Subject: Dificid PA 2753-A P12-2024

Drug

DIFICID  (fidaxomicin)

Policy:

Indications

FDA-Approved Indications

Dificid is indicated in adult and pediatric patients aged 6 months and older for the treatment of C. difficile-associated diarrhea (CDAD).

Usage

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Dificid and other antibacterial drugs, Dificid should be used only to treat infections that are proven or strongly suspected to be caused by C. difficile. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

Coverage Criteria

C. difficile-Associated Diarrhea (CDAD)

Authorization may be granted for the requested drug when the patient has the diagnosis of C. difficile-associated diarrhea (CDAD) confirmed by a positive stool assay.

Duration of Approval (DOA)

• 2753-A: DOA: 10 days

Place of Service:

Outpatient

The above policy is based on the following references:

1. Dificid [package insert]. Whitehouse Station, NJ: Merck & Co., Inc.; June 2022.
2. Lexicomp Online, AHFS DI (Adult and Pediatric) Online. Waltham, MA: UpToDate, Inc.; 2024. https://online.lexi.com. Accessed November 4, 2024.
3. Micromedex (electronic version). Merative, Ann Arbor, Michigan, USA. Available at: https://www.micromedexsolutions.com/ (cited: 11/04/2024).
4. McDonald L, Gerding D, Johnson S, et al. Clinical Practice Guidelines for Clostridium difficile Infection in Adults and Children: 2017 Update by the Infectious Diseases Society of America (IDSA) and Society for Healthcare Epidemiology of America (SHEA). Clinical Infectious Diseases 2018:66 (7): e1-e48. https://doi.org/10.1093/cid/cix1085. Accessed November 4, 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.

April 23, 2025