PBAC's latest decision on Ezetimibe with simvastatin: Not recommended (2012). Considered for Treatment, in conjunction with diet and exercise for the primary prevention of major cardiovascular events in patients with moderate to severe chronic kidney disease AND who do not fall into a category for which the GENERAL STATEMENT FOR LIPID LOWERING allows PBS subsidised treatment with a statin.
PBAC outcome
Not recommended
2012
ICER (AUD/QALY)
$75k/QALY
$45k/QALY–$75k/QALY · across 2 submissions
Submissions
3
first 2005
Submissions
3
2005 → 2012
Eligible population
patients with moderate to severe chronic kidney disease who do not fall into a category for which the GENERAL STATEMENT FOR LIPID LOWERING allows PBS subsidised treatment with a statin
Therapy area
Cardiovascular
Evidence base
RCT
Primary endpoint
MVE, MAE
Pivotal trial size
9,438 patients
Key trials
SHARP
Comparator
placebo
Economic model
CUA
ICER basis
Range aggregates 2 submissions (2009–2012) — not a single base case.
Why PBAC said no
Reasons cited in the latest PSD: high and unacceptable cost-effectiveness, inappropriate clinical management algorithm, limited applicability of trial data to requested PBS population, uncertainty around model assumptions regarding ESRD progression and CVD death risk, incremental benefit of ezetimibe over statin alone not addressed, TGA approval not yet obtained
Submission history
Jul 2005: Recommended with restriction · Authority Required
Mar 2009: Recommended with restriction · Authority Required (Streamlined) — ICER $45k/QALY