Identifying Secondary Progressive Multiple Sclerosis - Episode 16
Peter L. Salgo, MD: I didn’t hear the answer to step therapy.
Maria Lopes, MD, MS: Well, it’s frankly a scenario where especially for the IV [intravenous] medications, ocrelizumab included—although I think in all fairness, there are great head-to-head data versus high-dose interferon, so very positive and the only option if you have primary progressive MS [multiple sclerosis], even though I also learned that maybe that isn’t as effective as we’d like to see. But the bottom line is on the IV side, unless you have primary progressive MS [PPMS], for which there’s only one option, otherwise if you have relapsing MS [RMS], many payers will have some form of step therapy, typically the ABCR [Avonex, Betaseron, Copaxone, Rebif] agents, which are old and many patients have been on them. I would argue also that if an MS specialist or a neurologist is calling the health plan and making the medical director aware that that patient has highly active disease, spinal cord lesions, they may need and get access to these infused drugs.
Peter L. Salgo, MD: But does that answer make you happy? If what you tell me is you’ve got to get in and pound this thing with the best drug available in the first 6 months, step therapy is taking that time away.
Patricia K. Coyle, MD, FAAN, FANA: I don’t like that. I totally disagree with that. Ocrelizumab was a high-efficacy agent with no special monitoring put in place by the FDA. So they reviewed it and said it is pretty safe. We don’t need to do any special monitoring, unlike the other 2 high efficacy monoclonals. That clearly should be a first-line agent. You should be able to use it first-line. There shouldn’t be any step edit.
Peter L. Salgo, MD: All right. There’s another possibility here or another problem, which is you say it depends on the labeling. And the FDA went in, and I heard this, and they muddied the waters, maybe for the better, but they did. Because they expanded the indication. All the RMS approved agents have an SPMS [secondary progressive multiple sclerosis] indication, right?
Patricia K. Coyle, MD, FAAN, FANA Active SPMS.
Peter L. Salgo, MD: Active, yes. The label is not going to help you.
Maria Lopes, MD, MS: Well, if you’re going by the label indication for a therapy and the physician is checking off the appropriate label for which it is indicated, again we can’t challenge a prescriber, nor would we because we’re not the experts.
Peter L. Salgo, MD: Should the treatment for SPMS and PPMS be the same?
Patricia K. Coyle, MD, FAAN, FANA That’s a very interesting question because neurodegeneration seems to be identical in both. And there are trials where they do progressive MS trials, they combine both. In my opinion, if I felt confident I had a neurodegenerative therapy, I would think it should apply to both.
Peter L. Salgo, MD: Does the RMS indication translate to every subtype?
Patricia K. Coyle, MD, FAAN, FANA Well, by the FDA, and who am I to disagree with them.
Peter L. Salgo, MD: When they agree with you.
Patricia K. Coyle, MD, FAAN, FANA Right, relapsing MS is CIS [clinically isolated syndrome] high-risk, and relapsing-remitting, and active secondary progressive, so that’s just about covering everything.
Peter L. Salgo, MD: So here we are. You tried to back into a defense position of, we’ll go with the package insert, but the package insert just blew up. What’s that going to do to your formulary costs?
Maria Lopes, MD, MS: Well, these drugs are all high cost, right? I think the bigger question is, what are they doing in terms of changing the outcomes for areas like SPMS, where historically we haven’t really had options? I’ve even heard neurologists talk about how they don’t want to use the language with patients because they didn’t have options. It was almost admitting failure, if you will. So how are these new options going to change the landscape of a disease that’s progressive and evolving and maybe even beyond EDSS [Expanded Disability Status Scale].
Peter L. Salgo, MD: What you’re actually implying, it seems to me, is balancing the cost of these agents, which in isolated terms are very high.
Maria Lopes, MD, MS: Yes.
Peter L. Salgo, MD: Versus the total cost of this diagnosis on a patient, and on the family, and on society. And maybe it’s a net wash or even a benefit in your formulary.
Maria Lopes, MD, MS: Yes, and again, defining what is then the goal. If it’s not NEDA [no evidence of disease activity], which is certainly a high bar, how do we define what the approach is, how do we define how you sequence the options we have, when do you switch? I think this does beg the need for maybe a greater consistency coming from the experts, coming from the National MS Society, but with greater definition of what that looks like.
Patricia K. Coyle, MD, FAAN, FANA I’m going to make the following comment. When you’re treating progressive MS, your results will never be as good as when you’re treating relapsing MS because you don’t stop progression. You’re going to continue to get worse. So people talk about if this is justified, is it worth it? When you have a progressive MS patient sitting across the table from you and they say, “Gosh, I just heard we have a treatment for my disease, it slowed progression. I really want to go on it,” I’m not going to sit there and parse and say, “Well, it’s slowed progression, but it really wasn’t that meaningful, so I’m not going to bother treating you.” How do I not respond to that patient and say, “You’re entitled to get that treatment and try it if it slows progression”?
Maria Lopes, MD, MS: I would beg to disagree. No, if there is a drug that is indicated for secondary progressive, I would still say the opportunity has been what has happened along the way. But nevertheless, you now have a patient who meets that diagnosis for which there is a treatment, you’re going to have to approve that treatment.
Peter L. Salgo, MD: So they backed you into a corner. You’re going to go broke.
Maria Lopes, MD, MS: Again, these drugs are all high cost. And if we’re looking at it, what is it that we’re paying in failure, right? These patients are disabled, they’re consuming a lot of resources. Now maybe they’re actually in Medicaid because they’ve lost their insurance. I think the failure has been perhaps even earlier in the disease paradigm. Is there a failure to diagnose early? Is there a failure to treat with the appropriate treatment and perhaps demand more in the earlier stage to be able to control these patients?
Thomas P. Leist, MD, PhD: That is a very important thing. I agree with Pat Coyle that if a treatment is indicated for secondary progressive MS because it has shown benefit, then certainly this is part of the discussions that we are having. The money in multiple sclerosis is early on, and I do agree with Pat Coyle that step edit programs may not necessarily take into account the loss of time because patients will need to have failed to move to the next agent. Again, if I step outside into rheumatology, for example, that’s not what we want to do. And since the brain may be perhaps even more important than the joints, then I do think that a program that brings early effective therapy may perhaps mitigate these discussions around progressive disease for some patients.