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NICE Recommends Seagen's Tukysa for Advanced HER2-Positive Breast Cancer in England

NEW YORK – The UK's National Institute for Health and Care Excellence on Friday recommended the National Health Service make Seagen's Tukysa (tucatinib) in combination with Genentech's Herceptin (trastuzumab) and capecitabine available for advanced, previously treated, HER2-positive breast cancer patients.

The latest draft guidance is a reversal of NICE's recommendation in October against the Tukysa combination in this setting. At the time, NICE said that the comparison of the Tukysa regimen against standard chemo was too indirect to draw definitive conclusions about treatment benefit, and that the cost-effectiveness estimates for the regimen were too high.

According to NICE's draft guidance, the list price for Tukysa is £5,636.84 ($7,552.32) per 84-pack of 150 tablets, which makes the average cost of a course of combination treatment £7,016.91 for the loading dose and £6,677.14 for the following cycles. In the months since NICE's first review, Seagen has provided additional data on the treatment's benefit, including in patients with brain metastases, and has agreed to further discount Tukysa's price for use within the NHS. The company is not disclosing the discounted price.

"Because [Tukysa] is able to cross an intact blood-brain barrier, it offers people whose cancer has spread to their brain real hope of extending their lives and improving their quality of life," Helen Knight, director of NICE's Center for Health Technology Evaluation program, said in a statement. "We are therefore pleased to be able to recommend it for routine use in the NHS."

The treatment received the US Food and Drug Administration's approval in the same patient population in April 2020 based on data from the randomized HER2CLIMB trial.

NICE expects to issue a final guidance on treatment combination in March. Its guidance applies to NHS England but can also be taken up by NHS Wales.