Session Summary from VI HTA Symposium (11-12 June 2018)
DAY I, SESSION II:
HTA in Europe
Marcin Czech, Roman Topór-Mądry, Piotr Szymański, Ewa Warmińska, Izabela Pieniążek, Joanna Augustyńska
Joint Clinical Assessment
The theme of HTA in Europe session was a discussion on the challenges of developing a uniform clinical assessment in connection with the Proposal for a Regulation of the European Parliament and of the Council on health technology assessment and amending Directive 2011/24/EU. These changes are to form the basis for a permanent and lasting cooperation at the EU level in the field of, i.a., joint clinical assessments of the most innovative health technologies (both drugs and certain medical devices) with the largest potential impact on patients. The Regulation is to enter into force on the twentieth day following its publication in the Official Journal of the European Union, however it is to be applied after 3 years from the date of its entry into force. The Regulation proposal does not allow clinical assessments carried out by local HTA institutions for central assessments.
The main objectives of the initiative are to ensure improved functioning of the internal market for health technologies and to strive for a high level of protection of human health. The specific objectives of the initiative include increasing the availability of innovative health technologies for patients in the EU, ensuring an efficient use of resources, improving the quality of HTA in Europe and increasing the predictability of operating conditions. When referring to the Regulation proposal, the panellists primarily stressed the shortcomings in the field of legislation – the lack of a concrete solution to clarify how a common clinical assessment would serve all Member States. This is an important issue due to the differences existing in clinical practice. The second aspect is the validity of the clinical assessment in the context of new scientific evidence emerging.
During the session, the position of European Society of Cardiology regarding HTA in Europe was presented. Opportunities and threats with regard to medical devices have also been discussed. The potential opportunities include: better evidence base for national decision makers, increased investment in research and development, as well as improved access to innovative medical devices for patients. Threats on the other hand include the legal form of the proposed solutions which involve a large number of executive acts, the lack of the possibility of conducting clinical assessments at the national level for selected medical devices and the possibility of conducting a clinical assessment using measures other than those provided for by the regulation only with the consent of the EU Commission.
It was noted that the Regulation should ensure that joint clinical assessments take into account the needs of all Member States. In particular, a joint clinical assessment should include a broad spectrum of comparators, as appropriate. Bearing the above in mind, it is proposed that joint clinical assessments should be preceded by extensive consultations with clinical experts representing all Member States in order to identify the comparators and any other aspects necessary to be included in the clinical analysis.
HTA Master File
The idea of building the HTA Master File platform as a response to the Regulation proposal, which would be used for European HTA, was presented. It is comprehensive HTA documentation dedicated to a specific health technology which takes into account not only the clinical assessment itself but also geographical aspects, local conditions of individual countries, as well as the dynamic development of health technologies through continuous monitoring of clinical evidence. The intention behind this idea is to prevent duplicating of work and relying on existing materials regarding a given health technology. That would make it possible to create HTA dossiers which could be used in other Member States. HTA Master File will allow for the greater implementation of common clinical assessments.
Feasibility Study of the Joint Clinical Assessment in Poland
Methodological assumptions, as well as the results and conclusions of the feasibility study of the joint clinical assessment conducted by the Arcana Institute, have also been presented. The main goal of the project was to analyse the efficacy assessment carried out at the European level by EUnetHTA as part of the Rapid Relative Effectiveness Assessment (REA) in the light of the possibility of its use in the reimbursement process in Poland. The REAs carried out by EUnetHTA in the framework of Joint Action 2 and Joint Action 3 (a total of 9 processes) were analysed, which were compared in terms of methodology with the corresponding processes carried out by the AOTMiT. Some discrepancies have been identified; they regarded e.g. selection, comparisons and approaches to endpoints. Key conclusions from the analysis were presented, indicating both the opportunities and limitations associated with the use of REA in Polish settings.
Challenges of European HTA
During the debate, attention was mostly paid to organisational weaknesses and the Regulation’s “lack of maturity”. The problem of duplication of processes related to clinical assessment in individual Member States and the problem of failure to use European HTA resources have been emphasised. It was concluded that for the proposed solutions to be usable, the rules must be defined in a precise manner.
It was pointed out that in the latest version of the draft regulation, delegated acts were abandoned and the duration of the assessment was specified. The issue of non-clinical HTA was also touched upon, although the initial assessment was to cover only clinical issues. It was stressed that the most important issue from a legal point of view is the form in which the final document will be developed. If it is a regulation – it will be a mandatory legal act (prevailing over national law), hence the national regulations that will conflict with it will automatically cease to apply.
Another issue raised during the discussion was the possibility of the Polish Agency’s participation in works on the clinical assessment. The President of AOTMiT emphasised that the Polish agency has repeatedly declared its willingness to participate in analytical work, however without success. He pointed out that although the regulation mentions voluntary participation, in fact the procedure of admitting an HTA agency to works at the European level is a complex procedure – the agency must first have an observer status, then a reviewer status, and only then can it be allowed to participate in analytical works. With a larger number of applications, agencies with documented experience are preferred. The President of AOTMiT also stresses the significant discrepancy and disparity in the number of processes in the EUnetHTA vs AOTMiT, which is the result of both different priorities and different human resources. He also underlined that AOTMiT is one of the largest HTA agencies in Europe.
The President of the Agency (AHTAPol) pointed out that at the moment Poland only participates in methodological works. Therefore, it is important to work on strengthening our position in international talks and to increase our representation in HTA projects at the European level.