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. 2013 Dec 18;8(12):e82990.
doi: 10.1371/journal.pone.0082990. eCollection 2013.

Off-patent generic medicines vs. off-patent brand medicines for six reference drugs: a retrospective claims data study from five local healthcare units in the Lombardy Region of Italy

Giorgio L Colombo  1 , Enrico Agabiti-Rosei  2 , Alberto Margonato  3 , Claudio Mencacci  4 , Carlo Maurizio Montecucco  5 , Roberto Trevisan  6
Affiliations

Off-patent generic medicines vs. off-patent brand medicines for six reference drugs: a retrospective claims data study from five local healthcare units in the Lombardy Region of Italy

Giorgio L Colombo et al. PLoS One. .

Abstract

The scientific documentation supporting the potential clinical and economic benefits of a growing use of off-patent generic drugs in clinical practice seems to be limited in Italy as yet.

Methods: We compared differences in outcomes between off-patent generic drugs and off-patent brand drugs in real clinical practice. The outcomes were: persistence and compliance with therapy, mortality, and other health resources consumption (hospitalizations, specialist examinations, other drugs) and total costs. Retrospective analysis was carried out by using the administrative databases of five Local Healthcare Units (ASLs - Aziende Sanitarie Locali) in the Lombardy Region of Italy. Data from the five ASLs were aggregated through a meta-analysis, which produced an estimate indicator of the mean or percentage difference between the two groups (branded vs. generic) and their respective significance tests. The therapeutic areas and studied drugs were: diabetes: metformin - A10BA02; hypertension: amlodipine - C08CA01; dyslipidemia: simvastatin - C10AA01; psychiatry: sertraline - N06AB06; cardiology: propafenone - C01BC03; osteoporosis: alendronate - M05BA04.

Results: The 5 Local Healthcare Units (ASL) represent a population of 3,847,004 inhabitants. The selected sample included 347,073 patients, or 9.02% of the total ASL population; 67% of the patients were treated with off-patent brand drugs. The average age was 68 years, with no difference between the two groups. After 34 months of observation, compliance and persistence were in favor to generic drugs in all therapeutic areas and statistically significant in the metformin, amlodipine, simvastatin, and sertraline groups. The clinical outcomes (hospitalizations, mortality, and other health costs) show no statistically significant differences between off-patent generic vs. off-patent brand medicines.

Conclusions: Off-patent generic drugs appear to be a therapy option of choice in Italy as well, based on clinical outcomes and economic consequences, both for the National Health Service and patients, considering that the price difference between brand and generic drugs is completely charged on patients.

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Conflict of interest statement

Competing Interests: Author GLC is also scientific director of S.A.V.E. Studi Analisi Valutazioni Economiche, Milan (Italy). There are no patents, products in development or marketed products to declare. This does not alter the authors′ adherence to all the PLOS ONE policies on sharing data and materials.

Figures

Figure 1
Figure 1. Distribution of the sample per age group and studied drug.
See this image and copyright information in PMC

References

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