Moving away from the decentralized manner in which Health Technology Assessments (HTAs) have been conducted, Joint Clinical Assessment (JCA) aims to streamline HTA processes, minimize duplication of HTA body efforts, enhance efficiencies, accelerate access to medicines, and, ultimately, support EU member states in their national HTA processes.
JCA only focuses on clinical domains, without providing value judgements or conclusions on reimbursement. These are still within the mandate of each Member State, who give due consideration to the published JCA reports in their national HTA & decision-making processes. Further information may be incorporated at the national level, such as cost-effectiveness analysis. Research questions, aiming to cover the evidence requirements of all Member States, are developed as PICOs, defining population, intervention, comparator & outcome, giving a consolidated unified scope for the assessment.
JCA officially came into force in January 2025, covering new oncology medicinal products (MPs) & ATMPs, with the plan to expand to new orphan MPs in 2028, and eventually all new MPs in 2030. In April 2025, the European Commission shared that the first two JCAs have started. The first JCA is for a treatment of paediatric low-grade glioma, with Ireland’s National Centre for Pharmacoeconomics (NCPE) as the assessor and Germany’s Institute for Quality and Efficiency in Health Care (IQWiG) as the co-assessor. The second JCA is for an ATMP for the treatment of melanoma, with France’s National Authority for Health (HAS) as the assessor and Poland’s Agency for Health Technology Assessment and Tariff System (AOTMiT) as the co-assessor.
While JCA promises several efficiencies, it is not without its challenges.
- Burden & demand for resources: Evidence requirements are anticipated to be extensive and complex, with a high volume of PICOs per assessment. Investment from different departments within the pharmaceutical company, including HEOR and market access, would also be necessary. Additionally, there would be a need for local affiliates in smaller markets, as well.
- Uncertainty & need for agility: There are high levels of uncertainty around the number & nature of PICOs and the evidence acceptance thresholds during dossier review. Moreover, it is unpredictable what requirements each country will have, and how each Member State will practically apply JCA outputs in its national reimbursement decision-making.
- Time constraints: Timelines between PICO finalization and dossier submission are tight, putting additional pressure on health technology developers. Resource requirements need to be foreseen, as the JCA process will run in parallel with the regulatory EMA process. Furthermore, manufacturers would likely need to seek country-level reimbursement soon after JCA completion to prevent JCA from becoming outdated. Ultimately, reflecting on these points, commercial and market access strategy would need to be considered earlier on in the asset’s development cycle.
- EU-level versus national level: Alignment of JCA outputs with local, jurisdiction-level requirements is expected to be complex and demanding. Potential differences in methodology standards between JCA and local HTAs would also likely add layers of complexity.
How can GPI support you with JCA?
- Internal, cross-functional cooperation: Streamline the cooperation of cross-functional teams, facilitate the engagement of several internal stakeholders, align processes & communication
- PICO simulation: Foresee the different PICOs required to cover the needs of all Member States
- Evidence synthesis/generation: Plan how to fill in the identified evidence gaps, with data beyond clinical trials. For example, this may include statistical analyses, systematic literature reviews, indirect treatment comparisons, real-world evidence, Delphi panels to get KOL support, and more.
- Value communication: Support with the preparation of value dossiers and building a strong value story
Why GPI?
- We are experts in EU market access and HTA requirements. We can be your trusted ally in strategically navigating the changing European access landscape, and the uncertainties linked to JCA. Early preparation is key, and we can support you along the way, from early decisions (including which indication to pursue) and PICO scoping, to closing critical evidence gaps and integrating JCA outputs into national HTA submissions.
Learn more about our consulting team and how we support market access success, book a discovery call here.
