Peter Salgo, MD: What about strategies for preventive treatment?
Stephen Silberstein, MD: We have criteria and a number of criteria. First and foremost, if a person continues to have severe headache despite acute treatment, 2) if they have 1 or more migraine headaches a week, they should be treated because of risk of getting daily headache, 3) patient preference. If a person is in an occupation where to have a migraine would be horrible, like they play football, if you’re a neurosurgeon or an orthopedic surgeon—can you imagine having an orthopedic surgeon—or [a] neurosurgeon operating on your brain and going blind from [a] migraine?
Peter Salgo, MD: Speaking as an anesthesiologist, who could tell the difference? But that’s another question for another day.
Stephen Silberstein, MD: That’s a different issue. And then the other issue would be medication misuse, overuse, and last, unusual disorders like hemiplegic migraine, migraine with prolonged aura, basilar migraine, those would be the indications for treatment.
Peter Salgo, MD: I don’t want to make light of this, but this is a nasty disease. If a certain percent. Let me put it this way. What [percentage] of all patients probably should be on preventive treatments?
Stephen Silberstein, MD: Of all the patients with migraine.
Peter Salgo, MD: All-comers.
Stephen Silberstein, MD: Forty percent should be on it, and only 13% get it.
Peter Salgo, MD: I was going to go to that other half, and you beat me to the punch. All right. From a payer’s perspective or [an] employer’s perspective, [there is a] huge gap here—people who should be on it, people who aren’t on it, why not? Are there criteria that you’re using different [from] the criteria that he’s using?
Wayne N. Burton, MD: Well, I think the major reason is educational. And what employers are doing is educating employees and their families about the seriousness of migraine, the impact on work, and so forth. In terms of benefit plan design, the pharmacy benefit managers that major employers use have a design, and there’s a preapproval process depending on which migraine drug is used.
Peter Salgo, MD: I’m going to ask it again because I heard word salad: preapproval, there are procedures. Let’s boil this right down, shall we?
Stephen Silberstein, MD: It’s the cause of the opioid epidemic.
Peter Salgo, MD: It’s a cause.
Stephen Silberstein, MD: If you’re a family doctor, in the older days, [do] you want to spend an hour on the phone getting a triptan for your patient, or do you just write a prescription for narcotics?
Shoshana Lipson: Right.
Peter Salgo, MD: But again there’s a huge gap. I’m playing devil’s advocate. I don’t mean to be flippant about this, but a lot of doctors complain about this. They know what they want to do, they know that they should prescribe, they know that preventive treatment is right, and the paperwork or in this day and age, the silicon work beats the ever-loving something out of them and they give up. Why is that barrier there? I’m assuming there is a barrier.
Maria Lopes, MD, MS: Well, let’s put it into perspective.
Peter Salgo, MD: Please.
Maria Lopes, MD, MS: We do have generics, so generics usually do not have barriers. Those include the triptans. And unfortunately, many times what a payer sees is utilization. So we will have things like quantity limits that are based on a per-prescription fill, which can be seen as a barrier but it’s also the reality of the cost associated with some of these therapies. So in general, the generics, especially now that we have triptans, are not a barrier to access.
Peter Salgo, MD: OK. If I hear what you’re saying, there are no barriers. There are very few barriers. Cost, because there are generics, and some of these drugs are not the reason. So why is it that he wants more people on preventive treatment and they’re not getting it? Is it you?
Maria Lopes, MD, MS: Well, also let’s look at what are the options that can be used for [preventive] therapy, that hopefully from a patient perspective—especially given generic options—will offer the ability for patients to afford these therapies long term. And so back to the generics that are also encouraged as first-line [according to] the guidelines, and those include the beta-blockers, those include really optimization through a process [that] includes beta-blockers, antidepressants, etc. So we usually think of those lower-cost options first that are also based on guidelines and evidence-based medicine, including topiramate as well. If there’s contraindications to these, that’s usually when the prior authorization kicks in to try to move up upstream potentially higher-cost agents.
Peter Salgo, MD: But you understand the frustration, right, which is I’ve got a patient with migraines. There are really good drugs out there. I’m calling you, and you’re going to say give them a beta-blocker, and I’m going to go, No, I want to give them something that works.
