Harmonisation challenges in HTA across Europe

Kim Price

Cardiff Research Consortium – Capita Health Division

This year the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) celebrates its 15th anniversary. The objective of ISPOR in the broadest sense is to advance the field of pharmacoeconomics and outcomes research. ISPOR achieve this through a number of activities, including hosting three annual meetings. These meetings alone serve to show how global the imperative is to define value within healthcare.

The congress gives healthcare providers, policy makers, researchers, students, the pharmaceutical industry and health based consultancies the opportunity to interact and engage with each other. It provides a forum for both improving the science and methodology and also for discussing the best way forward to deliver better health policy and patient care. Two goals most of us who attend ISPOR strive for in our day jobs.

The theme for this year’s congress was “Health Technology Assessment: A European Collaboration” a suitable topic at a time when much of Europe is dealing with the serious economic downturn and having to manage in parallel ever increasing healthcare expenditures. Many of the delegates who attend ISPOR are at the coal face, helping decision makers manage new, and often costly, technologies in the face of restricted and even reduced public funds for healthcare.

Recent developments in the health care systems across Europe have put the spotlight on health and specifically health technology assessment (HTA). However, it is fair to say that most countries are still looking for the best model for HTA. Improving efficiency in the assessment of health technology is beginning to be seen as a strategically important objective if we are to improve health outcomes and the use of limited healthcare resources. In reflection of this the three main plenary sessions at the congress focused solely on HTA.

The first session kicked off with an open and frank look at the inefficiencies in the assessment of health technology within Europe at the current time. Means to reduce such inefficiencies with collaboration across Europe were discussed although it was evident that there are some genuine challenges. However, the development of a recent joint initiative between the European Commission and European Union Member States, the EUnetHTA Joint Action (JA) provides a forum to drive this forward. It was encouraging to see representation by Pharma on the JA with Clare McGrath from Pfizer (Senior Director of HTA Policy, Europe).


“Improving efficiency in the assessment of health technology is beginning to be seen as a strategically important objective…”


Throughout the first plenary session and the congress as a whole the harmonisation of HTA within Europe was given significant air time. Whilst this seems a reasonable objective on many levels, the congress only served to show that significant hurdles would need to be overcome to achieve any level of harmonisation of HTA across Europe. Harmonisation currently would not only be difficult to achieve but possibly even detrimental for health systems given the level of evidence available about its implications. There is an acceptance however, that a HTA process which is transparent and open to professional groups, industry and patient organisations should ultimately result in a better outcome for patients across Europe.

On the back of harmonisation, the debate over relative effectiveness naturally raises its head. Relative effectiveness has recently taken center stage in Europe mainly because NICE and other health technology assessment agencies are putting more demands on the pharmaceutical sector to justify why new interventions should be funded once they have been approved for marketing by drug regulators.

It would appear that existing European law permits the establishment of common criteria for determining the relative effectiveness of licensed drugs. But whether this can and will happen is the big question for the pharmaceutical sector? Representatives from bodies such at the EMEA called for the coordination of assessments of relative effectiveness, but many delegates, including those from the UK where drug subsidies are based on their effectiveness through the National Institute for Health and Clinical Excellence (NICE), felt that cultural differences among countries would make it impossible to reach consensus of what is the most effective treatment amongst the options available.

Whilst the majority of countries and delegates indicated that they favoured a harmonised approach to HTA many felt uncomfortable with harmonising decisions on cost-effectiveness. It appears that cost is an issue that many key member states consider best defined locally.

The challenge is for governments and pharmaceutical companies to agree on value-based criteria for deciding effectiveness. Without this agreement EU member states will have to continue with the procurement approach that decides on a country-by-country basis which medicines are better than others. This is a discussion that will run for some time yet. 


“…the congress only served to show that significant hurdles would need to be overcome to achieve any level of harmonisation of HTA across Europe.”


The second plenary session focused on the challenges of providing affordable healthcare systems whilst maintaining an environment of global innovation and included key speakers such as Mike Drummond, Professor of Health Economics at York and Dr Ansgar Hebborn from Hoffmann-La Roche AG (Basel) (Global Payer and HTA program Policy).

Although a number of pan European initiatives, such as the High Level Pharmaceutical Forum and the Exploratory Process for the Future of Medical Devices, have directly addressed potential conflicts between affordability and innovation, recently European governments have put in place cost-containment measures in response to the economic crisis that have a real potential to stifle innovation. Of note is the recently passed vote by The European Parliament’s Environment and Public Health Committee (ENVI) which will see HTA play a far more pivotal role in the appraisal of innovative technology, including medical devices, than at present.

It was evident that the continued spread of HTA across Europe and the trend towards regional HTA activities are potential barriers to innovation, as few European systems have the remit or incentive to support innovation in pharmaceutical as seen in the Belgian EU Presidency Projects and the UK’s NICE. This is despite recent evidence from The European Health Technology Institute for Socio-Economic Research, which along with other research bodies has been able to show that medical technology and innovation brings substantial advancements in health and economic benefits by saving lives, reducing major adverse events and complications, and shortening patient time in hospital1.

It seems we must work towards ensuring that HTA enhances potential decision-makers’ ability to implement decisions that capture the benefits of new technologies, overcome uncertainties and recognises the value of innovation, all within the constraints of local health system resources.

The third plenary session was much more lightweight entitled “Assessing a technology with limited resources: building capacity without breaking the bank”. The issues for countries wishing to build up a capacity in HTA were discussed. One might have thought there was little reason to attend this session unless you were commissioned to set up a HTA unit, but the lure of the chance to hear Dr Ken Patterson, Chair of the Scottish Medicines Consortium (SMC) drew in a sizeable audience. Dr Patterson’s presentation enabled even those of us who are familiar with the SMC to appreciate the efficiency, focus and remit of the SMC. 


“It was evident that the continued spread of HTA across Europe and the trend towards regional HTA activities are potential barriers to innovation…”


Regardless of specific HTA bodies, there was recognition, beyond that of the pharmaceutical sector, that HTA should adopt a broader definition of value and product benefit by considering patient preferences, quality, equity, efficiency and product acceptability among a wide range of stakeholders. Further exploration to reveal how non-quantifiable factors (e.g. preferences, equity concerns) are accounted for in assessments and decision-making will enable the social implications and constraints of efficient and equitable health to be addressed effectively. In pursuit of this aim, the opinions and experiences of health professionals and individual patients are needed to understand the real-world application and use of a product. The responsibility of and costs to collecting this evidence has to be identified both within pharma and health service providers. Yet one more challenge!

So what does all this mean for the industry? Well it is fair to say that HTA and use of cost-effectiveness isn’t going to go away any time soon regardless of the news running through British media over the last few weeks concerning NICE and that it, along with making a success of Value Based Pricing, should remain a priority for the industry.


1. www.together4healthinnovation.eu/index.php?mact=T4HINews,cntnt01,details,0&amp,cntnt01documentid=30&amp,cntnt01returnid=15

About the author:

Kim currently works at Cardiff Research Consortium, a health outcomes consultancy that provide creative and evidence based approaches to market access by combining access to patient level data with specialist analytical skills and effective communication.

If you are not familiar with ISPOR and you do have an interest in or responsibility for market access have a look at www.ispor.org. ISPOR have number of useful tools in the section “Tools for Health Care Decision Makers”, namely the ISPOR Global Health Care Systems Road Map and the Directory of HTA Organisations Worldwide.

How can we achieve HTA harmonisation across Europe?