On 5 May 2026, IFCCA participated in a POLITICO roundtable on patient-centred Health Technology Assessment and patient involvement in healthcare decision-making. Below, we reflect on some of the key themes from the discussion, now summarised in a POLITICO article: Putting patients at the heart of health innovation.
Clinical evidence is essential when evaluating new treatments, but it does not always capture the full impact of a disease or treatment on a person's life. Quality of life, daily functioning, mental wellbeing, and treatment preferences all matter and should be considered in healthcare decision-making. Time matters too: a chronic condition and its treatments unfold over many years, and the way benefits and risks play out over that horizon strongly shapes how we weigh one against the other. Our fears and concerns are part of that picture as well. Far from being a distraction from the evidence, they genuinely influence the decisions we make about our own care.
At IFCCA, we are people living with chronic diseases, and we are the experts in our own experience. The insights that come from that experience complement clinical evidence and help ensure that decisions reflect what matters most to us.
One of the key challenges discussed during the roundtable was the growing expectation placed on patient organisations to provide patient-based evidence. While regulators and HTA bodies increasingly recognise the importance of patient perspectives, many organisations lack the resources and capacity needed to collect and generate this information effectively.
Transparency was another important theme. We contribute our time and experiences through surveys, consultations, and research initiatives, and we need to understand how that input is used: not only for recognition, but because seeing how patient experience feeds into decisions is what lets us refine the methods that incorporate it and monitor the difference it actually makes. The new EU Health Technology Assessment Regulation is an important opportunity to put this on a firmer footing, but only if patient organisations are recognised as partners in the process and supported in contributing meaningful evidence.
Beyond the discussion at the roundtable, we would like to add a reflection of our own. The first joint clinical assessments completed under the new system have already taught us something worth pausing on. In one early case, the evidence submitted could answer only one of the eight comparisons the assessors had asked for, and it came without data on overall survival or on quality of life. When a trial is not designed to capture how a treatment affects daily life, no assessment, however careful, can recover that information afterwards. It is not only that many questions went unanswered; it is that the questions closest to patients were never measured in the first place.
For those of us in the IBD community, this is a moment to reflect rather than to relax. Many IBD treatments are not yet within the scope of joint clinical assessment, but we cannot assume they will stay outside it: advanced therapies are already covered, and the research now under way in IBD could bring such products into the new process sooner than expected. Just as important, the trials being designed and opened today are the ones that will be assessed when these therapies eventually reach patients, so the choices made now decide what evidence will be available then.
We have spent years working with researchers and trial sponsors to study patient preferences, map unmet needs, and build quality of life and other patient-relevant outcomes into studies from the start. That is exactly the kind of groundwork these early assessments show to be essential. We do not assume we have everything figured out, but we intend to be ready, so that when the time comes the evidence is there and the patient's perspective is already part of it. We look ahead to taking part in these assessments with confidence, as an opportunity to make decisions more patient-centred rather than a hurdle to clear. This progress has been possible because some sponsors have already opened their protocols to us and taken our feedback on board, and that willingness is exactly what allows better, more patient-relevant evidence to take shape. What we have seen so far suggests this collaborative path is the right one, and we encourage those who have not yet taken it to do the same, working with patient organisations, including ours, as they design their trials.
At IFCCA, we will continue advocating for healthcare decisions that value both clinical outcomes and our own lived experience.
Roberto Saldaña, Innovation and Patient Engagement Coordinator
