Advice
NICE is unable to make a recommendation about the use in the NHS of sirolimus for treating facial angiofibroma caused by tuberous sclerosis complex in people 6 years and over. This evaluation was initially terminated because Plusultra pharma stated that it would review and revise its evidence submission to NICE. A review of the revised evidence submission was started but this was stopped in November 2025 because NICE is not satisfied that the evidence submission is adequate for the committee to make a decision. We will review this decision if the company decides to change its submission.
Information
If NHS organisations wish to consider sirolimus 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.
ISBN: 978-1-4731-8441-1