CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Mekinist (trametinib) coverage and authorization criteria

Defines covered indications, documentation and authorization criteria (including FDA-approved and compendial uses) for Mekinist (trametinib), required BRAF mutation documentation, limits (e.g., not for colorectal cancer), and continuation/renewal conditions. Authorization periods are specified (typically 12 months) and many indications require combination with dabrafenib.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyMekinist (trametinib) coverage and authorization criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionSubmit BRAF mutation documentation to initiate prior authorization review for applicable indications.

POLICY UPDATE CHANGES

No material clinical/coverage changes - has_material_change=false.

12 monthsTypical authorization duration

BRAF V600E/V600KPrimary qualifying mutation(s)

>=1Minimum pediatric age

12Adjuvant melanoma max months

Coverage Summary & Covered Indications

Covered Indications (FDA-approved and Compendial)

The indications below including FDA-approved indications and compendial uses are considered a covered benefit provided that all the approval criteria are met, and the member has no exclusions to the prescribed therapy.

FDA-approved single-agent indication: Mekinist as a single agent in BRAF-inhibitor treatment-naïve patients for unresectable or metastatic melanoma with BRAF V600E or V600K mutations as detected by an FDA-approved test
FDA-approved combination with dabrafenib for melanoma: Mekinist in combination with dabrafenib for unresectable or metastatic melanoma with BRAF V600E or V600K mutations
FDA-approved combination with dabrafenib for adjuvant melanoma: Mekinist in combination with dabrafenib for adjuvant treatment of melanoma with BRAF V600E or V600K mutations with lymph node involvement following complete resection
FDA-approved combination with dabrafenib for NSCLC: Mekinist in combination with dabrafenib for metastatic non-small cell lung cancer (NSCLC) with BRAF V600E mutation
FDA-approved combination with dabrafenib for ATC: Mekinist in combination with dabrafenib for locally advanced or metastatic anaplastic thyroid cancer (ATC) with BRAF V600E mutation and no satisfactory locoregional treatment options
FDA-approved combination with dabrafenib for tumor-agnostic solid tumors: Mekinist in combination with dabrafenib for adult and pediatric patients ≥1 year with unresectable or metastatic solid tumors with BRAF V600E mutation who have progressed following prior treatment and have no satisfactory alternative treatment options
FDA-approved combination with dabrafenib for pediatric LGG: Mekinist in combination with dabrafenib for pediatric patients ≥1 year with low-grade glioma (LGG) with BRAF V600E mutation who require systemic therapy
Compendial uses including: melanoma (including brain metastases); glioma; meningioma; astrocytoma; uveal melanoma as single agent; brain cancer and neurofibromatosis type 1; NSCLC; ovarian/fallopian tube/primary peritoneal cancer; biliary tract cancers (gallbladder, extrahepatic cholangiocarcinoma, intrahepatic cholangiocarcinoma); histiocytic neoplasms (Erdheim-Chester disease, Langerhans cell histiocytosis, Rosai-Dorfman disease); anaplastic thyroid carcinoma; gastrointestinal stromal tumor; pancreatic adenocarcinoma; salivary gland tumor; gastric adenocarcinoma; esophageal and esophageal junction cancer; hairy cell leukemia; small bowel adenocarcinoma

Documentation requirement: BRAF mutation documentation must be submitted to initiate prior authorization review

Documentation & Prior Authorization Requirements

Prior Authorization

Prior authorization required with indication-specific criteria

Prior authorization is required; authorization of 12 months may be granted when the indication-specific criteria are met, including mutation status and combination therapy requirements. PA requires submission of the indication-specific criteria as listed in the policy; many covered indications require use in combination with dabrafenib and authorizations are typically for 12 months.

Documentation Required

Submit BRAF mutation documentation

BRAF mutation documentation must be submitted to initiate the prior authorization review for applicable indications.

Definition: BRAF V600 mutation — Activating mutation (e.g., V600E or V600K) detectable by an FDA‑approved test required for most covered indications.

Prior Authorization

Continuation renewal requirements

For continuation, authorize 12 months when there is no evidence of unacceptable toxicity or disease progression or recurrence while on the current regimen. For patients receiving Mekinist as adjuvant therapy for cutaneous melanoma, total therapy is limited to 12 months.

Documentation Required

Exclude colorectal cancer use

Do not authorize Mekinist for colorectal cancer; requests for colorectal cancer are excluded due to known intrinsic resistance to BRAF inhibition (denial risk if requested).

Indication-specific Authorization Criteria

Indication-specific Authorization Criteria (section III details)

Authorization of 12 months may be granted when specified criteria are met for each indication.

