New EU HTA templates formalize patient, carer and clinician input into JCAs, but transparency gaps remain

The European Commission has published three new templates designed to support written input from patients, carers and clinical experts during joint clinical assessments (JCAs), providing a more structured route for stakeholder perspectives to inform both assessment scoping and draft JCA reports. However, questions remain around how clearly the impact of that input will be reflected in final assessment scope and report.

The Baseline

• Three new templates have been published for patients, carers and clinical experts contributing to EU joint clinical assessments.
• Two templates support input during JCA scoping, while a third enables patients, carers and clinicians to comment on the JCA report.
• Patient and carer input will be shared with the JCA Subgroup, discussed when the assessment scope is finalized and published anonymously in the final JCA report.
• The templates do not, however, establish a clear mechanism for showing whether individual stakeholder comments resulted in changes to the final assessment scope.

The European Commission has published three new templates intended to support the written involvement of patients, carers and clinical experts in JCAs under the EU Health Technology Assessment Regulation.

Published by the Directorate-General for Health and Food Safety on September 14, 2026, the templates were developed following consultation with stakeholder organizations in the HTA Stakeholder Network. They provide separate formats for patient and carer input during JCA scoping, clinical expert input during scoping, and comments from patients, carers and clinicians on JCA reports.

The patient and carer template is structured around the population, intervention, comparator and outcomes (PICO) framework used to define the JCA research questions. Patients and carers are asked to consider whether the proposed population adequately reflects those affected by the condition, whether relevant subgroups may be missing and whether proposed comparators reflect real-world treatment experience. The template also invites input on treatment burden, convenience, monitoring requirements, travel and access.

For outcomes, contributors are asked whether the proposed measures reflect what matters to patients, with quality of life, functional status, symptom burden, long-term effects, survivorship and late toxicity among the examples highlighted. The template also provides space to comment on proposed subgroup analyses and other aspects of the assessment scope.

It also provides more detail on how written input will enter the scoping process. Submissions will be made available to the full JCA Subgroup and presented and discussed at the meeting where the assessment scope is finalized. Once agreed, the final scope is sent to the health technology developer and defines the information to be addressed in the JCA dossier. Patient and carer submissions will also be published anonymously in an appendix to the JCA report.

For health technology developers, the templates may also help signal the types of patient- and carer-led issues likely to surface during scoping. This could support earlier evidence-generation planning around outcomes, treatment burden, subgroups and comparators, reducing the risk of gaps becoming apparent only once the final assessment scope is agreed.

Greater structure, but questions remain over influence

However, the templates do not appear to resolve the transparency issue highlighted following the first completed JCA. The new patient and carer template states that stakeholder input will help to “improve and finalize” the assessment scope. It does not, however, set out whether assessors will be expected to document which comments resulted in changes to the final scope, or explain why particular suggestions were not taken forward.

Commenting on the tovorafenib assessment, François Houyez, EURORDIS said the carer contribution was informative, but that the report did not make clear how assessors had used it.

“Most importantly, the report never explains how those contributions influenced the assessment. The outcomes that matter most to patients are identified, but it is not clear how patient and carer input shaped the scope of the assessment, the choice of comparators or the final conclusions.”

In their latest Journal of Comparative Effectiveness Research article, Ramiro Gilardino and co-authors similarly distinguished between recording stakeholder participation and demonstrating its influence.

“For every practical purpose of audit and accountability, an influence that cannot be demonstrated is indistinguishable from an influence that never occurred.”

They argue that future JCA reports should explicitly state which patient-identified priorities influenced the final scope, which did not, and why.

While the templates provide greater structure around the collection and publication of stakeholder input, the “what happens to the input?” question remains. Future JCA reports may therefore face increasing scrutiny over whether they can demonstrate not only that patients, carers and clinicians were consulted, but how their contributions affected the final assessment scope.