What is a recommended policy for using Sublocade (buprenorphine extended-release)

Sublocade (Buprenorphine Extended-Release) Policy for Primary Care Facilities

Primary care facilities should implement Sublocade as a monthly maintenance treatment option for patients with moderate-to-severe opioid use disorder who have been stabilized on sublingual buprenorphine, prioritizing the 300-mg maintenance dose for patients who inject opioids and offering flexible injection sites beyond the abdomen.

Patient Selection Criteria

Eligible Patients

• Adults with moderate-to-severe opioid use disorder meeting DSM-5 diagnostic criteria 1
• Patients already stabilized on sublingual buprenorphine/naloxone (typically 12/3 mg daily for ≥7 days) 2
• Patients in current maintenance treatment episodes, particularly those maintained for >28 days 1
• Patients who inject opioids or use high doses of opioids (these patients specifically benefit from higher buprenorphine doses) 3

Contraindications and High-Risk Populations

• Patients not yet stabilized on sublingual buprenorphine should not receive Sublocade 2
• Patients with viable pregnancy, chronic opioid therapy for pain, anticipated surgery, or serious acute medical illness (heart failure, liver failure, kidney failure, respiratory failure) require special consideration 4

Dosing Protocol

Initial Dosing

• Administer 300 mg subcutaneously for the first two monthly injections 5, 3
• Patients must be stabilized on sublingual buprenorphine before initiating Sublocade 2

Maintenance Dosing Strategy

• For patients who inject opioids: Continue 300-mg monthly maintenance doses 3
• For non-injecting patients: Either 100-mg or 300-mg monthly maintenance doses are equally effective 3
• The 300-mg maintenance dose provides clinically meaningful improvements in treatment retention and opioid abstinence specifically for opioid-injecting participants 3

Injection Site Options

• Approved injection sites include: abdomen (reference site), upper arm, thigh, and buttocks 2
• All four sites maintain therapeutic buprenorphine plasma concentrations ≥2 ng/mL 2
• Upper arm and thigh produce approximately 39% and 52% higher peak concentrations respectively versus abdomen, but without increased adverse events 2
• Rotate injection sites to accommodate patient preferences and minimize injection site reactions 2

Clinical Monitoring and Safety

Expected Outcomes

• After 12 months of treatment, expect 62-76% of patients to achieve opioid abstinence 5
• Treatment retention rates of approximately 50% at 12 months 5
• Mean abstinence from non-medical opioids of 123 days over 24 weeks (versus 104 days with daily standard-of-care) 1

Adverse Event Management

• Injection-site reactions occur in 13.2% of patients, mostly mild-to-moderate severity 5
• Pain from drug administration is the most common adverse event (26.9% of all adverse events) 5
• Adverse event incidence decreases in the second 6 months of treatment compared to the first 6 months 5
• Monitor injection sites for pain, tenderness, erythema, induration, and swelling 2

Safety Assessments

• Both 100-mg and 300-mg maintenance doses have comparable safety profiles, including hepatic safety 3
• No clinically meaningful changes in safety assessments over 12 months of treatment 5
• Serious adverse events occur in approximately 7% of patients, with none judged related to study treatment 1

Integration with Comprehensive Treatment

Medication for Addiction Treatment Framework

• Sublocade must be combined with counseling and behavioral therapies as part of medication for addiction treatment 4
• This approach demonstrates better short-term improvement in treatment and illicit opioid use rates compared to referral only or brief intervention 4

Harm Reduction Components

• Provide overdose prevention education and take-home naloxone kits at every visit 4, 6
• Offer hepatitis C and HIV screening 4, 6
• Provide reproductive health counseling 4

Transition Protocols

From Sublingual Buprenorphine to Sublocade

• Stabilize patients on 12/3 mg daily sublingual buprenorphine/naloxone for minimum 7 days 2
• Initiate with 300-mg subcutaneous injection 5
• Continue monthly 300-mg injections for at least two doses before considering dose reduction 5, 3

Managing Treatment Discontinuation

• Recognize that discontinuing buprenorphine therapy precipitates withdrawal and increases relapse risk to illicit opioid use 6
• Buprenorphine plasma concentrations remain detectable for extended periods after final injection due to depot formulation 2

Cost-Effectiveness Considerations

Economic Analysis

• Sublocade is clinically superior to daily standard-of-care, delivering greater abstinence from opioids 1
• Sublocade is cost-effective (dominant—more effective and less costly) among patients with more severe opioid use disorder 1
• Sublocade is cost-effective (dominant) among patients whose current treatment episode exceeds 28 days 1
• Base case cost-utility analysis shows incremental cost of £1,033 with incremental QALY of 0.02, yielding ICER of £47,540/QALY 1

Common Pitfalls and How to Avoid Them

Critical Timing Issues

• Never administer Sublocade to patients not yet in withdrawal or not stabilized on sublingual buprenorphine—this risks precipitating severe withdrawal 4, 6
• For patients transitioning from methadone, wait >72 hours since last methadone dose and confirm moderate-to-severe withdrawal (COWS >8) before any buprenorphine administration 6

Dosing Errors

• Do not routinely reduce maintenance dose to 100 mg in patients who inject opioids—they specifically require 300-mg maintenance doses for optimal outcomes 3
• Recognize that opioid-injecting participants require higher buprenorphine plasma concentrations to achieve similar efficacy as non-injecting participants 3

Patient Selection Mistakes

• Prioritize Sublocade for patients already engaged in maintenance treatment for >28 days, as this population shows superior cost-effectiveness 1
• Consider that patients with more severe opioid use disorder benefit most from Sublocade versus daily standard-of-care 1