ModifiedHealth NetPolicy CP PHAR.50

Clinical Policy: Binimetinib (Mektovi)

Defines medical necessity, authorization, and coverage criteria for binimetinib (Mektovi) across commercial, HIM, and Medicaid lines of business for specified diagnoses including melanoma, NSCLC, and certain histiocytic neoplasms.

Policy Summary

PayerHealth Net

PolicyClinical Policy: Binimetinib (Mektovi)

Policy CodePolicy CP PHAR.50

Change TypeMaterial updates to indications and criteria

Effective Date09.01.18

Next Review Date

Key ActionSubmit prior authorization with documentation showing member meets indication-specific criteria and that generic binimetinib is used if available.

SourceLink

POLICY UPDATE CHANGES

Added FDA-approved and NCCN-compendium supported use in non-small cell lung cancer in combination with encorafenib (Braftovi).

For melanoma, added adjuvant therapy category 2A indication per NCCN and later added limited resectable melanoma.

Added off-label criteria for histiocytic neoplasms per NCCN category 2A recommendation.

Commercial approval durations standardized to 12 months or duration of request, whichever is less.

2Q 2025 annual review: for melanoma per NCCN, removed criterion for re-induction therapy as this is covered by unresectable or metastatic melanoma.

2Q 2024 annual review: for melanoma, added criteria for neoadjuvant therapy and re-induction therapy for disease progression/relapse; for NSCLC, removed redundant criteria for treatment naive or subsequent therapy, removed criteria for BRAF therapy, revised capsules to tablets.

RT4: added newly FDA-approved and NCCN compendium supported use in non-small cell lung cancer in combination with Mektovi.

45 mg BIDrecommended dosing

90 mg/day

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Coverage Criteria for Binimetinib (Mektovi)

inv-01: Initial Therapy - Melanoma

Covered when ALL of the following are met

Melanoma initial criteria: 1) Diagnosis of melanoma with BRAF V600E or V600K mutation; 2) One of the following melanoma disease states: unresectable or metastatic melanoma OR Stage III melanoma as adjuvant or neoadjuvant therapy OR limited resectable melanoma; 3) Prescribed by or in consultation with an oncologist; 4) For unresectable or metastatic melanoma: prescribed in combination with encorafenib (Braftovi) unless the combination is contraindicated; 5) Member must use generic binimetinib if available unless contraindicated or clinically significant adverse effects occur; 6) Dose does not exceed 90 mg per day and 6 tablets per day unless supported by practice guidelines or peer‑reviewed literature; 7) Prescribed regimen must be FDA‑approved or recommended by NCCN (for off‑label dosing, prescriber must submit supporting evidence).

Prescriber must submit supporting evidence for off‑label regimens

inv-02: Initial Therapy - NSCLC

Covered when ALL of the following are met

NSCLC initial criteria: 1) Diagnosis of advanced, metastatic, or recurrent non‑small cell lung cancer (NSCLC) with BRAF V600E mutation; 2) Prescribed by or in consultation with an oncologist; 3) Prescribed in combination with encorafenib (Braftovi); 4) Member must use generic binimetinib if available unless contraindicated or clinically significant adverse effects occur; 5) Dose does not exceed 90 mg per day and 6 tablets per day unless supported by practice guidelines or peer‑reviewed literature; 6) Prescribed regimen must be FDA‑approved or recommended by NCCN (for off‑label dosing, prescriber must submit supporting evidence).

Prior authorization may be required for encorafenib (Braftovi)

inv-03: Initial Therapy - Histiocytic Neoplasms (Off-label)

Covered when ALL of the following are met

Histiocytic neoplasms initial criteria: 1) Diagnosis of Langerhans cell histiocytosis or other relevant histiocytic neoplasm per NCCN compendium; 2) Prescribed by or in consultation with an oncologist or hematologist; 3) Disease is positive for a MAP kinase pathway mutation OR no detectable mutation OR mutation testing not available; 4) Prescribed as a single agent; 5) Member must use generic binimetinib if available unless contraindicated or clinically significant adverse effects occur; 6) Dose does not exceed 90 mg per day and 6 tablets per day unless supported by practice guidelines or peer‑reviewed literature; 7) Prescribed regimen must be recommended by NCCN (off‑label NCCN category 2A support required and prescriber must submit supporting evidence).

Off‑label NCCN category 2A support required and prescriber must submit supporting evidence

inv-04: Continuation Therapy

Covered when ALL of the following are met

Continued therapy: 1) Member is currently receiving Mektovi via the Centene benefit OR documentation supports current receipt of Mektovi for a covered indication and member has received medication for at least 30 days; 2) Member is responding positively to therapy; 3) If request is for a dose increase, the new dose does not exceed 90 mg/day and 6 tablets/day unless supported by practice guidelines or peer‑reviewed literature; 4) Member must use generic binimetinib if available unless contraindicated or clinically significant adverse effects occur; 5) Prescribed regimen must be FDA‑approved or recommended by NCCN (for off‑label dosing, prescriber must submit supporting evidence).

