Duración del proceso de financiación en España de los fármacos innovadores aprobados por la Agencia Europea del Medicamento: 2008-2013

Abstract

Background: In Spain, the decision of Price and Reimbursement (P&R) of a new drug must be taken between 180-270 days. The objective of this study was to assess the reimbursement timing in Spain for innovative drugs approved by the European Medicines Agency (EMA) between January 2008 and December 2013 and to explore the potential impact of drug's price on this time.Methods: Drugs approved were extracted from EMA's website, autho-rization dates in Spain from the Spanish Agency (AEMPS) and, P&R dates and prices from Nomenclátor and BotPlus. Depending on days from approval to reimbursement, drugs were quick (<180), on time (180-270) and delayed (>270). Depending on posology: chronic or acute. Depending on dispensing conditions: Retail or hospital drugs. It was calculated: Median, maximum, minimum, first, and third quartiles of time until reimbursement.Results: 431 drugs were approved by EMA; 285 were innovative, from them 147 were approved by the AEMPS and reimbursed: 103 chronic and 44 acute. Median price/day was €2.44 for chronic and €21 for acute. From 2008-2011, 80% of drugs were reimbursed, in 2012 21% and in 2013 17%. Time from approval to reimbursement move from 230 days in 2009 to 431 days in 2013. From the 139 drugs with reimbursement date 33 were quick, 44 on time and 62 delayed. Conclusions: The median time from approval by the EMA of innovative drugs since the reimbursement in Spain in 2013 is double that of 2008. The main driver of delays in the process of P&R seems to be the budget impact of the drug instead of its unit price.