Following marketing authorization in Spain, new medicines are assessed by the Inter-Ministerial Pricing Commission for Pharmaceuticals (CIPM), which provides reimbursement recommendations with a maximum ex-factory price. However, there are 17 autonomous regions, which can make distinct reimbursement decisions. To drive consistency, 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 published monthly, giving the opportunity to analyze the impact of TPRs on the speed and outcome of CIPM decisions, which this research evaluates.

Publicly-available CIPM and TRP decisions were identified from www.msssi.gob.es and www.aemps.gob.es, respectively. Marketing authorization dates were identified from www.ema.europa.eu or www.aemps.gob.es (10 March 2007-11 February 2018). Pearson's chi-squared and Mann-Whitney U statistical tests were performed using R.

One hundred and ninety-three drug-indication pairings with an associated TPR were identified. The majority (62% [120/193]) were recommended as alternative treatment options with only 19 percent (36/193) deemed to be superior and 19 percent (37/193) not recommended. One hundred and eight CIPM recommendations were identified across seven monthly reports, issued a mean of 12.2 months after market approval, 59 percent (64/108) were positive and 41 percent (44/108) were negative recommendations. There were 34 drug-indication pairings with both CIPM and TPR recommendations available. Of these, 24 percent, 56 percent and 21 percent had TPR outcomes of ‘superior’, ‘alternative’ and ‘not recommended’, respectively and 71 percent and 29 percent had positive and negative CIPM outcomes. Drug-indication pairings with ‘negative’ TPRs were significantly more likely to have negative CIPMs than those with either ‘alternative’ or ‘superior’ TPRs (71% vs. 19%, respectively, χ2 = 5.16, p = 0.02) and were more likely to experience significantly longer delays to CIPM recommendation (23.9 vs. 13.5 months, respectively, U = 50, p = 0.03).

Drug-indication pairings with ‘positive’ and ‘alterative’ TPR outcomes are associated with significantly better and faster CIPM recommendations than those with ‘not recommended’ TPR outcomes