Subsequent assessment in two addenda
In addition, the manufacturer had presented data on the comparison of ipilimumab with vemurafenib in its dossier. IQWiG did not examine these data in its dossier assessment because the G-BA had not specified vemurafenib as an appropriate comparator therapy at first. In March 2014, shortly before completion of the IQWiG dossier assessment, the G-BA commissioned the Institute to also assess the potential added benefit versus vemurafenib. Moreover, the manufacturer submitted corrected and updated data analyses in the commenting procedure on the dossier assessment in April 2014. Following the G-BA's commission, IQWiG now assessed these data in a second addendum.
Indirect comparison not interpretable
As so far there are no studies that directly compare ipilimumab with vemurafenib, the manufacturer used an indirect comparison, in which dacarbazine was used as a so-called common comparator. In this indirect comparison, on the one hand it used data from the BRIM-3 study, a randomized phase 3 study comparing vemurafenib with dacarbazine.
For the second side of the indirect comparison, the manufacturer did not use a direct comparison between ipilimumab and dacarbazine. Instead, it used the unadjusted indirect comparison again, which it had already used for examining the added benefit in comparison with dacarbazine. Hence the indirect comparison between ipilimumab and vemurafenib is also subject to great uncertainties. No conclusions on added benefit can be derived from this.
General weakness of analysis not resolved
In the second addendum, the Institute examined the corrected analyses subsequently submitted by the manufacturer. This correction reduced the exclusion of patients, but, in the outcome "overall survival", the exclusion w
|Contact: Dr. Anna-Sabine Ernst|
Institute for Quality and Efficiency in Health Care