Evaluating the ‘real’ cost-effectiveness of health technology: reconciling the public interest with patients’ interests

ABSTRACT

This journal supplement publishes four original studies that report the evaluation of a basal insulin analogue – glargine – for the treatment of type 1 and type 2 diabetes. Two of the studies present economic models that use data from the original randomised controlled trials (RCTs) of glargine versus neutral protamine Hagedorn insulin (NPH) and new evidence on the impact of fear of hypoglycaemia on health utility. Their findings suggest that glargine is cost-effective in both type 1 and type 2 diabetes, not just in type 1 as concluded by the original economic appraisal of glargine by NICE in 2002. The remaining two studies use ‘real-life’ data from a proprietary general practice database in the UK (The Health Improvement Network (THIN)) to determine the financial costs and outcomes of glargine treatment compared to treatment with insulin detemir (detemir). Their findings draw attention to the issue that pivotal clinical trials designed specifically to show non-inferiority with the comparator insulin, may not show the true value of glargine which was found to be less costly and resulted in improved outcomes in real-life use than detemir. Observational data are a vital component of drug evaluation and a reliable picture of the financial and clinical outcome can only be drawn following a thorough review of observational data in addition to clinical trial data. Viewed together, these studies are examples of how the current system of economic appraisal of health technology and its dogmatic reliance on RCT evidence may not be in the best interests of patients.

Key words: :

• Detemir
• Diabetes, type 1 and 2
• Glargine
• Hypoglycaemia
• Insulin analogues
• Neutral Protamine Hagedorn insulin (NPH)