Centene trametinib Coverage Update: Prior Auth

Coverage Criteria

Initial Therapy: Melanoma

Covered when ALL of the following are met

Melanoma initial therapy: 1. Diagnosis of melanoma with BRAF V600E or V600K mutation; 2. Disease is unresectable, limited resectable, or metastatic, OR presence of lymph node involvement following complete resection; 3. Prescribed by or in consultation with an oncologist; 4. Age ≥ 18 years; 5. Use generic trametinib if available unless contraindicated or clinically significant adverse effects are experienced; 6. Request meets one of the following: a) Dose does not exceed both 2 mg per day AND 3 tablets per day, OR b) Dose is supported by practice guidelines or peer‑reviewed literature (prescriber must submit supporting evidence); 7. Prescribed regimen must be FDA‑approved or recommended by NCCN.

All conditions required

Initial Therapy: Non-Small Cell Lung Cancer

Covered when ALL of the following are met

NSCLC initial therapy: 1. Diagnosis of advanced, metastatic, or recurrent non‑small cell lung cancer (NSCLC); 2. Prescribed by or in consultation with an oncologist; 3. Age ≥ 18 years; 4. Disease positive for BRAF V600E mutation; 5. Prescribed in combination with Tafinlar (dabrafenib) — prior authorization for Tafinlar may be required; 6. Use generic trametinib if available unless contraindicated or clinically significant adverse effects are experienced; 7. Request meets one of the following: a) Dose does not exceed both 2 mg per day AND 3 tablets per day, OR b) Dose is supported by practice guidelines or peer‑reviewed literature (prescriber must submit supporting evidence); 8. Prescribed regimen must be FDA‑approved or recommended by NCCN.

All conditions required

Initial Therapy: Anaplastic Thyroid Cancer

Covered when ALL of the following are met

Anaplastic thyroid cancer initial therapy: 1. Diagnosis of advanced or metastatic anaplastic thyroid cancer (ATC); 2. Prescribed by or in consultation with an oncologist; 3. Age ≥ 18 years; 4. Disease positive for BRAF V600E mutation; 5. Prescribed in combination with Tafinlar (dabrafenib) — prior authorization for Tafinlar may be required; 6. Use generic trametinib if available unless contraindicated or clinically significant adverse effects are experienced; 7. Request meets one of the following: a) Dose does not exceed both 2 mg per day AND 3 tablets per day, OR b) Dose is supported by practice guidelines or peer‑reviewed literature (prescriber must submit supporting evidence); 8. Prescribed regimen must be FDA‑approved or recommended by NCCN.

All conditions required

Initial Therapy: BRAF V600E Mutation-Positive Solid Tumor

Covered when ALL of the following are met

BRAF V600E mutation-positive solid tumor: 1. Diagnosis of a solid tumor positive for BRAF V600E mutation (see policy Appendix for examples); 2. Prescribed by or in consultation with an oncologist; 3. Age ≥ 1 year; 4. Request meets one of the following: a) Disease is unresectable or metastatic AND has progressed on prior treatment with no satisfactory alternative treatment options, OR b) Prescribed for an NCCN category 2A or higher supported indication (listed tumor types in policy); 5. For follicular and papillary thyroid carcinoma: disease is not amenable to radioactive iodine therapy; 6. For adult circumscribed glioma: may be prescribed as single agent or in combination with Tafinlar; for most other indications, prescribe in combination with Tafinlar (prior authorization for Tafinlar may be required); 7. For Mekinist requests, use generic trametinib if available unless contraindicated or clinically significant adverse effects are experienced; 8. For pediatric members, documentation of current body weight (kg) is required; 9. Request meets one of the following dosing conditions: a) Adults: dose does not exceed both 2 mg per day AND 3 tablets per day; b) Pediatric: dose does not exceed FDA‑approved maximum recommended dose per Section V; OR c) Dose is supported by practice guidelines or peer‑reviewed literature (prescriber must submit supporting evidence); 10. Prescribed regimen must be FDA‑approved or recommended by NCCN.

All conditions required

Initial Therapy: Pediatric Low-Grade Glioma

Covered when ALL of the following are met

Pediatric LGG initial therapy: 1. Diagnosis of low‑grade glioma (WHO grade 1 or 2); 2. Prescribed by or in consultation with an oncologist; 3. Age 1 to <18 years; 4. Disease positive for BRAF V600E mutation; 5. Prescribed in combination with Tafinlar (dabrafenib) — prior authorization for Tafinlar may be required; 6. Use generic trametinib if available unless contraindicated or clinically significant adverse effects are experienced; 7. Documentation of member's current body weight in kilograms required; 8. Request meets one of the following: a) Dose does not exceed the FDA‑approved maximum recommended dose for pediatric patients (see Section V), OR b) Dose is supported by practice guidelines or peer‑reviewed literature (prescriber must submit supporting evidence); 9. Prescribed regimen must be FDA‑approved or recommended by NCCN.

