CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Tepmetko (tepotinib) — coverage criteria for MET exon 14 skipping NSCLC

Defines medical necessity and authorization requirements for tepotinib (Tepmetko) for adult members with metastatic or locally advanced non-small cell lung cancer (NSCLC) harboring MET exon 14 skipping mutation; applies to medication requests processed by Evolent for Neighborhood Health Plan of Rhode Island lines of business listed.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyTepmetko (tepotinib) — coverage criteria for MET exon 14 skipping NSCLC

Policy CodePolicy N/A

Change TypeTemplate conversionidentifier replaced

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization for tepotinib (J8999) and document MET exon 14 skipping mutation confirmation by tissue or FDA‑approved liquid biopsy.

SourceLink

POLICY UPDATE CHANGES

Converted to new Evolent guideline template and replaced prior UM ONC_1422 Tepmetko (tepotinib).

1FDA/accepted indication described

J8999billing code listed

450 mgsingle dose max

60monthly treatment limit

Commercial/Exchange/Medicaid

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Coverage Criteria for Tepmetko (tepotinib)

Initial/Any-line therapy coverage criteria

Covered when ALL of the following are met

Eligibility: Member is an adult with metastatic or locally advanced non-small cell lung cancer (NSCLC)

Biomarker confirmation: Positive MET exon 14 skipping mutation confirmed by tissue or liquid biopsy (e.g., Guardant 360 or equivalent FDA‑approved test)

Line of therapy: May be used as initial or subsequent line therapy if not previously used

Supporting evidence: Use is supported by FDA product labeling, CMS‑recognized compendia, NCCN/ASCO guidelines, or acceptable peer‑reviewed literature per policy requirements

Concurrent use of tepotinib with other anti-cancer therapies is excluded. Specifically, the policy excludes simultaneous administration with other targeted therapies, cytotoxic chemotherapy, or immunotherapy.

Requests exceeding the specified dosing limits will be excluded. The policy defines a single dose limit of 450 mg for tepotinib and a maximum of 60 (225 mg) tablets per month; dosing above either threshold is not permitted.

Use of tepotinib for investigational or off‑label indications lacking sufficient supportive evidence is excluded. The policy requires evidence supported by CMS‑recognized compendia or acceptable peer‑reviewed literature and specifies criteria for sufficiency of evidence, including adequate representation of the patient population and cancer characteristics, appropriate study design, clinically meaningful outcomes (e.g., ASCO‑recommended thresholds), and preference against relying solely on case reports or meeting abstracts without full peer‑reviewed publication.

Treatment with tepotinib after documented disease progression on tepotinib or another MET inhibitor is excluded. The policy explicitly lists progression while taking tepotinib or another MET inhibitor (for example, capmatinib) as an exclusion criterion.

Requests for tepotinib that represent investigational or off‑label uses without sufficient supportive evidence are considered not medically necessary. The guideline’s evidence standards require support from FDA labeling, CMS‑recognized compendia, or acceptable peer‑reviewed literature as described in the exclusions section.

Regimen	Indication	HCPCS code	Coverage status
Tepotinib monotherapy (per FDA labeling)
Monotherapy for adult patients with metastatic or locally advanced non-small cell lung cancer with confirmed MET exon 14 skipping mutation (tissue or FDA‑approved liquid biopsy); may be used as initial or subsequent line therapy if not previously used.
J8999
Covered with criteria

Billing and Coding

Drug HCPCS CodesHCPCS

J8999

tepotinib

inv-08: single dose limit — <= 450 mg

Single dose maximum450 mg or less per single dose

Policy actionDosing that exceeds the single dose limit of 450 mg is excluded from coverage

Reference contextListed under Exclusion Criteria as dosing exceeds single dose limit of Tepmetko (tepotinib) 450 mg

inv-09: monthly tablet limit — <= 60 (225 mg) tablets/month

Monthly tablet maximum60 tablets per month (225 mg tablets total monthly limit)

Policy actionTreatment that exceeds the maximum limit of 60 (225 mg) tablets/month is excluded from coverage

Provider Actions, Prior Authorization & Documentation

Prior Authorization

Prior authorization required for tepotinib (J8999)

Prior authorization is required for tepotinib (J8999); use is limited to adult patients with metastatic or locally advanced non‑small cell lung cancer who have a confirmed MET exon 14 skipping mutation, and therapy must be consistent with FDA labeling or recognized compendia/guidelines.

Drug HCPCS code: J8999

Step Therapy

Continuation/renewal criteria

Continuation/renewal requests may be approved without a new prior authorization provided the member has not experienced disease progression on the requested medication, there has been no lapse greater than 30 days in an active authorization within the past year, and no additional medications are being added to the request.

No disease progression while on the medication
No lapse >30 days in active authorization within the last year
No additional medications added to the continuation request

Covered Regimens and Administration

Regimen	Indication	HCPCS code	Coverage status
Tepotinib monotherapy (per FDA labeling)
Monotherapy for adult patients with metastatic or locally advanced non-small cell lung cancer with confirmed MET exon 14 skipping mutation (tissue or FDA‑approved liquid biopsy); may be used as initial or subsequent line therapy if not previously used.
J8999
Covered with criteria

Line of Therapy

first-line | second-line

Line: May be used as initial or subsequent line therapy if not previously used

Biomarker and Diagnostic Requirements

inv-17: MET exon 14 skipping mutation — Confirmed by tissue or FDA-approved liquid biopsy (e.g., Guardant 360)

Biomarker confirmationMET exon 14 skipping mutation confirmed by tissue biopsy or an FDA‑approved liquid biopsy (e.g., Guardant 360)

Clinical indicationFor adult members with metastatic or locally advanced NSCLC

Evidence requirementDocumentation must support mutation confirmation via tissue or FDA‑approved liquid biopsy (e.g., Guardant 360)

inv-15: MET exon 14 skipping mutation (definition) — Confirmation may be performed by tissue biopsy or an FDA-approved liquid biopsy such as Guardant 360

DefinitionConfirmation of MET exon 14 skipping mutation may be performed by tissue biopsy or an FDA‑approved liquid biopsy such as Guardant 360

Acceptable tests

Background

Tepotinib (Tepmetko) is indicated as monotherapy for adult patients with metastatic or locally advanced non‑small cell lung cancer harboring a MET exon 14 skipping mutation. Mutation confirmation may be obtained via tissue or an FDA‑approved liquid biopsy; use must align with FDA labeling and accepted compendia or peer‑reviewed evidence.

Revision History

2025-03operational_updateLatest

Converted to new Evolent guideline template and replaced prior guideline identifier UM ONC_1422 Tepmetko (tepotinib).

2024-03operational_update

Updated Neighborhood Health Plan (NCH) verbiage to Evolent wording in the guideline text (administrative wording update).