Question to the Department of Health and Social Care:

To ask His Majesty's Government what safeguards exist to prevent patients from losing access to established, life-extending cancer treatments as a result of changes to NICE methodology.

The National Institute for Health and Care Excellence (NICE) evaluates all newly licensed cancer medicines and may recommend promising treatments for use through the Cancer Drugs Fund (CDF) where there is too much clinical uncertainty for routine commissioning. Under these arrangements, cancer medicines are made available to National Health Service patients for a defined period while further real‑world evidence is collected to address the uncertainties identified in NICE’s original appraisal.

At the end of the managed access period, NICE undertakes a full re‑appraisal of the medicine. This re‑appraisal considers all the evidence gathered during CDF use alongside updated clinical and cost‑effectiveness analyses. NICE then determines whether the medicine should be routinely funded by the NHS, or whether it cannot be recommended for routine commissioning. This re‑appraisal process is one of the limited circumstances in which NICE routinely re‑evaluates previous decisions.

In 2022, NICE updated its methods and replaced the earlier end‑of‑life flexibilities with the severity modifier. As a result, re‑appraisals of cancer medicines that originally entered the CDF under end‑of‑life criteria are now conducted in line with NICE’s current methods framework, ensuring consistency, fairness, and opportunity‑cost neutrality across all appraisals. NICE has recommended 96% of the medicines that it has re-appraised following a period of managed access for routine NHS use. Where NICE is unable to recommend a medicine for routine use following the period of managed access, it remains available for existing patients but is no longer routinely funded for new patients.