VITRAKVI (larotrectinib)

VITRAKVI (larotrectinib)

SELF ADMINISTRATION - ORAL

Diagnosis considered for coverage:

• Solid Tumors: Indicated for the treatment of adult and pediatric patients with solid tumors that:
  • have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion without a known acquired resistance mutation,
  • are metastatic or where surgical resection is likely to result in severe morbidity, and
  • have no satisfactory alternative treatments or that have progressed following treatment
  • This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials

Coverage Criteria: 

For diagnosis of solid tumors:

• Presence of solid tumors (e.g., salivary gland, soft tissue sarcoma, infantile fibrosarcoma, thyroid cancer, lung, melanoma, colon, etc.) with positive for neurotrophic receptor tyrosine kinase (NTRK) gene fusion (e.g. ETV6-NTRK3, TPM3-NTRK1, LMNA-NTRK1, etc.); AND
• Disease is without a known acquired resistance mutation [e.g., TRKA G595R substitution, TRKA G667C substitution, or other recurrent kinase domain (solvent front and xDFG) mutations]; AND
• Disease is one of the following:
  • Metastatic 
  • Unresectable (including cases where surgical resection is likely to result in severe morbidity); AND
• One of the following:
  • Disease has progressed on previous treatment (e.g., surgery, radiotherapy, or systemic therapy) 
  • Disease has no satisfactory alternative treatments 

Reauthorization Criteria:

For diagnosis of solid tumors:

• Patient does not show evidence of progressive disease while on therapy

Dosing: 

Solid Tumors:

• Adult and pediatric patients with BSA of at least 1 m²: 100 mg orally twice daily until disease progression or until unacceptable toxicity
• Pediatric patients with body surface area less than 1 m²: 100 mg/m² orally twice daily until disease progression or until unacceptable toxicity

Coverage Duration: 

• Initial: 1 year
• Reauthorization: 1 year

Authorization is not covered for the following:

The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics (P&T) Committee.

Additional Information: 

• Vitrakvi capsule or oral solution may be used interchangeably
• The safety and effectiveness of Vitrakvi in pediatric patients was established based upon data from three multicenter, open-label, single-arm clinical trials in adult or pediatric patients 28 days and older

Policy Updates:

• Effective 12/4/2019 – New policy approved by WHA P&T Committee. (P&T, 3/19/2019)
• Effective 6/1/2024 – Updated policy for solid tumors. (P&T, 5/21/2024)

References:

1. Vitrakvi Prescribing Information. Bayer HealthCare Pharmaceuticals Inc. Whippany, NJ. November 2023.