EU HTA Has Begun: What New Joint Clinical Assessments Mean for Access to Digestive Cancer Medicines
From January 12th 2025, all new oncology medicines will undergo Joint Clinical Assessments (JCAs) under the new EU Health Technology Assessment (HTA) Regulation. This marks a major shift in how evidence on clinical effectiveness is evaluated across Europe – a step intended to streamline processes, reduce duplication, and speed up patient access to innovative therapies.
A milestone for European collaboration
Until now, each Member State assessed new medicines independently, often repeating the same evidence reviews after the European Medicines Agency (EMA) approval. The new JCA system aims to coordinate this process: one joint assessment of clinical value at EU level, which Member States can then use as the basis for their own pricing and reimbursement decisions.
However, while JCAs promise greater efficiency, they also bring challenges — particularly for ensuring that patient voices are meaningfully included in this highly technical process.
Patient involvement: progress and practical challenges
As highlighted by the European Patients’ Academy on Therapeutic Innovation (EUPATI), patient involvement is now formally recognised in the EU HTA Regulation — an important milestone. Several capacity-building programmes, such as EUPATI’s HTA Module, HTA4Patients, and EUCAPA, are already providing free, multilingual training to prepare patients to engage in JCAs.
Yet, EUPATI warns that regulation alone is not enough: meaningful participation requires time, resources, and practical structures that allow patients to contribute effectively.
According to EUPATI, four key principles will determine the success of patient engagement in the new system:
- Training and capacity building – accessible, multilingual education (now available in six European languages) is essential to ensure patients can navigate the technical aspects of HTA and contribute with confidence.
- Timely engagement – patients should be involved early in the process, particularly in defining PICO criteria (Population, Intervention, Comparator, Outcome), with realistic timelines for input.
- Diversity and inclusivity – engagement should reflect a broad range of diseases, geographies, and communities, avoiding reliance on a small circle of experienced voices.
- Transparency and feedback – patients must receive clear communication on how their contributions are used in the final JCA report. This step is crucial to building trust and demonstrating that patient input directly influences what evidence is prioritised for clinical and reimbursement decisions.
Learnings from early experiences
Gilliosa Spurrier-Bernard, President of the Melanoma Patients Network Europe (MPNE), shared her organisation’s experience of being among the first to take part in a JCA process:
“The product that was being evaluated as first in the new JCA process has now been withdrawn, so we see it as a trial run and hope it will be resubmitted with a better process in place. We are thinking about developing a list of PICO criteria in melanoma at our November hubs meeting, as we gather the experiences of our community members who took part.”
Her reflections underline that this first year is still very much a learning phase — for regulators, industry, and patient advocates alike. Early engagement from disease-specific communities such as melanoma, and soon digestive cancers, will help shape a more patient-centred process as JCAs expand to other therapeutic areas by 2030.
What does this mean for patients with digestive cancer?
For digestive cancers, the implications are significant. The JCA process could:
- Accelerate access by reducing duplication between EMA evaluation and national HTA reviews.
- Improve evidence quality by aligning methodologies across Europe.
- Highlight patient-relevant outcomes, such as quality of life, nutritional impact, or treatment tolerability — if these are integrated early in the PICO design.
However, there are also risks. Short timelines and limited resources could exclude smaller patient groups from contributing meaningfully. Differences between Member States may still lead to variation in how JCA conclusions are used in national decisions, potentially affecting equal access across Europe.
DiCE perspective and call to action
Digestive Cancers Europe welcomes the start of the JCA era as an opportunity to ensure that patients’ experiences and priorities are embedded in the generation and interpretation of evidence. To make this vision real, we call for:
- Early, structured patient involvement in JCA scoping and PICO development.
- Transparent feedback on how patient input shapes assessment outcomes.
- Continued investment in multilingual training to empower patient communities in all EU countries.
EUPATI offers practical resources to help patient organisations prepare:
- EUPATI Open Classroom (HTA Module) – a structured online course introducing HTA and the EU HTA Regulation.
- EUPATI Toolbox (HTA & HTAR mini-course starter kit) – ready-to-use materials for patient education and workshops.
- EUCAPA Project Resources – mentoring and advanced training for patients contributing to HTA and regulatory processes.
By equipping patients with the skills and structures to engage, Europe can turn the promise of the new HTA Regulation into genuine progress — ensuring that innovative digestive cancer treatments reach patients faster, and that assessments truly reflect what matters most to them.
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