Neighborhood Health Plan RI Braftovi Coverage

Coverage Criteria for Encorafenib (Braftovi)

Colorectal Cancer - Initial and subsequent line

Covered when ALL of the following are met for colorectal cancer:

Colorectal Cancer coverage

Permitted regimen and sequencing: Encorafenib (Braftovi) will be used in combination with cetuximab (Erbitux) or panitumumab (Vectibix) after prior therapy with an oxaliplatin and/or irinotecan-containing regimen; OR encorafenib may be used in combination with FOLFOX plus cetuximab or panitumumab in the initial-line setting for stage IV metastatic BRAF V600E colorectal cancer when KRAS/NRAS status is wild-type or unknown.
Additional member requirements: Member has not had prior treatment with any selective BRAF inhibitors or EGFR inhibitors; and tumors are not MSI-H/dMMR unless the member is ineligible for or has progressed on immune checkpoint inhibitors.

Operational note: Use must be supported by FDA labeling or CMS-recognized compendia/peer-reviewed evidence as required by policy; prior authorization is required.

Melanoma

Covered when ALL of the following are met for melanoma:

Melanoma coverage: Member has unresectable or metastatic melanoma with a documented BRAF V600E or V600K mutation and encorafenib (Braftovi) will be used in combination with binimetinib (Mektovi).

Non-Small Cell Lung Cancer

Covered when ALL of the following are met for non-small cell lung cancer (NSCLC):

NSCLC coverage: Adult member has metastatic non-small cell lung cancer with a documented BRAF V600E mutation and encorafenib (Braftovi) will be used in combination with binimetinib (Mektovi).

Requests for Braftovi (encorafenib) will be excluded (denied) when any of the following apply: disease progression occurred while receiving Braftovi or another BRAF inhibitor (whether given alone or in combination); the prescribed dosing exceeds the stated single-dose maximum of 450 mg for melanoma and NSCLC or 300 mg for colorectal cancer; or the requested supply would exceed the monthly maximum of 180 capsules per month (75 mg strength).

Additionally, requests for Braftovi used for off-label or investigational indications will be denied when the supporting evidence is insufficient or not generally accepted by the medical community. Insufficiency is determined by whether the patient and tumor characteristics, the regimen used, and the reported outcomes are adequately represented in the published evidence, and whether outcomes demonstrate clinically meaningful benefit per standards such as ASCO (e.g., hazard ratio < 0.80 or at least a 3-month survival benefit for OS/PFS).

Investigational or off-label uses of Braftovi (encorafenib) that lack support from CMS-recognized compendia or acceptable peer‑reviewed literature are considered not medically necessary. Types of evidence that are generally unacceptable as sole support include case reports (considered uncontrolled and anecdotal) and meeting abstracts without a full peer‑reviewed publication.

Acceptable evidence should demonstrate that the study population and treatment regimen are representative of the clinical scenario under consideration, that study outcomes are clinically meaningful (for example meeting ASCO-recommended thresholds), and that the study design is appropriate to the question. Absence of these elements may render the evidence insufficient to support coverage for an off‑label indication.

Regimens and Indications Covered

Regimen	Indication	Biomarker	Line of therapy / constraints
Encorafenib in combination with cetuximab (Erbitux) or panitumumab (Vectibix)
Metastatic or unresectable colorectal cancer
BRAF V600E mutation positive
Used after prior therapy with an oxaliplatin and/or irinotecan-containing regimen; OR as initial-line in stage IV when given with FOLFOX + cetuximab or panitumumab if KRAS/NRAS is wild-type or unknown. Members must not have prior selective BRAF or EGFR inhibitor treatment; tumors should not be MSI-H/dMMR unless ineligible for or progressed on immune checkpoint inhibitors.

Regimen	Indication	Biomarker	Line of therapy / constraints
Encorafenib in combination with binimetinib (Mektovi)
Unresectable or metastatic melanoma
BRAF V600E or V600K mutation positive
No specific prior-line restriction stated in policy; use per FDA/compendia-supported indications for unresectable/metastatic disease.

Regimen	Indication	Biomarker	Line of therapy / constraints
Encorafenib in combination with binimetinib (Mektovi)
Metastatic non-small cell lung cancer (NSCLC)
BRAF V600E mutation positive
For adult members with metastatic disease; no additional line-specific restrictions detailed beyond requirement for documented BRAF V600E mutation and coverage criteria compliance.

