by Peter O'Donnell at the Medicines for Europe conference in Brussels
BRUSSELS, 22 Nov (APM) - The ambitions of the manufacturers of generics that offer additional patient benefits - so-called value-added medicines - have risen dramatically over recent months, as they set their sights on a new framework for the evaluation and reward of their products.
At the Medicines for Europe conference on this emerging class on Thursday, speaker after speaker called for a radical shift in the appreciation of known molecules that have been repurposed or reformulated or combined in new presentations with devices or digital apps to deliver additional patient benefit.
MfE member companies have constituted a formal group to advance value-added medicines (VAM) and invited regulators, patient groups, academics and physicians to join them in Brussels to plan what they called "a paradigm shift across the healthcare access and regulatory landscape".
Part of the plan is to promote the creation of a regulatory framework in which scientific advice on the merits of individual VAMs is harmonised across the EU.
These products are usually dealt with through the decentralised authorisation procedure, so the automatic EU view that the centralised procedure generates is absent for VAMs. Member state authorities are operating without coordination, so a product judged valuable by one national agency may be rejected by another.
But the new framework will also need to embrace payers, so as to build some common understanding of the type of data that is acceptable to support a reimbursement application, argues the group of manufacturers.
According to consultancy IQVIA, VAMs have seen volume growth of 1% in the EU over the last year. Some national authorities are starting to tailor assessment procedures to them, too.
Vinciane Knappenberg of Belgium's social security agency INAMI, told the meeting that Belgium had now received 26 VAM applications under a newly-implemented regulation that has been under preparation since health minister Maggie De Block initiated the process in 2014.
Eight of these products, in categories including migraine remedies and eye drops for glaucoma and offering - in Belgium's view - additional patient benefit, have now received reimbursement.
Three applications did not win reimbursement status, five applications were withdrawn by the sponsor before the procedure had been completed, eight other applications were rejected as not qualifying for the new procedure and two applications are still being evaluated.
Knappenberg explained that the process was based on a definition of what is value - "not just the classic concept of value but what matters to the patient".
Klara Marton, business development director of Egis, said Germany had also granted reimbursement to five VAMs under a new law that provides for assessing "more than the simple clinical impact, but takes account of improvements in patient experience".
She also hoped that a UK tax exemption scheme for new products may also provide incentives there.
Other speakers suggested there were some useful moves in this direction in France too, but on a case-by-case basis that would be even more valuable if systemised.
The VAM group's aim now is to refine the concept of a new regulatory and market access framework over the coming year, in discussions with all stakeholders, including payers.
European level action is needed by the industry because the promising schemes that are emerging to recognise VAMs are by definition national, and therefore not transferable.
The search is underway for consensus on how to secure timely approval of VAMs via streamlined scientific advice processes, fit-for-purpose trial designs and agreed approval pathways with tailor-made incentives for innovation, said MfE in a statement after the meeting concluded.
The group has also cooperated with a panel of physicians who have reflected on a set of 'next-generation guidelines' to provide up-to-date and appropriate advice to prescribers in the use of VAMs.
Medicines for Europe president Christoph Stoller told APM he sees particular potential in the development of digital health.
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