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.MethodsWe 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.ResultsThe 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.ConclusionsOff-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.
Highlights
The appearance of generic drugs on the world pharmaceutical market significantly changed both company strategies and the behaviors of all the stakeholders in health expenditure and in drug prescription [1,2]
It is well known that generic drugs are medicines made of one or more active ingredients, industrially produced, not protected by a patent or supplementary protection certificate, identified by the international non-proprietary name of the active ingredient or, in its absence, by the drug scientific name, followed by the name of the marketing authorization (MA) holder, bioequivalent to a medicinal product already authorized with the same qualitative and quantitative composition of active ingredients, the same pharmaceutical form, and the same therapeutic indications [6]
Important clinical literature supports the full replaceability of off-patent branded with off-patent generic drugs in cardiovascular diseases [8,9,10,11]
Summary
The appearance of generic drugs on the world pharmaceutical market significantly changed both company strategies and the behaviors of all the stakeholders in health expenditure and in drug prescription [1,2]. Almost half of drug consumption in Italy and about 28% of expenditure is composed of off-patent drugs, most prescriptions still focus on branded products, while generic (unbranded) drugs are preferred in other European countries. The presence of a relevant market share of off-patent generic (unbranded) drugs is a necessary condition for price competition to unfold among companies after patents expire, with strong reductions and simultaneous benefits for the public health system [12]
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