PBAC's latest decision on Semaglutide: Not recommended (2025). Considered for Treatment initiation and continuation in adults with established cardiovascular disease (myocardial infarction, stroke, or symptomatic peripheral arterial disease) and obesity, to reduce the risk of major adverse cardiovascular events.
PBAC outcome
Not recommended
Authority Required
ICER (AUD/QALY)
Redacted
commercial-in-confidence
Submissions
8
first 2019
PBS spend
$285M
2,397,521 scripts · 2024
Eligible population
Adults aged ≥18 years with established cardiovascular disease (prior myocardial infarction, stroke, or symptomatic peripheral arterial disease) and BMI thresholds ranging from ≥27 kg/m² (or ≥25 kg/m² for Aboriginal/Torres Strait Islander/Asian persons) to ≥40 kg/m² (or ≥37.5 kg/m² for Aboriginal/Torres Strait Islander/Asian persons), depending on the selected option.
Therapy area
Cardiovascular
Line of therapy
Any
Evidence base
RCT
Primary endpoint
Cardiovascular event reduction
Key trials
SELECT
Comparator
placebo in combination with standard of care therapies
Economic model
CUA
ICER note
ICER values are redacted (shown as commercial-in-confidence in pricing table)
Risk sharing
Risk-sharing arrangement in place — Risk sharing arrangement (RSA) noted as required by PBAC given extremely high estimated expenditure and criteria for defining patient population; special pricing arrangements proposed with lower effective DPMQs for lower dose strengths and higher effective DPMQ for 2.4 mg dose strength
PBS expenditure
The Australian government paid $285M in PBS benefits for Semaglutide in 2024 across 2,397,521 scripts, at $118 per script.
Submission history
Nov 2019: Recommended with restriction · Restricted
Mar 2020: Recommended with restriction · Authority Required
Mar 2021: Recommended with restriction · Authority Required
Mar 2022: Not recommended · Authority Required
Aug 2022: Recommended with restriction · Restricted