Rosiglitazone Maleate

ICER was modelled but not explicitly stated in the public document. Base case was reported as 'less than $15,000' for monotherapy and '$15,000 - $45,000' for dual therapy, but PBAC considered the economic analyses of questionable validity due to safety concerns.

The PBAC had serious doubts as to whether the difference in glycaemic control between rosiglitazone and sulfonylureas is clinically important and whether the adverse events associated with rosiglitazone do not outweigh any benefits, and thus considered the economic analyses to be of questionable validity. PBAC · 2007

PopulationType 2 diabetes patients whose HbA1c is greater than 7% despite treatment with metformin or for whom metformin is contraindicated or not tolerated; also dual therapy patients uncontrolled on metformin alone

• uncertain clinical importance of HbA1c difference, serious safety concerns regarding increased risk of myocardial infarction, adverse cardiovascular events, anaemia, LDL cholesterol elevation, weight gain, oedema and fractures in females, questionable validity of economic analysis, UKPDS extrapolations may not be appropriate for rosiglitazone due to its adverse events profile, uncertain magnitude and duration of incremental benefit