Januvia sitagliptin regulatory update

Germany's Federal Joint Committee (G-BA) said in a final benefit assessment that Januvia sitagliptin from Merck has "marginal" additional benefit to treat Type II diabetes as monotherapy vs. sulfonylurea and in combination with metformin vs. sulfonylurea and metformin. G-BA did say that Januvia has "no additional benefit" in combination with sulfonylurea vs. human insulin and sulfonylurea; in combination with sulfonylurea and metformin vs. human insulin and metformin; and in combination with insulin with or without metformin vs. human insulin and metformin. In a July preliminary assessment, Germany's Institute for Quality and Efficiency in Healthcare (IQWiG) said the drug had varying degrees of additional benefit in combination with metformin, depending on the specific patient population, vs. sulfonylurea and metformin but "no additional benefit" in 4 other combinations. The company will now negotiate a price for the product with Germany's Statutory Health Insurance Funds Association (GKV-Spitzenverband) (see BioCentury, July 15). ...