Ezetimibe With SimvastatinAKM EZETIMIBE SIMVASTATIN
Primary prevention of major cardiovascular events in patients with moderate to severe chronic kidney disease who do not fall into a category for which the General Statement for Lipid Lowering Drugs allows PBS subsidised treatment with a statin.
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 narrower than the PBS population
- Jul 2005Recommended · restricted
vs not applicable
- Mar 2009Recommended · restricted
Comparator changed: not applicable → simvastatin 40 mg, atorvastatin 20 mg and 40 mg…
- Mar 2009Recommended · restricted
Comparator changed: not applicable → simvastatin 40 mg, atorvastatin 20 mg and 40 mg…
- Mar 2012Recommended
ICER rose $45,000 → $75,000 (+67%)
- Mar 2012Recommended
ICER rose $45,000 → $75,000 (+67%)
- PBS listing · Authority Required
Cost-effectiveness
The PBAC noted that the model results and key sensitivity analyses are particularly sensitive to assumptions regarding the risk of progression to ESRD and risk of CVD death. PBAC · 2012
Decision context
PopulationAdults with moderate to severe chronic kidney disease (persistent proteinuria or eGFR < 60 mL/min/1.73 m²) who do not meet criteria for PBS-subsidised statin therapy under the General Statement for Lipid Lowering Drugs.
Why it was knocked back
- inappropriate clinical management algorithm, high and unacceptable cost-effectiveness, uncertain model assumptions regarding ESRD progression and CVD death risk, limited applicability of trial data to requested PBS population due to inconsistent CKD definitions, unknown incremental benefit of ezetimibe addition to statin therapy, TGA had not yet approved the indication
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Mar 2012 | Recommended | placebo | $45k–75k | RCT · MVE, MAE |
| Mar 2012 | Recommended | placebo (though PBAC considered statin therapy the appropriate comparator) | $45k–75k | RCT · MVE |
| Mar 2009 | Recommended · restricted | simvastatin 40 mg, atorvastatin 20 mg and 40 mg, rosuvastatin 20 mg | $15k–45k | RCT · TC:HDL-C ratio, LDL-C percentage change |
| Mar 2009 | Recommended · restricted | simvastatin 40 mg, atorvastatin 20 mg, atorvastatin 40 mg, rosuvastatin 20 mg | $15k–45k | RCT · TC:HDL-C |
| Jul 2005 | Recommended · restricted | not applicable | — | RCT · Other |
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to patients with inadequate control after ≥3 months of statin ≥40mg daily, plus CHD/diabetes or homozygous FH.