AstraZeneca and Daiichi win NHS backing for breast cancer drug Enhertu

AstraZeneca (AZN) and Daiichi Sankyo (4568) said that their breast cancer treatment Enhertu has been approved for use in England's state-run healthcare system, widening access to a drug that has been available in Scotland since 2023.

The approval by the National Institute for Health and Care Excellence clears a significant hurdle to broader adoption in the UK, after the watchdog had previously rejected funding on cost-effectiveness grounds. Enhertu can now be reimbursed for National Health Service patients with so-called HER2-low metastatic breast cancer, in which tumors express lower levels of a protein that contributes to their growth and spread.

The companies said about 1,000 women a year in England would be eligible. They did not disclose the terms of the agreement with NICE. The list price of Enhertu in the UK is £1,455 ($1,950) per 100mg vial.

The drug delivers chemotherapy directly to tumors identified by the HER2 marker while sparing healthy cells, and has been approved in several countries for certain breast, gastric and lung cancers. NICE based its recommendation on 2022 trial data showing the drug extended survival in some patients by about six months.

The decision follows changes to Britain's cost-effectiveness methodology and a US-UK agreement aimed at gradually bringing British drug prices closer to US levels. Laura McMullin, UK general manager at Daiichi Sankyo, said NICE's decision to revisit how it values late-stage cancer medicines was "a positive initial step which enabled this outcome."

The companies will now seek approval from health bodies in Wales and Northern Ireland.