Here is a transcript of Multiple Sclerosis News Today‘s interview with Dr. Tim Coetzee — chief advocacy, services and research officer for the National Multiple Sclerosis Society — about the importance of the U.S. Food and Drug Administration (FDA)’s awaited decision on Ocrevus (ocrelizumab), and the other ongoing research.
An in-depth article on this interview, in which Coetzee discusses Ocrevus and its potential impact on the MS community, can be found here.
Q: Ocrevus has shown considerable benefit in clinical trials, and for a first time, benefit to primary progressive MS patients. Is the National Multiple Sclerosis Society, and the MS community it represents, anticipating that the FDA will indeed approve this treatment?
A: At this point, we’re cautiously optimistic that the FDA is going to 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.
Q: In your opinion, is this drug’s possible approval in a few weeks’ time being awaited with as much interest — even excitement — as is generally thought? What are you hearing from the MS community regarding Ocrevus and its possible arrival on the market?
A: There is quite a bit of interest in the approval of Ocrevus. For those individuals with relapsing MS, there’s excitement about the availability of another treatment option to add to the other available disease-modifying therapies.
And of course, the idea of a treatment being approved for primary progressive MS is huge. I think everyone recognizes that Ocrevus had a modest effect in primary progressive MS, but to have any option is a critical first step to addressing the challenges of treating progressive MS.
Q: Peter Chin at Genentech recently said this drug has “the potential to change the way MS is treated,” largely by targeting of CD20-positive B-cells in contributing to myelin and nerve cell damage, and because NEDA (no evidence of disease activity) was maintained at two years in almost half of treated RMS patients in studies. Do you agree with his assessment of that potential — of Ocrevus as a possibly pivotal treatment?
A: I certainly agree that Ocrevus has the potential to be an important addition in the MS treatment toolbox. The findings in the clinical trials were certainly impressive, but I think we have to wait and see how it changes the treatment of MS. The fact that Ocrevus targets B-cells is certainly going to be helpful. We know that MS affects everyone differently and that every person’s treatment plan needs to be tailored to their situation. Thus, Ocrevus as its novel mechanism of action provides another tool that will aid physicians in fine-tuning the treatment of people with relapsing MS.
Q: New treatments do come with concerns, safety being foremost among them. From what you know of Ocrevus and its studies, what are your chief safety concerns, and how do they compare to other MS treatments?
A: Interfering with the immune inflammatory response is the cornerstone of MS disease modifying therapies. However, this interference comes with risks. Ocrevus depletes a population of immune system cells and this depletion increases the risk for some types of infection. In addition, Ocrevus may cause infusion reactions that include itching, rash, flushing and headache.
The clinical trial results indicated an imbalance in the number of cancers that occurred in the Ocrevus-treated patients compared to those who were on interferon in the relapsing remitting trial and those on placebo in the primary progressive trial. This imbalance will require continued careful observation and evaluation.
Q: Ocrevus is administered by intravenous (IV) infusion every six months, requiring treatment in a clinic or hospital setting. Is access to treatment for this reason of concern? Is the MS Society planning to work with Genentech to ensure access?
A: Access to all of the MS treatments is a major concern for us. This would not be the first MS therapy given by IV infusion. We’re confident that Genentech is working hard to ensure there will be sufficient clinics and hospitals with the capacity to deliver the treatment. 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.
We continue regular discussions with Genentech where we provide our perspective on access issues that are on the minds of people with MS.
Q: Can you address concerns you might have regarding the possible launch price of Ocrevus, given how costly treatments, especially new treatments, can be in the U.S.? Will the MS Society be addressing these concerns with Genentech, or are discussions already underway?
A: The cost of all MS medications continues to be a priority for us as it is a concern for people living with MS. We’ve been public about this through our Make MS Medications Accessible initiative.
We have shared these concerns directly with Genentech in multiple meetings with company leaders. The good news is they have been open and are listening to our concerns. No details have been shared regarding price; we will have to wait and see what the company does at the time of approval.
