In a response to criticism by Germany’s Institute for Quality and Efficiency in Health Care, EMA said the now-completed pilot program of its adaptive licensing pathway was “intended to be a learning exercise” about the use of real-world data, one of the pathway’s key components.
The EMA has rejected IQWiG’s conclusion that the pilot confirmed the limitations of real-world data, and said its report was not a judgment on the use of real-world data itself, but rather on the post-market data collection plans proposed by companies involved in the pilot. The agency also said the purpose of repeat discussions among stakeholders is to “refine and clarify real-world data collection plans.”
EMA has scheduled the workshop for Dec. 8 to collect stakeholders’ input on the pathway.
The adaptive pathway seeks to balance timely access for patients who are likely to benefit most from the medicine with the need to provide adequate evolving information on the benefits and risks of the medicine itself, bringing the drug to market through iterative phases of evidence gathering and licensing, with further approval of adjustments based on post-market trials and real-world evidence.