To analyze the cost-effectiveness of Omalizumab in addition to Standard of Care (SoC) in the treatment of paediatric patients (Ͼ6 yeas-old) with severe uncontrolled asthma from the perspective of the Public Health Care System in México. METHODS: A Markov model, with cycle duration of 2 weeks, was designed to analyze the cost-effectiveness of Omalizumab vs SoC. Effectiveness was evaluated by the number of exacerbations avoided. The model identifies 4 health-states, and death based on symptoms and exacerbations with and without omalizumab. Transition probabilities were obtained from two clinical studies identified after a systematic review, with approximately 627 patients. Omalizumab showed a reduction of 43% in the asthma exacerbation rate vs SoC (Lanier, 2009). Model time horizon was 20 years, with treatment duration of 6 years. A discount rate of 5% was used for costs and outcomes. Direct medical costs associated with exacerbations were elicited from an expert panel of clinicians and valuated by the unitary cost list of the Mexican Institute of Social Security. Drug costs are those from public tenders 2012. (US$1ϭMX$13.8). Probabilistic sensitivity analysis was performed using Monte Carlo technique. RESULTS: The expected 20 -year costs and number of exacerbations per patient with each treatment were: Omalizumab US$96,483/31.52; and SoC US$49,857/39.84. It represents 8.3 exacerbations avoided with an incremental cost-effectiveness ratio of US$5,617 per exacerbation avoided for omalizumab versus SoC, below the Mexican threshold of 1GDP per-cápitaϭUS$8,586. Probabilistic sensitivity analysis showed omalizumab was below the threshold 95% of the times, according to the acceptability curve. The model is more sensitive to changes in efficacy than price. CONCLUSIONS: For paediatric patients with severe uncontrolled asthma, treatment with omalizumab is a cost-effective option compared with current SoC in the health system. The higher drug acquisition cost of Omalizumab is off-set by the lower rate of exacerbations seen with patients on omalizumab and their related costs.
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