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. If barriers are put in place that limit access, we will speak out on behalf of people living with MS. The bottom line — medications can only change lives if people can access them!
Q: In the case of approval, are you planning meetings, webinars or the like, to bring news of Ocrevus — its use, access, and other pressing issues for patients — into the community, and to hear from patients about their concerns?
A: As with any new medication, there is a need for professional education and education for people living with MS about Ocrevus. We have reached out to the Consortium of MS Centers, an organization that supports MS professional educational, and will partner with them to provide information to health care professionals. The MS Coalition, made up of eight MS-focused organizations, including the National MS Society, will update their consensus document on disease modifying treatments and will include latest information about disease modifying treatments, including Ocrevus.
The Society will also have information about Ocrevus on our website for both professionals and people living with MS. Genentech, the drug manufacturer, will also have learning opportunities available for various audiences.
Q: The Society’s goal is to “end MS forever.” Are you, and the community you represent, increasingly optimistic that this goal is attainable? Do you believe Ocrevus represents a significant step on the way to achieving this?
A: I am optimistic that we are closer than ever to being able to end MS forever. If you step back and look at MS against other neurological diseases you can see a remarkable pace of progress. In the short span of 23 years, we’ve gone from a place of having no effective disease-modifying treatments [DMTs], to having 14 FDA-approved DMTs and the 15th, Ocrevus, on the horizon. If you throw in the three treatments for MS symptoms, you get a remarkable picture of progress.
There are many reasons why we’ve seen this progress, but I think one of the most important reasons is that we’ve developed a deep understanding of how the immune system goes off track in MS, and then have been able to develop treatments that address the dysfunction. Now, this progress is no reason to be satisfied — we are not. 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. It is a big hill to climb, but I believe firmly that by working together everyone with a stake in MS can help achieve our goal.
There has also been progress in identifying what makes people susceptible to MS, and some 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.
Q: Can you please talk about other treatments — potential or existing — that the MS Society is supporting, and watching most closely.
A: We are closely watching clinical trials that could lead to treatments for people with progressive forms of MS. For example, positive results were recently announced from a trial of BAF-312 (Siponimod) in secondary progressive MS.
In addition, studies include:
- The MS-SMART trial is testing three therapies that may have nerve-protecting properties in secondary progressive MS. The National MS Society is helping to fund this with the MS Society of the U.K.
- The SPRINT-MS trial of Ibudilast, an oral anti-inflammatory agent, is ongoing in people with secondary progressive and primary progressive MS thanks to a unique collaboration between NIH’s NeuroNEXT Network, MediciNova and the National MS Society.
- We are also closely following research related to Hematopoietic Stem Cell Transplants, or HSCT, and their potential for treating MS. There have been a couple of important studies from research groups led by Dr. Richard Burt at Northwestern University and Richard Nash at Colorado Blood Cancer Institute. These research teams have made important findings and we’re encouraging the research community to move quickly to do the Phase 3 clinical trials of HSCT in MS.
- Lastly, we are also very interested in wellness research to identify exercise, dietary and other approaches that will help people who have MS live their best lives. We just published a paper that outlined our wellness research priorities. We’re also investing in research that looks at diet and the impact of diet strategies in MS (Read about one trial here).
Q: Is there anything you would like to add, on Ocrevus or the Society’s work?
A: I’m proud that the Society is a leader in the International Progressive MS Alliance, which is a growing global initiative to end progressive MS. The Alliance began by bringing together the world’s leading experts in multiple sclerosis to identify the critical knowledge and treatment gaps where progress must be made to achieve breakthroughs necessary to change the world for people with progressive MS. As an innovator and leader, the Alliance is funding three essential global research networks, launched with a commitment of $14.1 million for four years.
There is still lots of work ahead but I believe that together we will find solutions for MS sooner rather than later.