In our recent Metastatic May campaign, the theme was ‘The Cost of Living’. Living with metastatic breast cancer affects personal finances, careers, and overall income. But we also explored the financial aspects of drug approvals. This an important but challenging topic. Cancer treatments can be prohibitively expensive, because they cost a lot to develop. The NHS will only approve drugs that are deemed to be cost-effective (and of course safe).
The pricing of drugs in England is negotiated confidentially, guided by NICE (National Institute for Health and Care Excellence) and the NHS. In 2022, a significant change in the methods NICE use introduced a ‘Severity Modifier’ to assess drugs for cost-effectiveness. This system has two tiers—medium and high severity—and the purpose was to increase the number and type of drugs eligible for extra funding. Most people assumed that metastatic breast cancer (MBC) would qualify for the highest severity because it is a severe disease AND has a low life expectancy. Unfortunately, under the new methods, all MBC drugs assessed so far have been assigned a medium severity.
Sadly, no increase in overall medicines funding was allocated for this change. Instead, money was redirected from treatments for short life expectancies, mostly advanced cancer therapies. This was justified by the following statement:
“There is no evidence that society values treatments at the end of life over other treatments. Evidence does show that society values health gains from treatments for very severe diseases over other treatments.”
However, it is not clear where the evidence that supports this statement comes from. NICE promised to review the impact of the Severity Modifier to ensure no groups of patients were disadvantaged. This review was discussed at the NICE Board meeting on 25 September 2024, generating significant interest from patients with advanced cancer.
We were disappointed to learn that the NICE Board concluded the Severity Modifier is functioning as intended and does not require changes. The intention of the severity modifier was to redistribute funding from patients with a short life expectancy to other conditions, but no additional funding was allocated. The human cost of this decision for patients is huge. Health and therefore life has been displaced from metastatic cancer patients to fund other treatments.
To get additional funding would have required input from the Department of Health and Social Care. Was this funding sought and refused or was it not asked for? Wes Streeting cannot answer for his predecessors, but he can answer for himself. And he will be asked.
Instead, NICE has commissioned further research into societal values related to severe diseases, which will take 2-3 years to complete. Three years to complete a research project is literally a lifetime when 2-3 years is the average life expectancy for MBC patients. Many MBC patients alive today will be dead by the time the research has concluded.
For many, like those with HER2-low metastatic breast cancer, the time lost means access to potentially life-extending treatments will be delayed or denied altogether. The urgency for this research was set out in a 2021 document from NICE, which highlighted the critical need to understand how society values health benefits in severe diseases. Yet, until now no efforts have been made to commission this research. This delay has a profound human cost.
Patients with HER2-low metastatic breast cancer, who have an average life expectancy of only 18 months on NHS care, have seen their disease classified as medium severity. Although the drug Enhertu could potentially extend their lives by an additional six months, they have been unable to access it due to the lack of agreement between NICE and the pharmaceutical companies. The pharmaceutical companies maintain they have offered NICE generous discounts. NICE claims that uncertainties in the data modelling mean they cannot fund Enhertu without larger discounts. Patients are stuck in the middle, locked out of the negotiations.
In contrast, patients in Scotland have access to Enhertu because a deal was reached there, highlighting inequalities in treatment availability across the UK. In fact, a deal has been reached in 18 European countries, and several other countries worldwide including Canada and Australia. Additionally, many patients in the UK with private health insurance have got Enhertu funded. There is both a postcode lottery and wealth divide, where patients’ chances of receiving crucial medications depend on their location and financial status.
We urge NICE and the pharmaceutical companies to reconsider their approach and stop punishing patients. It is vital that they demonstrate flexibility in their negotiations to ensure every patient in the UK with MBC has access to the life-extending drugs, like Enhertu, that they desperately need.
Who Really Cares?
Madeleine Meynell
Twitter @madmeynell
instagram @madeleinemeynell