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Clinical trials established in 2005 the efficacy of Ranibizumab (Lucentis, Genentech) for the treatment of neovascular age-related macular degeneration (wetAMD), the leading cause of legal blindness in the United States.This disease is affecting people over the age of 65 with a prevalence of 1.6 million and 200000 new cases per year in the USA .While awaiting approval for ranibizumab from the Food and Drug Administration, ophthalmologists began treating neovascular AMD with off-label use of bevacizumab (Avastin, Genentech), since the drug had a target specificity similar to that of ranibizumab and was available at low cost for about 50$ per monthly injection Vs 1950$ for Lucentis monthly injection.
Ranibizumab received the FDA approuval in 2006 to treat specifically the wetAMD,there was a huge debate about the cost effectiveness and the reimbursement of Lucentis in comparaison with Avastin for treating the eye disease.
This paper explores the dilemma from different angles.First,it make the emphasize on the need of realizing a head to head comparative study between the two drugs and the means to finance and to launch this study since many roadblocks have been identified.
Then, it explores and analyzes the Genentech reaction facing this problem and their strategy to emphasize on the higher risk of death with Avastin, as compared to Lucentis in one hand and in the other hand their strategy to extend the ophthalmologic indications for Lucentis, including diabetic macula edema (DME).
Finally it explores what value should be put on safety in health technology assessments HTAs by developing that we can’t just consider the dollar value of medicine alone but we need to consider the cost of adverse events caused by the treatment and the cost of living with these adverse events