The potential approval of Ocrevus (ocrelizumab) this month supports the idea that, someday, a world free of multiple sclerosis (MS) is possible, according to Dr. Tim Coetzee, the National Multiple Sclerosis Society’s chief advocacy, services and research officer.
While Coetzee — and the society he represents — realize the potential of Ocrevus to improve MS treatment, both also acknowledge that plenty of work remains to be done to reach its goal of “ending MS forever.”
Meanwhile, the society is working hard to make sure that the benefits Ocrevus may offer — if approved — will reach as many people as possible.
With the date for Ocrevus’ potential approval fast approaching, Multiple Sclerosis News Today spoke to Coetzee about how the possible therapy is viewed by the MS Society, its hopes and concerns, and work beyond Ocrevus.
“The idea of a treatment being approved for primary progressive MS is huge,” Coetzee said. Still, he and the society do not want to celebrate too soon, and are only cautiously optimistic that the U.S. Food and Drug Administration (FDA) will approve Ocrevus on March 28.
“Of course, you always have to be prepared for the unexpected — like the three-month delay in the agency’s decision late last year, but we certainly hope that doesn’t happen,” he added.
Ocrevus has been tested in three large global clinical trials: the two OPERA I and OPERA II trials (NCT01247324 and NCT01412333) in relapsing patients, and the ORATORIO (NCT01194570) study in people with primary-progressive MS. Researchers — both those involved in the trials and those not — consider the study data impressive.
Many patients also have high hopes for the treatment. According to Coetzee, relapsing MS patients are excited about the possibility of yet another, and possibly better, disease modifying treatment to choose from. And while primary progressive patients recognize that the treatment’s effect in clinical trials was modest — it is a huge step forward compared to no available treatment at all.
“To have any option is a critical first step to addressing the challenges of treating progressive MS,” Coetzee said, but advised restrained optimism.
So while Genentech’s Dr. Peter Chin noted that Ocrevus “has the potential to change the way MS is treated,” Coetzee underscored the importance of seeing how the drug works in wider usage.
“The findings in the clinical trials were certainly impressive,” he said, adding that Ocrevus’ strength is in targeting B-cells — its defining characteristic. But clinical trials do not always mirror real-life situations.
“We know that MS affects everyone differently, and that every person’s treatment plan needs to be tailored … Ocrevus [with] its novel mechanism of action provides another tool that will aid physicians in fine-tuning the treatment of people with relapsing MS,” Coetzee said.
With progress comes concerns
As with any new MS treatment, anticipation goes hand-in-hand with concerns — worries about access to the therapy, about pricing and about potential side effects.
As reported earlier, serious adverse events and serious infections in the Phase 3 trials were about as common in those receiving Ocrevus as in those in control groups. Still, the B-cells that are depleted by Ocrevus are part of the immune defense against microbes.
Certain types of benign or moderate infections — such as common colds or herpes virus infections — were more common in Ocrevus-treated relapsing patients than those receiving Rebif (interferon beta-1a).
Administered through an infusion, Ocrevus can also give rise to infusion-related reactions, such as itching or flushing.
And, across all three Phase 3 trials, there was an imbalance in the number of patients developing cancer after Ocrevus treatment. Although the numbers were low, not exceeding general population norms, a reason for vigilance exists.
“This imbalance will require continued careful observation and evaluation,” Coetzee said, echoing points made by Dr. Peter Calabresi of Johns Hopkins University School of Medicine in an editorial that accompanied publications of the trial data.
The always pressing issue of access
Concerns about access surface whenever a new drug is about to enter the market, and Coetzee underscored that such issues are not unique to Ocrevus. MS patients are, unfortunately, no strangers to drugs delivered by infusion, and improving access to centers is a constant point on the society’s agenda. But in this case, the National MS Society does believe Genentech is doing its part to meet that need.
“We’re confident that Genentech is working hard to ensure there will be sufficient clinics and hospitals with the capacity to deliver the treatment,” said Coetzee, pointing out that the society and Genentech continue to have regular discussions.
“With all treatments, we are concerned about barriers to access that may arise through insurance coverage, cost and restrictions and will monitor coverage of Ocrevus,” Coetzee added.
Cost is possibly the factor that most people worry about, and one the society focuses on in its Make MS Medications Accessible initiative. But the group has also been proactive in a more direct fashion when it comes to Ocrevus.
In several meetings with Genentech, society members shared patients’ concerns regarding pricing. According to Coetzee, Genentech has been open and considerate. At the moment, however, it has not released information about a potential price, and the company’s next move is awaited.
But costs borne by patients are not determined by a drug manufacturer alone, Coetzee underscored.
“While a lot of attention is being paid to Genentech’s actions, we also believe this issue isn’t just about Genentech. The actions of payers and pharmacy benefit managers will also have a significant impact on people being able to access the treatment,” he said.
“If barriers are put in place that limit access, we will speak out on behalf of people living with MS — medications can only change lives if people can access them.”
Education is key
In addition to negotiating with Genentech about pricing and availability, the society is preparing for Ocrevus’ potential approval with an array of educational initiatives. A large part of these focus on patients, but healthcare providers and policymakers are equally important to ensuring access.
Among other things, the society will be a resource, posting information about Ocrevus on its website. This information will be tailored to people living with MS and to professionals. Coetzee pointed out that Genentech will also offer resources and learning opportunities once the drug is approved.
Looking beyond Ocrevus
Ocrevus is currently at the forefront of what has been, according to Coetzee, a remarkable pace of progress in MS treatment development. “In the short span of 23 years, we’ve gone from a place of having no effective disease-modifying treatments, to having 14 FDA-approved disease-modifying treatments, and the 15th, Ocrevus, on the horizon,” he said.
This rapid development has, to a large extent, been possible thanks to research into disease mechanisms. “We have developed a deep understanding of how the immune system goes off track in MS, and … to develop treatments that address the dysfunction,” Coetzee said.
In addition, the field of prevention research has seen plenty of progress, including identifying risk and triggering factors. “When those are nailed down, then the possibility of preventing MS — so that no one is ever again told they have this disease — becomes a distinct possibility.”
More work is needed, but hope is growing.
“We need better treatment for all forms of MS. But the progress we’ve seen in relapsing MS, including Ocrevus, gives me great confidence that we can achieve our goal of a world free of MS. I am optimistic that we are closer than ever to being able to end MS forever,” he said.
Coetzee also spoke about other promising investigational treatments that the society believes can make a difference.
A recent report that BAF-312 (Siponimod) slows disease progression in patients with secondary progressive MS caught the society’s attention, as it keeps a close eye on stem cell transplant trials. It also supports initiatives assessing how lifestyle factors influence the disease, and recently published a report of its wellness research priorities, including dietary research.
“There is still lots of work ahead but I believe that together we will find solutions for MS sooner rather than later,” Coetzee concluded, before returning to work whose goal is to make sure this really will happen.
A full transcript of the interview with Dr. Tim Coetzee can be found here.