Pomalidomide -- Benefit Assessment According to §35a Social Code Book V

Background In accordance with §35a Social Code Book (SGB) V, the Federal Joint Committee (G-BA) commissioned the Institute for Quality and Efficiency in Health Care (IQWiG) to assess the benefit of the drug pomalidomide. The assessment was based on a dossier compiled by the pharmaceutical company (hereinafter referred to as “the company”). The dossier was sent to IQWiG on 30 September 2015. Research question The aim of this report was to assess the added benefit of pomalidomide in combination with dexamethasone compared with the appropriate comparator therapy (ACT) for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least 2 prior treatment regimens, including both lenalidomide and bortezomib, and have demonstrated disease progression on the last therapy. The G-BA distinguished between 2 patient groups in its specification of the ACT. Deviating from the G-BA, the company named high-dose dexamethasone as only comparator therapy for patients who are eligible for targeted therapy. For patients who are not eligible for targeted therapy, the company followed the G-BA’s specification and chose best supportive care (BSC) as ACT.