CurrentCignaPolicy N/A

Mekinist (trametinib) prior authorization

Cigna prior authorization policy for Mekinist (trametinib tablets and oral solution) outlining coverage criteria for FDA-approved indications and other uses with supportive evidence, limitations (not for colorectal cancer), approval durations, and history of changes.

Policy Summary

PayerCigna

PolicyMekinist (trametinib) prior authorization

Policy CodePolicy N/A

Change TypeAnnual revision — multiple indication edits and additions

Effective Date

Next Review Date

Key ActionPrior Authorization is recommended; document BRAF mutation or fusion status and relevant disease characteristics per indication criteria.

SourceLink

POLICY UPDATE CHANGES

Melanoma: Deleted age criterion ≥ 6 years of age.

Hairy Cell Leukemia: Added new indication and criteria based on Compendium recommendations.

Solid Tumors: 'occult primary' added to examples of solid tumors.

Glioma: Previously 'low-grade glioma' reworded and age requirement removed; added BRAF fusion-positive and circumscribed glioma options.

Requirement that 'requires systemic therapy' was removed in a prior revision.

10Covered Indications (listed)

1Not Covered (explicit)

1 year

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Coverage Summary & Scope

This Cigna prior authorization policy covers Mekinist (trametinib tablets and oral solution) with criteria for specified FDA‑approved indications and selected other uses with supportive evidence; approvals are generally provided for 1 year. The policy explicitly states Mekinist is not indicated for colorectal (colon or rectal) cancer due to known intrinsic resistance to BRAF inhibition.

Policy metadata

PayerCigna

Policy titleMekinist (trametinib) prior authorization

Policy numberN/A

StatusCURRENT

Last review date2025-08-27

Typical approval duration1 year

FDA-Approved Indications — General Criteria

FDA-Approved Indications - General

Mekinist is covered as medically necessary when criteria for the specific FDA-approved indication below are met. All approvals are for 1 year unless otherwise noted.

Indication-specific criteria (see corresponding indication nodes)

1. Glioma (Approve for 1 year)

2. Melanoma (Approve for 1 year)

3. Non-Small Cell Lung Cancer (Approve for 1 year)

4. Solid Tumors, Unresectable or Metastatic (Approve for 1 year)

5. Thyroid Carcinoma, Anaplastic (Approve for 1 year)

Other Uses with Supportive Evidence

Conditions Not Covered / Unproven

Mekinist is not indicated for colorectal cancer because of documented intrinsic resistance to BRAF inhibition. The policy also states that Mekinist is not medically necessary for any other use(s) beyond the listed FDA‑approved indications and other uses with supportive evidence.

Applicable Codes

DrugNDCCovered

No codes listed

Provider Actions & Authorization Requirements

Prior Authorization

Prior authorization required

Prior authorization is required for prescription benefit coverage of Mekinist. Approvals are provided per the policy and are typically for 1 year. Coverage is granted only when the patient meets the applicable indication-specific criteria outlined in the policy (e.g., FDA‑approved and Other Uses with Supportive Evidence sections).

Documentation Required

Documentation of mutation status or disease subtype

Providers must document relevant BRAF status and disease characteristics as required by the indication-specific criteria. Specifically, documentation should show BRAF V600 mutation-positive disease or BRAF fusion-positive disease where applicable, and disease features such as metastatic, unresectable, recurrent, or other indication-specific descriptors (e.g., locally advanced or Stage III/IV) per the policy criteria.

Clinical Evidence and Background

Mekinist (trametinib) is a MEK inhibitor with FDA‑approved indications across multiple tumor types including glioma, melanoma, non‑small cell lung cancer (in combination with dabrafenib), unresectable or metastatic solid tumors with BRAF V600E mutation (in combination with dabrafenib), and anaplastic thyroid carcinoma (in combination with dabrafenib). The policy aligns coverage with FDA labeling and the NCCN Drugs & Biologics Compendium recommendations and notes that the solid tumor indication was granted under accelerated approval.

Prescribing information: Novartis Mekinist tablets and oral solution, March 2025

Compendium: NCCN Drugs & Biologics Compendium, accessed 2025-08-25

Definitions

Tafinlar = dabrafenib capsules and tablets for oral suspension

Policy Revision History

04/11/2025revised

Glioma: Previously worded as 'low-grade glioma'; age ≥ 1 year requirement removed; added option for BRAF fusion-positive disease and option for circumscribed glioma. Melanoma: added option for BRAF fusion-positive disease and removed 'V600' specification from 'BRAF mutation'. Solid Tumors: removed age ≥ 1 year requirement; small bowel adenocarcinoma added to examples; high grade glioma removed from examples. Epithelioid Hemangioendothelioma: added to Other Uses with Supportive Evidence; small bowel adenocarcinoma condition removed.

04/09/2025revised

Administrative/criteria wording changes: 'requires systemic therapy' was removed; Melanoma: note added to refer uveal melanoma to separate criteria; Non-Small Cell Lung Cancer: added requirement that patient has recurrent, advanced, or metastatic disease; Solid tumors: 'unresectable or metastatic' verbiage removal and removal of 'no satisfactory alternative treatment options' requirement; Thyroid Carcinoma, Anaplastic: reworded combination with Tafinlar language; Histiocytic Neoplasm: removed multisystem/pulmonary/CNS lesion requirements for Langerhans cell histiocytosis.