Buprenorphine Hydrochloride With Naloxone HydrochlorideSuboxone Film
Treatment of opiate dependence, within a framework of medical, social and psychological treatment.
Decision on record
- Meeting Mar 2011 Recommended Opiate Dependence no PSD
Access path
- TGA registered · Suboxone Film
TGA label equal than the PBS population
- Nov 2005Recommended · restricted
vs buprenorphine alone
- Nov 2005Recommended · restricted
- PBS listing · Restricted
Cost-effectiveness
Cost-minimisation analysis; no ICER range provided.
The choice of the cost-minimisation approach was considered valid. PBAC · 2005
Decision context
PopulationOpiate-dependent patients requiring treatment within a framework of medical, social and psychological support.
Risk sharingRisk Management/Market Surveillance of Suboxone conducted by the National Drug and Alcohol Research Centre at UNSW, commencing March 2006 with final report December 2008. PBAC also requested monitoring of uptake, outcomes, diversion extent, and a report back 12 months after PBS listing.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2005 | Recommended · restricted | buprenorphine alone | — | RCT · Other |
| Nov 2005 | Recommended · restricted | buprenorphine alone | — | RCT |
Similar precedents
Regulatory · TGA
Label equal than PBS population — Both specify treatment of opiate dependence within a framework of medical, social and psychological treatment; PBAC clarifies the target population but adds no clinical restriction.