Subject: Lotronex PA 129-A, 690-A P10-2025

Drug

LOTONEX  (alosetron)

Policy:

Indications

FDA-approved Indications

Lotronex is indicated only for women with severe diarrhea-predominant irritable bowel syndrome (IBS) who have:

• chronic IBS symptoms (generally lasting 6 months or longer),
• had anatomic or biochemical abnormalities of the gastrointestinal tract excluded, and
• not responded adequately to conventional therapy.

Diarrhea-predominant IBS is severe if it includes diarrhea and one or more of the following:

• frequent and severe abdominal pain/discomfort,
• frequent bowel urgency or fecal incontinence,
• disability or restriction of daily activities due to IBS.

Because of infrequent but serious gastrointestinal adverse reactions associated with Lotronex, the indication is restricted to those patients for whom the benefit-to-risk balance is most favorable.

Clinical studies have not been performed to adequately confirm the benefits of Lotronex in men.

Coverage Criteria

Severe Diarrhea-Predominant Irritable Bowel Syndrome (IBS)

Authorization may be granted when the requested drug is being prescribed for a biological female or a person that self-identifies as a female with a diagnosis of severe diarrhea-predominant irritable bowel syndrome (IBS) when ALL of the following criteria are met:

• The patient has experienced chronic IBS symptoms lasting at least 6 months.
• Gastrointestinal tract abnormalities have been ruled out.
• The patient has had an inadequate response to conventional therapy.

Duration of Approval (DOA)

• 129-A: DOA: 36 months
• 690-A: DOA: 12 months

Place of Service:

Outpatient

The above policy is based on the following references:

1. Lotronex [package insert]. Roswell, GA: Sebela Pharmaceuticals Inc.; July 2016.
2. Lexicomp Online, AHFS DI (Adult and Pediatric) Online. Waltham, MA: UpToDate, Inc.; 2025. https://online.lexi.com. Accessed September 15, 2025.
3. Micromedex® (electronic version). Merative, Ann Arbor, Michigan, USA. Available at: https://www.micromedexsolutions.com/ (cited: 09/15/2025).

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.

February 14, 2026