The National Institute for Health and Care Excellence issued final draft guidance rejecting Roche's Kadcyla (trastuzumab emtansine) on grounds that the breast cancer drug, whose full list price exceeds 90 000 pounds ($151 000) per patient annually, was unaffordable for use on the NHS. The agency's chief executive Andrew Dillon noted that while Roche had proposed a discount to the drug's price, "it made little difference to its value for money, leaving it well above the top of our specially extended range of cost effectiveness for cancer drugs."
Dillon said NICE was "really disappointed" that Roche did not show "more flexibility to help us make a positive recommendation," adding the company was "well aware that we could not have recommended Kadcyla at the price it proposed." The guidance follows a provisional rejection by the agency in April, when it acknowledged that "despite some evidence of clinical efficacy," the therapy would cost "tens of thousands of pounds more than other currently available second-line treatments." NICE noted that interim results from the EMILIA trial found that median overall survival was 5.8 months longer for Kadcyla-treated patients, compared with those given GlaxoSmithKline's Tykerb (lapatinib) and Roche's Xeloda (capecitabine).
However, Roche general manager Jayson Dallas said NICE's decision demonstrated that the current system is "not fit for purpose and in need of a complete overhaul when it comes to reviewing cancer medicines." He remarked that "refusing patients access to this drug is an incredible injustice and tantamount to turning the clock back" with regard to cancer R&D, noting Kadcyla is the eighth consecutive treatment for advanced breast cancer rejected by the agency. Meanwhile, Roche spokeswoman Claudia Schmitt suggested Kadcyla would have had to be discounted by 60 percent in order to meet NICE's cost-effectiveness threshold, adding that such a cut was "simply not achievable." Both Roche and NICE declined to reveal how much of a discount the drugmaker had offered, but the company did indicate it would appeal the decision.
Kadcyla, which was approved in Europe last November for patients with previously treated HER2-positive advanced breast cancer, will remain available to patients in England through the supplementary Cancer Drugs Fund that pays for certain treatments NICE deems too expensive. NHS spokeswoman Emma Reynolds said approximately 1000 patients annually will have access to Kadcyla through the fund. Currently, about a quarter of all applications to the fund are for Roche's Avastin (bevacizumab), which NICE has previously rejected for metastatic colorectal cancer, for breast cancer in combination with Xeloda, and for advanced ovarian cancer.
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