In an early benefit assessment under the German Act on the Reform of the Market for Medicinal Products (AMNOG), the German Institute for Quality and Efficiency in Health Care (IQWiG) concluded that an added benefit of Danish insulin giant Novo Nordisk’s (NOV: N) NovoEight (turoctocog alfa) is not proven.
As no relevant study is available for comparison with the appropriate comparator therapy, the benefit assessment of the drug manufacturer is based on its own deliberations and assumptions, for which, however, a valid data basis is lacking, the IQWiG stated. NovoEight has been approved since November 2013 for the prevention and treatment of bleeding in patients with hemophilia A.
Other blood clotting factors VIII as comparator therapy
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