CurrentUnitedHealthcarePolicy 2025 P 1062-16

Mekinist (trametinib) prior authorization / coverage criteria

UnitedHealthcare prior authorization/notification policy for Mekinist (trametinib) specifying initial and reauthorization clinical criteria across multiple oncologic indications (including combination use with Tafinlar/dabrafenib), pediatric processing under age 19, and NCCN-recommended uses. Effective for pharmacy clinical programs and includes supply/automation notes.

Policy Summary

PayerUnitedHealthcare

PolicyMekinist (trametinib) prior authorization / coverage criteria

Policy CodePolicy 2025 P 1062-16

Change TypeAnnual reviewcriteria updates

Effective DateAug 1, 2025

Next Review Date

Key ActionPrior authorization/notification is required for Mekinist; authorization is typically issued for 12 months when criteria are met.

SourceLink

POLICY UPDATE CHANGES

Annual review and background/reference updates through 5/2025; added coverage criteria for hairy cell leukemia, salivary gland tumor, and GIST per NCCN.

Effective date set to 8/1/2025.

12 monthsTypical authorization duration

ManyCovered indications

Auto-processUnder 19 processing

Coverage Summary

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This prior authorization policy for Mekinist (trametinib) is effective 8/1/2025 and is a UnitedHealthcare Pharmacy Clinical Pharmacy Program that covers multiple oncology indications with criteria. The policy stance is covered_with_criteria and authorizations are typically issued for 12 months when criteria are met. The policy scope includes single-agent use and combination use with Tafinlar (dabrafenib), pediatric automatic processing for members under 19 years (prescriptions auto-process without coverage review), and NCCN-recognized regimen expansions.

Key policy facts

Policy number2025 P 1062-16

Effective date2025-08-01

Last review2025-05

Typical authorization duration12 months

Under-19 processingPrescriptions automatically process without coverage review; authorization issued for 12 months

Initial Therapy Criteria

Pediatric auto-processing

For members under the age of 19 years, the prescription will automatically process without a coverage review. Authorization will be issued for 12 months.

Patient is less than 19 years of age

Melanoma - Initial Authorization

Mekinist (trametinib) used for melanoma will be approved when criteria below are met. Authorization will be issued for 12 months.

ANY of the following

Combination therapy for cutaneous/unresectable/metastatic melanoma
- Diagnosis of unresectable or metastatic melanoma
- Used in combination with Tafinlar (dabrafenib)
- Cancer is positive for BRAF V600E or BRAF V600K mutation
Adjuvant therapy for melanoma involving lymph nodes
- Prescribed as adjuvant therapy for melanoma involving the lymph node(s)
- Used in combination with Tafinlar (dabrafenib)
- Cancer is positive for BRAF V600E or BRAF V600K mutation
Distant metastatic uveal melanoma
- Distant metastatic uveal melanoma

ALL of the following

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

ALL of the following

Note: When required by this branch, BRAF mutation must be detected by an FDA-approved test
Authorization duration: 12 months

Non-Small Cell Lung Cancer (NSCLC) - Initial Authorization

Mekinist in combination with Tafinlar (dabrafenib) for non-small cell lung cancer (NSCLC) will be approved when criteria below are met. Authorization will be issued for 12 months.

ALL of the following

Diagnosis of non-small cell lung cancer (NSCLC)
Cancer is positive for BRAF V600E mutation
Used in combination with Tafinlar (dabrafenib)
Authorization duration: 12 months

ALL of the following

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

Anaplastic Thyroid Cancer (ATC) - Initial Authorization

Mekinist in combination with Tafinlar (dabrafenib) for anaplastic thyroid cancer (ATC) will be approved when criteria below are met. Authorization will be issued for 12 months.

ALL of the following

Diagnosis of anaplastic thyroid cancer (ATC)
Cancer is positive for BRAF V600E mutation
Disease is one of: metastatic, locally advanced, or unresectable; OR prescribed as adjuvant therapy following resection
Used in combination with Tafinlar (dabrafenib)
Authorization duration: 12 months

ALL of the following

Thyroid carcinomas and related - Initial Authorization

Mekinist in combination with Tafinlar (dabrafenib) for follicular, oncocytic, and papillary thyroid carcinomas and related disease will be approved when criteria below are met. Authorization will be issued for 12 months.

ALL of the following

Diagnosis of follicular, oncocytic, or papillary thyroid carcinoma
One of the following disease states: unresectable locoregional recurrent disease, persistent disease, or metastatic disease
One of the following clinical statuses: symptomatic disease OR progressive disease
Disease is refractory to radioactive iodine treatment
Cancer is positive for BRAF V600E mutation

Brain metastases / CNS cancers - Initial Authorization

Mekinist in combination with Tafinlar (dabrafenib) for brain metastases / CNS cancers related to melanoma will be approved when criteria below are met. Authorization will be issued for 12 months.

