NICE clears Enhertu for NHS use in England, widening access to HER2-low breast cancer drug
NICE has approved Enhertu for NHS use in England for HER2-low metastatic breast cancer, with the companies set to pursue access in Wales and Northern Ireland.
AstraZeneca and Daiichi Sankyo said their breast cancer treatment Enhertu has been approved for use within England's state-run health system, opening the way for reimbursement of a therapy that had previously been turned down on cost-effectiveness grounds.
The green light from the National Institute for Health and Care Excellence (NICE) allows the drug to be funded for National Health Service patients with HER2-low metastatic breast cancer. The condition is characterised by varying levels of a protein called HER2, which drives tumour growth and spread.
Roughly 1,000 women a year are expected to become eligible for the treatment in England, the two companies said. They did not reveal the terms of their agreement with NICE. Enhertu carries a UK list price of £1,455 ($1,950) per 100 mg vial.
The medicine is designed to carry chemotherapy straight to tumours flagged by the HER2 marker while limiting damage to healthy cells. It has already won approval in a number of countries for certain breast, gastric and lung cancers.
NICE reached its recommendation on the strength of 2022 trial data indicating that Enhertu extended survival in some patients by around six months. The decision also comes after revisions to Britain's cost-effectiveness methodology and a US-UK arrangement intended to move British drug prices gradually closer to American 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.
With England cleared, the companies said they will now seek access approval from health bodies in Wales and Northern Ireland. The drug has been available in Scotland since 2023.