Claire Rowney, chief executive at Breast Cancer Now, said:
“We are deeply disappointed that NICE has opted not to make changes to the severity modifier following its recent review[1], and believe its introduction was pivotal to the recent devastating rejection of life-extending HER2-low secondary breast cancer treatment, Enhertu.
“NICE’s decision tragically marks a missed opportunity to offer a lifeline to thousands of people living with incurable breast cancer who desperately need access to Enhertu, now; instead, they, their family and friends face the heartbreaking reality of continuing to be denied access to this vital treatment and the hope it offers of six months more to live - time that could make all the difference in them being there to see their child start school, or to enjoy another Christmas with loved ones.[2]
“The continued stand-off around the price of Enhertu between NICE and pharmaceutical companies in England denies patients access to a treatment that, in stark contrast is now available via public healthcare systems in Scotland, 18 European countries, Australia, Japan, Canada, USA, Bahrain, Kuwait and the United Arab Emirates.
“We stand firm in our conviction that urgent change is needed, and will continue to explore all avenues in our efforts to see a solution reached so that Enhertu becomes available on the NHS in England, Wales and Northern Ireland, giving more people living with secondary breast cancer the access to world class treatment they deserve.”
ENDS
Notes to editors
[1] 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. With HER2-low secondary breast cancer after chemotherapy now being classed as ‘medium severity’ there is less room for vital commercial negotiations to make this life-extending and life-changing treatment available. We fear that secondary breast cancer will be classed as 'medium severity' for other drug indications too.
[2] 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).