CurrentColorado Rocky Mountain Health PlansPolicy 1 = 2025 P 3117-9

Step therapy for Braftovi (encorafenib)

Defines step therapy requirements and authorization rules for coverage of Braftovi (encorafenib) in combination with Mektovi (binimetinib) for melanoma and BRAF V600E NSCLC, and for patients <19 years. Applies to members under Colorado Rocky Mountain Health Plans following UnitedHealthcare Pharmacy Clinical Pharmacy Programs.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyStep therapy for Braftovi (encorafenib)

Policy CodePolicy 1 = 2025 P 3117-9

Change TypeAnnual review (no material criteria changes)

Effective Date11/1/2025

Next Review Date

Key ActionObtain prior authorization showing Braftovi will be used with Mektovi and document trial/failure of or contraindication to required alternative BRAF/MEK combinations or provide provider attestation.

SourceLink

POLICY UPDATE CHANGES

Non-small cell lung cancer (NSCLC) section was added to the program.

Updated background with new indications and added NSCLC section; annual review with no changes to coverage criteria in 8/2025.

Wording of provider attestation for appropriateness of alternatives was updated.

12 monthsauthorization duration

Braftovi + Mektovirequired combination for approval

Step therapyprogram type

Age <19 auto-approve

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Coverage Criteria for Braftovi (encorafenib)

Indication-specific coverage criteria

Coverage for Braftovi (encorafenib) in combination with Mektovi (binimetinib) is provided when the following criteria are met for each indication.

Patients <19 years: Member is less than 19 years of age

Authorization issued for 12 months

Melanoma - initial and continuation: Braftovi is to be used in combination with Mektovi (binimetinib) AND one of the following: (1) patient has a contraindication or history of intolerance to Tafinlar (dabrafenib) plus Mekinist (trametinib); (2) patient has a contraindication or history of intolerance to Zelboraf (vemurafenib) plus Cotellic (cobimetinib); OR (3) provider attests the patient is not an appropriate candidate for both alternative regimens based on clinical status or comorbidities; OR (4) continuation of therapy provided the patient has not been established on therapy via manufacturer samples or Pfizer Oncology Together co-pay assistance (see continuation criteria).

Patients requesting initial authorization who were established on therapy via manufacturer samples or Pfizer Oncology Together assistance must meet initial authorization criteria as if new to therapy

NSCLC (metastatic) - initial and continuation: Braftovi is to be used in combination with Mektovi (binimetinib) AND one of the following: (1) patient has a contraindication or history of intolerance to Tafinlar (dabrafenib) plus Mekinist (trametinib); OR (2) provider attests the patient is not an appropriate candidate for Tafinlar plus Mekinist based on clinical status or comorbidities; OR (3) continuation of therapy provided the patient has not been established on therapy via manufacturer samples or Pfizer Oncology Together co-pay assistance (see continuation criteria).

Patients requesting initial authorization who were established on therapy via manufacturer samples or Pfizer Oncology Together assistance must meet initial authorization criteria as if new to therapy

Coverage under this program may be modified by external requirements. State mandates for benefit coverage or compendia use can supersede the criteria in this document; any applicable federal regulatory requirements and the member-specific benefit plan terms may also affect coverage determinations. Other payer policies and utilization management programs (for example, prior authorization automation, supply limits, or notification rules) may apply and interact with these criteria.

For members under 19 years of age, prescriptions will automatically process without a coverage review as described in the program guidance; for all other members the criteria in this policy apply unless superseded by a mandate or specific plan language.

Approvals may be granted based on prior claim or medication history, diagnosis codes, and/or claim logic as allowed by UnitedHealthcare clinical rules; therefore automated approval pathways or other UM programs could result in a different outcome than a manual review of these criteria.

Coverage of Braftovi (encorafenib) in combination with Mektovi (binimetinib) requires meeting the program's step therapy requirement: the member must have tried an alternative BRAF inhibitor/MEK inhibitor combination regimen (for example, Tafinlar + Mekinist or Zelboraf + Cotellic) unless there is a documented contraindication or history of intolerance, or the provider attests the patient is not an appropriate candidate for the required alternatives.

If the step therapy requirement is not met (no documented trial of a required alternative and no documented contraindication/intolerance or provider attestation), the request would not meet the coverage criteria and may be considered not medically necessary. Note that UnitedHealthcare may still approve initial or reauthorization requests based solely on prior claim/medication history, diagnosis codes, and/or claim logic in accordance with its automated clinical rules.

Provider Requirements and Authorization Actions

Prior Authorization

Prior Authorization Required

Prior authorization required for Braftovi (encorafenib) when used in combination with Mektovi (binimetinib). Members <19 years may be auto-processed per payer rules; members currently on documented Braftovi + Mektovi therapy in claims history may continue without meeting new-step criteria. Authorization is required for new-to-therapy members.

