“It’s the evidence, stupid”

That is the quote from Iga Lipska, MD, PhD, MPH from the Medical University of Gdańsk, Clinical Trials Center in Warsaw, Poland. She was one the panelists at the ISPOR Europe Plenary speech. There were a lot of good sessions, many of which I will be posting on throughout the week.

The first plenary was titled “The Convergence of HTA and Regulation: A New HTA Reality and Collaboration with Regulatory Agencies” The main discussion point was how Regulation (EU) 2021/2282 would be implemented in pratice. According to the European Commission website, the regulation aims to provide:

…a transparent and inclusive framework by establishing a Coordination Group of HTA national or regional authorities, a stakeholder network and by laying down rules on the involvement in joint clinical assessments and joint scientific consultations of patients, clinical experts and other relevant experts.

The HTAR will also reduce duplication of efforts for national HTA authorities and industry, facilitate business predictability and ensure the long-term sustainability of EU HTA cooperation.

One of the key themes of the panel were around collaboration between regulatory experts and HTA bodies and sharing information. However, there was woefully little in terms of specifics of how this would be implemented in practice. Nevertheless, the HTAR regulation offers the potential for reducing some duplicative HTA efforts while at the same time allowing Member Nations to tailor value assessment, pricing and reimbursement to their own countries needs. Whether or not we will reach a happy medium between centralized efficiency in evidence evaluation at the EU level and decentralized decision-making, at the Member State level, however, is yet to be determined.

Looking forward to the rest of the conference!