UnitedHealthcare Mektovi Prior Auth Policy Update

Coverage / Medical Necessity Criteria

Melanoma — Initial Therapy

Initial Authorization — Melanoma (patients ≥19 years unless pediatric auto-processed)

Melanoma initial: Diagnosis of melanoma AND disease is unresectable or metastatic AND (EITHER: (both) patient is BRAFV600 mutation positive AND used in combination with Braftovi (encorafenib); OR (both) patient is NRAS mutation positive AND progression after prior immune checkpoint inhibitor therapy)

Authorization issued for 12 months

Melanoma — Reauthorization

Reauthorization — Melanoma

Melanoma reauth: Patient does not show evidence of progressive disease while on Mektovi therapy

Authorization issued for 12 months

Low-grade Serous Carcinoma — Initial

Low-grade serous carcinoma

Low-grade serous carcinoma initial: Diagnosis of low-grade serous carcinoma AND (EITHER used in combination with Braftovi (encorafenib) OR NRAS-mutated tumor)

Authorization issued for 12 months

Histiocytic Neoplasms

Histiocytic neoplasms (Langerhans Cell Histiocytosis)

LCH initial: Diagnosis of multisystem Langerhans Cell Histiocytosis OR single-system lung Langerhans Cell Histiocytosis OR Langerhans Cell Histiocytosis with CNS lesions AND disease is recurrent

Authorization issued for 12 months

LCH reauth: Patient does not show evidence of progressive disease while on Mektovi therapy

Authorization issued for 12 months

SDH-deficient GIST

SDH-deficient gastrointestinal stromal tumor (GIST)

SDH-deficient GIST initial: Diagnosis of SDH-deficient GIST AND disease is one of: gross residual disease (R2 resection), unresectable primary disease, tumor rupture, progressive, recurrent, or metastatic AND used in combination with imatinib mesylate (Gleevec)

Authorization issued for 12 months

SDH-deficient GIST reauth: Patient does not show evidence of progressive disease while on Mektovi therapy AND used in combination with imatinib mesylate (Gleevec)

Authorization issued for 12 months

NSCLC

Non-small cell lung cancer (NSCLC)

NSCLC initial: Diagnosis of NSCLC AND disease is recurrent, advanced, or metastatic AND patient is positive for BRAFV600 mutation AND used in combination with Braftovi (encorafenib)

Authorization issued for 12 months

NSCLC reauth: Patient does not show evidence of progressive disease while on Mektovi therapy AND used in combination with Braftovi (encorafenib)

Authorization issued for 12 months

NCCN Recommended Regimens

NCCN recommended regimens

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

Authorization will be issued for 12 months; state mandates and member benefits may affect coverage

Reauthorization

Reauthorization will be approved when ALL of the following are met

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

Authorization issued for 12 months

NCCN Recommended Regimens

Covered when regimen is recognized by NCCN Drugs and Biologics Compendium with specified categories

NCCN Regimen Acceptance: The drug is recognized for the cancer indication by NCCN with Category of Evidence and Consensus of 1, 2A, or 2B

Authorization will be issued for 12 months

GIST reauthorization

GIST-specific reauthorization requirement

GIST combination requirement: Reauthorization requires Mektovi to be used in combination with imatinib for GIST

NSCLC

NSCLC coverage expansion note

NSCLC coverage: Coverage expanded to include recurrent and advanced BRAF V600E NSCLC per NCCN; reauthorization requires use in combination with Braftovi

Coverage under this policy is contingent on meeting the criteria set forth in the sections below. Members under 19 years of age will have prescriptions for Mektovi automatically processed without a coverage review. Some state mandates require coverage for off‑label uses or require use of alternate compendia; where such state mandates apply, they supersede the terms of this policy. In addition, any federal regulatory requirements and the member’s specific benefit plan may affect coverage determinations.

Supply limits may be applied to Mektovi claims. UnitedHealthcare may also approve initial authorizations or reauthorizations using previous claim/medication history, diagnosis codes (ICD‑10), and claim logic through automated processes; availability of automated approval varies by program and therapeutic class. Member benefit plan terms and state mandates may further impact coverage and quantity limits.

Initial Therapy — Indication-Specific Rules

Initial Therapy Rules

Initial authorization examples

Melanoma initial (example): Diagnosis of melanoma; disease unresectable or metastatic; either BRAFV600 positive and used with encorafenib OR NRAS positive with progression after prior immune checkpoint inhibitor therapy

12 months

NSCLC initial (example): Diagnosis of NSCLC; disease recurrent/advanced/metastatic; BRAFV600 positive; used with encorafenib

12 months

Continuation / Reauthorization Criteria

Continuation/Reauthorization

Reauthorization criteria across indications

General reauth: Patient does not show evidence of progressive disease while on Mektovi therapy; additional combination requirements apply per indication (e.g., with encorafenib or imatinib)

Authorization issued for 12 months

Reauthorization / Continuation

Reauthorization conditions for continued therapy

Continuation: Patient without progressive disease on therapy AND continued combination with Braftovi for applicable indications

Authorization for 12 months

Provider Actions, Documentation & Operational Notes

Prior Authorization

Prior Authorization Required

Prior authorization/notification is required per UnitedHealthcare Pharmacy Clinical Pharmacy Programs for Mektovi (binimetinib). Prescriptions for members under 19 years will automatically process without a coverage review. State mandates that supersede this policy (for off‑label use or compendium references) will be applied where applicable.

