PBAC's latest decision on Ezetimibe: Recommended with restriction (2010). Considered for 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.
PBAC outcome
Recommended with restriction
2010
ICER (AUD/QALY)
$45k/QALY
$15k/QALY–$45k/QALY · across 2 submissions
Submissions
3
first 2005
Submissions
3
2005 → 2010
Eligible population
patients with uncontrolled cholesterol despite treatment with atorvastatin 20 mg or rosuvastatin 20 mg
Therapy area
Cardiovascular
Line of therapy
Later-line
Evidence base
RCT, Single-arm
Primary endpoint
ORR, QoL
Key trials
Trial 079, Trial 0692, EXPLORER
Comparator
up-titration of statin (atorvastatin 40 mg or rosuvastatin 40 mg)
Economic model
CUA
ICER basis
Range aggregates 2 submissions (2005–2010) — not a single base case.
Submission history
Nov 2005: Recommended with restriction — ICER $45k/QALY
Nov 2006: Recommended with restriction
Nov 2010: Recommended with restriction — ICER $45k/QALY