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Monday, August 20, 2018

UK regulator stands firm on ‘no’ for Roche med in postsurgery breast cancer


Back in June, England’s cost watchdog refused to recommend Roche’s Perjeta for postsurgery breast cancer patients. And it’s sticking by that decision.
In a new guidance document, the National Institute for Health and Care Excellence (NICE) once again declined to back the drug for routine NHS use, citing “uncertainty about how clinically effective” the drug is in the adjuvant setting.
“Overall survival is very likely to be overestimated,” it added, meaning that “cost-effectiveness estimates” from Roche are “implausible.”
That opinion isn’t the one the Swiss pharma giant was hoping for. It’s counting on Perjeta and other newer meds—such as multiple sclerosis-fighter Ocrevus and immuno-oncology product Tecentriq—to step up as biosimilars move in to challenge Roche’s older moneymakers, including Herceptin and Avastin.

And Roche has had success changing minds at NICE, too—including where Perjeta is concerned. In November 2016, after years of rejections, the gatekeeper finally gave Perjeta the OK in combination with Herceptin and chemo docetaxel as a treatment for early-stage breast cancer.
Roche still has time to turn things around in its newest indication, with a third appraisal committee meeting coming up in mid-October. But the company may need to sink Perjeta’s price if it wants to see an about-face.
Meanwhile, NICE isn’t the only agency that hasn’t been all that impressed by the drug’s postsurgery data. When the company unveiled results at last year’s American Society of Clinical Oncology meeting—and later when Perjeta grabbed an FDA approval—industry watchers and analysts dubbed the showing “weak.”

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