New era in health technology assessment in the EU: Joint Clinical Assessment Regulation comes into force

On 12 January 2025, Regulation (EU) 2021/2282 will enter into force in the European Union, introducing Joint Clinical Assessment (JCA) of medical technologies. This is the next step in the harmonisation of the medicines supply system in the EU.

What will change?

At the moment, although the registration of medicines in the EU is carried out through a single system (the European Medicines Agency, EMA), the Health Technology Assessment (HTA) is carried out by each Member State separately. It is the national HTA that determines whether a drug will be included in the reimbursement system and what its price will be. One of the most time-consuming parts of the HTA is the assessment of comparative clinical effectiveness. Repeating this process in each country leads to duplication of effort.

The introduction of JCA is aimed at:

• increasing the efficiency of assessment
• simplifying interactions between pharmaceutical companies and regulators
• eliminating repetitive procedures

At the same time, economic assessment and pricing remain the prerogative of each EU member state.

Stages of JCA implementation:

• from January 2025: JCA becomes mandatory for new oncology drugs and advanced technology medicinal products (ATMPs)
• from  2028: Orphan medicinal products will be included in the JCA.
• 2030: All new medicines authorised by the EMA will be subject to the JCA.

How does the JCA work?

1. Letter of Intent (LoI): The manufacturer informs the EMA and the HTA Secretariat that it is ready to submit a dossier for assessment.
2. Performance Analysis Framework (PICO): Developed on the basis of patient consultations,  clinical experts and professional societies (Population/Intervention/Comparator/Outcomes)
3. Submission of dossier: the manufacturer submits the dossier within 100 days (or 60 days for the fast-track procedure)
4. Checking the completeness of the dossier: the HTA Secretariat checks the completeness of the dossier
5. Clinical assessment: appointed experts from the HTA agencies of the EU countries prepare a draft report
6. Report review: the manufacturer has 7 days (or 5 days for the fast-track procedure) to check the report for factual accuracy
7. Report publication: the final report is published on the European Commission HTA platform.

Coordination and responsibility:

• HTA Secretariat: coordinates the process, liaises with manufacturers and supports appointed experts
• HTA Coordination Group (HTACG): approves the final reports.
• Appointed experts from HTA agencies of EU countries: directly analyze the data and prepare the report.

The final reports will be available on the European Commission platform via the link.

Importance for the EAEU and CIS countries:

"The experience of the European Union in conducting joint clinical assessment is extremely interesting for the countries of the Eurasian Economic Union and the CIS. Optimizing efforts to evaluate drugs, including orphan drugs, can facilitate patient access to innovative therapies in the future,” said Nuria Musina, Director of International Cooperation at NAERES.