The Health Technology Assessment (HTA) landscape in Europe is undergoing a significant shift, with the introduction of the Joint Clinical Assessment (JCA) as part of the European Union’s (EU) Regulation on HTA (HTAR; 2021/2282). JCA will be introduced in 2025, initially for oncology products and advanced therapy medicinal products (ATMPs), with expansion to orphan products in 2028 and all new medicines (including, under certain criteria, Class IIb and III medical devices and Class D in vitro diagnostic devices) in 2030.
The Regulation, which introduces a permanent legal framework for joint HTA in the EU, aims to encourage greater cooperation between the 27 EU Member States, culminating in cross-border harmonisation of the clinical assessment that forms part of national HTA processes. The Regulation also states that, through formalising this joint process for clinical assessment, it will:1
As we draw close to the point of JCA commencing “next year”, it is unsurprising that JCA was a dominant presence on the agenda at ISPOR Europe 2023. Most discussions concluded that, although the prospect of joint HTA holds promise, a lot of uncertainty remains around how this will work in practice, contributing to a palpable sense of intrigue (and anxiety?) among the ISPOR audience. Some key topics discussed are highlighted below.
It was clear there was some anticipation that the JCA could transform how HTA is conducted on a European level…However, we observed some continuing confusion and misaligned expectations over what the JCA aims to achieve. The expected benefits of the JCA, in terms of reducing duplication of effort for industry and national HTA bodies with regards to preparation and assessment of clinical evidence, was well-communicated and this does – at least in theory – represent a potential benefit of JCA. The extent to which this benefit is realised will depend on the success of the implementation. However, the conference also saw multiple references to “alignment of decisions” and “consistency in access to medicines” across Member States as an expected benefit of JCA. We may see more consistency in reimbursement decisions across Member States, to the extent to which current divergent decisions relate to differences in the clinical evidence assessed and the approaches used to do so. However, the reimbursement decision remains a matter for national consideration and there are a number of reasons these decisions will still differ despite a common JCA:
It will be interesting to see if JCA does lead to more consistency in final decisions, but we should avoid assuming this will be the case or putting this forward as an a priori benefit of JCA.
Additionally, given the variety across Member States with regards to factors such as capacity and health system requirements, it remains unclear how the JCA will impact access and uptake on a practical level. There was even discussion that larger Member States could realise the most benefit due to the increased resource they have available to juggle input into JCA alongside national HTA processes, and leave smaller Member States behind; something that would go against the objectives of this Regulation.
The feeling in the room during the Q&As was that industry, in general, does not feel it is ready (one comment simply asking directly for a delay summed-up this mood quite succinctly!). Concern was particularly focused on how industry will manage with having to prepare a detailed JCA dossier alongside other market access activities, particularly the European Medicines Agency (EMA) submission (see the Figure below for an overview of how the two processes are likely to interact). The hope for JCA is that there will ultimately be a lower burden on industry and collective European HTA bodies over the course of a product’s HTA lifecycle by reducing the need for multiple different clinical assessments. However, the trade-off is that there is likely to be a greater burden on industry up front, given the timing of the JCA and the potential for the JCA to be significantly more complicated than any national-level clinical submission as a result of potentially needing to address multiple PICOs to meet diverse member state requirements. Indeed, a spotlight session on the first day of ISPOR Europe highlighted a study that simulated consolidated EU PICOs for a hypothetical lung cancer product and found that the JCA would need to address 10 or more PICOs simultaneously. This challenge is compounded by the fact that the final PICOs to be addressed in the dossier (i.e. the scope) will only be confirmed to the manufacturer approximately three months before the JCA dossier submission is due. Inevitably, therefore, manufacturers will have to start work on addressing anticipated JCA PICOs in advance of final scope confirmation, and those at the conference agreed that early engagement with key stakeholders, such as the EMA and Member State representatives, will be critical in guiding these preparatory activities.
Although there was a lot of discussion on uncertainties, practical solutions were also covered. Four key themes related to preparation are highlighted below:
Industry will need to embrace preparation for the JCA process (it is happening!). However, there are some clear areas in which the approach to the JCA from the JCA Coordination Group, responsible for the scoping phase of a JCA, will have an important bearing on the success of the process:
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If you would like any further information on the themes presented above, please do not hesitate to contact Grace Lambert, Consultant or Matt Griffiths, Global Head of HTA (LinkedIn). Grace Lambert and Matt Griffiths are employees employee at Costello Medical. The views/opinions expressed are their own and do not necessarily reflect those of Costello Medical’s clients/affiliated partners.