Maria Lopes, MD, MS: Then tell us why.
Stephen Silberstein, MD: I disagree with you. There is no scientific evidence that any [preventive] drug works more than half the time. And…today most people who failed have tried beta-blockers, or topiramate, or divalproex, or…[an] SNRI [selective serotonin-norepinephrine reuptake inhibitors], or amitriptyline. I think the way to look at it is if there’s a medical contraindication to taking a class, let’s say in bradycardia, you can’t take a beta-blocker. Let’s say you’re manic; you can’t take an antidepressant. So basically, my bias—and I think many of the companies are reasonable—that if you failed or have contraindications to the major drugs, you’re eligible to move up, whether it’s for botulinum toxin or to an antibody. I think the problem is not the rules, but once you’ve made the criteria, the difficulty of going to the next step. And my advice to the payers would be [that] if you meet the guidelines and you say you have to fail 2 drugs, why not automatically approve it instead of having to talk to 10 people. It costs you money, it costs us money, and I think the process can be simplified.
Wayne N. Burton, MD: I think the other point here too is that more and more employer-sponsored plans are in high-deductible plans. So the employee has [a] high deductible, it’s [an] out-of-pocket expense, and they really will want the lower-cost options tried first before the higher-priced options.
Peter Salgo, MD: It may be worse than I even thought. If what you’re telling me is this large parentage of people are undertreated or not treated adequately, it’s not that they’re getting the newer expensive drugs; they’re not getting even the cheap stuff.
Stephen Silberstein, MD: That is correct.
Shoshana Lipson: That’s correct, yes.
Peter Salgo, MD: So whose fault is that?
Shoshana Lipson: That’s a really good question.
Peter Salgo, MD: Thank you.
Shoshana Lipson: Part of the problem is access to healthcare practitioners who actually are educated in treating, diagnosis, and effectively treating migraine. That’s a huge problem in America—actually, globally. So we only have just over 500 certified headache specialists, I believe, right now.
Stephen Silberstein, MD: That is correct.
Shoshana Lipson: But we have nearly 40 million people with migraine.
Stephen Silberstein, MD: Forty-seven.
Shoshana Lipson: Right. OK, so much worse than I thought.
Peter Salgo, MD: He’s picky about this.
Stephen Silberstein, MD: No, the new number just came out.
Shoshana Lipson: That’s wonderful. Is the number still about 6 million who are chronic?
Stephen Silberstein, MD: Yes.
Shoshana Lipson: So it’s a little bit higher. So if you were to put that down with the number of patients who have to be seen by every certified headache specialist, just those who are chronic, it’s completely undoable. So first just finding a physician who knows how to treat is a huge issue, and then you have the problem that a lot of insurance plans do not cover certified headache specialists. There is none in their network. And then you will go to 1 neurologist and then another neurologist, most of whom are actually specializing in other areas like movement disorders.
Peter Salgo, MD: Oh, that’s just great. Before we move on and change the topic just slightly, let’s put a button on this. What is the AHS [American Headache Society] position statement for the migraine preventive treatments?
Stephen Silberstein, MD: Basically, the American Headache Society—and I helped write the paper, adopted the guidelines that we created for migraine treatment, the same basic concept—…[says] that people should have the right to use the new monoclonal antibodies at the appropriate stage of their treatment and not have to go through hoops to get it.
Shoshana Lipson: I’d like to add there that there is a sense among the migraine community that the decision for effective treatment has been taken somewhat out of the hands of the physicians and the patients and put into the hands of the payer who doesn’t actually know all the patient history and the implications of the treatment. So your doctor will prescribe 1 medication, the insurance company will say no, you have to do this, and it’s very complex.
Peter Salgo, MD: Is that fair? I’m going to give you 1 last pop at this. They just took a swipe at you. You want to swipe back?
Maria Lopes, MD, MS: Well, we love guidelines. Guidelines really help us try to [be] not only evidence-based but also cost conscious. So if a guideline appropriately defines who is the right patient, what should the sequencing of options be, I think we all need to keep in mind that you can appeal. And there [are] always circumstances in which you may not quite fit the step approach, but we usually start with guidelines in terms of crafting policy.
Wayne N. Burton, MD: And really it’s the right drug in the right patient at the right time.