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Colorado Rocky Mountain HP Mektovi Prior Auth | OpenPayer

ModifiedColorado Rocky Mountain Health PlansPolicy N/A

Mektovi (binimetinib) — Clinical prior authorization and coverage criteria

Clinical prior authorization and coverage criteria for Mektovi (binimetinib) including indications, initial and reauthorization requirements, and pediatric automatic processing for members under 19; affects providers submitting pharmacy prior authorization requests to the payer.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyMektovi (binimetinib) prior authorization and coverage criteria

Policy CodePolicy N/A

Change TypeMaterial updates to reauthorization and indication scope

Effective Date3/1/2026

Next Review DateN/A

Key ActionSubmit prior authorization showing diagnosis, mutation status and concurrent use of encorafenib or imatinib as required by indication; approvals issued for 12 months when criteria are met.

SourceLink

POLICY UPDATE CHANGES

Reauthorization now requires that Mektovi be used in combination with Braftovi (encorafenib).

Added reauthorization requirement that Mektovi must be used in combination with imatinib for GIST (historical change noted).

NCCN-recognized regimens with Category 1, 2A, or 2B support authorization for 12 months.

Expanded NSCLC coverage to include recurrent and advanced disease per NCCN recommendation (recorded in change history).

12 monthsTypical authorization duration

MultipleIndications covered

1/2A/2B

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Coverage Criteria for Mektovi (binimetinib)

A. Patients less than 19 years of age

Covered when ALL of the following are met for patients <19:

Pediatric automatic approval: Patient is less than 19 years of age

Authorization will be issued for 12 months

B. Melanoma initial

Initial Authorization for melanoma — covered when ALL of the following are met:

Diagnosis of melanoma

Disease stage: Disease is unresectable OR metastatic

Mutation/combination options: Either (A) patient is positive for BRAFV600 mutation AND used in combination with Braftovi (encorafenib) OR (B) patient is positive for NRAS mutation AND has progression after prior immune checkpoint inhibitor therapy

Authorization will be issued for 12 months

B. Melanoma reauthorization

Reauthorization for melanoma — covered when ALL of the following are met:

No progression: Patient does not show evidence of progressive disease while on Mektovi therapy

Molecular context: Examples include BRAFV600 mutation positive OR MAP kinase pathway mutation OR no other detectable/actionable mutation OR testing not available

Authorization will be issued for 12 months

C. Low‑grade serous carcinoma initial

Initial Authorization for low-grade serous carcinoma — covered when ALL of the following are met:

Diagnosis of low-grade serous carcinoma

Treatment options: Either used in combination with Braftovi (encorafenib) OR NRAS-mutated tumor

Authorization will be issued for 12 months

D. Histiocytic neoplasms initial

Initial Authorization for histiocytic neoplasms (Langerhans Cell Histiocytosis) — covered when ALL of the following are met:

Eligible diagnoses: Multisystem Langerhans Cell Histiocytosis OR single-system lung Langerhans Cell Histiocytosis OR Langerhans Cell Histiocytosis with CNS lesions

Disease status: Disease is recurrent

Authorization will be issued for 12 months

E. SDH‑deficient GIST initial

Initial Authorization for SDH‑deficient GIST — covered when ALL of the following are met:

Diagnosis of succinate dehydrogenase (SDH)-deficient gastrointestinal stromal tumor (GIST)

Disease states: Gross residual disease (R2 resection) OR unresectable primary disease OR tumor rupture OR progressive OR recurrent OR metastatic

Combination therapy: Used in combination with imatinib mesylate (Gleevec)

Authorization will be issued for 12 months

F. NSCLC initial

Initial Authorization for non-small cell lung cancer (NSCLC) — covered when ALL of the following are met:

Diagnosis of non-small cell lung cancer (NSCLC)

Disease stage: Recurrent OR advanced OR metastatic

Molecular and combination: Patient is positive for BRAFV600 mutation AND used in combination with Braftovi (encorafenib)

Authorization will be issued for 12 months

Reauthorization

Reauthorization (general across indications) — covered when ALL of the following are met:

No progression: Patient does not show evidence of progressive disease while on Mektovi therapy

Authorization will be issued for 12 months

Combination requirement: Where applicable, continued use in combination with required partner drug (e.g., encorafenib or imatinib) per indication

G. NCCN Recommended Regimens

NCCN recommended regimens

NCCN recognition: Drug recognized by NCCN Drugs and Biologics Compendium with Category of Evidence and Consensus of 1, 2A, or 2B for the cancer indication

Authorization will be issued for 12 months; state mandates and member-specific benefit plans may impact coverage

Reauthorization

Reauthorization will be approved when ALL of the following are met:

Reauthorization requirements: (1) Patient does not show evidence of progressive disease while on Mektovi therapy AND (2) Used in combination with Braftovi (encorafenib)

Authorization will be issued for 12 months.

NCCN Recommended Regimens

Authorization will be granted for regimens recognized by NCCN when ALL of the following are met:

NCCN-recognized regimens: The drug has NCCN recognition with Category 1, 2A, or 2B in the NCCN Drugs and Biologics Compendium

Authorization will be issued for 12 months; state mandates and member-specific benefit plans may also impact coverage.

