Ezetimibe + RosuvastatinPHARMACOR EZETIMIBE ROSUVASTATIN composite pack
Treatment of hypercholesterolaemia in patients with inadequately controlled cholesterol levels on statin monotherapy who have cardiovascular risk factors (coronary heart disease, diabetes, peripheral vascular disease, heterozygous familial hypercholesterolaemia, cerebrovascular disease, family history of coronary heart disease, or hypertension); also for homozygous familial hypercholesterolaemia; and for patients with clinically important statin-related adverse events necessitating dose reduction.
Decision on record
- Meeting Nov 2013 Recommended ezetimibe 10 mg + rosuvastatin 5 mg; ezetimibe 10 mg + rosuvastatin 10 mg; ezetimibe 10 mg + rosuvastatin 20 mg; ezetimibe 10 mg + rosuvastatin 40 mg, tablet Rosuzet® Composite Pack Merck Sharp and Dohme Australia Pty Ltd Major submission Hypercholesterolemia Authority Required (STREAMLINED) listing
Access path
- TGA registered · PHARMACOR EZETIMIBE ROSUVASTATIN composite pack
- Jul 2014Recommended · restricted
vs ezetimibe and rosuvastatin co-pack; individual components…
- PBS listing · Authority Required
From the public summary
7.1 The PBAC recommended an Authority Required (Streamlined) listing of ezetimibe + rosuvastatin FDC for hypercholesterolaemia in combination with dietary therapy and exercise where cholesterol levels are inadequately controlled by a statin and patients have hypertension, coronary heart disease (or a family history), diabetes, peripheral vascular disease, heterozygous familial hypercholesterolaemia or cerebrovascular disease.PSD · Jul 2014
7.2 The PBAC noted that the listing should be consistent with the recommended listing for the ezetimibe + rosuvastatin co-pack.PSD · Jul 2014
6.10 The submission proposed that the price be calculated based on the atorvastatin + ezetimibe combination product at the ex-manufacturer level, incorporating a relativity between rosuvastatin and atorvastatin of 1:2.2.PSD · Jul 2014
6.11 In consideration of the ezetimibe + rosuvastatin co-pack, the PBAC considered this approach was appropriate based on the approved ex-manufacturer prices of the two drugs in November 2013.PSD · Jul 2014
6.5 The clinical claim in the submission is the same as that accepted by the PBAC in November 2013 for the co-pack.PSD · Jul 2014
6.6 The clinical claim is that the ezetimibe + rosuvastatin FDC is equivalent in terms of comparative effectiveness and safety to the co-administration of the individual components; and has similar efficacy and safety to ezetimibe + simvastatin FDC at therapeutically equivalent doses.PSD · Jul 2014
Cost-effectiveness
Cost-minimisation submission; no ICER calculated. Price based on relativity to atorvastatin + ezetimibe combination at ex-manufacturer level with rosuvastatin:atorvastatin relativity of 1:2.2.
The PBAC noted that both atorvastatin and rosuvastatin are included in the first cycle of simplified price disclosure and will be required to reduce their prices on 1 October 2014. PBAC · 2014
Decision context
PopulationAdults with hypercholesterolaemia inadequately controlled with statin monotherapy and specified cardiovascular risk factors (coronary heart disease, diabetes, peripheral vascular disease, heterozygous familial hypercholesterolaemia, cerebrovascular disease, family history of CHD, or hypertension); also patients with homozygous familial hypercholesterolaemia; and patients with statin-related adverse events necessitating dose reduction.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2014 | Recommended · restricted | ezetimibe and rosuvastatin co-pack; individual components used concomitantly; ezetimibe + atorvastatin co-pack; ezetimib | — | Single-arm · Cost-minimisation |