IQWiG finds added benefit for Olysio in certain HCV patient groups-J&J Janssen Cilag

In an early benefit assessment, the German Institute for Quality and Efficiency in Health Care (IQWiG) has found indications and hints of an added benefit of Olysio (simeprevir), from J&J Janssen Cilag, when the patients infected with Hepatitis C virus (HCV) genotype 1 have been untreated before or have relapsed after initially successful treatment. IQWiG found that it is not possible to rate the extent of added benefit, however. Data from three studies were available for treatment-naive patients with HCV genotype 1 infection (with or without cirrhosis of the liver) (PILLAR, QUEST-1 and QUEST-2).

With regard to sustained virological response, there is an advantage of simeprevir: depending on effect modifiers, there is an added benefit (indication or hint) for certain patients, which is non-quantifiable. Simeprevir offers advantages on further aspects of morbidity: in some people, fatigue and global health status improved more than in the comparator group. IQWiG sees an indication of major added benefit for adults with HCV genotype 1 infection in whom previous treatment had no effect (non-responders), based on the ATTAIN study.

There is also an indication of a non-quantifiable added benefit of treatment with simeprevir for the relapsed patient group, based on data from the PROMISE study. There were no evaluable data for further therapeutic indications and thus an added benefit is not proven: added benefit is not proven for patients with a variant of interleukin 28B (IL28B CC genotype). Overall, IQWiG determined an added benefit of simeprevir with the probability “indication” or “hint” for certain patients.