So I will go on the record as having been skeptical about the effectiveness of Botox for chronic migraine from the beginning. I doubted whether our patients would actually go through with the 31-injection procedure more than once, in order to get full effect. But I was hoping for the best. These teens with chronic migraine were suffering and why not try it.
We decided we would offer Botox for appropriate patients in our tertiary care headache program in 2016, and after jumping through many hoops within the institution, we started doing the procedure in August 2016. I went through the aesthetic training that was available (with additional resources for the migraine protocol). The challenge was and continues to be getting insurance approval, especially for those under 18 years. It has been a bit daunting, many phone calls and appeals. We need to make sure the documentation is adequate and clear, indicating that they meet the criteria, and so on.
After working out the systemic kinks, we have been consistently doing Botox for chronic migraine patients in clinic at least 5, up to 10+ times/month, depending on the timing of procedures (every 12 weeks). Already in the month of July, I have done 7 Botox procedures. I have been keeping an Excel spreadsheet, and have 155 individual procedures on 50 discrete patients since August 2016. We are now looking at the outcome data and planning to write up the results and our experiences for publication.
So how did it go? Well, consider me a believer! I have been so pleased with the positive effects for our teens. Almost every patient has had a positive effect. In the literature and anecdotally, it is reported that the biggest positive effect tends to be after the 2nd procedure. I have definitely seen that. I have seen a few patients achieve minimal improvement. But I have also had plenty of patients with very significant positive effect after just one procedure. There has been at least a 50% reduction in migraine for many teenagers. And there have been a few patients who went from having 3-5 migraine days/week to 1-3 migraine days/month, after 1 or 2 treatments. And there have been a few who, after 1 Botox procedure, had not had any migraine at all before the next scheduled procedure. I could not be more pleased!
As I said, we are looking at the data now for good statistical analysis, so my reporting here is just personal observations. I perform about 90% of the Botox procedures in the clinic, so I experience first-hand the positive results and life changing effects for our teens. I don’t want to be overly positive without the real numbers and stats, but WOW!
Our population for Botox has been those teens with chronic migraine between ages 16 and up, mainly starting with their first procedure at age 18. Insurance barriers have been significant and it can be discouraging to have to manage patients as best we can, until they reach the magic number of 18 years old. Since you never know when the insurance company will approve the procedure, we start making the effort for appropriate patients around age 16. We have definitely have been able to get some of those approved (I am guessing about 50%). And there have been a few under age 16 who have been approved for it.
You would think that undergoing the procedure is very challenging for teens (lots of shots! all over the head! even in the face!). I do have some patients who cry throughout the procedure, every single time. But for the most part, after the first time, they do great. As our youngest patient (age 13) said, “it is no worse than having your eyebrows waxed!” Some kids might disagree with that, but once they experience the positive effects, they manage just fine. I perform the procedure the same way every time, taking time when needed, being as compassionate as possible, but also getting it over with. They know what to expect, how to do breathing, when to put the ice pack on their forehead, and at the end, they get Gatorade and a snack.
There have been few side effects, mainly neck soreness, flu-like symptoms for 48h max, and the occasional temporary eyelid droop. Most kids have no side effects and so far no long-term adverse effects. They know they will not be able to raise their brows, and often will comment that they know it is time to come back when they can move them again. And every single mother, every time, will ask if there are any leftovers for them, to smooth out their wrinkles……. followed by the obligatory eye roll from the patient……..
One of the questions I am asked is how does it really work. Well, not to get too much in the scientific weeds about it, it is more than just paralyzing the muscles that are injected. It works on the local cellular level, within the same CGRP system (anti-CGRP). Since the medication stays where you put it, rather than acting systemically, there are fewer long term effect concerns. As I stated in a previous post (What’s the deal with these new migraine medications?), there are risks to using these agents systemically on the rapidly developing young brain and physical body (Aimovig, Ajovy and/or Emgality).
In my opinion, the reason it is working well for the adolescents is related to the years and level of chronicity of migraine. There is a huge difference between a teen chronic migraineur, who may have had chronicity for 1-2 years, and an adult who may have had chronic migraine for 10+ years. These kids are also going through a period of rapid brain development, which may help reverse/heal the chronic changes.
There has not been much in the literature about using Botox for chronic migraine in children and teens. This has made it challenging to get the medication approved through insurance. There is a recent retrospective study done by Shah, S, et al, in 2018, which does support the use of Botox for this population. Their conclusion is as follows: “The results of this retrospective review of longitudinal analysis of Onabotulinumtoxin A use for the indication of pediatric migraine are highly encouraging and showed a clinically and statistically significant decrease symptom burden in intensity, frequency, and duration of migraine. The authors conclude onabotulinumtoxin A appears to demonstrate high potential an as a therapeutic for the diagnosis of chronic migraine in the pediatric population.” AGREE!
Another concern I recently encountered was that in the approval process, when the insurance company asked about previous medications (to meet criteria), they asked if the patient had already tried an anti-CGRP medication. Since these medications are not approved in patient below age 18, I wonder why this is part of the criteria now. We are not comfortable prescribing them due to no real long-term data about the effects on the developing brain. My cynical, skeptical mind wonders if this request/requirement is more about payment/financials than clinical benefits, since the drug companies do offer these new medications for 1 year at very little cost to the patient and no cost to the insurance company. I do find it disturbing. We’ll have to see if this is a trend.
So while the hurdles are high, Botox for chronic migraine for teens is definitely worth the trouble. The clinical results have been great, minimal long-term risks or side effects. In the words of my now-young adult patient, who started Botox right after her 18th birthday: “Botox changed everything and gave me a life!”
Reference: Shah, S., Calderon, M.D., Wu, W.D., Grant, J. and Rinehart, J., 2018. Onabotulinumtoxin A (BOTOX®) for prophylactic treatment of pediatric migraine: a retrospective longitudinal analysis. Journal of child neurology, 33(9), pp.580-586.