Lora Fleifel, Director of Global Value Access & Pricing Operations Europe for Oncology at Merck, dissects the promise and pitfalls of the new EU Joint Clinical Assessment (JCA). The JCA aims to harmonise clinical evaluations to help reduce the significant disparities in patient access to innovative treatments that still exist across Europe. Yet, as Fleifel argues, deep-rooted national constraints and operational challenges may limit its potential to truly transform access.
The EU Joint Clinical Assessment (JCA) is a strategic initiative proposed by the European Commission aimed at harmonising Health Technology Assessment (HTA) across member states.1 This initiative seeks to broaden and accelerate access to innovative treatments in Europe, addressing the disparities in access and time to market highlighted by the W.A.I.T. (Waiting to Access Innovative Therapies) indicator.
According to the W.A.I.T indicator of 2024 survey2, only 46% of innovative medicines approved centrally in the period 2020-2023 (173 in total) were available to European patients in 2024, while the EU average time to availability rose to around 578 days. Availability rates vary significantly across European markets, from 90% in Germany to as low as 10% in Malta.
The EU HTA Regulation’s application to new oncology entities and advanced therapy medicinal products (ATMPS) started as of January 12th, 2025. One of the key advantages of the EU JCA is its potential to resolve the capacity and capabilities limitations of HTA in some member states. By streamlining processes, the JCA could significantly improve the clinical evidence evaluation necessary for informed reimbursement decisions and reduce backlogs, maybe helping member states in applying the transparency directives3,4 related to time to access. However, while the JCA may alleviate some challenges, it does not fully address the primary issue of budget constraints that smaller member states encounter. The implementation of accelerated and higher HTA standards alone will not resolve the multifaceted barriers to access across Europe.
The success of the EU JCA will depend to a certain extent on the willingness of national HTA bodies to adopt the JCA dossier. Currently, it appears that larger markets with robust HTA capabilities such as France and Germany, are likely to continue utilising their own methodologies.
As we await the first JCA assessments and the subsequent national access decisions, we expect the pharmaceutical and access ecosystem of Europe to undergo significant changes. Regardless of whether the JCA becomes a transformative force or merely adds another layer to the existing process, the pharmaceutical industry must prepare for the implications of JCA submissions. The level of readiness and organisational refinement of the pharma companies varies according to the size of the companies and whether they have assets undergoing EU JCA in the next few years5.
Implications of JCA
a) The implications of the JCA for the pharmaceutical industry are multifaceted:
Increased Workload and resources: Companies must brace for the extensive workload associated with JCA submissions. The scoping phase is expected to yield a significant number of Patient, Intervention, Comparison, and Outcome (PICO) frameworks, necessitating a greater volume of statistical analysis and indirect comparisons. This increased demand for resources will require careful planning and anticipation to meet the tight JCA dossier submission timelines following the scoping phase. Additionally, the JCA process will run in parallel to regulatory procedures, further increasing the workload for various global functions as they navigate the concomitant demands from multiple regulatory bodies and the JCA.
Parallel Processes: The JCA requests and responses will now occur concurrently with regulatory affairs processes, deviating from the traditional sequence that followed the Committee for Medicinal Products for Human Use (CHMP) and European Commission (EC) decisions. This shift necessitates a re-evaluation of governance and operating models within the industry, as HTA submissions, which previously fell under local ownership, will now have a global remit.
Local Adaptation: Local teams must adapt to the new submission landscape, where delta dossiers must address specific requirements of their member states while still referencing the JCA dossier. This will require upskilling in PICO capabilities to effectively contribute to the internal PICO simulation exercises, analyze JCA reports, and deploy agility to adapt to the new revised national process when applicable.
b) At the member state level, there are several critical steps that need to be taken:
Capacity and Capability Building: Member states must enhance their capacity and capabilities to effectively engage in the JCA process, recognising that JCA dossiers will be more exhaustive than typical national submissions, and upskill their PICO capabilities to effectively respond to the scoping survey.
Regulatory Updates: Local regulations regarding pricing and reimbursement (P&R) must be revised to align with JCA requirements, ensuring that they are inclusive and adaptable.
Dual Processes: Member states will need to manage two parallel processes until 2030: one following the JCA for oncology and ATMPs, and another for all other disease areas. This duality adds complexity to appraisals and may lead to backlogs for non-JCA assessments.
c) Some central questions remain:
- Will the JCA truly accelerate access to innovative therapies? There is hope that it will, particularly in markets where delays in access have stemmed from insufficient HTA capabilities or reliance on external HTA decisions, such as in Romania and Croatia. If national HTA bodies primarily rely on the JCA dossier for clinical evidence evaluation, as is expected in Spain, this could indeed shorten timelines for national evaluations. However, this acceleration is contingent on access delays not being budget-driven, as is the case in countries like Hungary and Slovakia.
