The National Institute for Health and Care Excellence (Nice) has reversed its earlier decision to reject a life-extending drug for use in the NHS in England, allowing it to be provided to around 1,000 women with HER2-low advanced breast cancer. The drug, Enhertu (also known as trastuzumab deruxtecan), is developed by Daiichi Sankyo and AstraZeneca. It is the first treatment specifically approved for patients with HER2-low breast cancer that has spread beyond the breast, a condition known as metastatic breast cancer, and cannot be surgically removed. This approval marks a significant development in the treatment of this specific and aggressive form of the disease.
Nice had previously concluded in 2024 that the treatment was not cost-effective for the NHS. However, a new commercial agreement has been reached, following updates to Nice’s evaluation methods as part of the UK/US Pharmaceutical Pricing Agreement. The drug is now available in England "from today," after being available in Scotland for over two years. Clinical trials showed that women receiving Enhertu survived for about two years, compared to 17.5 months for those receiving chemotherapy. This improvement has brought relief and hope to patients and their families, with some noting that some had "died waiting" for access to the drug.
Paula Van Santen, diagnosed with metastatic breast cancer in July 2022, said the approval gives her a "new sense of hope." She expressed gratitude for the decision, which allows her to witness her daughter's university graduation, become a grandparent, and continue being a mother to her children for longer. Similarly, Kathryn Hulland, 48, who was diagnosed with metastatic breast cancer in 2022, said the decision will allow her more time with her nine-year-old daughter, Grace. She emphasized the value of every additional month, which offers more opportunities to create cherished memories and support her daughter’s growth.
The charity Breast Cancer Now described the announcement as "momentous," with its chief executive, Claire Rowney, calling it a milestone for thousands of people who will now have access to a drug that could give them more time with loved ones. She urged Wales and Northern Ireland to also make Enhertu available on the NHS. Nice’s director of medicines evaluation, Helen Knight, acknowledged that the decision comes too late for many families and highlighted the changes to Nice’s cost-effectiveness criteria and the use of new methods to assess quality of life. Dr. Anne Rigg, a consultant medical oncologist, called the news "hugely positive" for women with secondary breast cancer, who will now have access to this life-extending treatment on the NHS. Tom Keith-Roach, UK country president for AstraZeneca, noted that the approval aligns England with Scotland and 26 other European countries, offering renewed hope to more than 1,000 women with this aggressive form of breast cancer.
NHS in England to Provide Life-Extending Breast Cancer Drug After Reversal of Earlier Decision
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