Change TypeName update; multiple clinical criteria revisions

Effective Date

Next Review Date

Key ActionPrior Authorization is recommended for Braftovi; approvals are provided for 1 year when criteria are met.

POLICY UPDATE CHANGES

Policy name changed to 'Oncology (Oral - BRAF Inhibitor) - Braftovi PA Policy'.

Colon/Rectal Cancer criteria updated to specify use in combination with Erbitux or Vectibix and FOLFOX for first-line therapy per FDA approval.

NSCLC FDA-approved indication and criteria were added.

Appendiceal adenocarcinoma added as an Other Use with Supportive Evidence.

History entry states most recent annual revision with 'No criteria changes' on 07/19/2023 and annual revision on 08/20/2025.

3FDA-Approved Indications Covered

1Other Use with Supportive Evidence

1 yearTypical Approval Duration

Coverage Summary

Coverage stance: Covered with criteria for FDA-approved indications and one other use with supportive evidence. Braftovi (encorafenib) is covered for FDA-approved indications in colon/rectal cancer (in combination with Erbitux or Vectibix and FOLFOX for first-line metastatic disease, and in combination with Erbitux or Vectibix for subsequent therapy), melanoma (BRAF V600 mutation-positive unresectable or metastatic disease), and NSCLC (BRAF V600E mutation-positive metastatic NSCLC in combination with Mektovi). In addition, an Other Use with Supportive Evidence is listed for appendiceal adenocarcinoma (BRAF V600E mutation-positive advanced or metastatic disease) in combination with Erbitux or Vectibix. Approvals are typically for 1 year. See scope_summary for policy scope and purpose.

Quick facts

PayerCigna

DrugBraftovi (encorafenib)

Coverage stanceCovered with criteria (prior authorization required)

Approval duration1 year

Number of FDA‑approved indications3

Other use with supportive evidenceAppendiceal adenocarcinoma (recommended by NCCN/compendium)

FDA-Approved Indications — Colon or Rectal Cancer

FDA-Approved Indications - Colon or Rectal Cancer

Approve for 1 year if the patient meets ALL of the following (A, B, and C):

ALL of the following

A
- Patient is ≥ 18 years of age
B
- Patient has BRAF V600E mutation-positive disease
C: ONE of
- i.

FDA-Approved Indications — Melanoma

FDA-Approved Indications - Melanoma

Approve for 1 year if the patient meets ALL of the following (A, B, and C):

ALL of the following

A: Patient is ≥ 18 years of age
B: Patient has unresectable, advanced, or metastatic melanoma
C: Patient has BRAF V600 mutation-positive disease

FDA-Approved Indications — Non-Small Cell Lung Cancer (NSCLC)

FDA-Approved Indications - Non-Small Cell Lung Cancer (NSCLC)

Approve for 1 year if the patient meets ALL of the following (A, B, C, and D):

ALL of the following

A: Patient is ≥ 18 years of age
B: Patient has recurrent, advanced, or metastatic disease
C: Patient has BRAF V600E mutation-positive disease
D:

Other Uses with Supportive Evidence

Other Uses with Supportive Evidence - Appendiceal Adenocarcinoma

Approve for 1 year if the patient meets ALL of the following (A, B, C, and D):

ALL of the following

A: Patient is ≥ 18 years of age
B: Patient has BRAF V600E mutation-positive disease
C: Patient has advanced or metastatic disease
D: The medication will be used in combination with Erbitux (cetuximab intravenous infusion) or Vectibix (panitumumab intravenous infusion)

Not Medically Necessary / Conditions Not Covered

ALL of the following

Braftovi (encorafenib capsules) is considered not medically necessary for ANY other use(s) beyond the criteria listed

Provider Actions

Prior Authorization

Prior authorization required

Prior Authorization is recommended for prescription benefit coverage of Braftovi; approvals are provided for 1 year when the policy criteria are met.

Documentation Required

Documentation of BRAF mutation status required

Provider must document BRAF mutation status using an FDA‑approved test. The policy requires BRAF V600E mutation‑positive disease for colorectal, appendiceal, and NSCLC indications and BRAF V600 (V600E or V600K) mutation‑positive disease for melanoma; include the laboratory report showing detection by an FDA‑approved test.

Applicable Codes

DrugNDCCovered

No codes listed

Companion/Concurrent Infusions (Referenced)HCPCS|CPT

J-code not specified	Erbitux (cetuximab) intravenous infusion referenced; no specific HCPCS provided in policy
J-code not specified	Vectibix (panitumumab) intravenous infusion referenced; no specific HCPCS provided in policy

Clinical Evidence & References

Key evidence sources listed in the policy include the Prescribing Information: Braftovi capsules [prescribing information], Array BioPharma; December 2024, and guideline sources from the National Comprehensive Cancer Network (NCCN) — version 2025 guideline documents for colon/rectal cancer, melanoma, and non-small cell lung cancer. The policy also notes NCCN Compendium support for appendiceal adenocarcinoma.

