Germany's IQWiG finds no added benefit for Novartis' Rasilamlo

The German Institute for Quality and Efficiency in Health Care (IQWiG) has examined whether the drug combination aliskiren and amlodipine, for which Swiss drug major Novartis (NOVN: VX) last year received marketing approval in Europe under the trade name Rasilamlo for the treatment of people with hypertension in whom aliskiren or amlodipine alone has an insufficient effect (The Pharma Letter April 29, 2011), offers an added benefit compared with the present standard drug therapy in people with essential hypertension.

However, in an early benefit assessment under Germany’s Act on the Reform of the Market for Medicinal Products (AMNOG), the IQWiG says that such an added benefit cannot be inferred from the dossier, as the drug manufacturer deviated from the specifications of the Federal Joint Committee (G-BA) and chose a different comparator therapy.

Calcium channel blocker and ACE inhibitor specified as comparator therapy