Approval durations: Medicaid/HIM 12 months; Commercial 12 months or duration of request, whichever is less.

Non‑FDA approved indications that are not specifically addressed in this policy are not authorized unless the provider supplies sufficient documentation of efficacy and safety in accordance with the applicable off‑label use policies: CP.CPA.09 (commercial), HIM.PA.154 (Health Insurance Marketplace), or CP PMN.53 (Medicaid), or as otherwise specified in the member's evidence of coverage.

During the 2Q 2021 annual review the policy removed colorectal cancer off‑label use because that indication is no longer included in the NCCN Drugs & Biologics Compendium; this change is reflected in the revision history.

Uses that are not listed in this policy and lack sufficient supporting evidence per the referenced off‑label use policies are considered not authorized (not medically necessary) and are not covered.

inv-22: Initial Therapy — Initial authorization requirements per indication (umbrella entry tying initial therapy criteria together)

Initial authorization requirements per indication

Initial therapy nodes: See per‑indication initial therapy criteria: melanoma (BRAF V600E/V600K mutation; disease state and combination with encorafenib where indicated), NSCLC (BRAF V600E mutation in combination with encorafenib), and histiocytic neoplasms (NCCN‑supported off‑label criteria). All initial requests must be prescribed by or in consultation with an appropriate specialist, use generic binimetinib if available unless contraindicated, adhere to dosing limits (90 mg/day and 6 tablets/day), and be FDA‑approved or NCCN‑recommended (off‑label evidence required).

Prescriber must submit supporting evidence for off‑label regimens; prior authorization may be required for encorafenib (Braftovi).

inv-23: Neoadjuvant — Initial therapy criteria updates (referenced additions in recent reviews)

Initial therapy criteria updates

neoadjuvant therapy: 2Q 2024 annual review: for melanoma, neoadjuvant therapy criteria were added (see melanoma initial therapy criteria).

Continuation and Re-induction Criteria

inv-24: Continuation Therapy — Requirements to continue therapy

Requirements to continue therapy

Continuation nodes: 1) Member must have documentation of prior use for at least 30 days or be currently receiving Mektovi via the Centene benefit; 2) Member must be responding positively to therapy; 3) Dose increases are limited to 90 mg/day and 6 tablets/day unless supported by practice guidelines or peer‑reviewed literature; 4) Member must use generic binimetinib if available unless contraindicated or clinically significant adverse effects occur.

Approval durations: Medicaid/HIM 12 months; Commercial 12 months or duration of request, whichever is less.

inv-25: Re-induction — Revisions related to continuation and re-induction

re-induction therapy: 2Q 2025 annual review: for melanoma, criterion for re‑induction therapy was removed because re‑induction is covered under unresectable or metastatic melanoma; prior 2Q 2024 review had added re‑induction criteria for disease progression/relapse (see revision history).

Provider Requirements and Prior Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required for Mektovi (binimetinib) and it must be prescribed by or in consultation with an oncologist. For requests involving combination therapy (for example, with Braftovi), prior authorization requirements apply to each agent and may require separate authorization. Requests for non‑FDA approved indications that are not addressed in this policy will not be authorized unless sufficient documentation is provided per applicable off‑label use policies.

Mektovi requires prior authorization and must be prescribed by or in consultation with an oncologist.
Combination regimens (e.g., with Braftovi) require prior authorization; prior authorization for the partner agent may also be required.
Non‑FDA approved indications require documentation per off‑label use policies (CP.CPA.09, HIM.PA.154, CP.PMN.53 as applicable).

Note

Policy Governance

This clinical policy governs prior authorization and medical necessity determinations for binimetinib (Mektovi) as used by the Health Plan. Coverage determinations and administration of benefits are subject to all terms, conditions, exclusions, and limitations of the member's coverage documents and applicable state and federal requirements. The Health Plan retains the right to change, amend, or withdraw this clinical policy.

Dosing, Tablet Limits, and Coding Notes

inv-08: Maximum daily dose — 90 mg/day

Maximum daily dose90 mg/day

Recommended dosing (melanoma, NSCLC)45 mg PO BID (total 90 mg/day)

Dose limit for dose-increase requestsNew dose must not exceed 90 mg/day unless supported by guidelines or peer-reviewed literature

inv-09: Maximum tablets per day — 6 tablets/day

Maximum tablets per day6 tablets/day

Dose‑increase constraintNew dose must not exceed 6 tablets/day unless supported by guidelines or peer-reviewed literature

Quantity limit reference

Step Therapy and Formulary Placement

Step	Requirement	Coverage
1	Member must use generic binimetinib first if available unless contraindicated or clinically significant adverse effects occur; dose must not exceed 90 mg per day and 6 tablets per day unless supported by guidelines or peer-reviewed literature	Covered

