Jeffrey Cohen, MD; Sarah Anderson, PharmD, NBC-HWC; and Alicyn Magruder, PharmD, BCACP, MSCS, share their final thoughts on the future landscape of clinical MS care in the biosimiliars era. [WATCH TIME: 12 minutes]
WATCH TIME: 12 minutes
The treatment paradigm for multiple sclerosis (MS) has come a long way since the early years of ABCR agents, with a therapeutic arsenal of disease-modifying therapies now numbering in the 20s. Yet, with all of the change that advances in pharmaceutical development have brought, there are still novel approaches being introduced—and perhaps the biggest recent introduction is biosimilars.
With the FDA approval of the first of these new products for MS in the fall of 2023, the era of biosimilar treatments has begun, and in this new era is a new challenge: education and awareness of these options, for both patients and clinicians.
In collaboration with the National MS Society, NeurologyLive® hosted a Roundtable Discussion focusing on this step forward for MS treatment, the changes that it will bring to care and the healthcare system as a whole, and the resources for the field to stay up to date on their use. Featured in the discussion are Jeffrey Cohen, MD, an MS specialist and director of Cleveland Clinic’s Mellen Center for Multiple Sclerosis Treatment and Research; Alicyn Magruder, PharmD, BCACP, MSCS, a clinical pharmacist at Mizzou Specialty Pharmacy within the Neurology and Sleep Disorders Clinic; and Sarah Anderson, PharmD, NBC-HWC, a pharmacist and director of Clinical Content and Resources on the Clinical Innovation and Strategy Team at the National Multiple Sclerosis Society.
Transcript below. Edited for clarity.
Matt Hoffman: As far as resources, it sounds like there are a plethora available. Dr. Magruder, you pointed to the patient forums that exist, too, and I know that the MS community as a whole tends to be a pretty proactive bunch. Patients with chronic disease tend to be interested in learning about their disease, and it's something they're going to have to deal with for the long term. Are there any other sort of tactics or patient–support strategies that either of you implement or could suggest to your colleagues outside of what we've already discussed?
Sarah Anderson, PharmD, NBC-HWC: I'll kick it off. I was just going to say, especially speaking to the general neurology population, being able to leverage the specialty pharmacists or the medication therapy management pharmacists, either within their clinic or that they have access to via other means. I think that can be invaluable when looking at the vast number of treatment options available, knowing there are more than 20 disease-modifying therapies on the market, and knowing that general neurologists might not be as in-the-know with all of the different treatments as MS specialists and neurologists are. I think leaning on those colleagues can be really beneficial in helping empower patients to participate in that shared decision-making with another knowledgeable individual, like Alicyn, for example. just wanted to throw that out there.
Jeff Cohen, MD: I would say that, in addition to patients, physicians need to avail themselves of these resources because many of us, up until recently, were not very familiar with the regulatory process for generics and biosimilars, and the logic behind them and so forth.
Matt Hoffman: Of course. I think, Dr. Anderson, you make a very good point about that general neurology community and making sure that they're up-to-date on this information because I can imagine just from the complexity of some of these therapies, and the sheer number that are available, choice paralyzation can be a real a real issue to deal with. Now that these biosimilars and generics are entering the market, I think that adds, again, just another wrinkle on top of all of it.
Before we wrap this up, I do want to look ahead a little bit to the future because this is the first of, eventually, several biosimilar products that are going to come to market in the United States. I'm curious, as this conversation continues to evolve over the next couple of years—5, 10, however many it may be—what do the 3 of you anticipate for this treatment category overall? Is there a long-term impact that you foresee happening on the positive side on the negative side? Or, simply, how it might impact—we talked a little bit about the hope of that long-term trickle-down for cost benefits for patients. But do we see anything on the clinical side in terms of perhaps adherence to medications or the overall costs of these medications in the market as a whole coming down? When you think of the future, what is top of mind for the 3 of you?
Jeff Cohen, MD: I think there's going to be increased numbers of biosimilars and generics for particular products. And as additional originator drugs, the brand products, go off patent, there's going to be follow-on products for those. I think the overall effect is going to be that we're going to see increasing use of generics and biosimilars. As we've said a few times, the ultimate goal is to lessen healthcare costs overall, and it remains to be seen how well that's accomplished. In the short run, in fact, it may not save money for individual patients because many of the sponsors of the originator drugs and the brand products have pretty well-developed, very sophisticated support programs, both financial support and educational support. It's going to be important that the companies that market the generics and biosimilars reproduce those same programs.
