Subject: Specialty Quantity Limit Vitrakvi 2800-H P2023
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 reactions, 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
|
300 mL per
30 days
|
600 mL 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:
- Vitrakvi [package insert]. Whippany, NJ: Bayer HealthCare Pharmaceuticals Inc.; December 2022.
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 31, 2023
