Adaptive pathways 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.
EMA ran a pilot project between March 2014 and August 2016 to explore the practical implications of the adaptive pathways concept with medicines under development.
This pilot provided a framework for informal dialogue between stakeholders, including patients and health technology assessment bodies, to explore different options in a ‘safe harbour’ environment and consider detailed technical and scientific questions based on concrete examples.
At the end of the pilot, 6 of the applicants had received parallel advice from EMA and HTA bodies and 1 benefited from EMA scientific advice.
See the EMA’s published final report here.
EMA will explore the adaptive pathways concept further in the context of parallel scientific advice with HTA bodies, with the inclusion of additional stakeholders, such as patients and payer organisations.