Peter L. Salgo, MD: Let’s talk about dosing and safety issues here. We talked about 70 mg versus 140 mg. How do you do that? How do you determine the need? How do you work through that?
Peter Goadsby, MD, PhD: The regulatory guidance says that 70 mg is the dose. For some patients, 140 mg will be useful. If you look at the clinical trials, about 4 out of 5 patients who are going to respond to erenumab will respond to 70 mg. If you’re a person who starts slow, then you start at 70 mg. If you’re a person who likes to jump in the water and get wet, you might start at 140 mg. Personally, I think it’s reasonable to start at 70 mg and move forward from there.
Peter L. Salgo, MD: These are parenterals?
Peter Goadsby, MD, PhD: They’re subcutaneous injections given monthly.
Peter L. Salgo, MD: It occurs to me that there are 2 possible outcomes for monthly injections. One is, “Great, I only need 1 injection per month.” The other is, “Oops, I forgot my monthly injection,” because it’s so infrequent. What’s your experience with this? How does it affect compliance?
Peter Goadsby, MD, PhD: The beauty of these medicines is that the effect is reasonably quick. If you forget your injection, the headaches will come back. You take your injection and they settle down pretty quickly. So, I don’t think that’s a huge problem. The affect comes on pretty quickly, and they’re well tolerated. You don’t have to gradually approach the dose because they don’t have cognitive problems, weight gain problems, or hair loss. You don’t have any of the problems that we’ve been talking about. So, it’s relatively easy to start and stop the medicine.
Peter L. Salgo, MD: It comes in either autoinjectors or prefilled syringes?
Peter Goadsby, MD, PhD: Autoinjectors.
Peter L. Salgo, MD: Is there a difference? Does it make a difference?
Peter Goadsby, MD, PhD: Oh, I think people prefer autoinjectors. I don’t think most people like injecting themselves.
Jill Dehlin, RN: The problem with the autoinjector is that it contains latex. So, people who have a latex allergy appreciate having the other option available.
Peter L. Salgo, MD: Can I ask the pharmaceutical industry why? Why would there be latex in an autoinjector? There’s got to be a technical reason, right? We’re trying to make the entire health care delivery system latex free. Maybe some people will require the prefilled syringes, right?
Jill Dehlin, RN: Yes. The autoinjector is easier to administer.
Peter L. Salgo, MD: Now that we’ve discussed the older therapies, going all the way back to the ergots and moving forward, which patients are candidates for treatment with the anti-CGRP [calcitonin gene‐related peptide] antibodies?
Jill Dehlin, RN: Insurance companies help decide that. Some insurance companies require a minimum of 4 headache or migraine days per month, then having failed 3 or more preventives, plus the use of triptans.
Peter L. Salgo, MD: Is that because these drugs are ruinously expensive?
Jill Dehlin, RN: They’re pretty expensive, but I participated in the Institute for Clinical and Economic Review [ICER] Hearing, and the people associated with ICER were pretty surprised that the price point of the drug came in as low as it did.
Peter L. Salgo, MD: Let’s stop dancing around this. How much does it cost?
Jill Dehlin, RN: $570 an injection.
Malaika Stoll, MD, MPA: $8000 a year.
Peter L. Salgo, MD: We’re not talking about some of the newer biologics, which are hundreds of thousands of dollars.
Malaika Stoll, MD, MPA: Right.
Jill Dehlin, RN: No. I think that’s why they were surprised.
Peter L. Salgo, MD: I’m surprised
Malaika Stoll, MD, MPA: It’s similar to Botox—the cost.
Peter L. Salgo, MD: Are you reserving this treatment for patients who fail other preventive therapies, or can we start these drugs because they work on treatment-naive patients? Why not just jump in, as you said, the deep end of the pool?
Peter Goadsby, MD, PhD: I don’t advocate for jumping in the deep end of the pool.
Jill Dehlin, RN: I don’t either.
Peter Goadsby, MD, PhD: I offered it as an option. It’s not unreasonable to have some step edits—to have had some reasonable exposure to simple preventives to make it easier for people who don’t respond to simple preventives to get easier access to these new medicines. I think there’s a collaborative way of thinking about this. Personally, I’m perfectly OK with having step edits and then having this medicine available.
Jill Dehlin, RN: Right. Sometimes Topamax [topiramate] works beautifully for people, or a beta-blocker.
Malaika Stoll, MD, MPA: And there’s a benefit for the patient, too—of not having to come in for that injection if they can manage it themselves.
Peter L. Salgo, MD: What are the side effects of the anti-CGRP antibodies? Are there any? What is the downside?
Jill Dehlin, RN: They are very minor. You may see constipation, rhinitis, injection site pain.
Peter L. Salgo, MD: So, nothing to write home about?
Jill Dehlin, RN: No. Because it’s such a large molecule, there’s no liver toxicity issue with the drug.
Peter L. Salgo, MD: So we’re not talking about a downside for patient toxicity. All that we’re really talking about, in terms of starting with one of these drugs as opposed to something else, is cost. If you can get away with something that’s efficacious and cheaper, why not, right?
Jill Dehlin, RN: Right.
Peter L. Salgo, MD: If that’s the only issue, there should be a rapid potential for escalation. Is there?
Malaika Stoll, MD, MPA: Absolutely. That’s where I revert back to the patient—physician relationship. You don’t want somebody who fails 1 or 2 options and goes away, just living with this. You want them to be educated of what the options are. You want someone kind of walking them through what the various options are, from the various providers. As a health plan, we have that responsibility, too—to educate.
Peter L. Salgo, MD: Is this class of drugs more geared for patients with episodic migraines or for chronic migraines?
Peter Goadsby, MD, PhD: Neither. The line between episodic and chronic migraine is entirely artificial in these half of 30% [patients]. That’s what the committee decided. I was on the committee at the time when the decision was made. The idea that 14 days or 13 days a month is not horribly disabling is silly. It seems to me that the question for these medicines is, who’s disabled? Who’s disabled, and what have they had? If they’ve had very reasonable exposures, and let’s talk about what the step edit should be, that’s a discussion to have. Putting a line at 15 days a month, I really don’t see great logic in that. I think it’s for people who are disabled, who have failed previous preventives at a reasonable number.