Identifying Secondary Progressive Multiple Sclerosis - Episode 11
Peter L. Salgo, MD: Let’s talk about treatment, because all this has been funneling toward this final common pathway. We understand that there are various presentations of this disease. There are various courses in this disease, and the object is to preserve function and to preserve gray matter and white matter. I think that that’s what we got. How do we do that? Now we’re going to talk about treatment. Are there National Multiple Sclerosis [MS] Society recommendations generally for treatment? And how do we start with that?
Thomas P. Leist, MD, PhD: We don’t just have National MS Society criteria. We also have from the American Academy of Neurology. We have guidance from other players in the MS field. And principally what it says is if a patient is diagnosed with a relapsing form of multiple sclerosis, this patient should be offered treatment. The second point is obviously that, with newer treatments available, we also have patients with primary-progressive multiple sclerosis who have now access to treatment or at least 1 treatment. We will talk about that later on. Over recent months, we have had approval of agents with a specific callout for active secondary-progressive disease. As Pat Coyle and I have mentioned, we still look at this as probably relapsing forms of multiple sclerosis and apply the treatments that are available.
Peter L. Salgo, MD: Are there specific guidelines for SPMS [secondary-progressive multiple sclerosis], or are they more general?
Patricia K. Coyle, MD, FAAN, FANA: I would say they’re more general. The American Academy of Neurology, AAN, practice guidelines were published in 2018, and they had a series of recommendations on initiating treatment, on switching treatment, or even considering withdrawing it. They speak a little about SPMS, and they really refer to the fact that if there is a relapsing component, that patient is entitled to be on treatment.
Peter L. Salgo, MD: What is your perspective here? How do you capture progression? Clearly, they’re talking about progression, progression, progression. So you’re sitting there saying, “How do I measure that,” right?
Maria Lopes, MD, MS: Well, that’s where the coding becomes important, right?
Peter L. Salgo, MD: Or lack thereof.
Maria Lopes, MD, MS: Or a lack thereof, exactly, with 1 code. Usually it’s the pattern, and it also depends. You have to remember what payers have is claims. What did we pay for? And so what we did pay for is also dependent on the history with that patient, with that payer. And as Dr Leist mentioned before, there’s Medicaid. The Medicaid patient may be in and out of the system. And so many times we lack the historical data: Has that patient been in the ER [emergency department], been hospitalized, been on corticosteroids, or been on IVIG [intravenous immunoglobulin]? What is that pattern, and over what time? The average commercial member is with a payer, on average, 12 to 18 months. And when they go to another payer, that other payer loses that full history.
Peter L. Salgo, MD: Wait, can you back this up? They’re on a single payer for 12 to 18 months?
Maria Lopes, MD, MS: We don’t have a single-payer system.
Peter L. Salgo, MD: No, I didn’t mean to say single payer. A given commercial payer.
Maria Lopes, MD, MS: A given commercial payer.
Peter L. Salgo, MD: Where do they go? What happens to them?
Maria Lopes, MD, MS: Well, they may lose their job, right? They may go part time. They may go on Medicaid. The tragedy is often the lack of continuity and understanding that patient journey. Going back to the physician and then calling to say this patient has highly active disease, we may not even have the history that’s long enough to be able to show MRIs [magnetic resonance imaging tests] or what treatments have they been on. And so the reliance is also on the provider to help us understand what has been tried, what has the patient failed, if it is lack of efficacy or tolerability, if it is highly active disease or lack of compliance. This becomes nuanced in the context of that individual and their journey.
Peter L. Salgo, MD: We could call this an episodic disease. We can call it an episodic payer disease too. That’s interesting.
Maria Lopes, MD, MS: Well, it’s a chronic disease.
Peter L. Salgo, MD: That’s really interesting, because if you don’t carry forward the patient’s history from payer to payer, how is the payer supposed to know what’s going on?
Thomas P. Leist, MD, PhD: Well, let’s be very clear. MS is not an episodic disease. It has episodic clinical manifestations.
