Will JCA Set the Tempo For Increased Global Harmonisation in the Access Landscape?

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.

Might EU JCA strike a chord in HTA markets beyond Europe?

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

1.

Markets with established HTA bodies
  • In established HTA markets, the promptness of delivery of EU JCA reports will likely determine whether they have any impact on local HTA.
  • The Roche survey of HTA experts indicated that established markets generally trust the quality and credibility of their appraisal processes and are unlikely to compromise the timeliness of their HTA process for additional JCA insights. For example, if regulatory approval processes in Europe and Canada – managed by the European Medicines Agency (EMA) and Health Canada, respectively – are initiated at similar times, Canada’s Drug Agency (CDA) could struggle to integrate findings from EU JCA reports into its decision-making.2, 4, 5
  • This challenge is not exclusive to non-EU countries. In Germany, the AMNOG dossier is submitted approximately 40 days following the EMA regulatory decision on average.6

2.

Markets with nascent HTA bodies
  • Nascent HTA bodies are typically resource-constrained.7 Local assessors could improve efficiency in decision-making by leveraging the pre-assessed strengths, weaknesses, and uncertainties of evidence presented in EU JCA reports to reduce redundancy in evidence assessment.
  • The full benefit of such efficiencies would likely require local HTA bodies to build additional capacity and expertise to ensure the applicability of JCA findings to the local context, where there could be differences in the target population, clinical practices, unmet needs and policy goals, and to then effectively incorporate these findings into appraisals. As such, efficiencies may not be fully realised for some time.
  • Additionally, the HTA timelines for nascent bodies could be much later than the JCA timelines, resulting in the availability of newer evidence – the JCA report may not be up-to-date, and efficiencies may be limited. JCA will likely not replace local clinical assessment, but supplement it.
  • Taiwan’s Center for Drug Evaluation (CDE) already references international HTA outputs from Australia, Canada and England when evaluating medical technologies, and it is compulsory for the CDE to consider international HTA decisions when evaluating high-cost cancer drugs. Given that cancer drugs are amongst the first products expected to undergo JCA, we might see the CDE integrating JCA reports into decision-making within the next 2–3 years. Similar trends may also be observed in other countries which reference international HTA decisions.
  • Familiarisation with EU JCA reports may also have the added benefit of paving the way for integration of relevant methodological elements, such as evaluating evidence certainty, into evolving local HTA frameworks.

Could cross-border collaboration set the stage for global harmonisation?

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.

What could define the success of future collaborations? A case study in Asia

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.

Looking to the future

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

  1. Costello Medical. ISPOR Europe 2023 Conference Report: The EU Joint Clinical Assessment – Ready or Not, Here it Comes. Available here. Last accessed: December 2024.
  2. J. Garcia. HPR133: The Global Impact Of EU HTA: Insights from 13 Non-EU Countries. Presented at ISPOR Europe Congress, Barcelona, Spain. 2024.
  3. M. J. Garcia. HPR133: The Global Impact Of EU HTA: Insights from 13 Non-EU Countries. Presented at ISPOR Europe Congress, Barcelona, Spain.  2024.
  4. EUnetHTA. D5.4: JCA Timelines. Available here. Last accessed: December 2024.  2024.
  5. Government of Canada. Notice to industry: Aligned reviews between Health Canada and health technology assessment organizations. Available here. Last accessed: December 2024.
  6. Educational Symposium 138. Ready for 2025? How Lessons Learned From National System Reforms Can Guide Our Response to the New EU HTA Regulations. Presented at ISPOR Europe Congress, Barcelona, Spain.  2024.
  7. N. Kochar. HTA131: A Review of Guidelines and Practices for Patient Involvement in HTA Across Europe, North America and APAC, to Identify Opportunities for Advancement in the Nascent Philippines HTA Market. Presented at ISPOR Europe Congress, Barcelona, Spain.  2024.
  8. Issue Panel 311. The Dawn of a New Era: Cross-Border Collaborations – Regional, Pan-Europeans and Transcontinetal – How Will They Shape the Future of Access?Presented at ISPOR Europe Congress, Barcelona, Spain.  2024.
  9. HTAsiaLink. Highlights from the 11th HTAsiaLink Annual Conference in Malaysia.  2024.

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.

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