ModifiedCentenePolicy CP.PHAR.494

Clinical Policy: Capmatinib (Tabrecta)

Defines medical necessity and prior authorization requirements for capmatinib (Tabrecta) for adults with recurrent, advanced, or metastatic non‑small cell lung cancer (NSCLC) harboring MET exon 14 skipping mutations; applies to Centene-affiliated health plans (Commercial, HIM, Medicaid).

Policy Summary

PayerCentene

PolicyCapmatinib (Tabrecta) for MET exon 14 skipping NSCLC

Policy CodePolicy CP.PHAR.494

Change TypeCoverage criteria updated (NCCN-aligned)

Effective DateSep 1, 2020

Next Review Date

Key ActionSubmit prior authorization with pathologist‑interpreted test report showing MET exon 14 skipping and documentation of oncologist involvement.

SourceLink

POLICY UPDATE CHANGES

Initial criteria now include an option allowing use as a single-agent for brain metastases per NCCN.

For EGFR mutant with high-level MET amplifications, Tabrecta can be administered with continuation of Tagrisso (osimertinib).

Positive MET amplification WITHOUT an Exon 14 skipping mutation is specified as not authorized for coverage.

Added option for capmatinib to be used as a single-agent for brain metastases per NCCN.

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

Removed the requirement that 'member does not have symptomatic CNS metastases' because Tabrecta may be used in CNS brain metastases per NCCN.

400 mg PO BIDStandard NSCLC dosing regimen

800 mg/dayMaximum dose

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6 monthsInitial approval (Medicaid)

Up to 12 moInitial approval (Commercial)

3Q 2025Review referenced

Coverage Criteria for Capmatinib (Tabrecta)

Continuation Therapy (NSCLC)

Covered when ALL of the following are met:

Continued NSCLC criteria: 1) Member is currently receiving capmatinib via the Centene benefit, or documentation supports that the member has received Tabrecta for a covered indication 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.

Initial therapy / indication updates

Covered when aligned with NCCN recommendations as updated:

NCCN-aligned indications: Tabrecta (capmatinib) is covered when used as a single-agent for brain metastases OR when administered with continuation of Tagrisso (osimertinib) for EGFR-mutant NSCLC with high-level MET amplifications, consistent with NCCN guidance.

Reflects 3Q 2025 annual review updates.

Coverage is NOT authorized for non‑FDA approved indications that are not specifically addressed in this policy unless the request is supported by the applicable off‑label use policy (see CP.CPA.09 for commercial, HIM.PA.154 for Health Insurance Marketplace, and CP.PMN.53 for Medicaid) or by other plan evidence of coverage documentation.

A prior exclusion that required the member to not have symptomatic CNS metastases has been removed. The policy now aligns with NCCN guidance allowing capmatinib (Tabrecta) to be used in patients with CNS brain metastases, including as a single‑agent for brain metastases in appropriate cases.

Requests for capmatinib will be denied when the tumor testing shows MET amplification WITHOUT a MET exon 14 skipping mutation. Appendix D specifies that the only positive test result that qualifies is the presence of an exon 14 skipping mutation; MET amplification alone should be considered negative and is not sufficient for approval.

The policy identifies specific situations that are not medically necessary for capmatinib, notably treatment of tumors with MET amplification only (without exon 14 skipping). This document is intended as a medical necessity guide to assist coverage determinations and does not replace clinical judgment; coverage decisions remain subject to plan contract terms and applicable laws and regulations.

Dosing and Regimens

Regimen	Tablet strengths	Standard dose	Maximum dose
Capmatinib (Tabrecta)
150 mg; 200 mg
400 mg PO twice daily (400 mg PO BID)
800 mg/day

Clinical context	Coverage option
Use as single‑agent in patients with brain (CNS) metastases per NCCN guidance
Covered: single‑agent capmatinib (Tabrecta) for brain metastases
Use concurrent administration with continuation of osimertinib (Tagrisso) for EGFR‑mutant NSCLC with high‑level MET amplifications per NCCN
Covered: capmatinib administered with continuation of osimertinib (Tagrisso) in appropriate EGFR‑mutant, high‑level MET amplification cases

Product Availability and Codes

Product availabilityNDC

NDC (not specified)

Tablets: 150 mg, 200 mg (product availability listed; specific NDCs not provided in this document)

Affected codes (unspecified in excerpt)mixed

affected codes

Policy references prior authorization/billing codes affected by updates (not specified in provided chunks)

Maximum daily dose

Maximum daily dose800 mg per day

Standard dosing regimen400 mg PO twice daily (NSCLC)

Tablet strengths available150 mg and 200 mg tablets

Tablet/day limitMaximum 4 tablets per day (as part of dosing limits)

Provider Responsibilities and Authorization Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for Tabrecta (capmatinib). Providers must submit evidence that the member meets the medical necessity criteria for use in NSCLC, including documentation of diagnosis, oncologist involvement, age ≥ 18, and presence of a MET exon 14 skipping mutation. Prescribed regimen must be FDA-approved or recommended by NCCN.

Submit chart notes, lab results, pathology reports, and other clinical information supporting all approval criteria.
Prescriptions should not exceed 800 mg/day or 4 tablets/day unless supported by practice guidelines or peer‑reviewed literature (prescriber must submit supporting evidence).
Tabrecta must be prescribed by or in consultation with an oncologist.

Documentation Required

Genetic Test Documentation Required

Prior authorization requests must include pathology‑interpreted genetic test documentation showing a MET exon 14 skipping mutation. Requests based solely on MET amplification without an Exon 14 skipping mutation will be denied.

