RESULTS
We included 484 patients who started treatment, but 58 did not complete the first year of treatment, leaving 426 (263 males/163 females; mean age 11.1±2.9 years) available for assessment. The results shown are those of patients with actual data. As these were retrospectively collected, missing results were frequent and some patients were excluded from some results.
The number of MSE showed an 86% decrease in year 1 of treatment with OMZ (from 7.86 to 1.08), and there was a further gradual decrease up to 96% in year 6 (0.33) (Table 2). A marked improvement in the values of control tests exceeding the MIDs appeared in the first year and increased thereafter (Table 2).
The cost of health encounters is shown in Figure 2 and Table E1. There was a decrease of more than 93% in the cost of health encounters since the first year (Figure 3), especially for hospitalizations and even more for PICU admissions (only one in year 1 and none thereafter).
There was a decrease in all types of drugs of pharmacologic treatment (other than OMZ) since year 1, except for ICS (Figure 4 and Table E2). For these there were increases some of the years as some patients receiving ICS+LABA were switched to ICS alone.
There were quite a few missing values in some variables, as shown in Tables E1 and E2, especially in unscheduled visits to the primary care pediatrician. Tables E3 and E4 display the same results as above for only the patients with complete data in all variables of health encounters and drugs; the results show the same decreasing tendency.
Figure 4 and Table 2 show the costs of health encounters plus medication per patient, and the increase of costs, compared to baseline, due to OMZ. There was an increase of \euro9,823 in costs in the first year when OMZ was added; that amount gradually decreased to \euro4,715 in year 6 even though there was further clinical improvement. The mean ICER per avoided MSE was \euro2,107 (95%CI 1,652 to 2,562) (median 1,472) (median \euro369) in year 6. Likewise, the ICER for MIDs in control tests showed a decrease from year 1 (\euro2,059) to year 6 (\euro380) per each 0.5 points of improvement in ACQ5, less marked for c-ACT (\euro3,141 and \euro2,322 per each 3 points improvement in years 1 and 6 respectively).