CurrentmhnPolicy CP.PHAR.50

Clinical Policy: Binimetinib (Mektovi)

Defines medical necessity criteria, approval durations, and use conditions for binimetinib (Mektovi) across melanoma, non-small cell lung cancer (NSCLC), histiocytic neoplasms (off-label), continuation criteria, and exclusions; includes dosing, product availability, and references. Applies to Commercial, HIM, and Medicaid lines of business.

Policy Summary

Payermhn

PolicyClinical Policy: Binimetinib (Mektovi)

Policy CodePolicy CP.PHAR.50

Change TypePeriodic review / revisions

Effective DateSep 1, 2018

Next Review Date

Key ActionProvider must submit documentation (office chart notes, lab results, or other clinical information) supporting that member meets all approval criteria.

POLICY UPDATE CHANGES

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

RT4/11.02.23: added newly FDA-approved and NCCN compendium supported use in non-small cell lung cancer in combination with Mektovi.

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 naïve or subsequent therapy, removed criteria for prior BRAF therapy, revised capsules to tablets; references updated.

3Covered Indications (melanoma, NSCLC, histiocytic neoplasms)

90 mg/dayMaximum daily dose

6Maximum tablets/day

30 days

Coverage Summary

Policy CP.PHAR.50 (effective 09.01.18, last reviewed 05.25) indicates binimetinib (Mektovi) is covered with criteria for specific indications. The policy scope covers medical necessity criteria, approval durations, dosing/product availability, and applies to Commercial, HIM, and Medicaid lines of business. Covered indications per the policy include: unresectable or metastatic melanoma with BRAF V600E/K (in combination with encorafenib), adult metastatic NSCLC with BRAF V600E (in combination with encorafenib), and histiocytic neoplasms (off-label, e.g., Langerhans cell histiocytosis) per NCCN-recommended criteria.

Key thresholds

Maximum daily dose90 mg/day

Maximum tablets per day6 tablets/day

Minimum treatment before continuation review≥ 30 days

Age≥ 18 years

Initial Therapy Criteria

I. Initial Approval Criteria - Melanoma

Covered when ALL of the following are met:

ALL of the following

Diagnosis of melanoma with BRAF V600E or V600K mutation (detected by an FDA-approved test).
Disease is one of the following: (a) unresectable or metastatic melanoma; (b) stage III melanoma as adjuvant therapy or neoadjuvant; or (c) limited resectable melanoma.
Prescribed by or in consultation with an oncologist.
Age ≥ 18 years.
For unresectable/metastatic vs stage III/limited resectable

Continuation / Reauthorization Criteria

For continuation/reauthorization, the policy requires documentation that the member has received Mektovi for at least 30 days and is responding positively to therapy; this minimum therapy before continuation requirement applies across all indications listed in Section I (melanoma, NSCLC, and histiocytic neoplasms).

Unapproved Indications / Exclusions

III. Diagnoses/Indications NOT authorized

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Provider Actions & Authorization Requirements

Documentation Required

Documentation submission required

Provider must submit documentation (office chart notes, lab results, or other clinical information) supporting that the member meets all approval criteria.

Prior Authorization

Combination therapy requirement

For unresectable or metastatic melanoma and for NSCLC, binimetinib must be prescribed in combination with encorafenib (Braftovi) unless the combination is contraindicated. Note that prior authorization may be required for encorafenib.

Applicable Codes & Policy Reference

Reference Numbermixed

CP.PHAR.50

Clinical policy reference number

Clinical Evidence & References

evidence:

Prescribing information: Mektovi Prescribing Information, Array BioPharma Inc.; September 2024.

Guideline support: National Comprehensive Cancer Network (NCCN) Drugs & Biologics Compendium and disease-specific NCCN guidelines (Melanoma, NSCLC, Histiocytic Neoplasms) — policy references these NCCN sources and supports NCCN-recommended uses.

Regulatory approvals: FDA approvals noted for Mektovi in combination with encorafenib for unresectable or metastatic melanoma with BRAF V600E/K and for adult metastatic NSCLC with BRAF V600E.

Off-label guideline support: NCCN-recommended (compendium) use is referenced by the policy for histiocytic neoplasms (off-label) and is included in the policy’s evidentiary support.

Background

Binimetinib (Mektovi) is a kinase inhibitor. The agent is FDA‑approved in combination with encorafenib (Braftovi) for unresectable/metastatic melanoma with BRAF V600E or V600K mutations and for adult metastatic NSCLC with BRAF V600E. The policy also incorporates NCCN-recommended off-label criteria for histiocytic neoplasms (e.g., Langerhans cell histiocytosis).

Definitions / glossary: BRAF = B‑Raf proto‑oncogene, serine/threonine kinase; NSCLC = non‑small cell lung cancer.

Revision History

11.02.23material

RT4/11.02.23: added newly FDA-approved and NCCN compendium supported use in non-small cell lung cancer in combination with Mektovi.

02.06.24material

02.13.25revisedLatest

I. Initial Approval Criteria - Non-Small Cell Lung Cancer (NSCLC)

Covered when ALL of the following are met:

ALL of the following

Diagnosis of advanced, metastatic, or recurrent non-small cell lung cancer (NSCLC) with BRAF V600E mutation (detected by an FDA-approved test).
Prescribed by or in consultation with an oncologist.
Age ≥ 18 years.
Prescribed in combination with encorafenib (Braftovi).
Member must use generic binimetinib, if available, unless contraindicated or clinically significant adverse effects are experienced.
ANY of the following
- ALL of the following
  - Dose does not exceed both of the following:
  - 90 mg per day.
  - 6 tablets per day.
- Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence).
Prescribed regimen must be FDA-approved or recommended by NCCN. Prior authorization may be required for encorafenib/Braftovi.

I. Initial Approval Criteria - Histiocytic Neoplasms (off-label)

Covered when ALL of the following are met:

ALL of the following

Diagnosis of Langerhans cell histiocytosis (histiocytic neoplasm).
Prescribed by or in consultation with an oncologist or hematologist.
Age ≥ 18 years.
Molecular testing/biology
- Positive for mitogen-activated protein (MAP) kinase pathway mutation.
- No detectable mutation.
- Mutation testing not available.
Prescribed as a single agent (binimetinib alone).
Member must use generic binimetinib, if available, unless contraindicated or clinically significant adverse effects are experienced.
ANY of the following
- ALL of the following
  - Dose does not exceed both of the following:
  - 90 mg per day.
  - 6 tablets per day.
- Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence).
Prescriber must submit supporting evidence of clinical rationale and relevant literature when requesting binimetinib for histiocytic neoplasms (off-label).
Prescribed regimen must be FDA-approved or recommended by NCCN. Prior authorization may be required. Single-agent use and molecular testing branches are acceptable as listed.