PBAC's latest decision on Rosiglitazone maleate: Not recommended (2007). Considered for Type 2 diabetes, alone or in combination with other diabetes therapies, in a patient whose HbA1c is greater than 7% prior to initiation of a thiazolidinedione (glitazone), despite treatment with metformin, or where metformin is contra-indicated or not tolerated.
PBAC outcome
Not recommended
2007
ICER (AUD/QALY)
$45k/QALY
Range: $15k/QALY–$45k/QALY
Submissions
1
first 2007
Submissions
1
2007 → 2007
Eligible population
Type 2 diabetes patients whose HbA1c is greater than 7% prior to initiation of a thiazolidinedione (glitazone), despite treatment with metformin, or where metformin is contra-indicated or not tolerated
Therapy area
Diabetes
Evidence base
RCT | Single-arm
Primary endpoint
HbA1c
Key trials
Trial 048, Trial 020, Trial 080, Trial 231, Garber et al 2006, Derosa et al 2005
Comparator
sulfonylureas (glibenclamide, gliclazide, glimepiride and glipizide)
Economic model
CUA
ICER note
Base case for monotherapy was <$15,000; dual therapy was $15,000-$45,000. However, PBAC considered the economic analyses of questionable validity.
Why PBAC said no
Reasons cited in the latest PSD: serious safety concerns regarding increased risk of myocardial infarction, uncertain clinical importance of HbA1c differences between rosiglitazone and sulfonylureas, higher rates of serious cardiovascular events, anaemia, weight gain, oedema and fractures in females with rosiglitazone, uncertain magnitude and duration of incremental benefit, questionable validity of economic model due to small difference in glycaemic control and adverse events potentially outweighing benefits, UKPDS-derived cardiovascular benefit estimates not appropriate for rosiglitazone given its adverse events profile, implausible utility estimates