Subject: Specialty Quantity Limit lapatinib-Tykerb 1903-H P2023

Drug

TYKERB  (lapatinib)

lapatinib

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 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.

 
   II.  COVERED QUANTITIES

Medication	Standard Limit	FDA-recommended dosing
Tykerb (lapatinib)   250 mg tablets	180 tablets   per 30 days	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.

           *The limits may apply to the generic equivalent medication.

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.; July 2022.

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 18, 2023