Melanoma

Authorized melanoma settings (any of the following)
- Unresectable or metastatic cutaneous melanoma when used either as single agent subsequent therapy for disease that is BRAF gene fusion- and non-V600 mutation-positive
- Combination therapy for unresectable or metastatic cutaneous melanoma: Unresectable or metastatic cutaneous melanoma in combination with dabrafenib with or without pembrolizumab for disease with a BRAF V600 activating mutation (e.g., V600E or V600K)
- Brain metastases from melanoma with a BRAF V600E activating mutation in combination with dabrafenib
- Neoadjuvant treatment for melanoma: Neoadjuvant treatment of BRAF V600 mutation-positive cutaneous melanoma in combination with dabrafenib if immunotherapy is contraindicated
- Adjuvant treatment of resected stage III melanoma: Adjuvant treatment of resected stage III cutaneous melanoma with a BRAF V600 activating mutation in combination with dabrafenib
- Limited resectable local satellite/in-transit recurrent disease with a BRAF V600 activating mutation in combination with dabrafenib
- Uveal melanoma single agent: Uveal melanoma as a single agent for metastatic or unresectable disease

Non-Small Cell Lung Cancer (NSCLC): BRAF V600E mutation-positive recurrent, advanced, or metastatic NSCLC in combination with dabrafenib when the member has not experienced disease progression on BRAF-targeted therapy12 months

Anaplastic Thyroid Cancer: BRAF V600E mutation-positive locally advanced or stage IV anaplastic thyroid carcinoma in combination with dabrafenib12 months

Central Nervous System Cancer

CNS tumor types
- Gliomas: BRAF V600 mutation-positive gliomas
- Meningiomas: BRAF V600 mutation-positive meningiomas
- Astrocytomas: BRAF V600 mutation-positive astrocytomas

Ovarian / Fallopian Tube / Primary Peritoneal Cancer: Persistent or recurrent epithelial ovarian cancer, fallopian tube cancer, primary peritoneal cancer, carcinosarcoma (malignant mixed Mullerian tumors), clear cell carcinoma of the ovary, grade 1 endometrioid carcinoma, low-grade serous ovarian carcinoma/ovarian borderline epithelial tumors (low malignant potential) or mucinous carcinoma of the ovary12 months

Biliary Tract Cancers: Subsequent treatment of progressive BRAF-V600E mutation-positive unresectable, resected gross residual (R2), or metastatic gallbladder cancer, extrahepatic cholangiocarcinoma, or intrahepatic cholangiocarcinoma in combination with dabrafenib12 months

Histiocytic Neoplasms: Erdheim-Chester disease, Langerhans cell histiocytosis, or Rosai-Dorfman disease as a single agent12 months

Solid Tumors (tumor-agnostic)

Tumor-agnostic criteria: Tumors are BRAF V600E mutation positive
Progression and alternatives: Disease has progressed following prior treatment and there are no satisfactory alternative treatment options
Age requirement: Member is 1 year of age or older>= 1 year
Exclude colorectal cancer: Requested medication will not be used for the treatment of colorectal cancer
Combination requirement:

Gastrointestinal Stromal Tumor (GIST): Neoadjuvant therapy for BRAF V600E mutation-positive GIST in combination with dabrafenib; or first-line therapy for gross residual disease (R2 resection), unresectable primary disease, tumor rupture or recurrent/metastatic disease for BRAF V600E mutation-positive GIST in combination with dabrafenib12 months

Pancreatic Adenocarcinoma: BRAF V600E mutation-positive recurrent, locally advanced, or metastatic pancreatic adenocarcinoma in combination with dabrafenib12 months

Salivary Gland Tumors: BRAF V600E mutation-positive recurrent salivary gland tumor in combination with dabrafenib12 months

Gastric / Esophageal / Esophagogastric Junction Cancer: Subsequent treatment of BRAF V600E mutation-positive unresectable locally advanced, recurrent, or metastatic disease or for members who are not surgical candidates, in combination with dabrafenib12 months

Hairy Cell Leukemia: Relapsed/refractory hairy cell leukemia in combination with dabrafenib if not previously treated with BRAF inhibitor therapy12 months

Small Bowel Adenocarcinoma: BRAF V600E mutation-positive advanced or metastatic small bowel adenocarcinoma in combination with dabrafenib12 months

Background, Evidence & Definitions

Background: Mekinist (trametinib) is a MEK inhibitor with FDA‑approved indications for treatment of multiple malignancies harboring BRAF V600 activating mutations (for example, V600E or V600K). FDA approvals include use as a single agent or in combination with dabrafenib for unresectable or metastatic melanoma and multiple tumor‑type and tumor‑agnostic indications; many indications are defined for use in combination with dabrafenib. This policy aligns coverage with FDA labeling and compendial (NCCN) uses and requires mutation documentation for prior authorization.

Source	Citation
Package insert	Mekinist [package insert], Novartis; August 2023
Compendium	NCCN Drugs & Biologics Compendium, 2024

Definitions: BRAF V600 mutation — an activating mutation (e.g., V600E or V600K) detectable by an FDA‑approved test and required documentation for most covered indications.

OpenPayer

Mekinist (trametinib) coverage and authorization criteria

Coverage Summary & Covered Indications

Documentation & Prior Authorization Requirements

Indication-specific Authorization Criteria

Limitations of Use & Exclusions

Continuation Therapy Criteria

Codes & Policy Identifiers

Background, Evidence & Definitions

Key Policy Parameters

Revision History