Subject: Specialty Quantity Limit Vitrakvi 2800-H P2022

Drug

VITRAKVI  (larotrectinib)

Policy:

I.   PROGRAM DESCRIPTION 

The standard limit is designed to allow a quantity sufficient for the most common uses of the medication. If member’s plan allows a quantity limit exception review for the requested medication, coverage of an additional quantity may be provided up to the exception limit with prior authorization. 

II.  COVERED QUANTITIES 

Medication	Standard Limit	Exception Limit*	FDA-recommended dosing
Vitrakvi (larotrectinib) 25 mg capsules	180 per 30 days	Not applicable	• Adult or pediatric patients with BSA of >1.0 m2:    100 mg orally twice daily   • Pediatric patients with BSA <1.0 m2:     100 mg/m2 orally twice daily, not to exceed     100 mg twice daily   • Dose reductions may be required for adverse    reeactions, drug interactions, and hepatic    impairment.   • Concomitant use with strong CYP3A4     inducers: double the Vitrakvi dose
Vitrakvi (larotrectinib) 100 mg capsules	60 per 30 days	120 per 30 days
Vitrakvi (larotrectinib) oral solution (20 mg/mL) 100 mL bottle	300 mL (3 bottles) per 30 days	600 mL (6 bottles) per 30 days

* Coverage up to the exception limits may be provided with prior authorization via the Specialty Post Limit
   Quantity Exception Criteria for approval.

Place of Service:

Outpatient

The above policy is based on the following references:

1.  Vitrakvi [package insert]. Whippany, NJ: Bayer HealthCare Pharmaceuticals Inc.; March 2021.

Copyright Aetna Inc. All rights reserved. Pharmacy Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.

December 29, 2022