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Attaining Approval of Drugs for Prevention of Migraine



Peter Salgo, MD: Why don’t you walk me through [this] from a patient’s perspective, because you see patients’ applications. Walk me through what steps are required for approval of these agents for the patients. I know we’ve done this sort-of piecemeal. Put it all together for me.

Maria Lopes, MD, MS: Sure. There’s usually an online form, a fax form, or a medical-necessity letter that has to be submitted. These are higher costs. I mean, let’s face it.

Peter Salgo, MD: Well, why don’t we stop for a second. How much higher? What do these things cost?

Maria Lopes, MD, MS: Over $500 per month. We usually start with what’s called the WAC-price per month. Then we have high-deductible plans. Patients are typically paying off that WAC, so they may be paying 25% coinsurance, 35% coinsurance. The reality is not just access. It’s whether patients can afford [it] based on their premium, their co-pays, and their coinsurance. Can they afford to take these drugs long term?

Peter Salgo, MD: OK, let’s continue walking me through this, all right? What does a patient have to do to get approval for these agents?

Maria Lopes, MD, MS: Age—older than 18; that they have tried and failed or it’s a contraindication; that they have tried at least 2 other agents. And we give usually a choice—the antidepressants, the antiepileptics, or the beta-blockers. As long as you have tried 2 of these agents; some health plans will have 2 months, others will have 3 months. But a period of time in which you have tried at least 2 other options. And some will incorporate…I haven’t seen a headache specialist.

Stephen Silberstein, MD: Some will require a neurologist or headache expert.

Maria Lopes, MD, MS: But it’s usually a neurologist; they’re a specialist.

Peter Salgo, MD: That’s it?

Maria Lopes, MD, MS: Yeah, 90%. That’s the prior authorization [PA].

Peter Salgo, MD: If I take my iPhone, I say, “Hey, Siri, call my insurance company.” And Siri says, “How old are you? And how long have you been on this? Otherwise I’m not calling.” That’s it, the patient can just call you? Can you call? Can an employer call and get this done like this?

Wayne N. Burton, MD: Well, it would be the physician.

Peter Salgo, MD: Right. Because it has to come from an MD.

Wayne N. Burton, MD: Yes.

Peter Salgo, MD: Or a DO. I mean a physician. And that’s it?

Wayne N. Burton, MD: Exactly. Remember that most of these drugs are to be prescribed by a primary care physician, and if the primary care physician is following evidence-based guidelines, then it shouldn’t be a problem in the guidelines that we’ve talked about.

Peter Salgo, MD: This all sounds like, let’s join hands and sing “Kumbaya, all is right in the world.” But you sound agitated. What’s going wrong with this?

Shoshana Lipson: It’s not. In theory, the system should work. But in reality, it really doesn’t work. Part of that is because, as far as treating migraine disease, the system is very broken in the very early stages. On average, medical students only get 4 hours of training among all headache disorders in total. Even neurologists get [only] a couple of hours in general. If you go back, all the way back to primary care physicians, many of them have had 0 education, absolutely 0 on headache disorders. And they don’t necessarily have the time to read the AHS [American Headache Society] recommendations—which, by the way, are fabulous. I love them.

Peter Salgo, MD: But let me stop you. They’re not talking about AHS [American Headache Society] guidelines. They said 18 years of age.

Shoshana Lipson: Right.

Peter Salgo, MD: They said you’ve got to have tried 2, sometimes 3, drugs for a period of—fill in the numbers: 2 to 3 months.

Shoshana Lipson: Sure.

Peter Salgo, MD: That’s it.

Shoshana Lipson: But there are so many obstacles along that way. First of all, the patient has got to get to the doctor. Even if they can get to headache specialists, that can be a 3- to 6-month wait. Then the doctor has to submit it to the insurance company. The insurance company, in my experience, always denies the first time. It requires a prior authorization, or a 48-hour exception, so that goes back to the doctor. Well, not the doctor [but] the doctor’s office, [which] is often overwhelmed. So it actually doesn’t happen, or it gets lost in the paperwork. In the meantime, the patient is there saying, “What has happened to my prescription? I can’t work. I’m dying from pain. What do I do?” And so the cycle goes on and on.

Peter Salgo, MD: You wanted to say something.

Stephen Silberstein, MD: Before we had the help of a specialty pharmacy, our office was psychotic with preauthorization. And basically speaking, here’s where it breaks down. You send the prescription to the specialty pharmacy. You have no idea whether the individual insurance company will make the 1 of the 3 you picked—first, or second, or third tier. That’s the first step. Then you have to change the prescription and provide documentation of the criteria. At that point in time, there’s correspondence that goes up and back, but sometimes it gets lost. So we generally will allow up to a month for the preapproval process because of these complications.

Peter Salgo, MD: Now, all of what you said sounded fine. What they’re telling me sounds like real-world experience. Where’s the disconnect here, in your view? Because there seems to be one.

Maria Lopes, MD, MS: Well, I think many times it’s the shuffling of the paperwork. It’s, “Where’s the prescription?” The most common reason for denial is lack of information. Over 80% [are for] lack of information. If we actually could have a clear understanding of the steps you have to go through and make sure the patients also understand that. It’s better for them.

Shoshana Lipson: It is better if we understand, yes.

Maria Lopes, MD, MS: Also going through these lower-cost options. But if they don’t work, they’re also lower cost for the patient, and they’re aligned with guidelines.

Peter Salgo, MD: If I were designing a form, from your perspective, this form might have 4 questions: What drugs have you been on? How do they work? How long have you been on it? Can I have the drug? And you would say, “Is that enough?”

Maria Lopes, MD, MS: Well, each health plan may have its own set of rules.

Peter Salgo, MD: OK, but in general, what you outlined was, these are the drugs, [and] this is the length of time you’re on them. And if you fail, we’ll approve this drug.

Maria Lopes, MD, MS: Yes.

Peter Salgo, MD: It’s 4 questions.

Maria Lopes, MD, MS: And the overall architecture is around the guidelines. I think we can all agree that ultimately this has to be evidence based.

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