Subject: Zelnorm PA Policy 2986-A 02-2022
Policy:
FDA-approved Indications
Zelnorm is indicated for the treatment of adult women less than 65 years of age with irritable bowel syndrome with constipation (IBS-C).
Limitations of Use
The safety and effectiveness of Zelnorm in men with IBS-C have not been established.
COVERAGE CRITERIA
The requested drug will be covered with prior authorization when the following criteria are met:
• The requested drug is being prescribed for the treatment of irritable bowel syndrome with constipation (IBS-C)
AND
• The requested drug is being prescribed for a biological female or a person that self-identifies as a female
less than 65 years of age
Place of Service:
Outpatient
The above policy is based on the following references:
- Zelnorm [package insert]. Covington, LA: Alfasigma USA, Inc.; June 2020.
- Lexicomp Online, AHFS DI (Adult and Pediatric) Online, Hudson, Ohio: UpToDate, Inc.; 2021; Accessed January 6, 2022.
- Micromedex (electronic version). IBM Watson Health, Greenwood Village, Colorado, USA. Available at: https://www.micromedexsolutions.com. Accessed January 6, 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 14, 2022
