PBAC's latest decision on Buprenorphine with naloxone: Not recommended (2020). Considered for Treatment of patients with opioid dependence, within a framework of medical, social and psychological treatment.
PBAC outcome
Not recommended
Restricted
ICER (AUD/QALY)
Cost-min
cost-minimisation analysis
Submissions
1
first 2020
Submissions
1
2020 → 2020
Eligible population
Adults with opioid dependence requiring treatment within a framework of medical, social and psychological treatment.
Therapy area
Pain
Line of therapy
Not applicable
Evidence base
RCT
Primary endpoint
Treatment retention
Key trials
OX219-006, OX219-007, OX219-008, NCT02038790
Comparator
buprenorphine/naloxone sublingual film (Suboxone)
Economic model
Cost-minimisation
Eligible patients/year
10,000
ICER note
Cost-minimisation analysis presented; no ICER calculated as this is a cost-minimisation submission comparing drug costs only.
Why PBAC said no
Reasons cited in the latest PSD: clinical need for Zubsolv was unclear, non-inferior clinical effectiveness to Suboxone film was not demonstrated, equi-effective doses were uncertain, significant quality use of medicines concerns relating to dose titration issues and prescriber confusion regarding strengths leading to incorrect dosing of patients