PBAC's latest decision on Buprenorphine: Recommended with restriction (2021). Considered for Maintenance and initiation treatment of opioid use disorder/dependence, with or without prior stabilisation on sublingual buprenorphine or buprenorphine/naloxone (weekly formulation), or maintenance treatment following stabilisation on weekly prolonged release buprenorphine or sublingual buprenorphine or buprenorphine/naloxone (monthly formulation).
PBAC outcome
Recommended with restriction
Restricted
ICER (AUD/QALY)
Cost-min
cost-minimisation analysis
Submissions
10
first 2005
Submissions
10
2005 → 2021
Eligible population
Adults with opioid use disorder/dependence; weekly formulation can be initiated with or without prior stabilisation on sublingual buprenorphine or buprenorphine/naloxone; monthly formulation requires prior stabilisation on weekly prolonged release buprenorphine, sublingual buprenorphine, or buprenorphine/naloxone.
Therapy area
Pain
Line of therapy
Any
Evidence base
RCT
Primary endpoint
Non-inferiority in efficacy and safety
Key trials
HS-11-421, HS-14-499, HS-17-585, dBC2531
Comparator
sublingual buprenorphine/naloxone
Economic model
Cost-minimisation
ICER note
Cost-minimisation analysis; no ICER calculated. Submission was recommended on a cost-minimisation basis versus sublingual buprenorphine/naloxone.
Submission history
Jul 2005: Recommended with restriction · Restricted
Mar 2015: Deferred · Authority Required
Nov 2015: Recommended · Restricted
Nov 2015: Not recommended · Authority Required
Jul 2016: Recommended · Authority Required
Nov 2018: Deferred · Not applicable
Mar 2019: Recommended · Restricted
Mar 2019: Not recommended · Restricted
Nov 2019: Recommended · Restricted
Nov 2021: Recommended with restriction · Restricted