Abstract
BackgroundObservational studies of switching from branded to generic formulations of the same drug substance often lack appropriate comparators for the subjects who switched. Three generic formulations were deemed equivalent to Concerta: an authorized generic (AG) identical except for external packaging, and two other generics (EG).ObjectiveCompare the incidence of a combined endpoint (switching back to Concerta, changing the use of immediate release methylphenidate (MPH), stopping all long-acting methylphenidate, or starting a new medication) among people switched from Concerta to the AG versus the EG.MethodsCohort study from the Truven CCAE database of people aged 6 to 65 diagnosed with ADHD, treated with Concerta, and switched to the EG or to the AG formulation.ResultsIn the EG arm 24.6% and in the AG arm 19.7% of subjects switched back to Concerta. The proportion of subjects meeting the combined endpoint was 39.5% in the EG arm, 32.9% in the AG arm, a crude risk ratio of 1.20 (95% CI 0.94, 1.54). After adjustment by propensity score stratification, the adjusted odds ratio (OR) was 1.23 (95% CI 0.90, 1.70). In an unplanned analysis using a different method of adjustment, the adjusted OR was 1.00 (95% CI 0.69, 1.44).DiscussionThis study did not detect a difference between the proportion of people who met the study endpoint in the two study arms, i.e. between those who switched to a generic formulation that was identical to Concerta except for external packaging and those who switched to the comparison generics. The high incidence of the combined endpoint in the AG arm demonstrates the need for an appropriate comparator in studies of this type.Trial registrationClinicalTrials.gov NCT02730572
Highlights
The need to control health care costs has led to substantial numbers of patients being switched from branded formulations to generic versions of the same or similar active drug substances, and many authors have sought to use retrospective analyses of health services databases to investigate the clinical consequences of such substitution
This study did not detect a difference between the proportion of people who met the study endpoint in the two study arms, i.e. between those who switched to a generic formulation that was identical to Concerta except for external packaging and those who switched to the comparison generics
Examples of such database studies of generic substitution include: Wu [1] who found that among adult patients with major depressive disorder treated with a branded SSRI, those who were switched to a generic SSRI for nonmedical reasons had more mental health hospitalizations and emergency department visits during the 6 months after their switch than did ageand-index-date matched subjects with major depressive disorder treated with a branded SSRI who were not switched to a generic SSRI
Summary
The need to control health care costs has led to substantial numbers of patients being switched from branded formulations to generic versions of the same or similar active drug substances, and many authors have sought to use retrospective analyses of health services databases to investigate the clinical consequences of such substitution These studies typically focus on how often some measure of failure of the new medication occurred among patients who made the substitution. Three generic formulations were deemed equivalent to Concerta: an authorized generic (AG) identical except for external packaging, and two other generics (EG)
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