Patient organizations welcome first EU JCA while highlighting areas for improvement

Fifteen European patient organizations have welcomed the publication of the first Joint Clinical Assessment (JCA) under the EU Health Technology Assessment Regulation (HTAR), describing it as an important milestone towards a more coordinated European approach to HTA. At the same time, the organizations have identified opportunities to further strengthen patient involvement, evidence generation, and transparency as the new framework continues to be implemented across Europe.

The Baseline

• Fifteen European patient organizations have welcomed publication of the first Joint Clinical Assessment (JCA) under the EU HTA Regulation.
• The groups recognized progress in incorporating patient and carer perspectives into the assessment process while calling for earlier, broader, and more transparent patient involvement in future assessments.
• The statement also highlights opportunities to strengthen evidence generation, transparency, and accessibility as implementation of the EU HTA framework continues.

In a joint statement published by members of the HTA Stakeholder Network, including Cancer Patients Europe, the European Patients' Forum, the International Diabetes Federation Europe, Childhood Cancer International Europe, Myeloma Patients Europe, and the European Institute of Women's Health, the organizations reflected on the assessment of tovorafenib, the first medicine to undergo the Regulation's new European-level clinical assessment process. The groups, which supported the identification of patients and carers who contributed to the assessment, described publication of the report as “an important step towards a more coordinated and patient-centered European HTA system.”

In their statement, the organizations welcomed efforts to incorporate patient and carer perspectives into the assessment framework. The report notes that a carer was invited to provide input on the assessment scope and comment on draft versions of both the JCA and summary reports. According to the organizations, this represents “a positive step towards ensuring that the experiences and priorities of patients, carers and families are reflected in European health technology assessments.”

While recognizing this progress, the groups argued that patient and carer involvement should begin earlier in future assessments, including during preparatory activities and the development of assessment scopes. Earlier engagement, they suggested, would help ensure that outcomes and evidence requirements better reflect issues that matter most to patients and families.

The statement also calls for broader and more sustained patient representation throughout the JCA process. While individual patient and carer contributions provide valuable insights, the organizations noted that “a single voice may not be fully representative of the wider community.” They therefore highlighted the role that patient organizations can play in bringing collective experience and wider community perspectives into assessments.

In addition, the groups emphasized the need for greater transparency regarding how patient input is used. Although contributions are collected and considered, they noted that final reports currently provide limited information on how patient perspectives influence assessment activities and conclusions. The statement therefore argues that “patients and carers should receive clear, concise and understandable feedback on how their contributions have been taken into account.”

The organizations also used the publication of the first JCA to highlight wider evidence-generation challenges. They noted that evidence remains limited for outcomes that are particularly important to patients and families, including health-related quality of life, patient-reported symptoms, functional outcomes, and treatment burden. The statement argues that future evidence generation should better capture these outcomes alongside traditional clinical measures.

The groups also highlighted the need for continued methodological discussion in situations where robust comparative evidence may be difficult to generate. They suggested that future guidance could help clarify how additional evidence sources and innovative methodologies may be incorporated while maintaining scientific rigor.

Accessibility of assessment findings was identified as another priority area. According to the organizations, summary reports should be written in clear, lay language and made available in all official EU languages to support broader understanding and engagement among patients, carers, and the public across Europe.

The signatories said they remain committed to working with stakeholders to ensure patient involvement becomes “meaningful, transparent and impactful throughout the assessment process.” They also called on national HTA bodies to build efficiently on JCAs when conducting national appraisal and reimbursement decision-making activities.