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Effective Date: 04/01/2019 Title: Vitrakvi (larotrectinib)
Revision Date: Document: BI614:00
CPT Code(s):
Public Statement

Effective Date:

a)    This policy will apply to all services performed on or after the above revision date which will become the new effective date.

b)    For all services referred to in this policy that were performed before the revision date, contact customer service for the rules that would apply.

1)    Vitrakvi (larotrectinib) requires prior authorization.

2)    Vitrakvi is used to treat adults and pediatrics with solid tumors that have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion. It is not used to treat a specific cancer.

3)  Vitrakvi is an oral specialty drug covered under the pharmacy benefit and must be obtained through a contracted specialty pharmacy.

Medical Statement

Vitrakvi (larotrectinib) is considered medically necessary for patients meeting the following conditions:

1)    Patient diagnoses with presence of solid tumors that are positive for neurotrophic receptor tyrosine kinase (NTRK) gene fusion (e.g. ETV6-NTRK3, TPM3-NTRK1, LMNA-NTRK1, etc.) AND

2)    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

3)    Disease is metastatic or unresectable (including cases where surgical resection is likely to result in severe morbidity) AND

4)    One of the following:

a.    Disease has progressed on previous treatment (e.g., surgery, radiotherapy, or systemic therapy)

b.    Disease has no satisfactory alternative treatments.

 

Reauthorization Criteria

·         Patient has not shown evidence of progression while on Vitrakvi therapy.


Limits

As an oral specialty drug, Vitrakvi is limited to a maximum 30 day supply per fill.


Reference

1)    Vitrakvi Prescribing Information. Loxo Oncology, Inc. Stamford, CT. November 2018.

2)    NCCN Drugs and Biologic Compendium. Accessed online 03-18-2019.


Application to Products
This policy applies to all health plans administered by QualChoice, both those insured by QualChoice and those that are self-funded by the sponsoring employer, unless there is indication in this policy otherwise or a stated exclusion in your medical plan booklet. Consult the individual plan sponsor Summary Plan Description (SPD) for self-insured plans or the specific Evidence of Coverage (EOC) for those plans insured by QualChoice. In the event of a discrepancy between this policy and a self-insured customer’s SPD or the specific QualChoice EOC, the SPD or EOC, as applicable, will prevail. State and federal mandates will be followed as they apply.
Changes: QualChoice reserves the right to alter, amend, change or supplement benefit interpretations as needed.
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