NICE Enhertu cancer treatment
The petition of Elaine Lynch,
The petitioner declares that the National Institute for Health Care and Excellence (NICE), should take steps to approve the further use of Enhertu in NHS cancer treatments in patients that have the HER2 mutation; notes that NICE has currently only approved the use of Enhertu in the treatment of breast cancer; further notes that Enhertu has been approved in the United States for patients with the HER2 mutation.
And the petitioners remain, etc.—[Presented by Saqib Bhatti, Official Report, 18 September 2023; Vol. 737, c. 1202.]
[P002858]
Observations from the Minister for Health and Secondary Care (Andrew Stephenson):
The Government are committed to supporting timely access to clinically and cost-effective new drugs for cancer patients. The National Institute for Health and Care Excellence (NICE) is the independent body responsible for developing authoritative, evidence-based guidance for the NHS on whether new medicines represent a clinically and cost-effective use of resources. NICE appraises all newly licensed medicines and is able to recommend the vast majority of new cancer medicines for use on the NHS, either for routine funding or for funding through the Government’s £340 million Cancer Drugs Fund (CDF). The NHS is legally required to fund medicines recommended by NICE, usually within three months of final guidance.
NICE published guidance in 2021 and 2023 recommending Enhertu for the treatment of NHS patients with HER2-positive breast cancer and it is now available through the CDF to eligible NHS patients in line with NICE’s recommendations. NICE is currently developing guidance on Enhertu for HER2-low metastatic or unresectable breast cancer after chemotherapy and has recently consulted on draft guidance that does not recommend it as a clinically and cost-effective use of NHS resources. NICE recognises that its decisions have real and important implications for NHS patients and only publishes final guidance on the use of a medicine after a careful consideration of the available evidence and engagement with interested parties. NICE will take the comments received fully into account in making its final recommendations and currently expects to publish final guidance in January 2024.
NICE is also due to appraise Enhertu for treating HER2-mutated unresectable or metastatic non-squamous non-small-cell lung cancer after one or more therapies. The company has requested a delay to the appraisal to ensure it can make a comprehensive evidence submission and this appraisal is anticipated to begin in mid-July 2024.