Subject: Specialty Quantity Limit Imbruvica 2282-H P2023a
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
|
|
Imbruvica (ibrutinib) 70 mg capsules
|
30 per 30 days
|
N/A
|
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
|
120 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 tablets
|
30 per 30 days
|
120 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) 280 mg tablets
|
30 per 30 days
|
60 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) 420 mg tablets
|
30 per 30 days
|
N/A
|
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) 560 mg tablets
|
30 per 30 days
|
N/A
|
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) 70 mg/mL
oral suspension
|
216 mL (2 bottles)
per 36 days
|
216 mL (2 bottles)
per 27 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
|
*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:
- Imbruvica [package insert]. South San Francisco, CA: Pharmacyclics LLC; May 2023.
- The NCCN Drugs & Biologics Compendium® © 2024 National Comprehensive Cancer Network, Inc. Available at: https://www.nccn.org. Accessed January 9, 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.
April 13, 2024
