Health Technology Assessment: what are policymakers talking about?

Since its inception in 2005, the development of EUnetHTA has registered progress in increasing the quality and efficiency of regulatory assessment of health technologies at European level. On 25 August, the Dutch National Health Care Institute and the European Commission signed the grant agreement for Joint Action and agencies were given 30 days to join the network. Subsequently, the Joint Action 3 is starting officially in the last week of September 2016.

When it comes to the health policy agenda in Europe, Health Technology Assessment - or “HTA”- is on the tip of everyone’s tongue, as it has been pegged as an important area where a closer European collaboration can demonstrate added value in terms of patient outcomes and health systems performance. To increase the added value of HTA, the European Commission is looking to stimulate European cooperation in this area and on 14 September presented five recommendations for improvement. But what is the role of HTA, and what needs to be addressed so that a wider cooperation is established? 

Sustainable healthcare systems

Independent agencies assess the impact of health interventions, from drugs and vaccines to medical devices and surgery, with a view to demonstrate that the new technology has a positive effect, and compare it with existing options to see if it is worth it or to what extent it should be reimbursed. The information gathered through these assessments can then be used by policymakers to make well-informed decisions and to choose a path that is beneficial to patients, healthcare systems and the society at large.

The idea is that this evidence-based policy making should make European healthcare systems more sustainable in the long run and provides answers to one of the bigger head scratchers of the moment: how can governments afford to give patients timely access to effective treatment? In practice this comes down to engaging all relevant stakeholders, including patients. A ground-breaking benefit of HTA is that patients get to voice their experiences with a particular medical process, drug, or technology. These insights and real-life information are rarely heard as normally the information is garnered from more official means, such as clinical trials.

Since HTA emerged in the 1970s to mitigate burdensome costs, a network of HTA agencies throughout Europe has been established to ensure information is shared and that resources are spent where they are needed. The European Commission believes that HTA could boost growth, jobs and investment on the internal market. The EUnetHTA Joint Action 3 will provide just the boost the Commission is looking for. However, even though “joint HTA assessments”, HTA efforts on which two or more countries work together, are becoming more common, European healthcare systems have not been able to reap the benefits. There are several challenges to make this happen.

Different perspectives on HTA characterise the debate in Europe. Whereas the European Commission is looking for ways to enhance EU-wide cooperation in the field, it recognises that health remains an affair of the individual Member States. And while EU Member States are indeed keen on emphasising that health remains a competence of national authorities, they engage in voluntary HTA cooperation.

Stakeholders like the European Federation of Pharmaceutical Companies and Associations (EFPIA) are well aware of the benefits HTA could bring in terms of stream-lining approval processes and avoiding redundant duplication. At the same time EFPIA  highlights the pitfalls of the current cooperation model. One of these is the different approaches and interpretations taken by different HTA actors  in various Member States on key HTA principles. Harmonisation here is to be desired. However, EFPIA is equally convinced that there should be no harmonisation when it comes to assessing the economics of a given treatment. Pricing of pharmaceuticals in their view is very locally driven by nationally competent authorities and according to the specific circumstances locally. EFPIA is  therefore firm in its belief that HTAs and the pricing of pharmaceuticals should be executed separately.  At the same tim, EFPIA agrees with  the European Patient Forum (EPF) that patients should be more involved in the process. But there are more challenges to making HTA cooperation work in Europe.

Putting together the HTA puzzle

Four challenges continue to pose over a wider HTA collaboration in Europe, and these are not new to the European single market: fragmentation, transparency, a lack of trust, and financial sustainability. First, with over 50 HTA agencies in Europe, there is a high level of fragmentation.[1] Different legal frameworks and limited pan-European standardisation makes it difficult to coordinate joint HTA efforts. At times, this even leads to duplication of work.[2] In a similar vein, the Commission highlights that the delay in market access of medicines also varies per country, which has a negative effect on access to treatment and the revenues of companies.

A second factor is the perceived lack of transparency, objectivity and accuracy of assessments, continuously being demonstrated by the different conclusions that separate assessments have engendered. Moreover, in some cases new technologies are not necessarily better than existing ones. Add to this the lack of transparency of the research process and the fact that researchers do not always manage to clearly communicate the evidence to the public, and you end up with a wide spectrum of evidence of which nobody can actually tell the value. One of the reasons for this is that HTA done at national level is also being done with the local context in mind.

This has led to a trust deficit, a third challenge, which is not only detrimental to innovation, but also colours the perception of patients and policy-makers. The latter are said to not always take on board HTA evidence in their decision-making, and –again- there is a clear fragmentation when it comes to the extent to which national health authorities take on board HTA assessments.

Finally, the fourth challenge for wider HTA collaboration in Europe is the lack of financial sustainability of the European HTA model as it is today. The Commission points out that European cooperation on HTA, currently funded through the Commission’s Public Health Programme which ends in 2020, is unlikely to continue without financial support from the EU budget.[3] However, the Commission also highlights that there is an option to reserve EU funding post 2020 for long-term voluntary cooperation on HTA.

These issues show that HTA is not the ultimate panacea for sustainable European healthcare systems. However, given the limited competence of the Commission in the field of healthcare, Europe has come a long way and there is ample political will. The emergence of voluntary cooperation networks and the outlook of creating a permanent HTA network in Europe are promising illustrations. There may be many challenges ahead, but we should be optimistic of what the EUnetHTA Joint Action 3 could bring.

[1] Directorate-General for Research and Development, Better regulations for innovation-driven investment at EU level (Commission Staff Working Document 2016).

[2] European Commission, Inception Impact Assessment: “Strengthening of the EU cooperation on Health Technology Assessment (HTA)” (September 2016).

[3] European Commission, Inception Impact Assessment: “Strengthening of the EU cooperation on Health Technology Assessment (HTA)” (September 2016).

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