EMA tests procedure for early stage drugs
Brussels - Healthcare institutions from Europe have launched a new pilot
process testing multi-stakeholder consultations in early-stage drug
development. The purpose of the project is to reach an agreement about what
constitutes a medicine’s value and the evidence required to demonstrate that
value most effectively, the European Medicines Agency said on its website.
The initiative is funded by the companies AstraZeneca, GlaxoSmithKline and
Johnson & Johnson.
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
staff from 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.
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 in