The importance of Health Technology Assessment in Urology: The EAU Perspective

Unlike marketing approval, which looks at the safety and efficacy demonstrated in clinical trials, HTA encompasses a broader spectrum of considerations, including medical, economic, social, and ethical implications of new technologies.

HTA serves as a critical instrument to ensure the quality, accessibility, and sustainability of European healthcare systems, particularly those that are publicly funded. It informs reimbursement decisions by evaluating new technologies against existing standards of care and assessing the financial implications for the health system.

Historically, HTA was a decision of individual EU member states. However, the landscape shifted in 2021 with the EU’s adoption of a regulation on HTA. This regulation introduces a collaborative framework for Joint Clinical Assessments at the EU level, starting in 2025 with cancer medicines and advanced therapies. While economic evaluations remain a national responsibility, the EU will provide a unified scientific opinion on the medical and clinical relevance of new innovations across Europe.

The regulation says that, from 2025 onwards, (urological) cancer treatments and advanced therapies will undergo this joint HTA route. The process will expand to include all new health technologies, streamlining access and ensuring more equitable distribution of innovations across the EU.

The EAU actively participates in the European Commission’s HTA stakeholder group, contributing to the development of guidelines, methods, and plans for joint assessments. This involvement is crucial for aligning the EAU’s efforts with those of regulators and HTA agencies, particularly in addressing research gaps through real-world evidence.

HTA is fundamental to achieving equitable access to urological care throughout the EU. The EAU’s engagement ensures that technologies recommended in its clinical practice guidelines have the highest likelihood of being accessible and affordable for urologists and patients EU-wide. Moreover, the EAU advocates for the implementation of the Regulation in a manner that supports clinical care without compromising it. The inclusion of clinical experts in the assessment process is anticipated, and the EAU is instrumental in determining how best to integrate clinical advice and expertise.

As we approach the implementation of the EU’s HTA regulation, understanding and participating in the HTA process becomes increasingly important for urologists. The EAU’s role is pivotal in shaping the future of urological care across Europe, ensuring that new technologies are not only clinically effective but also accessible and beneficial for patient outcomes.

We have responded to a number of consultations by the European Commission on implementation.

One important issue that has emerged is finding the right response to implement robust yet pragmatic Conflict of Interest policies. The EAU has made the following recommendations:

• Flexible COI Policies: We recommend a balanced, pragmatic and sufficiently flexible COI policy to prevent the exclusion of high-quality clinical expertise, especially in niche fields and rare diseases where expert pools are limited.
• Consultation with Medical Societies: Medical societies should be consulted in identifying the best available experts. These societies have their own COI policies to manage bias and ensure high-quality expertise in their activities.
• Transparency and Balanced Approach: Transparency in managing competing interests is key to maintaining high-quality HTA processes. Experts' involvement in EMA evaluations should not preclude their participation in JSC or JCA, provided transparency is maintained.

Read the full statement here.

Another important issue regards the Joint Clinical Assessment methodology, which we believe needs to be open to more evidence when evaluating advanced therapies for rare and ultra rare conditions. We have joined a coalition of 33 non-profit organisations who have called for the following:

• Revise the JCA methodological guidance to avoid discrediting evidence from single-arm trials

• Take a more pragmatic approach to running JCAs of ATMPs by using real-world data to fill evidence gaps

Read the full statement here.

From the EAU there are two representatives in the HTA Stakeholder group: Dr. Anders Bjartel and Dr. Peter-Paul Willemse.

If you would like resources in spreading awareness about the importance of HTA in urology, consider using this infographic to quickly inform yourself or others about the topic.