PBAC's latest decision on Sibutramine hydrochloride: Not recommended (2008). Considered for Management of type 2 diabetics with obesity and abnormalities in high density lipoproteins (HDL) and triglycerides.
PBAC outcome
Not recommended
2008
ICER (AUD/QALY)
$75k/QALY
$15k/QALY–$75k/QALY · across 3 submissions
Submissions
3
first 2006
Submissions
3
2006 → 2008
Eligible population
Type 2 diabetic adults between 18 and 65 years of age with obesity (BMI ≥30 kg/m²), who are normotensive or have adequately controlled hypertension (<145/90 mmHg), have not adequately responded to weight-reducing regimen alone, and have either triglycerides >150 mg/dL or HDL <50 mg/dL (females) or <40 mg/dL (males).
ICER range dependent on UKPDS mortality factor assumption: $15,000–$45,000 when UKPDS mortality rate is halved (base case); $45,000–$75,000 when UKPDS mortality factor assumed zero.
ICER basis
Range aggregates 3 submissions (2006–2008) — not a single base case.
Why PBAC said no
Reasons cited in the latest PSD: no direct data on cardiovascular outcomes, weight loss may be counterbalanced by effects on blood pressure and pulse rate in terms of cardiovascular risk, lack of data on sustainability of weight loss over time, economic modelling hampered by limitations in predicting long term weight changes, fourfold increase in risk of tachycardia with sibutramine
Submission history
Mar 2006: Not recommended — ICER $45k/QALY
Nov 2006: Not recommended · Authority Required — ICER $75k/QALY