from ISPOR News & Press Releases at on October 31, 2016 at 09:05AM

Building Collaboration Between Regulators and Health Technology Assessment Bodies 

Vienna, Austria—31 October 2016—The International Society for Pharmacoeconomics and Outcomes Research (ISPOR) opened its 19th Annual European Congress in Vienna, Austria this morning with the first plenary session, What Synergies Could Be Created Between Regulatory and Health Technology Assessments?

The plenary discussion was moderated by Hans-Georg Eichler, MD, MSc, Senior Medical Officer, European Medicines Agency, London, UK. Speakers included:

  • Guido Rasi, Executive Director, European Medicines Agency, London, UK
  • Wim Goettsch, PhD, MSc, Director, EUnetHTA JA3 Directorate, Zorginstituut Nederland, Diemen, Netherlands
  • Andrzej Rys, Director, Health Systems, Medical Products and Innovation, European Commission, Brussels, Belgium
  • Jens Grueger, PhD, Vice President and Head of Global Pricing and Market Access, F. Hoffmann-LaRoche, Basel, Switzerland

This session explored potential synergies that could be created between regulators and health technology assessment (HTA) bodies. Speakers noted that while regulators and HTA bodies play very different roles, both often rely on the same scientific data and share the goal of enabling patient access to beneficial new therapies.

Guido Rasi spoke on the topic of why HTA bodies and the European Medicines Agency (EMA) should collaborate. Rasi pointed out that collaboration allows all parties to do a better job—faster—and to do more with less. He concluded that a series of (isolated) reasonable decisions does not necessarily lead to a reasonable outcome, and that horizontal and vertical collaboration is necessary in the European Union (EU) to achieve timely patient access and sustainability of health care and continued industry productivity.

Wim Goettsch, PhD, MSc spoke on the HTA perspective of interactions between HTA and regulators in Europe. Goettsch noted that significant progress has been made since the first interactions between EMA and the European network for Health Technology Assessment (EUnetHTA) in 2010, and that a new work plan between both groups will be developed in the coming months.

Andrzej Rys spoke about EU cooperation on HTA. Rys described the cooperation that is currently taking place on HTA within the EU, including the HTA Network and the EUnetHTA Joint Action 3. He also addressed future initiatives that could help strengthen EU cooperation on HTA. He stressed that early dialogues (parallel scientific advice), early data sharing, and real-world data generation are issues that should be addressed toward the goal of collaboration.

Jens Grueger, PhD offered the industry perspective and noted that industry is willing to collaborate. Grueger outlined how the surge of innovative medicines has transformed patient outcomes in areas of high unmet need. He stressed that patients are awaiting access to these medicines and that saying “no” is not an option. He noted that elements of a solution have been piloted, but that a sustainable model for joint EMA/HTA scientific advice needs to be established.

Hans-Georg Eichler, MD, MSc summarized the discussions by pointing out that, “strong agreement existed for the need of collaboration between regulators and health technology assessment bodies, but that the solution must be a life span approach.”

Additional information on the ISPOR 19th Annual European Congress can be found here. Released presentations from the congress can be found here. Interested parties can follow news and developments from the conference on social media using the hashtag #ISPORVienna.