CurrentCignaPolicy N/A

Oncology (Oral - MEK Inhibitor) - Mektovi Prior Authorization Policy

Defines Cigna prior authorization requirements for Mektovi (binimetinib tablets) for oncology indications, including FDA-approved uses and select supportive-evidence uses; applies to Cigna-administered health benefit plans.

Policy Summary

PayerCigna

PolicyOncology (Oral - MEK Inhibitor) - Mektovi Prior Authorization Policy

Policy CodePolicy N/A

Change TypeAnnual revision with material coverage updates

Effective Date

Next Review DateAug 20, 2025

Key ActionObtain prior authorization and submit documentation including diagnosis, relevant mutation test results (BRAF V600 or NRAS), and prior therapies when required.

SourceLink

POLICY UPDATE CHANGES

An option for approval was added for melanoma patients with an NRAS mutation who have tried at least one immune checkpoint inhibitor therapy.

Non-Small Cell Lung Cancer indication updated to include recurrent or advanced disease as eligible.

Histiocytic neoplasm requirement that the patient has multisystem, pulmonary, or CNS lesions was removed.

Policy name changed to 'Oncology (Oral - MEK Inhibitor) - Mektovi PA Policy'.

3Covered indications listed

1 yearTypical approval duration

≥18Minimum patient age

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Recommended Authorization Criteria

inv-01: Melanoma — Initial Therapy

Covered when ALL of the following are met for the specific indication:

Melanoma (FDA-approved): Approve for 1 year if the patient meets ALL of the following (A, B, and C)

Melanoma criteria details: A) Patient is ≥ 18 years of age; AND B) Patient has unresectable, advanced, or metastatic melanoma; AND C) Patient meets ONE of the following (i or ii)

Melanoma pathway options: i. Patient meets BOTH of the following (a and b): a) Patient has BRAF V600 mutation-positive disease; AND b) The medication will be used in combination with Braftovi (encorafenib capsules); OR ii. Patient meets BOTH of the following (a and b): a) Patient has a NRAS mutation; AND b) Patient has tried at least one immune checkpoint inhibitor therapy (examples: nivolumab, nivolumab/relatlimab, pembrolizumab, ipilimumab).

inv-02: Non-Small Cell Lung Cancer — Initial Therapy

Covered when ALL of the following are met:

NSCLC (FDA-approved): Approve for 1 year if the patient meets ALL of the following (A, B, C and D)

NSCLC criteria details: A) Patient is ≥ 18 years of age; AND B) Patient has recurrent, advanced, or metastatic disease; AND C) Patient has BRAF V600E mutation-positive disease; AND D) The medication will be used in combination with Braftovi (encorafenib capsules)

inv-03: Histiocytic Neoplasm

Covered when BOTH are met:

Histiocytic Neoplasm: Approve for 1 year if: A) Patient is ≥ 18 years of age; AND B) Patient has Langerhans cell histiocytosis.

NCCN lists Mektovi as an 'Other Recommended Regimen' for histiocytic neoplasms

Coverage for Mektovi (binimetinib) is limited to the indications and clinical scenarios specifically listed in the Recommended Authorization Criteria. Uses that are not described in those criteria are not recommended for coverage and will be considered outside the scope of this policy. Providers should submit requests only for the covered indications and include supporting documentation as specified; requests for circumstances not listed in the criteria are not recommended for approval.

Mektovi (binimetinib) is considered not medically necessary for any uses other than the listed indications (FDA-approved or supportive-evidence uses provided in this policy). Requests for Mektovi for unlisted indications will be denied as not medically necessary.

Regimen	Indication	Coverage status
Mektovi (binimetinib) + Braftovi (encorafenib)
BRAF V600–mutated unresectable, advanced, or metastatic melanoma; BRAF V600E–mutated recurrent, advanced, or metastatic non‑small cell lung cancer (NSCLC)
Covered when criteria are met (see coverage criteria)

Regimen	Indication	Coverage status
Mektovi (binimetinib) monotherapy (single‑agent)
NRAS‑mutated unresectable, advanced, or metastatic melanoma after progression on at least one immune checkpoint inhibitor therapy
Covered when criteria are met (see coverage criteria)

Coding and Age Requirements

Drug identifier (no billing codes provided)mixed

binimetinib

Mektovi (binimetinib tablets) — drug name listed; no specific CPT/HCPCS/NDC codes provided in document

Minimum age requirement for covered indications

Minimum agePatient must be ≥ 18 years of age for all covered indications (melanoma, NSCLC, and histiocytic neoplasm)

ApplicationApplies to melanoma (FDA-approved), NSCLC (FDA-approved), and Langerhans cell histiocytosis (supportive evidence)

Approval durationTypical approval granted for 1 year when criteria are met

Prior Authorization, Documentation, and Step Therapy

Prior Authorization

Prior Authorization Required

Prior authorization is required for Mektovi (binimetinib) prescription benefit coverage. Approvals are provided for the durations noted in the clinical criteria (generally 1 year for approved indications). Submit prior authorization requests before dispensing to avoid claim denials or delays.

