Subject: Specialty Quantity Limit Kisqali 1652-H P2025

Drug

KISQALI  (ribociclib)

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 the treatment of 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
Kisqali (ribociclib) 600 mg daily dose carton [contains three blister packs   with 21 200-mg tablets each]	63 tablets per 28 days
Kisqali (ribociclib) 400 mg daily dose carton [contains three blister packs   with 14 200-mg tablets each]	42 tablets per 28 days
Kisqali (ribociclib) 200 mg daily dose carton [contains one blister pack   with 21 200-mg tablets each]	21 tablets per 28 days

FDA-recommended Dosing

Early Breast Cancer

The recommended dose is 400 mg taken orally once daily for 21 consecutive days followed by 7 days off treatment resulting in a complete cycle of 28 days.

Advanced or Metastatic Breast Cancer

The recommended dose is 600 mg taken orally once daily for 21 consecutive days followed by 7 days off treatment resulting in a complete cycle of 28 days.

Dose modifications may be required for adverse reactions, moderate to severe hepatic impairment, severe renal impairment or use with strong CYP3A4 inhibitors.

Place of Service:

Outpatient

The above policy is based on the following references:

        1. Kisqali [package insert]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; 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.

June 07, 2025