Camiel J F Boon1,2, Reinier O Schlingemann1,3, Marc J Sirks1, Elon H C van Dijk2, Noa Rosenberg4,5, Carla E M Hollak4,5,6, Stamatios Aslanis7, Chui Ming Gemmy Cheung8,9, Itay Chowers10,11, Chiara M Eandi3,12, K Bailey Freund13,14, Frank G Holz15, Peter K Kaiser16, Andrew J Lotery17, Kyoko Ohno-Matsui18, Giuseppe Querques19, Yousif Subhi20,21, Ramin Tadayoni22,23,24, Charles C Wykoff25,26, Dinah Zur27,28, Roselie M H Diederen1. 1. Department of Ophthalmology, Amsterdam University Medical Centres, University of Amsterdam, Amsterdam, The Netherlands. 2. Department of Ophthalmology, Leiden University Medical Centre, Leiden, The Netherlands. 3. Department of Ophthalmology, University of Lausanne, Jules Gonin Eye Hospital, Fondation Asile Des Aveugles, Lausanne, Switzerland. 4. Medicine for Society, Platform at Amsterdam University Medical Centres - University of Amsterdam, Amsterdam, The Netherlands. 5. Department of Endocrinology and Metabolism, Amsterdam UMC - University of Amsterdam, Amsterdam, The Netherlands. 6. Sphinx, Amsterdam Lysosome Center, Amsterdam, The Netherlands. 7. St. Erik Eye Hospital, Stockholm, Sweden. 8. Singapore National Eye Center, Singapore, Singapore. 9. Singapore Eye Research Institute, Singapore, Singapore. 10. Department of Ophthalmology, Hadassah Medical Center, Jerusalem, Israel. 11. Faculty of Medicine, Hebrew University of Jerusalem, Jerusalem, Israel. 12. Department of Surgical Sciences, University of Turin, Turin, Italy. 13. Vitreous Retina Macula Consultants of New York, New York, New York, USA. 14. Department of Ophthalmology, New York University Grossman School of Medicine, New York, New York, USA. 15. Department of Ophthalmology, University of Bonn, Bonn, Germany. 16. Cole Eye Institute, Cleveland, Ohio, USA. 17. Faculty of Medicine, University of Southampton, Southampton, UK. 18. Tokyo Medical and Dental University, Tokyo, Japan. 19. IRCCS San Raffaele Scientific Institute, University Vita Salute San Raffaele, Milan, Italy. 20. Department of Ophthalmology, Rigshospitalet, Glostrup, Denmark. 21. Department of Clinical Research, University of Southern Denmark, Odense, Denmark. 22. University of Paris, Paris, France. 23. Hôpital Lariboisière, AP-HP, Paris, France. 24. Hôpital Fondation Adolphe de Rothschild, Paris, France. 25. Retina Consultants of Texas, Retina Consultants of America, Houston, Texas, USA. 26. Blanton Eye Institute, Houston Methodist Hospital, Houston, Texas, USA. 27. Ophthalmology Division, Tel Aviv Medical Center, Tel Aviv, Israel. 28. Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.
Abstract
INTRODUCTION: Since July 2021, a worldwide shortage of verteporfin (Visudyne®) occurred: an essential medicine required for photodynamic therapy (PDT). PDT with verteporfin has a broad range of indications in ophthalmology, including chronic central serous chorioretinopathy, polypoidal choroidal vasculopathy and choroidal haemangioma. For these disorders, PDT is either the first-choice treatment or regarded as a major treatment option. MATERIALS AND METHODS: A questionnaire was sent to key opinion leaders in the field of medical retina throughout the world, to assess the role of PDT in their country and the effects of the shortage of verteporfin. In addition, information on the application of alternative treatments during shortage of verteporfin was obtained, to further assess the impact of the shortage. RESULTS: Our questionnaire indicated that the shortage of verteporfin had a major impact on ophthalmic care worldwide and was regarded to be a serious problem by most of our respondents. However, even though there is ample evidence to support the use of PDT in several chorioretinal diseases, we found notable differences in its use in normal patient care throughout the world. Various alternative management strategies were noted during the verteporfin shortage, including lowering the dose of verteporfin per patient, the use of alternative treatment strategies and the use of a centralized system for allocating the remaining ampoules of verteporfin in some countries. CONCLUSION: The shortage of verteporfin has had a large effect on the care of ophthalmic patients across the world and may have resulted in significant and irreversible vision loss. Mitigation strategies should be developed in consultation with all stakeholders to avoid future medication shortages of verteporfin and other unique ophthalmic medications. These strategies may include mandatory stock keeping, compulsory licensing to an alternative manufacturer or incentivizing the development of competition, for example through novel public-private partnerships.
INTRODUCTION: Since July 2021, a worldwide shortage of verteporfin (Visudyne®) occurred: an essential medicine required for photodynamic therapy (PDT). PDT with verteporfin has a broad range of indications in ophthalmology, including chronic central serous chorioretinopathy, polypoidal choroidal vasculopathy and choroidal haemangioma. For these disorders, PDT is either the first-choice treatment or regarded as a major treatment option. MATERIALS AND METHODS: A questionnaire was sent to key opinion leaders in the field of medical retina throughout the world, to assess the role of PDT in their country and the effects of the shortage of verteporfin. In addition, information on the application of alternative treatments during shortage of verteporfin was obtained, to further assess the impact of the shortage. RESULTS: Our questionnaire indicated that the shortage of verteporfin had a major impact on ophthalmic care worldwide and was regarded to be a serious problem by most of our respondents. However, even though there is ample evidence to support the use of PDT in several chorioretinal diseases, we found notable differences in its use in normal patient care throughout the world. Various alternative management strategies were noted during the verteporfin shortage, including lowering the dose of verteporfin per patient, the use of alternative treatment strategies and the use of a centralized system for allocating the remaining ampoules of verteporfin in some countries. CONCLUSION: The shortage of verteporfin has had a large effect on the care of ophthalmic patients across the world and may have resulted in significant and irreversible vision loss. Mitigation strategies should be developed in consultation with all stakeholders to avoid future medication shortages of verteporfin and other unique ophthalmic medications. These strategies may include mandatory stock keeping, compulsory licensing to an alternative manufacturer or incentivizing the development of competition, for example through novel public-private partnerships.
Authors: Elon H C van Dijk; Jeppe K Holtz; Marc J Sirks; Janni M E Larsson; Roselie M H Diederen; Reinier O Schlingemann; Camiel J F Boon; Yousif Subhi Journal: J Clin Med Date: 2022-08-16 Impact factor: 4.964