EzetimibeAKM EZETIMIBE
The submission requested that the definition of ‘inadequate control with a statin’ in the current restriction be extended to allow patients to add ezetimibe to lower doses of rosuvastatin or atorvastatin.
Decisions on record
- Meeting Jul 2014 Recommended ezetimibe 10 mg + rosuvastatin 5 mg, ezetimibe 10 mg + rosuvastatin 10 mg, ezetimibe 10 mg + rosuvastatin 20 mg, and ezetimibe 10 mg + rosuvastatin 40 mg, Rosuzet® Merck Sharpe & Dohme Australia Pty Ltd New listing (Major submission) High cholesterol Authority required (Streamlined) listing of a fi
- Meeting Nov 2012 Not recommended High cholesterol
- Meeting Mar 2011 Recommended High cholesterol levels no PSD
- Meeting Nov 2010 Recommended High cholesterol levels
- Meeting Nov 2009 Not recommended Lipid lowering drug no PSD
- Meeting Mar 2007 Recommended Cholesterol lowering drug no PSD
- Meeting Nov 2006 Recommended Lipid-lowering drug
- Meeting Nov 2006 Recommended Lipid-lowering drug
1 earlier decision
- Nov 2006 Not recommended Lipid lowering drug
Access path
- TGA registered · AKM EZETIMIBE
TGA label narrower than the PBS population
- Nov 2005Recommended · restricted
vs placebo co-administered with a statin
- Nov 2006Recommended · restricted
Comparator changed: placebo co-administered with a statin → placebo (co-administered with…
- Nov 2010Recommended · restricted
Comparator changed: placebo (co-administered with a statin) for Part A; ezetimibe…
- PBS listing
Cost-effectiveness
The PBAC considered that the requested change was consistent with clinical practice and the quality use of medicines. PBAC · 2010
Decision context
Populationpatients with uncontrolled cholesterol despite treatment with atorvastatin 20 mg or rosuvastatin 20 mg
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2010 | Recommended · restricted | up-titration of statin (atorvastatin 40 mg or rosuvastatin 40 mg) | $15k–45k | RCT, Single-arm · ORR, QoL |
| Nov 2006 | Recommended · restricted | placebo (co-administered with a statin) for Part A; ezetimibe monotherapy for Part B | — | RCT |
| Nov 2005 | Recommended · restricted | placebo co-administered with a statin | $15k–45k | RCT |
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to patients with inadequate cholesterol control on specific statin doses (atorvastatin/rosuvastatin 20mg), a subset of the broad TGA indication.