PBAC's latest decision on Buprenorphine/naloxone: Recommended with restriction (2019). Considered for Treatment of opioid dependence within a framework of medical, social and psychological treatment, for opioid substitution therapy in patients entering treatment or in maintenance treatment including detoxification.
PBAC outcome
Recommended with restriction
Restricted
ICER (AUD/QALY)
Cost-min
cost-minimisation analysis
Submissions
1
first 2019
Submissions
1
2019 → 2019
Eligible population
Patients with opioid dependence entering opioid substitution treatment or in maintenance treatment, including those undergoing detoxification.
Therapy area
Pain
Line of therapy
Any
Evidence base
RCT
Primary endpoint
Retention in treatment
Pivotal trial size
758 patients
Key trials
OX219-006, NCT02038790, OX219-008
Comparator
buprenorphine/naloxone sublingual film (Suboxone film)
Economic model
Cost-minimisation
ICER note
Cost-minimisation analysis; no ICER calculated by design