Are Nonclinical factors important for the Health Technology Assessment (HTA) processes? If yes, for who?

Traditionally, value assessment of new medicines and technology products is mostly based on the benefits and impact that these bring in terms of clinical efficacy, safety, and costs. However, there is an emerging discussion regarding nonclinical value factors and their role in HTA. Such factors may be related to aspects such as the route or the frequency of administration or the treatment setting, and others. These factors are generally important for patients, caregivers, and providers, and may lead to beneficial effects such as improved adherence, improved quality of life for patients etc. However, it remains questionable how important these nonclinical value drivers are for the decision makers. In a recent article published in Value & Outcomes Spotlight, Hunt et al, discuss the payer perceptions of Nonclinical Value Drivers through the examples of three recently approved therapies by the European Medicines Agency (EMA). The authors describe and discuss key elements of the HTA assessment of Ixazomib, Ravulizumab, and Onasemnogene abeparvovec in five countries namely, United Kingdom, Germany, France, Spain, and Italy. These new therapies demonstrate distinctive nonclinical value elements, that might be important for various stakeholders in many cases. How were these elements assessed by the various HTA processes in different countries? Considering the gradually upgrading role of patient advocacy groups how will this change in the future?