Rosuvastatin CalciumAPO-ROSUVASTATIN
Recommended CardiovascularRestrictedNot applicable line
Treatment of hypercholesterolaemia, including familial hypercholesterolaemia, as an adjunct to diet when the response to diet and exercise is inadequate.
2
Submissions
2006–06
On the record
—
ICER range
Cost-min
Cost basis
Decisions on record
- Meeting Mar 2010 Recommended Lowers blood cholesterol no PSD
- Meeting Nov 2006 Recommended Lipid-lowering agent no PSD
Access path
- TGA registered · APO-ROSUVASTATIN
TGA label narrower than the PBS population
- Jul 2006Recommended · restricted
vs atorvastatin
- Jul 2006Recommended · restricted
- PBS listing · Restricted
RecommendedDeferredNot recommended
Cost-effectiveness
Cost-minimisation analysis; no ICER calculated by design.
The choice of a cost-minimisation approach was valid. PBAC · 2006
Cost-effectiveness accepted
Decision context
PopulationPatients with hypercholesterolaemia (including familial hypercholesterolaemia) meeting criteria in the General Statement for Lipid Lowering Drugs, where response to diet and exercise is inadequate.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2006 | Recommended · restricted | atorvastatin | — | Meta-analysis |
| Jul 2006 | Recommended · restricted | atorvastatin | — | Meta-analysis · LDL-C |
Clinical evidence
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to patients meeting General Statement for Lipid Lowering Drugs criteria; TGA label applies broadly to hypercholesterolaemia when diet/exercise inadequate.