Some 1,000 patients with a specific form of advanced breast cancer in England can, at last, receive AstraZeneca and Daiichi Sankyo’s star antibody drug conjugate Enhertu via the National Health Service.
The National Institute for Health and Care Excellence (NICE), which issues guidance on whether a drug’s price-to-benefit ratio warrants inclusion on NHS formularies for England and Wales, has recommended routine NHS use of Enhertu in patients with HER2-low advanced or metastatic breast cancer whose disease has progressed after treatment.
With the endorsement, NHS England is wasting no time and making the treatment available to appropriate patients starting Thursday, NICE said in a release. The organization clarified that its guidance applies to England, while Wales has issued directions requiring the NHS there to fund the treatment within 60 days of the final guidance's publication.
NICE guidance does not automatically apply in Northern Ireland and decisions for NHS Scotland are managed by a separate group.
Clinical data have shown AZ and Daiichi's treatment to be life-extending for women whose breast cancer shows low levels of HER2 protein and is otherwise incurable, and it can also increase the time women have before their cancer gets worse compared to chemotherapy. Lack of access to the drug for women in England has been a source of public outcry since a previous cost-effectiveness rebuff several years back.
NICE’s recommendation was based on data from AstraZeneca and Daiichi Sankyo’s Destiny-Breast04 phase 3 trial, where Enhertu almost doubled progression free survival to 9.9 months compared to 5.1 months with a physician's choice of chemotherapy. The drug also increased median overall survival in patients with HER2-low advanced breast cancer to 23.4 months compared to 16.8 months in the group receiving chemotherapy.
Those results helped Enhertu score a historic FDA nod in HER2-low patients in August of 2022.
In issuing the guidance, NICE seemed acutely aware of the pent-up demand for Enhertu in HER2-low breast cancer.
"I'm pleased that a commercial solution, alongside recent changes to NICE's cost-effectiveness thresholds and the use of new methods for assessing quality-of-life, has meant this treatment can now be provided on the NHS," said Helen Knight, director of medicines evaluation at NICE, in a statement.
“However, we know this decision comes too late for many families, and our thoughts are with them today," she added. "Our role is important in ensuring NHS spending on new medicines reflects the benefits they deliver while protecting valuable health resources for other essential patient services.”
This is not Enhertu’s first time under NICE evaluation in the HER2-low indication. In a 2024 decision, the organization rejected NHS reimbursement for Enhertu for that use, arguing that the drug's price was too high to be deemed cost-effective. Enhertu is the only breast cancer treatment NICE has been unable to recommend since 2018, okaying 25 other treatments in that time period, according to a statement from the agency.
Prior to the new NHS inclusion, Enhertu could only be acquired privately in the U.K. with costs reported as high as 7,500 to 13,000 pounds sterling every three weeks ($10,000 to $17,400).
The new agreement between NICE and the drugmakers is due, in part, to the U.S.-U.K. pharma trade deal finalized this spring. Under the accord, the U.K. faces 0% tariffs on pharmaceutical exports to the U.S. for at least three years. In exchange, NICE agreed to increase its price ceiling for cost-effectiveness, and the NHS agreed to increase spending on new medicines by 25%.
The terms of the deal gel with the Trump administration's broader "most favored nation" drug pricing strategy, which has sought to bring U.S. prescription costs in line with those paid in a basket of high-income comparator countries. In promoting the policy, the administration—at times with industry support—has argued that other countries have been failing to pay their fair share for healthcare innovation.
Apart from the raised cost-effectiveness threshold, NICE also recently updated its methods for assessing quality of life. Under the new guidelines published in August, treatments that extend how long people live, like Enhertu, are considered more cost effective than those treatments that improve quality of life but don’t extend it. Together, the new metrics and more spending leeway gave the regulator more latitude to reach a commercial agreement with AZ and Daiichi.
The recent changes “improve how the UK values new medicines relative to other countries,” Tom Keith-Roach, AZ's U.K. president, said in a statement sent to Fierce. “Delivering faster, more equitable patient access in the future requires continued strong collaboration across the healthcare system.”
Enhertu will be immediately available to patients in England with funding from the NHS Cancer Drugs Fund until it is moved to the NHS’ routine commissioning budget 90 days after the NICE decision.