UK Approves Life-Extending Breast Cancer Drug After Price Reversal

Patients in England diagnosed with a specific type of incurable HER2-low breast cancer will now have access to Enhertu, a drug proven to extend lives, on the National Health Service (NHS). This decision follows a reversal by the National Institute for Health and Care Excellence (NICE), which had previously deemed the drug not to be cost-effective.

Enhertu can provide patients with an average of seven additional months of life, with some experiencing survival of up to three years longer. While the drug has been available to patients in Scotland since 2023 and is prescribed in 26 other European countries, its accessibility in England was hindered by cost concerns.

Charities and patient advocacy groups have campaigned for wider availability since 2024, following NICE's initial assessment. The drug is now available for prescription by doctors in England starting Thursday, with Wales expected to follow suit. Guidance for Northern Ireland is not automatically included.

Health Secretary Yvette Cooper stated that Enhertu can be "life-changing" and that the recommendation ensures NHS patients can finally benefit. She acknowledged the efforts of campaigners and charities who persistently advocated for this outcome.

This new access will impact approximately 1,000 women annually diagnosed with HER2-low metastatic breast cancer. Breast Cancer Now, a charity, noted that while the persistence of campaigners was successful, many individuals missed out on the drug's benefits during the delay, with some losing their lives.

Claire Rowney, chief executive of Breast Cancer Now, expressed that the organization's efforts paid off but emphasized the significant cost of the delay. For patients like Kate Wills, 51, who has HER2-low metastatic breast cancer that has spread to her bones and lungs, the ability to access Enhertu offers a profound shift.

"To know that I can get it now is absolutely everything," Wills said, describing the prior inability to access the drug despite its potential to extend her life as "incredibly painful."

The reversal in NICE's decision is attributed to a trade deal with the USA, which allows the UK government to increase its spending on medicines by 25%. As part of this agreement, NICE has raised its threshold for the amount the NHS will pay per Quality-Adjusted Life Year (QALY), from £30,000 to £35,000. Additionally, in late August, NICE introduced a more nuanced method for measuring a patient's quality of life.

These two changes, combined with sustained patient advocacy, were sufficient to alter the assessment. Daiichi Sankyo and AstraZeneca, the manufacturers of Enhertu, have welcomed the decision. AstraZeneca has called for robust collaboration across the healthcare system to ensure faster and more equitable patient access in the future.

Breast Cancer Now urged the government, NICE, NHS England, and the pharmaceutical industry to collaborate on reforming the system, preventing future instances where patients with incurable conditions must campaign for life-extending treatments. Helen Knight, director of medicines evaluation at NICE, expressed satisfaction that a commercial solution allows the treatment to be available but acknowledged that the decision comes too late for many families. She stated that NICE's role is crucial in ensuring NHS spending on new medicines aligns with their benefits while safeguarding resources for other essential services.