Europe’s new HTA reality: The JCA, one year on
The EU’s Joint Clinical Assessment (JCA), introduced 12th January 2025 under the EU Health Technology Assessment (HTA) Regulation, represents one of the most significant changes to Europe’s HTA landscape in decades.
Designed to reduce duplication and harmonise clinical evidence evaluation across member states, the system aims to streamline the assessment process for new medicines. However, as the first medicines move through the new process, industry stakeholders are beginning to test how the system works in practice.
Here, we examine the early realities of JCA implementation, exploring whether the system is delivering greater alignment across European markets, or whether it is creating new operational and strategic challenges for companies navigating national reimbursement negotiations.
Reshaping evidence strategies: JCA under EU HTA
While there is a hopeful trajectory for JCA’s potential to streamline assessments, tempered by the realities of national appraisal and affordability – one year on, quite a few questions still remain.
The EU HTA Regulation (2021/2282) establishes a permanent framework for JCAs. It began with oncology and advanced therapy medicinal products (ATMPs) in 2025 and will extend to orphan medicines in 2028 and all new medicinal products by 2030. A single EU-level submission could reduce duplication, align evidence expectations, and initiate national appraisal phases earlier – thereby supporting faster, wider patient access, if executed as intended.
Meanwhile, the Population, Intervention, Comparator, and Outcome (PICO) framework provides the standard format to define research questions and data needs for assessment, structuring population/subpopulations, intervention, comparators (with EU-wide hierarchy and clinical practice fallbacks), and patient‑centred outcomes, including when surrogates are justified.
The Member State Coordination Group on HTA (HTA CG) serves as the joint configuration and first point of contact for ongoing JCAs, with public information on the EU platform. A shared European lens (guidelines, comparators, outcomes) increases the odds that JCA becomes a genuine work-sharing platform, rather than 27 parallel exercises.
But access depends on more than clinical assessment alone. JCA clarifies the clinical side, but national appraisal, pricing, and affordability remain decisive – and may become more visible once clinical uncertainties are reduced.
As explained by the London School of Economics’ Fatima Wafqui and Caitlin Main, of LSE Health, as well as Dr Panos Kanavos, of the Department of Health Policy – HTAR (Health Technology Assessment Regulation) entails “three interconnected mechanisms designed to transform how the EU evaluates health technologies.”
First, addressing inefficiencies in current HTA processes and promoting fair and timely access to oncology treatments across the EU. This ‘fair’ aspect is facilitated by the JCA, aiming “to establish a more unified system that enables Member State collaboration by drawing on a wide range of expertise through the joint clinical assessment reports.” These utilise the PICO framework, which outlines the “essential evidence manufacturers must provide.”
Next, manufacturers discuss additional requirements with national HTA bodies, “such as cost-effectiveness and budget impact,” state Wafqui, Main, and Kanavos. It is here that new complexities arise, including four main questions: are HTA bodies ready? Is industry ready? What of varying standards of care? And how tight are the timelines?
The readiness factor
Throughout the development and roll-out of the new system, much of the narrative was dedicated to the eradication of ‘duplication’ with HTAR, however, doubts remain as to just how much overlap has been reduced.
“HTA bodies across the EU still need to adjust their national processes, and there is uncertainty about whether these processes will be streamlined or whether they will introduce additional complexity,” write Wafqui, Main, and Kanvos.
Yes, EU Member States can access technical assistance through the Technical Support Instrument (TSI), an EU programme that provides tailored expertise to help design and implement reforms. There’s also the Coordination Group on Health Technology Assessment (HTACG), which oversees the adoption of the joint HTA work. But, as the LSE authors note, “manufacturers are concerned that they will need significantly more preparation before engaging in randomised controlled trials (RCTs) and may find it difficult to generate the necessary PICOs evidence for current and future RCTs.”
Additionally, standards of care across EU Member States vary. In Germany, hospital care is delivered by public and private providers funded by para-public social insurance funds, with quality of healthcare overseen by the Gemeinsamer Bundesausschuss (G-BA). France operates similarly, overseen by the Haute Autorité de Santé (HAS), whereas in the Netherlands, hospital care is delivered mostly by private not-for-profit foundations, funded through mandatory, strictly regulated, private insurance. Its healthcare quality is overseen by the Inspectie Gezondheidszorg en Jeugd (IGJ).
By contrast, Bulgaria has a compulsory social health insurance (SHI) scheme, with a single purchaser – the National Health Insurance Fund – and voluntary health insurance (VHI) plays a small role, but there are limited resources. Indeed, Germany’s healthcare system, for example, is significantly more advanced in terms of infrastructure, staff quality, and patient experience. This is where the access issue becomes a wide, gaping hole. Bulgaria has made progress in recent years, but it still faces structural and resource challenges and, for most quality metrics, Germany surpasses EU countries such as Bulgaria, with the largest gaps in modern equipment, staff skill, and responsiveness. Each country is unique, so to speak. In this way, the end goal of harmonisation must still address the question of real-world practicality, of translation into true amelioration of access across EU member states.
Furthermore, although indirect treatment comparisons (ITCs) are a possibility when direct evidence is not available, reliability is questionable, and not always accepted by HTA agencies. As Wafqui, Main, and Kanavos note: “G-BA in Germany rejected the majority of indirect comparisons (71.5 %) on methodological grounds, demonstrating just how high the risk is for manufacturers […] Another analysis examining the acceptance rates of ITC methods in oncology across England, France, Germany, Italy, and Spain found an overall acceptance rate of 30%, with France demonstrating the lowest acceptance rate (0%) within this sample.”
