Ezetimibe And AtorvastatinAtozet
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.
Decisions on record
- Meeting Nov 2012 Not recommended At the time of PBAC consideration, Atozet Composite Pack’s TGA registration was yet to be finalised.
- Meeting Jul 2012 Not recommended High cholesterol
Access path
- TGA registered · Atozet
TGA label narrower than the PBS population
- Jul 2012Recommended
vs corresponding doses of ezetimibe and atorvastatin given…
- Nov 2012Not recommended
concerns over labelling and packaging of co-pack and risk of incorrect use by patients; superiority over…
- ↻ resubmittedNov 2012Recommended
Comparator changed: corresponding doses of ezetimibe and atorvastatin given…
- Jul 2013Recommended · restricted
Comparator changed: ezetimibe and atorvastatin given concomitantly; secondary comparator:…
- PBS listing · Authority Required
Cost-effectiveness
Cost-minimisation analysis; no ICER calculated. Submission based on non-inferiority for LDL-C reduction.
The submission presented a cost-minimisation analysis, which was based on a non-inferiority claim for LDL-C reduction, not including additional costs/offsets for administration/adverse events. PBAC · 2013
Decision context
PopulationPatients 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.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2013 | Recommended · restricted | co-administration of ezetimibe and atorvastatin components concomitantly; ezetimibe/simvastatin fixed-dose combination ( | — | Cost-minimisation · Cost-minimisation |
| Nov 2012 | Not recommended | corresponding doses of the components (ezetimibe and atorvastatin) given concomitantly, with ezetimibe/simvastatin fixed | — | RCT · LDL-C reduction |
| Nov 2012 | Recommended | ezetimibe and atorvastatin given concomitantly; secondary comparator: ezetimibe with simvastatin fixed dose combination | — | RCT · LDL-C |
| Jul 2012 | Recommended | corresponding doses of ezetimibe and atorvastatin given concomitantly, with ezetimibe/simvastatin fixed dose combination | — | RCT, indirect comparison · LDL-C reduction |
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to patients with specific cardiovascular risk factors or inadequate atorvastatin control; TGA label permits broader adjunctive use.