Objective Agitation is a syndrome commonly experienced by patients suffering with bipolar disorder or schizophrenia. It is considered as a state of cognitive and motor hyperactivity characterized by excessive or inappropriate motor or verbal activity with marked emotional arousal. The study aimed to evaluate the clinical and economic impact of the inhaled loxapine in acutely agitated patients from the Italian National Health Service (NHS) perspective.

Methods An Excel-based budget impact model was developed in order to estimate the costs of the patients who experience agitation episode in the emergency and hospital setting. Following International Society of Pharmacoeconomics and Outcome Research (ISPOR) good practice for budget impact modelling, a systematic literature review was performed in order to identify the epidemiological and economic data for estimating the population of interest and the direct costs associated to the disease.

Two scenarios were considered: 1) a Standard of Care scenario, with the current estimated distribution of patients over the various treatment (promazine, benzodiazepine, chlorpromazine, haloperidol, aripiprazole, valproate), versus 2) an innovative scenario, characterized by the gradual introduction of inhaled loxapine. A time horizon of 5 years was considered.

Results The model estimated a total of 115,299 episodes of agitation from patients with schizophrenia and bipolar disorder each year (91.5% in the emergency room). These events generated 80,710 hospitalizations over 5 years, for a total cost of approximately € 139.9 million. The introduction of inhaled loxapine could generate a reduction of over 1,210 hospitalisations with a cost reduction of approximately € 2.1 million. The incremental expenditure for the investment on the innovative drug (+ € 511 thousand) was covered by the positive effects generated by the reduction of hospitalisations. Overall, inhaled loxapine generated a reduction in spending of € 1,6 million five years after its introduction.

Conclusions Hospitalisations reduction obtained with the introduction of inhaled loxapine could reduce direct healthcare costs and, more important, improve the quality of life of patients.

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Key words: budget impact, economic evaluation, inhaled loxapine, schizophrenia, bipolar disorder