Life-extending breast cancer drug finally approved for NHS in England

P patients in England with a specific form of incurable breast cancer will now be able to access Enhertu on the NHS, marking a significant shift two years after the drug was initially deemed not cost-effective. The treatment is estimated to extend life by nearly seven months on average, with some individuals living up to three years longer.

Physicians in England can begin prescribing the medication from Thursday. While Wales is expected to implement similar guidance soon, it will not automatically apply in Northern Ireland. Scotland had already granted NHS access to the drug in 2023, and it is currently available across 26 other European nations.

The decision reverses a 2024 ruling by the National Institute for Health and Care Excellence (NICE), which had rejected the drug due to value-for-money concerns. Health Secretary Yvette Cooper praised the outcome, stating that the recommendation is “life-changing” and honoring the persistent efforts of charities and patients who campaigned for wider availability since last year.

Approximately 1,000 women annually diagnosed with HER2-low breast cancer are expected to benefit. However, charities highlight the human toll of the delay. Claire Rowney, chief executive of Breast Cancer Now, acknowledged that while their “persistence paid off,” thousands of patients missed out on the treatment and many have since died.

“We can’t celebrate this momentous decision without remembering the devastating cost of this delay,” Rowney said, calling for a collaborative effort between the government, NICE, the NHS, and pharmaceutical companies to repair what she described as a “broken system.”

Kate Wills, a 51-year-old patient with metastatic HER2-low breast cancer, expressed relief upon hearing the news. Despite maintaining a high-powered career and a full family life, Wills described the previous inability to access the drug as “incredibly painful.”

“I really can’t believe it. I’m so relieved, I’m overjoyed,” Wills said. “It’s so hard keeping hope when you have stage four cancer. This gives me enormous hope.” She shared that she had hoped to survive long enough to see her teenage and early-20s children marry, a milestone she now dares to dream of again.

The approval comes too late for Wills’s friend, Jeannie Ambrose, who passed away in January. Ambrose had spoken passionately about her desire to live two years prior, expressing frustration at being forced to campaign rather than enjoy her remaining time. Wills noted her friend would be thrilled but also angered by the prolonged wait.

NICE attributed the reversal primarily to a new trade agreement with the United States, under which the UK government agreed to increase medicine spending by 25%. Consequently, the upper threshold for the Quality-Adjusted Life Year (QALY) has risen from £30,000 to £35,000. Additionally, NICE introduced a more nuanced method for assessing patient quality of life in late August.

It is understood that pharmaceutical partners Daiichi Sankyo and AstraZeneca have not significantly reduced the drug’s price since the initial rejection. Both companies welcomed the decision, though AstraZeneca emphasized the need for “strong collaboration” to ensure faster and more equitable access in the future.

Helen Knight, director of medicines evaluation at NICE, acknowledged that while a “commercial solution” allowed for NHS availability, the decision arrives too late for some families. She reinforced NICE’s role in balancing NHS spending with the benefits delivered by new medicines while protecting resources for other essential services.

For Wills, the availability of the drug represents a profound change. “To know that I can get it now is absolutely everything,” she said, reflecting on the pain of nearly having access to a treatment that could have saved her life earlier.