Pharmaceutical Companies Navigate EU Health Technology Assessment Regulation with Strategic Planning

What's Happening?

The European Union has introduced the Health Technology Assessment Regulation (HTAR), effective from January 2025, which aims to harmonize clinical evaluations across its member states through the Joint Clinical Assessment (JCA). This regulation presents both challenges and opportunities for pharmaceutical companies, requiring a strategic approach to market access and reimbursement. Dr. Pamela Vo, VP of HEOR and Value & Evidence at EVERSANA, emphasizes the importance of early strategic planning and cross-functional collaboration to navigate this complex landscape. The JCA mirrors the centralized approach of the European Medicines Agency (EMA) but focuses solely on clinical evidence without providing value judgments. Companies must demonstrate cost-effectiveness or additional benefits of their products to succeed in the EU market.

Why It's Important?

The introduction of the JCA is significant as it aims to streamline the Health Technology Assessment (HTA) process, potentially leading to faster access to innovative treatments for patients across Europe. However, the integration of JCA findings at the national level remains uncertain, posing challenges for pharmaceutical companies in managing both EU-level and national dossiers. The focus on oncology and advanced therapy medicinal products (ATMPs) highlights the need for robust evidence generation, particularly in areas where direct comparator trials are impractical. The regulation elevates the importance of evidence-based assessments, impacting how companies plan their clinical development and market access strategies.

What's Next?

Pharmaceutical companies will need to adapt to the new HTAR framework by aligning their clinical development with HTA expectations early on. The JCA process requires evidence generation aligned with the PICO framework, necessitating early predictions and systematic literature reviews. Companies must navigate the complexities of both EU-level and national HTA processes, potentially facing increased duplication of work. The success of the JCA in streamlining HTA procedures will depend on how national bodies incorporate its findings into local reimbursement processes.

Beyond the Headlines

The JCA process introduces methodological challenges, particularly for therapies relying on single-arm trials or used in rare diseases. Indirect treatment comparisons (ITCs) become crucial for demonstrating relative effectiveness, requiring transparency and methodological rigor. The regulation offers opportunities for companies to seek early advice through the Joint Scientific Consultation (JSC), aligning their strategies with HTA expectations. EVERSANA provides end-to-end support for JCA submissions, helping companies proactively prepare for the changes and navigate the evolving HTA landscape.