PHP145 - A Regression Analysis Of The Impact Of Patient Access Schemes

Abstract

Patient Access Schemes (PASs) are part of the UK Pharmaceutical Price Regulation Scheme (2009). PASs enable patients to receive drugs, and allow pharmaceutical companies to collect cost-effectiveness and efficacy data, even if the payer classified the drug as outside the cost-effectiveness threshold. This project analysed the effect of PASs on patient access (PA) (defined by total sales in volume/prevalence of the particular disease group). A literature search of Medline and online resources was carried out to capture relevant data on PASs, however no suitable publications on the relationship between PA and PASs were obtained. Multiple regression was used to test if a relationship exists between the dependent variable, (change in PA) and the independent variable (existence of a PAS) and other factors that may affect change in PA. The other factors were: type of PAS, country, number of competitors, list price, how long the drug has been marketed for, and the orphan drug designation. Five drugs with approved PASs in the UK were analysed. These included: lenalidomide, erlotinib, bortezomib, sunitinib, and cetuximab. These were analysed in France, Germany, Italy, Spain and the UK, between 2010 and 2011 using IMS sales data and the Globocan Project 2008 prevalence data. The results of the regression analysis showed the existence of a PAS does not seem to have an effect on the change in PA. Therefore, this model cannot support a relationship between these two variables. The R442 is 0.6119, however the only variable which was statistically different from 0 is the number of competitors, with a p-value of 0.014; which means it is the only variable which had a significant effect on the change in PA. Further research needs to be conducted for a detailed analysis on this relationship.