Last Review Date: 04/07/2025

Date of Origin: 02/01/2018

Dates Reviewed: 02/2018, 06/2023, 12/2024, 04/2025

1. Length of Authorization

Coverage will be provided initially for 2 months and may be renewed annually thereafter.

2. Dosing Limits

     Max Units (per dose and over time):

     [Q9991]

• Loading dose: 1 billable unit for 1 dose
• Maintenance dose: 1 billable unit every 28 days

   [Q9992]

• Loading dose: 1 billable unit every 7 days for 2 doses
• Maintenance dose: 1 billable unit every 28 days

3. Initial Approval Criteria ¹

Coverage is provided in the following conditions:

• Patient is at least 18 years of age; AND

Universal Criteria ¹

• Documented participation in and adherence to a comprehensive management program including psychosocial support; AND
• Patients currently receiving treatment with transmucosal buprenorphine will transition off therapy upon initiation of Sublocade; AND
• Patient is NOT concomitantly receiving other long-acting products for the treatment of opioid abuse disorder (e.g., buprenorphine[Brixadi®] , naltrexone [Vivitrol®], etc.); AND

Opioid Dependence † ¹

• Patient has a diagnosis of moderate to severe opioid use disorder; AND
• Patient has initiated treatment with a single dose of a transmucosal buprenorphine product or is already being treated with buprenorphine

† FDA Approved Indication(s); ‡ Compendia Recommended Indication(s); Ф Orphan Drug

4. Renewal Criteria ¹

Coverage may be renewed based on the following criteria:

• Patient continues to meet the universal and other indication-specific relevant criteria identified in section III; AND
• Absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity include: adrenal insufficiency, severe injection site reactions, life-threatening respiratory and/or CNS depression, hepatitis, severe hypersensitivity reactions, QTc prolongation, severe orthostatic hypotension, etc.; AND
  • Patient has shown a documented continued clinical benefit as defined by complete abstinence from or reduction in the use of opioids confirmed on urine drug screen; AND
    • Continued administration is necessary to prevent relapse; OR
  • Patient did not demonstrate a satisfactory clinical response, as evidenced by self-reported illicit opioid use or urine drug screens positive for illicit opioid use; AND
    • Patient requires an increase in the maintenance dose to 300 mg monthly

5. Dosage/Administration ¹

6. Billing Code/Availability Information

HCPCS Code(s):

• Q9991 - Injection, buprenorphine extended-release (sublocade), less than or equal to 100 mg; 1 billable unit = 100 mg
• Q9992 - Injection, buprenorphine extended-release (sublocade), greater than 100 mg; 1 billable unit = 300 mg

NDC(s):

• Sublocade, 100 mg/0.5 mL single-dose prefilled syringe: 12496-0100-xx
• Sublocade, 300 mg/1.5 mL single-dose prefilled syringe: 12496-0300-xx

7. References

1. Sublocade [package insert]. North Chesterfield, VA; Indivior, Inc.; February 2025.  Accessed March 2025.
2. Reus VI, Fochtmann LJ, Bukstein O, et al. The American Psychiatric Association Practice Guideline for the Pharmacological Treatment of Patients With Alcohol Use Disorder. Am J Psychiatry. 2018 Jan 1;175(1):86-90.
3. The ASAM National Practice Guideline for the Treatment of Opioid Use Disorder: 2020 Focused Update. J Addict Med. 2020 Mar/Apr;14(2S Suppl 1):1-91. doi: 10.1097/ADM.0000000000000633.
4. Nasser AF, Greenwald MK, Vince B, et al. Sustained-Release Buprenorphine (RBP-6000) Blocks the Effects of Opioid Challenge With Hydromorphone in Subjects With Opioid Use Disorder. J Clin Psychopharmacol. 2016 Feb;36(1):18-26. doi: 10.1097/JCP.0000000000000434. PMID: 26650971; PMCID: PMC5549150.
5. Haight BR, Learned SM, Laffont CM, et al; RB-US-13-0001 Study Investigators. Efficacy and safety of a monthly buprenorphine depot injection for opioid use disorder: a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2019 Feb 23;393(10173):778-790. doi: 10.1016/S0140-6736(18)32259-1. Epub 2019 Feb 18. PMID: 30792007.

Appendix 1 – Covered Diagnosis Codes

Appendix 2 – Centers for Medicare and Medicaid Services (CMS)

The preceding information is intended for non-Medicare coverage determinations. Medicare coverage for outpatient (Part B) drugs is outlined in the Medicare Benefit Policy Manual (Pub. 100-2), Chapter 15, §50 Drugs and Biologicals. In addition, National Coverage Determinations (NCDs) and/or Local Coverage Determinations (LCDs) may exist and compliance with these policies is required where applicable. Local Coverage Articles (LCAs) may also exist for claims payment purposes or to clarify benefit eligibility under Part B for drugs which may be self-administered. The following link may be used to search for NCD, LCD, or LCA documents: https://www.cms.gov/medicare-coverage-database/search.aspx. Additional indications, including any preceding information, may be applied at the discretion of the health plan.

 Medicare Part B Covered Diagnosis Codes (applicable to existing NCD/LCD): N/A