CurrentColorado Rocky Mountain Health PlansPolicy N/A

Mekinist (trametinib) — Clinical prior authorization and notification criteria

Clinical prior authorization and notification criteria for Mekinist (trametinib) coverage within the Colorado Rocky Mountain Health Plans clinical pharmacy program; governs medical/pharmacy benefit coverage and applies to prescribers requesting Mekinist for plan members.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyMekinist (trametinib) — Clinical prior authorization and notification criteria

Policy CodePolicy N/A

Change TypeAnnual reviewclarifications and indication additions (non-material)

Effective DateAug 1, 2025

Next Review DateMay 29, 2025

Key ActionSubmit prior authorization with documentation of diagnosis, disease stage, BRAF V600 mutation status when required, prior systemic therapy history when applicable, and use in combination with dabrafenib where indicated.

SourceLink

POLICY UPDATE CHANGES

Annual reviews and multiple updates to coverage criteria, background, and references were recorded from 2013 through 2025, including additions of indications per NCCN and package insert.

12 monthsstandard authorization duration

members <19 auto-processauto-process for patients <19

BRAF V600E/V600Kmutation requirement

Multiple tumor types

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2013-2025change history years

Coverage Criteria for Mekinist (trametinib)

Patients less than 19 years

Covered when ALL of the following are met

Patients <19: Patient is less than 19 years of age

Authorization issued for 12 months

Melanoma

Initial authorization covered when ONE of the following groups is met

Melanoma indications: Unresectable melanoma OR metastatic melanoma OR prescribed as adjuvant therapy for melanoma involving the lymph node(s); AND used in combination with Tafinlar (dabrafenib); AND cancer is positive for BRAF V600 mutation

Authorization issued for 12 months

Distant metastatic uveal melanoma

Authorization issued for 12 months

Reauthorization for melanoma: Patient does not show evidence of progressive disease while on Mekinist therapy

Authorization issued for 12 months

Non-small cell lung cancer (BRAF V600E)

Covered when ALL of the following are met

NSCLC initial: Diagnosis of non-small cell lung cancer (NSCLC); disease is metastatic, advanced, or recurrent; cancer is positive for BRAF V600E mutation; used in combination with Tafinlar (dabrafenib)

Authorization issued for 12 months

NSCLC reauthorization: Patient does not show evidence of progressive disease while on Mekinist therapy

Authorization issued for 12 months

Thyroid cancers and glioma

Initial authorization covered when ONE of the following groups is met

Anaplastic thyroid cancer (ATC): Diagnosis of anaplastic thyroid cancer (ATC); cancer is positive for BRAF V600E mutation; used in combination with Tafinlar (dabrafenib); disease is metastatic, locally advanced, or unresectable OR prescribed as adjuvant therapy following resection

Authorization issued for 12 months

Follicular/Oncocytic/Papillary carcinoma: Diagnosis of follicular, oncocytic, or papillary carcinoma; unresectable locoregional recurrent, persistent, or metastatic disease; symptomatic or progressive disease; refractory to radioactive iodine; cancer is positive for BRAF V600 mutation; used in combination with Tafinlar (dabrafenib)

Authorization issued for 12 months

Glioma: Patient has a glioma; cancer is positive for BRAF V600E mutation; used in combination with Tafinlar (dabrafenib)

Authorization issued for 12 months

Brain metastases (melanoma)

Initial authorization covered when ALL of the following are met

Brain metastases: Patient has metastatic brain lesions AND Mekinist is active against the primary tumor (melanoma) OR cancer is positive for BRAF V600E mutation AND used in combination with Tafinlar (dabrafenib)

Authorization issued for 12 months

Reauthorization brain mets: Patient does not show evidence of progressive disease while on Mekinist therapy

