Subject: Specialty Quantity Limit Xtandi 1879-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 the 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
|
|
Xtandi (enzalutamide)
40 mg capsules
|
120 per 30 days
|
180 per 30 days
|
• 160 mg once daily
• 240 mg once daily if co-administered
with a strong CYP3A4 inducer
• 80 mg once daily if co-administered with
a strong CYP2C8 inhibitor
|
|
Xtandi (enzalutamide)
40 mg tablets
|
120 per 30 days
|
180 per 30 days
|
|
Xtandi (enzalutamide)
80 mg tablets
|
60 per 30 days
|
90 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:
- Xtandi [package insert]. Northbrook, IL: Astellas Pharma US, Inc.; September 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
