AstraZeneca/Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) has not been recommended by the National Institute for Health and Care Excellence (NICE) to treat advanced HER2-low breast cancer in adults.
Currently the most common form of cancer in the UK, breast cancer is a disease in which abnormal breast cells grow out of control and form tumours, and is responsible for around 55,000 cases in women and 400 cases in men every year.
NICE’s decision follows the conclusion of negotiations between NHS England and the companies when trying to agree a commercial arrangement to make Enhertu available at a cost-effective price for the NHS, which paused the agency’s appraisal of the drug.
“A key uncertainty in estimating Enhertu’s cost-effectiveness was how much longer people on Enhertu live compared with those receiving standard treatment in the future,” said Helen Knight, director of medicines evaluation at NICE.
After considering all evidence and noting Enhertu’s “significant development for people with HER2-low advanced breast cancer who currently have limited chemotherapy options,” the independent committee concluded that “the cost the NHS was being asked to pay was too high in relation to the benefits it provides for it to be recommended for routine use in the NHS,” explained Knight.
The decision follows NICE’s draft guidance published in September last year, which did not recommend Enhertu for people with this type of breast cancer after they had received chemotherapy.
The agency’s decision was based on uncertainties in the evidence, which meant that cost-effectiveness estimates were above the range that it would consider an acceptable use of NHS resources.
Knight said: “Without a commercial arrangement that results in a price that represents a cost-effective use of NHS resources, NICE cannot recommend Enhertu.”
If recommended, Enhertu was estimated to benefit around 1,000 people in the UK.
Registered consultees, including companies and patient carer groups, will have the opportunity to appeal against NICE’s final draft recommendations.
Similarly, NICE recently announced that it did not recommend Sanofi’s Xenpozyme (olipudase alfa) enzyme replacement therapy to treat acid sphingomyelinase deficiency (ASMD) types AB or B due to cost-effectiveness estimates being too high for NHS use.