Step	Policy revision summary	Impact on step placement
1	Policy revisions removed redundant criteria and adjusted indications across reviews (examples: 2Q 2024 removed redundant NSCLC criteria and revised capsule-to-tablet wording; RT4 added newly FDA-approved NSCLC indication in combination with Mektovi)	NSCLC combination with Mektovi added to covered indications; step therapy sequencing and criteria wording updated to reflect removal of redundant criteria and changes in formulation, which may affect therapy placement

Quantity Limits and Dispensing

inv-28: Binimetinib (Mektovi) — 6 tablets/day

Daily tablet limit for Mektovi6 tablets/day

Recommended dose regimen45 mg PO BID (tablets available as 15 mg strength) totaling 90 mg/day

Generic use requirementMember must use generic binimetinib if available unless contraindicated or causes clinically significant adverse effects

Definitions and Abbreviations

inv-19: BRAF — B-Raf proto-oncogene, serine/threonine kinase

DefinitionBRAF: B-Raf proto-oncogene, serine/threonine kinase

ContextMutation (e.g., V600E or V600K) referenced in indication criteria for therapy selection

inv-20: NSCLC — non-small cell lung cancer

DefinitionNSCLC: non-small cell lung cancer

Policy relevanceNSCLC with BRAF V600E mutation is an FDA‑approved indication when treated in combination with encorafenib (Braftovi)

inv-21: NCCN Compendium — NCCN Drugs and Biologics Compendium: referenced source for off-label and guideline-supported oncology uses.

Background on Binimetinib (Mektovi)

Binimetinib (Mektovi) is a MEK kinase inhibitor indicated for use in combination with encorafenib for BRAF V600E or V600K mutation‑positive unresectable or metastatic melanoma and has been added for certain metastatic non‑small cell lung cancers per FDA/NCCN updates. The policy also includes off‑label, NCCN‑supported criteria for select histiocytic neoplasms. Prescribing and authorization requirements (including specialist consultation and combination therapy where indicated) and dosing limits are defined in the coverage criteria.

Policy Revision History and Material Changes

11.02.23runtime_addition

RT4 runtime update added FDA-approved and NCCN compendium–supported use for non‑small cell lung cancer in combination with Mektovi (encorafenib combination).

02.06.24annual_review

2Q 2024 annual review: added melanoma neoadjuvant and re‑induction criteria; for NSCLC removed redundant criteria for treatment‑naive/subsequent therapy and criteria for BRAF therapy; capsules revised to tablets.

02.13.25annual_review

Policy Summary

PayerHealth Net

PolicyClinical Policy: Binimetinib (Mektovi)

Policy CodePolicy CP PHAR.50

Change TypeMaterial updates to indications and criteria

Effective Date09.01.18

Next Review Date

Key ActionSubmit prior authorization with documentation showing member meets indication-specific criteria and that generic binimetinib is used if available.

SourceLink

On This Page

Documentation Required

Required Clinical Documentation

Providers must submit supporting clinical documentation when requesting prior authorization. Acceptable documentation includes office chart notes, relevant laboratory or pathology results, imaging reports, and any other clinical information that demonstrates the member meets all approval criteria outlined in this policy. Failure to provide adequate documentation may result in denial.

Submit office chart notes, lab results, imaging, pathology, and other relevant clinical records.
Documentation must demonstrate the member meets all policy approval criteria (diagnosis, mutation status, prior therapies, dosing, etc.).

Billing Rule

Documentation and Claims

Providers must follow applicable coverage documents and billing rules when submitting claims. Authorization of therapy under this clinical policy does not guarantee payment; claims are adjudicated according to the member's evidence of coverage, contract terms, and applicable plan rules.

Authorization does not guarantee payment; submit claims per the member's coverage documents and payer billing rules.
Providers, members, and their representatives are bound by the terms of the clinical policy when submitting claims for payment.

Step Therapy

Step Therapy and Criteria Revisions

Step therapy and criteria in this policy have been revised over time. Recent revisions include removal of redundant criteria, addition of neoadjuvant and re‑induction criteria for melanoma (later removed for re‑induction as covered by unresectable/metastatic indication), addition of NSCLC indication, conversion from capsules to tablets, and inclusion of oral oncology generic redirection language. Providers should reference the policy history for specific changes.

2Q 2021: removed colorectal cancer off‑label use; added oral oncology generic redirection language.
2Q 2022–2024: added adjuvant/neoadjuvant melanoma indications, NSCLC FDA approval added, revised formulations and criteria.
2Q 2025: removed re‑induction criterion for melanoma as duplicative with unresectable/metastatic indication.

Denial Risk

Generic Preference and Dosing Limits

Members must use generic binimetinib when available unless contraindicated or clinically significant adverse effects occur. Dose and quantity limits apply: standard dosing is 45 mg twice daily (90 mg per day) with a maximum of 6 tablets per day when tablet strength and regimen would require that limit; dose increases must be supported by guidelines or peer‑reviewed literature and documented in the request.

Generic binimetinib required if available unless contraindicated or adverse effects.
Typical total daily dose: 90 mg/day (45 mg twice daily).
Dose/quantity limits: must not exceed 6 tablets per day; any dose increase requires clinical justification and supporting evidence.