CIRS Agenda_2015

HTA and Market Access Programme Research

Factors Influencing HTA Recommendations

As part of her programme of doctoral research, CIRS Senior Research Fellow Dr Iga Lipska is performing a statistical analysis of factors influencing HTA recommendations including whether the product is a biological or biotechnology product, is in the oncology therapeutic area, its orphan status, the use of an active comparator in registration trials, whether a non-standard type of marketing authorisation approval was used; the timing for marketing authorisation.  The recommendations of each jurisdiction will be analysed in a separate model.

Thus far, using information from European Public Assessment reports (EPARs) for six jurisdictions,  analysing the effect of the use of an active comparator in clinical trials, found no statistically significant associations. There was close to statistically significant association between active comparators and HTA recommendations in Scotland, where there were more positive recommendations with restrictions and fewer negative recommendations within the active comparator group.