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Reflector is Pharm Exec's Brussels correspondent.
Reflector reports on the EU's legislative move to push the fifty or so national and regional HTA organizations in Europe towards greater cooperation.
It’s taken a long time, but the European Union is at last trying to corral its numerous health technology assessment bodies into some form of standardization. The end of January is the scheduled release date for a legislative initiative that is likely to push the fifty or so national and regional HTA organizations in Europe towards greater cooperation.
The most prominent feature of the plans-according to leaked drafts-is that a joint HTA review at EU level will have to be conducted for all new medicines going through the centralized authorization procedure at the European Medicines Agency, and that joint HTA will have to be used when those medicines come up for pricing and reimbursement decisions at national level.
This is a big step forward for the EU-in terms both of the envisaged degree of coercion in a field that is very close to the fringes of the EU’s right to legislate, and of the deep sensitivity about the EU getting anywhere near national pricing and reimbursement decisions. So, in customary EU fashion, there are some get-out clauses. But the direction of travel seems assured: the EU is determined “to boldly go where no man has gone before”.
Central to the proposal is the creation of a formal pan-European body with a significant and permanent full-time staff of scientists, technologists and administrators, fully-funded from the EU budget, and responsible for coordinating national health technology assessment work beyond 2020. This will give some real teeth to the rather haphazard and entirely voluntary efforts of the last 15 years, which culminated in the anti-climax of the EUnetHTA3 programme, still struggling to make any impact two years after its launch.
A joint assessment of a medicine will be initiated at the latest when an application is filed with the EMA, with the aim of finalization by the time the drug is approved. It might even begin earlier than that: the system envisages a horizon scanning activity “to ensure that the health technologies expected to have a major impact on patients, public health or healthcare systems are identified at an early stage in their development and are included in the joint work.” With the disappearance of the current voluntary system, companies will no longer be able to decide which of their products should undergo a joint assessment. But they will be entitled to seek joint scientific consultations with the new EU HTA body, in the form of ‘early dialogues’ aimed at obtaining advice on the data and evidence likely to be required for a future joint clinical assessment.
Once the new system is in place, all HTA bodies in the EU will be required to take part in the assessment, and-even more controversially-obliged to take account of the resulting report. There will be little wriggle-room in the new system, according to the leaked draft. The new law would be in the form of a binding regulation (the strictest form of EU legislation, imposing rules directly on member countries), and the European Commission will be empowered to “verify the joint clinical assessment reports prior to their publication, to ensure reports have been prepared in line with the new rules”. The Commission will also be checking that “the most innovative health technologies are being assessed, taking into account technological developments in the sector”. It will monitor the way the new rules are working and the level of cooperation among member states, who will be legally obliged to report on their use of the joint clinical assessment reports.
The big get-out clause in the proposal is that it sticks firmly to clinical issues, and does not venture into the still-more thorny territory of economic assessment. That would be a bridge too far, and would doom the proposal to immediate flat rejection by member states who insist on maintaining their prerogative for setting drug prices and reimbursement. But even with this softer approach, it is a bold proposal.
The ostensible rationale is that numerous local HTA reviews generate wasteful duplication and delay, and are incompatible with a single European drug market with a centralized system for marketing authorizations. But the real dynamic can be perceived in the growing pressures for EU-level action on drug prices that are widely perceived as excessive and on swelling drug budgets that are blamed for jeopardising healthcare sustainability and impeding access to care.
Statements of the problem are now a routine feature of any European government's comment on public spending. Patient organizations, health activists, and even health ministers increasingly voice their dismay at the challenges posed by drug costs. And against this tsunami of denunciation, the EU finds itself virtually powerless-because the EU treaty prevents it getting involved in national questions of health and social security spending. Cooperation on HTA offers some sort of breakwater: it makes sense per se, and if it manages to focus spending on therapies that are of demonstrated worth then it can arguably save resources-and at the same time could edge drug research into areas of unmet need. Above all, it can be brandished as a demonstration that the EU “is doing something about drugs”, in the hope of averting-or at any rate responding to-accusations that it is timidly letting the drug industry get away scot-free.
Meanwhile, the European pharmaceutical industry stands to gain something if the new system reduces the inconvenience of diverse HTA decisions across Europe-and the industry has long argued for national bodies to be obliged to make use of the joint reviews that have been carried out. Otherwise joint HTA does nothing but add rather than diminish layers of assessment across the member states. Limiting the plan to clinical issues will also please industry, which vehemently opposes any shift towards standardization of pricing and reimbursement decisions. But drug firms may baulk at the requirement for all their new products to go through the new system.
Civil society reactions are neatly encapsulated in a new monograph from the European Public Health Alliance, which sees the outline proposal as “defiant, ambitious and optimistic,” and capable of promoting the sustainability of health systems and the benefit of patients. It could constrain drug firms that “prefer the status quo of the fragmented HTA landscape” out of fear that better-quality HTA will reveal: “the poor therapeutic value of some new medicines,” writes EPHA’s Yannis Natsis. There is much more at stake than boosting the competitiveness of the European pharmaceutical sector or easing the functioning of the EU’s single market, he argues: “HTA can be a powerful weapon to reduce inequalities and disparities in access-this must be the primary goal.” In his view, “navigating this minefield will be worth it”.