Ezetimibe + SimvastatinAKM EZETIMIBE SIMVASTATIN
Adjunctive therapy to diet in patients with primary (heterozygous familial and non-familial) hypercholesterolaemia or mixed hyperlipidaemia where use of a combination product is appropriate; and for homozygous familial hypercholesterolaemia.
Decisions on record
- Meeting Jul 2012 Recommended High cholesterol
- Meeting Mar 2012 Not recommended Lipid lowering drug
- Meeting Jul 2009 Recommended High cholesterol no PSD
- Meeting Mar 2009 Not recommended Lipid lowering drug
- Meeting Mar 2007 Recommended Cholesterol lowering drug no PSD
- Meeting Nov 2006 Recommended Lipid-lowering drug
Access path
- TGA registered · AKM EZETIMIBE SIMVASTATIN
TGA label equal than the PBS population
- Nov 2014Noted
vs concomitant ezetimibe and statin therapy, atorvastatin +…
- PBS listing · Restricted
From the public summary
7.1 In considering this matter, the PBAC noted that since it gave advice for Vytorin under subsection 101(4AC) of the Act in 2008, potential new alternative therapies to Vytorin have been PBS listed, or been recommended for listing and the CMWG report has become available.PSD · Nov 2014
7.2 The PBAC agreed with the submission that ezetimibe taken concomitantly with a statin is an alternative therapy to Vytorin. The PBAC also considered that pharmaceutical items containing the drugs: atorvastatin with ezetimibe and ezetimibe with rosuvastatin also constitute relevant alternative therapies, as these products contain ezetimibe in combination with a HmG Co-A reductase inhibitor (statin).PSD · Nov 2014
6.3 The submission was based on: One retrospective observational study using the 10% Medicare sample, referred to as the Vytorin Compliance Study IV, comparing Vytorin to concomitant use of ezetimibe and statins. Cohort 1 is a before and after study measuring adherence (n=between 304 and 1,205). Cohort 2 is used for the persistence analysis (n=16,594).PSD · Nov 2014
Commissioned Lipid lowering medications research: findings from quantitative research Unpublished. market survey with general practitioners and patients. Prepared July 2014.PSD · Nov 2014
Cost-effectiveness
This was a compliance submission under subsection 101(4AC) of the Act, not an economic evaluation. No ICER calculated.
Decision context
PopulationPatients with primary (heterozygous familial and non-familial) hypercholesterolaemia or mixed hyperlipidaemia, or homozygous familial hypercholesterolaemia, currently controlled on Vytorin.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2014 | Noted | concomitant ezetimibe and statin therapy, atorvastatin + ezetimibe co-pack, rosuvastatin + ezetimibe combination | — | Single-arm · Other |
Similar precedents
Regulatory · TGA
Label equal than PBS population — PBAC recommendation matches TGA label exactly: both cover primary hypercholesterolaemia, mixed hyperlipidaemia, and homozygous familial hypercholesterolaemia as adjunctive therapy.