PBAC's latest decision on Ezetimibe + rosuvastatin: Recommended (2014). Considered for Treatment of hypercholesterolaemia in patients with inadequately controlled cholesterol levels on statin monotherapy who have cardiovascular risk factors (coronary heart disease, diabetes, peripheral vascular disease, heterozygous familial hypercholesterolaemia, cerebrovascular disease, family history of coronary heart disease, or hypertension); also for homozygous familial hypercholesterolaemia; and for patients with clinically important statin-related adverse events necessitating dose reduction.
PBAC outcome
Recommended
Authority Required
ICER (AUD/QALY)
Cost-min
cost-minimisation analysis
Submissions
1
first 2014
Submissions
1
2014 → 2014
Eligible population
Adults with hypercholesterolaemia inadequately controlled with statin monotherapy and specified cardiovascular risk factors (coronary heart disease, diabetes, peripheral vascular disease, heterozygous familial hypercholesterolaemia, cerebrovascular disease, family history of CHD, or hypertension); also patients with homozygous familial hypercholesterolaemia; and patients with statin-related adverse events necessitating dose reduction.
Therapy area
Cardiovascular
Line of therapy
Not applicable
Evidence base
Single-arm
Primary endpoint
Cost-minimisation
Pivotal trial size
120 patients
Key trials
Protocol 417-00, Protocol 425-00
Comparator
ezetimibe and rosuvastatin co-pack; individual components used concomitantly; ezetimibe + atorvastatin co-pack; ezetimibe + simvastatin FDC
Economic model
Cost-minimisation
ICER note
Cost-minimisation submission; no ICER calculated. Price based on relativity to atorvastatin + ezetimibe combination at ex-manufacturer level with rosuvastatin:atorvastatin relativity of 1:2.2.