Tomas Bro1,2, Magdalena Derebecka3, Øystein Kalsnes Jørstad4,5, Andrzej Grzybowski6,7. 1. Futurum, the Academy for Health and Care in Region Jönköping, Jönköping, Sweden. tomas.bro@med.lu.se. 2. Ögonmottagningen, Höglandssjukhuset, 575 81, Eksjö, Sweden. tomas.bro@med.lu.se. 3. Department of Ophthalmology Regional Hospital in Elblag, Elblag, Poland. 4. Department of Ophthalmology, Oslo University Hospital, Oslo, Norway. 5. Faculty of Medicine, University of Oslo, Oslo, Norway. 6. University of Warmia and Mazury, Olsztyn, Poland. 7. Institute for Research in Ophthalmology, Poznan, Poland.
Abstract
PURPOSE: To analyse current off-label use of bevacizumab for wet age-related macular degeneration (AMD) in Europe. METHODS: The study was conducted as a combined survey and literature review. It included the 22 most populous countries in Europe. In each country, ophthalmologists with particular knowledge about off-label treatment responded to a questionnaire. RESULTS: Answers were obtained from twenty European countries. The off-label use of bevacizumab for wet AMD greatly differed between nations; the bevacizumab proportion varied from non-existent (0%) to very high (97%). There were also large disparities within single countries (e.g. 0-80%), which were attributable to differences in regional decision-making. Both governmental institutions and national ophthalmological societies expressed highly diverging opinions on the use of off-label treatment. Intravitreal administration of bevacizumab had been a matter of legal dispute in several countries. The question about responsibility for off-label therapy mainly remained unanswered. CONCLUSIONS: There was a highly varying utilization of bevacizumab between European countries. Despite an intention of a consistent approach to medical regulations, Europe has not yet reached a professional or political consensus on the ophthalmic off-label use of bevacizumab.
PURPOSE: To analyse current off-label use of bevacizumab for wet age-related macular degeneration (AMD) in Europe. METHODS: The study was conducted as a combined survey and literature review. It included the 22 most populous countries in Europe. In each country, ophthalmologists with particular knowledge about off-label treatment responded to a questionnaire. RESULTS: Answers were obtained from twenty European countries. The off-label use of bevacizumab for wet AMD greatly differed between nations; the bevacizumab proportion varied from non-existent (0%) to very high (97%). There were also large disparities within single countries (e.g. 0-80%), which were attributable to differences in regional decision-making. Both governmental institutions and national ophthalmological societies expressed highly diverging opinions on the use of off-label treatment. Intravitreal administration of bevacizumab had been a matter of legal dispute in several countries. The question about responsibility for off-label therapy mainly remained unanswered. CONCLUSIONS: There was a highly varying utilization of bevacizumab between European countries. Despite an intention of a consistent approach to medical regulations, Europe has not yet reached a professional or political consensus on the ophthalmic off-label use of bevacizumab.
Keywords:
Avastin; Bevacizumab; Health economics; Intravitreal injections; Off-label; Wet AMD
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