Roche raises outcry as cost watchdogs spurn Ocrevus—again—in tough-to-treat MS

Ocrevus
Roche is blaming a National Health Service "technicality" for the National Institute for Health and Care Excellence's negative decision on Ocrevus. (Roche)

England’s cost watchdogs are standing by their controversial decision to reject Roche’s Ocrevus in a form of multiple sclerosis for which it's the only approved treatment. Roche says pricing isn't to blame—and patient advocates are helping stir up a backlash.

The National Institute for Health and Care Excellence (NICE) has once again shot down Ocrevus for primary progressive multiple sclerosis (PPMS)—this time in its final draft guidance.

The reason? NICE’s usual: The price on the therapy is too high, it said, calling Roche’s cost-effectiveness estimates “far higher than those NICE normally considers an acceptable use of NHS resources.” And while it acknowledged that Ocrevus “slows disability progression compared with placebo,” the “size and duration of the effect are uncertain,” it said.

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But there's a larger issue at work, too, Roche says: indication-specific pricing, an approach payers in the U.S. are beginning to embrace. In other diseases, England's National Health Service allows prices to vary for a drug’s different indications, but it doesn’t do so in neurological diseases such as MS. And as a result, “NICE could not even consider the indication-specific price offered by Roche in order to make” Ocrevus cost-effective, Roche said.

In the U.K., Ocrevus bears a list price of £4,790 per 300 mg, but companies typically offer confidential discounts to get their meds past NICE. Roche had already served up a price break that would have gone into effect had NICE green-lighted Ocrevus, but it apparently wasn’t big enough to impress the gatekeeper.

The move will affect 12,600 U.K. patients living with PPMS, according to NICE, and the way Roche sees it, the news is “devastating.”

Patients suffering from the “highly disabling” disease “urgently deserve access to the first and only licensed treatment” that’s shown it can slow progression, Richard Erwin, Roche U.K.’s general manager, said in a statement.

And Roche wasn’t the only one to express disapproval Monday. The National MS Society launched a petition aimed at helping NICE, the NHS and Roche reach an agreement to get Ocrevus covered.

“This is a deeply disappointing decision, denying many desperate people access to a treatment which may slow down their disability progression,” Genevieve Edwards, the society’s director of external affairs, said in a statement.

RELATED: NICE reconsiders and agrees to back Roche’s Ocrevus in relapsing multiple sclerosis—with strings attached

Roche is calling on the NHS to change the rules for indication-specific pricing to allow Ocrevus to get a fair hearing at NICE.

“Failure to resolve this technicality between NHS England and NICE ultimately means that people with PPMS are denied access to the only effective treatment available for their condition. Within the NHS, the different MS indications are already monitored, therefore allowing flexibility should not cause additional burden to the system,” the drugmaker continued, adding that “we are unwavering in our commitment to people with PPMS.”

Roche and NICE have had a stormy relationship over the past few years. The agency has initially rejected a number of the Swiss pharma giant’s products—particularly in the pricey cancer field. With other drugs, though—and even with Ocrevus in relapsing remitting multiple sclerosis—Roche has had better luck changing NICE’s mind on the second go-round.