NICE Backs Enhertu for HER2-Low Metastatic Breast Cancer After QALY Methodology Shift
核心洞察
NICE has recommended Enhertu as a monotherapy for HER2 (搜索)-positive and HER2-low unresectable or metastatic breast cancer, reversing its 2024 rejection on cost-effectiveness grounds.
The recommendation follows NICE's August 2026 adoption of the EQ-5D-5L UK value set, which changed how health-related quality of life feeds into QALY calculations.
Enhertu, an antibody-drug conjugate developed by AstraZeneca and Daiichi Sankyo, has been shown to extend patient lifespans by an average of seven months.
The UK's National Institute for Health and Care Excellence (搜索) (NICE) has recommended Enhertu (trastuzumab deruxtecan) as a monotherapy option for patients with HER2-positive breast cancer (搜索), alongside a positive opinion from the EU's Committee for Medicinal Products for Human Use (搜索) (CHMP). The decision reverses NICE's 2024 rejection of the drug and opens NHS access for patients with HER2 (搜索)-low, unresectable or metastatic disease.
Enhertu is an antibody-drug conjugate (ADC) developed through a collaboration between AstraZeneca and Daiichi Sankyo. The agent uses targeted ADCs to deliver chemotherapeutic agents locally to cancer cells and has been demonstrated to extend patient lifespans by an average of seven months.
Adjuvant Need in Residual Disease
The recommendation covers a population with a well-documented risk of relapse. "Patients with HER2 (搜索)-positive early breast cancer who have residual disease after neoadjuvant treatment experience a substantially higher risk of recurrence, making effective adjuvant treatment especially important," said John Tsai, Global Head of R&D at Daiichi Sankyo.
A Two-Year Standoff and a Change in Valuation Rules
NICE declined to recommend Enhertu in 2024, citing prohibitive manufacturing costs. ADCs are high-cost therapies and face significant market hurdles when assessed for cost-effectiveness. The drug initially carried a price of £1,455 (US$1,940) per 100mg vial, and NICE resource allocation criteria, which divide treatment cost by quality-adjusted life year (QALY), blocked its rollout on the NHS.
Commercial negotiations with AstraZeneca and Daiichi Sankyo to secure NHS discounts 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," said UK Health Secretary Yvette Cooper.
DESTINY-Breast04 and Global Reach
The AstraZeneca and Daiichi Sankyo partnership, valued at US$6.9bn, began development in 2019, with accelerated FDA approval in the US the same year. After the Phase III DESTINY-Breast04 trial produced significant improvements in progression-free survival for HER2-low metastatic breast cancer (搜索) in 2022, Enhertu received approvals in more than 100 countries worldwide.
Broader Women's Health Milestones
The UK recommendation coincides with other NHS developments in women's healthcare. In August 2026, at-home cervical cancer (搜索) testing began being offered to over 4 million women, creating options for women with difficulty accessing in-person appointments. For patients with endometriosis (搜索), 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.