The introduction of the Joint Clinical Assessment (JCA) is designed to harmonise clinical evidence evaluation across all EU member states. By creating a single framework for assessing the relative clinical benefit of new therapies, the JCA aims to reduce duplication, streamline decision-making, and ultimately improve patient access to innovative medicines.

While harmonisation offers clear benefits, it also introduces new complexities and operational challenges. Pharmaceutical companies must now navigate a dual system where a centralised clinical assessment runs parallel to a centralised market authorisation process and preludes national pricing and reimbursement processes. With tight timelines, extensive evidence requirements, and the need to align with multiple country demands, it is understandable why some may feel uncertain about the road ahead. However, complexity should not mean hesitation.

With early planning, clear strategic focus, and an understanding of how to prioritise efforts, the JCA framework is manageable and presents an opportunity to enhance the accessibility of innovations.

In this article, Prof Matthias Schönermark, MD, PhD, chief strategy officer at Kintiga, explores the key challenges of the JCA and offers actionable insight to tackle uncertainty with confidence.

The JCA introduces a structured, harmonised process for clinical evaluations, providing a common foundation for decision-making across Europe. However, individual countries will continue to be responsible for their own reimbursement decisions. As a result, companies must now navigate both a centralised clinical assessment with the distinct needs of national HTA bodies.

A major challenge lies in the population, intervention, comparator, and outcomes (PICO) framework, where each EU member state defines its own requirements based on its national healthcare needs and standard treatment practices. This means that a single dossier must accommodate multiple national perspectives to meet the expectations of multiple EU countries. With only 100 days between finalising the PICO and submitting the dossier, strategic preparation is essential.

While this may sound daunting, the scale of this task should not deter companies from pursuing the opportunities that Europe offers. The key is to focus, not fret By planning early, prioritising strategically, and leveraging predictability, companies can take control of the process, rather than being overwhelmed by it.

Laying the groundwork: Early strategic planning

Preparation should begin well before EU member states define their PICO requirements. Anticipating potential evidence gaps and aligning internal teams – from clinical and regulatory to market access and biostatistics – ensures a seamless process once the 100-day countdown begins. 

Strategic scenario planning is essential, allowing companies to forecast different PICO outcomes and structure evidence generation accordingly. Without this foresight, the risk of late-stage bottlenecks increases, wasting valuable time and resources.

Focusing where it matters: Market prioritisation

Equally important is market prioritisation. Attempting to meet the full scope of every country’s needs may not be realistic; instead, companies must establish clear decision-making frameworks to assess where to fully align with national HTA requirements and where to adapt their approach based on the feasibility of evidence generation.

Leveraging predictability for strategic preparation

One advantage companies can leverage is the predictability and transparency of the JCA process, which is built upon the German HTA methodology. While the standards remain high, the predictability, transparency, and reliable methodology of the new approach means we can anticipate evidentiary requirements with greater certainty. With the right expertise, companies can plan effectively, ensuring that the necessary evidence is in place from the outset. 

Early engagement with regulatory bodies

Strategic planning must go hand in hand with early engagement. Securing joint scientific advice before clinical studies allows companies to validate their approach, align with national HTA expectations, and refine evidence plans. Different countries may have unique comparator and data requirements, and early dialogue helps companies tailor trial designs to meet both centralised and national assessments from the outset.

Plan evidence generation with real-world data in mind

With the increasing importance of real-world evidence (RWE), early planning is critical – especially for orphan diseases and advanced therapies, where long-term clinical trial data may be limited. Establishing registries, leveraging existing datasets, and integrating real-world insights early will strengthen submissions and support post-launch reassessments, ensuring long-term market access.

Shaping success through early action

The importance of early planning cannot be overstated. Companies that act early won’t just keep up with the changes – they’ll be the ones shaping how success looks in this new landscape.

While the JCA provides a harmonised clinical evaluation, its impact on pricing and reimbursement remains uncertain. National HTA bodies still hold final authority over pricing decisions, and as the system evolves, companies will need to adapt to how different countries interpret and integrate JCA outcomes into their reimbursement frameworks.

Germany has been among the first to publish its framework for how the JCA will feed into its national HTA process, offering an early indication of how others may follow. However, the extent to which JCA outcomes will directly influence pricing negotiations across Europe remains an open question. One major consideration is the price delta effect – the variation in pricing across different EU markets. If some countries use JCA outcomes to justify lower price expectations, this could create challenges for manufacturers seeking to maintain consistent pricing across Europe.

An opportunity for previously unstructured HTA systems

One of the main benefits that this brings is that the update introduces a significant advantage for markets that previously lacked structured HTA processes. For many smaller countries, the JCA provides a ready-made assessment framework, allowing them to incorporate clinical evaluations into their pricing and reimbursement decisions more transparently. This could, in turn, lead to greater consistency in how new therapies are valued across the EU, reducing disparities in access.

Ultimately, the full impact of JCA on pricing will take time to unfold. As national agencies refine their approaches and precedent cases emerge, companies will gain greater clarity on how to navigate pricing negotiations in this new environment. Until then, success will depend on closely monitoring national responses, adapting strategies in real time, and maintaining flexibility in pricing discussions across different markets.

The evolving EU HTA landscape presents new challenges, but companies should not shy away from launching in Europe. Europe possesses not only immense market potential but also the infrastructure and expertise needed to deliver the next generation of medicines, making it the best place to launch innovative therapies.

In addition, EU markets are sizable, predictable, and interconnected. While each retains control over pricing and reimbursement, they influence one another, creating a network of interdependencies that, when understood, can be leveraged for a more cohesive market access strategy.

Strategic partnerships for stronger market access

Navigating the JCA and national HTA requirements demands more than internal preparation – it requires expertise in European market access. Companies that partner with experts who understand the nuances of European market access will be better equipped to anticipate challenges, streamline submissions, and respond with agility. Those that invest in the right expertise and build agility into their approach will be best positioned to succeed in Europe’s evolving access landscape.

While the hurdles are high, they exist for a reason – to ensure only the most valuable treatments reach patients. For companies willing to embrace this evolving landscape with the right expertise and focus, Europe remains an opportunity well worth pursuing.