PNS281 DO SPANISH TPRS AFFECT THE NATIONAL PRICING AND REIMBURSEMENT OF DRUGS?

Abstract

In Spain, newly authorized medicines are assessed by the Inter-Ministerial Pricing Commission for Pharmaceuticals (CIPM), which provides national reimbursement recommendations with a maximum ex-factory price. However, there are 17 autonomous regions, where distinct reimbursement decisions can be made. To help drive consistent decision-making, the Spanish Agency for Medicines and Health Products has issued national Therapeutic Positioning Reports (TPRs) for new medicines since 2012. Since November 2017, CIPM recommendations have been regularly published, giving the opportunity to evaluate the impact of TPRs on the speed and outcome of CIPM decisions, which is the focus of this research. Publicly-available TPR and CIPM decisions were identified from www.aemps.gob.es and www.msssi.gob.es, respectively. Marketing authorization dates were identified from www.ema.europa.eu or www.aemps.gob.es (14/10/2012-31/05/2019). Pearson’s chi-squared and log-rank statistical tests were performed using R. 212 CIPM decisions, issued a mean of 10.3 months after market approval, were identified across 14 monthly reports, 65% (138/212) were positive and 35% (74/212) were negative decisions. TPRs for 226 drug-indication pairings were identified. The majority (65% [147/226]) were recommended as alternative treatment options with 19% (42/226) not recommended and only 16% (37/226) considered to be superior. There were 65 drug-indication pairings with both CIPM and TPR recommendations available. Of these, 63%, 23% 14% had TPR outcomes of ‘alternative’, ‘not recommended’, and ‘superior’, respectively and 63% and 37% had positive and negative CIPM outcomes. Drug-indication pairings with either ‘alternative’ or ‘superior’ TPRs were significantly more likely to have positive CIPMs than those with ‘not recommended’ TPRs (78% vs. 13%, respectively, Χ2=18.03, p<0.01) and were more likely to experience significantly shorter delays to CIPM decisions (10.5 vs. 24.3 months, respectively, Χ2=15, p<0.01). Drug-indication pairings with ‘positive’ and ‘alterative’ TPR outcomes are associated with significantly better and faster CIPM decisions than those with ‘not recommended’ TPR outcomes.