CurrentUnitedHealthcarePolicy 2025 P 3118-9

Step therapy program for Mektovi (binimetinib)

UnitedHealthcare step therapy program requiring trial of an alternate BRAF/MEK inhibitor combination prior to coverage of Braftovi/Mektovi for unresectable or metastatic melanoma with BRAF V600E/V600K and for metastatic NSCLC with BRAF V600E. Includes special rules for patients <19, continuity of current users, continuation criteria, and authorization durations.

Policy Summary

PayerUnitedHealthcare

PolicyStep therapy program for Mektovi (binimetinib)

Policy CodePolicy 2025 P 3118-9

Change TypeAnnual review (no material coverage changes)

Effective DateNov 1, 2025

Next Review Date

Key ActionNew-to-therapy members must try an alternate BRAF/MEK inhibitor combination unless contraindicated, provider attests patient is not an appropriate candidate, or continuation pathway criteria are met.

POLICY UPDATE CHANGES

8/2024 annual review added non-small cell lung cancer section, updated background with new indications and updated references.

8/2025 annual review with no changes to coverage criteria; updated references.

8/2023 updated wording of provider attestation that the patient is not an appropriate candidate for the required alternatives.

2Covered Indications (melanoma, NSCLC)

12Authorization Duration (months)

<19Pediatric auto-approval

What is changing

Summary: This change bulletin implements a step therapy requirement that new-to-therapy members must try an alternate BRAF/MEK inhibitor combination (e.g., Tafinlar + Mekinist or Zelboraf + Cotellic) before coverage of Braftovi/Mektovi (encorafenib + binimetinib) for approved indications. It adds coverage for non-small cell lung cancer (NSCLC) with BRAF V600E in addition to unresectable or metastatic melanoma with BRAF V600E/V600K. Members documented as current users in claims may continue therapy via a continuation pathway. Patients younger than 19 years are auto-approved without coverage review. Authorization durations are set at 12 months. State mandates and other regulatory or plan-specific requirements may supersede these criteria.

Key facts

Policy number2025 P 3118-9

Effective date2025-11-01

Authorization duration12 months

Pediatric auto-approvalage <19 auto-process

Covered indicationsMelanoma; NSCLC (BRAF V600E)

Coverage criteria (initial and continuation)

Melanoma - Initial or continuation coverage

Mektovi will be approved based on both of the following criteria:

ALL of the following

Mektovi is to be used in combination with Braftovi (encorafenib)
One of the following
- Patient has a contraindication or history of intolerance to Tafinlar (dabrafenib) plus Mekinist (trametinib)
- Patient has a contraindication or history of intolerance to Zelboraf (vemurafenib) plus Cotellic (cobimetinib)
- Provider attestation alternative
  - Provider attests that the patient is not an appropriate candidate based on the patient's clinical status or comorbidities for Tafinlar (dabrafenib) plus Mekinist (trametinib)
  - Provider attests that the patient is not an appropriate candidate based on the patient's clinical status or comorbidities for Zelboraf (vemurafenib) plus Cotellic (cobimetinib)
- Continuation pathway
  - As continuation of therapy
  - Patient has not received a manufacturer supplied sample at no cost from a prescriber's office, or any form of assistance from the Pfizer Oncology Together sponsored Co-Pay Savings Program (e.g. sample card which can be redeemed at a pharmacy for a free supply of medication) or a 30 day free trial from a pharmacy as a means to establish as a current user of Mektovi
    Patients requesting initial authorization who were established on therapy via manufacturer samples or Pfizer Oncology Together assistance shall be required to meet initial authorization criteria as if new to therapy.

