Article
The JCA unleashed: Key takeaways and outlook from early reports
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Ruairi O'Donnell, PhD
Ruairi O'Donnell, Cencora's Head of Market Access Europe and EU HTA Lead, explores early takeaways from the first Joint Clinical Assessment reports — and what they could mean for evidence expectations, rare disease evaluation, and patient access across Europe.
With the release of the first Joint Clinical Assessment (JCA) reports, a picture of the process and future implications is starting to emerge. Manufacturers are gaining insight into how the methods are being applied and the challenges these present.
The next area of focus will be how the findings impact decisions at the country level and how they achieve the overarching goal of improving patient access across each European Union market.
In an ISPOR panel discussion — Understanding the First JCAs: Practical Takeaways for Key Stakeholders – held on 23 June 2026, key stakeholders from industry, health technology assessment (HTA) authorities, patient advocacy groups, as well as a respected market access analyst came together to discuss the early reports and what the implications are for industry, innovation, and patient access.
The next area of focus will be how the findings impact decisions at the country level and how they achieve the overarching goal of improving patient access across each European Union market.
In an ISPOR panel discussion — Understanding the First JCAs: Practical Takeaways for Key Stakeholders – held on 23 June 2026, key stakeholders from industry, health technology assessment (HTA) authorities, patient advocacy groups, as well as a respected market access analyst came together to discuss the early reports and what the implications are for industry, innovation, and patient access.
Questions and concerns from early reports
As of mid-July 2026, the European Commission had published three JCA reports: one with critical findings relating to tovorafenib (Ojemda®) and two discontinuations. For industry stakeholders, the early reports pose questions about whether the framework has the necessary flexibility to adequately evaluate products for rare diseases where, in some cases, the gold standard of randomized controlled clinical trials (RCTs) is not feasible or ethical.
During the panel discussion, James Ryan, Director, Global HTA Policy, HTA and Modelling Science at AstraZeneca, raised concerns about what would be feasible in evidence terms in the context of a rare disease and the real-world decision-making factors that surround it. However, Anja Schiel, PhD, Senior Advisor, Norwegian Medical Products Agency, disagreed, noting that the JCA assessors do consider indirect treatment comparisons and do not narrowly focus their reviews on randomized controlled clinical trials (RCTs).
“When we do an HTA, we either assess the added benefit or we focus on cost-effectiveness, then we model and create scenarios, and we’re very open to all kinds of other constructs of evidence that will help us to understand the uncertainty around the methodology itself,” she said. However, she added that manufacturers need to ask how their single-arm trial can be designed to fit the real-world data, not the other way around. “Many HTAs are asking for real-world evidence. Make it convincing. Sometimes you have to generate your own. You can use different inclusion-exclusion criteria, you can look for a different population.”
The early reports also raise queries about patient input. Antonella Cardone, CEO of Cancer Patients Europe, a pan-European all-cancer patient association, noted that although patients and healthcare professionals were consulted per the JCA process and guidance, it is not clear how that feedback impacted the decisions in the report.
“What is documented is that the patient asked for the quality-of-life assessment on the long-term safety, real-world comparators, discontinuation, and tapering, and equity of access,” she said. “But those criteria were considered non-accessible. So, what is the purpose of involving the experts if what they recommend cannot be taken into consideration?”
She added that there are several issues with regards to the meaningful involvement of experts in the process, including how experts are selected, whether a single individual or patient group is sufficient to represent an entire patient community, how their input influenced the definition of the PICOs (Population Intervention Comparator Outcome), the number of PICOs identified, and the final conclusions of the report.
“We heard from the coordination group that they will be looking into ways to fix these problems and to be more transparent,” she said.
During the panel discussion, James Ryan, Director, Global HTA Policy, HTA and Modelling Science at AstraZeneca, raised concerns about what would be feasible in evidence terms in the context of a rare disease and the real-world decision-making factors that surround it. However, Anja Schiel, PhD, Senior Advisor, Norwegian Medical Products Agency, disagreed, noting that the JCA assessors do consider indirect treatment comparisons and do not narrowly focus their reviews on randomized controlled clinical trials (RCTs).
“When we do an HTA, we either assess the added benefit or we focus on cost-effectiveness, then we model and create scenarios, and we’re very open to all kinds of other constructs of evidence that will help us to understand the uncertainty around the methodology itself,” she said. However, she added that manufacturers need to ask how their single-arm trial can be designed to fit the real-world data, not the other way around. “Many HTAs are asking for real-world evidence. Make it convincing. Sometimes you have to generate your own. You can use different inclusion-exclusion criteria, you can look for a different population.”
