Improving Access to CGRP Therapies for Effective Migraine Treatment

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Welcome back to PopHealth Perspectives, a conversation with the Population Health Learning Network where we combine expert commentary and exclusive insight into key issues in population health management and more. 

Matthew S Robbins, MD, FAAN, FAHS: My name is Dr Matthew Robbins, I'm a neurologist and headache specialist. I work at Weill Cornell Medicine and New York Presbyterian Hospital in New York City, where I'm an associate professor of Neurology. I direct the Neurology Residency Training Program, and I'm the Louis and Rachel Rudin Foundation Education Scholar. I'm a headache specialist, which means that I am both a neurologist and completed additional training in the field of headache, and I serve in various roles in the headache field, including currently I'm the president elect of the American Headache Society. 

Could you discuss the current barriers patients face when accessing calcitonin gene-related peptide (CGRP) therapies for migraine treatment? 

Dr Robbins: Sure, I guess there are many barriers. I think we know that these anti-CGRP therapies, which have come out ever since 2018, have been pretty transformative in how we manage migraine overall. And they're generally separated into two groups. There are CGRP targeting treatments that are used for acute therapy, as rescue medicines when someone has a migraine attack, and which are used once an attack has already started. And then there are the treatments that we call preventative therapies that are used on a day-to-day basis, or cover someone on a daily basis, to reduce the frequency, the intensity, and the disability of migraine or chronic migraine overall. And because they're newer treatments, obviously where they fit into the hierarchy of how we use them is not totally certain based on experience, based on cost factors, based on comfort and clinical practice. 

I think naturally when they came about, there were many more barriers to using these treatments in clinical practice with lots of step therapy that's been required, where other treatments are required to be used first before then we move to one of these more specific migraine treatments. But, as we're learning over the years, that might not really be the best approach. And there's been this evolution of where we've been comfortable with recommending these treatments, especially as preventative treatments as among the first-line therapies. 

What strategies can be implemented to reduce unnecessary trial and error with non-specific treatments in relation to CGRP therapies?

Dr Robbins: Yeah, I think in clinical practice, there's a variety of ways in which this can be done. I think first of all, the science and the experience has to really dictate what we do. The clinicians, the doctors and specialty care and primary care, the other clinicians like advanced practice providers should be the ones to decide where these treatments are used, not some third party who has never met the patient. I think that judgment should always take precedence. I think how we kind of navigate these barriers in clinical practice, which seem to be diminishing over time, but certainly are still present, are in many ways different for when you use them as acute treatments or preventative treatments. I think for preventative treatments where we really have much more solid footing to say that they should be among the first-line preventative treatments. And perhaps at some point they will be “THE” first-line preventative treatments. I think we have to just really advocate for the patient in our documentation - why that they should be prescribed even if some of those other older preventative treatments that are nonspecific have even not been used. 

I can give a few concrete examples. One might be, say, a patient of mine has migraine that's very frequent. I really think an anti-CGRP treatment as a preventative therapy would be the best for them because I think it's going to work better. I think that the side effects are going to be fewer. Say this patient is, I don't know, a college student who is 21 years old. And I asked them about their history and other symptoms in life that they may have had. I might really find out pretty quickly that one, being on a preventative treatment that's older, that has a risk of cognitive side effects is just totally unacceptable to them, which I would find similarly as someone who's a professional. So therefore, a medicine like topiramate would be a bad idea for them. And why put them through the exercise of trying it when it has such a high risk of side effects? 

And say there is someone who is prone to getting lightheaded here and there when they get up out of bed too fast, then probably putting them on a blood pressure medicine like a beta blocker or a medicine called candesartan, those are among first-line treatments might also carry a much higher risk of having them pass out as a side effect. I think often what I've been shifting to in my own documentation is by sort of being upfront with these potential risks and saying, these are 2 strong relative contraindications to treatments that already exist for migraine. I think it makes sense to go with this newer treatment, which could be a CGRP-targeting monoclonal antibody or a CGRP blocker, which we call gepants, as the preventative therapy to use. And generally, it's been more successful taking this type of approach. 