Authorization issued for 12 months

Epithelial ovarian / fallopian tube / primary peritoneal cancer

Initial authorization covered when ALL of the following are met

Epithelial ovarian group initial: Diagnosis of epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer; AND persistent disease OR recurrence in BRAF V600E positive tumors OR recurrence of low-grade serous carcinoma

Authorization issued for 12 months

Reauthorization epithelial ovarian group: Patient does not show evidence of progressive disease while on Mekinist therapy

Authorization issued for 12 months

Hepatobiliary cancers

Initial authorization covered when ALL of the following are met

Hepatobiliary initial: Diagnosis of gallbladder cancer, extrahepatic cholangiocarcinoma, or intrahepatic cholangiocarcinoma; used as subsequent treatment after progression on or after systemic treatment; disease is unresectable or metastatic; cancer is positive for BRAF V600E mutation; used in combination with Tafinlar (dabrafenib)

Authorization issued for 12 months

Reauthorization hepatobiliary: Patient does not show evidence of progressive disease while on Mekinist therapy

Authorization issued for 12 months

Hepatobiliary cancers

Hepatobiliary cancers — Initial Authorization

Hepatobiliary cancers: (1) Diagnosis of gallbladder, extrahepatic cholangiocarcinoma, or intrahepatic cholangiocarcinoma; (2) Used as subsequent treatment after progression on or after systemic treatment; (3) Disease is unresectable or metastatic; (4) Cancer is positive for BRAF V600E mutation; (5) Used in combination with Tafinlar (dabrafenib)

Authorization issued for 12 months

Solid tumors (BRAF V600E)

Solid tumors with BRAF V600E mutation — Initial Authorization

Solid tumors (BRAF V600E): (1) Presence of solid tumor; (2) Used as subsequent treatment after progression on or after systemic treatment; (3) Disease is unresectable or metastatic; (4) Cancer is positive for BRAF V600E mutation; (5) Used in combination with Tafinlar (dabrafenib)

Authorization issued for 12 months

Histiocytic neoplasms

Histiocytic disorders — Initial Authorization

Histiocytic neoplasms: (1) Diagnosis of Langerhans Cell Histiocytosis, Erdheim-Chester Disease, or Rosai-Dorfman Disease; (2) Mitogen-activated protein (MAP) kinase pathway mutation, no detectable mutation, or testing not available

Authorization issued for 12 months

Pancreatic / ampullary adenocarcinoma

Pancreatic and ampullary adenocarcinoma — Initial Authorization

Pancreatic/ampullary adenocarcinoma: (1) Diagnosis of pancreatic adenocarcinoma or ampullary adenocarcinoma; (2) Disease is metastatic, locally advanced, or unresectable; (3) Cancer is positive for BRAF V600E mutation; (4) Used in combination with Tafinlar (dabrafenib)

Authorization issued for 12 months

Hairy cell leukemia

Hairy cell leukemia — Initial Authorization

Hairy cell leukemia: (1) Diagnosis of hairy cell leukemia; (2) Used in combination with Tafinlar (dabrafenib)

Authorization issued for 12 months

Salivary gland tumor

Salivary gland tumor — Initial Authorization

Salivary gland tumor: (1) Diagnosis of salivary gland tumor; (2) Disease is recurrent and unresectable or metastatic; (3) Cancer is positive for BRAF V600E mutation; (4) Used in combination with Tafinlar (dabrafenib)

Authorization issued for 12 months

GIST (BRAF V600E)

GIST — Initial Authorization

BRAF V600E-mutated GIST: (1) Diagnosis of BRAF V600E-mutated GIST; (2) Disease is gross residual (R2 resection), unresectable primary disease, tumor rupture, progressive, recurrent, or metastatic; (3) Used in combination with Tafinlar (dabrafenib)

Authorization issued for 12 months

NCCN-recognized regimens

NCCN Recommended Regimens

NCCN-recognized indications: The drug is recognized for treatment of the cancer indication by the NCCN Drugs and Biologics Compendium with a Category of Evidence and Consensus of 1, 2A, or 2B

Authorization will be issued for 12 months; state mandates and member benefit plan limitations may apply

Reauthorization (all indications)

Reauthorization

Reauthorization criterion: Patient does not show evidence of progressive disease while on Mekinist therapy

Authorization typically issued for 12 months

Some states mandate coverage for off‑label uses of medications and may require use of specific compendia as the standard for coverage decisions. Where a state law or compendium mandate applies, that mandate supersedes the criteria in this document.

