CurrentCignaPolicy N/A

Tepmetko (tepotinib) prior authorization for NSCLC

Defines Cigna's prior authorization coverage criteria for Tepmetko (tepotinib) for adults with advanced or metastatic non–small cell lung cancer (NSCLC) harboring MET exon 14 skipping alterations or high-level MET amplification; applies to Cigna-administered health benefit plans.

Policy Summary

PayerCigna

PolicyTepmetko (tepotinib) prior authorization for NSCLC

Policy CodePolicy N/A

Change TypeRevised coverage language — expanded disease stage wording

Effective DateN/A

Next Review DateFeb 19, 2025

Key ActionObtain prior authorization and document patient is ≥18 years with advanced or metastatic NSCLC and MET exon 14 skipping or high‑level MET amplification to approve for 1 year.

SourceLink

POLICY UPDATE CHANGES

Criterion that patient has metastatic disease was changed to include advanced; revised to read: Patient has advanced or metastatic disease.

1 yearauthorization duration

≥18minimum age

MET exon 14 skipping or high‑level MET ampbiomarker

Accelerated approvalregulatory status

Coverage Criteria for Tepmetko (tepotinib)

Policy Summary

PayerCigna

PolicyTepmetko (tepotinib) prior authorization for NSCLC

Policy CodePolicy N/A

Change TypeRevised coverage language — expanded disease stage wording

Effective DateN/A

Next Review DateFeb 19, 2025

Key ActionObtain prior authorization and document patient is ≥18 years with advanced or metastatic NSCLC and MET exon 14 skipping or high‑level MET amplification to approve for 1 year.

SourceLink

On This Page

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Initial therapy — FDA‑approved indication

Covered when ALL of the following are met

FDA-approved indication for Tepmetko

A: Age: Patient is ≥ 18 years of age
B: Disease stage: Patient has advanced or metastatic disease
C: Biomarker
- C.i MET exon 14 skipping: Patient has mesenchymal epithelial transition (MET) exon 14 skipping mutations as detected by an approved test
- C.ii High-level MET amplification: Patient has high-level MET amplification as detected by an approved test

Operational note: Prior authorization is recommended; approvals are issued for 1 year when FDA-approved criteria are met.

Tepmetko (tepotinib) is considered experimental, investigational, or unproven for any uses not specified in this policy. Requests for Tepmetko for indications outside the policy’s covered NSCLC indications will be managed as non‑covered and criteria will be updated if new published data become available.

Regimen	Indication	Coverage status
Tepmetko (tepotinib) as monotherapy per FDA indication and NCCN preferred listing
Advanced or metastatic non‑small cell lung cancer (NSCLC) with MET exon 14 skipping mutation or high‑level MET amplification
Covered with criteria

Provider Actions and Prior Authorization Requirements

Prior Authorization

Prior authorization required

Prior authorization is recommended for Tepmetko (tepotinib); approvals are provided for the duration noted in the policy and are issued for 1 year when FDA‑approved criteria are met.

Step Therapy

Step therapy not required

No step therapy requirements are specified in this policy.

Documentation Required

Required clinical documentation

Include documentation demonstrating the patient is an adult (≥ 18 years), has advanced or metastatic non‑small cell lung cancer, and has either a MET exon 14 skipping mutation or high‑level MET amplification as detected by an approved test.

Patient is ≥ 18 years of age
Patient has advanced or metastatic disease
Evidence of MET exon 14 skipping mutation OR high‑level MET amplification from an approved test

Denial Risk

Non‑covered indications — denial risk

Requests for Tepmetko for any use other than the specified FDA‑approved NSCLC indications (MET exon 14 skipping or high‑level MET amplification) may be denied as experimental, investigational, or unproven.

Biomarker Requirements for Coverage

inv-13: MET exon 14 skipping — biomarker requirement (source details)

Required biomarkerMET exon 14 skipping mutation detected by an approved test

Regulatory contextMET exon 14 skipping is the FDA‑listed indication for Tepmetko (see overview)

Test acceptanceDetection must be by an approved test as specified in FDA‑Approved Indication

inv-14: High‑level MET amplification — biomarker requirement (source details)

Required biomarkerHigh‑level MET amplification detected by an approved test

Alternative criterionHigh‑level MET amplification is accepted as an alternative to MET exon 14 skipping for coverage

Test acceptanceDetection must be by an approved test as specified in FDA‑Approved Indication

Definitions

inv-10: MET exon 14 skipping — definition and detection notes

DefinitionMET exon 14 skipping alterations are genomic alterations in the MET gene that cause exon 14 skipping

DetectionMust be detected by an approved test (per FDA‑Approved Indication) to meet coverage criteria

Clinical rolePresence of MET exon 14 skipping is the primary FDA‑approved indication for Tepmetko

inv-11: High‑level MET amplification — definition and detection notes

DefinitionHigh‑level MET amplification is elevated MET gene copy number as identified by testing and accepted by this policy

DetectionMust be detected by an approved test to satisfy the FDA‑Approved Indication for Tepmetko

Coverage roleAccepted as an alternative biomarker criterion (C.ii) for approval under the policy

OpenPayer

Tepmetko (tepotinib) prior authorization for NSCLC

Coverage Criteria for Tepmetko (tepotinib)

Covered Regimens and Indications

Product Coding and Authorization Duration

Provider Actions and Prior Authorization Requirements

Line of Therapy

Biomarker Requirements for Coverage

Definitions

Background