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That strict red line between regulatory authorization and market reimbursement is blurring pink – at least in Europe.
That strict red line between regulatory authorization and market reimbursement is blurring pink – at least in Europe. At a Drug Information Association [DIA] session earlier this week, European Medicines Agency [EMA] Senior Medical Officer Hans-Georg Eichler confirmed that the agency was finally moving to test the feasibility of a new, “holistic” approach to obtaining a license to sell a new medicine. Known as adaptive licensing or, in bureaucratic terminology, the Adaptive Medicines Pathway, it would formally align the process of evaluating safety and efficacy with the economic value and social benefit mandates imposed on drug makers by national reimbursement and market access authorities.
EMA work plans called for launch of a pilot project in 2012 to determine how to integrate the two strands of activity, but action has been delayed due to competing priorities. “We will be posting shortly an open call to invite companies to come forward to work with us around a live asset, beginning later in the third quarter of this year,” he said.
The EMA has been moving in this direction for some time. In contrast to the US Food and Drug Administration [FDA], the EMA has a mandate to ensure its policies help expand access to necessary medicines. The EMA must also cooperate with its member states, so there is an incentive for it to consider whether and how quickly an approved medicine is taken up by providers and patients. With that in mind, the EMA supplements its standard application protocols with what it calls parallel scientific advice, which gives payers, patients and other outside stakeholders the opportunity to offer guidance as a dossier moves forward through the decision chain.
Eichler noted that the adaptive licensing pilot is designed for broader application than the current standard around conditional marketing approval, which is used only for cases that involve a life threatening disease – i.e. drugs to treat obesity are not eligible – and stops at the license grant itself. The adaptive licensing path strives to build more rigor and consistency into negotiation of risk management and post marketing surveillance commitments, after launch. Payers would be more closely involved in that process, likely leading to greater engagement of the EMA around negotiated “coverage with evidence development” programs. The key point: such added commitments might subject the original marketing authorization to another go-round with regulators, at a later point in the product life cycle. This is well established in the reimbursement process already. Companies in Europe know that the launch price for a new medicine will never remain fixed – it will only go lower.