ISSUE: Many HTA bodies consider novel aspects of new treatments important to society in their deliberations, over and above quantified clinical and economic benefits. However, approaches to do so vary, and questions remain as to how (and how consistently) novelty is defined and considered in technology appraisals. Dan Ollendorf will moderate the session and present results from new research on documented policies for treatment novelty across diverse organizations as well as case studies on the application of these policies in practice. Dr. Kanavos will describe variation in the use and application of novelty concepts by HTA bodies internationally. Ms. Strammiello will represent the patient perspective, including efforts to integrate patient views on what aspects of novelty are important to the community. Dr. Crabb will represent the HTA agency perspective, and will discuss the challenges and benefits of considering novel aspects of treatment in analysis and deliberation.

OVERVIEW: Novel aspects of new technologies, including method of action; changes to route, setting, and/or frequency of administration; modifications to clinical practice; and unique approaches to addressing unmet need, are often stated considerations in HTA policy outside of traditional quantification of clinical and economic benefit. However, consideration of these aspects varies substantially by organization; for example, new methods of action are considered a benefit in some settings and an uncertainty in others. In addition, how these aspects are integrated into actual deliberations, whether there are stated policies for doing so, and how they affect decisions or recommendations remain open questions. This session will review current practice at representative HTA bodies, identify additional elements important to patients and other stakeholders that may be under-appreciated, discuss the challenges inherent in considering novel elements outside of a quantitative analytic framework, and develop potential guidance for the field on novel elements to be considered and potential approaches for doing so.