The UK National Institute for Health and Care Excellence (Nice) has decided not to recommend Daiichi Sankyo and AstraZeneca’s Enhertu, a treatment for advanced HER2-low breast cancer, for National Health Service (NHS) use.
In its final guidance, the regulator expressed disappointment that the companies have not proposed a cost-effective price for the therapy.
This decision marks the first time in six years that NICE could not endorse a breast cancer medication, breaking a series of 21 consecutive approvals.
Enhertu’s evaluation followed the same procedures as the approval for Talazoparib (Talzenna) to treat HER2-negative breast cancer, given in February 2024.
The price offered by the pharmaceutical companies did not meet the value criteria set by NICE for the NHS.
Approximately 1,000 patients could have benefited from Enhertu if it had been recommended.
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In 2022, NICE revised its methods to emphasise treatments for severe diseases more heavily.
Since then, 22 appraisals have been conducted using the new severity weighting, with 17 resulting in positive recommendations, including 15 for treating cancer.
This modification has also facilitated access to crucial drugs for cystic fibrosis, a change that was not feasible under the former appraisal methods.
Despite the setback with Enhertu, 79% of cancer medicine appraisals under the updated methods have received recommendations, closely aligning with the 78% approval rate for all cancer appraisals since 2009.
The severity modifier, which replaced the end-of-life modifier, is currently under evaluation to monitor its effectiveness.
NICE has indicated a willingness to reconsider Enhertu under its rapid review process if Daiichi Sankyo and AstraZeneca agree to lower the price to an acceptable level, with the potential for a decision in the early autumn of 2024.
NICE medicines evaluation director Helen Knight stated: “We are deeply disappointed that we are unable to recommend Enhertu for use in the NHS for advanced HER2-low breast cancer.
“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.
“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.”
This development comes after NICE issued final guidance endorsing Boehringer Ingelheim’s tenecteplase to treat acute ischaemic stroke for NHS use.
