CurrentmhnPolicy CP.PHAR.50

Clinical Policy: Binimetinib (Mektovi)

Defines medical necessity criteria, authorization requirements, and coverage limits for binimetinib (Mektovi) across commercial, HIM, and Medicaid lines of business for indicated malignancies and selected off-label histiocytic neoplasms.

Policy Summary

Payermhn

PolicyClinical Policy: Binimetinib (Mektovi)

Policy CodePolicy CP.PHAR.50

Change TypeNo material changes

Effective DateSep 1, 2018

Next Review Date

Key ActionSubmit prior authorization with documentation of diagnosis, mutation status when applicable, oncologist involvement, and dosing within policy limits.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

90 mg/dayMaximum daily dose specified

15 mgTablet strength

12 moTypical approval duration (Commercial)

6/12 moTypical approval duration (Medicaid/HIM)

NSCLC addedNewly supported use

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Continuation Therapy

Covered continuation when ALL of the following are met:

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

Coverage for indications that are not FDA‑approved and are not explicitly addressed elsewhere in this policy will not be authorized unless the provider supplies sufficient supporting documentation in accordance with the Health Plan's off‑label use requirements. When requesting coverage for an off‑label indication, include clinical rationale and evidence of efficacy and safety consistent with the applicable off‑label use policies cited by the Health Plan.

All coverage determinations are governed by the member's benefit terms and the Health Plan's administrative policies. Coverage under this clinical policy is subject to the terms, conditions, exclusions, and limitations of the member's evidence of coverage, certificate of coverage, policy, or contract. Where applicable, state Medicaid provisions supersede conflicting policy language. Providers should follow the Health Plan's prior authorization procedures and submit requests consistent with contractual requirements.

Initial Therapy Criteria

Continuation / Reauthorization

Continuation/Reauthorization

Continuation and reauthorization requirements

Continuation/Reauthorization: 1. Member is currently receiving therapy via the Centene benefit or has documentation of at least 30 days of Mektovi for a covered indication; 2. Member demonstrates a positive clinical response to therapy; 3. Use generic binimetinib if available unless contraindicated or clinically significant adverse effects occur; 4. For dose increases, new dose must either not exceed 90 mg per day and 6 tablets per day or be supported by practice guidelines or peer-reviewed literature (prescriber must submit supporting evidence); 5. Approval durations follow benefit line: Medicaid/HIM typically 6-12 months and Commercial 12 months or duration of request, whichever is less (see approval duration guidance).

Provider Actions & Requirements

Prior Authorization

Prior Authorization Required

Prior authorization required. Providers must follow the Health Plan’s prior authorization procedures and submit documentation that supports the member meets all approval criteria. Requests for binimetinib (Mektovi) must be submitted by or in consultation with an oncologist (or hematologist for histiocytic neoplasms) when specified in the clinical criteria. Combination therapy requirements (for example, use in combination with Braftovi for certain melanoma and NSCLC indications) must be documented; prior authorization may also be required for the companion agent (Braftovi).

Follow Health Plan prior authorization procedures and contractual terms
Prescriptions must be by or in consultation with an oncologist (hematologist for histiocytic neoplasms where listed)
Document combination therapy and note if companion agent (Braftovi) requires separate prior authorization

Note

Coverage Conditional on Benefit Terms

Coverage is conditional on the member’s benefits. All coverage decisions are subject to the terms, conditions, exclusions, and limitations of the member’s coverage documents (e.g., evidence of coverage, certificate of coverage, policy/contract) and applicable state and federal law. The Health Plan’s clinical policy is a guide to medical necessity but does not guarantee payment.

Coverage subject to member’s benefit document terms and applicable law
Clinical policy does not constitute a contract or guarantee of payment

Documentation Required

Required Clinical Documentation

Providers must submit supporting clinical documentation with the prior authorization request. Acceptable documentation includes office chart notes, recent lab results, pathology reports, mutation testing results (e.g., BRAF V600E or V600K status), imaging, and other relevant clinical information demonstrating the member meets the approval criteria.

Office notes, lab results, imaging, pathology reports
Documented mutation testing (BRAF V600E or V600K) when required by the indication
If mutation testing unavailable or no detectable mutation, include explanation and supporting evidence per policy (e.g., for histiocytic neoplasms)

Denial Risk

Insufficient Documentation — Denial Risk

Insufficient or missing documentation may result in denial or delay. Failure to provide required documentation—such as oncologist consultation notes, evidence of BRAF mutation testing when required, or justification for off‑label use and dosing—may lead to request denial.