I appreciate the examples, I feel like that really helps illustrate your point. In your opinion, what role do health care providers play in addressing barriers to access for these therapies? 

Dr Robbins: Yeah, I think advocacy is really important. I think step therapy is not just in a vacuum with how people with migraine need to access treatments that are going to be so right for them. I think that this happens in other areas. Within just neurology, we see this in people who have epilepsy or multiple sclerosis, certainly where newer treatments are more expensive but might really be cost saving in the long run by limiting disability over time, limiting unnecessary diagnostic tests, limiting unnecessary trials of other medications. I think going with medical professional and foundation advocacy events that help to work on step therapy sensible approaches are really important. 

There's the Safe Step Act that's currently a national issue when that many different professional advocacy organizations have been advocating on Capitol Hill to keep the momentum to get this passed. That benefits so many different people with so many different medical conditions. I think the example I gave of doing it within an individual clinical practice is really useful. I find that the more I dig about someone's background and their symptoms and maybe they're what we call comorbidities, the more you can reason that they should be on a very specific treatment for migraine rather than something that's non-specific. Because there is so many other medicines that have lots of side effects. They have gastrointestinal side effects. They have cognitive side effects.  They have other conditions that might be aggravated or drug interactions. And I think being sort of proactive about how those are relative or absolute contraindications, even just in your charting, can really help to get to the right treatment straight away instead of leading to unnecessary prescriptions and delays. 

How can clinical guidelines and payer policies be better aligned to ensure that patients receive the most effective migraine care? 

Dr Robbins: Yeah, that's a great question. I think there's always such a delay with payer policies relative to what the field is doing. It takes a while for review, it takes a while for independent adjudication of what they think is cost-effective. I think that's understandable in the system that we're in that, of course, is imperfect. I think one example is what we did at the American Headache Society. I was a co-author on this position paper. Which we've done iteratively; this was the third such position paper since the end of 2018 about these newer CGRP targeting therapies. And we finally agreed with a very strong consensus from our members, from input from patients, from experts, that we had enough evidence and clinical experience that we didn't really want to wait for a guideline which takes so long to come out that has to transcend many different organizations. And we thought that a position paper that really just upfront stated directly that these should be among the first-line preventative treatments indicated. 

I think this took internal advocacy and I think we are hopeful that newer guidelines that will come out from the American Academy of Neurology, in joint with the American Head of Society with input from other stakeholders, will reiterate what we already have in our position paper just because the level of evidence from randomized controlled trials studying people with episodic migraine, chronic migraine, medication overuse, not medication overuse, migraine with aura, migrant without aura. I mean, it's been done in such detail with so many different layers and strata of people with migraine as primary populations to study in these clinical trials, that the evidence is so overwhelming that we're hoping that when the guidelines fully come out, it will lead to an even bigger sea change in these type and the hierarchy of these medications to use for migraine. 

I think one other point to make is that these newer treatments for migraine are really easier to use than some of the other preventative treatments for migraine. And because of that, I think I really agree with an emphasis that it shouldn't just be specialty care like neurologists or headache specialists who are using these treatments. Really it should be accessible and done in primary care because migraine is one of the most common reasons to see a clinician, period, in any environment. I think that's why we think such a position paper guidelines will transcend not just specialty care, but primary care. 

And then the other piece of nuance is that for acute treatments, the CGRP-targeting therapies, I think the evidence seems to suggest pretty strongly that the new anti-CGRP therapies on the whole may not work as well as the triptans, the sort of first wave of designer drugs for people with migraine. But in some people they do, and most certainly they have fewer side effects and fewer contraindications. I think at some point, although we don't really have head-to-head studies, the clinical trials suggest that they may not work as well for all comers, but I think that there may be reasons to use them as first line for those other reasons that I mentioned. I think a lot of the emphasis that I've been discussing has been on preventative therapies, but I think a lot of consideration will have to be done for acute treatments as well. 

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