NEW YORK – The UK's National Institute for Health and Care Excellence on Tuesday said that no commercial arrangement representing a cost-effective price will be made for AstraZeneca and Daiichi Sankyo's Enhertu (trastuzumab deruxtecan) as a treatment for advanced HER2-low breast cancer with the National Health Service.
The agency published a final draft guidance that does not recommend Enhertu for this group of patients after ending pricing negotiations with the manufacturers. NICE had paused its evaluation of Enhertu in December while the price discussions were underway.
Although an independent appraisal committee found that based on available evidence, Enhertu is a significant advance for patients with HER2-low breast cancer who have limited chemotherapy options and no available targeted treatments, NICE's cost-effectiveness analysis found the cost the NHS was being asked to pay was too high compared to the benefits it would provide.
About 1,000 people would have been eligible for treatment with Enhertu had NICE recommended it. The manufacturer and patient groups will have the opportunity to appeal the final draft recommendation.
Enhertu is approved in more than 40 countries including the US, the EU, and China for patients with unresectable metastatic HER2-low breast cancer who have had prior systemic therapy or disease recurrence during adjuvant chemotherapy or within six months of completing adjuvant chemotherapy.
Evidence supporting the use of Enhertu in patients with HER2-low metastatic breast cancer comes from the Phase III DESTINY-Breast04 trial, in which the risk of disease progression or death was reduced by 50 percent for patients receiving Enhertu compared to physician's choice of chemotherapy. Median progression-free survival was 9.9 months for the Enhertu group compared to 5.1 months for those on chemotherapy.