UK’s NICE Rejects AstraZeneca, Daiichi Sankyo’s Enhertu for NHS Use

2024-03-06

抗体药物偶联物上市批准

Pictured: Signage of the National Health Service in London/iStock, TkKurikawa The U.K.’s National Institute for Health and Care Excellence said Tuesday that it will not recommend the use of AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate Enhertu (fam-trastuzumab deruxtecan-nxki) to treat patients with HER2-low breast cancer HER2-low breast cancer. In its final draft guidance, the National Institute for Health and Care Excellence (NICE) contends that while Enhertu has demonstrated that it can improve survival and delay disease progression versus chemotherapy, its overall benefits are unlikely to be cost-effective given the price of the antibody-drug conjugate (ADC). NICE is an executive and non-departmental government body in England that crafts guidelines regarding the appropriate treatments and care protocols for clinical practice, taking into consideration efficacy and safety data as well as the cost-effectiveness of a specific intervention. NICE’s recommendations affect what treatments are available within the National Health Service (NHS) and can also be used in the training of healthcare professionals and for the development of standards to evaluate clinical practice. “Despite accounting for the condition’s severity … and accounting for innovation and uncaptured benefits, the most likely cost-effectiveness estimate [is] above the upper end of the range NICE considers an acceptable use of NHS resources,” the draft document read. “So, trastuzumab deruxtecan is not recommended.” Enhertu is an ADC that works by targeting and binding to the HER2 protein found on cancer cells, after which it is internalized and releases its toxic payload, a topoisomerase inhibitor that inflicts DNA damage and triggers cell death. The ADC was first approved in the U.K. in February 2021 and can be used to treat patients with unresectable or metastatic HER2-positive or HER2-low breast cancer who have undergone prior lines of therapy. Enhertu is also indicated for specific forms of non-small cell lung cancer and gastric cancer. In the U.K., Enhertu has a list price of approximately $1,852 (£1,455) per vial, which contains 100 mg of the medicine to produce a concentrated solution for infusion. The NHS has a special arrangement with Daiichi Sankyo, which supplies Enhertu at an undisclosed discount, but the NICE nevertheless found the ADC unlikely to be cost-effective. In response to Enhertu’s rejection, patient group Breast Cancer Now has launched an online emergency petition calling on the agencies and Daiichi Sankyo and AstraZeneca to “do everything possible to find a solution that makes Enhertu available on the NHS.” Baroness Delyth Morgan, chief executive at Breast Cancer Now, in a statement called on NHS England, NICE, Daiichi Sankyo and AstraZeneca to “come back to the table” and find a solution that “puts women with secondary breast cancer first.” Tristan Manalac is an independent science writer based in Metro Manila, Philippines. Reach out to him on LinkedIn or email him at tristan@tristanmanalac.com or tristan.manalac@biospace.com.

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