NICE on BMS' Yervoy: The cost is too darn high

The breakthrough melanoma drug from Bristol-Myers Squibb ($BMY) isn't enough of a breakthrough for the U.K.'s cost-effectiveness watchdogs--at least not at its current price point. The National Institute for Health and Clinical Excellence has given Yervoy a thumbs-down in a draft guidance, saying the cost is simply too high.

There's no question about Yervoy's efficacy, at least for about one-third of patients, NICE said in a statement. It prolongs life for 30% of those with advanced melanoma, and about 10% have the potential to see long-term survival benefits, the agency said. For this deadly form of skin cancer, those are impressive numbers; as Bloomberg notes, Yervoy was the first drug proven to extend these patients' lives.

But NICE says the long-term benefits aren't clear. Plus, there's no way to identify which patients will respond to Yervoy. And for a drug this pricey--it runs £20,000 per dose, and typical treatment requires four--clarity is essential, NICE chief Andrew Dillon said. "We need to be sure that new treatments provide sufficient benefits to patients to justify the significant cost NHS is being asked to pay," Dillon said in a statement. To swing the balance in Yervoy's direction, BMS should "consider whether it wishes to reduce the acquisition cost to the NHS of the drug."

Given NICE's recent record on expensive cancer drugs, the Yervoy decision comes as no surprise. The agency gave the thumbs-down to AstraZeneca's ($AZN) Faslodex in August, and it initially turned down Takeda's Mepact and Novartis' ($NVS) Tasigna, reversing course only after the companies offered price breaks through patient-access schemes.

Dillon hinted at an opening for Yervoy when he said the drug costs £80,000 "whether it works for a patient or not." Perhaps if BMS offered some sort of risk-sharing deal--as Johnson & Johnson ($JNJ) did to persuade NICE on its blood cancer drug Velcade--that might be enough to turn the "no" into a "yes." The company pledges to persuade NICE that Yervoy is cost-effective, saying it's going to offer new evidence to the agency. "[W]e do not believe that the current ... method used by NICE has fully captured the value of Yervoy," the company's U.K. chief, Amadou Diarra, said in a statement, adding that Yervoy is "real value for money to the NHS."

- see the release from NICE
- get the Reuters story
- read the PharmaTimes piece
- check the Bloomberg coverage