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

Vitrakvi (larotrectinib) for NTRK fusion-positive solid tumors

Covers use of Vitrakvi for adult and pediatric patients with solid tumors harboring an NTRK gene fusion when approval criteria are met; applies to Neighborhood Health Plan of Rhode Island members per this policy.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyVitrakvi (larotrectinib) for NTRK fusion-positive solid tumors

Policy CodePolicy Vitrakvi 2799-A SGM P2023

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionObtain and submit laboratory documentation confirming NTRK gene fusion status (e.g., NGS or FISH) to initiate prior authorization.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsauth duration

NTRK fusion requiredbiomarker

FDA-onlycoverage scope

Coverage Criteria for Vitrakvi (larotrectinib)

Initial therapy for NTRK fusion-positive solid tumors

Covered when ALL of the following are met:

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FDA-approved indications for Vitrakvi: Solid tumor has an NTRK gene fusion without a known acquired resistance mutation

supported by FDA-approved labeling

Disease extent: Tumor is metastatic or surgical resection is likely to result in severe morbidity

per FDA indication

Prior treatments or alternatives: No satisfactory alternative treatments available or disease has progressed following treatment

per FDA indication

Diagnostic confirmation: Laboratory demonstration of NTRK gene fusion (e.g., NGS or FISH)

required for prior authorization

Continuation therapy / Reauthorization

Continuation of therapy covered when ALL of the following are met:

Indication continuity: Member is requesting reauthorization for an indication listed in Section I/III

Clinical benefit: No evidence of disease progression while on current regimen

required for reauthorization

Tolerability: No unacceptable toxicity on current regimen

required for reauthorization

Covered Regimens

Regimen	Indication / Criteria	Authorization Duration	Coverage
Vitrakvi (larotrectinib)	Treatment of adult and pediatric patients with solid tumors that have an NTRK gene fusion without a known acquired resistance mutation; tumor is metastatic or surgical resection is likely to result in severe morbidity; no satisfactory alternative treatments available or disease has progressed following treatment; laboratory demonstration of NTRK gene fusion (e.g., NGS or FISH) required for prior authorization.	Up to 12 months	Covered when all criteria are met

Required Provider Actions and Prior Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required for treatment of NTRK fusion–positive solid tumors. Submit chart documentation indicating NTRK gene fusion status (laboratory testing such as NGS or FISH) to initiate prior authorization. Authorization may be granted for up to 12 months for tumors with an NTRK gene fusion without a known acquired resistance mutation.

Required documentation: laboratory confirmation of NTRK gene fusion (e.g., NGS or FISH)
Authorization duration: up to 12 months for eligible NTRK fusion–positive solid tumors

Documentation Required

Required Documentation

Submit chart documentation indicating NTRK gene fusion status (laboratory testing such as next-generation sequencing [NGS] or fluorescence in situ hybridization [FISH]). This documentation must demonstrate the tumor has an NTRK gene fusion without a known acquired resistance mutation.

Acceptable tests: NGS, FISH, or other validated laboratory testing demonstrating NTRK gene fusion

Denial Risk

Non-covered Indications

Use of Vitrakvi for indications other than FDA‑approved or compendial NTRK fusion–positive solid tumors is considered experimental and investigational and is not medically necessary.

Non-covered indications: any diagnosis not meeting FDA‑approved criteria for NTRK fusion–positive solid tumors

Step Therapy

No step therapy requirements are specified for Vitrakvi in this policy.

Biomarker Requirements

inv-13: NTRK gene fusion — Without a known acquired resistance mutation

Required biomarkerPresence of an NTRK gene fusion without a known acquired resistance mutation

Disease extentTumor is metastatic or surgical resection would likely cause severe morbidity

Prior treatmentsNo satisfactory alternative treatments available or disease has progressed following prior therapy

Diagnostic confirmationLaboratory demonstration of NTRK gene fusion (e.g., NGS or FISH) required for authorization

inv-11: NTRK gene fusion definition — NTRK gene fusion without a known acquired resistance mutation

DefinitionNTRK gene fusion without a known acquired resistance mutation

Testing examplesDemonstration by laboratory testing such as next-generation sequencing (NGS) or fluorescence in situ hybridization (FISH)

Context of useRequired biomarker for coverage of Vitrakvi in solid tumors per FDA-approved indication

Background

Vitrakvi (larotrectinib) is indicated for the treatment of adult and pediatric patients with solid tumors that: (1) have a 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. Laboratory confirmation of an NTRK gene fusion is required for authorization.