Ezetimibe + AtorvastatinAtozet
Recommended CardiovascularAuthority RequiredSecond-line line 💬 consumer voice
Treatment of hypercholesterolaemia in patients with inadequately controlled cholesterol on statin monotherapy, or those with homozygous familial hypercholesterolaemia.
1
Submissions
1 resub
2014–14
On the record
—
ICER range
Cost-min
Cost basis
Decision on record
- Meeting Nov 2014 Recommended ezetimibe 10 mg + atorvastatin 10 mg tablet, 30 ezetimibe 10 mg + atorvastatin 20 mg tablet, 30 ezetimibe 10 mg + atorvastatin 40 mg tablet, 30 ezetimibe 10 mg + atorvastatin 80 mg tablet, 30 Atozet® Merck Sharp and Dohme (Australia) Pty Ltd New listing (Major submission) Hypercholesterolaemia Autho no PSD
Access path
- TGA registered · Atozet
- Nov 2014Recommended · restricted
vs ezetimibe + atorvastatin co-pack and individual components…
- PBS listing · Authority Required
RecommendedDeferredNot recommended
From the public summary
PBAC outcome
7.1 The PBAC recommended listing the FDC tablets for the same Authority Required (STREAMLINED) listings as applied to the existing composite packs, on a cost- minimisation basis with the individual components taken concomitantly.PSD · Nov 2014
7.2 The PBAC was satisfied that ezetimibe + atorvastatin FDC is equivalent to the ezetimibe + atorvastatin co-pack in terms of efficacy and safety and should be priced the same.PSD · Nov 2014
Economic analysis
6.6 The submission presented a cost-minimisation analysis, assuming the ezetimibe/atorvastatin FDC is equi-effective to the corresponding doses of the individual components given concomitantly. 2PSD · Nov 2014
6.7 The requested ex-manufacturer price of ezetimibe/atorvastatin FDC was based on the sum of atorvastatin and ezetimibe prices. This pricing method was previously accepted by the PBAC for the calculation of the co-pack price in July 2013. The requested price of ezetimibe/atorvastatin FDC is shown in the table below.PSD · Nov 2014
Clinical claim
6.4 The submission claimed that ezetimibe/atorvastatin FDC is equivalent to the co- administration of its components in terms of comparative effectiveness and safety.PSD · Nov 2014
The PBAC accepted this claim for the co-pack in July 2013 (paragraphs 6.4 and 6.5, July 2013 PBAC Minutes). The submission also claimed that the ezetimibe/atorvastatin FDC is bioequivalent to co-administration of corresponding doses of ezetimibe and atorvastatin for all tested pharmacokinetic parameters.PSD · Nov 2014
Cost-effectiveness
Cost-minimisation analysis performed; no ICER calculated by design.
Cost-effectiveness accepted
Decision context
PopulationPatients with hypercholesterolaemia inadequately controlled with a statin, or those with homozygous familial hypercholesterolaemia, including those with coronary heart disease, diabetes mellitus, peripheral vascular disease, heterozygous familial hypercholesterolaemia, cerebrovascular disease, family history of coronary heart disease, or hypertension.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2014 | Recommended · restricted | ezetimibe + atorvastatin co-pack and individual components taken concomitantly | — | Single-arm · Cost-minimisation |
Consumer voice
No consumer comments were received for this item.
The PBAC noted that no consumer comments were received for this item. Consumer comments · PSD