ModifiedCentenePolicy N/A

Capmatinib (Tabrecta) for MET exon 14 skipping NSCLC

Policy governing medical necessity criteria and prior authorization for capmatinib (Tabrecta) for adults with metastatic or recurrent non-small cell lung cancer (NSCLC) with MET exon 14 skipping mutation, applicable to Centene lines of business.

Policy Summary

PayerCentene

PolicyCapmatinib (Tabrecta) for MET exon 14 skipping NSCLC

Policy CodePolicy N/A

Change TypeMaterial updates: added exclusion and clarified NCCN-aligned uses

Effective DateSep 1, 2020

Next Review DateAug 25, 2025

Key ActionSubmit prior authorization with documentation showing metastatic/recurrent NSCLC, MET exon 14 skipping mutation, oncologist involvement, and dose ≤ 800 mg/day.

SourceLink

POLICY UPDATE CHANGES

Added explicit exclusion: positive MET amplification WITHOUT an Exon 14 skipping mutation is not authorized for coverage.

Clarified that Tabrecta can be administered with continuation of Tagrisso for EGFR mutant disease with high-level MET amplifications.

Added option for use as a single-agent for brain metastases.

400 mg PO BIDrecommended dosing for NSCLC

800 mg/daymaximum daily dose

150 mg, 200 mgavailable tablet strengths

6 months

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Coverage Criteria for Capmatinib (Tabrecta)

Initial Therapy

Covered when ALL of the following are met:

Initial Approval for Tabrecta: 1) Diagnosis of recurrent, advanced, or metastatic non-small cell lung cancer (NSCLC); 2) Primary tumor site: lung (non-small cell cancer); 3) Age ≥ 18 years; 4) Prescribed by or in consultation with an oncologist; 5) Tumor is positive for a mutation causing MET exon 14 skipping as interpreted by the reporting pathologist; 6) Clinical subcriteria (one of the following must be met): (a) disease is EGFR wild-type and ALK negative; OR (b) used as a single-agent for brain (CNS) metastases; OR (c) if EGFR mutant with high-level MET amplifications, Tabrecta can be administered with continuation of Tagrisso; 7) Generic capmatinib should be used if available unless contraindicated or clinically significant adverse effects occur; 8) Dose does not exceed 800 mg per day (4 tablets per day) unless supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence).dose <= 800 mg/day

Prescribed regimen must be FDA-approved or recommended by NCCN.

Continuation Therapy

Covered when ALL of the following are met:

Continued Therapy: 1) Member is currently receiving Tabrecta via the Centene benefit, or documentation supports at least 30 days of therapy for a covered indication; 2) Primary tumor site: lung (non-small cell cancer); 3) Member is responding positively to therapy; 4) New dose does not exceed 800 mg per day (4 tablets per day); if request is for a dose increase, the request must be supported by practice guidelines or peer-reviewed literature for the relevant off-label use (prescriber must submit supporting evidence).dose <= 800 mg/day

Prescribed regimen must be FDA-approved or recommended by NCCN.

Requests for capmatinib (Tabrecta) when testing shows positive MET amplification WITHOUT an Exon 14 skipping mutation are not authorized for coverage. The policy specifies that MET amplification in the absence of a MET exon 14 skipping mutation should be considered a negative result for coverage and such requests will be denied.

Pathology reports should be interpreted by the signing pathologist and explicitly document the presence or absence of a mutation causing MET exon 14 skipping; presence of MET amplification alone does not meet the biomarker requirement for coverage.

Coverage decisions under this clinical policy are intended to guide medical necessity determinations and the administration of benefits but are subject to the member's coverage documents and applicable administrative policies. The policy does not guarantee payment and is constrained by the terms, conditions, exclusions, and limitations of the member’s evidence of coverage, certificate, or contract, as well as applicable state and federal requirements.

If there is a discrepancy between this clinical policy and any legal or regulatory requirement, the law or regulation governs. Health Plans that adopt this policy retain the right to change, amend, or withdraw it at any time.

