Healthcare stakeholders from across Europe have launched a pilot initiative to test out a consultation process for drugs in early development involving regulators, clinicians, health technology assessors (HTAs), patient representatives, payers and the drug developers themselves.

The aim, said the European Healthcare Innovation Leadership Network (which laid the groundwork for the initiative) and the European Medicines Agency (which is one of the participants), 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”.

Other than the EMA, the pilot process involves a range of stakeholders from France, Germany, Italy, the Netherlands, Sweden and the UK. The participating companies – AstraZeneca, GlaxoSmithKline and Johnson & Johnson, all of which support and fund the Network – will seek early advice on medicines under development for either breast cancer or type 2 diabetes, with consultations planned over the next few months. Currently three pilots are planned for the latter half of 2010 and for early 2011.

The agreed consultation process will engage all the participants on issues of therapeutic value and a narrower group of HTAs and payers on questions of economic value derived from therapeutic benefits, explained the European Healthcare Innovation Leadership Network and the EMA.

The pilots, they noted, are the result of a collaborative design effort involving all the participants. It was informed partly by existing early advice processes offered by agencies such as the EMA, the US Food and Drug Administration and, in the HTA field, the UK’s National Institute for Health and Clinical Excellence.

Equal standing

Key among the agreed design principles was the equal standing of all the institutions involved. The pilot consultations will focus on the methodology of value assessment and on identifying areas where alignment is possible among the participating stakeholders around the data needed to show value.

Pricing is not currently part of the remit, since these decisions fall under national mandates, the European Healthcare Innovation Network pointed out.

The ensuing recommendations will be non-binding and will not supersede existing advice processes, nor will they replace existing channels for regulatory and reimbursement approval.

The European Healthcare Innovation Network was set up by professional services firm Tapestry Networks in 2006, initially with the support of GlaxoSmithKline and its chief executive officer Andrew Witty.

The stated aim was to “bring together a premier group of healthcare leaders from EU Member States who are committed to addressing the complementary goals of improving health outcomes as well as the climate for innovation within the constraints of pressures to control healthcare costs”.

Initial focus

Network members and Tapestry Networks identified breast cancer and type 2 diabetes as the initial focus for their discussions due to these diseases’ high unmet needs and impact on healthcare systems.

In 2009, Tapestry Networks convened working groups around the two therapeutic areas and the participants – leading medical experts, regulators, payers, reimbursement authorities, patients and industry representatives from across Europe – established a shared value framework, comprising an agreed set of attributes, therapeutic endpoints and economic inputs, for evaluating new medicines in these categories.

The working groups recommended multi-stakeholder consultations in early-stage drug development to help address obstacles to health systems delivering the right medicines to the right patients at the right time.

These obstacles, Tapestry Networks said, include the high cost of bringing innovative new medicines to market and the limited additional benefits over existing treatments offered by many of these medicines.

The European Commission gave the EMA a political mandate to start interacting with HTA agencies when it published the conclusions of the Pharmaceutical Forum in October 2008.

They included a recommendation that the EU Member states, with the involvement of the EMA, should continue their efforts to consider how information published on approved medicines can contribute to relative effectiveness assessments, the agency noted.