HTAi-DIA Working Group on Management of Uncertainty
Established in December 2021 (work completed in December 2022)
Leaders
Wija Oortwijn
Radboud University Medical Centre, The Netherlands
Inkatuuli Heikkinen
MSD, Denmark
Members
- Indranil Bagchi, United States of America
- Deirdre DeJean, Canada
- Hans-Georg Eichler, Austria
- Wim Goettsch, The Netherlands
- Melinda Goodall, United Kingdom
- Sharon Gorman, United Kingdom
- Inaki Gutierrez-Ibarluzea, Spain
- Ansgar Hebborn, Switzerland
- Milou Hogervorst, The Netherlands
- Isabelle Huys, The Netherlands
- Rosanne Janssens, Belgium
- Dimitra Lingri, Greece
- Ania Mitan, Switzerland
- Magdalini Papadaki, Greece
- Elena Petelos, Greece
- Bettina Ryll, Sweden
- Claudine Sapede, Switzerland
- Stefan Sauerland, Germany
- Valentina Strammiello, Belgium
- Massoud Toussi, France
- Sean Tunis, United States of America
- Despina Voulgaraki, United Kingdom
- Rick Vreman, The Netherlands
- Ian Watson, United Kingdom
Overview
During the 2021 HTAi Global Policy Forum, held virtually on February 22-26, 2021, key challenges and opportunities regarding uncertainty in HTA were discussed. Following the discussions, and building on recommendations made during the Forum, HTAi and the Drug Information Association (DIA) initiated a Working Group to provide guidance on management of uncertainty in the regulatory-HTA interface across the drug’s lifecycle. By the very nature and complexity of health technologies, as well as methodological challenges associated with their assessments, uncertainty will always exist at some level in both regulatory and HTA informed decision-making. A far more layered, nuanced and flexible response from all stakeholders in the health care ecosystem is required to achieve equity, efficiency and quality health care.
Purpose
To explore how to manage uncertainty in the regulatory-HTA interface across the health technology lifecycle and to create a platform and convene conversations between all key stakeholders in the healthcare system that share a common understanding – not simply information and data – to manage uncertainty in regulatory and HTA decision-making on drugs.
Deliverables
Publication
Hogervorst MA, Vreman R, Heikkinen I, et al.
Uncertainty management in regulatory and health technology assessment decision-making on drugs: guidance of the HTAi-DIA Working Group.
International Journal of Technology Assessment in Health Care. 2023;39(1):e40. doi:10.1017/S0266462323000375
Panel Presentation
Panel Presentation at DIA Europe March 2021: Uncertainty in the HTA-regulatory interface
Date: March 30, 2022
Panel Presentation: Deep Dive on Uncertainty – A Multistakeholder Discussion Hosted by the HTAi-DIA Joint Working Group
HTAi 2022 Annual Meeting in Utrecht, the Netherlands
Date: June 27, 2022
Panel Presentation at DIA Europe March 2022: Uncertainty Management in Regulatory and Health Technology Assessment Decision-Making – Guidance of the HTAi-DIA Working Group
Date: March 23, 2023
Other resources and material
Considering and communicating uncertainty in health technology assessment
Trowman R, Powers A, Ollendorf DA.
International Journal of Technology Assessment in Health Care. 2021;37(1):e74.