At long, long last, Roche’s Perjeta has backing from England’s cost-effectiveness watchdogs.
Thursday, the National Institute for Health and Care Excellence announced it had changed its mind on the cancer-fighter, recommending it in combination with fellow Roche med Herceptin and chemo docetaxel to treat early-stage breast cancer.
NICE’s “no’s” on Perjeta date back to 2013, the year the med won EU approval. The body spurned the med again this May, arguing in draft guidance that despite an ability to rid patients of cancer before surgery, there wasn’t enough evidence to convince NICE that Perjeta “would reduce the risk of the disease recurring and result in longer survival.”
So what made the difference this time around? Price, for one. The Swiss cancer giant offered up a discount on the med that made Perjeta a cost-effective use of NHS money “even with the uncertainties in the evidence,” Carole Longson, director of NICE’s center for health technology assessment, said in a statement.
“We ... welcome the company’s offer to share the long-term financial risks of a positive recommendation,” she said.
But “this was not simply about price,” Richard Erwin, Roche UK’s general manager, said in a statement. NICE also accepted that one key Perjeta trial endpoint—pathological complete response—was “more likely than not to have an association with longer term survival.”
Roche has found itself at odds with England's cost-effectiveness gatekeepers on more than one occasion. Last year, the Cancer Drugs Fund—now under NICE's control—gave the boot to its armed-antibody cancer therapy Kadcyla and a host of other treatments, a move Roche CEO Severin Schwan dubbed "stupid from a cost point of view."
"How the hell can you ignore all these benefits?" he asked at the time.
The company since decided that it would pursue risk-sharing deals with NICE, such as the one it struck on Perjeta. This time, though, the end result for Roche is a positive one. The company is counting on Perjeta—as well as fellow newcomers Tecentriq, an immuno-oncology med, and Ocrevus, a multiple sclerosis candidate nearing approval—to step in for aging superstars such as Herceptin and Avastin. Competition to the blockbusters is approaching, with copycat drugmakers this month submitting biosimilar applications to the FDA for each of those meds.
Meanwhile, though, some of Roche’s rivals didn’t get as lucky at NICE this week. Shire, for one, saw it turn down its pancreatic cancer med Onivyde on the grounds that it wasn’t cost effective.