CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Mekinist (trametinib) — Drug Policy / Coverage Criteria

Defines accepted indications, exclusion criteria, and utilization management requirements for trametinib (Mekinist) for members of Neighborhood Health Plan of Rhode Island processed by Evolent UM.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyMekinist (trametinib) — Drug Policy / Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateMay 31, 2024

Next Review DateN/A

Key ActionSubmit authorization requests to Evolent Utilization Management with supporting FDA labeling or accepted compendia/guidelines.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

May 31, 2024policy effective date

2single dose max (mg)

120max monthly (0.5 mg)

12adjuvant melanoma max (months)

>=6 yrsminimum age (some indications)

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Low Grade Glioma

Covered when ALL of the following are met for Low Grade Glioma:

Low Grade Glioma: Mekinist (trametinib) used in combination with Tafinlar (dabrafenib) for members with low grade glioma that harbor a BRAF V600E mutation.

Chunk 4

Malignant Melanoma

Covered when ANY of the following are met for Malignant Melanoma:

Adjuvant melanoma: Mekinist (trametinib) in combination with Tafinlar (dabrafenib) as adjuvant treatment following complete resection for melanoma with BRAF V600E or V600K mutation.

Chunk 5

Unresectable/metastatic melanoma: Mekinist (trametinib) in combination with Tafinlar (dabrafenib) for members with unresectable or metastatic BRAF V600E or V600K mutation–positive melanoma.

Chunk 5

Non-Small Cell Lung Cancer (NSCLC)

Covered when ALL of the following are met for NSCLC:

NSCLC: Member has recurrent, advanced, or metastatic BRAF V600E mutation–positive non-small cell lung cancer and Mekinist (trametinib) is used in combination with Tafinlar (dabrafenib) as first-line therapy OR as subsequent therapy if anti‑BRAF targeted therapy was not previously used.

Chunk 5

Solid Tumors with BRAF V600E (excluding colorectal)

Covered when ALL of the following are met for other solid tumors (excluding colorectal cancer):

Solid tumors with BRAF V600E: Adult or pediatric members ≥ 6 years with unresectable or metastatic solid tumors (excluding colorectal cancer) harboring a BRAF V600E mutation when Mekinist (trametinib) is used in combination with Tafinlar (dabrafenib) as subsequent therapy.>=6 years

Chunk 5

Thyroid Carcinoma

Covered when ALL of the following are met for Thyroid Carcinoma:

Thyroid carcinoma: Mekinist (trametinib) in combination with Tafinlar (dabrafenib) for radioactive iodine–refractory (if radioactive iodine therapy was appropriate) locally advanced or metastatic BRAF V600E mutation–positive anaplastic, papillary, follicular, or Hurthle cell thyroid cancer.

Chunk 6

The following uses are excluded from coverage: tumors that are BRAF wild-type are not eligible for Mekinist (trametinib) therapy in this policy. For colorectal cancer, the presence of KRAS or NRAS mutations excludes use of Mekinist in combination with dabrafenib. Additionally, requests for indications that are investigational or off‑label and lack sufficient supporting evidence per this policy are excluded; insufficient evidence includes lack of representation of relevant patient or cancer characteristics, inadequate representation of the administered regimen, or outcomes that are not clinically meaningful as defined by accepted standards.

Therapy is excluded when there is disease progression while the member was taking any MEK inhibitor plus BRAF inhibitor combination. Continuation or re‑initiation in the setting of progression on a prior MEK+BRAF regimen is not covered.

Coverage does not apply when proposed dosing exceeds established limits. Specifically, dosing that exceeds a single dose of 2 mg or that exceeds the policy's monthly tablet limits is excluded. Also excluded is treatment that exceeds the maximum duration of 12 months when used as adjuvant therapy for melanoma following complete resection and regional lymph node dissection.

Use of Mekinist (trametinib) is considered investigational or not medically necessary when the available evidence does not meet the policy's standards. Insufficient evidence includes lack of adequate representation of the patient or tumor characteristics in published studies, inadequate description of the treatment regimen, study outcomes that are not clinically meaningful (for example, failing to meet accepted effect-size or survival thresholds), inappropriate experimental design for the question, reliance solely on uncontrolled case reports, or abstracts without a full peer‑reviewed publication.