And then, finally, we do need some mechanism for monitoring for particularly rare are unexpected adverse effects. There have been a few examples of that, I think they're quite rare, but we do need to keep track of that. And then more importantly, as you say and as we've talked about, is there some way of monitoring that these products do, in fact, have comparable efficacy and safety and tolerability? Because we don't currently have a very good mechanism for capturing that for any medication other than formal studies—long-term extension studies and things like that. I think we're going to see more use of these, but there are also some questions.
Alicyn Magruder, PharmD, BCACP, MSCS: One thing I hope to change is formularies. Right now, I still see a lot of platform therapies being primary—what they want patients to try first. Hopefully, with biosimilars and generics hitting the market, maybe we can give access to through insurance to these drugs, as first-line choices. I mean, part of that issue is that we don't have specific guidelines. We have lots of expert opinions and consensus statements out there, but the guidelines don't help us as far as formularies for MS patients. That allows insurance to just pick whatever they want to pick—who's giving them the best kickback from the big pharma companies. I'm hopeful that as things progress, that we can see more access through insurance instead of having to go off and get support somewhere else.
Sarah Anderson, PharmD, NBC-HWC: I'll just tag on to what Alycin said. I think I'm hopeful that in collaborations with health plans—I know the National MS Society is working on trying to engage health plans a little bit more than we have in the past. We’ll be opening up that discussion for how could we reimagine the specialty tiers for the formularies. What do your P&T [pharmacy and therapeutics] committees look like? Do you have neurologists or MS specialists sitting on P&T committees who are reviewing some of those recommendations that are put forth for formulary design?
I'm hopeful that we're throughout the coming years here, we can be more collaborative as a whole amongst all the stakeholders to be able to all have a voice when it comes to some of those decisions that are made at the health plan level.
Alicyn Magruder, PharmD, BCACP, MSCS: I would also say that maybe it might give us some more data with the generics and biosimilars out there, potentially, for some nonsponsored head-to-head trials. Right now, we use a lot of statistical analysis to come up with which ones we think are higher efficacy therapies, but we don't have head-to-head trials to compare. Maybe as things become less expensive, that could be privately sponsored data that are out there.
Matt Hoffman: That's been a topic of conversation for the last several years that I've heard, a lot of similar hope for some type of head-to-head comparison for efficacy. There clearly are some remaining needs here. Perhaps, this is just the first step, it seems, toward affecting some of that change, and perhaps guidelines will be addressed down the road and that can improve things. And hopefully, there is that healthcare system savings that does translate to the patient down the road. I know we're all hoping that ends up being the case.
I'd like to just present you all with an opportunity if you have any final thoughts or, again, tips for the community, particularly the general neurologists and the MS specialists out there who are going to be encountering these medications, on how they can navigate this conversation with their patients and really get them up to speed on what is happening, what they can expect in the coming years, and how they might have to navigate a switch or change to one of these medicines.
Jeff Cohen, MD: Well, I mean, I would say that people do need to become familiar with this because it is coming. In fact, it's happening now. I would say that in general, our experience has been reassuring. But one needs to, as for everything, pay attention.
Alicyn Magruder, PharmD, BCACP, MSCS: I think if you're a part of a health system that doesn't already use your specialty pharmacy, if you have a health system specialty pharmacy, look at getting that pharmacist that's going to cover your MS medication. I know a lot of the questions about navigating insurance all comes back to me just because I can literally run a claim and tell you in seconds what insurance wants, versus having to hear it back and forth. But not everybody's going to have access to that.
For your general neurologist, just becoming familiar—reassuring patients that specialty meds are a process, regardless of the disease state. It's complex for all of these, and it is specialty for a reason. Give them the expectation that it can take time and that there are people who are fighting for them. It's just not always a quick process.
Sarah Anderson, PharmD, NBC-HWC: I was just going to add on to what everyone has said here by acknowledging that it can be confusing, it can feel messy. But at the end of the day, being able to help simplify and be that listening ear for the patient to understand their fears, challenges, past medication experiences, and how that plays a role in their preconceived expectations with medication moving forward can be really valuable with regards to helping combat misinformation.
And it makes sure that they have reputable resources at their disposal, whether it's resources like I mentioned from the National MS Society, resources that the FDA provides, resources their pharmacist can provide them, etc—there are lots of lots of resources out there. Having patients be knowledgeable about them can be a really great first step.
Matt Hoffman: Absolutely. I thank you all again for your time today. I think this has been a pretty up-to-date discussion on the latest in terms of the landscape of MS care as it relates to these biosimilars. As Dr. Cohen put it, it's not coming, it's happening now. Thank you all for your time. On behalf NeurologyLive and the National MS Society, this has been a Roundtable Discussion on biosimilars and multiple sclerosis, and I'll see you all later.