PBAC's latest decision on Alirocumab: Recommended (2023). Considered for Treatment of familial heterozygous hypercholesterolaemia (he-FH) and non-familial hypercholesterolaemia (non-FH), and prevention of cardiovascular events.
PBAC outcome
Recommended
Authority Required
ICER (AUD/QALY)
Cost-min
cost-minimisation analysis
Submissions
4
first 2017
Submissions
4
2017 → 2023
Eligible population
Patients with familial heterozygous hypercholesterolaemia (he-FH) and non-familial hypercholesterolaemia (non-FH) with high or very high cardiovascular risk and hypercholesterolaemia not adequately controlled with their lipid-modifying therapy.
Therapy area
Cardiovascular
Line of therapy
Any
Evidence base
Single-arm
Primary endpoint
Bioequivalence
Key trials
MSC14864 (NCT03415178)
Comparator
alirocumab 150 mg in 1 mL pre-filled pen
Economic model
Cost-minimisation
ICER note
Cost-minimisation analysis; no ICER calculated as submission demonstrated equi-effectiveness at the same cost.
Risk sharing
Risk-sharing arrangement in place — Existing Deed of Agreement in place for alirocumab; AI form will be subject to the same Deed arrangements.
Submission history
Nov 2017: Not recommended · Authority Required
Mar 2019: Recommended with restriction · Authority Required
Mar 2020: Recommended with restriction · Authority Required