Billing and Coding

HCPCS code for encorafenibHCPCSCovered

J8999

encorafenib

Single dose maximum

Single dose maximum (melanoma & NSCLC)450 mg per single dose

Single dose maximum (colorectal cancer)300 mg per single dose

ContextDosing limits are used to trigger exclusions if exceeded

Monthly maximum capsules

Monthly maximum quantity180 capsules per month

Capsule strength referenced75 mg capsules

Exclusion note

Provider Actions, Authorization & Documentation

Prior Authorization

Prior authorization processed by Evolent; criteria for continuation exemption

Prior authorization is required for Braftovi (encorafenib) requests and all medication requests are processed by Evolent. Continuation requests may be exempt from prior authorization when the member has not experienced disease progression on the requested medication, the medication was used within the last year without a lapse of more than 30 days of having an active authorization, and no additional medications are being added to the continuation request.

Evolent processes all medication requests; medications not authorized by Evolent may be deemed not approvable and not reimbursable.
Continuation exemption conditions: no disease progression on the medication; prior authorization active within the last year with ≤30-day lapse; no new medications added.

Step Therapy

Sequence and line restrictions for colorectal cancer

For metastatic BRAF V600E colorectal cancer, encorafenib must be used in combination with an anti‑EGFR agent (cetuximab or panitumumab) after prior therapy with an oxaliplatin and/or irinotecan‑containing regimen; initial‑line use in stage IV is allowed only when combined with FOLFOX plus an anti‑EGFR for KRAS/NRAS wild‑type or unknown tumors.

Biomarker and Molecular Test Requirements

BRAF V600E (and V600K for melanoma)

Required BRAF mutation for colorectal cancerBRAF V600E mutation positive unresectable or metastatic colorectal cancer

Required BRAF mutation for melanomaBRAF V600E or V600K mutation positive unresectable/metastatic melanoma

Required BRAF mutation for NSCLCBRAF V600E mutation positive metastatic non-small cell lung cancer

KRAS/NRAS

KRAS/NRAS requirement for initial-line FOLFOX + anti‑EGFRKRAS/NRAS must be wild‑type or unknown to use encorafenib + FOLFOX + cetuximab/panitumumab in initial-line stage IV colorectal cancer

KRAS/NRAS for post‑therapy combinationFor encorafenib + anti‑EGFR after prior oxaliplatin/irinotecan regimens, colorectal use is allowed regardless of KRAS/NRAS status

Line of Therapy Guidance

first-line | second-line

Line of therapy: Colorectal cancer: use after prior oxaliplatin and/or irinotecan-containing regimen in combination with an anti-EGFR OR initial-line use in stage IV disease when combined with FOLFOX + anti-EGFR for KRAS/NRAS wild-type or unknown. Melanoma: indicated in unresectable/metastatic disease (line not restricted) in combination with binimetinib. NSCLC: indicated in metastatic disease (line not restricted) in combination with binimetinib.

Key Definitions

BRAF V600E colorectal cancer

Definition for colorectal cancer indicationUnresectable or metastatic colorectal cancer that is BRAF V600E mutation positive; encorafenib intended for use in combination with cetuximab or panitumumab after prior oxaliplatin and/or irinotecan therapy, or with FOLFOX + cetuximab/panitumumab in initial‑line stage IV when KRAS/NRAS is wild‑type or unknown

Prior therapy restrictionMember must not have had prior treatment with any selective BRAF inhibitors or EGFR inhibitors

Biomarker independence noteBRAF V600E requirement applies regardless of KRAS/NRAS status for the post‑therapy encorafenib + anti‑EGFR regimen

BRAF V600-mutant melanoma and NSCLC

Melanoma biomarker definitionUnresectable or metastatic melanoma that is BRAF V600E or V600K mutation positive; encorafenib is used in combination with binimetinib

Background

Encorafenib (Braftovi) is a selective BRAF inhibitor targeted to tumors with activating BRAF V600 mutations. This policy addresses use of encorafenib in specified, biomarker‑defined settings—notably metastatic or unresectable BRAF V600E colorectal cancer (in combination with an anti‑EGFR agent, with sequencing rules for prior oxaliplatin/irinotecan exposure and certain initial‑line exceptions) and BRAF V600E or V600K melanoma and BRAF V600E NSCLC when used in recommended combinations (for example with binimetinib in melanoma and NSCLC).

OpenPayer

Braftovi (encorafenib) — Coverage Criteria