Buprenorphine/naloxone (SL), buprenorphine subdermal implant and buprenorphine extended-release (ER) injection
Indication(s)
Buprenorphine/naloxone sublingual (SL) tablet (Suboxone®, generics): substitution treatment in adults with problematic opioid drug dependence.
Buprenorphine HCl subdermal implant (Probuphine®): management of opioid dependence in patients clinically stabilized on no more than 8mg of SL buprenorphine in combination with counseling and psychosocial support.
Buprenorphine extended-release (ER) injection (Sublocade®): management of moderate to severe opioid use disorder (OUD) in adult patients who have been inducted and clinically stabilized on a transmucosal buprenorphine-containing product.
Formulary status
The Drug Advisory Committee (DAC) recommended that:
- Generic buprenorphine/naloxone (2/0.5 mg and 8/2 mg) SL tablets be listed as a general benefit on Serious Injury Formulary (27WS).
- Generic buprenorphine/naloxone (2/0.5mg and 8/2mg) SL tablets, buprenorphine (80 mg) subdermal implant (Probuphine®), and buprenorphine (100mg and 300 mg) ER injection (Sublocade®) be listed on the Musculoskeletal Injury (02WS), Skin Injury/Disorder (15WS), Cancer (19WS), and Psychotraumatic (22WS) formularies, with the following criteria:
Generic buprenorphine/naloxone:
(i) For the treatment of opioid use disorder and/or;
(ii) For the purposes of opioid tapering for injured workers currently taking high dose opioids (MED ≥90/day).
Buprenorphine subdermal implant:
(i) For the management of opioid dependence
(ii) For patients clinically stabilized on a dose of no more than 8 mg per day of SL buprenorphine in the preceding 90 days
Buprenorphine ER injection:
(i) For management of moderate to severe OUD
(ii) For patients induced and stabilized on an equivalent of 8 mg to 24 mg per day of transmucosal buprenorphine for a minimum of seven days.
The WSIB accepts the Drug Advisory Committee recommendations for listing.
Recommendation highlights
- Buprenorphine is a partial opioid agonist that exhibits reduced withdrawal symptoms compared to full agonists. Naloxone, an opioid antagonist with negligible oral and SL absorption, is included in the SL tablet formulation as a deterrent for abuse.
- Canadian Research Initiative on Substance Misuse 2018 National Guidelines for the Clinical Management of Opioid Use Disorder classifies buprenorphine/naloxone as a first-line agent for opioid agonist therapy.
- The McMaster 2017 Guideline for Opioids for Chronic Non-Cancer Pain suggests buprenorphine/naloxone may be used as a tapering strategy for patients on high dose opioids (MED ≥ 90/day).
- Buprenorphine has an equivalent efficacy and a superior safety profile compared to methadone, including lower risk of overdose, milder side effects, and fewer drug interactions.
- Buprenorphine/naloxone can be dispensed as multiple take-home doses more safely than methadone; this facilitates access to OUD treatment, especially in the return-to-work setting.
- Buprenorphine subdermal implant and ER injection were reviewed by the Canadian Agency for Drugs and Technologies in Health (CADTH) in 2018/2019, with a recommendation to reimburse with clinical criteria and/or conditions, based on phase III randomized-controlled trials and network meta-analyses. Despite higher drug cost, removal of barriers to access with more convenient injection/implants and potentially less interaction with the healthcare system are important to address the stigma and to improve adherence and outcomes of persons with OUD.
- The Ontario Drug Benefit Program lists generic buprenorphine/naloxone SL tablets, as well as buprenorphine subdermal implant and ER injection.
- The buprenorphine products discussed in this listing decision are not indicated for use in pain treatment.
Products available in Canada:
- Buprenorphine/naloxone 2/0.5 mg and 8/2 mg SL tablets (Suboxone® and generics)
- Buprenorphine/naloxone 12/3 mg and 16/4 mg SL tablets (Suboxone® only)
- Buprenorphine HCl 80 mg subdermal implant (Probuphine®)
- Buprenorphine 100 mg/0.5 mL and 300 mg/1.5 mL extended-release solution (Sublocade®)