PBAC's latest decision on Ezetimibe and atorvastatin: Recommended with restriction (2013). Considered for Hypercholesterolaemia in combination with dietary therapy and exercise where cholesterol levels are inadequately controlled by atorvastatin and patients have hypertension, coronary heart disease (or a family history), diabetes, peripheral vascular disease, heterozygous familial hypercholesterolaemia or cerebrovascular disease; also for homozygous familial hypercholesterolaemia and for patients who have developed clinically important statin-related adverse events necessitating dose reduction.
PBAC outcome
Recommended with restriction
Authority Required
ICER (AUD/QALY)
Cost-min
cost-minimisation analysis
Submissions
3
first 2012
Submissions
3
2012 → 2013
Eligible population
Patients with hypercholesterolaemia inadequately controlled by atorvastatin and at least one of: hypertension, coronary heart disease, family history of coronary heart disease, diabetes mellitus, peripheral vascular disease, heterozygous familial hypercholesterolaemia, or symptomatic cerebrovascular disease; also patients with homozygous familial hypercholesterolaemia; and patients who developed clinically important statin-related adverse events.
Therapy area
Cardiovascular
Line of therapy
Not applicable
Evidence base
Cost-minimisation
Primary endpoint
Cost-minimisation
Comparator
co-administration of ezetimibe and atorvastatin components concomitantly; ezetimibe/simvastatin fixed-dose combination (secondary comparator)
Economic model
Cost-minimisation
ICER note
Cost-minimisation analysis; no ICER calculated. Submission based on non-inferiority for LDL-C reduction.
Submission history
Jul 2012: Not recommended
Nov 2012: Not recommended
Jul 2013: Recommended with restriction · Authority Required