Abstract
Purpose:
In France, assessing treatment patterns in routine clinical practice is limited as there is no dedicated national electronic medical record system (EMR). In the wet age-related macular degeneration (wAMD) setting, the prescription of anti-vascular endothelial growth factors (anti-VEGF) is full covered by French governmental medicare for all patients and not driven by private insurances. LYVE employed a unique design that used 2 databases in France for identifying treatment patterns of anti-VEGF, ranibizumab and aflibercept, for wAMD in routine medical practice. Here, we describe the methodology and baseline characteristics.
Methods:
LYVE is a one-year analysis from databases that recorded delivered product and patients information: a nationally representative pharmacy records database (PRD) and a pharmacy-based questionnaire system (PQS). LYVE analyzed patients with wAMD who received their first prescription of ranibizumab/aflibercept from October 2013-July 2014. The primary objective is to evaluate the overall frequency of drug delivery. Key secondary objectives are: frequency of drug delivery with same treatment, duration for which patients remain on the same treatment and % patients who had a treatment-switch. Data will be analyzed at Months 6, 9 and 12.
Results:
Data were collected from a total 926 pharmacies from over 22 regions in France. The majority of prescriptions were dispensed by office based ophthalmologists (66.2%) than hospital based ones (33.8%). Of the 466 patients in the database, 313 (67.2%) were naïve to ranibizumab and 153 (32.8%) to aflibercept. Patients had a mean (±standard deviation [SD]) age of 78.4±9.24 years (“ranibizumab”: 78.0±7.8; “aflibercept”: 79.2 ±8.9 years; p=0.179) and 64.5% patients were female (“ranibizumab”: 63.6%; “aflibercept”: 66.0%; p=0.606). The presentation was bilateral in 14.2% patients (“ranibizumab”: 13.1%; “aflibercept”: 16.3%; p=0.346).
Conclusions:
The ranibizumab and aflibercept treatment groups were well-balanced with respect to baseline characteristics. The results from the first analysis at Month 6 are expected in March 2015.<br /> LYVE represents a unique national sample on the real-life data for wAMD treatment patterns in France and constitutes a non-biased informative database of ophthalmologists preferred practice.