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Variations in national health care regulations pose challenge for European Union
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MIAMI — Aside from a centralized approval process for biotechnology drugs and uniform drug labels, widespread variation exists among nations in the European Union regarding patient access to health care, according to a presentation here.
In an update on anti-VEGF therapy in Europe, Stephan Michels, MD, MBA, said at Angiogenesis, Exudation and Degeneration 2012 that approval of Lucentis (ranibizumab, Genentech) for diabetic macular edema and macular edema secondary to retinal vein occlusion may not be coupled with a smooth transition to clinical usage.
"The point is actually getting the approval and then also getting the reimbursement in Europe, and that is the problem. ... There is no European Union-wide decision on reimbursement. Each country decides individually. ... From [experience with age-related macular degeneration], we know that this can be a quite lengthy process," he said.
Moreover, national reimbursement agreements have led to variations in pricing, and many European health care systems enforce drug labels rather than the best evidence.
For instance, the European Medicines Agency label for ranibizumab indicates how to treat patients, but Dr. Michels believes that treatment should be resumed upon lost visual acuity. The label contradicts many national ophthalmology societies, which also suggest management according to disease progression or anatomic surrogates.
Approval of Eylea (aflibercept, Regeneron) for neovascular AMD is anticipated to occur during the second half of 2012, but again, there may be a lengthy transition to patient access, Dr. Michels noted.
"I think the success will be very much dependent on the label ... the time to national reimbursement, which will likely be very lengthy, the pricing ... and the evolution of the reimbursement [of injection procedure], which is also a key issue in Europe," he said.
- Disclosure: Dr. Michels is on the advisory board for Novartis, Bayer, Allergan, Sucampo and Clanotech.