New draft NICE guidance does not recommend lenalidomide as maintenance treatment after an autologous stem cell transplant for newly diagnosed multiple myeloma (MM).
NICE says the decision is due to a number of factors, including limitations in the cost-effectiveness model, and differences between the study population and the population treated in the NHS.
The main clinical evidence for lenalidomide maintenance treatment came from the UK phase 3 open-label randomised Myeloma XI trial.
The company’s submission focused on a smaller cohort of 1032 people from Myeloma XI. These people had had a first transplant and been randomised to have maintenance with lenalidomide 10 mg daily on days 1 to 21 of each 28-day cycle, or to have monitoring of their disease with no lenalidomide treatment.
The clinical trial results showed that lenalidomide maintenance treatment improves survival and extends the time before first relapse compared with monitoring alone in people with newly diagnosed MM who have had an autologous stem cell transplant.
However, the costs and effects of subsequent treatments in the lenalidomide clinical trials did not reflect NHS clinical practice in England. Also, the cost-effectiveness estimates were uncertain because the company did not present some of its methods in enough detail to be adequately scrutinised. In addition, NICE questioned some of the assumptions on which the submission was based.
The draft guidance is now open for comment. Closing date for receipt of comments is 29 September.
