Subject: Specialty Quantity Limit pirfenidone-Esbriet 3205-H P2025

Drug

ESBRIET  (pirfenidone)

pirfenidone (all other brands)  (pirfenidone)

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 idiopathic pulmonary fibrosis 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
Esbriet (pirfenidone) capsules 267 mg in 14-day titration blister pack	63 capsules per 14 days
Esbriet (pirfenidone) capsules 267 mg in 4-week maintenance blister pack	252 capsules per 28 days
Esbriet (pirfenidone) capsules/film-coated tablets 267 mg	270 capsules/tablets per 30 days
Esbriet (pirfenidone) film-coated tablets 801 mg	90 tablets per 30 days
pirfenidone film-coated tablets 534 mg	90 tablets per 30 days

FDA-recommended Dosing

Idiopathic pulmonary fibrosis

• Days 1 through 7: 267 mg (one 267 mg capsule/tablet) three times daily (801 mg/day)
• Days 8 through 14: 534 mg (two 267 mg capsules/tablets or one 534mg tablet) three times daily (1602 mg/day)
• Days 15 onward: 801 mg (three 267 mg capsules/tablets or one 801 mg tablet) three times daily (2403 mg/day)

Dosage Modification due to Drug Interactions

• Reduce pirfenidone dosage to 267 mg three times a day when used with a strong CYP1A2 inhibitor (e.g., fluvoxamine, enoxacin)
• Reduce pirfenidone dosage to 534 mg three times a day when used with a moderate CYP1A2 inhibitors (e.g., ciprofloxacin 750mg twice daily)

Place of Service:

Outpatient

The above policy is based on the following references:

1. Esbriet [package insert]. South San Francisco, CA: Genentech USA, Inc.; February 2023.
2. Pirfenidone [package insert]. Berkeley Heights, NJ: Laurus Labs Limited; March 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