ANY of the following

Metastatic brain lesions from melanoma
- Patient has metastatic brain lesions
- Mekinist is active against the primary tumor (melanoma)
- Cancer is positive for BRAF V600E mutation when required
- Used in combination with Tafinlar (dabrafenib)
Primary CNS tumor with BRAF V600E

Epithelial Ovarian / Fallopian Tube / Primary Peritoneal Cancer - Initial Authorization

Mekinist in combination with Tafinlar (dabrafenib) for epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer will be approved when criteria below are met. Authorization will be issued for 12 months.

ALL of the following

Diagnosis of epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer
One of the following disease states: persistent disease, recurrence of low-grade serous carcinoma, or recurrence in BRAF V600E positive tumors
Authorization duration: 12 months

ALL of the following

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

Hepatobiliary Cancers - Initial Authorization

Mekinist in combination with Tafinlar (dabrafenib) for hepatobiliary cancers will be approved when criteria below are met. Authorization will be issued for 12 months.

ALL of the following

Diagnosis of gallbladder cancer, intrahepatic cholangiocarcinoma, or extrahepatic 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)

Histiocytic Neoplasms - Initial Authorization

Mekinist (trametinib) for histiocytic neoplasms (Langerhans Cell Histiocytosis, Erdheim-Chester Disease, Rosai-Dorfman Disease) will be approved when criteria below are met. Authorization will be issued for 12 months.

ALL of the following

Diagnosis of one of: Langerhans Cell Histiocytosis, Erdheim-Chester Disease, or Rosai-Dorfman Disease
Presence of a MAP kinase pathway mutation, OR no detectable mutation or testing not available
Authorization duration: 12 months

ALL of the following

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

Solid tumor with BRAF V600E mutation - Initial Authorization (tumor-agnostic)

Mekinist in combination with Tafinlar (dabrafenib) for solid tumors with BRAF V600E mutation (tumor-agnostic), including pancreatic and ampullary adenocarcinoma, will be approved when criteria below are met. Authorization will be issued for 12 months.

ALL of the following

Presence of an unresectable or metastatic solid tumor
Used as subsequent treatment after progression on or after systemic treatment
Cancer is positive for BRAF V600E mutation
Used in combination with Tafinlar (dabrafenib)
Authorization duration: 12 months

Pancreatic and Ampullary Adenocarcinoma; Hairy Cell Leukemia; Salivary Gland Tumor - Initial Authorization

Mekinist in combination with Tafinlar (dabrafenib) for hematologic and other tumors (hairy cell leukemia, salivary gland tumor) will be approved when criteria below are met. Authorization will be issued for 12 months.

Hairy Cell Leukemia

Diagnosis of hairy cell leukemia
Used in combination with Tafinlar (dabrafenib)
Authorization duration: 12 months

Salivary Gland Tumor

Diagnosis of salivary gland tumor

NCCN Recommended Regimens

The drug has been recognized for treatment of the cancer indication by the National Comprehensive Cancer Network (NCCN) Drugs & Biologics Compendium with a Category of Evidence and Consensus of 1, 2A, or 2B. Authorization will be issued for 12 months. State mandates, federal requirements, and member-specific benefit plan coverage may affect applicability.

NCCN recognition: Category 1, 2A, or 2B for the specified cancer indication(s).

Authorization duration: 12 months when NCCN recognition criteria are met.

Continuation / Reauthorization Criteria

GIST - Reauthorization

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

Authorization will be issued for 12 months.

Exclusions / Limitations

Coverage is limited by indication-specific requirements and exclusions: most covered indications require documentation of an oncogenic BRAF V600E mutation (detected by an FDA‑approved test) and many approvals are limited to unresectable or metastatic disease or to settings after progression on prior systemic therapy. Several uses require combination therapy with Tafinlar (dabrafenib). Some tumor-agnostic and other approvals were granted under accelerated approval pathways and may have indication‑specific constraints and confirmatory trial requirements. Definitions note that detection of the BRAF V600E mutation is required for most covered indications per policy.

Applicable Codes

ICD-10 Diagnoses referenced (general: oncology diagnoses listed in criteria)ICD-10

Placeholder - populate relevant ICD-10 diagnosis codes corresponding to the oncology indications listed in the coverage criteria (e.g., melanoma, NSCLC, anaplastic thyroid cancer, thyroid carcinomas, CNS metastases, epithelial ovarian/fallopian tube/primary peritoneal cancer, hepatobiliary cancers, histiocytic neoplasms, pancreatic/ampullary adenocarcinoma, hairy cell leukemia, salivary gland tumor, GIST, tumor-agnostic solid tumors with BRAF V600E mutation).

NDC / HCPCS / CPT (not specified in document)mixed

Placeholder - populate NDC, HCPCS, and/or CPT codes for Mekinist (trametinib) and related administration or billing codes if available (document does not specify codes).

