CurrentCignaPolicy N/A

Oncology (Oral - BRAF Inhibitor) - Braftovi PA Policy

Defines prior authorization requirements and medical necessity criteria for coverage of Braftovi (encorafenib capsules) for FDA-approved indications (colon/rectal cancer, melanoma, NSCLC) and an other-use (appendiceal adenocarcinoma) with supportive evidence; approval durations and not-medically-necessary statement for other uses are included.

Policy Summary

PayerCigna

PolicyOncology (Oral - BRAF Inhibitor) - Braftovi PA Policy

Policy CodePolicy N/A

Change TypeMultiple selected and annual revisions (2023–2025)

Effective Date

Next Review Date

Key ActionPrior Authorization is recommended for Braftovi; document BRAF V600 mutation positivity and prescribe Braftovi only in the required combination regimens when specified.

SourceLink

POLICY UPDATE CHANGES

Non-Small Cell Lung Cancer: Added new FDA-approved indication and criteria.

Appendiceal Adenocarcinoma: Added new approval condition and criteria under 'Other Uses with Supportive Evidence'.

Colon or Rectal Cancer: Added new criterion for Braftovi use in combination with Erbitux and mFOLFOX6 for first-line therapy; modified subsequent therapy combination language to specify 'Erbitux or Vectibix'.

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

Annual Revision: No criteria changes (07/19/2023).

3FDA-Approved Indications covered

Other supportive indication

1Not medically necessary catch-all

Coverage Summary

Braftovi (encorafenib) is a BRAF inhibitor with FDA approvals for use in combination regimens for BRAF V600-mutated disease in colon/rectal cancer, melanoma, and non-small cell lung cancer (NSCLC). The policy notes an accelerated approval for first-line colorectal cancer. Approval duration for covered indications is 1 year, and the overall coverage stance is covered_with_criteria.

Covered FDA-approved indications include: metastatic colon or rectal cancer with a BRAF V600E mutation (used in combination with Erbitux and mFOLFOX6 or in subsequent lines with Erbitux/Vectibix); unresectable or metastatic melanoma with a BRAF V600 mutation; and recurrent/advanced/metastatic NSCLC with a BRAF V600E mutation in combination with Mektovi. The policy also includes an other-use with supportive evidence for appendiceal adenocarcinoma (BRAF V600E mutation-positive advanced or metastatic disease) when used in combination with Erbitux or Vectibix.

The policy defines prior authorization requirements and specific medical necessity criteria for these indications, including documentation of BRAF V600E (or V600 where specified) mutation-positive disease and required combination agents when applicable.

Key policy at-a-glance

FDA-Approved Indications covered3

Other supportive indication covered1

Not medically necessary catch-all1

Coverage stancecovered with criteria

StatusCURRENT

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 the following
  - i.

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
  Includes V600E or V600K as noted in definitions

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

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

Conditions Not Covered

Not medically necessary when any other use not specified in policy is requested:

ALL of the following

Braftovi (encorafenib capsules) is considered not medically necessary for ANY other use(s)

Applicable Codes

Drug (HCPCS/NDC not specified in document)mixedCovered

No codes listed

Provider Actions

Prior Authorization

Prior authorization required

Prior Authorization is recommended for prescription benefit coverage of Braftovi. All approvals are provided for the duration noted (approvals for approved indications are for 1 year).

Prior authorization required.
Approvals provided for 1 year for approved indications.

Documentation Required

Documentation of BRAF mutation

Documentation of BRAF mutation is required: BRAF V600E mutation‑positive disease must be demonstrated by an FDA‑approved test. For melanoma where specified, documentation may be for BRAF V600 mutations including V600E or V600K as detected by an FDA‑approved test.

FDA‑approved test documentation of BRAF V600E mutation-positive disease is required.

Definitions & Clinical Evidence

FOLFOX: 5-FU, leucovorin, and oxaliplatin.

Erbitux: cetuximab intravenous infusion.

Vectibix: panitumumab intravenous infusion.

Mektovi: binimetinib tablets.

Prescribing information: Braftovi capsules prescribing information, Array BioPharma; December 2024.

Guideline references: NCCN guidelines for colon, rectal, melanoma, and NSCLC (versions cited through 2025) and the NCCN Drugs & Biologics Compendium are referenced for recommended use and compendium recommendations.

Braftovi is a BRAF inhibitor with FDA approvals for use in combination for BRAF V600-mutated colorectal cancer, melanoma, and NSCLC; the colorectal first-line indication is approved under accelerated approval. See the Braftovi prescribing information (Array BioPharma, December 2024) and NCCN guideline guidance and compendium recommendations for supporting recommendations and use scenarios.

Revision History

07/19/2023annual_review

Annual Revision: No criteria changes (Annual Revision, Summary of Changes = No criteria changes.).

10/18/2023revised

Selected Revision, Review Date = 10/18/2023: Non-Small Cell Lung Cancer: Added new FDA-approved indication and criteria.

08/14/2024added

Annual Revision, Review Date = 8/14/2024: Appendiceal Adenocarcinoma: Added new approval condition and criteria under 'Other Uses with Supportive Evidence'.

Policy Summary

PayerCigna

PolicyOncology (Oral - BRAF Inhibitor) - Braftovi PA Policy

Policy CodePolicy N/A

Change TypeMultiple selected and annual revisions (2023–2025)

Effective Date

Next Review Date

Key ActionPrior Authorization is recommended for Braftovi; document BRAF V600 mutation positivity and prescribe Braftovi only in the required combination regimens when specified.

