The implementation of the New Health Technology Assessment (HTA) framework in Europe is a pivotal moment for the region’s healthcare landscape. While this initiative promises to streamline and harmonize the evaluation of health technologies across the European Union (EU), it also presents several significant challenges that stakeholders must address.
This blog explores the challenges and strategic considerations of Europe’s New HTA framework, and offers insights into navigating complex regulatory landscapes, managing data and uncertainty, and seizing opportunities to enhance patient access across the EU.
Increased Data Requirements within Accelerated Timelines
Under the Joint Clinical Assessment (JCA) process, a comprehensive body of evidence is needed to support the assessment, including detailed analyses of subpopulations, indirect treatment comparisons, and additional endpoints. Meeting these requirements within the tight timelines set by the new regulations will be particularly challenging.
The new framework mandates that a completed JCA be submitted within six months of EMA approval. However, it can take up to three months to gather all necessary PICO (Population, Intervention, Comparator, Outcomes) data from the various national stakeholder groups involved.
This leaves drug and technology developers with a very short window to respond to potentially complex and multifaceted data requests. Organizations may need to allocate significant resources to data collection, management and analysis, often requiring collaboration with specialized contract research organizations (CROs) that have the expertise to handle these demands efficiently.
The Complexity of HTA Processes
One of the core challenges in the New HTA framework is managing the complexity of the assessment processes. The introduction of the Joint Clinical Assessment (JCA) under the new framework is designed to simplify and unify the evaluation of health technologies. However, the JCA process itself is intricate, requiring coordination among multiple stakeholders, including the European Medicines Agency (EMA), national HTA bodies, and the technology developers.
Recent research identified 19 domains within four key areas—processes, uncertainty, comparator choice, and endpoint selection—that urgently need to be addressed for the New HTA regulation to be successful. [1]
These areas highlight the complexity of implementing a joint European HTA assessment and the need for careful consideration of how these processes are structured and executed. For instance, the selection of appropriate comparators and endpoints is crucial to ensure that the JCA provides a meaningful evaluation of the drug or technology’s value across different EU member states.
Regulatory Uncertainty and Strategic Adaptation
Finally, the introduction of the New HTA framework brings a degree of regulatory uncertainty. While the framework is designed to standardize assessments across the EU, individual member states still have the discretion to conduct additional assessments based on national priorities. This dual-layered approach can lead to discrepancies in how the JCA is interpreted and applied, potentially creating challenges for technology developers seeking to navigate multiple regulatory environments simultaneously.
To address these uncertainties, stakeholders must engage actively with regulatory bodies and industry groups. Staying informed about the latest developments in HTA regulations and participating in consultations, workshops, and other forums will be crucial for gaining insights into the evolving landscape. By proactively adapting internal processes and partnering with relevant experts, organizations can mitigate the impact of regulatory uncertainty and position themselves to succeed under the new system.
Conclusion
The New HTA framework in Europe presents both significant challenges and opportunities for stakeholders in the healthcare sector. The complexity of the assessment processes, the management of uncertainty, the stringent data requirements, and the regulatory uncertainties all pose hurdles that must be overcome to ensure the successful implementation of the new system. However, with proactive planning, investment in data capabilities, and strategic adaptation and external partnerships, these challenges can be effectively managed.
The implementation of a joint European HTA assessment is not just a regulatory change; it is a unique opportunity to strengthen the European Health Union. By addressing the identified challenges and embracing the new framework, stakeholders can ensure that the New HTA fulfills its promise of improving patient access to innovative health technologies across the EU.
Our experts can help you gather the right data within shorter timelines, navigate regulatory complexities, and streamline compliance with the New HTA framework—ensuring your team is prepared to enhance patient access across the EU.
References
[1] Julian, E., Pavlovic, M., Sola-Morales, O., Gianfrate, F., Toumi, M., Bucher, H. C., Dierks, C., Greiner, W., Mol, P., Bergmann, J-F., Salmonson, T., Hebborn, A., Grande, M., Cardone, A., & Ruof, J. (2022). Shaping a research agenda to ensure a successful European health technology assessment: Insights generated during the inaugural convention of the European Access Academy. Health Economics Review, 12(54). doi:10.1186/s13561-022-00355-8.
