Germany's IQWiG views Tafinlar, Stivarga and Cotellic

21 March 2016

German drug cost-effectiveness regulator the German Institute for Quality and Efficiency in Health Care (IQWiG) has released results of several recent reviews on cancer drugs, coming to various conclusions.

The first was for Swiss pharma giant Novartis’ (NOVN: VX) Tafinlar (dabrafenib), which has been approved since 2013 for the treatment of adults with advanced, ie, metastatic or unresectable, melanoma with a BRAF V600 mutation. Dabrafenib has been approved for this therapeutic indication also in combination with trametinib (trade name: Mekinist). At the end of 2015 (The Pharma Letter January 13, 2016), the IQWiG determined in two dossier assessments that there is an indication of a major added benefit for women and of a non-quantifiable added benefit for men for this combination therapy.

To quantify this added benefit also for men, the drug manufacturer subsequently submitted study data in the commenting procedure, which the Institute investigated in an addendum. According to the findings, there is now an indication of a considerable added benefit for men. For women, there is still an indication of a larger, ie, major added benefit.

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