Subject: Daliresp PA 646-A P09-2024_R

Drug

DALIRESP  (roflumilast)

Policy:

Indications

FDA-approved Indications

Daliresp is indicated as a treatment to reduce the risk of COPD exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations.

Limitations of Use

Daliresp is not a bronchodilator and is not indicated for the relief of acute bronchospasm.

Daliresp 250 mcg is a starting dose, for the first 4 weeks of treatment only and is not the effective (therapeutic) dose.

Coverage Criteria

Chronic Obstructive Pulmonary Disease (COPD)

Authorization may be granted when the requested drug is being prescribed to reduce the risk of chronic obstructive pulmonary disease (COPD) exacerbations in a patient with severe COPD associated with chronic bronchitis and a history of exacerbations.

Duration of Approval (DOA)

• 646-A: DOA: 12 months

Place of Service:

Outpatient

The above policy is based on the following references:

1. Daliresp [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; March 2019.
2. Lexicomp Online, AHFS DI (Adult and Pediatric) Online, Waltham, MA: UpToDate, Inc.; 2024. https://online.lexi.com. Accessed July 31, 2024.
3. Micromedex® (electronic version). Merative, Ann Arbor, Michigan, USA. Available at: https://www.micromedexsolutions.com/ (cited: 07/31/2024).

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.

March 16, 2025