European Commission publishes draft implementing act on joint clinical assessments of medicinal products
The Joint Clinical Assessment (JCA) process in Europe has been subject to much speculation over the past months. Now, the European Commission has made steps towards clarifying what is expected from the JCA process by publishing the draft implementing act, providing the procedural rules and methodological details for the coordinated assessment of medicinal products.
By transforming the health technology assessment (HTA) decision-making landscape and harmonizing HTA practices in the European Union, the European Regulation on Health Technology Assessment (HTAR), Regulation (EU) 2021/2282, aims to enhance the availability of healthcare interventions for patients. To be implemented under this regulation, the JCA process seeks to standardize the clinical assessment of medicines and medical devices throughout the 27 Member States of the European Union, effectively eliminating the need for multiple national HTA bodies to conduct the same systematic review of clinical evidence. The process will begin with the assessment of oncology drugs and advanced therapy medicinal products (ATMPs) from January 12, 2025, followed by orphan drugs in January 2028 and all healthcare interventions from January 2030.
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As health technology developers grapple with this new process, the European Commission has now published the draft implementing act on JCA, outlining the procedural requirements and timelines for conducting JCA to ensure a uniform and structured approach to the evaluation process. Specifications on the format and templates of the submission dossier and the JCA report are also provided. The long-awaited draft act is open for public consultation, with stakeholders encouraged to voice their opinions on the draft text until; April 2, 2024.
Key details
The 18-page document of the draft implementing act provides many rules outlining how the JCA process will be conducted, including:
Close coordination with the EMA: The JCA process will be conducted by the Member State Coordination Group on HTA (HTACG) comprised of four subgroups, with two JCA Subgroups directly responsible for the delivery of JCA reports. The process will be carried out in parallel with the EMA’s centralized marketing authorization procedure for that medicinal product. In the event of a negative opinion or withdrawal/variation of a marketing application, the JCA process will cease.
Stakeholder engagement: Patients, clinical experts and other relevant experts who have the required expertise in the therapeutic area may be consulted by the JCA subgroup any point during the evaluation process, ‘to ensure the highest scientific quality of JCA reports.’
Assessment scope: To inform the development of the assessment scope, health technology developers will be required to submit the summary of the product characteristics and the clinical overview section of their EMA application.
Assessors will prepare the assessment scope proposal based on information provided by health technology developers in terms of patient population, intervention, comparators, and health outcomes (PICO). This proposal will be shared with the JCA subgroup, and assessors will consolidate input from Member States to create a comprehensive assessment scope while still allowing Member States to submit PICO questions. The assessment scope will be finalized no longer than 20 days after the Committee for Medicinal Products for Human Use adopts its list of questions.
Explanation meetings: Where necessary, health technology developers may be invited to an assessment scope explanation meeting with the JCA subgroup, taking place within 30 days of finalization of the assessment scope. These meetings are, ‘for the high quality of the dossier and for the smooth conduct of the JCA.’
Dossier submission: Health technology developers should submit the JCA dossier, following the specified template, within 90 days of being notified of finalized assessment scope.
Data updates: Health technology developers can submit new data from clinical studies during the JCA process in parallel with submission of this data to the European Medicines Agency. After publication of a JCA report, health technology developers can also submit new evidence and request updates to the draft JCA and summary report.
Stakeholder discussions
No doubt over the next few weeks there will be much discussion around the details outlined in the act and their implications for health technology developers. Next week, at the World EPA Congress, several sessions will be dedicated to this topic and will provide the opportunity for experts to collectively share their thoughts on the procedural rules. The Evidence Base will be providing coverage of these discussions, including the session ‘EU HTA: How to ensure stake-holder alignment on a national level to accelerate broad patient access?’
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