Roche's Ocrevus continues winning streak as NICE flip-flops on initial rejection

Roche’s multiple sclerosis superstar Ocrevus has run into few obstacles on its path to nearly $1 billion in global sales this year. Now, one major obstacle on the drug's blockbuster journey—England's cost watchdog—has stepped aside.

The National Institute for Health and Care Excellence (NICE) changed its mind on covering Ocrevus for primary progressive MS, thanks to a confidential discount Roche offered. The agency had rebuffed the drug back in September.

"Unfortunately we couldn’t recommend it at the price offered at that time because it did not represent a cost-effective use of limited NHS resources," said Meindert Boysen, NICE’s director of the Centre for Health Technology Evaluation, in a release. "We are therefore pleased that NHS England and the company have been able to reach an agreement that will see this important new treatment made available to thousands of people with this form of MS."

Ocrevus is the first disease-modifying treatment for primary progressive MS in adults, which affects around 90,000 patients in England, Roche said in a release. Around 14% of new MS patients are diagnosed with the primary progressive form of the disease, Roche said.

Around 2,700 patients in England could be eligible for Ocrevus, which is given as an infusion at a clinic once every six months. The drug lists at £19,160 ($24,855) per patient per year in the country.

Ocrevus is one of a suite of recent drug launches that have propelled Roche’s global sales this year as the company faces stiff discounting in Europe and braces for U.S. biosim competition to its longtime oncology bestsellers Avastin, Herceptin and Rituxan.

Riding a strong U.S. label that covers around 90% of all MS patients, Ocrevus has skyrocketed to what Roche has called the best drug launch in its history. In its first full year after its mid-2017 launch, Ocrevus achieved blockbuster status with $2.4 billion in 2018 sales.

But that wasn’t all the drug had in store. In the first quarter of 2019 alone, Ocrevus raked in $829 million in global sales, beating an already upbeat analyst consensus by 15%.

With that rosy sales outlook in tow, Roche is hoping that Ocrevus’ world-beating first two years are only a sign of what’s to come.

On Wednesday, Genentech said it would present long-term data this week showing early treatment with Ocrevus significantly reduced the risk of disability progression among patients with relapsing and primary progressive MS, compared to solo treatment with interferon beta-1A or placebo, respectively. Higher exposure to Ocrevus over time was also tied to a lower rate of disability progression at 24 weeks, Roche said.

Also, interim results from a phase 3 study showed Ocrevus reduced the presence of a biomarker of nerve cell damage and inflammation, found in the bloodstream and cerebrospinal fluid, at 12, 24 and 52 weeks in patients with relapsing MS. All of that data was set to be presented at the American Academy of Neurology annual meeting in Philadelphia.

Fortunately for Roche, Ocrevus’ whirlwind success comes at a good time for the immunology market, which is seeing massive growth in nearly every indication. Credit Suisse analysts attributed Ocrevus’ fast uptake to physicians' familiarity with off-label use of Rituxan, an anti-CD20 therapy, as well as the drug’s efficacy and a safety score that topped that of anti-alpha4-integren competitor, Biogen’s Tysabri. 

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