Subject: Specialty Quantity Limit lapatinib-Tykerb 1903-H P2025

Drug

TYKERB  (lapatinib)

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

The limits may apply to the generic equivalent medication.

Medication	Standard Limit
Tykerb (lapatinib) 250 mg tablets	180 tablets per 30 days

FDA-recommended Dosing

Breast cancer in combination with capecitabine:

1250 mg once daily

Breast cancer in combination with letrozole:

1500 mg once daily

Dose modifications may be needed due to adverse reactions, hepatic impairment and drug interactions.

Place of Service:

Outpatient

The above policy is based on the following references:

1. Tykerb [package insert]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; March 2022.
2. Lapatinib [package insert]. Baltimore, MD: Lupin Pharmaceuticals, Inc.; November 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.

June 07, 2025