Subject: Specialty Quantity Limit Gilotrif 1753-H P2024
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:
° P-gp inhibitors: reduce daily dose by 10 mg. Resume the previous dose
after discontinuation of the P-gp inhibitor.
° 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:
- Gilotrif [package insert]. Ridgefield, CT: Boehringer Ingelheim Pharmaceuticals, Inc.; April 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.
August 18, 2024
