Clopidogrel Hydrogen SulfateClopidogrel Winthrop
Recommended CardiovascularAuthority RequiredFirst-line line
Treatment of acute coronary syndromes (myocardial infarction or unstable angina) in combination with aspirin to prevent early and long-term atherothrombotic events.
1
Submissions
1 resub
2008–08
On the record
$15k
ICER range
1 sourced ICER · 2008
ICER stated
Cost basis
Decisions on record
- Meeting Dec 2021 Recommended Indication not stated no PSD
- Meeting Jul 2011 Recommended Anti-platelet drug no PSD
- Meeting Mar 2010 Recommended Anti-platelet no PSD
- Meeting Nov 2009 Recommended Anti-platelet drug no PSD
- Meeting Mar 2008 Recommended Anticoagulant
Access path
- TGA registered · Clopidogrel Winthrop
TGA label narrower than the PBS population
- Mar 2008Recommended · restricted
vs aspirin alone
- PBS listing · Authority Required
RecommendedDeferredNot recommended
Cost-effectiveness
The submission estimated the incremental cost per QALY to be less than $15,000; no lower bound was explicitly stated.
The submission calculated the incremental cost per extra QALY gained to be less than $15,000. PSD · 2008
ICER uncertain
Decision context
PopulationPatients with acute coronary syndromes (unstable angina, NSTEMI, or STEMI) treated with dual antiplatelet therapy (clopidogrel plus aspirin).
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Mar 2008 | Recommended · restricted | aspirin alone | $15k | RCT · Composite of death from cardiovascular causes, nonfatal myocardial infarction, or stroke (CURE); occluded infarct-related artery on angiography or death or recurrent MI (CLARITY) |
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to acute coronary syndromes only; TGA label also includes chronic prevention in symptomatic atherosclerotic disease history.