Added benefit for certain patients found by IQWiG with Janssen's Olysio

In an early benefit assessment pursuant to the Act on the Reform of the Market for Medicinal Products (AMNOG), the German Institute for Quality and Efficiency in Health Care (IQWiG) found that US health care giant Johnson & Johnson (NYSE: JNJ) subsidiary Janssen’s Olysio (simeprevir) offers an added benefit over the appropriate comparator therapy in adult patients with chronic hepatitis C infection.

The drug manufacturer’s dossier provided indications and hints of an added benefit of simeprevir when the patients infected with hepatitis C virus (HCV) genotype1 have been untreated before or have relapsed after initially successful treatment. It is not possible to rate the extent of added benefit, however. The IQWiG sees an indication of major added benefit for adults with HCV genotype 1 infection in whom previous treatment had no effect (non-responders). There were no evaluable data for further therapeutic indications and thus an added benefit is not proven. Olysio was  approved by the European Commission earlier this year.

Major added benefit for non-responders