European Commission presents policy options to integrate fragmented national HTA systems

The European Commission has published a policy document arguing for greater urgency in the harmonisation of health technology assessments (HTAs) conducted across the European Union. The report sets out potential roadmaps for integrating the fragmented national-level HTA systems. The authors recommend that the current fragmented arrangements cause severe regulatory duplication (and wasted efforts) as well as unnecessarily divergent HTA outcomes in Europe.

The analysis is available to read on the European Commission's website here.

HTAs are estimated to cost national agencies between EUR30,000 (USD33,845) and EUR100,000 each. According to the policy paper, 70% savings could be realised assuming that "10 member states carry out HTAs for one (and the same) technology and that these could be replaced by one joint report". These savings are estimated on the basis that costs of producing a single joint assessment is equivalent to triple the cost of generating a single national-level report.

The four potential roadmaps discussed by the paper can be summed up as follows. In the first scenario, the European Commission examined the "status quo" whereby the HTA system is regulated and organised at the national level and the number of joint HTA assessments is strictly limited. The European Commission assesses that, under Joint Action 3, the number of joint HTAs would increase to a total of 80 by 2020 (alongside 35 early dialogues). This arrangement would be highly unsatisfactory for the European pharmaceutical industry.

A second option examined the prospect of long-term voluntary co-operation (with member states and the pharmaceutical industry) financed by the EU beyond 2020. This model would effect the continuation of the current system, albeit on a longer-term time horizon. In addition, under this scenario, the European Commission foresees the uptake of joint outputs in national-level HTA activity remaining on a voluntary basis. This means that the system of national-level HTA processes would essentially continue for the most part and that co-operation would focus primarily on incentivising a common approach to tools, methodologies, and assessments. The idea of a more sustainable financing mechanisms under the EU budgetary framework (and partly co-funded by EU member states) would presumably be welcomed by the pharmaceutical industry as a step in the right direction, although the ambition of this option falls well short of industry expectations.

The third, fourth, and fifth options explored in the discussion paper offer an increasing degree of complexity and are more suited to the pharmaceutical industry's requirements in terms of addressing the challenges of regulatory convergence and HTA harmonisation in Europe. The third option is perhaps the middle-of-the-road alternative in terms of enhancing HTA compatibility in Europe. It foresees the adoption of a pan-European legal framework for HTA co-operation and the possibility of preparing joint HTA reports on a voluntary basis. The legal framework envisages establishing precise protocols for how data are collected, shared, and ultimately used by national-level authorities.

The fourth and fifth options go substantially further in attempting to establish a permanent central structure aimed at co-ordinating joint HTA reports among member state bodies. Certain elements of the fourth option would be attractive to the pharmaceutical industry and some regulatory authorities in terms of the scope of the HTA system and feasibility of implementation. The fourth scenario looks at making relative effectiveness assessments available to national-level bodies through a shared repository. The report suggests that this system has unique advantages, in terms of putting in place permanent European support structures, while the document acknowledges that participation by member states could be on either a voluntary or mandatory basis.

The fifth option discussed would have the most far-reaching implications for the pharmaceutical sector. This involves the joint production of full HTA reports across Europe on a mandatory basis. It implies that preparation of HTA reports could be voluntary, but that subsequent updates are mandatory or, alternatively, that assessment and uptake of assessment are mandatory. The remit of joint HTAs would extend beyond co-operation in the domain of relative effectiveness assessments to preparations on cost effectiveness, as well as economic, ethical, and legal considerations. This scenario has substantially higher-cost implications, requiring a combination of unspecified (but probably burdensome) pharmaceutical-sector fees and contributions from individual member states. For that reason, the idea of full HTA functionality at the EU level, outlined by the fifth optional roadmap, is unlikely to be favoured by the industry and would be strongly opposed by certain member states on the grounds that participation and uptake should not infringe the discretion of national systems.

Outlook and implications

The European Commission report concludes that the benefits of HTA co-operation in Europe to date have not been fully maximised and that the "long-term sustainability of EU co-operation is not guaranteed" (current financing under the Joint Action 3 programme ends in 2020). The report was published in the context of calls by the European Commission and the European Parliament for further steps toward enhancing HTA collaboration at the EU level. The recommendations outlined by this paper regarding the future harmonisation of HTA structures in Europe are likely to be broadly welcomed by the pharmaceutical industry as a means of alleviating uncertainty by developing common HTA guidelines, producing joint HTA assessments, and reducing parallel national processes. The prospect of enhanced HTA co-operation among EU member states has the potential to reduce delays and unpredictability in price and reimbursement decisions in Europe, and thereby shorten time to market, as well as improve patient access to innovative drugs across the bloc.