Prior auth required for Braftovi except members <19 may be auto-processed
Braftovi approvals are contingent on combination use with Mektovi (binimetinib)
Existing members on documented Braftovi + Mektovi in claims may continue therapy

Step Therapy

Step Therapy Requirement

A step-therapy trial of an alternative BRAF inhibitor + MEK inhibitor combination is required prior to coverage of Braftovi for new-to-therapy members. Specifically, patients must have tried or have documented contraindication/intolerance to the following combinations before approval for Braftovi: Tafinlar (dabrafenib) + Mekinist (trametinib) and Zelboraf (vemurafenib) + Cotellic (cobimetinib).

Initial Authorization Requirements

Initial therapy requirements

Initial authorization for Braftovi (encorafenib) used with Mektovi (binimetinib) requires documentation of diagnosis and prior trial/intolerance of alternatives or provider attestation.

Initial melanoma: Braftovi is to be used in combination with Mektovi (binimetinib) AND one of: (a) contraindication or history of intolerance to Tafinlar (dabrafenib) plus Mekinist (trametinib); (b) contraindication or history of intolerance to Zelboraf (vemurafenib) plus Cotellic (cobimetinib); OR (c) provider attests the patient is not an appropriate candidate for either alternative regimen based on clinical status or comorbidities

Patients established on therapy via manufacturer sample or Pfizer Oncology Together assistance must meet initial authorization criteria as if new to therapy

Initial NSCLC: Braftovi is to be used in combination with Mektovi (binimetinib) AND one of: (a) contraindication or history of intolerance to Tafinlar (dabrafenib) plus Mekinist (trametinib); OR (b) provider attests the patient is not an appropriate candidate for Tafinlar plus Mekinist based on clinical status or comorbidities

Patients established on therapy via manufacturer sample or Pfizer Oncology Together assistance must meet initial authorization criteria as if new to therapy

Continuation Authorization Requirements

Continuation therapy

Continuation of Braftovi (encorafenib) with Mektovi (binimetinib) is permitted for members already on therapy when prior use is documented and certain conditions are met.

Continuation criteria: Patient is continuing Braftovi plus Mektovi AND patient has not been established on therapy via receipt of a manufacturer supplied sample at no cost from a prescriber's office or any form of assistance from the Pfizer Oncology Together Co‑Pay Savings Program (including sample cards or a 30‑day free trial used to establish current use)

Authorization issued for 12 months; members already on therapy may be authorized based on claims/medication history provided the sample/co‑pay assistance restriction is met

Step Therapy Details

Required prior trial	Exceptions/Acceptable alternatives
Trial of an alternative BRAF/MEK inhibitor combination (examples provided)	Tafinlar (dabrafenib) + Mekinist (trametinib) — required trial unless contraindicated or intolerant; or
Or trial of an alternative BRAF/MEK inhibitor combination (alternate example)	Zelboraf (vemurafenib) + Cotellic (cobimetinib) — required trial unless contraindicated or intolerant; or provider attests patient is not an appropriate candidate
If continuation of therapy, prior use may satisfy requirement	Continuation allowed when member is currently on Braftovi + Mektovi as documented in claims history and patient has not been established via manufacturer sample or Pfizer Oncology Together co-pay assistance

Background and Indications

Braftovi (encorafenib) administered in combination with Mektovi (binimetinib) is indicated for patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation and for patients with metastatic non-small cell lung cancer (NSCLC) with BRAF V600E mutation. This policy implements a step therapy program that requires a trial of a BRAF inhibitor/MEK inhibitor combination prior to coverage of Braftovi/Mektovi for these indications, while allowing members already established on Braftovi + Mektovi (as documented in claims history) to continue therapy. Alternative approved BRAF/MEK combinations referenced in the program include Tafinlar (dabrafenib) + Mekinist (trametinib) and Zelboraf (vemurafenib) + Cotellic (cobimetinib).

Key Definitions

inv-09: BRAF V600E or V600K mutation — definition and relevance to eligibility for therapy

DefinitionSpecific activating mutations in the BRAF gene (V600E or V600K) that confer eligibility for BRAF/MEK inhibitor therapy as noted in product labeling.

Role in therapy selectionPresence of a BRAF V600E or V600K mutation is required to consider Braftovi (encorafenib) combined with Mektovi (binimetinib) for unresectable or metastatic melanoma.

NSCLC relevanceBRAF V600E mutation identifies patients with metastatic non-small cell lung cancer who may be treated with Braftovi + Mektovi.

Alternative combinationsOther approved BRAF/MEK combinations (Tafinlar + Mekinist; Zelboraf + Cotellic) are indicated for the same BRAF V600E or V600K–mutant melanoma population and are required as step-therapy alternatives unless contraindicated or intolerant.

Documentation implicationMutation documentation is part of the coverage determination for Braftovi + Mektovi and supports meeting the policy's indication-specific criteria.