Non-Small Cell Lung Cancer (NSCLC) - Initial or continuation coverage

Mektovi will be approved based on both of the following criteria:

ALL of the following

Mektovi is to be used in combination with Braftovi (encorafenib)
One of the following
- Patient has a contraindication or history of intolerance to Tafinlar (dabrafenib) plus Mekinist (trametinib)
- Provider attests that the patient is not an appropriate candidate based on the patient's clinical status or comorbidities for Tafinlar (dabrafenib) plus Mekinist (trametinib)
- Continuation pathway
  - As continuation of therapy

Other Indications

Authorization considerations:

ALL of the following

Authorization will be issued for 12 months12 months
State mandates, federal regulatory requirements, member specific benefit plan coverage, and other policies/utilization management programs may impact coverage

What providers must do

Step Therapy

Step therapy prior authorization requirement

Members who are new to therapy must try an alternate BRAF/MEK inhibitor combination regimen before coverage is provided for Braftovi (encorafenib) + Mektovi (binimetinib), unless they have a documented contraindication/intolerance, provider attestation that required alternatives are not appropriate, or they meet the continuation pathway.

Tafinlar (dabrafenib) + Mekinist (trametinib)
Zelboraf (vemurafenib) + Cotellic (cobimetinib)

Documentation Required

Provider attestation for inappropriateness

When using the attestation pathway, the provider must state that the patient is not an appropriate candidate for the required alternative regimens based on the patient’s clinical status or comorbidities.

Attestation must specify which alternative regimen is inappropriate (Tafinlar+Mekinist and/or Zelboraf+Cotellic).
Attestation should reference relevant clinical status or comorbid conditions that preclude use of the alternatives.

Documentation Required

Continuation - sample/copay assistance exclusion

To use the continuation pathway, documentation must show the patient is a current user and that their status was not established by receipt of manufacturer samples, Pfizer Oncology Together co-pay assistance, or a 30-day free pharmacy trial; patients who established use via those assistance methods must meet initial authorization criteria as new-to-therapy.

Manufacturer supplied sample given at no cost in prescriber's office
Any form of assistance from the Pfizer Oncology Together sponsored Co-Pay Savings Program (e.g., sample card redeemable at a pharmacy)
A 30-day free trial from a pharmacy

Billing Rule

Automatic processing for <19 years

Prescriptions for members under 19 years of age will automatically process without a coverage review and an authorization will be issued for 12 months.

Age threshold: <19 years

Denial Risk

Automated approval/denial logic

UnitedHealthcare may approve initial and reauthorization decisions using prior claim or medication history, diagnosis codes (ICD-10), and/or claim logic; the use of these automated approval/denial processes varies by program and therapeutic class.

Definitions and references

Definition — Continuation of therapy: Member currently on Braftovi and Mektovi therapy as documented in claims history will be allowed to continue on their current therapy; the continuation pathway requires that the patient has not received a manufacturer supplied sample at no cost, assistance from the Pfizer Oncology Together Co-Pay Savings Program, or a 30-day free pharmacy trial to establish current user status. Background note: the program references multiple FDA-indicated BRAF/MEK combinations (Braftovi/Mektovi; Tafinlar/Mekinist; Zelboraf/Cotellic) and states that where state mandates apply they may supersede policy language.

Evidence

P&T Approval Dates1/2019, 2/2020, 2/2021, 2/2022, 4/2022, 4/2023, 8/2023, 8/2024, 8/2025

Package inserts referencedMektovi; Braftovi; Zelboraf; Cotellic; Tafinlar; Mekinist (various 2020-2025)

Patient has not received a manufacturer supplied sample at no cost from a prescriber's office, or any form of assistance from the Pfizer Oncology Together sponsored Co-Pay Savings Program (e.g. sample card which can be redeemed at a pharmacy for a free supply of medication) or a 30 day free trial from a pharmacy as a means to establish as a current user of Mektovi

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

OpenPayer

Step therapy program for Mektovi (binimetinib)

What is changing

Coverage criteria (initial and continuation)

Referenced products / codes

What providers must do

Definitions and references

Policy updates and change log

Mektovi	binimetinib (product referenced in step therapy program)
Braftovi	encorafenib (required combination agent)
Tafinlar	dabrafenib (alternative BRAF inhibitor)
Mekinist	trametinib (alternative MEK inhibitor)
Zelboraf	vemurafenib (alternative BRAF inhibitor)
Cotellic	cobimetinib (alternative MEK inhibitor)