Europe Launches Early-Drug-Development Pilot

A European pilot initiative will test the impact of consultations with a number of stakeholders such as patient representatives and payers on early-stage drug development.

According to a statement from the European Medicines Agency (EMA), which is also involved in the initiative, 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.” Ultimately, the aim will be to provide better medicines that better meet the requirements of European healthcare systems.

The pilot will involve a number of stakeholders from France, Germany, Italy, The Netherlands, Sweden, and the UK, including clinicians, health technology assessors (HTAs), patient representatives, payers, regulators, and drug developers.

“The agreed consultation process will engage all participants on issues of a medicine’s therapeutic value, and a narrower group of HTA and payers on questions of economic value deriving from therapeutic benefits,” explained EMA.

A Frequently Asked Questions document also added that the pilots are designed to provide a proof-of-concept opportunity on which subsequent pilots and broader initiatives for early consultation may be based. The recommendations of the consultations, however, will be nonbinding and will not replace existing channels for regulatory and reimbursement approval.

AstraZeneca (London), GlaxoSmithKline (London), and Johnson & Johnson (New Brunswick, NJ) will provide drugs from their pipelines for the pilots, as well as support and funding. Three pilots are planned for the latter half of 2010 and early 2011, and, according to EMA, the participating companies will seek early advice regarding a drug in development for either breast cancer or Type 2 diabetes.

The pilot arose from the European Healthcare Innovation Leadership network, which aims to improve patient-health outcomes and enhance the climate for innovation while also acknowledging pressures to control healthcare costs.