August 13, 2024

JCA a Better Way: Understand JCA in one minute

Understand JCA in one minute

What is the JCA and when does it take effect?

The Joint Clinical Assessment (JCA) is a new mandatory evaluation process for new medicines within the European Union. It aims to provide a streamlined assessment of new drugs' safety and effectiveness across all EU member states. This assessment will occur in parallel with the European Medicines Agency (EMA) marketing authorization process. While the JCA is not legally binding, EU member states are expected to consider its findings in their national decision-making processes. The rollout will begin in January 2025 with oncology drugs and Advanced Therapy Medicinal Products (ATMPs), followed by orphan drugs in 2028, and by 2030, all new medicines will be included within this framework.

What are the challenges with the JCA?

There are two primary challenges with the JCA. First, the impact of the JCA will vary among member states. Countries with fewer resources for conducting Health Technology Assessments (HTAs) may find the JCA more impactful, while those with established HTA pathways and differing national HTA requirements may experience less impact. This variation means that both the JCA and country-specific requirements must be considered in launch strategies, potentially adding complexity.

Second, the tight timelines pose a significant challenge. The scope of the JCA assessment is defined through PICOs (Population, Intervention, Comparator, Outcomes) development, which consolidates diverse needs from all member states into several PICOs. Once these PICOs are communicated to pharmaceutical companies, they have only 100 days to submit the JCA dossier. This deadline is especially challenging given the need to conduct systematic literature reviews (SLRs) on all the PICOs.

What solutions can FIECON offer to overcome these challenges?

  • PICO Prediction

    Using our extensive European stakeholder network and expertise, we instruct artificial intelligence software to screen for likely relevant populations, interventions, comparators, and outcomes. This involves screening multiple databases, libraries, HTAs, and conference presentations.
    We draft the PICOs based on these AI predictions and validate them with local experts, allowing us to start preparing the JCA dossier before receiving the final PICOs.
  • Dossier development
  • Local validation

About Amanda, FIECON's JCA expert

Amanda Hansson Hedblom is a Manager at FIECON, specialising in high-quality HEOR and Access solutions. With rich experience in HEOR and Market Access consulting, Amanda excels in Nordic HTA submissions, medical device research, and Market Access strategy. Recently, she led the development of FIECON's AI-driven systematic literature review workflow, showcasing her commitment to innovation and excellence in health economics research.

Still in the dark about JCA? Everything you always wanted to know about JCA is here. Check out our JCA fundaments page to learn more.

Will your next EU product launch face tight deadlines with the JCA? Check out Our JCA solution page to get started.

Company updates

NICE published surrogate endpoints guidance: insights from Dawn
On January 20th, NICE published a new report offering best practice recommendations for using surrogate endpoints in health economic models. In this interview, Dawn Lee, a member of FIECON's Strategic Council who participated in the meetings to develop the guidance and reviewed the draft, shares her insights as a NICE committee member.
Read more
Starting a career to drive positive change
Grace Newman, a recent graduate who joined FIECON in September 2024, shares her journey and experiences as an Associate, offering insights for recent graduates interested in joining the team.
Read more
Stories over statistics: Richard and Caroline talk about Rare Disease
As Rare Disease Day approaches, Caroline, Associate Director at FIECON, and Richard, Head of Client Partnerships at FIECON, discuss the crucial role of HEOR in improving the lives of rare disease patients, and their families and care givers.
Read more