Health care payers (governments or insurance plans) are increasingly challenging new health services, including medicines, to prove their value and several European countries have established agencies to help with this task. The example of NICE in England is one example but the Scottish Medicines Consortium (SMC) offers another.
In its first four years the SMC has considered 14 endocrinology products, accepting eleven for use (79%). Manufacturers submit evidence that is critically appraised by pharmacy and economics reviewers, who advise a committee of doctors, pharmacists, manager s and lay-people on the likely effectiveness and cost-effectiveness. Successful endocrinology submissions include teriparatide for osteoporosis and insulin glargine for diabetes, while examples of products not recommended include pegvisomant for acromegaly and cincalet for hyperparathyroidism in ESRD. The most common reason for not recommending a product was that the cost-effectiveness evidence submitted was either deeply flawed or gave an unacceptable cost per unit of health benefit. Typically, advice was issued to Scottish prescribers just over three months after receipt of the submission. Many Europeans already access this guidance at
What can European colleagues learn that might benefit their own countries?
Lesson 1 confining assessment to efficacy alone merely repeats the licensing process. Payers want to know about effectiveness compared to current practice and cost-effectiveness.
Lesson 2 all new medicines should be appraised, avoiding arbitrary criteria for topic selection. Those responsible for supplying the evidence cannot say they were taken by surprise.
Lesson 3 timing of the appraisal. Evidence accrues after a medicine has been launched but prescribing practices also become habits. Early assessment is essential.
Lesson 4 independent review of all the available evidence is attractive but time-consuming and expensive. Asking manufacturers of medicines to provide evidence that is then critically assessed is quicker, cheaper and (to date) seems to lead to similar recommendations.
01 - 05 Apr 2006
European Society of Endocrinology