Peter L. Salgo, MD: Fair enough. How about chronic-relapsing payer disease?
Thomas P. Leist, MD, PhD: It’s a disease obviously, so it is ongoing on individuals. Where this becomes more important is when we look at the mode of actions of different treatments that we have. Every year the modes of action or the different agents may be differently positioned in an armamentarium that is available to the patient. That’s the formulary. It is very important, so that the patient who has failed a given mode of action within a formulary is not re-exposed to that mode of action because it’s unlikely going to help later on. So that’s where this also becomes important to know the treatment history of an individual.
Peter L. Salgo, MD: You know, it’s shocking to me. I never knew the number of months that a given patient is with a particular payer. That’s shockingly small.
Maria Lopes, MD, MS: Small.
Peter L. Salgo, MD: It really is. And the lack of continuity of information about a patient from payer to payer makes a big difference, I would assume.
Maria Lopes, MD, MS: Absolutely.
Peter L. Salgo, MD: So given that, we’re going to get deep in the woods in a few months of pharmacology. But regarding the current treatment options for RRMS [relapsing-remitting multiple sclerosis], not looking forward at some of the newer therapies, what are the standard options that all doctors have prescribed and still prescribe?
Patricia K. Coyle, MD, FAAN, FANA: I put them into 3 groups. We have the injectables that go back to the 1990s. This would be all the interferon betas, 5 different ones, and glatiramer acetates, the brand and 2 injections in 2 different forms. Five orals. The oral agents date to 2010, 2013—2 originally added. Then the intravenous monoclonal antibodies—3 of them are the high-efficacy agents.
Peter L. Salgo, MD: I want to back up, because we’re going there, I promise you. But you would have heard a decade ago—and what you still hear, I would suspect—are lifestyle modifications. Does that help?
Patricia K. Coyle, MD, FAAN, FANA: We are increasingly learning that a wellness lifestyle has positive impacts on the brain and the central nervous system. If you don’t follow a wellness program, you are negatively impacting anatomically on your central nervous system.
Peter L. Salgo, MD: That goes back to exercise, cholesterol, blood pressure, blood sugar.
Patricia K. Coyle, MD, FAAN, FANA: Absolutely.
Peter L. Salgo, MD: All that stuff.
Patricia K. Coyle, MD, FAAN, FANA: Absolutely.
Thomas P. Leist, MD, PhD: As an adjunct to treatment.
Patricia K. Coyle, MD, FAAN, FANA: Yes. The key is to hit that reserve, that brain reserve.
Peter L. Salgo, MD: But I want to get the minimal platform for this.
Patricia K. Coyle, MD, FAAN, FANA: Let’s talk about following a wellness program, recognizing comorbid conditions and getting them treated, and recognizing the symptoms of MS and getting them appropriately treated. If you have an acute attack, there’s a treatment for that and we have the disease-modifying therapies.
Peter L. Salgo, MD: Right. Now, historically, there were muscle relaxants, pain relievers, and steroids.
Patricia K. Coyle, MD, FAAN, FANA: Symptom management.
Thomas P. Leist, MD, PhD: I do think we have to differentiate. You bring up a very important point. When we talk about MS treatments, we are talking about medications that are meant to modify the disease of multiple sclerosis. As individuals incur injury because of multiple sclerosis, they develop secondary clinical manifestations from this injury. For example, stiffness, walking difficulty. The problems can also be on another side. Fatigue is a very important symptom in MS; mood disorders are very important symptoms in multiple sclerosis. These then require treatment with other agents targeting these symptoms.
Peter L. Salgo, MD: Those are secondary signs.
Patricia K. Coyle, MD, FAAN, FANA: For quality of life.
Peter L. Salgo, MD: For quality of life.
Patricia K. Coyle, MD, FAAN, FANA: For quality of life. They don’t prevent damage.
Peter L. Salgo, MD: They’re not disease modifiers.
Patricia K. Coyle, MD, FAAN, FANA: Exactly.
Peter L. Salgo, MD: They’re quality-of-life interference drugs.