CurrentUnitedHealthcarePolicy N/A

Tabrecta (capmatinib) prior authorization

Coverage and prior authorization requirements for Tabrecta (capmatinib) for treatment of adult patients with metastatic NSCLC with MET exon 14 skipping or high-level MET amplification; includes pediatric auto-approval rule and reauthorization criteria. Affects prescribers and pharmacy prior authorization reviewers for UnitedHealthcare members.

Policy Summary

PayerUnitedHealthcare

PolicyTabrecta (capmatinib) prior authorization

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateOct 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization for members aged 19 and older; members under 19 auto-process without coverage review.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsauthorization duration

Age <19 auto-approveautomatic pediatric processing

METex14 / high MET ampcovered biomarkers

2020-2025P&T review history

Coverage Criteria for Tabrecta (capmatinib)

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inv-01: Initial Therapy — Initial Authorization criteria (covered when ALL of the following are met).

Initial Authorization — Covered when ALL of the following are met:

Initial Authorization for adults: Diagnosis of non-small cell lung cancer (NSCLC) AND presence of either MET exon 14 skipping–positive tumor OR high‑level MET amplification in lung cancer

Applies to members aged 19 years and older; authorization issued for 12 months per prior authorization rules

inv-02: Continuation/Reauthorization — Reauthorization criteria (covered when the following is met).

Reauthorization — Covered when the following is met:

Reauthorization criteria: Patient does not show evidence of progressive disease while on Tabrecta therapy

Authorization period: 12 months if criterion met

inv-03: Pediatric Auto-Approval — Auto-approval rule for patients under 19 years.

Pediatric (patients <19 years)

Pediatric automatic approval: Patient is less than 19 years of age

Prescription for members under 19 will automatically process without a coverage review; authorization issued for 12 months

State mandates may supersede this coverage policy. When a state law requires coverage for off-label use of medications for specified diagnoses or under certain circumstances, or mandates use of specific compendium references, those state requirements take precedence over the terms of this benefit document and the notification criteria.

Initial Therapy

inv-12: Initial Therapy — primary top-level criteria node for initial authorization.

Initial therapy for adults (primary criteria node): Both of the following: (1) Diagnosis of non-small cell lung cancer (NSCLC) AND (2) One of: presence of MET exon 14 skipping–positive tumors OR high‑level MET amplification in lung cancer

Authorization applies to members 19 and older; see pediatric auto-approval for younger patients

Provider Actions and Prior Authorization Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for members age 19 and older. For patients less than 19 years of age, authorization will be issued for 12 months.

Prior authorization required for members ≥19 years.
Patients <19 years: authorization duration = 12 months.

Note

Automated Approval and Supply Limits

UnitedHealthcare may use automated approval and re-approval processes based on previous claim/medication history, diagnosis codes (ICD-10), and/or claim logic. Use of these automated processes varies by program and therapeutic class. Supply limits may be applied; if supply limits are in place, they will be enforced according to program rules.

Automated approval/re-approval may rely on prior claims, medication history, and diagnosis codes (ICD-10).
Supply limits may be enforced.

Documentation Required

Required Documentation

Providers must document the clinical indication and biomarker status supporting therapy. Required documentation includes clinical records showing diagnosis of non-small cell lung cancer (NSCLC) and laboratory/pathology reports demonstrating either MET exon 14 skipping mutation or high-level MET amplification as applicable. For reauthorization, documentation should demonstrate lack of disease progression while on Tabrecta therapy.

Documented diagnosis of NSCLC.
Pathology or molecular test report confirming MET exon 14 skipping OR high-level MET amplification.
For reauthorization: clinical evidence that the patient does not show progressive disease on therapy.

Denial Risk

Coverage-Triggered Denials

Requests may be denied if documentation is missing or does not meet coverage-trigger criteria: absent or non-diagnostic tumor biomarker test results (no MET exon 14 skipping or insufficient evidence of high-level MET amplification), no documented NSCLC diagnosis, or for reauthorization if there is evidence of progressive disease while on therapy.

Denial risk if tumor biomarker testing is missing or inconclusive (no MET exon 14 skipping or insufficient MET amplification evidence).
Denial risk if NSCLC diagnosis is not documented.
Denial risk for reauthorization if progressive disease is documented while on Tabrecta.

Key Definitions

MET exon 14 skipping (genomic alteration)

TermMET exon 14 skipping

DefinitionGenomic alteration in the MET gene that results in skipping of exon 14, creating an actionable mutation for targeted therapy

Clinical relevanceIndication for Tabrecta (capmatinib) in adult patients with metastatic non-small cell lung cancer (NSCLC)

High-level MET amplification (elevated MET gene copy number)

TermHigh-level MET amplification

DefinitionElevated MET gene copy number (high-level amplification) considered an actionable alteration per NCCN guidance

Clinical relevanceNCCN also recommends Tabrecta as single-agent therapy for NSCLC with high-level MET amplification; listed as an alternative biomarker for coverage

Background

Tabrecta (capmatinib) is a kinase inhibitor indicated for the treatment of adult patients with metastatic non‑small cell lung cancer (NSCLC) whose tumors have MET exon 14 skipping. The NCCN also recommends Tabrecta as a single‑agent option for NSCLC with high‑level MET amplification. Prior authorization is required for members aged 19 and older and, when criteria are met, approvals are issued for 12 months. For members under 19 years of age, prescriptions automatically process without coverage review and receive a 12‑month authorization.

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