NICE is unable to make a recommendation about the use in the NHS of baloxavir marboxil for treating acute uncomplicated influenza. This is because Roche has confirmed that it does not intend to make an evidence submission for the appraisal at this time. Roche considers that there is not enough evidence to provide an evidence submission for this appraisal.
If NHS organisations wish to consider baloxavir marboxil for this indication, they should follow the advice on rational local decision making in the NHS Constitution for England and the NHS Commissioning Board and Clinical Commissioning Groups (Responsibilities and Standing Rules) Regulations 2012. This outlines the approach that should be taken when there is no NICE guidance.
NICE will review the position if the company decides that it wants to make an evidence submission.