HQ Team
July 29, 2024: Daiichi Sankyo and AstraZeneca’s breast cancer treatment ran into opposition from the UK’s healthcare spending watchdog, which wants Enhertu drug to be offered at a “fair price.”
“We are deeply disappointed that we are unable to recommend Enhertu for use in the NHS for advanced HER2-low breast cancer,” said Helen Knight, Director of Medicines Evaluation of the National Institute for Health and Care Excellence (NICE).
“As we’ve always made clear, the fastest and only guaranteed way to get medicines like Enhertu to the patients who need them is for companies to offer a fair price,” she said in a statement.
Daiichi Sankyo and partner company AstraZeneca have been unwilling to offer a price that would enable NICE to recommend Enhertu as cost-effective for the National Health Service (NHS) in final guidance published on July 29, according to the statement.
New evaluation method
The decision was based on NICE’s updated methods and processes to evaluate medicines during 2022 to allow greater weight to be given to medicines that address severe diseases.
Enhertu, an antibody-drug conjugate jointly being developed by AstraZeneca and Daiichi Sankyo, had been shown in end-stage clinical trials to reduce the risk of disease progression or death by 22% compared to chemotherapy.
It also showed data of a median progression-free survival of 13.2 months compared to 8.3 months in women whose condition worsened after endocrine therapy.
“NICE and NHS England offered as much flexibility as possible, but the companies did not put forward a new price, so we have no choice but to publish our final decision which is not to recommend the medicine in this group of patients,” Helen Knight said.
Drop price, rapid review
If Daiichi Sankyo and AstraZeneca decide they are willing to drop their price to a level that makes Enhertu good value for money for the taxpayer, NICE will consider it under its rapid review process, with a decision potentially within weeks, according to the statement.
Enhertu is the first breast cancer treatment NICE has been unable to recommend for six years and breaks a line of 21 positive breast cancer recommendations.
This includes the positive recommendation in February for Talazoparib (Talzenna) for treating HER2-negative locally advanced or metastatic breast cancer. Enhertu is the branded name for trastuzumab deruxtecan.
Talzenna was approved using the same process as the evaluation of Enhertu for advanced HER2-low breast cancer.
Tumours that are not classified as HER2-positive are classified as HER2-negative. HR-positive and HER2-negative are the most common breast cancer subtypes, accounting for approximately 70% of all breast cancers.
1,000 people
Breast cancer is the second most common cancer and one of the leading causes of cancer-related deaths worldwide. More than two million breast cancer cases were diagnosed in 2022 with more than 665,000 deaths globally.
“I would like to thank the breast cancer community for their hard work on this issue and I am sorry we do not have better news,” Knight said.
It is estimated that around 1,000 people would have been eligible for treatment with trastuzumab deruxtecan if NICE had been able to recommend it.
After the new updated methods for evaluation, 79% of the appraisals for cancer medicines carried out have been recommended. The approval rate for all cancer appraisals carried out since 2009, under previous methods was 78%.
