NICE approves Enhertu for about 1,000 English women with HER2‑low breast cancer

From Thursday, about 1,000 women a year with HER2‑low advanced breast cancer will be able to receive the drug Enhertu on the NHS, the National Institute for Health and Care Excellence (NICE) announced, as reported by The Guardian. The decision follows a price agreement reached between the UK government and the drug’s manufacturers, AstraZeneca and Daiichi Sankyo.

NICE recommendation expands access

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NICE said the new guidance allows NHS England to spend up to £35,000 a year on each patient’s treatment, up from the previous £30,000 ceiling, a change that was essential for the approval, as reported by The Guardian. The institute had rejected the drug in July 2024, deeming it too costly despite evidence of benefit. Ministers, including former health secretary Wes Streeting, negotiated a commercial solution that satisfied NICE’s cost‑effectiveness criteria.

Clinical trial evidence supports the move

Trials of Enhertu demonstrated a near‑doubling of median progression‑free survival, rising from 5.1 months with standard chemotherapy to 9.9 months, according to The Guardian. Overall survival also improved, reaching 23.4 months compared with 16.8 months for patients receiving conventional treatment. Dr Anne Rigg, a consultant medical oncologist and NHS England’s national speciality adviser for chemotherapy, called the approval "hugely positive news for women with secondary breast cancer who will now be offered this life‑extending treatment on the NHS," as reported by The Guardian.

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Implementation and next steps

The drug has been available in Scotland since December 2023, and Welsh and Northern Irish health services are expected to follow NICE’s recommendation, The Guardian noted. Health secretary Yvette Cooper said the decision will allow patients to benefit from a cutting‑edge therapy, adding that it reflects the government’s changes to the NICE framework. Patients will be identified through oncology clinics, and prescriptions will be processed through existing NHS oncology pathways.

“"Enhertu can be life‑changing and this recommendation means NHS patients will finally be able to benefit from it,"”

Yvette Cooper, health secretary