Subject: Specialty Quantity Limit Imbruvica 2282-H P2024_R

Drug

IMBRUVICA  (ibrutinib)

Policy:

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.

Covered Quantities

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

Medication	Standard Limit	Exception Limit
Imbruvica (ibrutinib) 70 mg capsules	30 per 30 days	N/A
Imbruvica (ibrutinib) 140 mg capsules	90 per 30 days	120 per 30 days
Imbruvica (ibrutinib) 140 mg tablets	30 per 30 days	120 per 30 days
Imbruvica (ibrutinib) 280 mg tablets	30 per 30 days	60 per 30 days
Imbruvica (ibrutinib) 420 mg tablets	30 per 30 days	N/A
Imbruvica (ibrutinib) 560 mg tablets	30 per 30 days	N/A
Imbruvica (ibrutinib) 70 mg/mL oral suspension	216 mL (2 bottles) per 36 days	216 mL (2 bottles) per 27 days

FDA-Recommended dosing

Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma and Waldenström’s Macroglobulinemia:
420 mg orally once daily until disease progression or unacceptable toxicity.

Chronic Graft versus Host Disease (cGVHD):
For patients age 12 years and older with cGVHD the dosage is 420 mg orally once daily, and for patients 1 to less than 12 years of age with cGVHD the dosage is 240 mg/m2 orally once daily (up to a dose of 420 mg), until cGVHD progression, recurrence of an underlying malignancy, or unacceptable toxicity.

Dose reduction: 70 mg to 280 mg orally once daily.

Place of Service:

Outpatient

The above policy is based on the following references:

1. Imbruvica [package insert]. South San Francisco, CA: Pharmacyclics LLC; May 2024.
2. The NCCN Drugs & Biologics Compendium® © 2024 National Comprehensive Cancer Network, Inc. Available at: https://www.nccn.org. Accessed June 6, 2024.

 

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.

January 01, 2025