This is a quote from Iga Lipska, MD, MPH, Medical University of Gdansk, Warsaw Clinical Trials Center, Poland.She was one of the panelists for this meeting ISPOR Europe All speeches. There are a lot of great sessions, many of which I’ll be posting throughout the week.
The title of the first plenary session was “The Convergence of HTA and Regulation: The New HTA Reality and Cooperation with Regulators” The main discussion point was how Regulation (EU) 2021/2282 will be implemented in practice. According to the European Commission website, the regulation aims to provide:
…to establish a transparent and inclusive framework through the establishment of HTA national or regional authority coordination groups, stakeholder networks, and through the development of rules for participation in joint clinical assessments and joint scientific consultation of patients, clinical specialists and other relevant experts.
HTAR will also reduce duplication of efforts by national HTA authorities and industry, promote business predictability and ensure the long-term sustainability of EU HTA cooperation.
One of the main themes of the group is cooperation and information sharing between regulatory experts and HTA agencies. However, specific details on how this is implemented in practice are sadly scarce. Nonetheless, HTAR regulations offer the potential to reduce some duplication of HTA work, while allowing member states to tailor value assessments, pricing and reimbursement to their own national needs. It remains to be determined, however, whether we will achieve a pleasant balance between centralised efficiency of evidence assessment at EU level and decentralized decision-making at member state level.
Looking forward to the rest of the session!
