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Ezetimibe With Atorvastatin

Recommended CardiovascularNot applicableNot applicable line

Treatment in conjunction with dietary therapy and exercise for co-administration of ezetimibe with atorvastatin in patients whose cholesterol levels are inadequately controlled with a statin alone, or patients with homozygous familial hypercholesterolaemia.

1
Submissions
2012–12
On the record
ICER range
Cost-min
Cost basis

Access path

1 submission · public record
  1. Jul 2012
    Recommended

    vs ezetimibe and atorvastatin given concomitantly (as separate…

  2. PBS listing · Not applicable
RecommendedDeferredNot recommended

Cost-effectiveness

Cost-minimisation analysis presented; no ICER calculated

The PBAC noted that it could only recommend a higher price for the ezetimibe and atorvastatin co-pack if it is satisfied that the co-pack provides, for some patients, a significant improvement in efficacy or reduction of toxicity over the alternative therapy or therapies. PBAC · 2012

Decision context

PopulationPatients with hypercholesterolaemia whose cholesterol levels are inadequately controlled with a statin at maximum tolerated dose, including those with coronary heart disease, diabetes mellitus, peripheral vascular disease, heterozygous familial hypercholesterolaemia, symptomatic cerebrovascular disease, family history of coronary heart disease, or hypertension; also patients with homozygous familial hypercholesterolaemia

Why it was knocked back

  • concerns over labelling and packaging of the co-pack and risk of incorrect patient use, failure to demonstrate superiority in comparative efficacy and safety over ezetimibe/simvastatin fixed dose combination, proposed price higher than alternative therapy without demonstrated clinical benefit, inadequate indirect comparison evidence

Submission history

1 entries
DecidedOutcomeComparatorICEREvidence
Jul 2012 Recommended ezetimibe and atorvastatin given concomitantly (as separate tablets); ezetimibe/simvastatin fixed dose combination as se RCT · LDL-C