Subject: Specialty Quantity Limit Ibrance 1904-H P2023
Policy:
I. PROGRAM DESCRIPTION
The standard limit is designed to allow a quantity sufficient for
the most common uses of the medication. The recommended
dosing parameters for all FDA-approved indications fall within
the standard limits. Coverage of an additional quantity may be
reviewed on a case-by-case basis upon request.
II. COVERED QUANTITIES
|
Medication
|
Standard Limit
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FDA-recommended dosing
|
|
Ibrance (palbociclib) 75 mg tablets
|
21 tablets per 28 days
|
Breast Cancer: • Starting dose: 125 mg once daily for 21 consecutive days followed by 7 days off treatment to comprise a complete cycle of 28 days • First dose reduction: 100 mg once daily for 21 consecutive days followed by 7 days off treatment to comprise a complete cycle of 28 days • Second dose reduction: 75 mg once daily for 21 consecutive days followed by 7 days off treatment to comprise a complete cycle of 28 days
Dose modifications may be required for adverse reactions, severe hepatic impairment, or use with strong CYP3A4 inhibitors.
|
|
Ibrance (palbociclib) 100 mg tablets
|
21 tablets per 28 days
|
|
Ibrance (palbociclib) 125 mg tablets
|
21 tablets per 28 days
|
|
Ibrance (palbociclib) 75 mg capsules
|
21 capsules per 28 days
|
|
Ibrance (palbociclib) 100 mg capsules
|
21 capsules per 28 days
|
|
Ibrance (palbociclib) 125 mg capsules
|
21 capsules per 28 days
|
Place of Service:
Outpatient
The above policy is based on the following references:
- Ibrance capsules [package insert]. New York, NY: Pfizer Inc.; September 2019.
- Ibrance tablets [package insert]. New York, NY: Pfizer Inc.; November 2019.
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.
June 18, 2023