The early reports also raise queries about patient input. Antonella Cardone, CEO of Cancer Patients Europe, a pan-European all-cancer patient association, noted that although patients and healthcare professionals were consulted per the JCA process and guidance, it is not clear how that feedback impacted the decisions in the report.
“What is documented is that the patient asked for the quality-of-life assessment on the long-term safety, real-world comparators, discontinuation, and tapering, and equity of access,” she said. “But those criteria were considered non-accessible. So, what is the purpose of involving the experts if what they recommend cannot be taken into consideration?”
She added that there are several issues with regards to the meaningful involvement of experts in the process, including how experts are selected, whether a single individual or patient group is sufficient to represent an entire patient community, how their input influenced the definition of the PICOs (Population Intervention Comparator Outcome), the number of PICOs identified, and the final conclusions of the report.
“We heard from the coordination group that they will be looking into ways to fix these problems and to be more transparent,” she said.
Responding to the PICOs
In its own assessment of its evidence, Ipsen – the recipient of the first JCA report – flagged limitations inherent in their matching adjusted indirect comparison analysis, noting that they were attempting to answer the PICO. However, none of the company’s commentary on their own evidence was included in the report; only the assessor’s criticism.
As has been highlighted, there is a lack of evidence available on the very varied standards of care in the particular disease setting, pediatric low-grade glioma. While the JCA places the onus on manufacturers to expand their analysis, without the evidence required to conduct the analysis or to carry out a comparison arm, the credibility of the process is open to question, which then leaves those manufacturers at risk of criticism in the JCA report.
Ryan noted that later JCAs that are based on large RCTs will have larger dossiers and will have much bigger JCA reports with far more available outcomes, including a lot of comparators and potentially many subpopulations. “When we get dossiers running to thousands of pages, we will get very large JCA reports and the question will be, how do people handle that and use it in a way that ultimately is focusing on the key bits that the decision maker needs to focus on?”
As has been highlighted, there is a lack of evidence available on the very varied standards of care in the particular disease setting, pediatric low-grade glioma. While the JCA places the onus on manufacturers to expand their analysis, without the evidence required to conduct the analysis or to carry out a comparison arm, the credibility of the process is open to question, which then leaves those manufacturers at risk of criticism in the JCA report.
Ryan noted that later JCAs that are based on large RCTs will have larger dossiers and will have much bigger JCA reports with far more available outcomes, including a lot of comparators and potentially many subpopulations. “When we get dossiers running to thousands of pages, we will get very large JCA reports and the question will be, how do people handle that and use it in a way that ultimately is focusing on the key bits that the decision maker needs to focus on?”
What’s next at the country level?
For the discontinuations and for any JCAs with negative findings, the question as to what happens to those products at the country level becomes pertinent. Do the products become blocked at a country level? If not, does that undermine the integrity of the JCA? And what are the implications for future JCAs and access to innovative products at a time when the European market is viewed negatively, especially in light of concerns over the impact of Most Favored Nation (MFN) policies and tariffs.
Industry scrutiny will intensify as the JCA process progresses and as products from that process start to make their way into the country assessment and pricing process. “Countries are preparing and adapting their templates, but we don’t know how the JCA report is going to impact HTA decisions in the Member States,” said Cardone.
While Schiel says HTA authorities have committed to reuse as much of the JCA as possible, it depends on the kind of assessment each member state wants to do and whether the report is relevant. “If the report contains nothing that is relevant for my decision-maker's framework, then there's little I can reuse.”
She added that many countries have different assessment criteria, including alternative pathways, simplified procedures and other approaches, and in very rare diseases the Norwegian Medical Products Agency does not do cost utility analysis at all and that decision-makers understand that they are often dealing with uncertainty.
“Companies can submit something that's not identical to the JCA, and they probably will because they will read the JCA and realize they haven't addressed the relevant PICOs,” she said. “We are not actively going out reading JCAs and making HTA assessments because we rely on what is submitted to us.”
The JCA also has the potential to influence HTA markets outside of Europe, which will be looking at how they can bring something similar into their processes, panelists noted.
“The limitations of taking a JCA report and applying it across healthcare and HTA systems that operate on different principles and standards of care may be open to question,” said Neil Grubert, independent pharmaceutical market access specialist. “That being said, I'm sure there's going to be enormous interest because it is new, it does represent a multi-country perspective, and it is in English. I know from panel discussions that NICE (UK’s National Institute for Health and Care Excellence) will be studying those first JCA reports with interest, but to what extent that influences their work remains to be seen.”
