Accesso precoce al mercato: dalle approvazioni condizionate di EMA agli accordi negoziali particolari di AIFA

Abstract

The European Medicines Agency (EMA) has adopted assessment systems and drug registration procedures to respond to the needs for rapid patient access to therapies, such as Conditional Marketing Approval (CMA) and Under Exceptional Circumstances approval (UEC). The Italian Medicine Agency (AIFA) has introduced tools for governing prescriptive behaviour in order to promote appropriateness and correct use of drugs and to manage the uncertainty of financial impact, including Managed Entry Agreements (MEAs). The MEAs are conditional access agreements to the market for new drugs aimed at managing the uncertainty on the clinical and economic effects of the drugs themselves. The aim of this study is to analyse, through the use of the information systems of the AIFA and the institutional website of the EMA, how the drugs authorised by EMA with CMA or UEC have been managed on the access side to the Italian NHS. This in order to understand how the uncertainty deriving from the authorisation processes was subsequently...