ModifiedUnitedHealthcarePolicy 2026 P 1355-6

Tepmetko® (tepotinib) - Prior Authorization/Notification - UnitedHealthcare Commercial Plans

Defines UnitedHealthcare Commercial Plans' prior authorization and reauthorization requirements for tepotinib (Tepmetko) for treatment of NSCLC with MET exon 14 skipping alterations or high-level MET amplification, includes pediatric automatic approvals under age 19, authorization durations, references, and notes on state mandates and automated approvals.

Policy Summary

PayerUnitedHealthcare

PolicyTepmetko® (tepotinib) - Prior Authorization/Notification - UnitedHealthcare Commercial Plans

Policy CodePolicy 2026 P 1355-6

Change TypeRevised coverage criteria (NSCLC) and updated references

Effective DateMar 1, 2026

Next Review Date

Key ActionProviders must obtain prior authorization/notification for Tepmetko for covered indications per the criteria; authorization will be issued for 12 months when criteria are met.

SourceLink

POLICY UPDATE CHANGES

Updated coverage criteria for NSCLC according to NCCN guidelines; updated background and references; minor formatting changes.

Annual review with no change to clinical criteria; updated references/background in prior years (4/2021-4/2025).

2Covered Indications (molecular criteria options)

12 moAuthorization Duration

Under 19Pediatric Processing

Coverage Summary

UnitedHealthcare Commercial Plans require prior authorization/notification for Tepmetko (tepotinib) for treatment of non‑small cell lung cancer (NSCLC) when medical criteria are met. Tepmetko will be authorized for adult patients with recurrent, advanced, or metastatic NSCLC who have either a MET exon 14 skipping alteration or high‑level MET amplification. Prescriptions for members under 19 years of age will automatically process without a coverage review. When authorization is approved, it will be issued for 12 months. State mandates, federal regulatory requirements, and member‑specific benefit plans may supersede or modify these criteria.

Policy facts (compact)

Authorization Duration12 months

Covered Indications (molecular criteria options)2

Pediatric ProcessingUnder 19 auto-approve

Effective Date2026-03-01

Last Review2026-01

Policy Number2026 P 1355-6

Initial Therapy Criteria (Adults)

Initial Authorization (Adults)

Tepmetko will be approved based on the following criteria:

ALL of the following

Diagnosis of non-small cell lung cancer (NSCLC)
Disease is recurrent, advanced, or metastatic
ONE of the following
- mesenchymal-epithelial transition (MET) exon 14 skipping mutation positive tumor(s)
- High level MET amplification

Pediatric Processing (under 19)

Patients less than 19 years of age

Tepmetko will be approved based on the following criterion:

ALL of the following

Patient is less than 19 years of age

Operational Note: Pediatric prescriptions will automatically process without a coverage review and authorization will be issued for 12 months.

Billing Rule

Pediatric automatic processing under age 19

Prescriptions for members under 19 will automatically process without a coverage review; when approved, an authorization will be issued for 12 months.

Continuation / Reauthorization Criteria

Reauthorization Criteria

Tepmetko will be approved for reauthorization based on the following criterion:

Patient does not show evidence of progressive disease while on Tepmetko therapy

Authorization will be issued for 12 months.

Denial Risk

Reauthorization denial if progression

Evidence of progressive disease while on Tepmetko will preclude reauthorization; reauthorization requires no evidence of progression on therapy.

Compendia Recognition

NCCN Recognition

Recognition of regimen by compendium supports coverage:

Drug is recognized in the NCCN Drugs and Biologics Compendium with a Category of Evidence and Consensus of 1, 2A, or 2B

Evidence references include the Tepmetko package insert and the NCCN Drugs and Biologics Compendium. Tepmetko [package insert], EMD Serono, Inc.; February 2024 is cited as the product label. The NCCN Drugs and Biologics Compendium (Categories 1, 2A, 2B) is referenced; NCCN guidance was used to update the coverage criteria.

Provider Actions

Prior Authorization

Prior authorization required for Tepmetko

Providers must obtain prior authorization/notification for Tepmetko for covered indications per the policy criteria; when criteria are met, authorization will be issued for 12 months.

Documentation Required

Diagnosis and molecular test documentation

Document the diagnosis of NSCLC and the presence of a MET exon 14 skipping mutation or high‑level MET amplification for initial approvals; automated approvals may be granted based on previous claims, medication history, or diagnosis codes.

Applicable Codes

ICD-10 (diagnosis codes may be used in automated approvals)ICD-10

No codes listed

NDC / HCPCS / CPT (not specified in policy text)mixed

No codes listed

Background

Tepmetko (tepotinib) is a kinase inhibitor indicated for adult patients with metastatic NSCLC harboring MET exon 14 skipping alterations. The NCCN also recommends Tepmetko as single‑agent therapy for NSCLC with high‑level MET amplification. Some states mandate coverage for off‑label uses or require different compendium references, which can supersede these coverage criteria.

The package insert is dated February 2024 and the compendium reference is the NCCN Drugs and Biologics Compendium (access details noted in the policy).

Revision History

2026-01-01material_changeLatest

Updated coverage criteria for NSCLC according to NCCN guidelines; updated background and references; minor formatting changes.

2025-04-01annual_review

Annual review with no change to clinical criteria; updated references/background in prior years (4/2021-4/2025).

2024-04-01annual_review

Annual review with no change to clinical criteria; updated references/background in prior years (4/2021-4/2025).