CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Binimetinib (Mektovi) — Coverage Criteria

Covers medical necessity and prior authorization criteria for binimetinib (Mektovi) use for FDA-approved and selected compendial oncology indications for members of Neighborhood Health Plan of Rhode Island.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyBinimetinib (Mektovi) — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit BRAF or NRAS mutation documentation to initiate prior authorization review.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthstypical authorization duration

BRAF V600E/Krequired mutation for FDA-indicated melanoma and NSCLC

Includes compendial usescompendia-listed tumor types permitted

Prior-auth requiredmutation documentation required

Coverage Criteria

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ALL of the following

Member has previously received and responded to therapy with Mektovi (binimetinib) or is currently receiving Mektovi under the plan's initial authorization.
There is documentation that the member has not experienced disease progression while on Mektovi therapy.
Treatment is for an FDA-approved indication or a compendial use covered by this policy (e.g., cutaneous melanoma in listed settings, BRAF V600E-mutant NSCLC in combination with encorafenib, central nervous system BRAF V600-mutant tumors, Langerhans cell histiocytosis when cobimetinib or trametinib are not tolerated).
The prescriber documents ongoing clinical benefit (stable disease, partial response, or complete response) and monitors for adverse effects; therapy discontinuation is recommended for unacceptable toxicity or clear disease progression.

Covered Regimens and Combinations

Indication	Regimen	Coverage status / Notes
Unresectable or metastatic melanoma with BRAF V600E or V600K mutation	Binimetinib (Mektovi) in combination with encorafenib (Braftovi)	covered — Meets FDA-approved indication when mutation detected by an FDA-approved test; authorization may be granted for 12 months.
Metastatic non-small cell lung cancer (NSCLC) with BRAF V600E mutation	Binimetinib (Mektovi) in combination with encorafenib (Braftovi)	covered — Meets FDA-approved indication when mutation detected by an FDA-approved test; authorization may be granted for 12 months when no prior progression on BRAF-targeted therapy.

Indication	Regimen	Coverage status / Notes
Locally advanced unresectable or metastatic NRAS-mutant melanoma (previously untreated or progressed after prior immunotherapy)	Binimetinib (Mektovi) — single agent	covered with criteria — single-agent use for NRAS-mutant melanoma; authorization may be granted for 12 months.
Langerhans cell histiocytosis when cobimetinib or trametinib are not tolerated	Binimetinib (Mektovi) — single agent	covered with criteria — single-agent use permitted if other MEK inhibitors are not tolerated; authorization may be granted for 12 months.

Prior Authorization and Provider Actions

Prior Authorization

Prior Authorization Duration

Prior authorization is required. Authorizations may be granted for up to 12 months when the applicable clinical criteria are met. This duration applies to initial approvals and reauthorization requests for covered indications when there is no evidence of unacceptable toxicity or disease progression on the current regimen.

Authorization duration: up to 12 months for initial and continuation therapy when criteria are met.
Continuation rule: reauthorization may be approved for 12 months when there is no unacceptable toxicity or disease progression.

Documentation Required

Required Molecular Diagnostic Documentation

Submission of molecular diagnostic documentation is required to initiate prior authorization review when applicable. Provide results confirming BRAF (e.g., V600 activating mutations such as V600E or V600K) or NRAS mutation status as indicated by the clinical scenario. Absence of required mutation documentation may result in denial or delay of the request.

Required documentation: lab/pathology report or molecular testing report showing BRAF or NRAS mutation type and method.
Commonly requested: BRAF V600 (e.g., V600E, V600K) or NRAS mutation status depending on the indication.

Step Therapy

Therapy Sequencing and Clinical Considerations

When applicable, therapy sequencing and clinical considerations must be documented. Encorafenib (Braftovi) is intended for use in combination with binimetinib for BRAF V600–mutant disease in many indications; specific sequencing considerations include prior intolerance or undesirable side-effect profiles with alternative BRAF/MEK regimens (for example, dabrafenib + trametinib). For certain settings encorafenib may be used as a single agent (eg, NRAS‑mutant melanoma) per the coverage criteria. Document prior therapies, reasons for switching (toxicity or intolerance), and any contraindications to recommended alternatives.

If member had unacceptable toxicity to dabrafenib + trametinib, document toxicity and rationale for choosing encorafenib-based therapy.
For NRAS‑mutant locally advanced unresectable or metastatic melanoma, encorafenib may be used as monotherapy when indicated.
For NSCLC and CNS BRAF V600–mutant disease, document prior BRAF-targeted therapy status (no progression on prior BRAF-targeted therapy when required).

Line of Therapy

first-line | second-line

Line of therapy notes: May be used in first-line or subsequent settings as per indication specifics: examples include unresectable/metastatic BRAF V600–mutant melanoma in combination with encorafenib; BRAF V600E metastatic NSCLC in combination with encorafenib when not progressed on BRAF-targeted therapy; NRAS-mutant melanoma single-agent use for previously untreated patients or after progression on immunotherapy.

Authorization length and specifics follow indication criteria (authorization of up to 12 months when criteria met).

Biomarker and Diagnostic Requirements

inv-17: BRAF V600 (e.g., V600E or V600K) — detected by an FDA-approved test where specified

When requiredDocumentation of a BRAF V600E or V600K mutation is required for FDA‑approved melanoma and NSCLC indications when specified (detected by an FDA‑approved test).

Detection standardThe FDA‑approved indications specify detection by an FDA‑approved test for BRAF V600 mutations.

Relation to therapyPresence of a BRAF V600 mutation indicates use of binimetinib in combination with encorafenib for unresectable/metastatic melanoma and for BRAF V600E metastatic NSCLC.

inv-18: NRAS mutation — documentation and relevance to certain indications

Documentation requiredSubmission of documented NRAS mutation status is necessary to initiate prior authorization review where applicable.

Clinical relevanceNRAS mutation–positive disease supports single‑agent binimetinib use for locally advanced unresectable or metastatic melanoma in specified settings.

Use contextNRAS-mutant melanoma may be treated with single‑agent binimetinib when the member is previously untreated or progressed after prior immunotherapy.

Background

Binimetinib (Mektovi) is a MEK inhibitor used in oncology settings. In this policy it is described primarily in combination with encorafenib for BRAF V600–mutant disease, and compendial uses include treatment of BRAF V600–activating mutation–positive central nervous system tumors (for example, glioma, meningioma, and astrocytoma) as well as other malignancies. Single‑agent binimetinib is also referenced for select indications such as NRAS‑mutant melanoma and Langerhans cell histiocytosis when other MEK inhibitors are not tolerated.

inv-15: BRAF V600 activating mutation — definition and examples (V600E, V600K)

DefinitionBRAF V600 activating mutation refers to alterations at codon 600 of the BRAF gene (examples include V600E and V600K) that predict eligibility for BRAF/MEK–targeted therapy.

Required for FDA indicationsPresence of a BRAF V600E or V600K mutation is required for FDA‑approved use of binimetinib in combination with encorafenib for unresectable or metastatic melanoma.

Detection methodMutation must be detected by an FDA‑approved test where specified in the FDA indications.

Compendial relevanceBRAF V600 activating mutations (e.g., V600E or V600K) are also the criterion for compendial CNS tumor uses (glioma, meningioma, astrocytoma).