As the European Union (EU) gears up for the Joint Clinical Assessment (JCA) process, anticipation is building, not only within Europe but also internationally. At last year’s ISPOR Europe 2023, we highlighted the uncertainty around the implementation of JCA.1 This year, discussions with global teams of health technology developers (HTDs) and Asian health technology assessment (HTA) body representatives emphasised that this uncertainty extended to questions around the potential impact of JCA in non-European countries.
Interestingly, a number of speakers expressed a cautious optimism about the JCA’s potential to provided extended benefits beyond the EU. There is hope in some quarters that it might initiate a trend towards more international collaboration in knowledge-sharing and ultimately in decision-making, potentially shaping global healthcare dynamics.
While the applicability of evidence presented in JCA reports to non-European markets is likely to present a key barrier to their integration into decision-making elsewhere, conference discussions suggested that the influence of JCA reports on HTA systems in non-European countries could largely hinge on how well-established their existing HTA frameworks are. Insights from a Roche survey of HTA experts in 13 non-EU countries, along with perspectives from David Shum (Director of Strategic Access and Pricing at Roche Canada) and Fang-Ju Ling (Associate Professor at National Taiwan University) gave some clues as to the potential impact of EU JCA in different HTA systems:2, 3
Beyond JCA, various cross-border initiatives have been launched over the past decade in the EU and beyond (Table 1), aiming to accelerate drug market access by increasing process efficiency, enhancing decision-making, and expanding HTA body capacity through workload sharing. These collaborations extend beyond clinical assessment, covering aspects such as horizon scanning, economic evaluation, pricing negotiations, and the sharing of data and best practice.8
Brian O Rourke, ex-CEO of the CDA, proposed that this may reflect a trend towards greater cross-border collaborations globally across clinical assessments as well as other elements of reimbursement assessment.2
A commonly voiced concern about the upcoming EU JCA is whether it can accommodate the diverse needs, priorities, and circumstances of partnering countries. Other current and future cross-border collaborations will likely face similar challenges. How well potential partners are able to overcome differences in their processes, methods and policy factors will be key in whether increasing global harmonisation is possible. Tracking the progress of the collaborations listed below will likely provide relevant learnings and insights for both EU JCA and other existing or future potential cross-border collaborations beyond.
Table 1: European and trans-continental cross-border collaborations
Footnotes: aFor example, information on HTA methodology and best practice. bThis collaboration initially aimed to facilitate drug procurement too, but this is now left to national bodies.
Building on discussions on harmonised HTA in Asia earlier this year at the HTAsiaLink Annual Conference,9 and to further explore the theme of international collaboration in HTA, we caught up with Chris Munoz (Citizen’s Representative of HTA Philippines) about the prospects for pan-Asian HTA collaboration. Chris was sceptical about achieving HTA harmonisation in Asia to the level seen with the JCA, BeNeLuxA, and Nordic initiatives, given the varying socio-economic landscapes and policy priorities between Asian countries. However, Chris supported greater knowledge-sharing and data exchange among Asian HTA bodies. Chris suggested establishing a comprehensive library for sharing assessments and pricing outcomes, which would enable bodies to learn from each other. Chris emphasised patient involvement as an area where sharing methodologies could prove beneficial, particularly given the growing emphasis on patient centricity in HTA; collaboration could allow participating bodies to share insights and identify the most effective approaches to enhancing patient participation in decision-making.
As such, while decision-making would remain a local activity, insights from other countries could provide valuable guidance on how to best do this.
While a global trend towards collaborative efforts in HTA appears to be emerging, a one-size-fits-all approach is very unlikely to be effective in establishing successful collaborations. Joint HTA efforts must be tailored, with clear objectives that align with the unique needs of participating countries. The success of future collaborations will depend on transparent communication and developing mutual understanding of where the remit of the collaboration ends and local processes take precedence.
References
If you would like any further information on the themes presented above, please do not hesitate to contact Naman Kochar, Senior Analyst (LinkedIn), Fern Woodhouse, Consultant (LinkedIn), Helen Bewicke-Copley, Consultant (LinkedIn), Amrita Viswambaram, Deputy Head of APAC Market Access and Health Economics (LinkedIn) or Matt Griffiths, Global Head of HTA (LinkedIn). Naman, Fern, Helen, Amrita and Matt are employees at Costello Medical. The views/opinions expressed are their own and do not necessarily reflect those of Costello Medical’s clients/affiliated partners.