Joint Clinical Assessment in Europe: What is the Advice for Pharma Companies After 10 Months?

After 10 months of Joint Clinical Assessment (JCA) is it possible to identify some early advice for pharma companies? This article provides some early insights and offers suggestions for future opportunities.

The JCA is a collaborative initiative by the European Union designed to harmonize the clinical assessment of medicinal products and medical technologies across its Member States.

Health Technology Assessment (HTA) collaboration and harmonization has been a long time EU goal, starting from the European Network for Health Technology Assessment (EUnetHTA) Joint Action 1, in 2010.

Effective since January 2025, the JCA aims to provide a unified and scientifically rigorous clinical evaluation, utilizing the PICO methodology (Population, Intervention, Comparator, Outcomes).

The initial focus is on new oncology medicines and advanced therapy medicinal products (ATMPs), with plans for phased expansion to include orphan drugs (2028) and all medicinal products and medical devices (2030).

The primary output is a JCA report to inform national HTA bodies, streamline the evaluation process and accelerate patient access to innovative treatments. Notably, the JCA focuses solely on clinical data and does not address health economics or pricing, which remain under national authority.

*Figure 1: Indicative timeline Pan-EU HTA timeline [1]*

In this initial period, larger EU countries with mature HTA systems (Germany, France, Italy) are key assessors/co-assessors, while smaller countries are in training phase or hiring new resources, therefore a more heterogenous participation is expected in the future.

National Implementation: Varying Approaches

While JCA reports are non-binding on country level pricing and reimbursement, most EU countries are expected to leverage them to increase efficiency in their HTA processes. However, the integration is likely to vary significantly:

Streamlined Adoption: some countries with less structured existing pricing & reimbursement and HTA approaches (e.g. the Baltic countries) will likely benefit the most, adopting JCA reports as the key piece of evidence to inform reimbursement decisions impact and economic data.
Additional HTA Data Requirements: HTA authorities of -for example- Germany and France have stated that additional HTA data beyond the JCA dossier will be required to meet national requirements.
Non-EU Usage: it is expected, but still to be verified, that non EU countries (e.g., Turkey, Brazil, and APAC countries) might leverage JCA reports even before product launches

Progress to Date

Since its launch in January 2025, the JCA has made significant progress in establishing a foundation for European HTA collaboration. The first wave of assessments includes oncology medicines (tovorafenib for pediatric low-grade glioma being a notable example) and ATMPs. While initial projections anticipated 25 assessments this year, 9 were completed as of September [2] , with expectations for a busier end to the year.

It is probably early to identify key lessons learned for pharma companies to deal with JCA, but some advice can be certainly identified.

Early advice for Pharmaceutical Companies

Early Preparation is Critical: JCA necessitates earlier and more comprehensive planning, requiring strong cross-functional collaboration and an evidence generation strategy aiming to consider as much as possible the perspective of the majority of the Member States.
Proactive PICO Planning: PICO elements must be considered early and continuously throughout development. A single product may have multiple PICO permutations across different member states: a recent study on one product showed how 16 countries generated 13 different PICOs [3] . This situation calls for a robust strategy to prioritize the approaches and to justify choices of comparators and outcomes.
Navigating Operational Challenges: JCA implementation poses new operational hurdles (in particular the harmonization of different methodologies) as well as the engagement with new stakeholders with different background and experiences. Pharma companies should prepare for this transition.
Leveraging Joint Scientific Consultations (JSC): The Joint Scientific Consultation (JSC) represents a great opportunity for joint advice, even though its eligibility is strict: the trial design must still be in the planning phase and not yet finalized. Currently, the JSC faces significant capacity constraints, as only 10 slots were available this year, and they filled up quickly. Indications suggest that more slots will be available next year.

How Can Windrose Help?

Windrose is helping clients to navigate the upcoming EU HTA and complex uncertainty that it brings. Through our ongoing work in market access, extensive experience working across the European markets, and commitment to staying atop of developments in this space, we endeavour to ensure Global Market Access teams are equipped with strategies that align with the criteria for success (e.g., PICO planning through multiple simulations).

For more information, please get in touch via email at info@windrosecg.com.

Conclusion: Pharma companies need to change their approach to HTA in Europe, starting earlier, considering as many markets as possible and learning to deal with new stakeholders.

Article written by Alessandro Goldaniga, with many thanks to the contributions of Georgina Powell, Gordon Bache and Anaïs Frappé.

Alessandro Goldaniga, Principal, Windrose Consulting Group

Sources:

EUnetHTA: Practical Guidelines (D4.2 Scoping Process); available here: eunethta.eu
https://health.ec.europa.eu/document/download/d947533e-7e4e-4e82-a9c6-e06830d708f8_en?filename=hta_ongoing-jca_en.xlsx.
The 9 products are: Autologous melanoma-derived tumor infiltrating lymphocytes, ex vivo-expanded, Tovorafenib, Sasanlimab, Onasemnogene abeparvovec, Lurbinectedin, Camizestrant, Tarlatamab, Catequentinib, Senaparib
https://www.ecker-ecker.de/application/files/9917/3047/5006/Poster_HTA238_PICO_JCA_Dossier_2024.pdf