AstraZeneca and Daiichi Sankyo's breast cancer treatment Enhertu has been approved for use within England's state-run healthcare system, the companies said on Thursday. The drug has already been available to patients in Scotland since 2023, and the companies confirmed they will now seek approval for access from health bodies in Wales and Northern Ireland.

The approval was granted by the National Institute for Health and Care Excellence, clearing a significant hurdle to wider adoption of the drug across the UK. Funding for Enhertu had previously been rejected by the regulator on cost-effectiveness grounds, meaning this decision reverses an earlier setback for the treatment's availability on the NHS.

Enhertu can now be reimbursed in England for NHS patients with what is known as HER2-low metastatic breast cancer. Breast cancer can express varying levels of a protein called HER2, which contributes to tumour growth and spread, and this variation determines which patients are eligible for particular treatments targeting the protein.

According to AstraZeneca and Daiichi Sankyo, approximately 1,000 women a year will now become eligible for the treatment as a result of the decision. The companies did not disclose details of their specific agreement with NICE. Enhertu's list price in the UK stands at £1,455, or around $1,950, per 100mg vial.

The drug functions by delivering chemotherapy directly to tumours identified through the HER2 marker, while aiming to spare healthy cells from the effects of treatment. Enhertu has already received approval in several countries for use in treating certain forms of breast, gastric and lung cancer, reflecting its broader application across multiple cancer types beyond the specific use case now approved for NHS patients in England.

NICE based its recommendation on trial data from 2022, which showed that Enhertu extended survival in some patients by approximately six months. This data played a central role in the regulator's reassessment of the drug's value.

The decision also comes against a backdrop of wider changes affecting how medicines are evaluated and priced in Britain. NICE has altered its cost-effectiveness methodology in recent times, and the approval follows a separate agreement between the UK and the United States aimed at gradually aligning British drug prices more closely with those in the American market.

Commenting on the decision, Laura McMullin, UK general manager at Daiichi Sankyo, said NICE's willingness to revisit how it values late stage cancer medicines represented a positive initial step that had enabled this outcome. Her remarks point to the broader significance of the decision beyond Enhertu itself, suggesting it may reflect a shift in how NICE approaches the evaluation of costly cancer treatments more generally.

The approval represents a notable development for patients in England who had previously been unable to access the treatment through the NHS, despite its availability just across the border in Scotland since 2023. For AstraZeneca and Daiichi Sankyo, the decision also marks a commercial win following the earlier funding rejection, and the companies will now turn their attention to securing similar approval from the relevant health authorities in Wales and Northern Ireland.

Whether other high cost cancer treatments will benefit from a similar reassessment under NICE's revised methodology remains to be seen, though the outcome for Enhertu may offer an indication of how the regulator intends to balance cost considerations against clinical benefit in future decisions involving late stage cancer medicines.

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