- France allows off-label use of Roche's Avastin (bevacizumab) for age-related macular degeneration (AMD)—and the industry is not pleased.
- Citing safety standards and the need to ensure regulatory compliance, the European Federatoin of Pharmaceutical Industries and Associations (EFPIA) has called on the European Commission to address the issue as a "public health" matter.
- The agency that regulates pharmaceuticals in France, the ANSM, put a law into effect as of September 1 which allows Avastin to be used to treat AMD. Avastin is considerably cheaper (1/30th of the cost) than Lucentis and other drugs indicated for treatment of AMD.
France is not alone in its effort to contain costs in situations where evidence clearly supports the use of a less expensive drug for a condition such as AMD. In fact, in May, the World Health Organization (WHO) rejected Novartis' request to add Lucentis (ranibizumab) to the List of Essential Medicines to treat AMD (wet age-related macular degeneration), a leading cause of blindness.
When France first put forth this recommendation last summer, French lawmakers cited costs as the reason to recommend Avastin over Lucentis, saying that swapping one for the other could save $273 million.
Both Avastin and Lucentis have a mechanism of action that involves inhibition of vascular endothelial growth factor (VEGF). VEGF inhibitors reduce the growth of new blood vessels, including in the eyes, and thereby have the effect of decreasing growth of abnormal blood vessels in the central retina of patients with AMD.
Within the previous three years, the two drugs have been tested head to head. Results from the Comparison of AMD Treatments Trial (CATT), a two-year clinical trial, were first published in the New England Journal of Medicine in May 2011. Researchers found that Avastin and Lucentis have "equivalent effects on visual activity when administered according to the same schedule."