NICE publishes final draft guidance on Enhertu for treating advanced HER2-low breast cancer in adults
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On 06 March 2024 NICE has published final draft guidance that does not recommend Enhertu (also called trastuzumab deruxtecan and made by Daiichi Sankyo) for treating advanced HER2-low breast cancer in adults.
The decision follows the conclusion of negotiations between NHS England and the company that sought to agree a commercial arrangement to make Enhertu available at a cost-effective price for the NHS.
The Final Draft Guidance has been sent to consultees for this appraisal who have 15 working days to consider whether they wish to appeal against it and/or notify us of any factual errors. The FDG has been sent to commentators for information, who can consider notifying us of any factual errors only. Subject to any appeal by consultees, the FDG may be used as the basis for NICE's guidance on the use of the appraised technology in the NHS in England.
The appeal period for this appraisal will close on 19 March 2024, and the publication is expected on 03 April 2024
Why the committee made these recommendations?
HER2-low is a newly classified subgroup of breast cancer previously considered HER2-negative. People with HER2-low metastatic or unresectable breast cancer
have cancer cells with low amounts of HER2. They are offered treatments for HER2-negative cancer; which type depends on whether the cancer is hormonereceptor negative or positive. Sacituzumab govitecan is a possible treatment for triple-negative breast cancer. Trastuzumab deruxtecan is the first licensed treatment for HER2-low metastatic or unresectable breast cancer, and it specifically targets HER2.
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. Because of a lack of evidence it is not possible to reliably compare trastuzumab deruxtecan with sacituzumab govitecan.
Despite accounting for the condition’s severity, by applying a severity modifier, and accounting for innovation and uncaptured benefits, the most likely cost-effectiveness estimate are above the upper end of the range NICE considers an acceptable use of NHS resources. So, trastuzumab deruxtecan is not recommended.
The Final Draft Guidance is available at this link
and available at NICE Website: NICE publishes final draft guidance on Enhertu after commercial discussions conclude without a price to make it a cost-effective use of NHS resources. | News | News | NICE