Early Assessment of Benefits

In their review article the authors present the results from the licensing studies for two recently approved hepatitis C virus (HCV) protease inhibitors (boceprevir, telaprevir). Both substances were evaluated by Germany’s Institute for Quality and Efficiency in Health Care (IQWiG), which was commissioned by the Federal Joint Committee Gemeinsamer Bundesausschuss, G-BA) (early benefit assessment). The evaluation was discussed in expert circles with great excitement and sometimes in an unobjective manner. We therefore expressly welcome the matter-of-fact presentation of the authors.

The authors’ assessment is largely consistent with that of IQWiG. With regard to the end point “sustained virologic response (SVR),” IQWiG has also concluded on the basis of the available literature that it is a sufficiently valid surrogate for the subsequent complication “hepatocellular carcinoma” (HCC). We therefore noted an additional benefit for boceprevir and telaprevir in most patients. In the early assessment of benefits, however, the extent of the additional benefit also needs to be determined. This means putting a number to the risk reduction for the development of HCC. This is not possible on the basis of existing studies. The mention of a possible “cure” does not solve this problem, because the disease may progress even in patients with SVR, and HCC may develop.

Our evaluation differs in one crucial point from the authors’ conclusions. From the authors’ point of view, all patients benefit from treatment with boceprevir and telaprevir. However, some patient groups merely develop more adverse effects when taking boceprevir and telaprevir, without any improvement to the virological response (1, 2). This information should be made available to doctors and patients in an unredacted form, so that they may take this into account when deciding on treatment.

All documents regarding the early assessment of benefits are accessible to the public at the G-BA website (www.g-ba.de).

DOI: 10.3238/arztebl.2012.0755a

Dr. med. Thomas Kaiser

PD Dr. med. Stefan Lange

Dr. rer. nat. Beate Wieseler

Prof. Dr. med. Jürgen Windeler

Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen (IQWiG), Köln

thomas.kaiser@iqwig.de

Conflict of interest statement

The authors work for IQWiG. They declare that no other conflict of interest exists.