CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

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

This guideline governs medical necessity and authorization criteria for Tepmetko (tepotinib) use in adults with metastatic or locally advanced non-small cell lung cancer (NSCLC) harboring MET exon 14 skipping mutations, and applies to providers submitting medication requests to the payer/Evolent.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

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

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization and document MET exon 14 skipping mutation by tissue or liquid biopsy (e.g., Guardant 360) to support coverage.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

MET exon 14 skippingrequired biomarker for coverage

450 mgsingle dose maximum

60 tabletsmonthly treatment max

J8999billing code

Commercial/Medicaidlines of business

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Coverage Criteria for Tepmetko (tepotinib)

COVERAGE CRITERIA

Covered when ALL of the following are met

NSCLC indication for Tepmetko

Biomarker confirmation: MET exon 14 skipping mutation confirmed by tissue biopsy or liquid biopsy (e.g., Guardant 360 or equivalent FDA-approved test)
Line of therapy: Tepotinib may be used as initial or subsequent line therapy if not previously used

Supporting evidence requirement: Use is supported by FDA-approved labeling, CMS-recognized compendia, NCCN/ASCO guidelines, or peer-reviewed literature meeting CMS standards

Coverage will be denied when the request meets any of the listed exclusion criteria. Specifically, requests will be excluded if there is disease progression while taking Tepmetko (tepotinib) or another MET inhibitor (for example, capmatinib/Tabrecta), or if Tepmetko is prescribed concurrently with other anticancer therapies such as other targeted agents, cytotoxic chemotherapy, or immunotherapy. Additionally, dosing that exceeds the single-dose limit of 450 mg or monthly dispensing that exceeds 60 (225 mg) tablets per month will be denied. Investigational or off-label uses lacking sufficient supporting evidence per CMS-recognized compendia or acceptable peer-reviewed literature are also excluded.

The policy defines sufficiency of evidence for investigational or off‑label Tepmetko use by explicit criteria. Evidence should demonstrate that the study population meaningfully represents the clinical characteristics of the patient and tumor; the administered regimen (chemotherapy/biologic/immune/targeted or other oncologic therapy) is relevant to the requested use; and reported outcomes are clinically meaningful (for example, ASCO‑style thresholds such as a hazard ratio 0.80 or an overall survival/progression‑free survival benefit of at least 3 months where applicable). Study design considerations are included: nonrandomized trials with substantial subject numbers may provide supportive evidence, whereas case reports and abstracts without a full peer‑reviewed article generally do not provide adequate evidence. The appropriateness of experimental design (randomization, blinding, use of control groups) should be weighed in context of the research question.

Regimen	Indication / Requirements	Concurrent therapies
Tepmetko (tepotinib) monotherapy	Adults with metastatic or locally advanced non‑small cell lung cancer (NSCLC) with confirmed MET exon 14 skipping mutation by tissue or liquid biopsy (e.g., Guardant 360 or equivalent FDA‑approved test); may be used as initial or subsequent line therapy if not previously used	Concurrent use with other anti‑cancer therapy (other targeted therapy, chemotherapy, or immunotherapy) is excluded

Billing and Coding

Drug HCPCS CodeHCPCS

J8999

tepotinib

inv-05: Single dose limit — 450 mg

Single dose limit450 mg per single dose of Tepmetko (tepotinib)

Source contextRequests exceeding this single dose will be excluded (denied)

Related exclusionDosing above 450 mg is listed under exclusion criteria

inv-06: Monthly tablet maximum — 60 (225 mg) tablets/month

Monthly tablet maximum60 (225 mg) tablets per month

ImplicationTreatment exceeding 60 (225 mg) tablets/month is listed as an exclusion criterion

Billing consideration

Provider Requirements and Operational Notes

Prior Authorization

Prior Authorization Required

Prior authorization is required for Tepmetko (tepotinib). Continuation requests for a previously authorized medication may be exempt from prior authorization when continuation conditions are met; otherwise submit a new prior authorization request.

Continuation exemption applies only if: member has no disease progression on the medication; the medication was used within the last year without a lapse >30 days of active authorization; and no additional medications are being added to the continuation request.

Denial Risk

Concurrent Therapy Restriction

Concurrent use with other anti-cancer therapies is not allowed. Requests for Tepmetko will be denied if the member is receiving other targeted therapy, chemotherapy, or immunotherapy concurrently.

Concurrent use exclusion applies to other targeted therapy, chemotherapy, and immunotherapy.

Background

Tepotinib is a targeted MET inhibitor indicated for adult patients with metastatic or locally advanced non‑small cell lung cancer harboring MET exon 14 skipping mutations. Appropriate genomic testing (tissue or liquid biopsy) is required to identify eligible patients. Use of Tepmetko is limited to monotherapy in this indication, and continuation or authorization decisions must consider the policy’s exclusion and evidence sufficiency criteria.

Definitions

inv-12: MET exon 14 skipping — definition and qualification by tissue or liquid biopsy

DefinitionMET exon 14 skipping mutation is a genomic alteration in MET that qualifies a patient for Tepmetko therapy

Qualification by testingMust be confirmed by tissue biopsy or liquid biopsy (e.g., Guardant 360 or an equivalent FDA-approved test)

Indication linkageRequired for coverage of Tepmetko in metastatic or locally advanced NSCLC

Line of Therapy

Line of therapy: May be used as initial (first-line) or subsequent (second-line or later) therapy provided tepotinib has not been previously used for the patient

Required Biomarker for Coverage

inv-14: MET exon 14 skipping — confirmed by tissue or liquid biopsy (e.g., Guardant 360 or equivalent FDA-approved test)

Required diagnostic confirmationMET exon 14 skipping must be confirmed by tissue biopsy or liquid biopsy (e.g., Guardant 360 or equivalent FDA‑approved test)

Acceptable tests exampleGuardant 360 or an equivalent FDA-approved liquid biopsy test

Documentation expectationClinical documentation must demonstrate positive MET exon 14 skipping result from the tissue or liquid assay