Applies to Mektovi (binimetinib tablets)
Typical approval duration: 1 year for approved indications

Step Therapy

Step Therapy for NRAS‑Mutated Melanoma

When requesting coverage for Mektovi for NRAS-mutated melanoma, the patient must have tried at least one immune checkpoint inhibitor prior to approval. Examples of immune checkpoint inhibitors include nivolumab (Opdivo), nivolumab/relatlimab (Opdualag), pembrolizumab (Keytruda), and ipilimumab (Yervoy).

NRAS-mutated melanoma: documentation of prior trial of ≥1 immune checkpoint inhibitor required
Examples: Opdivo (nivolumab), Opdualag (nivolumab/relatlimab), Keytruda (pembrolizumab), Yervoy (ipilimumab)

Line of Therapy Specifications

Genomic/Mutation Requirements

BRAF V600E or V600K — required mutation for BRAF/MEK combination indications

Required mutation(s)BRAF V600E or V600K mutation-positive disease is required for BRAF/MEK combination therapy in melanoma

Detection methodMutation must be detected by an FDA-approved test (per indication language)

Regimen contextRequired when Mektovi is used in combination with Braftovi (encorafenib) for melanoma

NRAS — biomarker relevant for monotherapy NRAS-mutated melanoma criterion

Relevant biomarkerNRAS mutation is required for the single-agent (monotherapy) NRAS-mutated melanoma pathway option

Prior therapy requirementPatient must have tried at least one immune checkpoint inhibitor therapy for NRAS-mutated melanoma monotherapy eligibility

Permitted Drug Regimens

Drug(s)	Required biomarker / patient criteria	Notes	Coverage status
Mektovi (binimetinib) + Braftovi (encorafenib)
Melanoma: BRAF V600E or V600K mutation (detected by an FDA‑approved test). NSCLC: BRAF V600E mutation (detected by an FDA‑approved test). Patient ≥ 18 years of age.
Melanoma: for unresectable, advanced, or metastatic disease. NSCLC: for recurrent, advanced, or metastatic disease. Approvals typically for 1 year.
Covered when all applicable criteria are satisfied (see coverage criteria).

Drug	Required biomarker / patient criteria	Prior therapy requirement	Coverage status
Mektovi (binimetinib) — single‑agent
NRAS mutation–positive melanoma; patient ≥ 18 years of age
Patient must have tried at least one immune checkpoint inhibitor therapy prior to approval (examples include nivolumab, pembrolizumab, relatlimab‑nivolumab combination, ipilimumab).
Covered when all applicable criteria are satisfied (see coverage criteria).

Drug and Mutation Definitions

Mektovi (binimetinib) — drug identifier / short definition

Drug name (generic)Binimetinib

Brand nameMektovi (binimetinib tablets)

Mechanism/descriptionA MEK inhibitor used orally; indicated in combination with encorafenib for BRAF V600–mutated melanoma and NSCLC

BRAF V600E or V600K — definition of BRAF V600 mutation-positive disease

DefinitionBRAF V600 mutation-positive disease refers to presence of BRAF V600E or V600K mutations

Clinical contextRequired for use of Mektovi in combination with Braftovi for treatment of unresectable or metastatic melanoma

Clinical Background and Guidelines

Mektovi (binimetinib) is a MEK inhibitor used in oncology settings. It is indicated in combination with Braftovi (encorafenib) for certain BRAF V600–mutated malignancies and is also listed by guideline sources for other select uses. National Comprehensive Cancer Network (NCCN) guidance supports the use of BRAF/MEK combinations as preferred therapy for BRAF V600–mutated melanoma and non–small cell lung cancer (NSCLC), and lists Mektovi among recommended options for histiocytic neoplasms and some melanoma contexts. This policy defines prior authorization requirements for Mektovi across those covered indications and specifies required biomarker status, age thresholds, and any prior-therapy conditions needed for approval.

Policy Revision History

2025-08-20Annual revisionLatest

Annual revision updated; material changes in prior April 8, 2025 update summarized including NRAS melanoma option, NSCLC criteria expansion, and histiocytic neoplasm criterion removal.

2025-04-08Selected revision

Policy updated: added melanoma approval option for NRAS-mutated patients after at least one immune checkpoint inhibitor; added examples of immune checkpoint inhibitors; expanded NSCLC criteria to include recurrent or advanced disease; removed multisystem/pulmonary/CNS lesion requirement for histiocytic neoplasm; and changed policy name to 'Oncology (Oral - MEK Inhibitor) - Mektovi PA Policy'.