EMA defended its Adaptive Pathways program on Thursday, 8th December, amid concerns from payers and technology assessment bodies that it could lower the evidentiary standards for drug approvals.
At a workshop of stakeholders, representatives from European payers and HTA bodies said EMA’s willingness to accept and review observational data as part of the iterative review process could weaken standards.
In response, EMA Senior Medical Officer Hans-Georg Eichler reiterated the agency was not lowering the evidentiary bar for its benefit-risk assessment of new drugs. He said Adaptive Pathways uses existing regulatory tools such as conditional approval and parallel EMA-HTA scientific advice to help companies and regulators plan ahead for how stakeholders will handle uncertainty.
In its final report on the pilot, published in August, EMA said patients and payers should be more involved in early discussions, and more work was needed to develop a methodology for using real-world data.