A letter to the NICE board ahead of their September meeting
20 September 2024
Dear Board Member
We are writing to you ahead of the September meeting of the NICE board, where we understand you will be discussing the use of the severity modifier in technology appraisals.
As organisations representing people with breast cancer, as well as breast cancer clinicians, we believe that urgent change to the severity modifier is needed to ensure that people with secondary breast cancer in England, Wales and Northern Ireland can continue to access world class care.
Enhertu
We were deeply troubled by the recent rejection of trastuzumab deruxtecan (Enhertu, TA992) for treating HER2-low metastatic or unresectable breast cancer after chemotherapy. As the debate on the cost-effectiveness of this treatment has played out, patients have found themselves caught in the middle of a standoff between NICE and pharmaceutical companies on price. As a result, they are currently not able to access an effective treatment that could give them an additional 6 months to live.
We understand that all funding decisions are complex, and that NICE has a responsibility to ensure the NHS is paying a fair price for treatments. But cost-effectiveness concerns do not appear to have been a major barrier in Scotland, or the 18 European countries who have chosen to reimburse Enhertu for use in this indication. We understand it is also now reimbursed in Australia, Japan, Canada, the USA, Bahrain, Kuwait and the United Arab Emirates.
We think that the severity modifier has been key to this divergence with international best practice and that under the previous end-of-life criteria, Enhertu could have been swiftly approved.
Severity modifier
We supported the introduction of a severity modifier, on the grounds that it could benefit a wider range of treatments and conditions than the end-of-life criteria, and that it acknowledges quality as well as quantity of life. However, as the board have already acknowledged, the lower-than-expected use of the modifier shows that it is not achieving these aims in its current form.
We voiced concerns at the time of development about the potential unintended consequences of the severity modifier on some end-of-life drugs. We are now seeing these concerns play out in real time, with devastating effect. We fear that secondary breast cancer will be classed as 'medium severity' for other drug indications that would previously have been considered 'end of life', leaving less flex for commercial negotiations to make treatments available. There is a significant risk that England, Wales and Northern Ireland could fall behind other countries in access to new and innovative treatments as a result.
We understand that the process to develop the modifier was time intensive and NICE will not wish to rush decisions about its future, but people with secondary breast cancer do not have time to wait for a comprehensive review to play out.
We urge you to make urgent changes to the severity modifier to ensure that drugs for secondary breast cancer that would previously have benefited from the end-of-life criteria are not disadvantaged. Short term changes can and should be made that would allow a deal to be done on Enhertu during the rapid review period.
We also want to see the pharmaceutical companies being as flexible as possible to ensure that there are no additional barriers placed in the way of patients that need to access this and other treatments. We will continue to robustly hold them to account for this.
We look forward to hearing from you about the outcome of the discussion.
Yours sincerely
Claire Rowney, CEO, Breast Cancer Now
Jo Taylor, Founder, METUPUK
With support from:
Professor Mark Beresford, Co-chair, UK Breast Cancer Group
Dr Catherine Harper-Wynne, Co-chair, UK Breast Cancer Group