Background

Background: Braftovi (encorafenib) is a BRAF inhibitor. The policy describes FDA-approved combination indications for BRAF V600E or V600K mutation-positive disease: colorectal cancer (in combination with Erbitux and FOLFOX for first-line metastatic disease, and with Erbitux for subsequent therapy), melanoma (in combination with Mektovi for unresectable or metastatic disease with BRAF V600E or V600K), and non-small cell lung cancer (in combination with Mektovi for metastatic NSCLC with BRAF V600E). The policy also notes that appendiceal adenocarcinoma (BRAF V600E mutation-positive advanced or metastatic disease) is supported by guideline/compendium recommendations for use in combination with Erbitux or Vectibix.

Definitions

Thresholds / Notes

Revision History

04/08/2025name_update

Policy name changed to 'Oncology (Oral - BRAF Inhibitor) - Braftovi PA Policy'.

08/14/2024criteria_update

Colon/Rectal Cancer criteria updated to specify use in combination with Erbitux or Vectibix and FOLFOX for first-line therapy per FDA approval; wording changed from mFOLFOX6 to FOLFOX and combination references clarified.

10/18/2023indication_added

Non-Small Cell Lung Cancer (NSCLC) FDA-approved indication and criteria were added.

Policy Summary

PayerCigna

PolicyOncology (Oral - BRAF Inhibitor) - Braftovi PA Policy

Policy CodePolicy N/A

Change TypeName update; multiple clinical criteria revisions

Effective Date

Next Review Date

Key ActionPrior Authorization is recommended for Braftovi; approvals are provided for 1 year when criteria are met.

On This Page

a: The medication will be used as first-line systemic therapy for metastatic disease

b: The medication will be used in combination with Erbitux (cetuximab intravenous infusion) or Vectibix (panitumumab intravenous infusion)

c: The medication will be used in combination with FOLFOX (5-FU, leucovorin, and oxaliplatin)

ii.

a: Patient has previously received a chemotherapy regimen for colon or rectal cancer
Examples include fluoropyrimidine (5-FU, capecitabine), oxaliplatin, irinotecan, FOLFOX, or CapeOX
b: The medication is used in combination with Erbitux or Vectibix

Documentation Required

Document concurrent Erbitux/Vectibix + FOLFOX use

When submitting a request for Braftovi for colorectal or appendiceal disease, document the planned concurrent use with Erbitux (cetuximab IV infusion) or Vectibix (panitumumab IV infusion) and with FOLFOX (5‑FU, leucovorin, and oxaliplatin) when indicated by the criteria. Companion/concurrent infusions (Erbitux or Vectibix) and FOLFOX are explicitly referenced in the policy code_groups and the colorectal/appendiceal approval criteria; include this information in the clinical documentation to support medical necessity.

Documentation Required

Document BRAF V600 mutation status

Document BRAF mutation testing results demonstrating the presence of a qualifying BRAF V600 mutation according to the indication. For colorectal, appendiceal, and NSCLC criteria the policy requires BRAF V600E mutation‑positive disease; for melanoma the policy specifies BRAF V600 (V600E or V600K) mutation‑positive disease. Ensure the mutation and the specific V600 subtype (as applicable) are recorded in the request.

The medication will be taken in combination with Mektovi (binimetinib tablets)

Documentation Required

Document planned combination with Mektovi (NSCLC)

When requesting Braftovi for NSCLC, document planned combination therapy with Mektovi (binimetinib tablets) and confirm the patient has BRAF V600E mutation‑positive disease per the NSCLC criteria. Include the planned concurrent use of Mektovi in the clinical notes and the mutation test result to support the combination regimen requirement.

Evidence for the 'Other Use' (appendiceal adenocarcinoma) is drawn from guideline/compendium recommendations. The policy cites NCCN guideline/Compendium support recommending Braftovi in combination with Erbitux or Vectibix for BRAF V600E mutation-positive advanced or metastatic appendiceal adenocarcinoma; these guideline/compendium recommendations are referenced as the supporting evidence.

Documentation Required

Documentation of combination therapy

Provider must document planned concurrent use with the specified agents when required by the indication: Erbitux or Vectibix (with FOLFOX when indicated) for colorectal or appendiceal disease, and Mektovi for NSCLC. Include the intended concomitant therapy in the treatment plan to demonstrate the combination therapy requirement.

Operational note: The policy references companion/concurrent intravenous infusions (e.g., Erbitux/cetuximab and Vectibix/panitumumab) as part of combination regimens, and companion/concurrent infusion J/HCPCS codes are referenced in the policy context; however, specific HCPCS/J‑codes are not provided in the policy. Providers should document the planned infusion agents when applicable.

07/19/2023other_use_added

Appendiceal adenocarcinoma added as an Other Use with Supportive Evidence.

08/20/2025administrative_reviewLatest

Annual revision recorded; history notes administrative review with 'No criteria changes' in that cycle.