Detection of clinical relapses in multiple sclerosis cohorts: construction and validation of a model based on administrative data.

Multiple sclerosis (MS) is the main cause of chronic disability in young people during their most productive years of life and therefore carries a high social and economic burden. The present study aimed to: (1) verify the capacity of an administrative data source to furnish data for constructing a model able to detect the occurrence of clinical relapses in MS patients and (2) validate the constructed theoretical model on a set of real-world data. Two MS experts identified some administrative variables as proxies of clinical relapses. Thereafter, the two MS experts analysed 889 events in 100 MS patients, considering only the administrative data relating to these patients, while a third neurologist independently analysed the real-world data (documented medical history) of the same patients in the same period. Absolute concordance between the theoretical model and the real-world data was found in 86 % of the events. The model we propose is easily and rapidly applicable, requiring the collection of just a few variables that are already present in local health authority administrative databases in Italy. It can be used to estimate, with a good level of reliability, the occurrence of relapses in various settings. Moreover, the model is also exportable to different and larger MS cohorts and could be useful for healthcare planning and for evaluating the efficacy of drugs in the real-world, thus favouring better resource allocation and management.

Cost and appropriateness of treating asthma with fixed-combination drugs in local health care units in Italy.

BACKGROUND: Bronchial asthma is a chronic airways disease and is considered to be one of the major health problems in the Western world. During the last decade, a significant increase in the use of ß2-agonists in combination with inhaled corticosteroids has been observed. The aim of this study was to assess the appropriateness of expenditure on these agents in an asthmatic population treated in a real practice setting. METHODS: This study used data for a resident population of 635,906 citizens in the integrated patient database (Banca Dati Assistito) of a local health care unit (Milano 2 Azienda Sanitaria Locale) in the Lombardy region over 3 years (2007-2009). The sample included 3787-4808 patients selected from all citizens aged ≥ 18 years entitled to social security benefits, having a prescription for a corticosteroid + ß2-agonist combination, and an ATC code corresponding to R03AK, divided into three groups, ie, pressurized (spray) drugs, inhaled powders, and extrafine formulations. Patients with chronic obstructive lung disease were excluded. Indicators of appropriateness were 1-3 packs per year (underdosed, inappropriate), 4-12 packs per year (presumably appropriate), and ≥13 packs per year (overtreatment, inappropriate). RESULTS: The corticosteroid + ß2-agonist combination per treated asthmatic patient increased from 37% in 2007 to 45% in 2009 for the total of prescribed antiasthma drugs, and 28%-32% of patients used the drugs in an appropriate manner (4-12 packs per years). The cost of inappropriately used packs increased combination drug expenditure by about 40%, leading to inefficient use of health care resources. This trend improved during the 3-year observation period. The mean annual cost per patient was higher for powders (€223.95) and sprays (€224.83) than for extrafine formulation (€142.71). CONCLUSION: Based on this analysis, we suggest implementation of better health care planning and more appropriate prescription practices aimed at optimizing use of health care resources for the treatment of bronchial asthma. The results of our study should be extended to other regional/national reference local health care units, in order to define and compare average standard costs per pathology, and consolidated through the wide sample considered.