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UK's NICE Gives Negative Guidance on Seagen's Tukysa Combo in HER2-positive Advanced Breast Cancer

NEW YORK – The UK's National Institute for Health and Care Excellence on Tuesday proposed that the National Health Service not provide tucatinib (Seagen's Tukysa) in combination with trastuzumab (Genentech's Herceptin) and capecitabine for previously treated, HER2-positive advanced breast cancer patients in England.

In a draft guidance for public consultation, NICE said that an indirect comparison of the tucatinib regimen against standard chemotherapy showed that people on the tucatinib combination lived longer without worsening disease and lived longer overall. However, the differences in the studies included in the indirect comparison didn't allow NICE to get a read on the extent to which the tucatinib regimen benefited patients.

NICE said in a statement that the cost-effectiveness estimates for the tucatinib combination are higher than what it normally considers "an acceptable use of NHS resources," despite factoring in that the regimen would be given as an end-of-life treatment. Seagen's list price is £5,636.84 ($7,780.45) per pack of 84 (150 mg) tablets, which brings the average cost of a course of the combination treatment to £7,016.91 for the loading dose and £6,677.14 for subsequent cycles. Seagen has a commercial arrangement that would have kicked in if NICE had recommended the treatment.

In England, patients with HER2-positive advanced breast cancer that has metastasized may receive other anti-HER2 targeted drugs such as pertuzumab (Genentech's Perjeta) with trastuzumab and docetaxel, or they can receive trastuzumab with paclitaxel. After receiving two or more anti-HER2 regimens, patients are typically given chemotherapy.

Seagen's tucatinib in combination with trastuzumab and capecitabine is licensed to treat HER2-positive locally advanced or metastatic breast cancer patients who have received at least two other anti-HER2 treatment regimens. The US Food and Drug Administration last year approved this same tucatinib regimen for advanced, unresectable, metastatic HER2-positive breast cancer patients after one or more anti-HER2-based regimens in the metastatic setting.

"Tucatinib is a promising, innovative new treatment that has the potential to increase the length of time before the disease gets worse and how long people live overall," Meindert Boysen, deputy chief executive and director of the NICE Centre for Health Technology Evaluation, said in a statement. "We will continue to work with the company as they seek to address the issues highlighted in today's draft recommendations."

According to NICE, there are 47,000 newly diagnosed breast cancer patients in England each year, and one-in-five cases have HER2-overexpressing tumors. Approximately 400 people would have been eligible for the tucatinib regimen in the country.

NICE's draft guidance is open for public comment until Nov. 16.