MedStar Georgetown Headache Center
Professor of Clinical Neurology
Department of Neurology
MedStar Georgetwon University Hospital
Jessica Ailani, MD, has disclosed that she has received consulting fees from Allergan, Amgen, Biohaven, Health Monitor, Impel, Lilly, Lundbeck, Neurodiem, Revance, Satsuma, Teva, Theranica, and Zosano; funds for research support paid to her institution from Allergan, American Migraine Foundation, Biohaven, Lilly, and Zosano; and fees for non-CME/CE services from Allergan, Amgen, Biohaven, Lilly, Lundbeck, and Teva.
CGRP Monoclonal Antibodies in Clinical Practice
There is not a day in my headache practice since May 2018 that I don’t hear about how the CGRP monoclonal antibodies (mAbs) have changed the lives of my patients.
Many patients do feel better right after the first injection, with little to no adverse events. I have not been able to discern if one of the 3 SQ CGRP mAbs (erenumab-aooe, fremanezumab-vfrm, galcanezumab-gnlm) is better than another, and eptinezumab-jjmr, although FDA approved, has not been ready for prescription as of the time this article is written.
I have had some surprises since using these medications, but my biggest is the variability in onset of efficacy. In patients with refractory disease (failure of several previous preventive and acute options), CGRP mAbs can take much longer to see an effect. I have found that if patients return for a follow-up after 3 injection cycles (3 months) and feels no different, then stopping the CGRP mAb is appropriate. If, however, they have the same frequency but improved severity or improved disability after 3 rounds, then I will have them continue for a total of 6 rounds of medication before deciding to continue or stop.
I have also found that patients can develop injection-site reactions months after being on the CGRP mAb. In fact, it does not usually happen the first month or so. This is something to consider when talking to patients about these reactions and what to expect.
Challenges and Coverage
The greatest challenge I face is deciding which CGRP mAb to use for the person with migraine in front of me. In my mind, any patient with migraine who needs a preventive medication, who is not considering pregnancy in the next 6 months and is not lactating, would be a good candidate for our first class of migraine specific preventives.
I do recognize this presents a healthcare economic issue. Most insurance companies will require the patient to have tried and failed 2, sometimes 3, specific oral generic preventive medications before they qualify for using a CGRP mAb. If my patient meets this criterion, then the next decision step becomes an insurance one.
Each insurance pharmacy benefit plan (PBM) has their own preferred CGRP mAb and their own set of regulations in who can qualify for the CGRP mAb. Most patients do not know who their PBM is, and often think they can just call the back of their insurance card to find an answer to what is covered. We ask patients to check with their PBM which CGRP mAb is preferred before they make their choice. Sometimes they get a clear answer, but often it is incorrect.
I have limited sampling CGRP mAbs for this reason. I have had situations where the patient is started on one medication in my office after getting a verbal confirmation over the phone about which CGRP mAb is covered. Later, we can get our prior authorization denied because that specific CGRP mAb is not covered. As we have no evidence about switching CGRP mAbs, I would rather my patient not try one mAb one month only to switch to another the next month.
If my patient does not have commercial insurance, cost can be a real deterrent for starting a CGRP mAb or, worse, for staying on a CGRP mAb. Although CGRP mAbs are covered by Medicare/Medicaid, patients may still have to pick up a significant part of the cost. If they are in certain financial circumstances, many of the pharmaceutical companies that make the mAbs offer programs to help cover the cost of the drug, but most of my patients have been just above the income limit and have not qualified. I have had patients trying to choose between their CGRP mAb and their various blood pressure medications or their spouse’s medications.
If insurance offers to cover the 3 currently available options and patients have commercial insurance and can use a copay savings card, the decision comes down to the type of injector they prefer. We review the 3 options, let the patients sit with them for a few minutes, and almost always, they decide. From what I can see thus far, patients prefer a monthly autoinjector that is easy to use and has the least adverse events. There is no evidence to support my clinical observations!
Ongoing Questions on CGRP mAbs
There are no head-to-head comparison studies of the CGRP mAbs, so there is no evidence to suggest one CGRP mAb is better than another. There is also no evidence about switching CGRP mAbs. If a patient does not respond to one CGRP mAb, should they switch to another? If they do, how long do they wait? With long half-lives, it can take 5-6 months for the medication to be cleared from the system. If they start one CGRP mAb right after stopping another and they get better, is that from a combination of CGRP mAbs? Are we causing any harm to patients if we don’t wait several months between switching CGRP mAbs? How do patients do when they combine these medications with others commonly used in people with migraine and how does this affect health over decades? These are all questions that future research needs to focus on as well as continued collection of safety data with real-world use.
The CGRP mAbs have changed the practice of headache medicine. Many more people are able to return to “what life is supposed to be like,” using less acute medication and, in some cases, returning to work after a decade of disability.
Being more specific, CGRP mAbs have fewer adverse events than commonly used oral migraine preventives but come with a higher cost. We need more long-term safety data to have a better understanding of what suppression of CGRP over decades does to people with migraine.
What are your observations and challenges in prescribing CGRP mAbs for your patients with chronic migraine? How do you discuss the options with your patients? Answer the polling question and leave a comment in the discussion section.
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