NICE is unable to make a recommendation about the use in the NHS of alpelisib with fulvestrant for treating hormone-receptor positive, HER2-negative, PIK3CA-positive advanced breast cancer because Novartis did not provide an evidence submission. The company intends to develop and submit a broader evidence package to show clinical and cost effectiveness in the current treatment pathway in the UK.
If NHS organisations wish to consider alpelisib with fulvestrant for treating hormone-receptor positive, HER2-negative, PIK3CA-positive advanced breast cancer, 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.