Industry perspectives on the first Joint Clinical Assessments under EU HTA: insights from Nicole Yurgin

Since January 2025, the EU HTA Regulation has entered its first phase of implementation, with 13 Joint Clinical Assessments (JCAs) currently underway. While activity is increasing, no final reports have yet been published, leaving stakeholders navigating a process that is still taking shape. With initial outputs expected in June, insights from those directly involved are becoming increasingly important.

Building on her presentation at the World Evidence, Pricing & Access Congress 2026, “The first JCA club: life in the first wave of assessments,” in this interview Nicole Yurgin, Founder & Managing Director, Yurgin Advisory GmbH shares perspectives from stakeholders actively engaged in these early assessments, offering insight into how the process is unfolding in practice and what it may signal for the future of EU HTA.

Nicole, thanks for speaking with us. Your presentation has garnered a lot of interest since the congress. To begin, could you share what motivated you to explore the early experiences of companies undergoing the first wave of JCAs?

It all started over dinner with a market access colleague whose company is going through JCA right now. We spent the whole meal talking about their experience — what was working, what was frustrating, what they wished they’d known. And at the end, even they said: “But that’s just my experience. I don’t know if it’s representative.”

That really stuck with me. Here is someone actively inside the process, and even they couldn’t tell whether their challenges were unique or universal. And it makes sense — any single company will only go through JCA a handful of times.

You can’t build a complete picture from one experience. And I realized: if we’re going to learn at any real speed about how JCA works in practice, we need to share learnings as a community. No single company can do it alone.

So, I set out to have structured conversations with people across multiple companies to find out what’s common, what’s surprising, and what advice they’d give to others. The response was encouraging, people wanted to share. They recognized that collective learning would benefit everyone, including the patients waiting for these medicines.

Your work draws on interviews with manufacturers involved in ongoing JCAs. Could you describe your methodology and the types of stakeholders you engaged with during this research?

In early 2026, I conducted six semi-structured interviews across five companies; four of the five are currently involved in a JCA, while one is preparing but not yet in the formal process.

The conversations were open-ended, covering five themes: what’s working, frictions, uncertainties, national planning, and advice for newcomers. I deliberately avoided confidential operational details.

I looked for patterns across respondents, noted where multiple companies raised the same point independently, and also drew out observations that I considered would be interesting or useful to others in the process. This is not a purely academic exercise; it is intended as practical insights sharing. All insights are anonymized, and any errors in interpretation are my own.

From these conversations, what have been some of the key practical challenges companies are encountering as they navigate the JCA process for the first time?

The PICO. Full stop. Every company, unprompted, identified their number one challenge as the PICO (which defines the population, intervention, comparator, and outcomes that together set the scope of the comparative clinical evidence that must be submitted). I started calling it “the PICO puzzle” because it’s really four problems wrapped in one.

1. Predicting scope before it is defined. Companies are having to anticipate PICOs before the formal scope is confirmed. And that means investing significant resources in scenarios that might never materialize. But this is unpredictable. One company braced for a huge number and got fewer than expected. And one got PICOs with comparators that didn’t make clinical sense. Prediction is therefore something of a gamble, even for well-prepared companies. Expect some PICO surprises and prepare your organization for this.
2.  The label gap. Dossier development is taking place in parallel with an evolving product label that is not yet finalized. This is particularly challenging in oncology, where data maturity can shift late in development. As one interviewee noted, “You are still waiting for things to finalize while you are writing your dossier.”
3. Methodology. This one is fascinating. How PICO questions are posed to country affiliates can significantly influence the responses received. Ask about individual P-I-C-O components and you get one answer. Ask for the most likely complete PICO scenarios and you get something entirely different. This has important implications for companies still refining their approach.
4. Organizational readiness. Regulatory, biostatistics, HEOR, clinical development all need to be working together much earlier than most companies are used to. You can’t run JCA as a relay race. It’s more like synchronized swimming!

