Depot Buprenorphine is a new long acting formulation of an existing opioid pharmacotherapy, buprenorphine.
New interim guidelines for depot buprenorphine were developed to provide a framework for clinical decision making by clinicians and consumers in a range of service settings involved in the delivery of treatment with long acting depot buprenorphine products.
For additional advice on selected topics not included in the above guidelines, please see the Depot buprenorphine clinical guideline addenda
There are two depot buprenorphine products at this time: Buvidal® and Sublocade®
- Buvidal® is available on the Pharmaceutical Benefits Scheme (PBS) from 1 September 2019 under a s100 Opioid Dependence listing.
- Sublocade® is in the process of gaining PBS approvals with the Australian Government Therapeutic Goods Administration (TGA).
The TGA approved depot buprenorphine products with an initial restricted access period of a minimum of 6 months. The restriction is to ensure experienced OTP prescribers who work in well supported clinical contexts (hospitals and specialist rehabilitation settings) are delivering this treatment.
Eligibility is limited in the first six months to accredited prescribers who meet both criteria 1. and 2. below:
- Specialised skills:
Providing services in appropriately supported settings – that is, public or private clinics with on-site dispensing that have sufficient clinical/ staffing resources to implement depot buprenorphine.
- Addiction Medicine specialists and Addiction Psychiatry specialists in any setting, or
- VMOs, CMOs, Nurse Practitioners and Registrars working in public OTP clinics, or
- Prescribers in private OTP clinics with at least five years continuous accreditation and at least 100 patients
During the restricted access period the TGA requires intending eligible prescribers to review the depot buprenorphine educational packages from the pharmaceutical companies. Please refer to the education package for Buvidall®. The Sublocadel® education package will be available once the product listed on the PBS.
To register as a Depot Buprenorphine prescriber in the restricted access period please contact Pharmaceutical Regulatory Unit.