Introduction
The EU Health Technology Assessment (HTA) is set to undergo significant transformation at the beginning of next year, with the upcoming joint clinical assessments (JCAs) aiming to streamline processes across member states. The new framework marks a substantial departure from the previous decentralized model of HTA in Europe.
This shift presents both opportunities and challenges for pharmaceutical and biotech companies as they prepare to navigate new regulatory landscapes and harmonized standards. This blog explores several potential benefits associated with this new approach.
1. Increased Harmonization Across Member States:
- Previously, each EU member state conducted its own HTA, leading to considerable variability in the timing, methodology, and outcomes of assessments. This often resulted in disparities in patient access to new treatments, with some countries adopting technologies much faster than others.
- The New HTA seeks to harmonize these processes by creating a unified, EU-wide assessment that can be used by all member states. This reduces duplication of efforts, promotes consistency, and is expected to lead to more equitable access to innovative health technologies across Europe. [1]
2. Streamlined Processes and Faster Access:
- Under the old framework, the time required to complete individual HTAs in each country could lead to significant delays in the availability of new treatments. Pharmaceutical companies and medical device manufacturers had to navigate multiple, often complex, national HTA processes, which could slow down the overall time to market.
- The New HTA framework aims to streamline this process by introducing the JCA, which is designed to be completed within a strict six-month timeframe following European Medicines Agency (EMA) approval. This is expected to expedite the adoption of new technologies, potentially allowing patients to benefit from innovative treatments more quickly. [2]
3. Improved Evidence-Based Decision-Making:
- The JCA under the New HTA is structured around the PICO framework—Population, Intervention, Comparator, and Outcomes—which ensures that the assessment is comprehensive and tailored to the specific needs of the target population. This approach facilitates a more rigorous, scientifically sound evaluation of new technologies, considering their clinical effectiveness, safety, and added value relative to existing treatments.
- By focusing on high-quality evidence and standardized methodologies, the New HTA enhances the credibility and reliability of the assessments, supporting more informed decision-making by policymakers and healthcare providers. [3]
4. Cost-Effectiveness and Resource Efficiency:
- The previous model of conducting separate HTAs in each member state often led to duplication of efforts and increased costs for both healthcare systems and technology developers. The New HTA reduces these inefficiencies by consolidating the assessment process at the EU level.
- This harmonization is not only expected to lower the administrative burden on national healthcare systems but also to make the process more cost-effective, potentially freeing up resources that can be redirected to other areas of healthcare. [4]
5. Greater Patient Involvement and Transparency:
- The New HTA framework also emphasizes the importance of involving stakeholders, including patients and clinicians, in the assessment process. This participatory approach ensures that the perspectives and needs of those directly affected by new health technologies are considered, leading to assessments that are more aligned with patient needs.
- Additionally, the transparency of the JCA process, with clearly defined criteria and methodologies, is expected to increase trust and confidence in the outcomes of these assessments among all stakeholders. [5]
Conclusion
The New HTA in Europe represents a paradigm shift in how health technologies are evaluated and adopted within the EU. By introducing a more harmonized, efficient, and evidence-based approach, the New HTA framework addresses many of the challenges associated with the previous national-level assessments. It is expected to help improve patient access to innovative treatments, enhance consistency and quality of decision-making, and to help ensure that healthcare resources are used more effectively across Europe. As the New HTA becomes fully implemented in the coming years, its impact on European healthcare systems is likely to be profound, setting a new standard for health technology assessment globally.
Curious about the new HTA framework and its impact on your clinical development? Connect with us today to explore how Phastar can guide you through these regulatory changes.
References
[1] European Network for Health Technology Assessment (EUnetHTA). About EUnetHTA from https://www.eunethta.eu/about-eunethta/
[2] PwC Strategy&. Access alchemy: EU HTA regulation as a strategic opportunity. Retrieved from The EU HTA regulation as a strategic opportunity | Strategy
[3] European Medicines Agency (EMA). The new HTA regulation: Key elements and next steps [Presentation by Flora Giorgio]. Retrieved from The New HTA Regulation: key elements and next steps – Flora Giorgio (B6, DG SANTE, European Commission)
[4] Desmet, T., Brijs, M., Vanderdonck, F., Tops, S., Simoens, S., & Huys, I. (2024). Implementing the EU HTA regulation: Insights from semi-structured interviews on patient expectations, Belgian and European institutional perspectives, and industry outlooks. Frontiers in Pharmacology, 15, Article 1369508. https://doi.org/10.3389/fphar.2024.1369508
[5] European Patients’ Academy on Therapeutic Innovation (EUPATI). (n.d.). HTA for Patients. Retrieved from https://eupati.eu/hta4patients/
