HER2-Low Breast Carcinoma

Draft guidance published in September 2023 did not recommend Enhertu for breast cancer patients post-chemotherapy. Credit: ORION PRODUCTION / Shutterstock.com. The UK National Institute for Health and Care Excellence ( Nice ) has declined to recommend Daiichi Sankyo ‘s Enhertu (trastuzumab deruxtecan) for the treatment of advanced HER2-low breast cancer in adults. The final draft guidance comes after unsuccessful negotiations between National Health Service (NHS) England and Daiichi Sankyo to reach a cost-effective commercial deal to offer the therapy for NHS use. The appraisal of Enhertu by NICE had been on hold since December 2023 while discussions were underway. Draft guidance published in September had already set a precedent by not recommending Enhertu for patients post-chemotherapy, citing uncertainties in the data and cost-effectiveness that exceeded the institute’s acceptable range for NHS resource use. Approximately 1000 individuals would have been eligible for treatment with Enhertu if recommended. See Also: MorphoSys files patent for antibodies for treating inflammatory, autoimmune diseases, or cancer Kura Oncology files patent for combination treatment for head and neck cancer Registered consultees, including Daiichi Sankyo and patient carer groups, can appeal against the final draft recommendations. NICE maintains its position of not endorsing Enhertu for NHS use without a commercial arrangement that leads to a cost-effective price. NICE medicines evaluation director Helen Knight stated: “We are extremely disappointed not to be able to recommend Enhertu for use in the NHS for advanced HER2-low breast cancer. “The backdrop to the commercial discussions was the independent appraisal committee’s belief that, based on the available evidence, Enhertu represents a significant development for people with HER2-low advanced breast cancer who currently have limited chemotherapy options. Most have no targeted treatments available to them. “However, 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. The independent committee carefully considered all the evidence and applied its judgement on the most clinically plausible approach on which to base its decision.” The latest development comes after NICE recommended Pfizer ‘s ritlecitinib as a new treatment option for severe hair loss associated with alopecia areata .

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. 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.

The UK’s National Institute for Health and Care Excellence (NICE) said Tuesday that it won’t recommend coverage of AstraZeneca and Daiichi Sankyo’s cancer drug Enhertu for treating advanced HER2-low breast cancer in adults. NICE said that while NHS England has been negotiating with the company over the price of the drug since December, they weren’t able to reach an agreement. It’s not a huge surprise — NICE’s draft guidance in September said it didn’t recommend Enhertu because of doubts around its cost-effectiveness. You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.