The U.K.'s cost-effectiveness police have turned up their noses at Roche's ($RHHBY) new breast cancer drug Perjeta. The National Institute for Health and Care Excellence (NICE) says the drug's ability to extend patients' lives is unclear--and that it's far more costly than currently available treatments.
Approved last year in the U.S. and earlier this year in Europe, Perjeta is designed to be used in tandem with Roche's gold-standard HER2-positive cancer treatment, Herceptin, and the chemotherapy docetaxel. In studies in patients with advanced HER2-positive disease, the Perjeta combination stalled cancer's growth 6 months longer than the two-drug combination did, NICE said. But the evidence couldn't confirm how long Perjeta could extend patients' lives.
Plus, when Roche's own estimate for Perjeta's life-extending benefits was plugged into NICE's standard formula, the result still fell outside the agency's standard cost-benefit parameters. The sticker price for the drug is £2,395 per 420 mg vial, and the dosing schedule calls for an 840mg initial dose, with 420mg a week after that, NICE says. Total, per PMLiVE, is about $190,000.
"[D]espite the research data suggesting the treatment could help delay the growth and spread of the disease, the evidence was not robust enough to confirm for how long pertuzumab may actually extend people's lives," NICE chief Sir Andrew Dillon said in a statement. "The committee also noted that even the manufacturer estimated that the treatment would not be considered cost-effective for the NHS."
A key piece of the package is missing, however. As PMLiVE reports, Roche's discount offer--known as a patient access scheme--is held up at the U.K.'s Department of Health. The company says NICE's committee has reviewed the proposal, but higher-ups haven't issued a decision yet. "The scheme, already given the green light by NICE's own independent group of experts, is with the DH for ministerial ratification," the company said. "[T]his inability to make a decision casts a looming shadow of doubt over the future availability of this life-extending personalized cancer drug."
The draft guidance is just that; NICE is taking comments through Aug. 28, with another draft due in the coming months. Roche will no doubt come back with additional analysis and information. The company's discount proposal will (Roche hopes) be ratified. And NICE probably will get an earful from patient groups, which have plenty of practice fighting NICE's rejections.
NICE is a tough audience; in recent years, the agency has racked up rejection after rejection as pricey new cancer treatments made their debuts. Pfizer's ($PFE) new, targeted lung cancer drug Xalkori was rejected in March, and Novartis' ($NVS) Afinitor failed to win a recommendation for a new indication in breast cancer last month. Until the end of last year, NICE had nixed a new round of melanoma treatments, Roche's Zelboraf and Bristol-Myers Squibb's ($BMY) Yervoy. The agency changed its mind after the companies offered discounts off their $83,000 (Zelboraf) and $128,000 (Yervoy) prices.