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The European Union is at last groping its way towards some form of standardization in judging the value of medicines.
The European Union’s proposed health technology assessment network to encourage “cooperation and exchange of scientific information among member states” is a significant step, says Reflector. But, as far as standardizing an approach to value is concerned, will it be a damp squib?
The European Union is at last groping its way towards some form of standardization in judging the value of medicines. A tiny crack is now appearing in the defensive wall that member states have maintained around themselves to keep the EU out of reflections on pricing and reimbursement. Last year, when the EU adopted its new rules on the application of patients’ rights in cross-border healthcare, it set up a network connecting national authorities and bodies responsible for health technology assessment (HTA). The network is only voluntary, but it is nonetheless a significant step - not least because it was the member states themselves that adopted the new rules. There is - or at least there shortly will be - a network “to support and facilitate cooperation and exchange of scientific information among member states.”
The crack created by the EU’s promotion of cross-border health care is going to be put under stress from an even greater pressure - the growing recognition in Europe that national healthcare systems are heading for collapse unless something dramatic is done to rein in costs. And for the first time, member states desperate to escape from the crisis affecting their public finances are ready to swop ideas and experiences in search of the best solutions.
As a new report from GlobalData (European Healthcare Policy, GlobalData, August 2012) puts it, “The most important issues facing the EU in 2012 stem from the continuing problems related to the global financial crisis.” And top of the list for the pharma industry is “pricing, a problem that is becoming increasingly intertwined with the ongoing financial crisis.” Meanwhile, the UK’s National Institute for Health and Clinical Excellence (NICE) continues to demand supportive data on value, and to put pressure on companies to offer their medicines at more affordable prices. And the German government has imposed new limits on pharmaceutical prices in response to soaring costs - GlobalData estimates that Germany’s pharmaceutical market grew from $43.4 billion in 2005 to $51.6 billion in 2010. Here too, new medicines are now required to demonstrate clinical benefit as part of the pricing process.
Deus ex machina or damp squib?
But how far will the upcoming HTA network help national authorities find common approaches - and how far will any progress in that direction help the pharmaceutical industry? The jury is still out on whether joint reflections will prove to be a deus ex machina - or just a damp squib.
Expectations are high among EU officials. Health commission John Dalli declared strong support for HTA co-operation in Europe, because “limited resources could be better used if work-sharing and reusing HTA information were to be increased.”
There is also a thriving emerging industry around HTA, and the current embryonic HTA network in Europe attracts a growing number of academics, national officials and health economists to meetings of increasing frequency and displaying an almost missionary spirit.
But industry is adopting a more measured position, conscious that the initiative may not deliver even on its limited current promises. In August, the main European drug industry association, EFPIA, gave only muted support to the plan for an HTA network. HTA cooperation may be useful - but only if the conditions are right, it said. The processes would have to be transparent, for example. Cooperation would have to “tackle unnecessary duplication and enable greater clarity, lead to a raising of standards of methodological and process aspects in HTA, improve predictability, and contribute to better and more timely access of medicines to patients.” And the process would also need to get the correct balance: HTA should serve not only to “improve patients’ access to innovative medicines”, but also to “provide incentives for industry to research, develop and invest in new medicines.”
Drug companies claim a right to be involved in the development of this HTA network. They have the expertise: “Based on their first-hand experience of HTA systems across Europe, EFPIA members have a high understanding of HTA methodologies and policies.” And they have a legitimate interest: HTA decisions have a major impact on companies’ clinical development plans and, further downstream, on decision-making on pricing and reimbursement, prescribing guidance or recommendations relating to use of vaccines, EFPIA points out.
But crucially, for EFPIA, even if there is cooperation at European level on HTA, that should remain separate from national decisions. EFPIA emphasises the importance of “keeping the pricing and reimbursement decisions fully at national level.” This certainly threatens to turn a potential deus ex machina into a damp squib, because if consensus in value is not to be reflected in any concrete outcomes, then the gap seems likely to remain as wide as ever at the heart of EU industrial policy for pharmaceuticals.