Biomarker and Testing Requirements

MET exon 14 skipping

Required biomarkerPresence of a mutation causing MET exon 14 skipping (pathologist‑interpreted test report required)

Test interpretationThe test must be interpreted by the pathologist who signs the report (Appendix D)

Exclusive positive resultThe ONLY positive test result that qualifies is the Exon 14 skipping mutation of MET; other MET aberrations are negative

MET amplification (high‑level)

MET amplification (high‑level)Recognized in context of EGFR‑mutant NSCLC to permit concurrent management per NCCN guidance; numeric threshold not specified in this policy (NCCN referenced)

Role in therapyHigh‑level MET amplification allows consideration of administering Tabrecta with continuation of Tagrisso (osimertinib) per NCCN

Line of Therapy Context

informational

Used for treatment of recurrent, advanced, or metastatic NSCLC in adults with MET exon 14 skipping mutation; specific line (first-line vs subsequent) is not specified in this policy — follow FDA/NCCN guidance and prescriber judgment.

Line of therapy: Used for treatment of recurrent, advanced, or metastatic NSCLC in adults with MET exon 14 skipping mutation; specific line (first-line vs subsequent) not specified — follow FDA/NCCN guidance and prescriber judgment.

unspecified

Usage contexts (line not specified):

usage contexts: Use as single-agent for brain metastases; or use with continuation of Tagrisso in EGFR-mutant NSCLC with high-level MET amplification per NCCN.

Lines (first-line/second-line) not specified in these chunks.

Background on Capmatinib (Tabrecta)

Capmatinib (Tabrecta) is a selective MET kinase inhibitor indicated for the treatment of adults with metastatic non‑small cell lung cancer (NSCLC) whose tumors harbor a MET exon 14 skipping mutation.

Key Definitions

Definition — MET exon 14 skipping mutation qualifies

Qualifying mutationA mutation causing MET exon 14 skipping is required for coverage; this must be the only positive MET result

MET amplification alonePresence of MET amplification WITHOUT an Exon 14 skipping mutation is considered negative and is not eligible for coverage

Other MET aberrationsAny other genomic aberration (mutation, deletion, rearrangement) of MET is considered negative for the required biomarker

Definition — Tabrecta single-agent use for brain metastases

Single‑agent use for brain metastasesTabrecta may be used as a single agent for CNS (brain) metastases per NCCN and is included as an option in initial approval criteria

Policy update context

Policy Summary

PayerCentene

PolicyCapmatinib (Tabrecta) for MET exon 14 skipping NSCLC

Policy CodePolicy CP.PHAR.494

Change TypeCoverage criteria updated (NCCN-aligned)

Effective DateSep 1, 2020

Next Review Date

Key ActionSubmit prior authorization with pathologist‑interpreted test report showing MET exon 14 skipping and documentation of oncologist involvement.

SourceLink

On This Page

Include the pathologist-signed report demonstrating presence of a MET exon 14 skipping mutation (the ONLY positive MET test acceptable).
Negative findings that do NOT meet criteria: MET amplification without exon 14 skipping or any other MET genomic aberration (mutation, deletion, rearrangement).

Documentation Required

Provider Responsibilities and Documentation Context

Providers must submit supporting clinical documentation (office notes, labs, imaging, prior therapy history) to demonstrate the member meets initial or continued therapy criteria. The policy is a guide to medical necessity determinations; providers should exercise clinical judgment.

For continued therapy, documentation must show member has received Tabrecta for at least 30 days and is responding positively to therapy.
If dose increases are requested, include rationale and supporting guidelines or literature when exceeding standard dosing limits.

Billing Rule

Generic Redirection

If a generic formulation of capmatinib is available, members must use the generic unless it is contraindicated or the member experiences clinically significant adverse effects with the generic.

Document contraindications or adverse reactions to justify use of brand-name Tabrecta instead of generic capmatinib.

Step Therapy

Step Therapy / Treatment Sequence

No explicit step therapy requirements are specified in this section. Coverage is determined by meeting the initial or continued therapy criteria and required documentation.

Operational updates reflect NCCN alignment allowing single-agent use in brain metastases and revised guidance for use with Tagrisso in select EGFR‑mutant with high‑level MET amplification scenarios.

Policy noteExact numeric criteria for 'high‑level' amplification are not defined in this document; follow NCCN guidance or testing lab definitions

MET amplification — high-level per NCCN guidance

NCCN‑referenced classificationMET amplification designated as 'high‑level' per NCCN guidance for specific EGFR‑mutant scenarios; this policy does not specify a numeric threshold

Clinical implicationHigh‑level amplification may permit Tabrecta use with continuation of osimertinib in EGFR‑mutant NSCLC

Action for providersIf relying on MET amplification to justify combined therapy, submit documentation indicating high‑level amplification per NCCN or lab criteria

This option was added in the 3Q 2025 annual review to align with NCCN guidance and removes prior exclusion for symptomatic CNS metastases

DocumentationPrior authorization requests should indicate brain metastases and reference NCCN guidance supporting single‑agent use

Definition — Concurrent Tabrecta + Tagrisso

Concurrent administration with TagrissoFor EGFR‑mutant NSCLC with high‑level MET amplification, Tabrecta can be administered with continuation of Tagrisso (osimertinib) per NCCN

Policy language updateLanguage revised from 'used with Tagrisso' to 'can be administered with continuation of Tagrisso' during 3Q 2025 review to reflect NCCN guidance

Provider actionWhen requesting coverage, document EGFR mutation status, evidence of high‑level MET amplification, and intent to continue osimertinib