In a benefit assessment, the Institute for Quality and Efficiency in Health Care (IQWiG) examined whether darolutamide offers patients an additional benefit compared to the appropriate comparator therapy. The result: An additional benefit has not been proven.

The manufacturer submitted a study to IQWiG and the G-BA comparing darolutamide + ADT with placebo + ADT. However, there is no study for the benefit assessment that directly compares darolutamide with the current medical standard of apalutamide. And this despite the fact that apalutamide was already available at the time of study planning. The manufacturer therefore had no choice but to carry out an adjusted indirect comparison: It used placebo-controlled studies on both active ingredients, whereby only data that could be interpreted with sufficient certainty for overall survival were available. The indirect comparison showed no benefit for darolutamide.

“If the manufacturer had conducted a direct comparative study, it would now be possible to make much more reliable statements about the possible advantages or disadvantages of darolutamide compared to apalutamide,” says Volker Vervölgyi, Head of Oncology (Solid Tumors) at IQWiG. “In addition, the patients in the comparison group of the study on darolutamide would have been spared inferior therapy with placebo.”

The dossier evaluation is part of the early benefit assessment in accordance with the Drug Market Reorganization Act (AMNOG), for which the G-BA is responsible. After publication of the dossier evaluation, the G-BA conducts a comment procedure and decides on the extent of the additional benefit.

Editor: X-Press Journalistenbüro GbR

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