Germany’s IQWiG sees no added benefit of Onglyza as monotherapy

In an early benefit assessment under the Act on the Reform of the Market for Medicinal Products (AMNOG), the German Institute for Quality and Efficiency in Health Care (IQWiG) concluded that no added benefit could be derived on the basis of the dossier submitted by Anglo-Swedish drug major AstraZeneca (LSE: AZN) and US partner Bristol-Myers Squibb (NYSE: MBY) for their type 2 diabetes drug Onglyza (saxagliptin).

Onglyza has been approved also as monotherapy in Germany since July 2013 for certain adults with type 2 diabetes mellitus. It is an option when drug treatment is needed, but the drug metformin is not tolerated or cannot be used.

Saxagliptin in combination with other drugs has already been available in Germany since 2009 and was already assessed by the IQWiG as part of the assessment of the established drug market. Since the middle of this year, it can also be used as monotherapy. However, the precondition is that the patient has metformin intolerance or contraindication. The Federal Joint Committee (G-BA) specified a sulfonylurea (glibenclamide or glimepiride) as appropriate comparator therapy.