CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Mekinist™ (trametinib)

Defines clinical inclusion and exclusion criteria, continuation rules, dosing limits, and acceptable evidence for coverage of Mekinist (trametinib), typically in combination with dabrafenib (Tafinlar), across specified malignancies for members of Neighborhood Health Plan of Rhode Island.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyMekinist™ (trametinib)

Policy CodePolicy N/A

Change Typeclarified

Effective DateMay 31, 2024

Next Review Date

Key ActionSubmit prior authorization requests supported by FDA labeling, CMS-recognized compendia, NCCN/ASCO guidelines, or acceptable peer-reviewed literature per CMS Medicare Benefit Policy Manual Chapter 15.

POLICY UPDATE CHANGES

Policy effective date set to May 31, 2024 and committee approval dated May 08, 2024; clinical coverage statements list approved indications and exclusions.

6Covered Indications (listed)

7Exclusion Criteria (listed)

3Pediatric age thresholds referenced

Coverage Summary

Scope: This policy for Neighborhood Health Plan of Rhode Island defines clinical inclusion/exclusion criteria and continuity rules for Mekinist (trametinib), which is covered with criteria and is typically used in combination with dabrafenib (Tafinlar). Coverage requires indication- and age-specific criteria (e.g., low grade glioma in patients >= 1 year, solid tumors >= 6 years, melanoma, NSCLC, thyroid carcinoma) and adherence to dosing/quantity limits. Acceptable evidence to support use includes FDA labeling, CMS-recognized compendia, NCCN/ASCO guidelines, or peer-reviewed literature meeting CMS Chapter 15 and ASCO clinically meaningful outcomes and requests are processed by Evolent on behalf of the payer.

Provider Actions & Authorization Requirements

Prior Authorization

Prior authorization required

Evolent (on behalf of the payer) processes medication requests for Mekinist (trametinib). Prior authorization is required; medications not authorized by Evolent may be denied and not reimbursable. Requests must be supported by FDA-approved product labeling, CMS-recognized compendia, NCCN or ASCO clinical guidelines, or peer-reviewed literature that meets the requirements of the CMS Medicare Benefit Policy Manual Chapter 15.

Documentation Required

Documentation of mutation status required

Requestors must supply evidence of relevant mutation status when required by the indication. Provide documentation of BRAF V600E or V600K mutation for indications that require it (e.g., melanoma, NSCLC, thyroid carcinoma, low-grade glioma, unresectable/metastatic solid tumors) and provide evidence of KRAS or NRAS mutation when needed to exclude colorectal cancer.

Melanoma (adjuvant or unresectable/metastatic) — BRAF V600E or V600K
Non-Small Cell Lung Cancer (NSCLC) — BRAF V600E
Thyroid carcinoma — BRAF V600E
Low-grade glioma — BRAF V600E
Unresectable/metastatic solid tumors (excluding colorectal cancer) — BRAF V600E

Billing Rule

Adhere to dosing and quantity limits

Adhere to the specified dosing and quantity limits. Claims exceeding these limits may be excluded per policy.

Single dose limit: 2 mg
Monthly tablet limits: 30 tablets (2 mg strength) OR 120 tablets (0.5 mg strength) per month
Adjuvant melanoma maximum duration: 12 months

Clinical Evidence & References

Evidence and background: Primary references cited include the Mekinist prescribing information (Novartis 2024), key clinical studies such as COMBI-v (Robert et al.), and guideline sources including NCCN. The policy’s evidence standard requires support from FDA labeling, CMS-recognized compendia, NCCN/ASCO clinical guidelines, or peer-reviewed literature that meets requirements of the CMS Medicare Benefit Policy Manual Chapter 15 and uses ASCO definitions for clinically meaningful outcomes.

Definitions

Definitions: Sufficient evidence — evidence supported by FDA labeling, CMS-recognized compendia, NCCN/ASCO guidelines, or peer-reviewed literature that meets CMS Medicare Benefit Policy Manual Chapter 15 requirements, including clinically meaningful outcomes per ASCO (for example, hazard ratio < 0.80 and recommended survival benefit thresholds).

Revision History

2024-05-08approval

Committee approval dated May 08, 2024; no explicit clinical changes called out (policy lists approved indications and exclusions).

2024-05-31effectiveLatest

Policy effective date set to May 31, 2024; no explicit clinical changes called out (clinical coverage statements list approved indications and exclusions).

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyMekinist™ (trametinib)

Policy CodePolicy N/A

Change Typeclarified

Effective DateMay 31, 2024

Next Review Date

On This Page

OpenPayer

Mekinist™ (trametinib)

Coverage Summary

Approved Indications / Initial Therapy Criteria

Continuation Therapy Criteria

Exclusion Criteria / Investigational Uses

Provider Actions & Authorization Requirements

Applicable Codes

Clinical Evidence & References

Definitions

Revision History