June 18/19 in Strasbourg:

Two days on Health Policy & EU HTA in the global context - Summary & Reflections

On Thursday June 18th, a symposium was held at the premises of the University of Strasbourg addressing ‚Drug Pricing and Innovation in a New Geopolitical Era‘. Key contributions included James Robinson (University of California, Berkeley), Nicolas Schlumberger (Sanofi France), Filippo Drago (Università di Catania), and Heiner Haug (AstraZeneca).

It's not easy to summarise the excellent contributions and the vibrant discussion - however, one of the take-home messages was: Most Favoured Nation, MFN, is here to stay. Even in case of a change in the US government during the next elections the principle of challenging the transatlantic and global disparities in drug spending and drug prices will persist. Additionally, China is developing an ever more powerful and innovative life science industry creating additional challenges for Europe. The net effect of MFN on drug prices was discussed controversially. Expectations are that MFN might increase prices in the US rather than lowering them. Manufacturers will behave rationally and delay marketing authorisation in low price reference countries in order to protect or even increase price levels in the US.

On Friday, June 19th, a ’Sharing Experience’ meeting took place at the premises of the European Parliament. Tiemo Woelken, MEP and one of the ‚fathers of the EU HTA Regulation‘, virtually opened the meeting. Roisin Adams, Anne Willemsen and Leslie Pibouleau provided a ’state of play’ overview from the perspective of the Coordination Group and the European Commission. Anne-Pierre Pickaert covered the patient perspective. The industry perspective was provided by Matias Olsen (EUCOPE) and Heiner Haug (AstraZeneca), who invited HTD representatives from Ipsen, Novartis, AstraZeneca, Amgen, and BeOne Medicines to share their experiences. HTAbody insights were contributed by Mariane Cossito (INFARMED), Beate Wieseler (IQWiG and Chair of the CG Methodology Subgroup), Pierre Cochat (Haute Autorité de Santé) and Enrico Costa (AIFA).

A big THANK YOU goes out to Francis Megerlin and the University of Strasbourg for organising and hosting the two events and to Francis Megerlin and Filippo Drago (Università di Catania) for bringing together such variety of different stakeholders and for orchestrating the discussion on EU HTA.

The EAA’s Joerg Ruof participated in the meeting and reflecting on the key message from this convention his own take is: i) we need and support HTA; ii) Europe is the world leader in HTA; iii) the developing EU HTA process carries a risk of being over-engineered; iv) in a highly competitive global context we always need to keep in mind recital 1 of the EU HTA regulation: ’The development of health technologies is a key driver of economic growth and innovation in the Union and is key to achieving the high level of health protection that health policies need to ensure for the benefit of all.’

He also had the pleasure and privilege to present a strategic proposal on how to approach the Equity/ Excellence Dilemma at the EU HTA Experience Sharing Meeting. While it is well known that European healthcare systems are superior to those in the US with regards to equity of healthcare, it has to be noted that innovation is driven by excellence rather than equity. Therefore, EU HTA should strive for excellence all throughout in order to strengthen Europe’s position in a increasingly competitive global environment, and support access for patients in need to medicines that harbour an additional benefit over current best standard of care. Equity, a topic of utmost importance, however is subject to healthpolicy rather than scientific excellence. Thus, EU HTA should focus on the relative effectiveness versus best available comparative treatment. Accordingly, methodological requirements for secondary PICOs schemes should be adjusted.

Further, in an internationally increasingly competitive environment Europe needs to avoid the impression of being complicated and fragmented with regards to access. As with the history of the European Medicines Agency, the point of EU HTA is that it should pave the way to ‚one stop shopping‘ i.e., giving a clear guidance to the developers which comparative regimen relative effectiveness data should be developed against for EU-wide HTA.

Download the slides on the "equity/ excellence dilemma" HERE.

New Manuscript: Legal implications of joint clinical assessments under the EU HTA regulation

With the first JCA procedures well under way a variety of challenges have been discussed but the legal implications of practically relevant issues remain to be explored in more detail. This excellent manuscript, developed as part of the ASCERTAIN project, investigates legal aspects of PICO disparities, Conflict of Interest management, uptake of JCA reports and consequences for patient access. A highly recommended read for anyone interested in EU HTA!