The UK’s National Institute for Health and Care Excellence (NICE) has announced that negotiations with AstraZeneca (NASDAQ: AZN) and Daiichi Sankyo (TYO: 4568) for the reimbursement of the antibody-drug conjugate (ADC) Enhertu (trastuzumab deruxtecan) within the National Health Service (NHS) have concluded without an agreement. Enhertu is approved in the UK for the treatment of adults with unresectable or metastatic HER2-low breast cancer who have received prior chemotherapy.
In a statement, NICE expressed deep disappointment, stating, “We are unable to recommend Enhertu for use in the NHS for advanced HER2-low breast cancer,” and attributed the failure to the manufacturers’ unwillingness to propose a new price. “NICE and NHS England offered as much flexibility as possible, but the companies did not put forward a new price,” the statement read.
AstraZeneca’s CEO, Pascal Soriot, in an interview with Sky News, argued that the issue lies in NICE’s cost-effectiveness evaluation system, which he believes undervalues metastatic breast cancer by classifying it as only moderately severe. “Most people would say it’s a severe disease… It looks like a technical detail, but it’s very important because it drives willingness to pay,” Soriot said, noting that Enhertu is already reimbursed in 17 countries across Europe, including Scotland, which uses a different assessment methodology.
Enhertu’s list price in the UK is £1,455 ($1,863) per vial, with a recommended dosage of 5.4 mg/kg administered intravenously once every three weeks for breast cancer treatment. NICE’s documentation revealed that the disease severity multiplier applied to Enhertu resulted in a cost exceeding its threshold of £30,000 per quality-adjusted life year (QALY) gained.- Flcube.com