Coverage determinations may be affected by external requirements in addition to the clinical criteria listed here. Authorization is typically issued for 12 months when criteria are met, but state mandates, federal regulatory requirements, the member’s specific benefit plan, and other policies or utilization management programs can modify coverage or applicable requirements.

For members under age 19, prescriptions automatically process without coverage review as noted in the policy; for all other members, failure to meet the listed clinical criteria may result in denial or a requirement for additional documentation.

Initial Therapy Criteria

Initial therapy

Initial therapy coverage requires diagnosis-specific criteria including mutation status and often use in combination with dabrafenib.

General initial requirement: Cancer diagnosis matching a listed indication AND cancer positive for BRAF V600E or V600K mutation where specified AND used in combination with dabrafenib when required by indication

Authorization usually issued for 12 months

Initial therapy rules

Initial authorization criteria by indication

Typical initial criteria: Diagnosis per indication; disease stage (unresectable/metastatic or specified); BRAF V600E mutation positive when required; use in combination with Tafinlar when required; used as subsequent treatment after progression when specified

Authorization issued for 12 months

Reauthorization / Continuation Criteria

Reauthorization / Continuation

Reauthorization is approved when the patient does not show evidence of progressive disease while on Mekinist therapy.

General reauthorization: Patient does not show evidence of progressive disease while on Mekinist therapy

Authorization issued for 12 months

Reauthorization / Continuation

Reauthorization requirements across indications

Continuation: Patient must not show evidence of progressive disease while on Mekinist therapy to qualify for reauthorization

Authorization issued for 12 months

Provider Actions and Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization/notification is required for Mekinist for members 19 years and older. Prescriptions for members under 19 years will automatically process without a coverage review. Failure to meet the listed coverage criteria for members 19 and older will result in denial.

Applies to all Mekinist (trametinib) prescriptions for members ≥19 years.
Members <19 years: automatic processing without coverage review.

Denial Risk

Denial Risk and Common Triggers

Requests lacking required documentation or clinical criteria will be at risk for denial. Common denial triggers include absence of documented BRAF V600E or V600K mutation when required, and lack of documentation showing prior systemic therapy when the indication requires Mekinist as subsequent treatment. Note: some change-history entries do not list explicit denial triggers beyond standard criteria enforcement.

Step Therapy Rules

Requirement	Detail
Step requirement
Used as subsequent treatment after progression on or after systemic treatment
Applicable diagnoses
Gallbladder cancer; Extrahepatic cholangiocarcinoma; Intrahepatic cholangiocarcinoma
Disease stage
Unresectable or metastatic
Mutation status
Cancer is positive for BRAF V600E mutation
Combination therapy
Used in combination with Tafinlar (dabrafenib)
Authorization duration
Authorization will be issued for 12 months

Requirement	Detail
Step requirement
Must have progressed on or after systemic therapy (used as subsequent treatment)
Indication scope
Presence of a solid tumor; disease is unresectable or metastatic
Mutation status
Cancer is positive for BRAF V600E mutation
Combination therapy
Used in combination with Tafinlar (dabrafenib)
Authorization duration
Authorization will be issued for 12 months

Background

Mekinist (trametinib) is a MEK kinase inhibitor indicated as monotherapy or in combination with Tafinlar (dabrafenib) for multiple BRAF V600 mutation–positive malignancies. Indications referenced in this policy include unresectable or metastatic melanoma (including adjuvant settings with nodal involvement), metastatic non‑small cell lung cancer with BRAF V600E, anaplastic thyroid cancer with BRAF V600E, certain pediatric and adult solid tumors with BRAF V600E (including select accelerated approvals), and other tumor types where NCCN or package‑insert guidance supports use. The Mekinist package insert and the NCCN Drugs & Biologics Compendium are cited as primary reference standards for coverage updates and indication-specific language.

