Subject: Symproic PA 1713-A P10-2024_R

Drug

SYMPROIC  (naldemedine)

Policy:

Indications

FDA-approved Indications

Symproic 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.

Coverage Criteria

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)       

• 1713-A: DOA: 12 months

Place of Service:

Outpatient

The above policy is based on the following references:

1. Symproic [package insert]. Raleigh, NC: BioDelivery Sciences International, Inc.; July 2021.
2. Lexicomp Online, AHFS DI (Adult and Pediatric) Online. Waltham, MA: UpToDate, Inc.; 2024. https://online.lexi.com. Accessed September 12, 2024.
3. Micromedex® (electronic version). Merative, Ann Arbor, Michigan, USA. Available at: https://www.micromedexsolutions.com/ (cited: 09/12/2024).

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.

February 16, 2025