Abstract
As health technology assessment (HTA) seeks to combine complex sets of evidence, values, and perspectives to support open, accountable, and transparent decision making, uncertainty is inherent. Uncertainty is present in the clinical and economic inputs that inform HTA and is a critical factor during context-specific deliberations where the evidence is weighed and decisions are made, taking uncertainty into account through either financial or evidence-generation mechanisms. The presence and impact of uncertainty must also be communicated to all relevant stakeholders during the HTA output stage. This article summarizes the 2021 HTAi Global Policy Forum discussion on “Considering and Communicating Uncertainty in HTA” that debated some of the key challenges and opportunities regarding uncertainty in HTA. Through a combination of small and large group discussions, core themes related to the topic of uncertainty in HTA were identified. These discussions revealed that: utilization of a life cycle/HTA management approach helps manage uncertainty; genuine stakeholder input and engagement (and not just consultation) can clarify uncertainty; tolerance of risk, the relationship of risk to uncertainty, and the context in which uncertainty is considered is critical; transparent and early dialogues could be increased to further reduce the uncertainty during HTA; and communicating uncertainty in HTA outputs is critical. The paper ends with suggested next steps that HTA agencies and stakeholders (such as industry, patients, regulators, payers, and others) might take to move the field forward. The paper promotes further discussion on aspects of uncertainty that should be more openly discussed, debated, and addressed.
Health technology assessment of paediatric medicines: European landscape, challenges and opportunities inside the conect4children project
