Patients with incurable HER2-low breast cancer in England can now access the drug Enhertu following a new commercial agreement.
Key facts
- •Approximately 1,000 women in England with HER2-low breast cancer are expected to benefit from the drug annually.
- •NICE previously rejected the drug in July 2024, citing concerns that it did not represent good value for money.
- •The NHS has increased its maximum spending threshold for patient treatment from £30,000 to £35,000 per year.
- •Enhertu was already available to patients in Scotland and 26 other European countries prior to this decision.
- •Health Secretary Yvette Cooper credited the approval to the persistent efforts of campaigners and charities.
The National Institute for Health and Care Excellence (NICE) has recommended the drug Enhertu for routine use on the NHS in England, granting access to approximately 1,000 patients annually. Doctors began prescribing the treatment on Thursday following a negotiated commercial solution between the government, NHS England, and the drug's manufacturers, AstraZeneca and Daiichi Sankyo. The decision reverses a previous rejection by NICE, which had deemed the medication too expensive for routine use.
By the numbers
Clinical Impact and Availability
Enhertu is designed for patients with HER2-low advanced breast cancer. Clinical trials indicated that the drug provides a median overall survival of 23.4 months, compared to 16.8 months for those not receiving the treatment, representing a gain of approximately 6.6 months. Some patients may experience up to three years of additional life. While the drug has been available in Scotland since December 2023 and is used in 26 other European countries, patients in England had previously been denied access. Wales is expected to follow the new guidance, though it does not automatically apply to Northern Ireland.
Negotiations and Policy Changes
The reversal follows two years of campaigning by charities and patients. While the BBC reported that the manufacturers did not substantially lower their prices, The Guardian noted that the government and drugmakers reached a commercial deal. A significant factor in the approval was a change in the threshold for how much the NHS can spend on a patient's treatment, which increased from £30,000 to £35,000 per year for a quality-adjusted life year (QALY).
Timeline
- July 2024NICE rejected Enhertu for routine use on the NHS, citing cost concerns.
- December 2023Enhertu became available to patients in Scotland.
- ThursdayDoctors in England began prescribing the drug following the new commercial agreement.
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This article was independently rewritten by ManyPress editorial AI from reporting originally published by BBC Health, The Guardian Health.
