ABSTRACT
Background: Discrepancies are seen between arguments in favor of and against prescribing generic versus brand-name drugs.
Objective: To provide real-world evidence on treatment persistence, economic and clinical outcomes of pregabalin, generic versus brand-name (Lyrica®, Pfizer), routinely used to treat neuropathic pain (NP) or generalized anxiety disorder (GAD).
Methods: Electronic medical records from subjects’ first starting treatment with pregabalin between January-2015 and June-2016 were analyzed. Persistence, resources utilization, and costs were assessed, along with remitter and responder rates.
Results: A total of 4860 records were analyzed. Discontinuation was lower with brand-name than with generic in NP (adjusted hazard ratio [HR]: 0.70 [95% CI: 0.58–0.85], p < 0.001) and GAD patients (HR: 0.63 [0.45–0.84], p < 0.001). Adjusted mean total costs were lower with brand-name: €1500 [1428–1573] vs. €2003 [1864–2143] in NP and €1528 [1322–1734] vs. €2150 [1845–2454] in GAD (both p < 0.001). More patients were remitters/ responders with brand-name in NP (55.0% vs. 46.7% and 59.2% vs. 48.4%, respectively; p < 0.001) and GAD (58.6% vs. 48.7% and 64.6% vs. 47.2%, respectively; p < 0.001).
Conclusions: As a consequence of higher persistence in routine practice, patients who first started therapy with pregabalin brand-name versus generic showed better pain or anxiety outcomes at a lower cost to payers in Spain.
Declaration of interest
A Sicras-Mainar is an employee of ClinicResearch who was paid consultant to Pfizer, SLU in connection with the development of this manuscript. J Rejas-Gutiérrez and M Pérez-Páramo are employees of Pfizer, SLU. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed. This investigational analysis was approved by the Institutional Research Board of the Universitat Internacional de Catalunya in Barcelona and the Spanish Agency of Medicines. Patient consent was not obtained as the Spanish legislation exempts to existing data that are aggregated for analysis and personal data are stripped of identifying details as specified in Spanish Law 15/1999, of 13 December, on Personal Data Protection.
Reviewer disclosures
Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.
Author contributions
The investigational analysis was performed by A Sicras-Mainar and L Sánchez-Álvarez. R Navarro-Artieda was responsible for the literature review and bibliographic support. All authors contributed to the data interpretation, drafting, revision and approval of the final version of submitted manuscript to be published. All authors agree to be accountable for all aspects of the work.