Vitrakvi (larotrectinib)
Indications for Prior Authorization
Vitrakvi (larotrectinib)
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For diagnosis of 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 and 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.
Criteria
Vitrakvi
Prior Authorization (Initial Authorization)
Length of Approval: 12 Month(s)
- 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.) [1] 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] [1] AND
- Disease is one of the following:
- Metastatic
- Unresectable (including cases where surgical resection is likely to result in severe morbidity)
- One of the following:
- Disease has progressed on previous treatment (e.g., surgery, radiotherapy, or systemic therapy)
- Disease has no satisfactory alternative treatments
Vitrakvi
Prior Authorization (Reauthorization)
Length of Approval: 12 Month(s)
- Patient does not show evidence of progressive disease while on therapy
P & T Revisions
2024-02-20, 2023-06-26, 2023-03-16, 2022-01-28, 2021-02-03, 2020-01-21
References
- Vitrakvi Prescribing Information. Bayer HealthCare Pharmaceuticals Inc. Whippany, NJ. November 2023.
Revision History
- 2024-02-20: 2024 Annual review: no criteria changes.
- 2023-06-26: Removed specialist requirement.
- 2023-03-16: Annual review - no criteria changes.
- 2022-01-28: 2022 Annual Review - No changes to criteria
- 2021-02-03: 2021 Annual Review
- 2020-01-21: 2020 Annual Review
HEALTHY LIVING