- Will the JCA broaden access to innovative therapies? While the JCA may overburden Health Technology Developers (HTDs) by addressing PICOs in countries where launches are not initially planned, the ultimate decision to launch remains within the remit of the HTD. The JCA will not resolve other barriers to drug availability, including but not limited to budget constraints, insufficient infrastructure, and stringent country requirements for evidence or HTA referencing, etc. 6
- Will the JCA merely introduce another hurdle in the access landscape? The JCA report will not provide value judgments nor recommendations, leaving final appraisals to individual member states. The willingness of national HTA bodies to accept JCA findings without reassessing the same evidence using their methodologies remains uncertain. Most importantly, can the JCA foster greater equity of access across Europe? Simplifying the complex access hurdles in member states to merely inadequate HTA capabilities may overlook the broader systemic issues at play.
Potential Ex-EU Spillover Effects
The JCA report, being a European HTA clinical evaluation, will be publicly available in English following the European Medicines Agency (EMA) marketing authorisation. This accessibility positions the JCA report as a potential reference for HTA bodies outside the EU, similar to the roles played by the UK National Institute for Health and Care Excellence (NICE), the German Federal Joint Committee (G-BA), and the French National Authority for Health (HAS) in some Middle Eastern and Latin American markets.
The first two JCA under the EU HTA regulation are currently ongoing7, and focus on two innovative therapies: one for paediatric low-grade glioma which will be assessed by the National Centre for Pharmacoeconomics, Ireland, and the Institute for Quality and Efficiency in Health Care, Germany; and another for advanced melanoma which will be assessed by the French National Authority for Health and the Agency for Health technology Assessment and Tariff System, Poland
While awaiting the first JCA reports by the end of 2025, the pharma industry will need to proactively monitor these assessments. This vigilance will enable the industry to provide constructive improvement recommendations and support evidence-based policy discussions at the time of a potential reevaluation of the JCA following the 2027 Commission and 2028 Member States reports1.
In the current geopolitical climate, access to innovation must consider factors beyond mere HTA clinical evaluations. The attractiveness of the EU for pharmaceutical investments, alongside national-level considerations regarding industry requirements and budget allocations, will play a crucial role in shaping access to innovative treatments. As cost-containment measures exert increasing pressure on the industry, fostering a collaborative partnership between authorities and the pharmaceutical sector is essential. Such collaboration can create common ground that enables the industry to thrive, ensuring sustainable access to innovation in the EU. Ultimately, investing in health is not just a moral imperative but also a strategic investment in a nation’s economy, promoting a healthier, more productive population.
* The content of this publication has been developed by the author. Consequently, statements in this publication are the personal opinion of the author and do not reflect the Merck company position (as the employer of the author)
References:
1- Regulation (EU) 2021/2282 of the European Parliament and of the Council of 15 December 2021 on health technology assessment and amending Directive 2011/24/EU (Text with EEA relevance)
Regulation – 2021/2282 – EN – EUR-Lex
2- EFPIA Patients W.A.I.T Indicator 2024 survey, May 2025- efpia-patients-wait-indicator-2024-final-110425.pdf
3- Transparency of decisions regulating the prices and reimbursement of medicinal products in European Union Member States – Directive 89/105/EEC– Transparency of decisions regulating the prices and reimbursement of medicinal products in European Union Member States | EUR-Lex
4- Proposal for a DIRECTIVE OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL relating to the transparency of measures regulating the prices of medicinal products for human use and their inclusion in the scope of public health insurance systems- EUR-Lex – 52012PC0084 – EN – EUR-Lex
5- Simon-Kucher industry insights: Are pharmaceutical companies ready for EU JCA?, March 2025- https://www.simon-kucher.com/en/insights/simon-kucher-industry-insights-are-pharmaceutical-companies-ready-eu-jca#:~:text=Drawing%20on%20in-depth%20interviews%20with%2012%20senior%20P%26MA,to%20help%20pharmaceutical%20companies%20achieve%20EU%20JCA%20readiness.
6- The root cause of unavailability and delay to innovative medicines: Reducing the time before patients have access to innovative medicines, May 2025, CRA report
cra-efpia-root-causes-of-unavailability-and-delay-final-2025-report-summary-29-apr-2025-stc.pdf
7- European Commission Newsroom- https://ec.europa.eu/newsroom/sante/newsletter-archives/62551
