Roche bolsters MS blockbuster Ocrevus with new long-term disability data

Ocrevus was already the most successful drug launch in Roche’s 122-year history, having hit blockbuster status this summer as patients and doctors embraced the immune-targeted multiple sclerosis medicine. Now Roche is rolling out new five-year data from a trial that could ratchet up the enthusiasm for the product—and sway payers that may be hesitant to cover it.

During the trial, patients with relapsing multiple sclerosis (RMS) who were treated with Ocrevus for five years had better outcomes in brain atrophy and disability progression compared with people who switched to the drug after being treated with interferon for two years, the company said at the 34th Congress of the European Committee for Treatment and Research in Multiple Sclerosis in Berlin. And patients with RMS who started on interferon showed a “rapid suppression of disease activity” and a reduction in relapses after switching to Ocrevus.

In total, patients who took Ocrevus for five years showed a reduction in confirmed disability progression of 16.1%, while those who switched from interferon after two years had a 21.3% reduction in progression.

Patients in the trial with the less common primary progressive multiple sclerosis (PPMS) also did well on Ocrevus. Disability progression dropped by 9.6% in those people compared with patients who were initially treated with a placebo. And upper-limb disability dropped by 13.4% in PPMS patients taking the drug.

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“From the moment of diagnosis, reducing disease progression is an important goal for people with MS,” Stephen Hauser, M.D., professor of neurology at the University of California, San Francisco, and director of the UCSF Weill Institute for Neurosciences, said in a statement. The data represent “the largest body of evidence for any medicine to significantly slow disability progression in primary progressive MS,” added Hauser, who chairs the scientific steering committee for the trial.

During the conference, Roche also presented an interim analysis from a separate study of patients with relapsing-remitting MS (RRMS) who did not respond to six months of treatment with a rival therapy. The company said that 59% of patients who switched to Ocrevus had no relapses in 48 weeks of treatment.

If there’s any country where this data could be most useful to Roche, it’s England. The company has been in an all-out fight there with the National Institute for Health and Care Excellence (NICE), the cost watchdog that determines which drugs will be covered by that country’s National Health Service (NHS). In September, NICE rejected Ocrevus for patients with PPMS, citing its price of £4,790 ($6,298) per 300-mg dose as too high—despite the fact that it's the only approved PPMS drug out there. Roche’s estimates of cost effectiveness are “far higher than those NICE normally considers an acceptable use of NHS resources,” the agency said.

NICE did bless Ocrevus for use in RRMS, after initially rejecting it based on what it said was a lack of evidence comparing the drug with older products. The agency was ultimately swayed by analyses suggesting that Ocrevus does a better job slowing disease progression than Sanofi’s Aubagio, Biogen’s Tecfidera and Teva’s Copaxone.

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

Ocrevus, which works by targeting immune cells that contribute to nerve damage, was introduced in the U.S. last year at a list price of $65,000—a 25% discount over Merck’s Rebif. That pricing helped the drug pull in $200 million in sales in its first quarter on the market. Evaluate Pharma pegged the drug as the No. 1 approval of 2017 and forecast $4.1 billion in annual sales of it in 2022.

Meanwhile, Ocrevus is helping Roche weather the erosion of some of its older cancer blockbusters, including Herceptin and Rituxan, both of which are getting slammed by biosimilar competition. During Roche’s second-quarter earnings call, CEO Severin Schwan, Ph.D., credited Ocrevus for prompting the company to boost its sales expectations for the year. Roche now expects mid-single digit sales growth. It was the second time this year the company dialed up its 2018 forecast.