Peter Salgo, MD: Here [it] comes, I’m afraid to say this, the $64-billion question: cheap drugs, new expensive drugs? What are the coverage criteria for these CGRPR [calcitonin gene-related peptide receptor] antagonists? Who wants to take that one on? You can.
Maria Lopes, MD, MS: Well, I can start. Usually, we start with the FDA-approved indication, and also back to how the drug was studied. These are for patients who are usually 18 and older—back to the steps criteria, that’s quite common—right? Because these are typically patients who have tried and failed other options. Most payers don’t define failure except for the fact that they’ve tried it. So usually you’re looking at a look-back period of have they tried at least 2 agents? And many of them will also have duration limits, because you know you want to make sure that it wasn’t just that you fill the prescription. But perhaps you didn’t even take it for the appropriate time. So it’s not unreasonable that you’ll see the criteria that [reflect] 2 other options, which may be topiramate [Topamax], and antiepileptics, beta-blockers, or antidepressants, for a period of at least 2 months.
And then after that, the criteria are pretty straightforward, in terms of access to these agents. We do also usually reauthorize—the reauthorization piece. And that can be 3 months, that can be 6 months. Some may even have a year. But usually with a reauthorization process, you’re really looking to see, is there clinical benefit? Many have incorporated the 50% reduction in migraine days, which is a self-reported measure, but nevertheless it’s a checkoff box that occurs to make sure that these drugs have been effective.
Peter Salgo, MD: Now 1 of you 2 brought up the bugbear of the 2 drugs previously. Was that you and that you didn’t like that as a criterion?
Shoshana Lipson: No, I understand theoretically that it’s an important criterion, but there are some issues along with that. Part of it is that people’s healthcare plans keep changing. And so while it may be easy to track what patients have taken, if they stay with your healthcare plan, the reality is that most people do not. And so all that information just goes into records, records that are often not read. The physicians frankly do not have time to read all the medical records. I know that people like myself, who’ve been chronic for so long, we have tombs of records. To pile through that makes the appeal process much, much more complex. It doesn’t always work. And then there are tolerability issues and contraindications. My approach of migraine patients would tend to be [that] it should be in the hands of the physician and not in the hands of the payer.
Peter Salgo, MD: They want to say.
Stephen Silberstein, MD: Let me just [interrupt] for a second.
Peter Salgo, MD: Go ahead.
Stephen Silberstein, MD: You’re both right. But I think it should be failure of…
Peter Salgo, MD: Have you considered a job at the United Nations?
Stephen Silberstein, MD: No. Failure of, contraindication to, or adverse events—3 strikes on the same drug. So you’re right; you’re both right. If for some reason you can’t take 2 drugs, you should be an automatic candidate. If you took 2 drugs and you got horrible [adverse] effects, you should be a candidate, and you shouldn’t be forced to take a drug, which you could not tolerate for 2 months. So I think we’re both saying the same thing.
Shoshana Lipson: Right.
Stephen Silberstein, MD: Most of the companies include that in their language.
Shoshana Lipson: Right, absolutely.
Peter Salgo, MD: Is that fair?
Maria Lopes, MD, MS: Oh, yes. There’s the policy, and then there [are] the nuances of the circumstance, right? And usually you have to incorporate that in.
Wayne N. Burton, MD: We do.
Shoshana Lipson: One of the challenges is that a lot of patients are not aware of the appeal process. A lot of doctors’ offices don’t have the time to follow through effectively. And so, I hear from a lot of patients who say the medication was denied. And I’ll say, “Well, appeal.” “How do I appeal?” They say, “I was denied again.” “Appeal again.” And so patients don’t always know their rights. They don’t know the process, and sometimes we get kind of driven around. We’ll contact their doctor. Their doctor will say, “I submitted it.” We’ll contact the company to make sure. The company will say, “I never got any information.” Go to the pharmacy, [and] the pharmacist says, “Don’t involve us.” And so it just feels [as if] we’re on a merry-go-round, because the process is not clearly laid out, and the patient’s role in that process is not clear.
Peter Salgo, MD: My sense is, your process makes sense to you, your paperwork makes sense to you, but it’s opaque to a patient and often opaque to a doctor’s office [that] doesn’t do it every day. Is there some way to make all this a lot more transparent?
Maria Lopes, MD, MS: Well, usually in the building of PA [prior authorization] criteria, we actually involve a neurologist. We have a neurologist sitting in our P&T [pharmacy and therapeutics] committee.
Stephen Silberstein, MD: I have been involved.
Maria Lopes, MD, MS: Thank you. I think this does illustrate a gap and an opportunity—an educational opportunity—at so many levels. And when we think about where patients are accessing care, whether it’s the ER [emergency department], whether it’s their PCP [primary care physician], there are so many gaps, not only in terms of physician education but also member self-empowerment education.
Peter Salgo, MD: I remember very well [that] I was asked to go to a conference in which there were a lot of insurance people, and this was not for health insurance but life insurance. And they said, “We’re really happy, we’ve rolled out a form online that folks can use to apply for life insurance and do it themselves.” And I read the form, and it wasn’t written in English. It was written in insurance speak, and that’s tricky. Because to people in the payer’s side, all these words make sense, but they’re very specific words. From your perspective, that’s what we say. But not from somebody who is trying to use this form—some poor person with migraines or a physician’s office.
