AstraZeneca, Daiichi Sankyo's Enhertu Gets NICE Nod for NHS Use in England for HER2-Low Breast Cancer
London: AstraZeneca and Daiichi Sankyo said on Thursday their breast cancer treatment Enhertu has been approved for use in England's state-run healthcare system, expanding access to a drug that has been available in Scotland since 2023.
The companies said they will now seek approval for access from health bodies in Wales and Northern Ireland.
The approval by the National Institute for Health and Care Excellence (NICE) clears a key hurdle to wider adoption in the UK after funding for Enhertu had previously been rejected on cost-effectiveness grounds.
Enhertu can now be reimbursed in England for National Health Service patients with so-called HER2-low metastatic breast cancer. Breast cancer can express varying levels of a protein called HER2 that contributes to tumour growth and spread.
About 1,000 women a year will be eligible now for the treatment, AstraZeneca and Daiichi said. They did not disclose details of the agreement with NICE. Enhertu's list price in the UK is £1,455 ($1,950) per 100 mg vial.
The drug works by delivering chemotherapy directly to tumours identified by the HER2 marker while sparing healthy cells. It has been approved in several countries for treating certain breast, gastric and lung cancers.
NICE based its recommendation on 2022 trial data showing Enhertu extended survival in some patients by about six months.
The decision also follows changes to Britain's cost-effectiveness methodology and a US-UK agreement aimed at gradually bringing British drug prices closer to US levels.
"NICE's decision to revisit the way it values late-stage cancer medicines is a positive initial step which enabled this outcome," Laura McMullin, UK general manager at Daiichi Sankyo, said in a statement.
