Pilots of multi-stakeholder consultations in early-stage drug development
25/10/2010 - Healthcare institutions from Europe have launched a new pilot process testing multi-stakeholder consultations in early-stage drug development. The purpose of the consultations is to improve clarity and alignment among the stakeholders regarding what constitutes a medicine's value and the evidence required to demonstrate that value most effectively.
The pilot initiative involves clinicians, health technology assessors (HTAs), patient representatives, payers, regulators and drug developers from France, Germany, Italy, the Netherlands, Sweden, the United Kingdom and the European Medicines Agency.
Participating companies will seek early advice regarding a medicine under development for the treatment of either breast cancer or type 2 diabetes, with consultations planned over the next four months. The agreed consultation process will engage all participants on issues of therapeutic value and a narrower group of HTAs and payers on questions of economic value deriving from therapeutic benefits.
The pilots are the result of a collaborative design effort involving all participants. Key among design principles agreed by participants is the equal standing among all institutions. Consultation recommendations will be non-binding and will not supercede existing advice processes. Participants anticipate that this experimental initiative could help shape subsequent pilots and broader initiatives for early consultation.
The pilots arose from the European Healthcare Innovation Leadership Network. The Network comprises healthcare leaders from across Europe who are committed to addressing the complementary goals of improving patient health outcomes and enhancing the climate for innovation while acknowledging pressures to control healthcare costs.
AstraZeneca, GlaxoSmithKline and Johnson & Johnson support and fund this initiative that is independently led by Tapestry Networks in accordance with its principles and guidelines for public-private networks.