Definitions

BRAF V600 mutation (definition)

DefinitionBRAF V600E or V600K mutation as detected by an FDA-approved test

Implication for coverageRequired for FDA-labeled indications of Mekinist (e.g., unresectable/metastatic melanoma, adjuvant melanoma, select solid tumors, NSCLC, ATC)

Testing expectationMutation must be detected by an FDA-approved test (documentation of test result required when criterion specifies mutation-positive disease)

BRAF V600E mutation — clinical significance

DefinitionBRAF V600E mutation — a specific activating mutation in the BRAF gene commonly required by the policy for Mekinist coverage in multiple tumor types

Role in indicationsPresence of BRAF V600E is specified for indications including NSCLC (metastatic), anaplastic thyroid cancer, pediatric and adult solid tumors, glioma, hepatobiliary, pancreatic/ampullary, salivary gland, and GIST

Revision History

7/2013policy_created

New prior authorization criteria for Mekinist were established following FDA approval (5/29/2013).

2/2014coverage_update

Updated approval to reflect combination therapy with Tafinlar (dabrafenib).

5/2014administrative_update

Auto-update to maintain on-cycle review. (administrative)

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyMekinist (trametinib) — Clinical prior authorization and notification criteria

Policy CodePolicy N/A

Change TypeAnnual reviewclarifications and indication additions (non-material)

Effective DateAug 1, 2025

Next Review DateMay 29, 2025

SourceLink

On This Page

Reauthorization thyroid/glioma: Patient does not show evidence of progressive disease while on Mekinist therapy

Authorization issued for 12 months

No documented BRAF V600E or V600K mutation (when mutation is required) — denial likely.
No documentation of prior systemic therapy/progression when indication requires subsequent treatment — denial likely.
If criteria for disease stage (eg, unresectable, metastatic, locally advanced) are missing, request may be denied.
Change history notes do not always list explicit denial triggers; absence of explicit trigger does not waive requirements.

Documentation Required

Mutation Testing Documentation Required

When a BRAF mutation is required by the coverage criteria, documentation must show the tumor is positive for a BRAF V600E or V600K mutation as detected by an FDA-approved test or other accepted companion diagnostic where indicated. Include the test name, date, and result in the submission.

Document test method and result (eg, FDA-approved companion diagnostic) showing BRAF V600E or V600K mutation.
Required for FDA-labeled indications and for multiple NCCN-recommended off-label uses referenced in criteria.

Documentation Required

Required Clinical Documentation

Provide clinical documentation to support the request, including diagnosis, disease stage (metastatic, unresectable, or locally advanced where specified), prior systemic therapies and dates, evidence of progression when required for subsequent-line use, and relevant molecular testing results.

Diagnosis and disease stage (metastatic, unresectable, locally advanced, or specific surgical status like R2 resection).
Prior systemic therapy details and documentation of progression when Mekinist is requested as subsequent treatment.
Molecular testing results (BRAF V600E/V600K) with test name and date.

Step Therapy

Step Requirement — Hepatobiliary Cancers

For hepatobiliary cancers (gallbladder cancer, extrahepatic cholangiocarcinoma, intrahepatic cholangiocarcinoma), Mekinist is covered only as subsequent treatment after progression on or after systemic treatment. Authorization is contingent on meeting all listed criteria including unresectable or metastatic disease, BRAF V600E mutation, and use in combination with Tafinlar (dabrafenib).

