CurrentCignaPolicy N/A

Oncology - Vitrakvi (larotrectinib) Prior Authorization Policy

Defines Cigna prior authorization requirements and coverage criteria for Vitrakvi (larotrectinib) for FDA‑approved indications and selected evidence‑supported uses, affecting prescribers and benefits administrators for Cigna plans.

Policy Summary

PayerCigna

PolicyOncology - Vitrakvi (larotrectinib) Prior Authorization Policy

Policy CodePolicy N/A

Change TypeAdded pediatric diffuse high-grade glioma supportive-use criteria

Effective DateN/A

Next Review DateFeb 26, 2025

Key ActionSubmit prior authorization with documentation of NTRK gene fusion testing and clinical details to support the requested FDA‑approved or evidence‑supported use.

SourceLink

POLICY UPDATE CHANGES

Pediatric Diffuse High-Grade Gliomas: Added new approval condition and criteria under 'Other Uses with Supportive Evidence' based on guideline recommendations.

1 yearauthorization duration for approved indications

NTRK fusionbiomarker requirement for coverage

≤21 yrsage limit for supportive-use approval

2025-02-26policy review

Coverage Criteria for Vitrakvi (larotrectinib)

FDA-Approved Indication - Solid Tumors

Covered when ALL of the following are met

FDA-Approved Solid Tumors: Approve for 1 year if the patient meets BOTH of the following (A and B):

A) Biomarker: The tumor is positive for neurotrophic receptor tyrosine kinase (NTRK) gene fusion;

B) Disease status: Patient meets ONE of the following: i. The tumor is metastatic; OR ii. Surgical resection of tumor will likely result in severe morbidity.

Other Uses with Supportive Evidence - Pediatric Diffuse High-Grade Gliomas

Covered when ALL of the following are met

Policy Summary

PayerCigna

PolicyOncology - Vitrakvi (larotrectinib) Prior Authorization Policy

Policy CodePolicy N/A

Change TypeAdded pediatric diffuse high-grade glioma supportive-use criteria

Effective DateN/A

Next Review DateFeb 26, 2025

Key ActionSubmit prior authorization with documentation of NTRK gene fusion testing and clinical details to support the requested FDA‑approved or evidence‑supported use.

SourceLink

On This Page

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Provider Actions and Authorization Requirements

Prior Authorization

Prior Authorization Recommended

Prior authorization is recommended for prescription benefit coverage of Vitrakvi. Approvals are granted for 1 year when the authorization criteria are met.

Vitrakvi (larotrectinib) — approvals provided for 1 year when criteria are met

Step Therapy

No step therapy or prior agent sequencing requirements are specified in this policy. Providers do not need to document trials of alternative agents prior to requesting authorization when submitting requests that otherwise meet the coverage criteria.

Documentation Required

Required Documentation

Prior authorization requests should include documentation consistent with the member's benefit plan and sufficient clinical information to support medical necessity. Recommended documentation includes evidence of NTRK gene fusion testing (test name, date, and result) and clinical information such as diagnosis, tumor site, disease stage, prior therapies, and rationale for use (for example, metastatic disease or expected morbidity from resection).

Include NTRK gene fusion test name, date, and result
Provide diagnosis, tumor site, and staging information
List prior therapies and dates
Explain indication (metastatic disease, surgical morbidity risk, adjuvant use, or recurrent/progressive disease) and patient age when relevant

Denial Risk

Not Recommended / Experimental Uses

Requests for indications, uses, or clinical scenarios not listed in the Recommended Authorization Criteria are considered experimental, investigational, or not recommended and are not covered.

Coverage not recommended for indications not specified in the policy criteria

Definitions

Neurotrophic receptor tyrosine kinase (NTRK) gene fusion — molecular alteration required for coverage under this policy.

DefinitionNeurotrophic receptor tyrosine kinase (NTRK) gene fusion — a tumor genomic rearrangement resulting in an NTRK fusion oncogene; presence is required for coverage under this policy.

Coverage requirementThe tumor must be positive for an NTRK gene fusion to meet the biomarker criterion for FDA‑approved solid tumor coverage (required for approval).

Resistance mutationsNTRK gene fusion must be present without a known acquired resistance mutation as described in the product indication.

Clinical contextApplies to adult and pediatric solid tumors considered metastatic or where surgery would likely cause severe morbidity per the FDA‑approved indication.

Supporting sourceSee FDA‑approved indication and overview for Vitrakvi specifying NTRK fusion requirement for treatment eligibility.

OpenPayer

Oncology - Vitrakvi (larotrectinib) Prior Authorization Policy

Coverage Criteria for Vitrakvi (larotrectinib)

Provider Actions and Authorization Requirements

Background

Definitions

Line of Therapy

Biomarker Requirements