All conditions required

Initial Therapy: Off-Label NCCN Compendium Indications

Covered when ALL of the following are met

Off-label NCCN compendium recommended indications: 1. Diagnosis of one of the listed NCCN‑recommended off‑label indications (examples include histiocytic neoplasms positive for MAP kinase pathway mutation or without detectable mutation, pediatric LCH CNS neurodegeneration, hairy cell leukemia, recurrent low‑grade serous carcinoma, metastatic uveal melanoma, metastatic or unresectable melanoma with BRAF gene fusion/non‑V600 mutations, epithelioid hemangioendothelioma); 2. Prescribed by or in consultation with the appropriate specialist (hematologist/oncologist for histiocytic neoplasms or hairy cell leukemia; oncologist for other indications); 3. Age ≥ 18 years except where pediatric LCH exceptions apply; 4. For hairy cell leukemia, prescribed in combination with Tafinlar; for other indications, prescribed as single agent unless policy specifies combination; 5. Use generic trametinib if available unless contraindicated or clinically significant adverse effects are experienced; 6. Request meets one of the following: a) Dose does not exceed both 2 mg per day AND 3 tablets per day, OR b) Dose is supported by practice guidelines or peer‑reviewed literature (prescriber must submit supporting evidence); 7. Prescribed regimen must be FDA‑approved or recommended by NCCN.

All conditions required

Continuation Therapy

Covered for renewal when ALL of the following are met

Continuation therapy: 1. Member is currently receiving Mekinist via the Centene benefit or documentation supports member has received Mekinist for at least 30 days; 2. Member is responding positively to therapy; 3. Use generic trametinib if available unless contraindicated or clinically significant adverse effects are experienced; 4. For pediatric members, documentation of current body weight (kg) is provided; 5. If request is for a dose increase, new dose must meet one of the following: a) Adults: dose does not exceed both 2 mg per day AND 3 tablets per day; b) Pediatric members: dose does not exceed FDA‑approved maximum per Section V; OR c) New dose is supported by practice guidelines or peer‑reviewed literature (prescriber must submit supporting evidence); 6. Prescribed regimen must be FDA‑approved or recommended by NCCN.

All conditions required

Initial/Continuation Criteria

Covered when ALL of the following are met:

Continued therapy and response: Member is currently receiving medication via Centene benefit or documentation supports current use for at least 30 days30 days

See policy for documentation requirements

Clinical response: Member is responding positively to therapy

Generic use: Member must use generic trametinib if available unless contraindicated or adverse effects

Pediatric documentation: For pediatric members, submit current body weight in kg

Mekinist (trametinib) is not indicated for the treatment of patients with colorectal cancer due to known intrinsic resistance to BRAF inhibition. This limitation of use is specified in the FDA‑approved labeling and is applied as an exclusion in coverage determinations.

Non‑FDA approved indications that are not specifically addressed in this policy are excluded from coverage unless the provider supplies sufficient documentation of efficacy and safety consistent with the applicable off‑label use policies: CP.CPA.09 (Commercial), HIM.PA.154 (Health Insurance Marketplace/ICHRA), or CP.PMN.53 (Medicaid), or there is contrary evidence of coverage in plan documents.

When state Medicaid coverage provisions conflict with this clinical policy for Medicaid members, the state Medicaid coverage provisions take precedence. Providers should consult the applicable state Medicaid manual for any state‑specific coverage rules that supersede this policy.

Use of Mekinist for indications that are non‑FDA approved and lack sufficient supporting evidence per the referenced off‑label use policies is considered not authorized and will not be covered under this policy.

Initial Therapy Criteria

Initial Therapy Overview

Initial authorization criteria per indication group

Initial therapy groups: See individual criteria sets for melanoma, NSCLC, anaplastic thyroid cancer, BRAF V600E solid tumors, pediatric low‑grade glioma, and NCCN off‑label indications; all require oncologist involvement, appropriate mutation testing, age‑specific limits, generic‑first use, dosing limits (typically 2 mg/day and 3 tablets/day for adults) or guideline‑supported dosing, and regimen must be FDA‑approved or NCCN‑recommended.