And when it comes to timelines, the EU-27 HTA timelines are strict; starting-from-the-day-of-marketing-authorisation strict.
All this considered, as the authors speculate, “one thing is certain: the HTAR is set to significantly reshape the landscape for industry and HTA bodies in the EU and, possibly, beyond.”
Practical bottlenecks
To find out more, we spoke to Shivani Shah, a manager at EVERSANA, specialising in Market Access, EU HTA (JCA/JSC), and oncology & rare diseases. Shah’s division has supported PICO planning for 10+ assets that will undergo JCA, including early PICO planning, and they are currently supporting end-to-end JCA submissions for three products.
“JCA has been a very resource-intensive process,” said Shah. “Companies are still determining what should be managed internally and what should be outsourced to vendors. The 100-day timeline to respond to questions also makes it challenging and, in the real world, it is less than that. We have seen clients planning submissions for 2028-2030 already starting resource planning now, due to budget and resource constraints.”
Nonetheless, pricing and reimbursement negotiations have not fundamentally changed.
“While PICO exercises are being conducted centrally, companies are still considering input from country affiliates to understand the impact of not addressing a particular PICO on local P&R outcomes,” shared Shah. “Big companies often have a central person or department managing this process, while also coordinating with country affiliates. Smaller or mid-sized firms without local affiliates are using external PMR support for validation. Country-level feedback therefore remains highly relevant, but is now more consolidated.”
A recent key takeaway from the Danish Medicines Council on the EU HTA and JCA process, notably, was that the final HTACG PICO list will be grounded in routine clinical practice, not regulatory approval status alone.
“Early engagement with the HTA Secretariat, particularly through the Letter of Intent (LOI), is more than procedural,” it was discussed. “It signals how a sponsor will operate within a coordinated, capacity-constrained system. LOIs are expected around six months before EMA submission, yet 57% of 2025 LOIs were submitted late. In a system dependent on coordination and predictability, such delays are meaningful.”
On duplication and clinical benefit, and the national pricing issue
EVERSANA’s Shah also spoke to the JCA potential to reduce duplication across national HTA systems.
“It has definitely reduced duplication for the clinical section of submissions,” she said. “However, even before JCA, companies often used Global Value Dossiers (GVDs). Now, in addition to GVDs, they also need alignment with the EU-JCA dossier. The main added complexity is the increased number of PICOs that need to be addressed. For example, subgroup analyses that may previously have been requested only by Germany may now need to be submitted for multiple countries.”
Indeed, as RTI Health Solutions notes, “national HTAs build on a fixed clinical foundation […] elevating the GVD from a harmonisation tool to a strategic bridge between JCA findings and local reimbursement strategy.” Additionally, there is still uncertainty about how EU-JCA reports will influence national pricing decisions. As the RTI report continues: “Although pricing and reimbursement remain a national process, the basis for comparison of clinical effectiveness and safety underlying those decisions is now a centralised process.” In short, if Europe operates with a more unified clinical voice, yet healthcare remains national, then pricing decisions may become more politicised or harder for member states to justify.
As a recent study by Adam Johns et al in The Journal of Market Access & Health Policy stated, the JCA framework “excludes economic evaluations that may be required nationally, necessitating HTDs to align their CE models with the JCA PICO parameters outlined by member states.” Nonetheless, as Shah continued: “Companies are currently approaching evidence planning in a similar way to how they approached GVDs. The main change is the stronger focus on early PICO planning exercises before evidence generation begins. Early scientific advice, such as from G-BA, has also gained greater importance.”
As the Johns-led study put it, “close collaboration and communication between HTDs and national HTA bodies during both the JCA and national procedures will help ensure that the clinical and economic assessments synergistically address key national questions without adding unnecessary overwhelming complexity.”
Needless to say then that, a year on, while we have hints of what is to come, it is still too early to fully understand the impact of JCA reports on pricing and access decisions.
“We do not yet know how influential they will be,” admitted Shah. “Each country still has its own methodological guidelines, which remain unchanged. In addition, many cost-effectiveness markets remain highly budget-impact and cost-driven. For example, even with a strong clinical dossier, Germany and France may recommend a product, while Sweden could still decide not to recommend it if the price is considered too high.”
As Prof Schönermark previously remarked, “different countries may have unique comparator and data requirements, and early dialogue helps companies tailor trial designs to meet both centralised and national assessments from the outset.”
Going forward? As Pharmaceutical Technology reported, the European Commission is to conduct a formal review of the JCA in 2028. And GPI reported that, according to its Annual Work Programme (AWP) report, there would be a suggested total maximum of ~ 58 JCAs for 2026, with “the HTACG estimating it may potentially initiate ~ 35 JCAs for oncology MPs, ~ 15 JCAs for ATMPs, ~ 3 JCAs for variations, and ~ 5 JCAs for selected medical devices.”
The JCA numbers are going up, and the proof will be in the pudding, so to speak. But, bluntly, this year will certainly present the first real test of JCA at scale. An overarching question yet to be addressed is: can Europe align around clinical value without aligning around access?