Indications covered: gallbladder cancer; extrahepatic cholangiocarcinoma; intrahepatic cholangiocarcinoma.
Must be used after progression on or after systemic therapy.
Must be combined with Tafinlar (dabrafenib) and tumor must be BRAF V600E positive.
Authorization duration: 12 months when criteria met.

Step Therapy

Subsequent Treatment Requirement

For multiple covered indications, Mekinist is authorized only as subsequent-line therapy after documented progression on or after prior systemic treatment. Ensure documentation of prior therapy and progression is provided; approvals are typically issued for 12 months when all criteria are met.

Subsequent treatment requirement applies to solid tumors, hepatobiliary cancers, and other specified indications per criteria.
Provide prior systemic therapy details and evidence of progression.
Typical authorization duration: 12 months when criteria are satisfied.

Note

Reference Documents

References to support coverage criteria and required clinical information include the Mekinist package insert and the NCCN Drugs & Biologics Compendium. Use these sources for indication specifics, dosing, and diagnostic test guidance.

Mekinist [package insert], Novartis Pharmaceuticals Corporation; April 2025.
NCCN Drugs and Biologics Compendium (NCCN Compendium™). Accessed April 8, 2025.
Change history and prior authorization updates are recorded in the policy change control notes.

Combination requirementWhen BRAF V600E-positive disease is listed, Mekinist is frequently required to be used in combination with Tafinlar (dabrafenib) per indication-specific criteria

Reference standards

Primary referencesMekinist package insert (Novartis) and the NCCN Drugs and Biologics Compendium are the reference standards used for coverage updates and criteria

Evidence basisCoverage criteria and indication additions are aligned to FDA approvals and NCCN recommendations (Category 1, 2A, or 2B where recognized)

Change history useAnnual reviews and dated updates (2016–2025) cite the package insert and NCCN compendium when adding or revising indications and authorization durations

9/2014administrative_update

Administrative change removing Tried/Failed exemption for State of New Jersey. (administrative)

5/2015coverage_update

Updated coverage criteria and background to align with NCCN melanoma recommendations and updated references; authorization duration increased (partial entry continuing in source).

5/2016annual_review

Annual review and change of authorization duration to 12 months; added coverage for NSCLC with BRAF V600E mutation when used in combination with Tafinlar and updated references.

3/2017annual_review

Annual review with minor wording change (member → patient) and reference updates; no change to coverage criteria.

3/2018annual_review

Annual review updating background and criteria to include NSCLC indication with BRAF V600E mutation and adjuvant melanoma use in combination with Tafinlar per NCCN; references updated.

3/2019annual_review

Annual review adding adjuvant melanoma indications and updating criteria and background to include ATC with BRAF V600 mutations per NCCN; references updated.

3/2020annual_review

Annual review adding general NCCN recommendations for use criteria and updating references.

3/2021annual_review

Annual review adding NCCN-recommended criteria for infiltrative supratentorial astrocytoma/oligodendroglioma, distant metastatic uveal melanoma, and epithelial ovarian/fallopian tube/primary peritoneal cancer (persistent disease or low‑grade serous carcinoma recurrence); references updated.

3/2022annual_review

Annual review updating CNS cancer criteria and adding hepatobiliary cancer and histiocytic neoplasm indications per NCCN; background and references updated.

8/2022coverage_update

Updated background and coverage criteria to include a new indication for solid tumors with BRAF V600E mutation per the package insert.

5/2023coverage_update

Updated background and coverage criteria to add pediatric low‑grade glioma indication per prescribing information and added/updated NCCN‑aligned criteria for pancreatic and ampullary cancers and ovarian group indications.

5/2024coverage_update

Updated references and added coverage criteria for additional indications (source notes coverage additions; entry present in change history).

2025-04reference_updateLatest

References updated to cite Mekinist package insert (April 2025) and NCCN Compendium (accessed April 8, 2025); change history covers annual reviews from 2013 through 2025.