EMA Defends Adaptive Pathways Against Fresh Attack Following Pilot Report
The European Medicines Agency has dismissed a call to stop accepting applications for its adaptive pathways program until it has better evidence on how to use real-world data.
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Bayer outlined its initial experience with the European Medicines Agency’s adaptive pathways pilot at the recent DIA EuroMeeting in Glasgow, saying that the process had been “disappointing” but that it had learned some valuable lessons.
While the German pricing and reimbursement authority continues to argue that there is insufficient comparative data for drugs that are granted conditional marketing authorization, health technology assessment bodies and payers in the EU generally agree that they need to find innovative solutions to work around these evidence gaps.
The first marketing authorizations under the European Medicines Agency’s hotly debated adaptive pathways concept for getting drugs to patients faster could be granted in just a few years’ time.