ModifiedmhnPolicy CP.PHAR.494

Capmatinib (Tabrecta) for MET exon 14 skipping NSCLC

Defines medical necessity and prior authorization criteria for capmatinib (Tabrecta) for adult patients with metastatic non-small cell lung cancer harboring MET exon 14 skipping mutations for members of the payer's lines of business.

Policy Summary

Payermhn

PolicyCapmatinib (Tabrecta) for MET exon 14 skipping NSCLC

Policy CodePolicy CP.PHAR.494

Change TypeCriteria additions and clarifications (NCCN-aligned)

Effective Date09.01.20

Next Review Date

Key ActionSubmit prior authorization with documentation that member is ≥18, has metastatic NSCLC with a MET exon 14 skipping mutation, and meets dosing and prescriber requirements.

SourceLink

POLICY UPDATE CHANGES

Initial criteria: added option for 'used as a single-agent for brain metastases'.

For EGFR mutant with high-level MET amplifications, updated from 'Tabrecta is used with Tagrisso' to 'Tabrecta can be administered with continuation of Tagrisso'.

Section III: Positive MET amplification WITHOUT an Exon 14 skipping mutation declared not authorized for coverage.

Updated EGFR mutant with high-level MET amplifications criteria from 'Tabrecta is used with Tagrisso' to 'Tabrecta can be administered with continuation of Tagrisso' per NCCN guideline.

Removed phrase stating member does not have symptomatic CNS metastases because Tabrecta may be used in CNS brain metastases per NCCN.

800 mg/dayMaximum daily dose

400 mg BIDStandard NSCLC dosing

≥18

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Coverage Criteria for Capmatinib (Tabrecta)

inv-01: Initial Therapy - NSCLC

Covered when ALL of the following are met:

Initial Approval - NSCLC: 1. Diagnosis of recurrent, advanced, or metastatic non-small cell lung cancer (NSCLC); 2. Prescribed by or in consultation with an oncologist; 3. Age ≥ 18 years; 4. Disease is positive for a mutation causing MET exon 14 skipping (see Appendix D); 5. Member meets ONE of the following: a) Disease is EGFR wild-type and ALK negative; b) Used as a single-agent for brain metastases; c) If EGFR mutant with high-level MET amplifications, Tabrecta can be administered with continuation of Tagrisso; 6. For Tabrecta requests, member must use generic capmatinib, if available, unless contraindicated or clinically significant adverse effects are experienced; 7. Request meets ONE of the following: a) Dose does not exceed BOTH: i) 800 mg per day; and ii) 4 tablets per day; b) Dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence).

Prescribed regimen must be FDA-approved or recommended by NCCN

inv-02: Continuation Therapy - NSCLC

Covered when ALL of the following are met:

Continued Therapy - NSCLC: 1. Currently receiving medication via Centene benefit, or documentation supports that member is currently receiving Tabrecta for a covered indication and has received this medication for at least 30 days; 2. Member is responding positively to therapy; 3. If request is for a dose increase, request meets ONE of the following: a) New dose does not exceed BOTH: i) 800 mg per day; and ii) 4 tablets per day; b) New dose is supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence).

Prescribed regimen must be FDA-approved or recommended by NCCN

Non‑FDA approved indications that are not specifically addressed in this policy are not authorized unless there is sufficient documentation of efficacy and safety in accordance with the applicable off‑label use policies (CP.CPA.09 for commercial, HIM.PA.154 for Health Insurance Marketplace, and CP.PMN.53 for Medicaid) or other evidence of coverage documents. Additionally, a tumor that is positive for MET amplification WITHOUT an Exon 14 skipping mutation is considered negative for approval and is explicitly not authorized for coverage.

For Medicaid members, when state Medicaid coverage provisions conflict with this clinical policy, the state Medicaid coverage provisions take precedence. Providers should refer to the applicable state Medicaid manual for any state‑specific coverage provisions related to this policy.

Use of capmatinib for tumors with MET amplification alone (without an Exon 14 skipping mutation) is explicitly stated as not authorized and is considered not medically necessary. Appendix guidance clarifies that the only positive test result acceptable for approval is the presence of a MET exon 14 skipping mutation; MET amplification in isolation and other MET genomic aberrations should be considered negative for coverage.

