CurrentUnitedHealthcarePolicy N/A

Vitrakvi (larotrectinib) prior authorization

Prior authorization and notification requirements for Vitrakvi (larotrectinib) for UnitedHealthcare members, including initial and reauthorization criteria and special rules for members under age 19.

Policy Summary

PayerUnitedHealthcare

PolicyVitrakvi (larotrectinib) prior authorization

Policy CodePolicy N/A

Change TypeNo material change

Effective DateApr 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization with documentation of a solid tumor positive for NTRK gene fusion, no known acquired resistance mutation, and metastatic or unresectable disease.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsauthorization period

age <19pediatric auto-process

NCCN 1/2A/2BNCCN recognition

2025 P 1271-7program number

Coverage Criteria for Vitrakvi (larotrectinib)

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Initial Authorization: (1) Presence of a solid tumor

Initial Authorization: (2) Disease is positive for an NTRK gene fusion (e.g., ETV6-NTRK3, TPM3-NTRK1, LMNA-NTRK1)

Initial Authorization: (3) Disease is without a known acquired resistance mutation (e.g., TRKA G595R, G623R, G696A, F617L)

Initial Authorization: (4) Disease is metastatic OR unresectable

Authorization issued for 12 months

Patients less than 19 years of age

Automatic processing for pediatric members:

Pediatric: Patient is less than 19 years of age; prescription will automatically process without a coverage review

Authorization issued for 12 months

State-specific mandates and compendium requirements may supersede the criteria in this policy. Where applicable, state laws requiring coverage for off‑label uses or adherence to particular compendia take precedence over the notification and coverage criteria set forth here. For members under 19 years of age, prescriptions for Vitrakvi will automatically process without a coverage review in accordance with this policy and any applicable state mandates.

Initial Therapy Requirements

Initial Therapy

Initial therapy coverage logic:

Initial therapy: Solid tumor with NTRK gene fusion; no known acquired resistance mutation; disease is metastatic or unresectable

Authorization issued for 12 months

Continuation / Reauthorization Criteria

Continuation Therapy

Continuation / reauthorization criteria:

Continuation: Patient does not show evidence of progressive disease while on Vitrakvi therapy

Authorizations are issued for 12 months

Provider Actions and Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior Authorization Required: Prior authorization is required for Vitrakvi (larotrectinib). Pediatric cases (patients <19 years) may be auto-processed per program rules; when auto-processing does not apply, submit a prior authorization request with required clinical documentation. Initial authorizations are typically issued for up to 12 months.

Initial authorization: confirm presence of a solid tumor and documented NTRK gene fusion; disease must be metastatic or unresectable.
Pediatric: patients <19 years — authorization will be issued for 12 months (may be auto-processed where program allows).
Reauthorization: patient must not show evidence of progressive disease on Vitrakvi therapy.

Documentation Required

Documentation Requirements

Documentation must demonstrate tumor type and molecular findings. Absence of required documentation may delay or result in denial of the request.

Evidence of a solid tumor (histology, imaging, or pathology report).
Laboratory/pathology report confirming NTRK gene fusion (examples: ETV6‑NTRK3, TPM3‑NTRK1, LMNA‑NTRK1).
Testing results or report showing no known acquired resistance mutations (e.g., TRKA G595R, G623R, G696A, F617L).
Clinical notes/supporting records showing disease is metastatic or unresectable where applicable.

Denial Risk

Denial Risk — Incomplete or Exclusionary Documentation

Denial Risk: Missing or incomplete documentation for tumor type, NTRK fusion status, or presence of resistance mutations may lead to denial. Presence of a known acquired resistance mutation is a contraindicating reason for coverage.

Absence of documentation confirming a solid tumor or NTRK gene fusion may result in denial.
Documentation indicating a known acquired resistance mutation (e.g., TRKA G595R, G623R, G696A, F617L) may result in denial.

Note

Additional Approval Logic and Limits

Additional Approval Logic: UnitedHealthcare may approve initial or reauthorization requests based solely on prior claim/medication history, diagnosis codes (ICD‑10), and/or automated claim logic. Supply limits may apply.

Approvals may be granted using automated processes that consider prior claims, medication history, and diagnosis codes.
Supply limits may be imposed; verify allowed quantity/dispense limits during authorization.

Definitions

inv-10: NTRK gene fusion — definition and examples

DefinitionNTRK gene fusion-positive disease: solid tumors that harbor a neurotrophic receptor tyrosine kinase (NTRK) gene fusion and meet indications for larotrectinib (metastatic or where surgical resection likely causes severe morbidity; no satisfactory alternatives).

Example fusion — ETV6-NTRK3Listed as an illustrative NTRK fusion in policy examples of NTRK fusion–positive tumors.

Example fusion — TPM3-NTRK1Included among representative NTRK gene fusions observed in solid tumors considered for therapy.

Example fusion — LMNA-NTRK1Provided as an additional example of NTRK gene fusion–positive tumors in the policy context.

inv-11: Acquired resistance mutation — known examples

DefinitionAcquired resistance mutation: a mutation in the NTRK gene that confers resistance to NTRK inhibitors and excludes patients from coverage unless absent

Example — TRKA G595RSpecifically named in the policy as a known acquired resistance mutation (TRKA G595R).

Example — G623RListed in the policy as an example of a resistance-associated substitution (G623R).

Example — G696AIncluded among examples of acquired resistance mutations (G696A).

Example — F617LCited in the policy text as a known acquired resistance mutation (F617L).

Background

Larotrectinib (Vitrakvi) is a small‑molecule kinase inhibitor indicated for treatment of adult and pediatric patients with solid tumors that harbor an NTRK gene fusion. Approval is for tumors that are metastatic or where surgical resection would likely result in severe morbidity, and the tumor must be without a known acquired resistance mutation (examples include TRKA G595R, G623R, G696A, F617L). Continued approval is based on clinical benefit observed in ongoing evaluation; this policy’s coverage criteria reflect those indication specifics for initial and continued therapy.

Quantity Limits and Supply

inv-14: Vitrakvi (larotrectinib) — supply / quantity limit notes

Quantity limits noteSupply limits may be in place for Vitrakvi (larotrectinib); UnitedHealthcare may apply program-specific limits.

Automated approval considerationsUnitedHealthcare may approve based on previous claim/medication history, diagnosis codes, and/or claim logic; automated processes vary by program/therapeutic class.

Authorization periodAuthorizations are issued for 12 months per policy rules (see coverage criteria for specifics).

Policy Summary

PayerUnitedHealthcare

PolicyVitrakvi (larotrectinib) prior authorization

Policy CodePolicy N/A

Change TypeNo material change

Effective DateApr 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization with documentation of a solid tumor positive for NTRK gene fusion, no known acquired resistance mutation, and metastatic or unresectable disease.

SourceLink

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