OBJECTIVES: The objective of the study is to provide utilization data for lisdexamfetamine dimesylate (LDX) following its launch in 2013 in Europe for treatment of attention deficit hyperactivity disease (ADHD).
METHODS: This is a multi-country drug utilization study using database analysis. Longitudinal EMR databases (Disease Analyzer, Germany and CPRD, United Kingdom), National Registries (Denmark, Sweden), prescription databases using pharmacy retail data (IFAK/New Index, Switzerland) and cross-sectional databases (Prescribing Insights Spain, Switzerland) were used. The study includes all patients in the databases who have been prescribed LDX at least once during the study period (March [first EU launch] 2013 – December 2014).
RESULTS: The majority of patients treated with LDX were males in all six European countries studied: Germany (84% in Paediatrician Panel, 78% in Neurology/Psychiatry panel), UK (82%), Spain (87%), Denmark (63%), Sweden (60%) and Switzerland (75%). Less than 1% of all patients were < 6 years in all countries studied. The proportion of patients treated with LDX >18 years of age was estimated to be 12% in Germany (Neurology/Psychiatry Panel Germany), 12% in the UK (CPRD), 45% in Denmark, 60% in Sweden and 70% in Switzerland. Prescribed average daily dose (ADD) of LDX was within the recommended range (30-70mg) for 97% to 100% of the patients, with a mean ADD of 44mg in Germany, 48mg in UK and about 44mg in Sweden. In Denmark and Switzerland, the recommended dose was not recorded on the prescription.
CONCLUSIONS: Overall, the findings indicate that LDX is mainly prescribed within the EMA-approved Summary of Product Characteristics with regard to the indicated patients and dose regimen. Adult use is more common in Switzerland where use of LDX was already licensed for adults in 2014, or in Denmark and Sweden where use of LDX is indicated for adults as of 2015. Prescribed use in patients less than 6 years is ≤1%.
