Expert Engagement
Patients, carers and clinical experts* are involved throughout JCA and JSC procedures under the EU HTA framework. Participation is essential, as it brings real-world experience and clinical practice knowledge into assessments and early advice.
Patients and carers provide lived experience of disease, treatment pathways and unmet needs, which helps HTA bodies understand how a new technology might change daily life, symptom burden and quality of care.
Clinical experts contribute up-to-date insights on standard of care, treatment pathways and feasibility of using a new technology in routine practice, which strengthens the clinical relevance and practical applicability of the assessment.
BCCH supports selected participants throughout their involvement by providing practical support and administrative assistance. Our support includes:
- Onboarding
- Contracting
- Kick-off meetings
- Payment administration
- Practical support
- Follow-up throughout participation
Role of experts in JCAs
How patients, carers and clinical experts contribute across the phases of a Joint Clinical Assessment, from scoping input to draft review.
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Role of experts in JSCs
How experts feed into the briefing package and discussion meeting of a Joint Scientific Consultation with the health technology developer.
Learn moreRole of experts in JCAs
- Phase 1
The Scoping Phase
Assessors prepare the draft assessment scope, the set of PICO questions the assessment will focus on. Following review by the JCA subgroup, patients, carers and clinical experts have seven days to review the draft consolidated scope and share written comments. If clarification is needed, experts may be invited to a dedicated part of a Subgroup meeting. A final scope is then agreed and sent to the health technology developer.
Role of experts in this phase- Review the assessment scope proposal
- Share your experience of the condition, current treatments, clinical practice and any unmet needs
- Comment on whether the proposed population, comparators and outcomes reflect real-world needs and practice
- Highlight important outcomes or considerations that may be missing (e.g. fatigue, impact on daily activities)
- Provide written input and, in some cases, participate in an online meeting
- Phase 2
The Assessment Phase
Assessors draft the JCA report and summary report, using results from studies (like clinical trials) that answer the PICO questions agreed in the scoping phase. Following review by the JCA subgroup, patients, carers and clinical experts have seven days to read the draft report and share written comments. If further clarification is needed, experts may be invited to a Subgroup meeting to discuss their input directly.
Role of experts in this phase- Read the draft JCA report and summary report and consider whether patients' needs and clinical practice realities are appropriately reflected
- Comment on whether the outcomes presented are important and meaningful for patients and clinical practice
- Flag any key patient concerns or clinical considerations that are missing
- Note whether important challenges with current treatment options are adequately described
- Provide feedback in writing and, in some cases, participate in an online meeting
Role of experts in JSCs
- Phase 1
Briefing Package Phase
The health technology developer submits a briefing package describing how it intends to develop the product and generate evidence. The JSC subgroup may request clarifications, which the developer addresses through an amended briefing package. This is shared with experts, whose input contributes to the List of Issues, a document structured around the PICO framework that is subsequently shared with the developer ahead of the discussion meeting.
Role of experts in this phase- Review the briefing package and focus on what matters from the perspective of patients, carers and clinical experts
- Highlight whether the proposed population, outcomes and comparators reflect real-world needs and practice
- Raise important concerns (e.g. quality of life, disease symptoms, unmet needs, current standards of care)
- Provide input in writing and/or through an interview
- Review the List of Issues in preparation for the discussion meeting
- Phase 2
The Discussion Meeting Phase
Experts participate in a virtual discussion meeting with the health technology developer, the assessors, the JSC subgroup and other experts. Participants discuss the List of Issues and the proposed evidence generation plan. In parallel procedures, representatives from the European Medicines Agency (EMA) also participate.
Role of experts in this phase- Attend and participate in the virtual discussion meeting
- Share your perspective, drawing on lived experience or clinical practice.
- Discuss the impact of the condition, unmet needs, standard of care, outcomes, comparators and feasibility of the evidence generation plan
- Clarify the input provided during the Briefing Package phase and answer questions from other participants