Provider Actions

Prior Authorization

Prior authorization required

Prior authorization/notification is required for Mekinist per UnitedHealthcare Pharmacy Clinical Pharmacy Programs. When criteria are met, authorization is typically issued for 12 months.

Documentation Required

BRAF V600E mutation documentation

Coverage generally requires documentation that the cancer is positive for the BRAF V600E mutation as detected by an FDA‑approved test when specified in the indication. Use the FDA‑approved test results in the patient record to support approval.

Documentation Required

Evidence of non-progression for reauthorization

For reauthorization across indications, documentation must show the patient does not have evidence of progressive disease while on Mekinist therapy; reauthorizations are issued for 12 months when this criterion is met.

Prior Authorization

Pediatric automatic processing under 19

For members under age 19, prescriptions will automatically process without a coverage review and authorization will be issued for 12 months.

Billing Rule

Supply limits and automated approvals

Supply limits may be in place. UnitedHealthcare may approve initial authorization and reauthorization based solely on prior claims/medication history, diagnosis codes (ICD‑10), and/or claim logic via automated processes — authorizations may be approved through these automated processes.

Clinical Evidence & References

Evidence sources cited in the policy include the Mekinist package insert (Novartis), April 2025 and the NCCN Drugs & Biologics Compendium (accessed April 2025). The package insert supports FDA‑approved indications and the tumor‑agnostic accelerated approval based on response rate and duration of response; the NCCN compendium provides expanded, evidence‑and‑consensus–based recommended regimens that the policy references for additional covered uses.

Background

Background: Mekinist (trametinib) is a mitogen‑activated protein kinase kinase (MEK) inhibitor (kinase inhibitor) indicated as a single agent or in combination with Tafinlar (dabrafenib) for multiple BRAF V600 mutation‑positive malignancies. Labeled indications include unresectable or metastatic melanoma (BRAF V600E or V600K), metastatic NSCLC with BRAF V600E (in combination with dabrafenib), adjuvant treatment of melanoma with BRAF V600 mutations involving lymph nodes following resection, locally advanced or metastatic anaplastic thyroid cancer with BRAF V600E mutation when no satisfactory locoregional options exist, pediatric and adult unresectable or metastatic solid tumors with BRAF V600E mutation (accelerated approval for some tumor‑agnostic indications), and pediatric low‑grade glioma with BRAF V600E (in combination with dabrafenib). The NCCN Drugs & Biologics Compendium further expands recommended uses across additional tumor types and settings, which the policy incorporates for coverage decisions.

Definitions

BRAF V600E mutationOncogenic mutation in the BRAF gene detected by an FDA-approved test; required for most covered indications per policy

Revision History

2025-05annual_review_and_referencesLatest

Annual review and background/reference updates through 5/2025; added coverage criteria for hairy cell leukemia, salivary gland tumor, and GIST per NCCN.

2025-08-01program_effective_date

Program effective date set to 8/1/2025 (non-material program effective date).

Policy Summary

PayerUnitedHealthcare

PolicyMekinist (trametinib) prior authorization / coverage criteria

Policy CodePolicy 2025 P 1062-16

Change TypeAnnual reviewcriteria updates

Effective DateAug 1, 2025

Next Review Date

Key ActionPrior authorization/notification is required for Mekinist; authorization is typically issued for 12 months when criteria are met.

SourceLink

On This Page

Authorization duration: 12 months

Reauthorization: Patient does not show evidence of progressive disease while on Mekinist therapy
Authorization duration: 12 months

Used in combination with Tafinlar (dabrafenib)

Authorization duration: 12 months

ALL of the following

Reauthorization: Patient does not show evidence of progressive disease while on Mekinist therapy
Authorization duration: 12 months

Diagnosis of a primary CNS tumor (e.g., infiltrative supratentorial astrocytoma/oligodendroglioma)

Cancer is positive for BRAF V600E mutation

Used in combination with Tafinlar (dabrafenib)

ALL of the following

Reauthorization: Patient does not show evidence of progressive disease while on Mekinist therapy
Authorization duration: 12 months

Authorization duration: 12 months

ALL of the following

Reauthorization: Patient does not show evidence of progressive disease while on Mekinist therapy
Authorization duration: 12 months

Authorization duration: 12 months

Pancreatic / Ampullary specific

Diagnosis of pancreatic adenocarcinoma or ampullary adenocarcinoma
Disease is metastatic, locally advanced, or unresectable
Cancer is positive for BRAF V600E mutation
Used in combination with Tafinlar (dabrafenib)
Authorization duration: 12 months

Disease is recurrent and unresectable or metastatic

Cancer is positive for BRAF V600E mutation

Used in combination with Tafinlar (dabrafenib)

Authorization duration: 12 months

ALL of the following

Reauthorization: Patient does not show evidence of progressive disease while on Mekinist therapy
Authorization duration: 12 months