Rachael Franklin, interim chief executive at Breast Cancer Now, said:
“We are both devastated and angry that womens’ lives will be shortened as a direct result of NICE, NHS England, Daiichi Sankyo and AstraZeneca failing to agree a solution that would make Enhertu (trastuzumab deruxtecan) available on the NHS in England for thousands of people with HER2-low secondary breast cancer. This was an avoidable tragedy.
“Patients have found themselves caught in the middle of a stand-off about cost and the system which is denying them precious hope of more time to live – that’s time with their families, children and doing what matters most to them.[1] With Enhertu available to women in so many other countries, including Scotland, it is unacceptable this promising treatment will be out of reach for women in England, Wales and Northern Ireland. [2]
“A deep injustice is at play here and we will continue to do all in our power to see this decision reversed. We have raised this situation with the new government and will continue to work with patient advocates and the hundreds of thousands of people who have backed our Enhertu Emergency campaign to press all parties to see a solution found. However, the heartbreaking but inescapable reality is, that these women don’t have time to wait.
“We’re hugely concerned that the introduction of the severity modifier, as part of changes to NICE methods in 2022, will lead to other effective treatments for secondary breast cancer being rejected by NICE.[3] We simply cannot afford for this to happen given what’s at stake. NICE’s review of the severity modifier must be open and transparent – involving patient organisations – and crucially lead to the urgent change needed to ensure people with secondary breast cancer never find themselves in this unacceptable position again.”
ENDS
Notes to editor
1 Trastuzumab deruxtecan (Enhertu) has been 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. https://breastcancernow.org/about-us/media/press-releases/dark-day-as-life-extending-drug-blocked-from-nhs-use-in-england/
Clinical trial DESTINY-Breast 04 found that Enhertu offered an additional 4.8 months of progression free survival than chemotherapy (median 9.9 months for trastuzumab deruxtecan compared to 5.1 months for chemotherapy) and an additional 6.4 months of overall survival (median 23.9 months for trastuzumab deruxtecan versus 17.5 months for chemotherapy).
2 Wales and Northern Ireland normally follow NICE decisions. Enhertu was approved by the Scottish Medicines Consortium in December 2023. Enhertu is currently available in Northern Ireland on an interim commissioning (cost per case) basis.
3 In 2022 NICE, published its new methods and process manual which sets out how medicines and health technologies will be evaluated. As part of this, a severity modifier was introduced replacing the end-of-life modifier which had been part of NICE’s methods since 2009. A ‘modifier’ can be taken into account during decision-making and can apply extra weight for severe diseases. Breast Cancer Now is concerned about the impact this change may have had on the appraisal of Enhertu.
We know from board papers that NICE will conduct a review of the severity modifier in 2024/5, with support from the NICE Decision Support Unit.
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Notes to editor
1 Trastuzumab deruxtecan (Enhertu) has been 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. https://breastcancernow.org/about-us/media/press-releases/dark-day-as-life-extending-drug-blocked-from-nhs-use-in-england/
Clinical trial DESTINY-Breast 04 found that Enhertu offered an additional 4.8 months of progression free survival than chemotherapy (median 9.9 months for trastuzumab deruxtecan compared to 5.1 months for chemotherapy) and an additional 6.4 months of overall survival (median 23.9 months for trastuzumab deruxtecan versus 17.5 months for chemotherapy).
2 Wales and Northern Ireland normally follow NICE decisions. Enhertu was approved by the Scottish Medicines Consortium in December 2023. Enhertu is currently available in Northern Ireland on an interim commissioning (cost per case) basis.
3 In 2022 NICE, published its new methods and process manual which sets out how medicines and health technologies will be evaluated. As part of this, a severity modifier was introduced replacing the end-of-life modifier which had been part of NICE’s methods since 2009. A ‘modifier’ can be taken into account during decision-making and can apply extra weight for severe diseases. Breast Cancer Now is concerned about the impact this change may have had on the appraisal of Enhertu.
We know from board papers that NICE will conduct a review of the severity modifier in 2024/5, with support from the NICE Decision Support Unit.