Dosing and Regimens

Regimen	Indication / Notes
400 mg PO BID (maximum 800 mg/day)
Tablets available: 150 mg and 200 mg

Regimen / Use	Coverage stance / Notes
Capmatinib (Tabrecta) can be administered with continuation of Tagrisso (osimertinib)
May be used as a single-agent for brain (CNS) metastases per NCCN; policy language updated to reflect this option

Key Dosing and Coding Metrics

inv-06: Maximum daily dose — 800 mg/day

Maximum daily dose800 mg/day

Standard regimen400 mg PO BID

Tablet strengths150 mg and 200 mg tablets available

Tablet limitDose limit includes maximum of 4 tablets/day

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior authorization requirement — documentation that all approval criteria are met including diagnosis of recurrent/advanced/metastatic NSCLC, molecular testing demonstrating a MET exon 14 skipping mutation, oncologist involvement, age, dosing limits, and regimen rationale.

Provider must submit supporting documentation (office notes, lab results, pathology reports) showing member meets all approval criteria.
Prescriber should document molecular testing results confirming MET exon 14 skipping mutation; MET amplification alone is NOT sufficient.

Documentation Required

Supportive Documentation Required

Provider must submit documentation (such as office chart notes, lab results or other clinical information) supporting that member has met all applicable criteria. Documentation should include pathology/genetic test interpretation identifying the Exon 14 skipping mutation and any rationale for off-label dosing if applicable.

Intended Line(s) of Therapy

inv-18: mixed

Line of therapy: Policy applies to adult patients with recurrent, advanced, or metastatic NSCLC; no explicit restriction to a specific line of therapy is stated — coverage is determined by molecular eligibility (MET exon 14 skipping) and clinical judgment per NCCN guidance.

NCCN recommendations referenced

Biomarker and Testing Requirements

inv-19: MET exon 14 skipping — Presence of an exon 14 skipping mutation as interpreted by the signing pathologist

Required biomarkerPresence of an exon 14 skipping mutation in the MET gene

InterpretationThe test is interpreted by the pathologist that signs the report

Negative results examplesMET amplification without exon 14 skipping or any other MET genomic aberration should be considered negative

FDA indication noteTabrecta indicated for adult patients with metastatic NSCLC whose tumors have a mutation leading to MET exon 14 skipping as detected by an FDA-approved test

inv-20: MET amplification/status — high-level MET amplifications (as referenced); guidance on co-occurring EGFR-mutant disease

MET amplification — coverage stance

Definitions

inv-16: MET exon 14 skipping mutation — definition and interpretation by signing pathologist; other MET alterations noted

DefinitionMET exon 14 skipping mutation: presence of an exon 14 skipping event in the MET gene

Pathologist interpretationThe test result must be interpreted by the pathologist who signs the report

Exclusions for other MET alterationsOther MET genomic aberrations (mutation, deletion, rearrangement) or MET amplification alone are considered negative for approval

Regulatory noteFDA indication specifies Tabrecta for metastatic NSCLC tumors with mutations leading to MET exon 14 skipping detected by an FDA‑approved test

inv-17: Health Plan — definition of Health Plan adopting this policy

Definition of Health Plan

Background

Capmatinib (Tabrecta) is a MET kinase inhibitor indicated for adult patients with metastatic non‑small cell lung cancer (NSCLC) whose tumors harbor a MET exon 14 skipping mutation. The policy emphasizes that the Exon 14 skipping event as interpreted by the signing pathologist is the required biomarker for coverage; other MET genomic aberrations or MET amplification without exon 14 skipping are not considered sufficient.

Revision History and Policy Changes

2025-04-10annual_reviewLatest

3Q 2025 annual review: initial criteria updated to add option for single‑agent use in brain metastases and revised EGFR‑mutant language to allow Tabrecta to be administered with continuation of Tagrisso per NCCN; references reviewed and updated.

2022-08-24regulatory_update

RT4: NSCLC indication converted to full FDA approval; standard oral oncology generic redirection language added and legacy WellCare approval duration consolidated to standard Medicaid durations; template changes applied and references updated.

2022-05-03annual_review