Is treatment outcome affected by the need to obtain health care providers’ approval first? Anti-VEGF real-life data from a large cohort in Germany at one center without individual applications

Abstract

Purpose: Real life data of anti-VEGF therapy usually fall behind published data from prospective trials. This is due to a number of circumstances, among them restricted patients’ access to therapy. One such restriction is the need to obtain approval by healthcare providers to cover costs before treatment. Recently, the AURA study reported on patients treated at one center in Germany. In Germany generally patients were required to wait for treatment until coverage of costs was granted by public healthcare. In contrast, we were able at our hospital to treat patients according PRN scheme without prior individual approval, based on a general contract for AMD, DME, and RVO, thus possibly offering faster access to therapy. Functional outcome and frequency of injections were evaluated and are compared to the AURA study.

Methods: Retrospective study, files of 1015 patients evaluated. Inclusion: at least one anti-VEGF treatment between 2008 and 2014, exclusion: none. Data from 1,280 eyes, including 8,840 injections, 10,790 OCT scans, and 20,930 VA measurements.

Results: 71% of cases had been treated for wet AMD, 18% for DME, and 9% for RVO. Median age was 79 years, baseline VA 0,25 (20/80). 15% of cases had previous treatment or relevant concomitant diseases.<br /> Mean functional improvement was found for AMD cases during the first 21 months with a letter score of +4.8 between months 3 - 6, from there on declining. Letter score for AMD was +2.8, and -0.2 for year 1 and 2, respectively. AMD cases received an average of 4.8 and 3.0 injections in year 1 and 2, respectively.<br /> 5 year data show ca. 1/3 of AMD cases to have lasting improvement (>= 5 letters), 1/3 to be stable (>-5 and <5 letters), and 1/3 to have a loss in VA (<-5 letters).

Conclusions: The AURA study reports for its German population a letter score of +1.1 and -0.8 for 1^st and 2^nd year, respectively with 5.6 injections in the first 2 years.<br /> In our study both the letter score for year 1 and 2 and the number of injections are slightly higher (letter score: +1.7 and +0,6, injections +2.2).<br /> These findings suggest that routines of individual application to grant treatment may play a significant role in the frequency of injections and consequently in functional outcomes after treatment, possibly by delaying access to therapy.