US Pharm. 2016;41((7):HS-20.

Osimertinib was approved in February for the treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor T790M mutation-positive non–small-cell lung cancer. In an early benefit assessment, The German Institute for Quality and Efficiency in Health Care examined whether the drug offers an added benefit compared with the appropriate comparator therapy, concluding that it did not.

The appropriate comparator therapy for patients with T790M mutation who have already been pretreated with another inhibitor was either chemotherapy or—if this was not an option—best supportive care, including pain relief and other measures to enhance quality of life. Only one of the historic comparisons addressed the benefit assessment research question. However, no effects of osimertinib treatment were large enough to derive an advantage.