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On May 23, 2024, the European Commission (EC) adopted the updated Implementing Act (IA) on JCA, heralding a major shift in the EU’s clinical assessment of oncology drugs, advanced therapy medicinal products (ATMPs), and medical devices.

Steps to improving patient involvement in the JCA process

The Implementing Act on JCA is a significant step in the right direction by involving patients and patient advocacy groups from the outset, beginning with the assessment of PICO (Population, Intervention, Comparator, Outcome) and extending to the evaluation of the final JCA dossier.

Patients will be involved in two steps of the JCA process:

1. Preparing PICO-S: PICO is a framework used to formulate research questions in healthcare, while PICO-S includes Scope in addition to the usual PICO components. Patients will contribute to developing the scoping document, which will be sent to member states for feedback and acceptance.
2. Evaluating the JCA dossier: Patients will have the opportunity to evaluate the approved JCA dossier, ensuring the consideration of patient perspectives in the decision-making process.

The JCA framework is expected to have a significant impact across the pharmaceutical industry, with companies now needing to consider patient involvement early in the HTA evaluation process. Industry understanding of the changes introduced by JCA will be critical to quelling uncertainties and ensuring success following its implementation.

Patient involvement in clinical assessment is crucial because it brings a unique perspective to the decision-making process. The firsthand experience of living with a condition enables patients to provide valuable insights into the effectiveness, safety, and overall impact of treatments. By incorporating these perspectives, healthcare professionals and policymakers can make more informed decisions that better address patients’ needs and improve healthcare outcomes.

Concerns and challenges in JCA implementation

The JCA framework is a positive step towards ensuring that patients are heard, and their voices are taken into account in healthcare decision-making. However, there are concerns that the JCA process could be risky in terms of patient advocacy groups’ capacity to engage effectively. It is essential to have good representation at the national level to ensure that patient voices are not lost in the process.

Additionally, there is a paradox that the more frequent a disease, the stronger the voice, highlighting the challenge for smaller patient groups, particularly those representing rare diseases. While large organisations have the capacity to understand the JCA process, it could be challenging for smaller patient groups to participate. It is important to emphasise the significance of organisations representing rare diseases, as there can be a knowledge barrier among decision-makers on these conditions.

The successful implementation of the JCA framework faces challenges. For example, patients may find the process complicated, and some may lack the requisite technical knowledge to participate effectively. Addressing these hurdles requires a careful evaluation of patient involvement’s quality, including the patient organisation’s role.

All stakeholders must work together to ensure that patient involvement in clinical assessment is meaningful and sustainable, leading to better healthcare outcomes for all.

Across Europe, the landscape of patient involvement in the HTA processes is fragmented with significant variation in the level of patient involvement and an absence of common rules across countries.

Several countries have made significant progress in integrating patient perspectives into their decision-making frameworks. However, in other countries, patients are only involved in a limited number of HTA processes, their involvement is not meaningful, or they are not involved at all.

Challenges

There are several challenges to improving patient involvement in HTAs in Europe. These include:

Lack of a standardised approach
There is no standardised approach to patient involvement in HTAs across Europe. This makes it difficult for patients to participate effectively in the HTA process and for HTA bodies to ensure that patient perspectives are taken into account in decisionmaking. This represents a major barrier to equitable access to healthcare, as patients from different countries with the same disease may have different opportunities to be involved in the decision-making process.

Lack of transparency
In many countries, the process for involving patients in HTAs is not transparent. This can make it difficult for patients to understand how they can participate and how their input will be used.

Lack of resources
Many patient organisations do not have the resources to participate effectively in the HTA process. This can make it difficult for them to collect and analyse data, develop evidencebased positions, and engage with HTA bodies.

Lack of time
The HTA process is often very timeconsuming. This can make it difficult for patients to participate, especially if they are also dealing with a serious illness.

Opportunities

Despite the challenges, there are also several opportunities to improve patient involvement in HTAs in Europe. These include:

The increasing recognition of the importance of patient involvement
There is a growing recognition among policymakers, HTA bodies, and patient organisations of the importance of patient involvement in HTAs. This is creating momentum for change.

The development of new tools and resources
New tools and resources are being developed to support patient involvement in HTAs. These include guides, toolkits, and training programs.

The increasing use of patient-reported outcomes (PROs)
PROs are increasingly being used in HTAs to measure the impact of health technologies
on patients. This is giving patients a more direct voice in the HTA process.