The International Society for Pharmacoeconomics and Outcomes Research (ISPOR) opened last Monday its 19th Annual European Congress in Vienna, Austria with a plenary session entitled 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. This session explored potential synergies thatcould 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, Executive Director, European Medicines Agency, London, UK answered the question 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 saving resources for regulators and HTA bodies. He cited the PRIME scheme launched by the EMA as a chance to avoid failures in drug development. He concluded that a series of (isolated) reasonable decisions does not necessarily lead to a reasonable outcome, and that horizontal (across Member States) and vertical (across decision makers) collaboration is necessary in the European Union to achieve timely patient access and sustainability of health care and continued industry productivity.
- Wim Goettsch, PhD, MSc Director, EUnetHTA JA3 Directorate, Zorginstituut Nederland, Diemen, Netherlands 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. He also pointed that HTA was not only for pharmaceuticals but that interaction for medical devices with regulators (notifying bodies) was also urgently needed.
- Andrzej Rys, Director, Health Systems, Medical Products and Innovation, European Commission, Brussels, Belgium 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, Vice President and Head of Global Pricing and Market Access, F. Hoffmann-LaRoche, Basel, Switzerland 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 first plenary discussion 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.”
Access to all the released presentations of the congress http://www.ispor.org/Event/ReleasedPresentations/2016Vienna