CurrentNeighborhood Health Plan of Rhode IslandPolicy Vitrakvi 2799-A SGM P2023

Vitrakvi (larotrectinib) — Coverage Criteria for NTRK Fusion–Positive Solid Tumors

Policy governs prior authorization and coverage criteria for Vitrakvi (larotrectinib) for adult and pediatric members with solid tumors harboring NTRK gene fusions; coverage requires meeting approval criteria, documented NTRK fusion, and absence of exclusions. Prior authorization is required; approvals may be granted for up to 12 months for initial and continued therapy when criteria are met.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyVitrakvi (larotrectinib) — Coverage Criteria for NTRK Fusion–Positive Solid Tumors

Policy CodePolicy Vitrakvi 2799-A SGM P2023

Change TypeNo material change

Effective Date

Next Review Date

Key ActionSubmit prior authorization with chart documentation confirming NTRK gene fusion status to initiate review; approvals may be granted for up to 12 months.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsinitial authorization period

12 monthscontinuation/reauthorization period

NTRK fusionrequired biomarker

FDA-approved onlycoverage limits

Coverage Criteria for Vitrakvi (larotrectinib)

Initial therapy for NTRK fusion-positive solid tumors

Covered when ALL of the following are met

Initial therapy criteria: 1) Patient has a solid tumor with an NTRK gene fusion without a known acquired resistance mutation (demonstrated by laboratory testing, e.g., next-generation sequencing or FISH); 2) Disease is metastatic or surgical resection is likely to result in severe morbidity; 3) There are no satisfactory alternative treatments or the disease has progressed following prior treatment; 4) Member has no exclusions to the prescribed therapy.

Authorization of up to 12 months may be granted.

Continuation of therapy / Reauthorization

Covered when ALL of the following are met

Continuation/reauthorization: 1) Request is for reauthorization for an FDA‑approved or compendial indication listed in the policy; 2) No evidence of unacceptable toxicity while on the current regimen; 3) No evidence of disease progression while on the current regimen.

Authorization of up to 12 months may be granted for continued treatment.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyVitrakvi (larotrectinib) — Coverage Criteria for NTRK Fusion–Positive Solid Tumors

Policy CodePolicy Vitrakvi 2799-A SGM P2023

Change TypeNo material change

Effective Date

Next Review Date

Key ActionSubmit prior authorization with chart documentation confirming NTRK gene fusion status to initiate review; approvals may be granted for up to 12 months.

SourceLink

On This Page

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All indications for Vitrakvi (larotrectinib) that are not described in the FDA-approved indication — specifically tumors that do not harbor an NTRK gene fusion or uses outside of FDA-approved or recognized compendial indications — are considered experimental/investigational and not medically necessary. Such requests may be denied.

Use of Vitrakvi outside of the FDA-approved indication and compendial uses (i.e., for tumors without an NTRK gene fusion) is not medically necessary and therefore not covered.

Population	Regimen	Coverage status	Notes
Adult patients with solid tumors harboring an NTRK gene fusion without a known acquired resistance mutation (metastatic or unresectable)
Vitrakvi (larotrectinib)
covered
Indication requires NTRK gene fusion, disease metastatic or surgery likely to cause severe morbidity, and no satisfactory alternatives or progression after prior treatment; authorization may be granted for up to 12 months.

Provider Requirements and Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required. Approval may be granted for up to 12 months for treatment of solid tumors that have an NTRK gene fusion without a known acquired resistance mutation.

Authorization duration: up to 12 months

Step Therapy

No step therapy sequence is specified. Coverage is contingent on meeting NTRK fusion and clinical criteria described in the policy.

Documentation Required

Required Documentation

Chart documentation indicating NTRK gene fusion status must be submitted to initiate prior authorization review. Laboratory evidence may include next-generation sequencing (NGS), fluorescence in situ hybridization (FISH), or other validated molecular testing documenting an NTRK gene fusion and absence of known acquired resistance mutations.

Required: Documentation of NTRK gene fusion status (e.g., NGS, FISH)
Include evidence that tumor is metastatic or surgical resection would likely cause severe morbidity, and that no satisfactory alternatives exist or disease progressed following treatment

Denial Risk

Experimental/Investigational Exclusions

Use of Vitrakvi for indications other than the FDA‑approved or compendial uses described in the policy is considered experimental/investigational and is not covered.

All other indications are not medically necessary

Required Biomarker for Coverage

inv-12: NTRK gene fusion — required biomarker (without a known acquired resistance mutation)

Required biomarkerPresence of an NTRK gene fusion (NTRK1/2/3) without a known acquired resistance mutation

Demonstration methodMust be demonstrated by laboratory testing (e.g., next‑generation sequencing [NGS] or fluorescence in situ hybridization [FISH])

Tumor typesApplies to solid tumors (adult and pediatric) that harbor the NTRK fusion

Associated clinical contextTumors must be metastatic or resection would likely cause severe morbidity, and no satisfactory alternatives exist or disease has progressed following treatment

Coverage implicationRequired for initial authorization and continuation of Vitrakvi (larotrectinib) per policy criteria

inv-10: Definition — Neurotrophic receptor tyrosine kinase (NTRK) gene fusion explanation

DefinitionNeurotrophic receptor tyrosine kinase (NTRK) gene fusion: a genomic rearrangement involving NTRK1, NTRK2, or NTRK3 that results in an oncogenic fusion protein and is required for Vitrakvi coverage

Affected genesNTRK1, NTRK2, NTRK3

Clinical significanceDrives oncogenesis in a subset of solid tumors and is the biomarker specified in the FDA‑approved indication for larotrectinib

Coverage scopeRequired biomarker for treatment of adult and pediatric patients with solid tumors under this policy

Line of Therapy Guidance

Line of therapy positioning

Line of therapy: Indicated when no satisfactory alternative treatments exist or following progression after prior treatment; specific line (first‑line versus later) is not explicitly delineated in this policy.

Background on Vitrakvi

Vitrakvi (larotrectinib) is indicated for the treatment of adult and pediatric patients with solid tumors that: 1) have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion without a known acquired resistance mutation, 2) are metastatic or where surgical resection is likely to result in severe morbidity, and 3) have no satisfactory alternative treatments or have progressed following treatment. Authorization may be considered when these criteria are met.

Covered Regimens and Dosing

Population	Regimen	Coverage status	Notes
Pediatric patients with solid tumors harboring an NTRK gene fusion without a known acquired resistance mutation (metastatic or unresectable)
Vitrakvi (larotrectinib)
covered
Indication requires NTRK gene fusion, disease metastatic or surgery likely to cause severe morbidity, and no satisfactory alternatives or progression after prior treatment; authorization may be granted for up to 12 months.