I recently attended the conference HTA 2.0 Europe – Teaming Up for Value organised by EUnetHTA in Rome. The HTA network, which is mainly composed by members of the national authorities and bodies responsible for HTA in Europe, is responsible for the strategic governance and the long-term planning of HTA cooperation in the EU. At the EU level, we refer to a ‘network’ not to an ‘agency’ when we discuss HTA, because there is no EU agency empowered with HTA responsibilities at present. HTA powers remains concentrated at the national or regional level. By contrast, regulatory bodies - which are responsible for issuing marketing authorisation to medicines - at the member state level have delegated part of their powers to a centralised body, the European Medicines Agency (EMA), which evaluates efficacy and safety of pharmaceutical products that seek approval in the EU through centralised procedure.
An EU HTA agency: reality or chimera?
The creation of a fully-fledged HTA agency in the EU faces a number of obstacles. In particular, major conflicts persist concerning what it is considered acceptable evidence by different payors in Europe. During the conference, the former Executive Director of the EMA, Professor Guido Rasi, pointed out that an agreement on common standards for surrogate outcome measures could be easily reached; in fact, the definition of surrogate endpoint is based on scientific knowledge and principles that are expected to be the same across Europe. Conversely, the selection of the comparators poses serious difficulties, as standards of care vary significantly among EU healthcare systems. Furthermore, cost-effectiveness analysis results are infrequently, if ever, applicable to all EU member states, as the cost of a technology across Europe differs considerably. In addition, member states apply different assessment models, limiting opportunities for HTA harmonisation. Furthermore, the definition of both health policies and healthcare budget remains a national or even regional responsibility in Europe. Therefore, in contrast to what happened with the creation of the EMA, there are a number of factors which present significant resistance to the delegation of full HTA decision powers to an EU agency. HTA evaluations have a direct impact on the management of healthcare resources at the national or regional level - and as such EU member states are in general unwilling to relinquish the authority over pharmaceutical HTA and its resulting impact on healthcare spending.
All in all, the creation of an EU HTA agency does not seem a realistic scenario ... at least not for now. However, cooperation among member states is likely to further intensify going forward.
Boosting collaborations on HTA in Europe, an effective strategy for efficient and quicker HTA decisions?
The further development of the current EU HTA network, whilst not exerting legally binding powers, can allow increasing collaboration and synergies at the EU level for the production of shared HTA information. In particular, boosting synergies across the EU on HTA decisions may allow parties involved to cut the risk of costly repetitions and duplication of efforts in their separate filings for national bodies. In smaller countries with limited resources or countries that have recently implemented HTA, involvement in the HTA network is expected to be beneficial for reducing barrier to entry. Meanwhile, countries that have been using HTA for a longer period of time may be able to boost efficiency and quality through the further development of a joint work. Furthermore, a progressive harmonisation of the type of evidence requested by European payors to pharmaceutical companies (even if limited to surrogate endpoints, for the reasons discussed above) may potentially have a positive impact on market access. Pharmaceutical industry interest in the EUnetHTA process is also demonstrated by the framework of collaboration signed by the European Federation of Pharmaceutical Industries and Associations (EFPIA) and EUnetHTA in July 2013.
Furthermore, collaborations are also likely to strengthen between the EMA and EUnetHTA. Further to the EMA decision to launch an adaptive licensing pilot project, early assessments and dialogues among different stakeholders are expected to play an increasingly important role in Europe.
Potential future evolution of the EU HTA network
My impression is that EU cooperation on HTA is currently going through a crucial phase and it should not miss the opportunity to demonstrate its essential role. In particular, the EUnetHTA Joint Action (JA) 2, launched by the European Commission in 2012, will be ongoing until 2015. The Commission is already planning to launch, with funding from the new EU health programme, a EUnetHTA JA 3, which will presumably run between 2015- 2020. However, health programme funding cannot be extended further after 2020. It will be, therefore, essential for the network to ensure its financial sustainability by attracting additional resources at national level. In order to attract new resources, as pointed out in the Strategy for EU cooperation on Health Technology Assessment, signed by the HTA network on 29 October, it will be essential to demonstrate benefits of EU cooperation on HTA and the results achieved in the EU member states. However, member states are not the only stakeholders that need to be convinced of the benefits of EU cooperation on HTA. Long-term strategy also needs to take into consideration crucial concerns expressed by both patients and the pharmaceutical industry. In particular, it will be necessary to show that results of joint assessments, either rapid relative effectiveness assessments (REAs) or full HTA, have a tangible impact on the decisions taken at the national or regional level and the time required to bring a new drug to the market.
Federica Benassi is a life sciences analyst for IHS
Posted on November 24, 2014