Differences in evidentiary requirements between European Medicines Agency and European health technology assessment of oncology drugs—can alignment be enhanced?

Value in Health

5 December 2022 - National health technology assessments across Europe show differences in evidentiary requirements from assessments by the EMA, affecting time to patient access for drugs after marketing authorisation. 

This article analyses the differences between EMA and health technology assessment bodies’ evidentiary requirements for oncology drugs and provides recommendations on potential further alignment to minimise and optimally manage the remaining differences.

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Michael Wonder

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Michael Wonder