Botox® and Migraine

I thought I needed to add a news item because Botox® (Botulinum Toxin Type A) in the treatment for migraine is getting a lot of hype in the news and that will only increase in the coming year.

Background: I think it was sometime in the 90s that cosmetic medical providers (those who were injecting Botox® for crows feet and wrinkles) started to hear testimonials from their patients, who had migraines, that their migraines were better. Allergan, the makers of Botox®, saw an opportunity to investigate this claim from a scientific perspective.

Through the 90s and early part of this past decade many studies were done looking at injecting Botox® in preventing migraines.  While each study showed improvement, none of the early studies show enough improvement to meet the high standards of the FDA.

It was noticed that those patients with “Chronic Migraine” (a definable condition or type of migraine) did the best. So a multi-center nationwide study was done to specifically look at Botox® in the prevention of Chronic Migraine. That study did meet the threshold of the FDA for efficacy and Botox® was approved in the fall of 2010 for the preventative treatment of Chronic Migraine.

Is it a cure? Patients have to be very careful not to assume that Botox® is a magic cure for migraine. Nothing is. Like our other types of treatments, it does help, in my personal experience, about 50% of patients who use it. That benefit can be anything from the total prevention of the headaches to a modest improvement in frequency and severity.

I have many patients calling, asking for Botox® for their migraines.  The expectations must be realistic. It may help, even when other things have failed, but it may not.

How do I get it? Like any treatment, including the “natural treatments” there is a risk. The risk with Botox® is low. This is not a full disclosure of the risks and side effects of Botox® so I advise you to go here for more information.  The most relevant hindrance for using Botox® is its financial risk. Since it is not easy to manufacture Botox®, it is very expensive. We pay retail about $1100 for one bottle, which is enough to treat one patient.  Because of this great expense, the cost of using it is the most limiting factor in its use.

The insurance companies are  reasonably selective who they will approve for Botox® treatments. Many insurances do not pay for it at all. To qualify, the basic standards of the following have to be met:

  • Have headaches at least 15 days per month, each lasting at least four hours.
  • Have failed four good preventative medications trials
  • Been diagnoses by a neurologist as Chronic Migraine. While I’m not a “neurologist” I have been a Neurology PA for most of 30 years and the insurance companies recognize my expertise and that I know how to diagnose chronic migraine better than most neurologists.

If a patient wants to pay out of pocket to try Botox® for their migraine treatments, then there is nothing stopping them. However, with the cost of the Botox® itself, the hour-long visit to do the procedure and supplies, the cost could easily go beyond $1500 per episode. Botox® is repeated every 90 days.

How does it work? I will simply say no one knows. I’ve  had the opportunity to listen to the brightest minds in the world on the topic and none of them know so I won’t profess to know.  There are a few ideas but it is too complex to discuss here.

How experienced am I? I had my initial training in doing Botox® injections for migraine prevention when I was at the Mayo Clinic around 2000. Since then I’ve been to so many workshops that I can honestly remember but it is more than ten.  I began doing Botox® injections for migraine in 2002 and have done about 300 patients since.

Is there an Alternative to Botox®? Like with many branded drugs, there are “generics.”  In the situation with Botox®, it is a brand but it is also a unique chemical. This family of chemicals (which by the way are “natural” chemicals made by the clostridium botulium bacterium) have different unique agents, all which do the same thing.  Dysport® (see package insert here) is a brand, which is also a different chemical altogether from Botox® . The pros and cons of using this agent are the following;

  • Pros:
  1. It is cheaper, costing retail about $750 per treatment.
  2. The company which makes Dysport® is very easy to work with, allowing the ordering their products in timely manner and gives us full support.  This is not true for Botox® and the Allergan company. They have made it very difficult for us to order their product and give us very little support as a clinic for reasons that I can’t even begin to understand.
  3. I have also done twenty one treatments with Dysport® for migraine.

 

  • Cons:

 

  1. While Dysport® is widely used in Europe, there have only three small studies with migraine. While it looks promising, and equal to Botox®, the later has much more data to support it.

J. Michael Jones, MPAS-C