Ezetimibe And RosuvastatinEzalo Composite Pack
Treatment of hypercholesterolaemia in patients with inadequate cholesterol control on statin monotherapy and specified cardiovascular risk factors or familial hypercholesterolaemia, in combination with dietary therapy and exercise.
Access path
- TGA registered · Ezalo Composite Pack
TGA label narrower than the PBS population
- Nov 2013Recommended · restricted
vs ezetimibe + rosuvastatin (concomitant), ezetimibe +…
- PBS listing · Restricted
Cost-effectiveness
Cost-minimisation analysis; no ICER calculated by design
The PBAC considered that the cost-effectiveness of the combination drug ezetimibe+ rosuvastatin would be acceptable if it were cost-minimised against the combination drug atorvastatin+ezetimibe, with a relativity of rosuvastatin:atorvastatin of 1:2.2. PBAC · 2013
Decision context
PopulationAdults with hypercholesterolaemia inadequately controlled with statin monotherapy and having at least one of: coronary heart disease, family history of coronary heart disease, diabetes mellitus, peripheral vascular disease, heterozygous familial hypercholesterolaemia, symptomatic cerebrovascular disease, or hypertension; treated in conjunction with dietary therapy and exercise.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2013 | Recommended · restricted | ezetimibe + rosuvastatin (concomitant), ezetimibe + simvastatin fixed dose combination (Vytorin), and atorvastatin + eze | — | RCT · Surrogate |
Clinical evidence
| Trial | Phase | N | Primary outcome | Status |
|---|---|---|---|---|
| EXPLORER | Ph 3 | — | To compare the efficacy of rosuvastatin alone with rosuvastatin combined with ezetimibe by… | completed |
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to statin monotherapy failure plus specified cardiovascular risk factors; TGA label includes all primary hypercholesterolaemia regardless of risk profile.