PBAC's latest decision on Evolocumab: Recommended with restriction (2024). Considered for Treatment of homozygous familial hypercholesterolaemia (HoFH), heterozygous familial hypercholesterolaemia (HeFH) and non-familial hypercholesterolaemia (non-FH) to reduce LDL cholesterol.
PBAC outcome
Recommended with restriction
Restricted
ICER (AUD/QALY)
Not modelled
no economic evaluation
Submissions
12
first 2015
Submissions
12
2015 → 2024
Eligible population
Adults with HoFH, HeFH, or non-FH with symptomatic atherosclerotic cardiovascular disease or elevated LDL cholesterol despite optimised statin and ezetimibe therapy.
Therapy area
Cardiovascular
Line of therapy
Not applicable
Evidence base
Cost-minimisation
Economic model
Not modelled
ICER note
Not a full economic submission; Category 3 submission requesting restriction level changes and clinical criteria modifications only.
ICER (historical)
$25k/QALY–$35k/QALY across 4 submissions (2016–2022) — the latest submission carried no numeric base case. No single PSD states this combined range; see source PSDs.
Submission history
Mar 2015: Noted · Authority Required
Mar 2016: Not recommended · Authority Required — ICER $45k/QALY
Jul 2017: Recommended · Restricted
Nov 2017: Recommended with restriction · Authority Required
Mar 2018: Recommended with restriction · Authority Required — ICER $45k/QALY
Jul 2018: Not recommended · Authority Required
Jul 2019: Recommended with restriction · Authority Required
Nov 2019: Recommended with restriction · Authority Required — ICER $45k/QALY