Overview

Health Technology Assessment (HTA) is a multidisciplinary process to determine the value of a health technology at different points in its lifecycle, all in service of promoting an equitable, efficient, and high-quality healthcare system. 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. This has been underscored by the onset of the global health care crisis associated with COVID-19. The pandemic has disrupted attitudes, structures and processes – collectively leading to increased levels of uncertainty and complexity. 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

With the above in mind, the intent of the HTAi-DIA Working Group is to explore how to manage uncertainty in the regulatory-HTA interface across the health technology lifecycle. Specifically, we seek 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. The better and more effectively this is done, the greater the benefit for patients and healthcare systems. 

It is understood that the processes and methods for exploring and dealing with uncertainty are context and situation specific. Context includes jurisdiction, HTA structures and setting/remits which vary globally, for example regarding established social values or practices in a specific country, at institutional or individual level, or in a specific disease area. In some countries, situations where technologies are considered for children or disadvantaged populations, may also be allowed additional tolerance for greater uncertainty. This is all affected by the appetite for risk within a decision-making organization generally, as well as for the individuals deliberating on its behalf. 

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.  

Papers & Articles

Background Paper: Example background paper link

R. Trowman, on behalf of the HTAi Global Policy Forum

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Journal Article: Example Journal link

R. Trowman, D. Ollendorf, A. Powers. Published online 15 July 2021. DOI: 10.1017/S0266462321000453

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Presentations

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