To assure the right products are brought to patients in an appropriate way, it is essential to involve patients in the health technology assessment (HTA). If patients are truly heard, they can have a meaningful impact during reimbursement decision making.
True patient involvement is an essential step to assure market access becomes patient access. Therefore, Hict is closely monitoring developments in the process of patient involvement within the Belgian reimbursement process.
As of the end of June 2026, 21 drugs had started the Joint Clinical Assessment (JCA) journey. Three JCAs had been completed, three had been discontinued and the remaining 15 were in progress. With the JCA process now clearly moving from theory into practice, we recently followed the ISPOR webinar on the practical takeaways from the first JCA, conducted for Ojemda (tovorafenib) (Ojemda is a medicine used to treat patients aged six months and older with paediatric low-grade glioma (a type of brain tumour)) (ISPOR - Understanding the First JCAs: Practical Takeaways for Key Stakeholders).
During the panel discussion, Antonella Cardone, CEO of Cancer Patients Europe raised several relevant points regarding patient involvement in the JCA process. The challenges highlighted during the webinar are not only relevant at European level but are also relevant in a national context. These issues were also (indirectly) listed in the evaluation report on the first year of patient participation in the Belgian reimbursement procedure, published by VPP and la LUSS (Dutch: evaluatierapport-patientenparticipatie-in-de-ctg.pdf).
Although the JCA process and the Belgian CTG procedure operate in different contexts, both are still in the early stages of structurally incorporating patient input into health technology assessment and reimbursement decision-making. Both processes have established mechanisms to involve patients but are still refining how patient input should be collected, assessed, reported and fed back to participating organisations.
A number of common challenges can be identified.
At European level, one of the concerns raised during the webinar was that it remains unclear how patient input influenced the first JCA. Although patients and experts were consulted, it was not reported whether, or how, their input affected the PICOs or the overall outcomes of the JCA report.
A similar challenge is described in the Belgian evaluation report by VPP and la LUSS. Patient organisations involved in the CTG procedure expressed a clear need for feedback. They want to understand what added value it brought, and whether it had an impact on the discussion or assessment.
Closely related to the previous point is the risk that patient involvement is perceived as a formality rather than as a meaningful contribution.
During the webinar, it was noted that several elements raised by patients in the JCA process, such as quality of life, real-world comparators and equity of access, were considered non-assessable. Patients questioned the purpose of their involvement if the information they provided could not be integrated into the assessment.
The Belgian evaluation report identifies a similar concern. Patient organisations indicated that transparent feedback is essential to maintain their motivation to participate. They want to understand the added value of their contribution and, in some cases, currently experience the process as a formality or a “tick-the-box” exercise.
The level of representation was another important point raised during the webinar. In the first JCA, input was reportedly collected from one carer and one healthcare professional. Concerns were raised about whether the perspective of one person per group can sufficiently represent the broader patient or clinical community at European level.
The Belgian approach tries to address this issue by working through patient organisations and encouraging the collection of collective experiential knowledge. VPP and la LUSS also stimulate collaboration between patient organisations wherever possible, as a joint submission can provide a stronger and more representative signal. In the first year of Belgian patient participation, organisations collaborated in five submissions to provide one joint questionnaire. However, the Belgian report also shows that collaboration is not always straightforward. Patient organisations indicated that working together requires an additional workload, which can be challenging within strict deadlines. The language barrier formed an additional barrier to collaboration.
Both the European JCA process and the Belgian procedure for patient involvement are still in their infancy and evaluating and improving the initially developed procedures. The main shared challenge is to avoid patient involvement becoming a procedural requirement without clear impact. The objective should be to move towards meaningful involvement: input that is representative, relevant to the disease area, and accompanied by clear and transparent feedback on how it was considered.
At European level, the webinar indicated that the HTA Coordination Group is looking for ways to involve more experts and to improve transparency on how patient and expert input is taken into account. In Belgium, VPP and la LUSS have formulated a series of action points to further optimise patient involvement in the CTG procedure.
Both processes therefore recognise the current challenges and are searching for ways to improve. The coming years will be important to see whether patient involvement can evolve from formal consultation towards a more transparent, representative and impactful contribution to assessment and reimbursement decision-making.
Would you like to discuss the future of reimbursement processes and patient involvement, or you would like more information on the matter? Contact our colleague Lies Schoonaert!
