CurrentNeighborhood Health Plan of Rhode IslandPolicy 2799-A

Vitrakvi

Covers larotrectinib (Vitrakvi) for FDA‑approved indications and specified compendial uses when approval criteria are met; includes prior authorization documentation and authorization/reauthorization durations. All other uses are experimental/investigational and not medically necessary.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyVitrakvi

Policy CodePolicy 2799-A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionSubmit chart documentation indicating NTRK gene fusion status (e.g., NGS or FISH) to initiate prior authorization review.

SourceLink

POLICY UPDATE CHANGES

No material clinical/coverage changes in this policy update.

3Covered Histiocytic Subtypes

12Authorization Duration (months)

NTRKRequired Biomarker

Coverage Summary

Policy 2799-A (status: CURRENT): Vitrakvi (larotrectinib) is covered with criteria for the FDA‑approved solid tumor indications and for specified compendial histiocytic neoplasms (Erdheim‑Chester Disease, Langerhans Cell Histiocytosis, Rosai‑Dorfman Disease). Coverage requires documentation of an NTRK gene fusion without a known acquired resistance mutation and submission of chart documentation (e.g., NGS or FISH) with the prior authorization request; initial and reauthorization approvals may be granted for up to 12 months when all criteria are met.

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Covered / Medically Necessary Criteria

Authorization of 12 months may be granted when ALL of the following are met:

ALL of the following

Diagnosis of a solid tumor or specified histiocytic neoplasm with an NTRK gene fusion without a known acquired resistance mutation
Tumor is metastatic OR surgical resection is likely to result in severe morbidity (for solid tumors)
No satisfactory alternative treatments exist OR disease has progressed following treatment (for applicable indications)
Chart documentation indicating NTRK gene fusion status is submitted with prior authorization request

Initial Therapy Criteria

FDA-Approved Solid Tumor Indication

Covered when ALL of the following are met:

ALL of the following

Patient (adult or pediatric) has a solid tumor with NTRK gene fusion without known acquired resistance mutation
Tumor is metastatic or surgical resection likely causes severe morbidity
No satisfactory alternative treatments or tumor progressed after treatment

Histiocytic Neoplasms (Compendial / Covered Uses)

Authorization of 12 months may be granted for NTRK fusion‑positive histiocytic neoplasms when ALL apply:

ALL of the following

Diagnosis of NTRK gene fusion-positive histiocytic neoplasm of one of the following subtypes: Erdheim-Chester Disease (ECD), Langerhans Cell Histiocytosis (LCH), or Rosai-Dorfman Disease
ONE of
- Symptomatic disease
- Relapsed or refractory disease
No known acquired resistance mutation to NTRK inhibitors

Continuation / Reauthorization Criteria

NTRK Fusion Positive Gastrointestinal Stromal Tumor (GIST) - Reauthorization

Covered for reauthorization when ALL are met:

ALL of the following

Member previously authorized and currently receiving larotrectinib for NTRK fusion-positive GIST
No evidence of unacceptable toxicity while on current regimen

All Other Indications / Reauthorization

Covered for reauthorization when ALL are met:

ALL of the following

Member currently receiving larotrectinib for an indication listed in coverage criteria
No evidence of unacceptable toxicity or disease progression while on the current regimen

Unproven / Exclusions

Not Covered / Experimental or Investigational

Not medically necessary when the following apply:

Indication is not FDA-approved for larotrectinib and not listed as a covered compendial use (all other indications)

Requests for larotrectinib for indications other than the FDA‑approved solid tumor indication or the specified NTRK fusion‑positive histiocytic neoplasms are considered experimental/investigational and will be denied as not medically necessary; chart documentation of NTRK fusion status must be submitted to initiate prior authorization review.

Provider Actions & Prior Authorization

Prior Authorization

Prior authorization required with documentation of NTRK gene fusion

Submit chart documentation indicating NTRK gene fusion status (examples: next-generation sequencing [NGS] or fluorescence in situ hybridization [FISH]) with the prior authorization request to initiate review.

Chart documentation: NTRK gene fusion status (NGS or FISH)

Documentation Required

Laboratory evidence required

Laboratory evidence demonstrating an NTRK gene fusion without a known acquired resistance mutation is required. Acceptable examples of testing include next-generation sequencing (NGS) or fluorescence in situ hybridization (FISH).

Laboratory demonstration of NTRK gene fusion without known acquired resistance mutation
Examples: NGS or FISH

Prior Authorization

Authorization duration

Initial and reauthorization approvals may be granted for up to 12 months when the coverage criteria are met.

Authorization duration: up to 12 months for initial approval
Reauthorization: up to 12 months when criteria are met and no unacceptable toxicity or progression (as applicable)

Denial Risk

Not covered if indication is not listed

Requests for larotrectinib for indications that are not FDA‑approved or not listed as covered compendial uses (including histiocytic neoplasms specified) are considered experimental/investigational and will be denied as not medically necessary.

Not covered if the indication is not listed in the policy (will be denied as not medically necessary)

Background

Background: Larotrectinib is indicated for tumors with NTRK gene fusions; this policy aligns coverage to the FDA‑approved solid tumor indication and select compendial uses for NTRK fusion‑positive histiocytic neoplasms. Authorization decisions require documentation of NTRK fusion status (laboratory demonstration such as NGS or FISH) and absence of known acquired resistance mutations. Definition: NTRK gene fusion without a known acquired resistance mutation — presence of an NTRK gene fusion as demonstrated by laboratory testing (e.g., NGS or FISH) and absence of documented resistance mutations.

Key Clinical Thresholds / Statistics

Covered Histiocytic Subtypes3 (ECD, LCH, Rosai‑Dorfman Disease)

Authorization Duration12 months (initial and reauthorization when criteria met)

Required Biomarker (NTRK fusion)1 (laboratory documentation of NTRK gene fusion; absence of known acquired resistance mutation)

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyVitrakvi

Policy CodePolicy 2799-A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionSubmit chart documentation indicating NTRK gene fusion status (e.g., NGS or FISH) to initiate prior authorization review.

SourceLink

On This Page

OpenPayer

Vitrakvi

Coverage Summary

Initial Therapy Criteria

Continuation / Reauthorization Criteria

Unproven / Exclusions

Provider Actions & Prior Authorization

Applicable Codes

Clinical Evidence

Background

Revision History