Prior authorization/notification required for Mektovi (binimetinib).
Members under age 19: automatic processing without coverage review.
State mandates and federal regulatory requirements supersede policy language where applicable.

Prior Authorization

Reauthorization Requirements

Reauthorization will be approved when the patient does not show evidence of progressive disease while on Mektovi therapy and when Mektovi is being used in the required combination for the indication (e.g., with Braftovi [encorafenib] for BRAF V600-mutant disease; with imatinib for SDH-deficient GIST). Authorizations are issued for 12 months.

Reauthorization requires no evidence of progressive disease.

Quantity Limits and Coding Notes

Mektovi (binimetinib) — Quantity / Supply Limits

Quantity limit noteSupply limits may be in place for Mektovi (binimetinib)

Limit applicationSupply limits may apply at initial authorization or reauthorization and may be enforced by automated claim/medication history logic

Approval basisUnitedHealthcare may approve initial and reauthorization requests based on previous claim/medication history or diagnosis codes where applicable

Program variationUse of automated approval and re‑approval processes varies by program and therapeutic class

Documentation implicationProviders should ensure claim history and diagnosis coding are accurate to avoid operational denials when supply limits are applied

Step	Requirement / Notes
No explicit step therapy sequence specified	Coverage and prior authorization decisions are based on diagnosis, tumor mutation status (e.g., BRAF V600E/V600K, NRAS), and required combination therapy per indication (for example, with encorafenib for BRAF-mutated melanoma or NSCLC; with imatinib for SDH-deficient GIST).
Clinical documentation required	Providers should supply diagnosis and mutation status or prior therapy documentation as applicable to the indication to support authorization (e.g., BRAFV600 mutation testing, evidence of prior immune checkpoint inhibitor therapy for NRAS‑mutated melanoma).
Reauthorization considerations	Reauthorization generally requires that the patient does not show evidence of progressive disease while on Mektovi therapy; additional indication‑specific combination requirements apply (e.g., continued use with encorafenib or with imatinib for GIST). Authorization is issued for 12 months where criteria are met.
NCCN‑recognized regimens	Regimens listed in the NCCN Drugs & Biologics Compendium with Category 1, 2A, or 2B are accepted for authorization; authorization issued for 12 months. State mandates and member benefits may affect coverage.

Definitions and Background Information

BRAFV600 mutation — Definition and requirements

Required mutation statusBRAF V600E or V600K mutation status is required for indicated combinations with encorafenib (Braftovi)

NSCLC specificationFor NSCLC, a BRAF V600E mutation is required when used in combination with encorafenib

Melanoma specificationFor unresectable or metastatic melanoma, BRAF V600E or V600K mutation is required when Mektovi is used with encorafenib

NCCN recognized expansionsNCCN also recommends Mektovi for NRAS‑mutated melanoma after progression on checkpoint inhibitors and other indications, but BRAF V600 mutation is specifically required for encorafenib combinations

Mektovi (binimetinib) is a MEK kinase inhibitor used 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 (NSCLC) with BRAF V600E when used with encorafenib. NCCN recommendations also support additional uses including NRAS‑mutated melanoma after progression on immune checkpoint inhibitors, Langerhans Cell Histiocytosis, low‑grade serous carcinoma, and use in combination with imatinib for succinate dehydrogenase (SDH)‑deficient GIST; the precise coverage criteria and required combination partners are detailed in the criteria sections that follow.

Policy Revision History

2026-03-01policy_effective_dateLatest

Policy effective date updated to 2026-03-01 per policy header.

2025-12annual_review

Annual review completed with no changes to coverage criteria; background and references updated.

2024-12annual_review_material_change

Annual review updated formatting of criteria for melanoma and histiocytic neoplasms and added a reauthorization requirement that Mektovi must be used in combination with imatinib for SDH-deficient GIST; NSCLC coverage expanded to include recurrent and advanced disease per NCCN and reauthorization requires combination with Braftovi (encorafenib).

OpenPayer

Mektovi (binimetinib) prior authorization

Coverage / Medical Necessity Criteria

Initial Therapy — Indication-Specific Rules

Continuation / Reauthorization Criteria

Provider Actions, Documentation & Operational Notes

Quantity Limits and Coding Notes

Definitions and Background Information

Policy Revision History