Baroness Delyth Morgan, chief executive at Breast Cancer Now, said:
“Today’s devastating provisional decision will deny certain patients living with incurable secondary breast cancer of the hope that trastuzumab deruxtecan could bring them, of both more time to live and more time before their disease progresses.
“This could have been a crucial moment to change practice and for the first time, provide an effective HER2-targeted treatment for patients whose breast cancer is HER2-low; but instead, trastuzumab deruxtecan, and the invaluable extra time it could bring patients to do the things that matter most to them, remains out of reach.
“We urge NICE and Daiichi Sankyo to work together to explore all possible solutions to ensure this provisional decision is reversed without delay. This should include NICE reviewing any additional flexibilities and the company exploring the further analyses requested, and considering scope to improve the cost-effectiveness of trastuzumab deruxtecan for use on the NHS.
“It’s also vital that NICE consider this appraisal when reviewing the impact of its new methods for evaluating health technologies. We must avoid the incredibly distressing prospect of patients being denied access to potentially life-extending medicines that may have previously been approved on the NHS.”
Notes to editors
There is now a period of consultation about this provisional recommendation until 5pm on 17 October. The NICE Committee will then reconsider this treatment at a committee meeting on 7 November.
 trastuzumab deruxtecan has been provisionally rejected for use on the NHS in England for treating HER2-low secondary (metastatic) or unresectable (cannot be removed by surgery) breast cancer after chemotherapy. It is the first treatment licensed for HER2-low breast cancer.
It is estimated that around 1,000 people would be eligible for treatment with trastuzumab deruxtecan.
 All invasive breast cancers are tested for HER2 (human epidermal grow factor receptor 2) levels. Some breast cancer cells have a higher than normal level of HER2 on their surface, which stimulates them to grow. There are various tests to measure HER2 levels. IHC (immunohistochemistry) is usually done first. It’s reported as a score of 0-3.
Historically, patients usually find out whether their breast cancer is HER2 positive or HER2-negative. HER2 positive breast cancers can be treated with HER2-targeted therapies such as pertuzumab (Perjeta), trastuzumab deruxtecan (Enhertu), trastuzumab emtansine (Kadcyla). Around one in five invasive breast cancers are HER2 positive.
Those whose breast cancer has lower levels of HER2 have always been considered HER2 negative and are not eligible for HER2 targeted treatments. Instead they would be treated according to their hormone receptor status or whether they are triple negative. But now, within the HER2 population, there are breast cancers which have low levels of HER2 expression which are now being termed HER2-low rather than HER2-negative. It is estimated that around 50% of all breast cancers show low levels of HER2.
[Historically, a score of 0 or 1+ means the breast cancer is HER2 negative. A score of 2+ is borderline and a score of 3+ means the breast cancer is HER2 positive. Breast cancers with borderline results should be retested using more specialised techniques. This is called an in situ hybridization (ISH) test. Now there is the additional classification of HER2-low. This is defined as a score of IHC 1+ or IHC 2+/ISH-]
 All NICE assessments evaluated using the new methods are being tracked and analysed to identify how the introduction of the severity modifier and other changes have been utilised. The outcome of this review will be presented to the NICE Board towards the end of 2023.