Coverage of Mektovi is subject to the criteria listed in this policy. Where state law or a state-mandated compendium requires coverage for off-label use or specifies a different compendia reference, those state mandates supersede the criteria in this document. For members under 19 years of age, prescriptions will automatically process without a coverage review per the payer’s rules.

Supply limits and other program-specific clinical rules may constrain access to therapy. If a requested supply exceeds an applicable quantity limit, the request may be implicitly excluded or denied. Providers should verify any plan-specific supply limits prior to submission.

Authorization decisions may be processed using automated claim- or history-based logic. Initial approvals and reauthorizations can be granted solely on prior claim/medication history, diagnosis codes (ICD-10), and claim logic when program rules permit, and use of these automated pathways varies by program. Because some states mandate coverage or alternate compendia, automated denials based on claim logic should be reviewed in the context of any applicable state requirements.

What Providers Must Do / Watch For

Prior Authorization

Prior Authorization Required

Prior authorization required. Providers must obtain prior authorization before initiating therapy; approvals are generally issued for 12 months when the clinical criteria are met.

Prior authorization is required for Mektovi (binimetinib) in the covered indications.
Authorizations, when granted under the documented criteria, are typically issued for a 12-month supply.

Prior Authorization

Reauthorization: no progression; combination therapy requirements

Reauthorization approvals require documented absence of disease progression and, for most covered indications, continued use in combination with encorafenib (Braftovi). For GIST reauthorization, policy history added a requirement that Mektovi be used in combination with imatinib.

Reauthorization requires that the patient does not show evidence of progressive disease while on Mektovi.
Reauthorization generally requires combination therapy with Braftovi (encorafenib) where specified by the indication; check indication-specific criteria (e.g., NSCLC, melanoma).

Initial Therapy Authorization Rules

Initial therapy

Initial authorization criteria vary by indication and generally require diagnosis, disease stage, mutation status when applicable, and combination therapy where specified.

Melanoma initial: See melanoma criteria: diagnosis, unresectable/metastatic, BRAFV600+ with encorafenib OR NRAS+ with progression after checkpoint inhibitor

Authorization for 12 months

NSCLC initial: NSCLC diagnosis, recurrent/advanced/metastatic, BRAFV600+ and used with encorafenib

Authorization for 12 months

SDH‑deficient GIST initial: SDH‑deficient GIST with listed disease states and used with imatinib

Authorization for 12 months

Reauthorization / Continuation Rules

Continuation therapy

Continuation (reauthorization) rules

Clinical benefit: Patient does not show evidence of progressive disease while on Mektovi therapy

Authorization issued for 12 months

Combination therapy: Where applicable, continued use in combination with encorafenib or imatinib as specified by indication

Reauthorization

Reauthorization/continuation rules

Continuation/Reauthorization: Patient must not show evidence of progressive disease on Mektovi and Mektovi must be used in combination with Braftovi (encorafenib)

Definitions and Key Terms

Mektovi (binimetinib) — drug definition and indications

Drug classMEK (kinase) inhibitor

Brand / genericMektovi (binimetinib)

Primary FDA-indicated useIn combination with Braftovi (encorafenib) for unresectable or metastatic melanoma with BRAF V600E or V600K mutation; also for metastatic NSCLC with BRAF V600E (in combination with encorafenib)

Additional NCCN-recommended usesNRAS‑mutated melanoma after progression on checkpoint inhibitors; recurrent/advanced BRAF V600E NSCLC; Langerhans Cell Histiocytosis; low‑grade serous carcinoma; combination with imatinib for SDH‑deficient GIST

Typical authorization durationAuthorization issued for 12 months when criteria are met

BRAFV600 mutation — definition and requirement for covered use

Background

Mektovi (binimetinib) is a MEK kinase inhibitor used primarily in oncology. It is indicated in combination with encorafenib (Braftovi) for unresectable or metastatic melanoma with BRAF V600E or V600K mutations and for metastatic non-small cell lung cancer with BRAF V600E in combination with encorafenib. In addition, professional guidelines such as the NCCN recognize Mektovi for several other tumor types (for example, NRAS‑mutated melanoma after progression on checkpoint inhibitors, Langerhans Cell Histiocytosis, low‑grade serous carcinoma, and certain SDH‑deficient GIST scenarios) where use is conditioned on diagnosis, disease status, molecular testing, and when required, concurrent administration with a specified partner drug. Prior authorization is required for covered indications and, when criteria are met, approvals are generally issued for 12 months.

Quantity and Supply Limits

Mektovi (binimetinib) — supply and quantity limits

Quantity/supply policySupply limits may be in place for Mektovi; approvals may be subject to these limits

Automated approvalsUnitedHealthcare may approve initial and re-authorization based solely on previous claim/medication history and diagnosis codes, which can be constrained by supply limits

Impact on coverageIf requested supply exceeds limits, authorization may be denied or adjusted per payer program rules