AstraZeneca-Daiichi breast cancer drug approved for NHS use in England

• NICE reversed its previous rejection, basing approval on clinical trial data showing Enhertu extended survival by about six months in some patients
• The drug's UK list price is £1,455 ($1,950) per 100mg vial, though specific pricing terms of the NHS agreement were not disclosed
• The approval follows changes to Britain's cost-effectiveness methodology and a US-UK agreement aimed at aligning British drug prices closer to US levels

Summary: AstraZeneca-Daiichi Breast Cancer Drug Approved for NHS Use in England

Key Development:

AstraZeneca and Daiichi Sankyo announced Thursday that their breast cancer treatment Enhertu has received approval from England's National Institute for Health and Care Excellence (NICE) for use in the National Health Service (NHS). The drug has been available in Scotland since 2023, and the companies are now pursuing approval in Wales and Northern Ireland.

Patient Impact:

Approximately 1,000 women annually in England will be eligible for Enhertu treatment for HER2-low metastatic breast cancer. The drug delivers chemotherapy directly to tumors identified by the HER2 protein marker while minimizing damage to healthy cells.

Pricing and Commercial Details:

Enhertu's UK list price is £1,455 ($1,950) per 100 mg vial. The companies did not disclose specific financial terms of their agreement with NICE. This approval follows an earlier rejection based on cost-effectiveness concerns.

Clinical Efficacy:

NICE's recommendation was based on clinical data showing Enhertu extended patient survival by approximately six months in some cases.

Market Context:

The approval follows changes to Britain's cost-effectiveness evaluation methodology and a US-UK agreement aimed at gradually aligning British drug prices with US levels. The drug has received approvals in multiple countries for treating certain breast, gastric, and lung cancers.

Significance:

This decision represents a notable shift in NICE's approach to evaluating late-stage cancer medicines, potentially setting precedent for future drug approvals in the UK healthcare system.