PBAC's latest decision on Icosapent ethyl: Recommended with restriction (2024). Considered for Treatment of patients with atherosclerotic cardiovascular disease (ASCVD) and elevated triglycerides (≥1.7 mmol/L and <5.6 mmol/L) who are receiving statin therapy to reduce the risk of cardiovascular events.
PBAC outcome
Recommended with restriction
Authority Required
ICER (AUD/QALY)
$55k/QALY
Range: $45k/QALY–$55k/QALY
Submissions
2
first 2023
Submissions
2
2023 → 2024
Eligible population
Adult patients with atherosclerotic cardiovascular disease (ASCVD) with triglyceride level ≥1.7 mmol/L and <5.6 mmol/L, and LDL cholesterol level >1.0 mmol/L and ≤2.6 mmol/L, receiving statin therapy.
Therapy area
Cardiovascular
Line of therapy
Not applicable
Evidence base
RCT
Primary endpoint
Surrogate
Key trials
REDUCE-IT
Comparator
standard of care
Economic model
CUA
Risk sharing
Risk-sharing arrangement in place — Two-tiered RSA with expenditure caps based on revised financial estimates and lower price, with rebates applying between tiers and above the second tier.
Submission history
Nov 2023: Recommended with restriction · Authority Required
Mar 2024: Recommended with restriction · Authority Required — ICER $55k/QALY