The charity, Breast Cancer Now, is urging industry partners to reconsider after the National Institute for Health and Care Excellence (NICE) published final draft guidance that does not recommend Enhertu for advanced HER2-low breast cancer.
Enhertu, or trastuzumab deruxtecan made by Daiichi Sankyo, would have benefited around 1,000 people each year if it had been approved for NHS use in England.
NICE previously provisionally rejected the drug as a treatment post-chemotherapy in September 2023 due to cost-effectiveness issues.
NICE’s appraisal had been on pause since December while NHS England and the manufacturer sought to reach a commercial arrangement that would see Enhertu available at a price deemed cost-effective for the NHS. Enhertu has already been approved for use across NHS Scotland.
“This is a dark day for people affected by incurable secondary breast cancer.”
NICE’s medicines evaluation director, Helen Knight, said: “Despite accounting for the condition’s severity by applying a severity modifier, and accounting for innovation and uncaptured benefits, the cost the NHS was being asked to pay was too high in relation to the benefits it provides for it to be recommended for routine use in the NHS.”
Chief executive at Breast Cancer Now, Baroness Delyth Morgan, reacted: “This is a dark day for people affected by incurable secondary breast cancer. NHS England, NICE, Daiichi Sankyo and AstraZeneca have failed people living with the disease.”
She continued: “They’ve blocked a vital treatment that offers hope of more time to live for thousands of people with a certain type of secondary breast cancer.”
Breast Cancer Now has drawn attention to the impact of the new severity modifier, which was introduced into NICE’s evaluation process in 2022, replacing the end-of-life modifier.
Baroness Morgan added that “without an urgent review by NICE of the impact of its new methods for evaluating health technologies, we risk being left with a broken system”.
She has called for NICE, NHS England, Daiichi Sankyo and AstraZeneca to stay at the negotiating table and find a solution with the launch of the #EnhertuEmergency petition.
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