Question to the Department of Health and Social Care:

To ask Her Majesty’s Government what steps they are taking to restore the availability of, and access to, the anti-GD2 antibody which had previously been approved.

The National Institute for Health and Care Excellence (NICE) has not yet published its final guidance on dinutuximab (Unituxin) as a maintenance treatment after therapy for high-risk neuroblastoma. NICE’s Appraisal Committee is currently considering its draft guidance in light of the Appeal Panel’s decision to uphold an appeal against its final appraisal determination.

Dinutuximab was referred to NICE under the single technology appraisal programme following its consideration through the established topic selection process including a public consultation and a scoping workshop with stakeholders.

NICE is also currently appraising another anti-GD2 antibody product, APN311, for use in the treatment of high-risk neuroblastoma. APN311 is not yet licensed for use in the United Kingdom and has only been available in the UK in clinical trials.

Neither treatment has been routinely commissioned for National Health Service patients in England.