SourceLink

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 a fluoropyrimidine such as 5-fluorouracil (5-FU), capecitabine; oxaliplatin, irinotecan; or regimens such as FOLFOX or CapeOX
b: The medication is used in combination with Erbitux or Vectibix

Prior Authorization

Prior authorization, mutation documentation, and combination therapy requirements

Prior authorization is required for Braftovi (encorafenib) prescription benefit coverage. Approvals for approved indications are provided for 1 year. Documentation of a BRAF V600E mutation (or V600 where specified for melanoma: V600E or V600K) detected by an FDA‑approved test is required. When required by the policy criteria, Braftovi must be prescribed in combination with specified agents — for colon/rectal first‑line therapy: Erbitux (cetuximab) or Vectibix (panitumumab) plus FOLFOX (5‑FU, leucovorin, oxaliplatin); for subsequent colon/rectal therapy: Erbitux or Vectibix; for NSCLC: Mektovi (binimetinib); and for appendiceal adenocarcinoma: Erbitux or Vectibix.

Prior authorization required; approvals provided for 1 year.
Documentation of BRAF V600E (or V600 where specified for melanoma: V600E or V600K) mutation-positive disease by an FDA‑approved test is required.
Combination requirements when specified by criteria: colon/rectal first-line — Erbitux or Vectibix + FOLFOX; colon/rectal subsequent — Erbitux or Vectibix; NSCLC — Mektovi; appendiceal — Erbitux or Vectibix.

Prior Authorization

Prior authorization and BRAF mutation documentation

Prior authorization is required for Braftovi prescription coverage; approvals are provided for 1 year. Documentation of BRAF V600E mutation-positive disease (or V600 where specified for melanoma: V600E or V600K) detected by an FDA‑approved test is required.

Prior authorization required; approvals provided for 1 year.
FDA‑approved test documentation of BRAF V600E (or V600/V600K for melanoma where specified) mutation-positive disease.

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

Prior Authorization

Prior authorization, mutation documentation, and NSCLC combination requirement

Prior authorization is required for Braftovi; approvals are provided for 1 year. Documentation of BRAF V600E mutation-positive disease (or V600 where specified for melanoma: V600E or V600K) detected by an FDA‑approved test is required. When required by the criteria for the indicated disease, Braftovi must be used in combination with Mektovi (binimetinib) for NSCLC.

Prior authorization required; approvals provided for 1 year.
FDA‑approved test documentation of BRAF V600E (or V600/V600K for melanoma where specified) mutation-positive disease.
For NSCLC indications, Braftovi must be taken in combination with Mektovi when specified by the criteria.

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

Prior Authorization

Prior authorization, mutation documentation, and Erbitux/Vectibix combination requirement

Prior authorization is required for Braftovi; approvals are provided for 1 year. Documentation of BRAF V600E mutation-positive disease detected by an FDA‑approved test is required. When required by policy criteria for colon/rectal or appendiceal disease, Braftovi must be used in combination with Erbitux (cetuximab) or Vectibix (panitumumab) — and for first-line colon/rectal therapy also with FOLFOX (5‑FU, leucovorin, oxaliplatin).

Prior authorization required; approvals provided for 1 year.
FDA‑approved test documentation of BRAF V600E mutation-positive disease.
When specified by criteria, Braftovi must be used in combination with Erbitux or Vectibix (and with FOLFOX for first-line colon/rectal).

For melanoma where specified, BRAF V600 mutation-positive disease (V600E or V600K) is required.

Billing Rule

Use appropriate combination agents

Use appropriate combination agents as specified by indication: for colon/rectal disease when criteria require first-line therapy, Braftovi must be used with Erbitux (cetuximab) or Vectibix (panitumumab) plus FOLFOX (5‑FU, leucovorin, oxaliplatin); for subsequent colon/rectal therapy, Braftovi must be used with Erbitux or Vectibix; for NSCLC, Braftovi must be taken in combination with Mektovi (binimetinib); and for appendiceal adenocarcinoma, Braftovi must be used with Erbitux or Vectibix when required by criteria.

Colon/rectal first-line: Erbitux or Vectibix + FOLFOX required by criteria.
Colon/rectal subsequent: Erbitux or Vectibix required by criteria.
NSCLC: combination with Mektovi required by criteria.
Appendiceal adenocarcinoma: Erbitux or Vectibix required by criteria.

01/29/2025revised

Selected Revision, Review Date = 01/29/2025: Colon or Rectal Cancer: Added new criterion for Braftovi use in combination with Erbitux and mFOLFOX6 for first-line therapy based on FDA approval; modified subsequent therapy combination language to specify 'Erbitux or Vectibix'.

04/08/2025clarified

Update, Summary of Changes = 04/08/2025: Policy name changed to 'Oncology (Oral - BRAF Inhibitor) - Braftovi PA Policy'.

08/20/2025revisedLatest

Annual Revision, Review Date = 08/20/2025: Colon or Rectal Cancer: Vectibix was added and 'mFOLFOX6' was updated to 'FOLFOX' in the requirement stating the medication will be used in combination with Erbitux or Vectibix and FOLFOX; additional refinements to subsequent therapy language.