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Will EUnetHTA's HTA tools translate into practice at national level?

16 December 2013 Maria McGee

When I attended ISPOR’s 16th Annual European Congress,in Dublin, earlier this month I attended an interesting discussion on EUnetHTA. The deputy director for France’s HTA agency, HAS, shed some light on the current opportunities and challenges facing the EU-wide HTA collaboration. As I dug deeper into this HTA initiative I found myself asking: Will these “pretty-on-paper” objectives translate into practice and add value to the HTA process at national level, as per its objectives?

To take one step back, the EUnetHTA collaboration was permanently set up just over five years ago, in 2008. Its 15 founding partners signed an agreement to continue the work that had been initiated in the 2006 EUnetHTA project. Shortly after this event, in 2010, the so called Joint Action 1 (JA1) was launched. This was a programme that sought to establish an effective and sustainable HTA collaboration in Europe that would bring added value at the European, national and regional level. The objectives were broken down into eight work packages (WP) that mainly focused on developing tools, such as the Core HTA Model, in order to avoid duplication of HTA work in Europe. Another important objective was to focus on work revolving around relative effectiveness for pharmaceuticals. However, following this initial JA, the “real” challenge remained in gaining traction at a national level and ensuring these tools were put into practice. This is still on the agenda for the second, and ongoing, Joint Action (JA2) which spans until 2015.

However, given that the material produced by EUnetHTA is not legally binding, and in light of the numerous differences of priorities at a national (and indeed regional) level, will payors and HTA bodies across Europe conform to the Core HTA Model? It was interesting to find that while the model attempts to “define and standardise elements of an HTA” it simultaneously claims that it “should not be understood as an attempt to completely standardise HTAs”- acknowledging that there may be good reasons for local assessments to divert from this process.

So will EUnetHTA’s tools translate into practice? While survey results suggest implementation rates ranged from 10% to <50% by 2011, the insight into the uptake of EUnetHTA’s tools have so far been limited. Bear in mind that one of the lead partners, the Association of Austrian Social Insurance Institutions (Hauptverband der Österreichischen Sozialversicherungsträger, HVB) is currently working on an evaluation as per the WP3 subsection of JA2. This will, eventually, give insight into the real progress made, and impact of, the EUnetHTA collaboration as it aims to provide an evaluation plan to test the capacity for which national HTA bodies produce full core HTAs. This includes metrics for success criteria and indicators. So at this point, the question about EUnetHTA’s influence and ability to implement its tools is not only being asked by analysts like myself, but also by its own partners and stakeholders, and among them, industry representatives.

It is inevitable though, that a collaboration such as EUnetHTA will present a number of opportunities and threats for the industry, issues that would not be made justice in this brief blog post. It is, however, worth highlighting the recent three-year agreement with the European regulator, the EMA, which places early dialogue with developers at the forefront of the discussions. This was announced a few weeks after the recent ISPOR meeting when the HAS director suggested an elevated focus would be placed on this particular course of action. Early dialogue may prove to be an interesting opportunity for pharmaceutical companies, although again it will depend on the success of its implementation.

It is nonetheless relatively early days to comment on EUnetHTA’s full impact with any level of accuracy, but it is a reasonable estimation that it will continue to operate by placing focus on sustainable HTA collaboration in the coming months and years. Its objective to bring added value to the HTA process is certainly realistic from a payor perspective, including other HTA bodies, and moderately so for the industry. In so far as the objective of practical application at a national level goes, I believe this is a more challenging aspiration. However, EUnetHTA is a robust network with a wealth of expertise and should be well capable of identifying its own shortcomings and working to address these in the long term.

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