Initial Therapy Indications

Initial coverage limited to the listed BRAF V600–mutated indications in combination with dabrafenib where specified:

Initial therapy: Mekinist (trametinib) used in combination with Tafinlar (dabrafenib) for FDA- or compendia-supported BRAF V600–mutated indications as listed (malignant melanoma [adjuvant and unresectable/metastatic], NSCLC, thyroid carcinoma, low grade glioma, and select solid tumors).

Chunks 4-6

Continuation and Renewal Criteria

The requested medication was used within the last year.

The member has not experienced disease progression and/or intolerance to the requested medication.

No additional medication(s) are being added to the continuation request:

Denial Risk

Provider Action — Triggers for Denial and Supporting Evidence Requirements

Provider action — do not assume continuation requests will be approved without documentation. If the continuation exemption conditions are not fully met, submit a prior authorization with complete supporting clinical evidence. Missing or insufficient documentation is a common cause for denial.

Include objective evidence of prior use (pharmacy claims, prescription records, or administration logs).
Include clinical notes addressing disease status and tolerance/adverse effects during the prior therapy period.
If adding any new medication(s), include justification for the change and documentation supporting medical necessity for the added agent(s).

Provider Actions and Authorization

Prior Authorization

Prior authorization processed by Evolent; final approval by UM Committee

Authorization requests for Mekinist are processed by Evolent Utilization Management; final approval is granted by the Utilization Management Committee. Evolent is responsible for processing all medication requests from network ordering providers and medications not authorized by Evolent may be deemed not approvable and not reimbursable.

Evolent UM processes medication requests
Final approval by the Utilization Management Committee
Medications not authorized by Evolent may be deemed not approvable and not reimbursable

Documentation Required

Required supporting evidence

Use must be supported by one of the following sources: FDA‑approved product labeling; CMS‑approved compendia; NCCN or ASCO clinical guidelines; or peer‑reviewed literature that meets the requirements of the CMS Medicare Benefit Policy Manual Chapter 15.

FDA‑approved product labeling
CMS‑approved compendia
NCCN or ASCO clinical guidelines
Peer‑reviewed literature meeting CMS Medicare Benefit Policy Manual Chapter 15 requirements

Denial Risk

Denial triggers and limit breaches

Requests may be denied for specified exclusion or threshold breaches, including BRAF wild‑type tumors, KRAS/NRAS mutations in colorectal cancer, disease progression on prior MEK+BRAF therapy, dosing or quantity exceedances, treatment beyond adjuvant duration limits, or investigational/off‑label uses lacking sufficient evidence.

BRAF wild‑type tumors
Presence of KRAS or NRAS mutations in colorectal cancer
Disease progression while on any MEK inhibitor + BRAF inhibitor combination
Single dose exceeds 2 mg
Exceeds monthly limits (30 tablets of 2 mg or 120 tablets of 0.5 mg)
Adjuvant melanoma treatment beyond 12 months
Investigational/off‑label indications without sufficient evidence per policy criteria

Revision History

May 31, 2024policy_effectiveLatest

Policy became effective for Mekinist (trametinib).

2024-05-08last_review

Clinical policy was last reviewed on 2024-05-08 by the UM committee prior to the May 31, 2024 effective date.

05/10/23committee_review

Policy was reviewed by the committee on 05/10/23.

04/12/23committee_review

Policy was reviewed by the committee on 04/12/23.

02/08/23committee_review

Policy was reviewed by the committee on 02/08/23.

08/10/22committee_review

Policy was reviewed by the committee on 08/10/22.

05/11/22committee_review

Policy was reviewed by the committee on 05/11/22.

11/15/21committee_review

Policy was reviewed by the committee on 11/15/21.

04/12/21committee_review

Policy was reviewed by the committee on 04/12/21.

11/11/20committee_review

Policy was reviewed by the committee on 11/11/20.

02/12/20committee_review

Policy was reviewed by the committee on 02/12/20.

04/07/16committee_review

Policy was reviewed by the committee on 04/07/16.

11/12/14committee_review

Policy was reviewed by the committee on 11/12/14.

10/06/14committee_review

Policy was reviewed by the committee on 10/06/14.

09/18/13committee_review

Policy was reviewed by the committee on 09/18/13.

OpenPayer

Mekinist (trametinib) — Drug Policy / Coverage Criteria

Coverage Criteria for Mekinist (trametinib)

Initial Therapy Criteria

Continuation and Renewal Criteria

Provider Actions and Authorization

Coding and Quantity Limits

Quantity Limit Summary

Definitions

Background

Revision History