Although the EUnetHTA network was set up to coordinate the activities of national HTA bodies as long ago as 1993, there remain significant differences in the evaluation processes and methodologies that are used. Amongst other shortcomings, apart from the National Institute for Health and Care Excellence (NICE) in the UK, patients and the general public are rarely involved in assessments.
In the next funding round €20 million has been allocated to EUnetHTA for the 2016-20 period. However, according to the paper, the Commission recognises that the, “Current model does not remove the fragmentation of the national systems and the duplication of assessment efforts”. To tackle this, I-Comm Europe says Relative Effectiveness Assessments (REAs) should be harmonised and a new European HTA agency established.
From the report:
“The first step could be harmonisation around REAs between EU countries and regions within countries, since processes and value dossier format requirements seem to be less different if compared with economic assessment.
Despite this, the most frequently mentioned problem for the production of cross–border REAs is the choice of the comparator. For instance, some countries include drugs used off-label, or best supportive care as a comparator, while others do not. The process for choosing the right comparator may alternatively be based on a proposal from the manufacturer, or on input from a national physicians’ organisation.
Ultimately, the most important requirement is to have data - preferably from randomised clinical trials. Nevertheless, given that this could be inconclusive, conflicting and potentially biased, it would also be necessary to create an ex-ante agreement covering what type of conclusions may be drawn from such trials, but (more importantly) how they should be drawn. (...)
A centralised European HTA agency may then be the logical evolution of a mutual recognition process on assessment, with the role model for this coming from the European Medicines Agency. This level of harmonisation requires more than mutual recognition and, under the current HTA environment in the European Union it seems unthinkable for the time being.
Despite the unlikelihood of complete harmonisation within the immediate future, the general expectation is that HTA will continue to spread: it is now time to rethink instruments to manage this process”.
I-Com, HTA in the European Union: state of art and future scenarios - Background document.
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