But Wait, There's More! Nurtec ODT Joins the Migraine Landscape!
The past two years have seen some amazing developments in the migraine treatment landscape. Even so, as a migraine patient, nothing prepared me for the air of excitement that has been created in the past four months.
Maybe, like me, you can relate to the phrase we see so often with new products being shared on TV: “But wait, there’s more!”
This has never more so been the case than with the surprise FDA approval of Nurtec ODT, also known as rimegepant, on February 27.1 Probably the best-kept secret in migraine approvals to date, Biohaven’s groundbreaking oral dissolving tablet finally received FDA approval and is expected to hit the marketplace sometime in March 2020.
Reyvow, Ubrelvy, Vyepti, and now Nurtec!
The anticipation of new things to come started in late October with the FDA approval of Reyvow, followed up in late December with the FDA approval of Ubrelvy (both of which became available on the market for prescription in February 2020).
These two new abortive migraine medications were followed quickly by the approval of Vyepti (eptinezumab) the fourth CGRP monoclonal antibody preventive to hit the market - this time in a quarterly intravenous (IV) formula. And finally, Nurtec, the much anticipated first CGRP receptor antagonist in ODT form for faster absorption and bioavailability. 2
What is important to know about Nurtec ODT?
- It comes in the form of a 75mg oral dissolving tablet
- It may be taken up to once daily as needed (note: the safety of treating more than 15 migraine attacks in a 30 day period has not yet been established)
- The half-life is approximately 11 hours for healthy patients which means the majority of the medication is out of the body in just over two days, although it lasts long enough to have a sustained effect on a migraine attack.
- In trials, with many patients it helped relieve the “most bothersome symptom” (besides pain) within two hours including nausea, vomiting, and photosensitivity.
- It is not a controlled or scheduled substance.
- This medication does not cause vasoconstriction and so may be safe for those with cardio or cerebrovascular conditions. Please talk with your doctor for medical advice about your specific situation.
- Very few side effects presented in the clinical trials with the most frequent ones being nausea (2 percent), urinary tract infections (1.1 percent), and hypersensitivity reactions (<1 percent).
- It is approved for adults with either episodic or chronic migraine, with and without aura.
- Possibly most exciting: it is currently being tested in a clinical trial for preventive use. Topline results from that are expected shortly.3
Safety and contraindications
Triptans, Botox & CGRP monoclonal inhibitors: it is important to know that Nurtec was not specifically tested with triptans or Botox in the clinical trials, and there was only one extremely small trial for patients taking Aimovig (erenumab) concomitantly. We applaud Biohaven for recognizing proactively that patients on the CGRP preventive inhibitors are likely to use Nurtec. However, there is a long way to go to be sure of safety. A recent article in Neurology stated, “The mechanism underlying the benefits of concomitant use of a small molecule CGRP receptor antagonist and an anti-CGRP receptor antibody is unknown and requires further study.”4
Other contraindicated medications: using Nurtec at the same time as P-gp or BCRP inhibitors or strong CYP3A4 inhibitors can result in a significant increase in medication exposure and should be avoided. Using Nurtec at the same time as moderate CYP3A4 inhibitors can result in an increase in medication exposure; a second dose of Nurtec within 48 hours is not recommended. Strong and moderate CYP3A inducers used at the same time as Nurtec can result in a significant reduction in medication exposure and should be avoided.5 Partial lists of these medications can be found on the Hope for Migraine website,6 As always, please consult with your doctor for medical advice about your particular situation.
How do I know what to try?
This is one of the hottest questions out there right now. Which medication should I try first and which one is more likely to work for me? Unfortunately, migraine is a complex neurological disease that presents itself differently with each person. As a result, this is the unanswerable million dollar question!
In short, currently, there is no way to know which medication is more likely to help any individual person. Neither is it possible for us to know who will experience intolerable side effects. Similar to the use of triptans, it is likely that lack of efficacy with one medication in a class doesn’t necessarily mean a lack of efficacy with another. For example, it is possible that Ubrelvy may not be helpful to some patients but Nurtec will be. This is even more so the case with different classes of medications such as Reyvow.
If your doctor’s office offers free samples then that is a great place to start, but bear in mind that samples are often limited in quantity. As a result, this may not give you the best opportunity to really test the medication out, and particularly when there are multiple possible doses for a medication. In this situation, samples are unlikely to give sufficient opportunity for extensive testing. That all means turning to copay programs for those who have commercial insurance. For those with government-funded insurance, it means fighting for affordable coverage from day one.
How do I handle my insurance company?
- If you have commercial insurance, don’t rely on a copay card for indefinite coverage. Some programs will cover you for up to a year, even if your insurance keeps denying. Other copay programs require you to get insurance approval after just one prescription fill. What this means is that you need to be on top of the process from day one!
- If you have government-funded insurance such as MediCare, Medicaid, or Tricare, then don’t give up before you begin. A lot of people are discovering that appeals are successful, and the squeaky wheel often gets the oil! Prior authorization (PA) requests have to be determined within 72 hours of submission according to the CMS, so a quick word of warning when dealing with MediCare: it's not a good idea to have a PA submitted on Thursday or Friday because if they need additional information to make a determination your doctor's office is likely to be shut and you'll get an automatic denial as that 72-hour window runs out. The subsequent appeal process is much longer!
- If your insurance denies coverage, don’t give up with the first denial! A lot of insurance plans routinely deny new medications the first time. However, it could be as simple as your doctor’s office submitting information for prior authorization or requesting a formulary exception due to medical necessity.
- Stay on top of the denial appeal process and by communicating regularly with your doctor, insurance company, and pharmacy. This enables you to see what additional information may be needed, or even if the process has become “stuck” somewhere en-route!
It’s a new day – so be hopeful!
Most of all, remember that this is a NEW DAY in migraine treatment. Stay hopeful, stay informed, and don’t get discouraged or give up! Migraine is a devastating and often incapacitating disease and you have a right to adequate effective treatment, as well as insurance coverage for the medication that you need.
So, is this new medication one that you are looking forward to trying? Have you been without an effective abortive treatment for migraine? Let us know when you try Nurtec if this is a good option for you!
Can you tell when a migraine attack is coming?