Subject: Specialty Quantity Limit Gilotrif 1753-H P2022

Drug

GILOTRIF  (afatinib)

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 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
Gilotrif (afatinib)    20 mg tablets	30 per 30 days	• Initial dose: 40 mg once daily  • Dose adjustment for severe renal impairment:    30 mg once daily  • Dose adjustment for adverse reactions: resume     treatment when the adverse reaction fully     resolves, returns to baseline, or improves to     Grade 1. Reinstitute at a reduced dose (10 mg     per day less than the dose at which the adverse     reaction occurred)  • Dose adjustment for drug interactions:     º  P-gp inhibitors: reduce daily dose by 10 mg.         Resume the previous dose after         discontinuation of the P-gp inhibitor.     º  P-gp inducers: increase daily dose by 10 mg.         Resume the previous dose after         discontinuation of the P-gp inducer.
Gilotrif (afatinib)    30 mg tablets	30 per 30 days
Gilotrif (afatinib)    40 mg tablets	30 per 30 days

Place of Service:

Outpatient

The above policy is based on the following references:

1. Gilotrif [package insert]. Ridgefield, CT: Boehringer Ingelheim Pharmaceuticals, Inc.; October 2019.

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.

August 24, 2022