NICE: Draft guidance consultation Trastuzumab deruxtecan for treating HER2-low metastatic or unresectable breast cancer after chemotherapy
NICE has published on 26 September 2023 a draft guidance for public consultation that does not recommend trastuzumab deruxtecan for treating advanced HER2-low breast cancer in adults.
NICE’s independent appraisal committee has asked the company for more information ahead of its next meeting. This includes further analyses looking at how much benefit trastuzumab brings for people’s length of life, more evidence that the benefit of treatment continues even when the disease becomes worse and more analyses looking at the outcomes that people experience on standard care given in the NHS.
Helen Knight, director of medicines evaluation at NICE, said: “Trastuzumab deruxtecan represents a potentially significant development for people with this type of advanced breast cancer who currently have limited chemotherapy options and no targeted treatments available to them.
“Clinical trial evidence shows that trastuzumab deruxtecan increases how long people live and how long they have before their cancer gets worse compared with chemotherapy treatments used for HER2‑negative breast cancer.
“However, because there were a number of uncertainties in the company’s economic model, this meant that even when taking into consideration the condition’s severity and its effect on quality and length of life, the cost-effectiveness estimates were too high for it to be recommended for use in the NHS.
“The committee has identified a number of areas for clarification by the company before its next meeting and NICE will work with the company to address these.”
Some breast cancer cells have a protein called human epidermal growth factor receptor 2 (HER2) on their surface, which stimulates them to grow. HER2‑low is a newly classified subgroup of breast cancer previously considered HER2‑negative.
People with HER2‑low breast cancer that can’t be removed surgically or that has spread to other parts of the body (called unresectable or metastatic breast cancer) have tumours with low amounts of HER2. They are offered treatments for HER2-negative cancer (usually chemotherapy). But, after chemotherapy, people with HER2‑low cancer may be able to have targeted treatments.
Trastuzumab deruxtecan (also called Enhertu and made by Daiichi Sankyo) is the first licensed targeted treatment for this type of breast cancer.
It is estimated that around 1,000 people would have been eligible for treatment with trastuzumab deruxtecan if NICE had recommended it.
Draft guidance is at link https://www.nice.org.uk/guidance/GID-TA10813/documents/129
Expected publication of the Guidance is 31 January 2024