If there is anybody, who still doubts in the interest of the industry in real-world research should probably take a closer look at this week’s agenda for the Autumn Symposium of the German Institute for Quality and Efficiency in Health Care (IQWiG).
Without getting into national stereotypes, the German HTA specialist are long-known for their reluctance for anything that is not controlled, randomized and isn’t called an RCT. Some of the presentation titles, such as ‘Ist das Zeitalter der Kausalität vorbei?’ (eng. ‘Is the era of causality over?’) clearly suggest an intense discussion. One could even say it seems provocative, given that non-interventional studies cannot prove causality, what though doesn’t automatically render them unfit for the use in HTA.
During this year’s ISPOR some posters and discussion circulated around the use of real-world data in HTA. Some even around the EARLY use thereof, what might come as a shock to some specialists.
For this reason I reckon the presence of EMA representative, Dr. Eichler, speaking about ‘Adaptive Pathways to Patients: The expected contribution of Real World Data’, will surely add some flavor into the coffee break discussions. MAPPs are thought to change the way we get new drugs to the market, however, it goes hand-by-hand with a parallel cost-effectiveness analysis being conducted earlier on, after the initial market authorization. I am most interested in the conclusions of these forthcoming discussions, in the uncharted waters.
Obviously, the fact that it is being talked about, doesn’t mean it will change IQWiG’s perspective overnight, but it surely implies the necessity to address the issue - a symbolic first step, if you may, commencing all longest journeys.