Generic vs brand originator alendronate: analysis of persistence and compliance in five local Healthcare Units in the Lombardy Region of Italy

Abstract

INTRODUCTION: The appearance of off-patent generic drugs in the world pharmaceutical market is a highly interesting fact from the socio-economic point of view. However, the scientific documentation supporting the potential clinical and economic benefits of a growing use of off-patent alendronate generic in clinical practice seems to be limited in Italy as yet. PATIENTS AND METHODS: Comparing differences in persistence and compliance between off-patent generic alendronate and off-patent brand alendronate originator (Fosamax ®) in real clinical practice. The retrospective analysis was carried out by using the administrative databases of five Local Healthcare Units (ASL - Aziende Sanitarie Locali) in the Lombardy Region, in Italy. RESULTS: The selected sample of 5 ASLs included 20,711 patients; the average age was 73 years, with no difference between the two groups. After 34 months of observation, the persistence and compliance were no statistically different between off-patent generic alendronate vs off-patent brand alendronate. Data on days in persistence varied between 316 (Brand) vs 362 (Generic). Patients' compliance varied in average between 0.70 (Brand) and 0.72 for generic group. CONCLUSIONS: Off-patent generic drugs appear to be a therapy option of choice in Italy as well, both for the National Health Service and for citizens. Off-patent generic drugs can bring about an increased efficiency in health systems and increase the percentage of population benefitting from a medical care plan