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The 'drug value' in the European pharmaceutical system
Abstract:
European regulatory authorities (EMEA, European Commission) and/or national pharmacological and medical decision-makers can utilise the drug value to help themselves to decide which drugs to define as really innovative instead of new, which regulations to implement, which drugs to include on formularies, or which restrictions to enforce. As economic research becomes widely accepted for pharmaceutical evaluation, it needs to utilise prospective rather than retrospective study design. Analyses conducted at the time of therapy have better access to patients and can obtain both more accurate information on consumption of resources and the impact of pharmacotherapy on non-monetary quality of life for patients, survival, comparative clinical effectiveness and economic outcomes within social health service or in wider economy.