Initial Therapy

Initial therapy coverage conditions

Initial therapy prerequisites: Member is starting or currently receiving Mekinist for a covered indication; prescriber must follow FDA‑approved or NCCN‑recommended regimen; approvals and dosing must adhere to policy maxima unless supported by guidelines or literature

See Sections I and V for indication‑specific requirements

Continuation / Renewal Criteria

Continuation Therapy

Renewal/Continuation criteria

Renewal requirements: Member currently receiving Mekinist for a covered indication for ≥30 days; member responding positively to therapy; generic trametinib used if available unless contraindicated; pediatric weight documented; dose increases limited to specified maximums (adults: 2 mg/day and 3 tablets/day; pediatric per FDA max) or supported by practice guidelines/peer‑reviewed literature.

All conditions required

Continuation Therapy

Continuation requires ongoing clinical benefit and adherence to dosing maxima; approvals issued for standard durations.

Ongoing therapy: Member is responding and has been on therapy (≥30 days) or currently receiving via Centene benefit; approvals issued for up to 12 months for Medicaid/HIM/ICHRA and up to 12 months or duration of request for commercial30 days

Coding and Related Policies

Referenced policy cross-links (no billing codes present in this section)mixed

No codes listed

Maximum dose — 2 mg/day

Maximum daily dose2 mg/day

Tablet limit (adults)3 tablets per day

Applies toAll adult indications unless pediatric FDA maxima apply

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for Mekinist (trametinib). Requests for combination therapy with dabrafenib (Tafinlar) may require separate prior authorization for Tafinlar.

Prior authorization required for Mekinist.
Combination therapy with dabrafenib (Tafinlar) may require separate prior authorization.

Prior Authorization

Prior Authorization — Continuation Criteria

Prior authorization requests must document that the member is currently receiving Mekinist via the Centene benefit or has received Mekinist for at least 30 days and is responding positively to therapy for continuation approvals.

Member currently receiving Mekinist via Centene benefit, or documentation of at least 30 days of therapy.
Member demonstrating positive response to therapy.

Step Therapy Requirements

Step	Requirement	Notes
1	Use generic trametinib as the first step if available	Generic-first requirement applies unless contraindicated or clinically significant adverse effects are experienced
Exception	Do not require generic trametinib when contraindication or clinically significant adverse effects are documented	Provider must submit supporting clinical documentation of contraindication or adverse effects

Step	Requirement	Notes
1	Prescribed regimen must be FDA-approved or recommended by NCCN	Applies to initial and continuation requests; regimen selection should align with FDA labeling or NCCN recommendations
2	Off‑label uses require adherence to off‑label policies and submission of supporting evidence	Prescriber must provide practice‑guideline or peer‑reviewed literature support when dose or regimen deviates from FDA/NCCN guidance

Quantity Limits and Product Availability

inv-38: Trametinib — 2 mg

DrugTrametinib

Standard adult dosing2 mg (1 tablet) PO QD

Role in therapyUsed as monotherapy for certain melanoma indications and in combination with dabrafenib for multiple indications

inv-39: Trametinib — 3

Tablet maximum (numeric)3 tablets/day

Equivalent mg limitSubject to 2 mg/day maximum mg limit (adults)

Use noteDose increases must not exceed this tablet limit unless supported by guidelines or literature

Background

Trametinib (Mekinist) is a MEK kinase inhibitor with FDA approvals for multiple BRAF V600 mutation–positive indications. Approved uses include single‑agent therapy for unresectable or metastatic melanoma with BRAF V600E or V600K mutations and combination therapy with dabrafenib (Tafinlar) for melanoma (including adjuvant), metastatic NSCLC with BRAF V600E, locally advanced or metastatic anaplastic thyroid cancer with BRAF V600E when no satisfactory locoregional options exist, and treatment of adult and pediatric patients aged ≥1 year with unresectable or metastatic BRAF V600E mutation‑positive solid tumors after prior therapy. Mekinist is also approved for pediatric low‑grade glioma (LGG) with BRAF V600E who require systemic therapy. The product labeling includes a limitation noting that Mekinist is not indicated for colorectal cancer because of intrinsic resistance to BRAF inhibition.

Definitions

inv-28: Mekinist — Trametinib (Mekinist): a kinase inhibitor

Generic nameTrametinib (Mekinist)

Drug classKinase inhibitor (MEK inhibitor)

FDA approvalsMultiple indications including melanoma, NSCLC, ATC, and certain pediatric solid tumors

inv-29: low-grade glioma — LGG

TermLow-grade glioma (LGG)

AbbreviationLGG

ContextReferenced for pediatric indications (patients ≥1 year) in policy Appendix/criteria

Site of Care

Note

No site‑of‑care restrictions specified

No site‑of‑care restrictions are specified for Mekinist in this policy.

OpenPayer

Trametinib (Mekinist) coverage

Coverage Criteria

Initial Therapy Criteria

Continuation / Renewal Criteria

Coding and Related Policies

Provider Actions and Requirements

Step Therapy Requirements

Quantity Limits and Product Availability

Background

Definitions

Site of Care