The enhanced procedural guidance for Joint Clinical Assessments (JCAs) aligns with Regulation (EU) 2021/2282 and the Implementing Regulation (IA JCA-MP), providing detailed steps and timelines for producing JCAs of medicinal products. Recent refinements streamline timelines, ensure stakeholder collaboration, and incorporate additional flexibility for stakeholders, particularly during the scoping and reporting phases.
Overview and Key Principles
The guidance serves as a roadmap for harmonized clinical assessments across EU Member States. It emphasises:
- Timely Delivery: Total duration for the standard procedure is 406 days, reduced to 277 days for accelerated assessments.
- Stakeholder Engagement: Increased involvement of Health Technology Developers (HTDs), Member States (MS), and clinical experts through surveys and reviews.
- Transparency and Accountability: All submissions, including factual accuracy checks, are accessible to the entire JCA subgroup.
Phases of the JCA Process
- Initiation Phase (2–4 weeks)
Timeline: Begins with the HTD’s Letter of Intent (LoI) and submission to the EMA.
- Key Actions:
- Appointment of assessors, co-assessors, and optional “watchers” (learning participants).
- Public announcement of JCA initiation.
- Recent Updates:
- Optional watcher role added to facilitate learning within the subgroup.
- Scoping Phase (87 days)
Timeline: Duration reduced from 125 days to 87.
- Key Actions:
- Assessors develop a draft assessment scope using the PICO (Population, Intervention, Comparator, Outcomes) framework.
- Stakeholders participate in a three-week PICO survey (previously two weeks under EUnetHTA 21).
- HTDs are informed of the consolidated scope, with an explanation meeting held virtually (fixed monthly slots).
- Highlights:
- Streamlined timelines for administrative setup.
- Scope explanation meetings last 60 minutes and focus on clarifying, not modifying, the finalized PICO.
- Dossier Submission Phase (Standard: 100 days; Accelerated: 60 days)
Timeline: HTDs have 100 days from finalizing the scope to submit their dossier, aligned with the IA JCA-MP.
- Key Actions:
- HTA Secretariat verifies dossier completeness within 15 working days (10 for accelerated procedures).
- HTDs address completeness check outcomes and resubmit as needed.
- Observations:
- No clock stops during the JCA process, even for changes to the therapeutic indication.
- Assessment Phase (Approximately 3–4 months)
Timeline: Includes drafting, review, and subgroup validation of the JCA report.
- Key Actions:
- Assessors and co-assessors prepare reports collaboratively, incorporating input from JCA subgroup members.
- HTDs conduct a factual accuracy check within 7 days (5 for accelerated cases).
- Revised reports undergo final subgroup validation and HTA Coordination Group (HTACG) endorsement.
- Enhancements:
- Extra time allocated for subgroup reviews and revisions of draft reports.
- Publication Phase (10 days post-endorsement)
Timeline: Begins after HTACG endorsement.
- Key Actions:
- European Commission publishes the final reports on the IT platform.
- HTD comments and responses are made publicly available.
- Post-Publication: An erratum process addresses any factual inaccuracies discovered post-release.
Timelines for Standard and Accelerated Procedures
Standard Procedure:
- Total Duration: 406 days from submission to EMA to HTACG endorsement.
- Scoping Phase: 87 days.
- Dossier Submission: 100 days.
- Assessment Phase: ~120 days.
- Publication: 10 days post-endorsement.
Accelerated Procedure:
- Total Duration: 277 days.
- Shortened scoping and submission phases maintain expedited delivery.
Supporting Groups and Engagement Mechanisms
Supporting groups assist assessors in areas such as statistical analysis and scoping. These groups ensure methodical and procedural integrity without direct involvement in decision-making.
Stakeholders, including patients, clinical experts, and organizations, contribute insights at various stages, particularly during scoping and reporting phases. These collaborations ensure the JCA reflects real-world perspectives.
By optimising timelines, increasing transparency, and incorporating robust stakeholder engagement, the framework aligns with evolving regulatory needs. The introduction of additional flexibility and learning mechanisms further underscores the EU’s commitment to efficient, inclusive, and transparent health technology assessments.
The improvements reflect a thoughtful balance between administrative efficiency and the collaborative spirit essential for delivering meaningful clinical assessments, ultimately benefiting patients and healthcare systems across the EU.
If you would like to discuss any of the developments outlined above, discover more about PICORadar, or discuss your market access and HEOR needs, please get in touch at hello@initiateconsultancy.com.
