PBAC's latest decision on Clopidogrel hydrogen sulfate: Recommended with restriction (2008). Considered for Treatment of acute coronary syndromes (myocardial infarction or unstable angina) in combination with aspirin to prevent early and long-term atherothrombotic events.
PBAC outcome
Recommended with restriction
Authority Required
ICER (AUD/QALY)
$15k/QALY
Base-case
Submissions
1
first 2008
Submissions
1
2008 → 2008
Eligible population
Patients with acute coronary syndromes (unstable angina, NSTEMI, or STEMI) treated with dual antiplatelet therapy (clopidogrel plus aspirin).
Therapy area
Cardiovascular
Line of therapy
First-line
Evidence base
RCT
Primary endpoint
Composite of death from cardiovascular causes, nonfatal myocardial infarction, or stroke (CURE); occluded infarct-related artery on angiography or death or recurrent MI (CLARITY)
Pivotal trial size
12,562 patients
Key trials
CURE, CLARITY
Comparator
aspirin alone
Economic model
CUA
Budget impact
$80M
Eligible patients/year
75,000
ICER note
The submission estimated the incremental cost per QALY to be less than $15,000; no lower bound was explicitly stated.