CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Vitrakvi (larotrectinib) drug coverage

Defines accepted indications, inclusion and exclusion criteria, and utilization management for Vitrakvi (larotrectinib) for Neighborhood Health Plan of Rhode Island members; applies to medication requests processed by Evolent/UM.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyVitrakvi (larotrectinib) drug coverage

Policy CodePolicy N/A

Change TypeNo material change

Effective DateJuly 26, 2024

Next Review DateN/A

Key ActionSubmit authorization requests through Evolent with documentation confirming NTRK gene fusion via an FDA companion diagnostic or validated laboratory testing and supporting evidence per FDA labeling, CMS compendia, or NCCN/ASCO guidance.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

NTRK+ tumorsPrimary covered indication

100Adult single-dose maximum (mg)

60 / 240Monthly tablet maximums

2024-07-26Policy effective date

When Vitrakvi (larotrectinib) Is Covered

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General inclusion

Vitrakvi is covered when ALL of the following are met:

All of the following

Member is adult or pediatric with locally advanced or metastatic NTRK gene fusion-positive solid tumors
NTRK gene fusion confirmed by an FDA companion diagnostic or laboratory testing (e.g., next-generation sequencing)
Vitrakvi (larotrectinib) is being used as a single agent
Dosing limits apply: adult single dose limit 100 mg; monthly tablet maximums: 60 tablets (100 mg) or 240 tablets (25 mg)

Continuation therapy exceptions

Continuation requests for a not-approvable medication are exempt from this policy when ALL of the following are met:

Continuation exemptions

The requested medication was used within the last year
The member has not experienced disease progression and/or no intolerance to the requested medication
No additional medication(s) are being added to the continuation request

Exclusion criteria (not covered)

Vitrakvi is not approvable when ANY of the following exclusion criteria apply:

Any of the following

Use after disease progression with the same regimen
Disease progression on another NTRK inhibitor (e.g., entrectinib/Rozlytrek)
Concurrent use with other chemotherapy or other anti-cancer therapies
Dosing exceeds single dose limit for adults (100 mg)
Adult single dose limit: 100 mg
Monthly treatment exceeds maximum of 60 tablets (100 mg strength) or 240 tablets (25 mg strength)

Authorization, Documentation, and Denial Conditions

Prior Authorization

Authorization and supporting evidence required

Evolent processes all medication requests for Vitrakvi; requests must be supported by FDA-approved product labeling, CMS-recognized compendia, NCCN or ASCO clinical guidelines, or peer-reviewed literature that meets the requirements of the CMS Medicare Benefit Policy Manual Chapter 15.

Documentation Required

Confirmatory testing required

Providers must document that the tumor harbors an NTRK gene fusion using an FDA companion diagnostic or validated laboratory testing (for example, next-generation sequencing) before Vitrakvi will be approved.

Denial Risk

Denial conditions

Requests will be denied if any exclusion criterion applies, including prior progression on the same regimen or another NTRK inhibitor, concurrent chemotherapy or other anti-cancer therapies, dosing above established limits, monthly tablet overages, or investigational/off-label use lacking sufficient supporting evidence.

Progression on the same regimen or progression on another NTRK inhibitor (e.g., entrectinib/Rozlytrek).
Concurrent use with other chemotherapy or other anti-cancer therapies.
Adult single-dose exceeds 100 mg.
Monthly treatment exceeds 60 tablets (100 mg strength) or 240 tablets (25 mg strength).
Investigational or off-label use not supported by CMS-recognized compendia or acceptable peer-reviewed literature per the evidence considerations listed (e.g., inadequate representation in published evidence, lack of clinically meaningful outcomes, reliance on abstracts or case reports).

Clinical Context

Larotrectinib (Vitrakvi) is a targeted inhibitor indicated for treatment of adult and pediatric patients with solid tumors that harbor an NTRK gene fusion. Coverage is limited to single‑agent use in members with locally advanced or metastatic NTRK gene fusion‑positive solid tumors, with confirmation of the fusion by an FDA companion diagnostic or validated laboratory testing (for example, next‑generation sequencing).

Authorization and continued use must be supported by accepted sources of evidence consistent with program requirements, including FDA product labeling, CMS‑recognized compendia, and clinical practice guidance such as NCCN or ASCO recommendations; Evolent processes medication requests and verifies that supporting documentation meets these standards.

Defined Terms

Definitions

NTRK gene fusion-positive solid tumorA tumor that harbors a neurotrophic tyrosine receptor kinase (NTRK) gene fusion detectable by an FDA companion diagnostic or other validated laboratory testing (e.g., next-generation sequencing).

Continuation request (not-approvable medication)A request to continue a medication not otherwise approvable by policy that was used within the past year without disease progression or intolerance and without adding other medications to the regimen.