Subject: Specialty Quantity Limit Iclusig 1721-H P2025

Drug

ICLUSIG  (ponatinib)

Policy:

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.

Covered Quantities

Medication	Standard Limit
Iclusig (ponatinib) 10 mg tablet)	30 tablets per 30 days
Iclusig (ponatinib) 15 mg tablet	30 tablets per 30 days
Iclusig (ponatinib) 30 mg tablet	30 tablets per 30 days
Iclusig (ponatinib) 45 mg tablet	30 tablets per 30 days

FDA-recommended Dosing

Initial dosing

45 mg orally once daily.

Initial dosing with strong CYP3A inhibitors or hepatic impairment (Child-Pugh A, B or C) or newly diagnosed Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia (Ph+ All)

30 mg once daily.

Dose adjustments

Dose adjustments may be required for adverse reactions, hepatic impairment, or use with strong CYP3A4 inhibitors.

Place of Service:

Outpatient

The above policy is based on the following references:

1. Iclusig [package insert]. Lexington, MA: Takeda Pharmaceuticals America, Inc.; September 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.

October 12, 2025