Subject: Amitiza PA 13-A, 990-A P10-2025

Drug

AMITZA  (lubiprostone)

Policy:

Indications

FDA-approved Indications

Chronic Idiopathic Constipation in Adults

Amitiza is indicated for the treatment of chronic idiopathic constipation (CIC) in adults.

Opioid-Induced Constipation in Adult Patients with Chronic Non-Cancer Pain

Amitiza is indicated for the treatment of opioid-induced constipation (OIC) in adult patients with chronic, non-cancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent (e.g., weekly) opioid dosage escalation.

Limitations of Use

Effectiveness of Amitiza in the treatment of opioid-induced constipation in patients taking diphenylheptane opioids (e.g., methadone) has not been established.

Irritable Bowel Syndrome with Constipation

Amitiza is indicated for the treatment of irritable bowel syndrome with constipation (IBS-C) in women at least 18 years old.

Coverage Criteria

Chronic Idiopathic Constipation (CIC)

Authorization may be granted when the requested drug is being prescribed for the treatment of chronic idiopathic constipation (CIC) in an adult patient.

Irritable Bowel Syndrome with Constipation (IBS-C)

Authorization may be granted when the requested drug is being prescribed for the treatment of irritable bowel syndrome with constipation (IBS-C) in a biological female or a person that self-identifies as a female when the following criteria is met:

• The patient is 18 years of age or older.

Opioid-Induced Constipation (OIC)

Authorization may be granted when the requested drug is being prescribed for the treatment of opioid-induced constipation (OIC) in an adult patient with chronic, non-cancer pain, including chronic pain related to prior cancer or its treatment, who does NOT require frequent (e.g., weekly) opioid dosage escalation.

Duration of Approval (DOA)

• 13-A: DOA: 36 months
• 990-A: DOA: 12 months

Place of Service:

Outpatient

The above policy is based on the following references:

1. Amitiza [package insert]. Webster Groves, MO: SpecGx LLC; Bridgewater, NJ: Sucampo Pharma Americas LLC; January 2024.
2. Lexicomp Online, AHFS DI (Adult and Pediatric) Online. Waltham, MA: UpToDate, Inc.; 2025. https://online.lexi.com. Accessed August 4, 2025.
3. Micromedex® (electronic version). Merative, Ann Arbor, Michigan, USA. Available at: https://www.micromedexsolutions.com/ (cited: 08/04/2025).

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