Navigating the EU’s Joint Clinical Assessment

Ruairi O’Donnell, PhD, EU HTA Lead, Cencora

January 2025 marked a much-anticipated milestone in the global pharmaceuticals and medical supply markets, which companies across the European Union have been preparing for—some for many months and others even for years. The EU health technology assessment (HTA) regulation¹ went into effect last month starting with the implementation of one of its key pillars, the Joint Clinical Assessment (JCA).² JCA is a process designed to standardize the clinical evaluation of medical products and devices and functions through the collaboration of EU member states. JCA is mandatory in all 27 EU member states and aims to bring medicines to patients more efficiently and reliably and with greater transparency.

Practically speaking, it means any developer of new oncology drugs or advanced therapy medicinal products—such as cell and gene therapies—that apply for marketing authorization via the European Medicines Agency is, as of January, subject to the JCA. This change is significant because it requires substantial evidence review work, complex statistical analyses, as well as high-quality medical writing. New orphan drugs will follow in 2028, as will all other new pharmaceutical products from 2030 onwards.

The regulation promises great benefits. They include more protections for human health and safety; greater transparency for patients and stakeholders across the industry; elimination of redundant activities; and speeding up market access for new, innovative products that patients need. But the degree to which these benefits are realized in the initial stages of the regulation’s rollout is contingent on health technology developers’ (HTD) ability to navigate the new landscape, which means making the right updates to their systems and processes and responding to challenges quickly.

JCA readiness: Rising to the challenge

While some organizations have been preparing extensively for JCA implementation, others are working quickly to ensure they are ready for the more stringent new requirements. Some of the biggest challenges to JCA readiness are:

Accelerated timelines. When working with pharmaceutical products under standard procedure, HTDs have just 100 days to finalize their dossiers to answer the patient/population, intervention, comparison, and outcomes (PICO) identified by the scoping process. For products under accelerated procedure, the HTD has just 60 days to finalize their dossiers. In addition to the updates to analyses needed, HTDs must ensure that their critical stakeholders are aligned to the key messaging and content of their dossier before making the final submission.

Technically complex materials and measures. The JCA contains comprehensive evidence summaries, with potentially numerous and complex statistical analyses to review and approve. This means that now more than ever, appropriately skilled individuals with the ability to interpret the technical content must be involved in the governance framework process.

Breadth of scope. As a pan-European HTA report, the JCA has the potential to impact companies across the European region—and beyond to other international markets. HTDs will need a governance membership that incorporates global and, potentially, cross-functional perspectives.

Succeeding post-JCA Implementation

For companies to thrive in the new JCA-contingent environment, it will be important for them to continue to invest resources and attention in three main areas: employee support and education; systems and processes; and stakeholder engagement.

Internally, organizations should remain focused on education and engagement for employees in order to bring them on board and adapt to these extensive changes.

It’s critical that the right people within the HTD organization are aware and informed of the challenges associated with the new HTA procedure and have a plan to address those challenges effectively and reliably. While this starts with market access and health economics and outcomes research (HEOR) functions, the potential impacts are broader, as teams from commercial, medical, regulatory, and government affairs all need to understand the changes and participate in the preparation and the changes.

In particular, given the interdependencies of the new procedure on the marketing authorization task, regulatory affairs teams need to be fully engaged in the JCA and ready for new collaborative working models with their market access and HEOR colleagues.

Capacity and capability also need to be considered. Some important questions for companies getting up to speed quickly include:

• Do HTDs have the appropriately skilled people in the right places, at the right volume?
• Given the evidence demands driven by PICO multiplicity, it is likely that most HTDs need to examine if they have enough statisticians and outcomes researchers in place.
• Similarly, if they write their own HTAs in-house, do they have the right volume of technical writers available to manage the JCA implementation?

Rethinking processes

HTDs likely have reevaluated and made changes to the processes and procedures in place to manage HTA activities. Most often, we are seeing global market access or HEOR teams take on responsibility for JCA activities within HTD companies.

Traditionally, however, HTA submissions have been managed by individual country teams, which develop strong local expertise and experience with their own local procedures. The challenge with JCA is that global teams may not have the same institutional experience in managing the finite details of HTA submissions, which means many global or regional teams may discover an urgent need to map out the steps and activities needed to prepare the appropriate research and analysis needed for the JCA.

Working out the details on managing the flow of research is important here, and global or regional teams will likely need to collaborate in new ways with their cross-functional and affiliate colleagues.

Under this time-sensitive, data-intensive process, teams will benefit from having “playbooks” in place for now, but should expect to do some editing and fine-tuning down the road.

Managing stakeholders

The JCA will impact stakeholder relations in two key areas: one internal, inside the HTD; and one external, considering the range of influencers that may shape the JCA process and the downstream country procedures.

Managing these new realities with internal stakeholders requires having a clear and lean governance framework, and many companies have been working to adapt their operations accordingly ahead of the JCA.

Externally, it’s important that companies educate and prepare their key stakeholders across the region for not only the process itself but also the disease states under assessment. For example, HTDs must now ensure they have a broad network of clinical and patient group relationships in place to stay abreast of perceptions of disease burden and unmet need. In addition, HTDs need to make sure they are participating in regional initiatives and industry organizations to ensure they help shape the policy landscape over time.

The road ahead

While the JCA is ushering in significant changes, the process is manageable for companies that think holistically and continue to take steps to remain attentive and flexible to evaluate and adapt where needed. For larger HTD organizations, in particular, thinking beyond the purely technical demands of the new HTA process is critical to success. And for companies more broadly, navigating the JCA environment will require fine-tuning internal processes and governance, as well as continually managing stakeholder relationships to ensure submissions are timely and of the highest quality.

Ruairi O’Donnell, PhD, is EU HTA Lead, Cencora

References

1. Health Technology Assessment. European Commission. https://health.ec.europa.eu/health-technology-assessment_en

2. Joint Clinical Assessments. European Commission. https://health.ec.europa.eu/health-technology-assessment/implementation-regulation-health-technology-assessment/joint-clinical-assessments_en