In formulating criteria for Health Technology Assessment (HTA) and priority setting a number of such criteria have been suggested and are used, for example in multi-criteria decision making. Besides taking central aspects like severity of disease, effectiveness, cost-effectiveness and patient safety into account, we also find references to criteria like unmet needs, and lack of alternative treatment. Often these criteria are treated as on par with each other, only given different weights in decision making. However, it seems like there is a conceptual overlap between some of these criteria and if that remains unnoticed, there is a risk of taking the same criteria into account twice. One such example is the relationship between severity of disease and unmet need. The aim of this presentation is to present a tentative analysis of the relationship between severity of disease and unmet need.

The presentation is based on a conceptual and normative analysis.

First it will be argued that we have reason to clarify what is meant by unmet needs, whether it is a need which is not met to any degree or if it is a need for which there is no treatment with curative intent or for which there is only palliative treatment, for example. Second, analyzing unmet needs in relation to severity, a number of different scenarios will be examined, showing that unmet needs can be captured in terms of severity of disease (to some extent dependent upon how we operationalize severity of disease).

The general conclusion of the study is that we have reason to carefully analyze criteria used for decision making in HTA from a conceptual and normative perspective in order to uncover logical relationships and avoid overlapping criteria. In relation to the specific question of unmet needs versus severity of disease, the conclusion is that in most cases unmet need will be redudant in relation to severity and we should be careful using both of them in decision making unless we can provide reasons for why it is an exceptional case.