Commercial negotiations over the breast cancer drug Enhertu have restarted between NHS England, the National Institute for Health and Care Excellence, and its manufacturers AstraZeneca and Daiichi Sankyo, raising the prospect of access for around 1,000 patients a year in England, Wales, and Northern Ireland. The talks follow three successive breakdowns in pricing discussions stretching back to 2023 and represent the most significant opening since the drug was first blocked from NHS use.

Negotiations collapsed without agreement in March 2024, again that summer, and for a third time in November 2024. Each round ended with NICE concluding that the manufacturers had not offered a price that met the required threshold for taxpayer value, while AstraZeneca and Daiichi Sankyo maintained that the framework used to assess the drug's benefit was itself flawed. AstraZeneca's chief executive Pascal Soriot publicly criticised NICE's severity scoring system, which classified advanced HER2-low metastatic breast cancer as a moderately severe condition rather than a severe one, a designation that directly limits the maximum price the NHS is permitted to pay. The companies argued this rating did not accurately reflect the reality faced by patients with incurable, advanced disease.

The deadlock persisted despite direct intervention from Health Secretary Wes Streeting, who met with Breast Cancer Now and urged both sides to return to the table. Streeting had previously stated that an improved offer from the manufacturers was the only route to getting the drug to patients, though that offer did not materialise before November's final breakdown.

What has changed the conditions for negotiation is a significant revision to the framework governing what the NHS can pay for new medicines. In December 2025, the government announced that NICE's cost-effectiveness threshold would increase by 25 per cent, rising from a range of £20,000 to £30,000 per quality-adjusted life year to £25,000 to £35,000, with the new thresholds taking effect from April 2026. The change, the first of its kind since NICE was established, was announced as part of a broader trade agreement with the United States and was presented as a measure to improve the environment for pharmaceutical investment in Britain. Following the announcement, talks between NICE, NHS England, and Enhertu's manufacturers resumed, and a joint statement from AstraZeneca and Daiichi Sankyo confirmed ongoing discussions aimed at identifying a solution to support patient access in England, Wales, and Northern Ireland.

The drug at the centre of these negotiations is trastuzumab deruxtecan, an antibody-drug conjugate that delivers a cytotoxic agent directly to cancer cells expressing low levels of the HER2 protein. It is the first treatment licensed specifically for this subtype of breast cancer, which accounts for a substantial proportion of metastatic cases. Clinical trial data showed that the drug extended progression-free survival to a median of 9.9 months compared with 5.1 months on standard chemotherapy, and improved overall survival by 6.4 months. NICE has never disputed the clinical evidence. The sole obstacle has been price.

The geographic disparity created by successive rejections has added considerable pressure to the process. Enhertu has been available through NHS Scotland since December 2023 and is reimbursed in 19 European countries. Patients in England have been left to fund treatment privately or go without, a situation that charities have described in increasingly urgent terms. Claire Rowney, chief executive of Breast Cancer Now, noted that a number of women who had campaigned publicly for access to the drug in 2024 have since died without receiving it.

NICE has previously stated that updated guidance recommending the drug could be issued within weeks of a commercially acceptable price being agreed. That commitment remains on the table. Whether the expanded threshold is sufficient to close the remaining gap between what the manufacturers are willing to accept and what NICE considers reasonable value for public money is a question the current round of talks must now resolve. Patient groups have been explicit that the window for further delay has closed.