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Boceprevir: Indication of added benefit for specific patients
Date:12/9/2011

th boceprevir given in a triple combination with the former two drugs.

Reduction in secondary diseases: extent cannot be classified.

For the two indications of pretreated (treatment-experienced) and non-pretreated (treatment-naive) patients without cirrhosis, data from one approval study each (SPRINT-2 and RESPOND-2) were available. With the available studies, it is not possible to assess directly whether the new active ingredient influences secondary diseases, such as the development of liver cancer. This is partly because the studies have not lasted long enough for these patient-relevant outcomes to be recorded.

With respect to SVR, there was a clear advantage for boceprevir, both for pretreated patients and for non-pretreated patients without liver cirrhosis. However, SVR is not itself a patient-relevant outcome and cannot be equated with "cure", and there are no studies in which SVR is validated as a surrogate outcome in accordance with the usual criteria employed by IQWiG. Nevertheless, the Institute accepts SVR in the context of the assessment as a surrogate for the reduced incidence of liver cancer. This is because it is currently accepted that patients with no detectable hepatitis C virus in the blood are at lower risk of liver cancer. However, it is unclear how many cases of liver cancer can in fact be prevented by boceprevir.

For the outcome "secondary diseases", IQWiG recognizes an "indication" of a benefit for boceprevir. The requirements for a "proof" are not fulfilled, one reason being that the data are only derived from a single study each, with a comparatively small number of patients. Moreover, the scientific data do not permit a conclusive assessment of the number of patients in whom liver cancer is actually prevented. It is therefore unclear whether the added benefit is "minor", "considerable" or "major". For such a case, the corresponding legal ordinance specifies the assessment category of "unquanti
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Contact: Anna-Sabine Ernst
presse@iqwig.de
49-022-135-6850
Institute for Quality and Efficiency in Health Care
Source:Eurekalert

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