Across all of these challenges, the 100-day submission window was repeatedly highlighted as “the biggest challenge” by multiple companies. That clock starts whether you’re ready or not.

Did any aspects of the process differ from what companies initially expected, whether in terms of timelines, coordination, evidence expectations, or levels of interaction?

There were also some genuine positive surprises, which is important to highlight. The HTA Secretariat received consistent praise for being proactive, responsive, and efficient. Even when the answer is simply “please refer to the guidance,” responses are provided quickly. For a newly established system, that level of responsiveness matters.

Views on the scoping explanation meeting were more mixed. Some people felt the format was highly formal and therefore of limited practical value. Others acknowledged the formality, but noted that assessors do listen. In a process with very few interaction points, that stands out as a potential opportunity to share any questions.

Overall, though, the limited strategic dialogue disappointed companies further in the process. At the national HTA level, there’s usually a constructive back-and-forth. In JCA, it’s much more one-directional. One interviewee called it “a missed opportunity.”

There were also operational challenges. Timelines have not always held, with early assessments taking longer than initially indicated and no reports published yet. Post-submission interactions with assessors can be inconsistent, ranging from formal requests to ad hoc questions requiring rapid turnaround, sometimes within 48 hours. One interviewee described this as “messy.”

Finally, conflict of interest rules have had unintended consequences. In rare diseases, they can exclude the very clinicians who know the most about the condition. The patient questionnaire was also described as generic, with some interviewees questioning how much impact it could have on the process.

From an industry perspective, what are the main implications of these early experiences for evidence generation and submission strategies?

There are three big strategic questions coming out of this that the industry needs to grapple with.

The first is efficiency. Is JCA actually reducing burden, or adding to it? One interviewee asked whether they’d be able to use their JCA submission directly for the German AMNOG process, with similar PICOs and structure, effectively allowing reuse of the same dossier. Their honest answer right now: “It’s unclear if we are going to save any time from this.” That’s a question worth watching as the first reports come out.

Second is national planning. No country has yet clearly defined how JCA outputs will be used at the national level. While local HTA bodies cannot request analyses already covered within JCA, this creates a new dynamic rather than simplifying the process. More forward-looking companies are already engaging with key markets to ensure that country-specific needs are reflected within the JCA submission itself. This kind of early planning is likely to distinguish those that are better prepared.

And the third is long-term commitment. This is an aspect that can take companies by surprise. Once you’re in JCA, you’re in. If more than one country requests an update, you’re required to provide one. Like Hotel California, “You can check out any time you like, but you can never leave.” This has clear implications for resourcing and long-term evidence planning, extending well beyond the initial assessment.

Based on these conversations, what practical advice would you give to a company that’s about to enter the JCA process? And, equally, is there anything you’d tell them not to over-invest in at this stage?

This was my favorite part of the interviews because the advice was remarkably consistent. Five different companies, across products and stages, independently shared very similar recommendations. That gives me confidence that these are real, practical lessons.

1. Start early. This came up in every conversation. Not just on PICO prediction, but on building the evidence you’ll actually need. Explore comparative data, consider real-world evidence, take advantage of Joint Scientific Consultation if you can. One interviewee’s advice on working with internal colleagues was to communicate “endlessly.” I loved that.
2. Define the strategy before the detail. One interviewee used the analogy of planning a trip. Get the big picture first — regulatory positioning, access strategy, national landscapes — before diving into the details of individual PICOs. Don’t make the mistake of jumping straight to tactics.
3. Invest in PICO prediction but keep it simple. Some companies are using “archetype countries” instead of trying to map all 27 Member States. Testing assumptions with key opinion leaders can also help refine predictions.
4. Build the right internal model. To survive the 100-day window and make a timely submission possible, you need to “build a village”. This means coordinated input from regulatory, biostatistics, and medical teams from the outset.

In terms of where to save energy: patient and HCP engagement is limited in JCA right now. While this may evolve, the mechanisms are not yet fully developed. So extensive JCA-specific external engagement may not be the best use of resources at this stage. Another practical point raised was don’t build heavy governance; smaller, agile teams are empowered to make decisions without a committee meeting.

