Januvia sitagliptin regulatory update

Merck and Germany's Statutory Health Insurance Funds Association (GKV-Spitzenverband) agreed on prices for Type II diabetes drugs Januvia sitagliptin and Janumet sitagliptin/metformin. Merck declined to disclose the negotiated prices. In an October final benefit assessment, Germany's Federal Joint Committee (G-BA) said the products had "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 (see BioCentury, Oct. 7, 2013).

Janumet and 4 other dipeptidyl peptidase-4 (DPP-4) inhibitors are the first group of drugs being assessed under drug pricing law AMNOG that were launched in Germany before the law came into effect in January 2011. Janumet is a combination of Merck's Januvia sitagliptin, a DPP-4 inhibitor, plus metformin. Ono has a license to co-develop sitagliptin under a 2004 deal with Merck (see BioCentury, Nov. 14, 2004). ...