Enhertu: NICE Approval Expands NHS Breast Cancer Care

The oncology drug Enhertu has received a recommendation from the EU’s Committee for Medicinal Products for Human Use (CHMP) and the UK’s National Institute for Health and Care Excellence (NICE) as a monotherapy option for HER2-positive breast cancer patients.

Developed in collaboration between AstraZeneca and Daiichi Sankyo, Enhertu is an antibody-drug conjugate used to treat certain patients with HER2-low, unresectable or metastatic breast cancer.

The drug uses targeted antibody-drug conjugates (ADCs) to locally deliver chemotherapeutic agents to cancer cells. It has been demonstrated to extend patient lifespans by an average of seven months.

“Patients with HER2-positive early breast cancer who have residual disease after neoadjuvant treatment experience a substantially higher risk of recurrence, making effective adjuvant treatment especially important,” says John Tsai, Global Head of R&D at Daiichi Sankyo.

“This positive CHMP opinion underscores the potential role of Enhertu in the curative-intent setting where it is critical to maximise the potential for sustained long-term outcomes.”

Enhertu’s approval: reframing quality of life valuation

After a two-year standoff between healthcare providers and Enhertu’s pharmaceutical manufacturers, the drug’s approval accompanies a shift in quality-of-life valuation methodologies.

AstraZeneca and Daiichi Sankyo’s US$6.9bn partnership began development in 2019 and received accelerated FDA approval in the US the same year.

After the drug’s clinical trial DESTINY-Breast04 Phase III produced significant improvements in progression-free survival for HER2-low metastatic breast cancer in 2022, Enhertu saw approvals in over 100 countries worldwide.

However, NICE did not recommend the drug in 2024, citing its prohibitive manufacturing costs.

ADCs are high-cost therapies and therefore face significant market hurdles when evaluated for cost-effectiveness by assessment bodies.

Initially carrying a price of £1,455 (US$1,940) per 100mg vial, Enhertu’s approval was prohibited by NICE resource allocation criteria, which divide treatment cost by Quality-Adjusted Life Year (QALY) to determine its suitability for NHS rollouts.

Commercial negotiations with AstraZeneca and Daiichi Sankyo to procure NHS discounts for the drug were affected by a change in NICE regulations. 

In August 2026, NICE introduced the EQ-5D-5L UK value set for reference-case analyses, replacing the EQ-5D-3L value set and changing how health-related quality of life is incorporated into QALY calculations. 

“Enhertu can be life-changing and this recommendation means NHS patients will finally be able to benefit from it,” says UK Health Secretary Yvette Cooper.

Broadening options in women’s healthcare

The NHS approval signals a landmark widening of treatment options for over 1,000 patients annually in the UK with terminal breast cancer, with access expected to increase in the years ahead.

“Our clinical research strategy for breast cancer is ultimately focused around the patient,” said Professor Peter Schmid, Clinical Director of the Breast Cancer Centre at St. Bartholomew’s Hospital in London.

 “What we want to achieve is improved patient outcomes.”

Enhertu’s UK approval coincides with a series of healthcare milestones opening new treatment pathways for women’s healthcare.

In August 2026, at-home cervical cancer testing began being offered to over 4 million women, creating options for women with difficulty accessing in-person appointments.

For patients with endometriosis – a condition flagged by the Women and Equalities Committee’s 2024 report as a particular subject of clinical dismissal – extended-length specialist appointments have been allocated to develop tailored treatment plans for each patient.

From testing to treatment, the scope of women’s healthcare solutions is broadening, suggesting a shift in the NHS’s Women’s Health strategy to provide new treatment options and prioritise women’s quality of life.

AstraZeneca - key partners

Tempus AI

CEO: Eric Lefkofsky | HQ: Chicago, Illinois

Tempus is an AI and precision-medicine company working with AstraZeneca on oncology drug discovery and development. Its collaboration combines Tempus’ multimodal clinical and molecular data with AstraZeneca’s R&D capabilities to identify novel drug targets and advance precision therapies. In 2025, the companies expanded their relationship to develop a multimodal foundation model for oncology. 

Merck & Co.

CEO: Robert M. Davis | HQ: Rahway, New Jersey

Merck & Co. and AstraZeneca have a strategic oncology collaboration spanning the development and commercialisation of Lynparza and selumetinib in combination with their respective immuno-oncology medicines. Separately, Merck & Co. and Daiichi Sankyo are collaborating on three DXd antibody-drug conjugates, combining Daiichi Sankyo’s ADC expertise with Merck’s oncology development capabilities. 

University of Oxford

Leadership: Professor Irene Tracey, Vice-Chancellor | HQ: Oxford, UK

The University of Oxford has partnered with AstraZeneca across healthcare research, most notably through the development, manufacture and distribution of the Oxford-AstraZeneca COVID-19 vaccine. The partnership combined Oxford’s vaccine research expertise with AstraZeneca’s global development, manufacturing and distribution capabilities, helping take the vaccine from university research towards large-scale production and international distribution.