Shoshana Lipson: Definitely, right.
Peter Salgo, MD: But from the patient’s perspective, sometimes even a language shift is important, yes?
Maria Lopes, MD, MS: Well, it’s interesting from whose perspective, right?
Shoshana Lipson: Right.
Maria Lopes, MD, MS: And how transparent the process is—how easy the process is. But a lot of these prior authorization criteria are actually online. We’re trying to facilitate the ability to check off boxes so that we’re not overly burdensome to the provider or even the patient. But it is a process.
Peter Salgo, MD: Let’s spell it out. What are the coverage criteria for the CGRPR antagonists? Is there a criterion across all coverage or across all employers?
Maria Lopes, MD, MS: Each health plan will have [its] own criteria.
Peter Salgo, MD: I knew you were going to say that.
Maria Lopes, MD, MS: Yes.
Stephen Silberstein, MD: It’s failure of contraindications or significant [adverse] effects. And depending on the plan, it could be 1, 2, or 3 prior drugs. And there’s 1 health plan that probably should require the failure of a triptan, not realizing it’s not a [preventive] drug.
Peter Salgo, MD: All right.
Shoshana Lipson: There [are] also a couple of health plans that actually require that the CGRP inhibitors be prescribed by a headache specialist. And some states don’t have certified headache specialists.
Peter Salgo, MD: You pointed that out earlier. There aren’t enough.
Shoshana Lipson: Right.
Peter Salgo, MD: I’ll ask a loaded question. Do you think this is deliberate? Do you think that they’re doing this so that they don’t have to prescribe these drugs?
Shoshana Lipson: You shouldn’t be asking me that. You’re really putting me on the spot now.
Peter Salgo, MD: You’re the one with the blog.
Shoshana Lipson: Well, there is some concern—that would be putting that mildly—in my group. And some people get angry. I always tell people, “Don’t get angry: advocate. Get informed, advocate for yourself, and talk to your physician.” Open that conversation up, and see if you can effect change.
Peter Salgo, MD: Are these agents on the formulary?
Maria Lopes, MD, MS: Yes.
Peter Salgo, MD: They are?
Shoshana Lipson: Not always. They’re not always on the formulary. I know that for myself that they’re not. But I also know that I know how to appeal, so it is possible to get formulary exceptions. Again, a lot of patients don’t know that.
Peter Salgo, MD: [For] each individual prescription for these medications, does each of them require step therapy and prior authorization?
Maria Lopes, MD, MS: For the CGRPs, yes.
Peter Salgo, MD: Yeah.
Maria Lopes, MD, MS: As does also botulinum [onabotulinumtoxinA]. They usually follow a step approach to be able to get these agents.
Peter Salgo, MD: In your view, do patients have appropriate access to these new drugs?
Stephen Silberstein, MD: I am very lucky, because where I am, they’ve opened their own specialty pharmacy that has the ability to do the appeals now in 3 states, which is the majority of my patients. All I have to do now is send the prescription to my specialty pharmacy, [which has] access to my records to the same institution, and that has been a significant burden relief for me. And then they can find out, from the individual payer, which of the drugs are approved and what can be done. To have done that before, I had insanity among my staff.
Peter Salgo, MD: Once you’ve started on 1 of these new drugs—the biologics—let’s start clinically, in your perspective, how long do you give it before you decide it’s either working or not?
Stephen Silberstein, MD: We actually have data. We actually analyze over our studies because I originally was of the incorrect opinion that if it doesn’t work immediately, it was not going to work. We looked at people who failed at 1 and 2 months, how they did several months later. We found that, of those who failed, almost half did very well later with almost no headaches. So I think that my bias now is at least a 6-month trial.
Peter Salgo, MD: Do you give them 6 months?
Maria Lopes, MD, MS: Well, the reauthorization criteria, again, for health plans that have a shorter time frame, 3 months, that’s an educational opportunity. Especially with real-world data, [they help] us understand how long a trial should look like. So 6 months usually. Some will give a year.
Peter Salgo, MD: What do you think?
Wayne N. Burton, MD: I would agree. I think the guidelines do vary from 1 insurance company to 1 provider [or] another. And major companies are using more than 1 provider. So we would support the evidence-based, the guidelines, from national organizations in that regard.
Peter Salgo, MD: Six months? A year?
Shoshana Lipson: I would definitely say 6 months. If you can tolerate the medication, then definitely 6 months, partly—not only because of the clinical evidence from the trials but also because migraine is such a variable disease. It goes up and down.
You could go on 1 of the new medications, and you could suddenly have 2 really bad migraine months. It doesn’t mean that the drug is failing you, it just means that you are having 2 bad migraine months. And the converse is also true. So you need to give it a reasonable period of time.
Stephen Silberstein, MD: I believe these drugs act as neuromodulators. I’ll give you an example. [In] people with epilepsy or depression who had implanted vagus nerve stimulators, you don’t get results for a year. So I think a year is probably too long. I think 3 months is too short; 6 months is the sweet spot. And I think that if a person is tolerating it, give them the extra 3 months because we’ve tried everything else in the world. It’s sort of the end-of-the-line therapy for them, salvaging them.