Industry scrutiny will intensify as the JCA process progresses and as products from that process start to make their way into the country assessment and pricing process. “Countries are preparing and adapting their templates, but we don’t know how the JCA report is going to impact HTA decisions in the Member States,” said Cardone.
While Schiel says HTA authorities have committed to reuse as much of the JCA as possible, it depends on the kind of assessment each member state wants to do and whether the report is relevant. “If the report contains nothing that is relevant for my decision-maker's framework, then there's little I can reuse.”
She added that many countries have different assessment criteria, including alternative pathways, simplified procedures and other approaches, and in very rare diseases the Norwegian Medical Products Agency does not do cost utility analysis at all and that decision-makers understand that they are often dealing with uncertainty.
“Companies can submit something that's not identical to the JCA, and they probably will because they will read the JCA and realize they haven't addressed the relevant PICOs,” she said. “We are not actively going out reading JCAs and making HTA assessments because we rely on what is submitted to us.”
The JCA also has the potential to influence HTA markets outside of Europe, which will be looking at how they can bring something similar into their processes, panelists noted.
“The limitations of taking a JCA report and applying it across healthcare and HTA systems that operate on different principles and standards of care may be open to question,” said Neil Grubert, independent pharmaceutical market access specialist. “That being said, I'm sure there's going to be enormous interest because it is new, it does represent a multi-country perspective, and it is in English. I know from panel discussions that NICE (UK’s National Institute for Health and Care Excellence) will be studying those first JCA reports with interest, but to what extent that influences their work remains to be seen.”
Impact of the JCA into the future
In 2028, orphan medicines will be subject to the mandatory JCA, which some observers have noted will raise further questions about the process and whether its methods support decision-making for medicines that may not fit traditional clinical evidence data models.
“When the new HTA regulation came into place we hoped it would take some of the burden away from the HTA assessment in the countries and accelerate access to treatment. But will this happen? Nobody can tell,” Cardone said.
Ryan said it is his hope that the reports or the use of the regulatory dossier will provide some context at the local level, adding that if decision-makers depend solely on the JCA report, or more concerningly the summary report, it could pose a risk for how HTA decisions are reached across Europe.
“When the new HTA regulation came into place we hoped it would take some of the burden away from the HTA assessment in the countries and accelerate access to treatment. But will this happen? Nobody can tell,” Cardone said.
Ryan said it is his hope that the reports or the use of the regulatory dossier will provide some context at the local level, adding that if decision-makers depend solely on the JCA report, or more concerningly the summary report, it could pose a risk for how HTA decisions are reached across Europe.
“The interesting thing to observe going forward will be what role the assessor and co-assessor play, and to what extent they may influence the output, even if that's unintentional,” said Grubert, adding that he expects that over time there will be methodological convergence in the approach that different agencies bring to their work on the JCA as assessors and co-assessors.
“I’m sure everyone is going to be studying not just this first one, but the others that follow and see what common features there are, and indeed what problems may arise that we need to address,” he added. “And that perhaps also speaks to the review process that is meant to start in a matter of months with a view to submitting a report in January 2028 to the Commission in terms of what adaptations may be required.
The overall goal of the European Commission and Member States is to promote broader availability, accessibility, and affordability of new medicines, and JCA plays a role in that objective. However, some of the core elements of the HTA lie beyond the scope of the JCA, Grubert noted, added to which there are geopolitical uncertainties impacting the launch of drugs in Europe.
“The JCA is just one element in that broader picture, but if it goes to plan, it should lead to a convergence in terms of approaches to HTAs, which we hope will result in faster and more uniform access and reduction in the disparities in standard of care,” he said.
“I’m sure everyone is going to be studying not just this first one, but the others that follow and see what common features there are, and indeed what problems may arise that we need to address,” he added. “And that perhaps also speaks to the review process that is meant to start in a matter of months with a view to submitting a report in January 2028 to the Commission in terms of what adaptations may be required.
The overall goal of the European Commission and Member States is to promote broader availability, accessibility, and affordability of new medicines, and JCA plays a role in that objective. However, some of the core elements of the HTA lie beyond the scope of the JCA, Grubert noted, added to which there are geopolitical uncertainties impacting the launch of drugs in Europe.
“The JCA is just one element in that broader picture, but if it goes to plan, it should lead to a convergence in terms of approaches to HTAs, which we hope will result in faster and more uniform access and reduction in the disparities in standard of care,” he said.
About the author:
Ruairi O’Donnell is Vice President, Market Access Europe, and EU HTA Lead, at Cencora. A 20-year veteran of the global market access and HEOR consulting services sector, Ruairi has held numerous leadership positions in leading global consulting organizations, with a strong background in value strategy, evidence development, and market access pathways.
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