Migraine Headache Prevention with Botox™ By John D. McCann, MD, PhD

Discovery of Botox™ Benefit for Migraine Prevention
Many years ago when treating cosmetic patients with Botox™ to reduce wrinkles in the forehead and eyebrow region some patients began to note an improvement in headaches which lasted as long as the Botox™ was effective for reducing wrinkles. I used to think the overlap was atypical but it is not surprising when you realize that 18% of women suffer from migraines. An over abundance of these patients collected in my practice because they liked both the reduction in wrinkles and the reduction in headaches. Eventually this was studied and it was found in double blinded placebo controlled studies that Botox™ reduces the frequency and severity of chronic migraine headaches.

Insurance Coverage
The major hold back to the treatment for years was that insurance companies would not pay for it. Now most insurance companies will pay for Botox™ treatment for headaches if the patient has what is defined as chronic migraine headaches and if they have failed standard treatment for chronic migraine headaches.

What is a chronic migraine headache?
When screening for chronic migraine headaches the best question to ask patients is “how many days per month do you not have a headache.” If the answer to this question is less than 15 days per month, then they will likely meet criteria for chronic migraine headache treatment. On the days they do have headaches, the headaches need to last 4 or more hours and at least 8 days of the month the headache needs to be associated with classical signs of migraine including: nausea, vomiting, sensitivity to light, or sensitivity to sound.

Other insurance company requirements
Insurance companies do not consider Botox™ to be a first line of treatment for chronic migraine headache and currently many have other exclusion criteria. If the migraines are causing missed days at work or interfering with other activities of daily living, this is important to note. Many insurance companies require that the patient has had a neurological work up including an MRI scan of the brain, which nearly all of these patients have had. Nearly all insurance companies require documentation of a trial on other types of medication for migraine prevention with failure at least three medications from at least two different classes with each treatment trial lasting at least 60 days. This is the hardest criterion to meet because patients have trouble recalling the names of the various medications, and I often have to ask them to elicit the help of their pharmacist in documenting prior treatment history.

Experience to date with treating Chronic Migraine
The initial clinic trials with Botox™ showed as much as a 60% reduction in the number of headaches days. My own experience has been better than this with at least three of four patients having a marked reduction in the frequency and severity of headaches. I have found it very useful to have patients keep a headache diary that in most cases clearly documents resolution of headaches after each Botox™ treatment and recurrence at the end of the 90-day cycle. Most impressive of all is the impact of the treatment on the patients’ ability to function. Many of these patients had trouble keeping a job because they missed so many days at work or had poor job performance because of the headaches. The treatments have helped them be at work more often and to perform better and to be more functional family members. Most of these patients were pretty hopeless prior to Botox™ treatments. They had tried nearly every known treatment for migraine yet still had a headache more than half of their waking hours. Botox™ treatments have undoubtedly improved the quality of life for these patients. I have found the efficacy of Botox™ amongst such a treatment resistant population to be truly remarkable.

The Future of Botox for Migraine Prevention
I have found Botox™ to be a very safe drug. I have used Botox more than any other medication for more than 20 years and have yet to encounter a single patient who had an allergy or any other form of systemic toxicity from treatment. When compared to every other drug in the Migraine Prevention Table, Botox™ has by far the lowest degree of systemic toxicity. It is true that Botox™ can cause local ocular side effects such as a droopy eyelid but this is not likely when using Botox™ for the treatment of migraine as Botox™ only spreads about 1 cm from where it is injected and the sites of injection for migraine are greater than 1 cm from the eyelid and orbit. It is reasonable to hypothesize that if Botox™ was a first line drug for migraine prevention it would be even more effective as we would be treating a less treatment resistant population of patients. So Botox™ is likely the safest and most efficacious treatment for migraine prevention. Migraine headaches cost 13 billion dollars in lost worker productivity per year and cause 113 million lost workdays per year. Health insurance is largely purchased by employers who are the ones suffering from these losses. I would not be surprised if we saw a demand by employers that some of the exclusion criteria be loosened in order to keep the work force productive and at work. This also could improve the quality of life for many of the 14 million patients whom suffer from chronic migraine headache who have not yet received effective treatment.

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