Stakeholders meet to feedback on JCA and shape the implementation of 2025 HTA Regulations

On 11th June 2024, the European Commission chaired the 3rd Health Technology Assessment (HTA) Stakeholder Network meeting in Brussels. Fifty-one stakeholders including 35 representatives from member organisations, 1 observer organisation representative, 27 representatives from the Coordination Group, covering eleven member states and Norway, the European Medicines Agency (EMA), and the Directorate-General for Health and Food Safety. The meeting focused on the implementation of the new HTA Regulation and Joint Clinical Assessments (JCAs), particularly addressing challenges in direct and indirect comparisons, outcomes, and reporting issues.

Key discussion points

• Guidance on Direct and Indirect Comparisons: Concerns were voiced about tight evidence preparation timelines and evidence acceptability in JCAs. Updated guidance for evolving methods, and access to EU-level data to improve indirect comparisons was requested. Patient representatives stressed the need for including patient-generated data.
• Enhancing Joint Scientific Consultations (JSCs)for Medicinal Products: The value of previous EUnetHTA work raised concerns over strict conflict-of-interest rules. Stakeholders agreed on the need for flexible, EMA-aligned approaches and early identification of patient organisations and experts, advocating for face-to-face involvement and early access to information. Economic assessments in JSC submissions will remain voluntary.
• Involving Patients in HTA: The need to integrate patient input throughout the HTA process to ensure meaningful patient involvement was highlighted. There was recognition of the challenges around capacity limitations and the need for accessible guidance and training materials, agreeing that patient perspectives will be vital for robust HTAs.

Refining PICO exercises

Ongoing PICO (Population, Intervention, Comparator, Outcomes) exercises aim to refine the scoping process and identify evidence gaps. The meeting highlighted the need for HTDs to provide transparent justifications when data for specific PICOs is missing. Additionally, future guidance on PICO development, expected by January 2025, will incorporate lessons learned from these exercises, ensuring that PICOs are well-defined and reflective of stakeholder needs, including those of patients.

Six PICO exercises (three for medicinal products and three for medical devices) are being conducted to gather insights for developing guidance on HTA scoping. These exercises aim to identify evidence gaps and refine the PICO process, helping Member States clarify their expectations from HTAs.

HTA simulation workshop insights:

An HTA simulation workshop held in December 2023 highlighted gaps in PICO definition processes and emphasised the importance of incorporating the patient perspective within EU HTA. It identified a lack of awareness among patient organisations about the new EU HTA Regulation and stressed the need for increased preparedness and training for patient contributions.

There is also an ongoing consensus-building exercise aimed at reducing fragmented feedback from national and EU organisations. The goal is to promote coherent and unified input, minimising heterogeneity across the EU when it comes to HTA processes.

FIECON solutions to address numerous PICOs challenges

Launching a product under the Joint Clinical on Health Technology Assessments (JCA) will be challenging, when dealing with Numerous PICOs and finite time: Our "PICO Prediction" approach combines European stakeholder insights and AI-driven systematic literature reviews (SLRs) to quickly identify key populations, interventions, and outcomes while ensuring high-quality research meets deadlines.

• Strategic approach: Comprehensive understanding of Health Technology Assessment (HTA) and a dedicated focus on aligning with evolving European Network for Health Technology Assessment (EUnetHTA) standards.
• New process, existing expertise: Utilising our team’s extensive experience in conducting HTAs and adhering to procedural templates and legislation uniquely positions us to excel in this area.
• Prepared and proactive: Vigilant in staying current with changes and regulations, ensuring we are well-prepared to undertake JCA projects effectively and successfully.
• Minimise risk: Complete pre-scoping work and management of ad-hoc JCA clinical requests at the country level and subsequent HTA submissions

FIECONs comprehensive range of JCA services

• JCA Roadmap Development
• PICOs Prediction
• Identify Evidence Gaps
• Systematic Literature Reviews (SLRs)
• Indirect Treatment Comparisons (ITCs)
• Joint Scientific Consultation (JSC) Support
• Preparation of JCA Dossiers

Check out FIECON's JCA Solution page to learn more about our services.

Reference: 3rd Meeting of the Health Technology Assessment Stakeholder Network 11 June 2024, Brussels Summary minutes - https://health.ec.europa.eu/document/download/d719351f-ac09-460f-95cb-6be8358a62fc_en?filename=hta_20240611_sr_en.pdf