OBJECTIVES: The safety profile of treatments are a key consideration in early approval decisions. The safety profile is usually evaluated during regulatory approval, although the economic value of improved safety is rarely considered in its own right. The objective, therefore, was to develop a novel modelling framework to quantify the value of different treatments safety profiles and provide an evidence-based evaluation for the preferability of each treatment’s adverse event (AE) risk.

METHODS: The distributions of the safety profiles were mapped for the frequency of the expected disutility of each AE. The model estimated the utility effects, cost, adherence rates, distribution of effects and resources used to treat the AEs. The total cost of AE profiles were estimated based on the expected cost per episode and risk of each AE. The resourcing implications of AEs were evaluated based on the duration and time-to-event for the scheduling of hospitalisations and treatment needs.

RESULTS: The cost and QALYs lost differences between safety profiles was calculated. By evaluating both the severity and duration of AEs, the model provides insights into the advantages of using a particular product, beyond the treatment costs incurred. The resource use evaluation highlights the peak times for hospital usage due to AEs for informed resource planning.

CONCLUSIONS: Analysing safety profiles provides evidence on the wider benefits of introducing a new treatment. This, combined with traditional economic modelling approaches, allows treatments with similar health gains to differentiate based on safety. AEs impact the healthcare budget, through treatment cost, and the resource use following treatment commencement, due to additional physician visits and hospitalisations. Treatments with safety profiles indicating high risk of hospitalisations can put unexpected strain on the limited capacity of hospitals, which would otherwise be avoidable using alternative therapy options. Further validation of these modelling approaches will be developed over time.