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, duration of approvals, and not medically necessary conditions.

Policy Summary

PayerCigna

PolicyMekinist (trametinib) prior authorization

Policy CodePolicy N/A

Change TypeAnnual revision / updates (material changes)

Effective Date

Next Review DateAug 27, 2025

Key ActionPrior Authorization is recommended/required for prescription benefit coverage of Mekinist; document BRAF V600 mutation-positive or BRAF fusion-positive status and the covered diagnosis to support approval.

SourceLink

POLICY UPDATE CHANGES

Deleted multiple age ≥6 or ≥1 year criteria across indications and added BRAF fusion-positive and circumscribed glioma options; added and removed several indication-specific requirements.

Hairy Cell Leukemia added as a new indication with criteria requiring no prior BRAF inhibitor and use in combination with dabrafenib for relapsed/refractory disease.

Non-Small Cell Lung Cancer requirement for recurrent, advanced, or metastatic disease was added.

Solid tumor examples updated to add 'occult primary' and remove 'unresectable or metastatic' phrase in one revision; some requirements about lack of satisfactory alternatives were removed.

10+Covered Indications (including other uses with supportive evidence)

1Typical approval duration (years)

Coverage Summary

This Cigna prior authorization policy covers Mekinist (trametinib tablets and oral solution) and summarizes FDA-approved indications and other uses with supportive evidence. Mekinist is a MEK inhibitor with approvals across multiple tumor types including glioma, melanoma, non-small cell lung cancer (in combination with dabrafenib/Tafinlar), certain solid tumors, and anaplastic thyroid carcinoma; other covered uses with supportive evidence are also listed. The policy notes limitations such as the lack of activity in colorectal cancer and that the solid tumor indication was approved under accelerated approval and continued approval may be contingent on verification of clinical benefit in a confirmatory trial. This policy requires prior authorization and documents coverage criteria (including mutation/fusion status) and typical approval durations (generally 1 year).

Quick Facts

Covered Indications10+

Approval duration1 year

Not covered conditionColon/Rectal Cancer

Last review2025-04-09

Next review2025-08-27

General Policy Statement

Prior Authorization is recommended for prescription benefit coverage of Mekinist. All approvals are provided for the duration noted below.

ALL of the following

Drug: Mekinist (trametinib tablets and oral solution - Novartis).
Prior Authorization: Recommended for prescription benefit coverage.
Coverage Determination: Mekinist is covered as medically necessary when the criteria for FDA‑approved indications or other uses with supportive evidence are met; approvals are provided for the durations specified in the policy (typically 1 year).
Note: If patient has uveal melanoma, refer to separate criteria for uveal melanoma.

FDA-Approved Indications — Glioma

FDA-Approved Indications - Glioma

Approve for 1 year if the patient meets BOTH of the following (A and B):

ALL of the following

A) Patient meets ONE of the following (i or ii):
- i: Patient has BRAF V600 mutation-positive disease
- ii: Patient has BRAF fusion-positive disease
B) Patient meets ONE of the following (i or ii):
- i: The medication will be taken in combination with Tafinlar (dabrafenib capsules or tablets for oral suspension)

FDA-Approved Indications — Melanoma

FDA-Approved Indications - Melanoma

Approve for 1 year if the patient meets BOTH of the following (A and B):

ALL of the following

A) Clinical status: A) Patient has unresectable, advanced (including Stage III or Stage IV disease), or metastatic melanoma
Includes adjuvant treatment in Stage III with no evidence of disease post-surgery.
B) Mutation status
- i: Patient has BRAF mutation-positive disease
- ii: Patient has BRAF fusion-positive disease

FDA-Approved Indications — Non-Small Cell Lung Cancer (NSCLC)

FDA-Approved Indications - Non-Small Cell Lung Cancer (NSCLC)

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

NSCLC criteria

A) Disease status: A) Patient has recurrent, advanced, or metastatic disease
B) Mutation: B) Patient has BRAF V600 mutation-positive disease
C) Combination therapy: C) The medication is prescribed in combination with Tafinlar (dabrafenib capsules or tablets for oral suspension)

FDA-Approved Indications — Solid Tumors

FDA-Approved Indications - Solid Tumors (Unresectable or Metastatic)

Approve for 1 year if the patient meets BOTH of the following (A and B): Note includes examples of solid tumors.

Solid tumor criteria

A) Mutation: A) Patient has BRAF V600 mutation-positive disease
B) Combination therapy: B) The medication will be taken in combination with Tafinlar (dabrafenib capsules or tablets for oral suspension)

FDA-Approved Indications — Anaplastic Thyroid Carcinoma

FDA-Approved Indications - Thyroid Carcinoma, Anaplastic

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

Thyroid anaplastic criteria

A) Disease status: A) Patient has locally advanced or metastatic anaplastic disease
B) Mutation: B) Patient has BRAF V600 mutation-positive disease
C) Combination therapy: C) The medication will be taken in combination with Tafinlar (dabrafenib capsules or tablets for oral suspension)

Other Uses with Supportive Evidence

Other Uses with Supportive Evidence - Epithelioid Hemangioendothelioma

Approve for 1 year.

Patient has epithelioid hemangioendothelioma

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Provider Actions

Prior Authorization

Prior authorization required

Prior Authorization is recommended/required for prescription benefit coverage of Mekinist; approvals are issued for durations noted (typically 1 year).

Documentation Required

Document mutation/fusion status and indication

Providers must document BRAF V600 mutation-positive or BRAF fusion-positive status (as applicable) and the covered diagnosis/indication to support approval.

Applicable Codes

DrugNDCCovered

No codes listed

Companion/Combination drug referencedmixedCovered

dabrafenib

Tafinlar (dabrafenib capsules or tablets for oral suspension) referenced as required combination in many indications

Clinical Evidence & References

The policy references the Novartis Mekinist tablets and oral solution prescribing information (March 2025) and the NCCN Drugs & Biologics Compendium (accessed 2025) as sources of supportive evidence for the indications and criteria in this policy.

Revision History

revisedLatest

Deleted multiple age criteria (e.g., removed ≥1 or ≥6 year age requirements across glioma, melanoma, NSCLC, solid tumors, thyroid carcinoma, histiocytic neoplasm, and ovarian/peritoneal cancers) and added BRAF fusion-positive and circumscribed glioma options; other wording edits to combination therapy language and indication-specific requirements.

addedLatest

Hairy Cell Leukemia added as a new indication with criteria requiring no prior BRAF inhibitor, use for relapsed/refractory disease, and use in combination with Tafinlar (dabrafenib).