• Article

Budget impact model of omalizumab in the treatment of chronic spontaneous urticaria In Italy

A 3-year budget-impact model (BIM) was developed to estimate the impact on the Italian health care budget of introducing omalizumab for the treatment of patients with chronic spontaneous urticaria (CSU) with inadequate response to H1-antihistamines (licensed dose).

The model considered patients with CSU aged ≥12 years. The BIM was developed from the perspective of the Italian National Health Service (NHS). Only direct medical costs were considered: drug costs (omalizumab 300mg and H1-antihistamines), drug-related costs (administration, screening and monitoring) and disease-related costs (physician, emergency department and hospitalisation). Omalizumab 300mg uptake was assumed to be 10.9% in the first year, 17.5% in the second year and 28.6% in the third year (only treatments that would be substituted for omalizumab were included in the market treatment shares). Ex-factory prices (included all discounts) and National Tariffs were considered to estimate costs of drug and medical resource used, respectively. Costs were assessed in Euros (2015 values).

The total number of patients treated in the first year was estimated to be 27,490, with 2,996 of those treated with omalizumab, increasing to a total of approximately 27,708 in the third year, with 7,925 receiving omalizumab. Considering only drug costs, the incremental budget impact of introducing omalizumab 300mg to the current market share was estimated to be €4.4 million in the first year, increasing to €11.7 million in the third year. Considering total direct medical costs, it was possible to show that part of the incremental drug costs of introducing omalizumab 300mg was offset by decrease in other resources: €1.4 million (total incremental budget) in the first year to €3.7 million in the third year.

The use of omalizumab to treat CSU with inadequate response to H1-antihistamines increases drug and drug-related costs, but this is partially offset by reduced disease-related costs in omalizumab recipients.


Ravasio, R., Cawson, M., McBride, D., Balp, M., & Roccia, A. (2015). Budget impact model of omalizumab in the treatment of chronic spontaneous urticaria In Italy. Value in Health, 18(7), A417. [PSS13]. https://doi.org/10.1016/j.jval.2015.09.537