Non‑FDA–approved indications for capmatinib that are not specifically addressed in this policy are not covered unless there is sufficient supporting documentation of efficacy and safety under the applicable off‑label use policies (for example, CP.CPA.09 for commercial, HIM.PA.154 for Marketplace, or CP.PMN.53 for Medicaid) or unless coverage is otherwise allowed in the member’s evidence of coverage.

Providers requesting coverage for off‑label uses must submit adequate clinical evidence and follow the referenced off‑label use policies to support medical necessity.

Coding and Dosage

Codes mentionedmixed

N/A	No explicit CPT/HCPCS/ICD-10 codes listed in this part of the document

Maximum daily dose

Maximum daily dose800 mg/day

Recommended dosing regimen400 mg PO BID

Tablet strengths (from brief)150 mg, 200 mg

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior Authorization Required: Prior authorization is required for Tabrecta (capmatinib). Requests must document that the member has recurrent, advanced, or metastatic non-small cell lung cancer (NSCLC); is age ≥ 18 years; and that the medication is prescribed by or in consultation with an oncologist. Requests must demonstrate the tumor is positive for a MET exon 14 skipping mutation (see Appendix D) and meet any additional clinical criteria in the policy (e.g., EGFR/ALK status or specific clinical scenarios). Off-label uses require supporting practice guideline or peer-reviewed literature citations. Dosing must not exceed 800 mg per day (4 tablets per day) unless supported by guideline or literature and prescriber justification.

Effective Date: 2020-09-01
Prescriber: Oncologist or in consultation with an oncologist
Age requirement: ≥ 18 years
Required biomarker: MET exon 14 skipping mutation (see Appendix D)
Dose limit: 800 mg/day (4 tablets/day) unless supported by evidence

Documentation Required

Background

Capmatinib (Tabrecta) is a small‑molecule kinase inhibitor that targets MET and is FDA‑approved for adult patients with metastatic non‑small cell lung cancer (NSCLC) whose tumors harbor a mutation causing MET exon 14 skipping as detected by an FDA‑approved test. Coverage under this policy is contingent on documentation of that mutation by the reporting pathologist.

Testing interpretation and biomarker status are critical: MET exon 14 skipping must be present for authorization, while MET amplification alone—in the absence of exon 14 skipping—is considered negative for coverage. The recommended dosing for approved indications is typically 400 mg PO twice daily with a maximum daily dose of 800 mg/day unless otherwise supported by guidelines or peer‑reviewed literature for off‑label use.

Definitions and Biomarkers

MET exon 14 skipping — definition and testing requirement

DefinitionGenomic alteration in the MET gene that leads to skipping of exon 14 as detected by testing

Requirement for coveragePresence of a mutation causing MET exon 14 skipping, as interpreted by the reporting pathologist, is required for coverage

Testing standardDetected by an FDA‑approved test for MET exon 14 skipping (per FDA indication)

MET amplification (without exon 14 skipping) — definition and coverage implication

DefinitionPresence of MET gene amplification in the absence of an exon 14 skipping mutation

Coverage implicationA positive MET amplification WITHOUT an Exon 14 skipping mutation is NOT authorized for coverage (exclusion)

Line of Therapy

first-line | second-line | salvage

Line of therapy note: Policy allows use in recurrent, advanced, or metastatic disease and aligns with FDA approval for metastatic NSCLC; NCCN language supports use in recurrent disease and single‑agent use for CNS (brain) metastases.

Biomarker Requirements for Coverage

MET exon 14 skipping — biomarker requirement

Biomarker required for coverageMutation causing MET exon 14 skipping must be present and is required for coverage

Test interpretationThe test should be interpreted by the pathologist who signs the report

Test typeDetection should be by an FDA‑approved test for MET exon 14 skipping when applicable

MET amplification — coverage implication

Coverage stanceMET amplification alone (without exon 14 skipping) is considered negative for coverage

Authorization consequenceRequests for capmatinib when only MET amplification is present would be denied

Covered Regimens and Dosing

Regimen	Indication	Coverage
400 mg PO BID	NSCLC with MET exon 14 skipping mutation	Covered with criteria (dose limit: maximum 800 mg/day)