Peter Salgo, MD: Let’s look at some new data for the prevention of chronic migraines, all right? There’s another trial. There [are] trial results and design implications from the REGAIN study and the erenumab study. One of these days, I’m going to get a drug that I can pronounce. Erenumab, a chronic-migraine study. What are the implications of the study to the decrease in migraine-specific days? And does treatment vary based on migraines, with or without aura?
Stephen Silberstein, MD: One of the biggest shocks to me is my patients getting the antibodies and telling me their auras got better.
Peter Salgo, MD: Why is that shocking? It’s all part of the syndrome, no?
Stephen Silberstein, MD: People believe that the aura may be [because of] a wave of electrical activity that cross the brain, which then could trigger the migraine headache. Since the mechanism of the antibodies is really in the headache part, I don’t think I could come up with a good explanation as to why it should work for aura. The drugs are designed for the headache of migraines independent of whether you have aura or not.
Peter Salgo, MD: All right. What are the implications of the decrease in migraine-specific days? We’re going to talk about what this means to patients’ lives, in terms of how you use the drugs [and] how you view these drugs.
Stephen Silberstein, MD: I think it’s quite clear that these drugs are effective. They decrease the number of headache days, the number of migraine days, and the number of days that are either non-specific or specific migraine. It hits all the major points we care about for patients who have migraines and have failed other things. It’s really a life-turning-around event for many of these people. The shocking part to me is [that] I’ve had patients for 10 or 15 years who have failed every drug known to mankind, and now they’re back to normal.
Peter Salgo, MD: Well, for those patients, these drugs work great, right?
Stephen Silberstein, MD: Right.
Peter Salgo, MD: That’s your personal clinical experience.
Stephen Silberstein, MD: Correct.
Peter Salgo, MD: Share some more with me about these drugs.
Stephen Silberstein, MD: The first thing is, I do not know who’s going to respond and who’s not. I have people [who] have given up all hope; they don’t believe me. They come back 3 months later and say, “Oh my God, I should have believed you. I’ve never felt this good in my life. I haven’t had a headache since I’ve been on the drug.” And we have other people who do not do well at all.
The fundamental issue is [that] it seems to be [for both] CGRP [calcitonin gene-related peptide]—responsive and CGRP non-responsive [migraines]. Up front we cannot tell the difference. We don’t know whether Botox and the antibodies are synergists or not. Our game plan will be to analyze the patients, see how they did with the combinations, and then stop. If they’re doing great, stop the Botox, let it wear off, and see if they get better or worse.
Peter Salgo, MD: If you can’t tell a priori whether the drugs will work or not, does it make sense to you to say, “Try these drugs, Call us. Let us know who’s going to stay on them, and let us know who we’re going to take off.” As 1 way of getting data—you keep asking for data—there [are] some data for you.
Maria Lopes, MD, MS: We published data as well. But yes, 1 criterion that I already mentioned with reauthorization is, are these drugs effective? And the great hope is that they are reducing several migraines very significantly. Usually, that’s not the only [criterion] we’re asking to make sure that we’ll continue the therapy. The other is—the severity of the headaches—looking for a decrease in pharmacotherapy, back to the point that we had before. Hopefully, the rescue agents are being reduced. And there’s even a self-reported instrument that we’ll accept. What we’re looking for is not only is this the right patient, sequencing with at least 2 prior options that should have been used before, but also, if once they’re on the CGRP, is the drug working? I think that’s what we want to ensure.
Peter Salgo, MD: How do you respond when he tells you that what you’re asking for is not clinically relevant to the description of the patients he’s given you?
Maria Lopes, MD, MS: I guess we have a disagreement that needs to go back to what the criteria are, for which there should be a reasonable disagreement. Maybe there’s an educational gap, or there’s a literature gap, or [a] scientific gap, but I think that must be reconciled.
Peter Salgo, MD: And if there is a disagreement, who should make the call? Should it be the MD or the payer? I’ll ask each of you, and I bet I’ll get a different answer. I don’t even have an arbiter here.
Maria Lopes, MD, MS: With an appeal process, you go to a different physician if you appeal a second time. And you can ask for an expedited appeal with a specialty match reviewer. What that allows for is a dialogue to occur between the requesting physician and a similar specialist or a neurologist—dialogue that hopefully can get to the nuances of the case and make a recommendation. Usually the health plan then accepts that recommendation.
Peter Salgo, MD: Does that satisfy you?
Stephen Silberstein, MD: If you are not in the ability to have access to accessory health, the time it takes for a physician to go through this process is overwhelming. That’s the reason that many physicians will not take care of headache patients.