Statement on NICE Interim Unituxin Decision

As you may have heard, last week the National Institute for Health and Care Excellence (NICE) released a statement to say they are considering not approving the drug Unituxin (dinutuximab) for high-risk neuroblastoma patients, under the European Medicines Agency (EMA) marketing authorisation granted in August. There are a number of factors contributing to the point of view of NICE including the drug’s cost-effectiveness in the NHS and concerns surrounding its side-effects.

This antibody was approved by the FDA in March 2015 and is produced by United Therapeutics. It is now used in the COG in North America following stem cell transplant as standard of care. Another antibody is currently being studied in clinical trials in Europe, ch14.18/CHO, and the license is held by Apeiron in Vienna. The current trials in Europe are conducted by SIOPEN and these are not affected by the NICE determination concerning Dinutuximab.

We wanted to reassure anybody that is concerned by the news that this is not a decision that is set-in-stone. NICE is opening up a consultation process for organisations involved to bring forward their comments and views to be brought before the board for a final decision in the new year. We are involved in discussions with NICE, doctors, charity partners, and families to ensure we have a strong submission to the committee before the deadline of 25th November.

We know the situation is far from ideal at the moment but we are doing what we can and working hard to deliver a response that will explain the impact this drug could have on children and families affected by neuroblastoma. We will keep you up-to-date with any developments as and when they come through to us.