Absent or incomplete mutation testing documentation increases denial risk
Lack of oncologist consultation or missing supporting evidence for off‑label dosing/regimen may result in denial

Note

Documentation and Benefit Governance

Documentation and coverage governance: the Health Plan’s clinical policy was developed by licensed professionals using available evidence and guidelines. Providers remain subject to plan-level administrative policies and procedures and should reference the appropriate off‑label use policies when requesting non‑FDA approved indications.

Follow Health Plan administrative policies and applicable off‑label use policies (e.g., CP.CPA.09, HIM.PA.154, CP.PMN.53) as relevant to the member’s line of business
Policy was developed from clinical guidelines and evidence but final coverage is governed by contract terms

Note

Policy Updates and Annual Review Notes

Policy changes and annual review notes: the policy has been updated in multiple annual reviews — e.g., removal of certain off‑label indications, addition or revision of melanoma adjuvant/neoadjuvant and limited resectable criteria per NCCN, addition of NSCLC indication, capsule-to-tablet revisions, and updates to approval duration language. Providers should reference the latest policy version and document rationale consistent with current NCCN/FDA‑approved recommendations.

2Q2021–2025 annual review updates include changes to indications, NCCN alignment, and approval durations
Providers must document treatment rationale consistent with current NCCN/FDA recommendations

Coding & Dosage

inv-07: Maximum daily dose

Maximum daily dose90 mg/day

Typical dosing regimen (per dosing section)45 mg PO twice daily (approx. 12 hours apart) = 90 mg/day

Dose limit confirmation in initial criteriaRequests must not exceed 90 mg/day unless supported by practice guidelines or peer-reviewed literature (prescriber must submit evidence)

Step Therapy / Therapeutic Alternatives

Therapeutic alternative	Formulary preference / Step rule
Tafinlar (dabrafenib) + Mekinist (trametinib)	Listed as a therapeutic alternative in Appendix B; may be a preferred alternative per formulary and may require prior authorization

Quantity Limits

inv-21: Binimetinib (Mektovi)

Quantity limit (tablets/day)6 tablets/day

Dose corresponding to tablets45 mg twice daily (15 mg tablets) approximates 6 tablets/day to reach 90 mg/day

Policy requirementDose must not exceed 6 tablets/day unless supported by guidelines or peer-reviewed literature (prescriber must submit evidence)

Definitions

inv-17: BRAF definition

BRAF definitionB-Raf proto-oncogene, serine/threonine kinase

Abbreviation contextBRAF appears in appendices and coverage criteria as the mutation target (e.g., V600E/V600K)

Clinical relevanceBRAF mutation status is required for melanoma and NSCLC coverage determinations per criteria

Background

Binimetinib (Mektovi) is an oral kinase inhibitor used in oncology. It is prescribed in combination with encorafenib (Braftovi) for BRAF V600E or V600K mutated unresectable or metastatic melanoma and for BRAF V600E mutated metastatic non‑small cell lung cancer. The agent is also supported by NCCN for selected off‑label use in certain histiocytic neoplasms (e.g., Langerhans cell histiocytosis) under the conditions defined in this policy.

Typical dosing for approved indications is 45 mg twice daily (approximately 12 hours apart), with the policy specifying a maximum daily dose of 90 mg/day and a quantity limit of 6 tablets/day. Tablet strength availability and dosing details are provided in the dosing appendix.

Policy Summary

Payermhn

PolicyClinical Policy: Binimetinib (Mektovi)

Policy CodePolicy CP.PHAR.50

Change TypeNo material changes

Effective DateSep 1, 2018

Next Review Date

Key ActionSubmit prior authorization with documentation of diagnosis, mutation status when applicable, oncologist involvement, and dosing within policy limits.

SourceLink

On This Page

OpenPayer

Clinical Policy: Binimetinib (Mektovi)

Coverage Criteria

Initial Therapy Criteria

Continuation / Reauthorization

Provider Actions & Requirements

Coding & Dosage

Step Therapy / Therapeutic Alternatives

Quantity Limits

Definitions

Background