Subject: Buprenorphine-Naloxone Limit 1553-H P12-2024

Drug

SUVOXONE  (buprenorphine and naloxone )

ZUBSOLV  (buprenorphine and naloxone )

Policy:

Indications

FDA-approved Indications

Buprenorphine and Naloxone Sublingual Tablet (Suboxone Tablet)

Buprenorphine and naloxone sublingual tablets are indicated for the maintenance treatment of opioid dependence. Buprenorphine and naloxone sublingual tablets should be used as part of a complete treatment plan that includes counseling and psychosocial support.

Suboxone Film

Suboxone sublingual film is indicated for treatment of opioid dependence. Suboxone sublingual film should be used as part of a complete treatment plan that includes counseling and psychosocial support.

Zubsolv

Zubsolv is indicated for treatment of opioid dependence. Zubsolv should be used as part of a complete treatment plan that includes counseling and psychosocial support.

Initial Limit Quantity

This limit is coded for daily dose. Limits do not accumulate together. Patient is allowed the maximum limit for each drug and strength.

Drug	Daily Limit
Suboxone 2 mg/0.5 mg, 4 mg/1 mg, 8 mg/2 mg	3 units / day
Suboxone 12 mg/3 mg	2 units / day
Zubsolv 0.7 mg/0.18 mg, 1.4 mg/0.36 mg, 2.9 mg/0.71 mg, 5.7 mg/1.4 mg	3 units / day
Zubsolv 8.6 mg/2.1 mg	2 units / day
Zubsolv 11.4 mg/2.9 mg	1 unit / day

Place of Service:

Outpatient

The above policy is based on the following references:

1. Buprenorphine and Naloxone tablets [package insert]. Berkeley Heights, NJ: Hikma Pharmaceuticals USA Inc.; July 2024.
2. Suboxone Sublingual Film [package insert]. North Chesterfield, VA: Indivior, Inc.; December 2023.
3. Zubsolv [package insert]. Morristown, NJ: Orexo US, Inc.; December 2023.
4. Lexicomp Online, AHFS DI (Adult and Pediatric) Online. Waltham, MA: UpToDate, Inc.; 2024. https://online.lexi.com. Accessed November 5, 2024.
5. Micromedex® (electronic version). Merative, Ann Arbor, Michigan, USA. Available at: https://www.micromedexsolutions.com/ (cited: 11/05/2024).
6. Cunningham C, Edlund MJ, Fishman M, et al. The ASAM National Practice Guideline for the Treatment of Opioid Use Disorder: 2020 focused update. American Society of Addiction Medicine. January 2020. 1-91.

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