With the first JCA reports expected later this year, what should stakeholders be watching most closely, and what challenges or opportunities do you anticipate in the next phase of implementation?

The first JCA reports will be the most closely watched documents in EU HTA this year, possibly in several years. Everyone I spoke with is waiting for them, and there are many open questions: what will they actually say, and how will they be structured? One interviewee described the anticipated output as “an IQWiG dossier with a French flavor” and wondered whether that would be useful to the other 25 Member States. I thought that was a brilliant observation.

“The bigger question is what happens downstream. How will countries use these reports in their national processes? Will products in JCA get streamlined national assessments, or will Germany, for example, still ask a hundred additional questions? Nobody knows yet, and that makes national planning incredibly difficult.”

There is also a potential global dimension. One interviewee raised something I hadn’t considered: will JCA reports start influencing how other regions think about clinical evidence? Japan, China, the UK, even the US. If JCA becomes a reference point beyond Europe, the stakes are much higher than the current conversation suggests.

Finally, looking ahead to the 2028 review and the planned expansion of JCA scope in 2028 and 2030, what changes would you most like to see, and what would a more mature and effective JCA system look like in your view?

The good news is that everyone sees the 2028 review as an opportunity. When I asked one interviewee what worries them, they corrected me: “Worried is not the right word.” That tells you something about the overall attitude. Despite the growing pains of a new system, I heard a lot of optimism about the potential with JCA.

If I had a wish list, it would start with more strategic dialogue. The constructive exchange between companies and assessors that makes national HTA processes work is largely missing in JCA. Both sides would benefit from more of it.

Equally important: patients need a real voice, not a token one. Right now, patient input is limited to a generic questionnaire that multiple interviewees described as not fit-for-purpose. If the North Star of this legislation is faster access for patients, then patients should have a genuine seat at the table. Not a questionnaire. A seat.

More predictability across the board would help too. Clearer timelines, standardized question processes, defined procedures for unexpected labels or new evidence. Less ad hoc, more system.

And as JCA expands to orphan drugs in 2028 and all medicines in 2030, the resourcing question gets very real. Sweden has already added five headcount. Slovenia hired its first HTA scientist ever. The system needs to demonstrate that it’s worth that kind of investment for all 27 Member States.

A more mature JCA system, in my view, would be one where there’s reasonable predictability, genuine dialogue, a meaningful patient voice, and outputs that are actually useful at the national level so the process reduces effort rather than duplicating it.

“Ultimately, this process should be judged on one thing: does it get medicines to patients faster? That was the North Star that came through in nearly every interview, and it should be the standard we hold the system to as it evolves.”

I believe we can get there. Most of the people I spoke with believe that too. And I plan to keep tracking this as it evolves. The first reports will give us a whole new set of questions to explore, and I’m looking forward to that next chapter.

Interviewee

Nicole Yurgin
Founder and Managing Director, Yurgin Advisory GmbH

Nicole Yurgin is the Founder and Managing Director of Yurgin Advisory GmbH, a consultancy specialising in market access strategy for the pharmaceutical and biotech industry. Nicole has spent over 20 years in the pharmaceutical industry leading Market Access and Evidence teams. With extensive experience in EU HTA, pricing, and reimbursement, Nicole advises companies on navigating complex regulatory and access landscapes. Her recent research on the first wave of EU Joint Clinical Assessments was presented at the World EPA Congress in Amsterdam in 2026. You can learn more about Yurgin Advisory GmbH at www.yurgin.com.

Acknowledgments

Nicole would like to thank the six anonymous interviewees who agreed to share their time and insights with the broader access community.

Disclaimer

The interview findings are based on anonymized qualitative interviews. No finding is attributed to a specific company. Any errors in interpretation are those of the interviewee. All other opinions expressed in this feature are those of the author and do not necessarily reflect the views of The Evidence Base® or Becaris Publishing Ltd.