Publication

European health systems face significant fiscal constraints in meeting the increasing needs of their citizens at a time of intensifying austerity. Drug developers also face increasing competition for funds to invest in research and development of innovative products to treat unmet needs.

European healthcare leaders from eight Member States have completed six pilots of multi-country, multi-stakeholder consultations in drug development from mid-2010 through early 2012. The pilots have tested the feasibility and benefits of a novel approach to identifying the potential value of a new medicine along with the evidence required to demonstrate that value. The pilots have brought together the key constituencies along a drug’s path from the laboratory to the patient—including regulators, health technology assessors, budget holders, clinical experts, and patient representatives—in an early dialogue addressing the most significant questions facing the drug developer. The pilots evolved over the six consultations from a process similar to traditional early advice to a forum where stakeholders can address the total health system value proposition of the treatments under discussion. This report synthesizes the lessons learned through completion of the pilot consultations, addressing drugs in five therapeutic areas from the pipelines of three pharmaceutical companies.