The National Institute for Health and Care Excellence (NICE) has issued draft negative guidance for daratumumab (Darzalex®) monotherapy as a treatment for relapsed and refractory myeloma patients. Although daratumumab monotherapy was granted a licence by the European Medicines Agency (EMA) based on results of two Phase II trials, the degree of uncertainty for the clinical effectiveness of daratumumab from these trials has led to NICE not recommending it as a cost effective use of NHS resources. The Scottish Medicines Consortium (SMC) similarly issued a negative recommendation in 2016. The current recommendations are out for public consultation until 7 April 2017.


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