Subject: Specialty Quantity Limit Imbruvica 2282-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
|
FDA-recommended dosing
|
|
Imbruvica
(ibrutinib)
70 mg capsules
|
30 per 30 days
|
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
|
|
Imbruvica
(ibrutinib)
140 mg capsules
|
90 per 30 days
|
|
Imbruvica
(ibrutinib)
140 mg tablets
|
30 per 30 days
|
|
Imbruvica
(ibrutinib)
280 mg tablets
|
30 per 30 days
|
|
Imbruvica
(ibrutinib)
420 mg tablets
|
30 per 30 days
|
|
Imbruvica
(ibrutinib)
560 mg tablets
|
30 per 30 days
|
|
Imbruvica
(ibrutinib)
70 mg/mL
oral suspension
|
216 mL
(2 bottles)
per 36 days
|
Place of Service:
Outpatient
The above policy is based on the following references:
- Imbruvica [package insert]. South San Francisco, CA: Pharmacyclics LLC; May 2023.
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
