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Botox Approval for Chronic Migraine: What Does this Mean?
December 24th, 2010 - Posted by Dr HutchinsonBotox was recently approved by the FDA for chronic migraine prevention. The use of Botox injection for migraine prevention is not new; most headache centers have been injecting Botox “off label” for years with relatively good success. So, what will this new FDA approval mean for migraine sufferers?
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In my opinion, insurance companies can no longer deny Botox on the grounds that it is “investigational” and not FDA approved as they often did before this recent approval. Now insurance companies have to consider approving Botox for chronic migraine prevention.
Keep in mind that the current FDA approval is only for the prevention of chronic migraine and not for episodic migraine prevention. Chronic migraine refers to patients that are having 15 or more days a month of headache. Not all of the headaches have to be full-blown migraine; some headaches may be tension headaches but at least some of the headaches have to be migraine.
What is the current downside of injecting Botox? Answer: the cost!!! Botox is very expensive. At the time of writing this blog, my cost as a medical provider is $525 for a 100 unit vial and $1050 for a 200 unit vial. The current recommendation, based on clinical studies, is to inject 155 units in 31 sites across the forehead, around the eyes, temples, neck and upper back. Also, this quoted cost does not include the procedure fee or the supplies, including needles and syringes, needed for the Botox procedure. Until the recent approval, many headache centers, including mine, were injecting 100 units to keep the cost down. However, now I am recommending the full 155 units.
Are insurance companies beginning to approve Botox? Answer: Yes, but not all of them. Most are requiring prior authorization. My office is swamped with requests to get the Botox approved. In some cases, the insurance company is paying for and shipping the Botox directly to my office. This direct payment for Botox by the insurance company is desirable since I don’t have to order directly and charge the patient for the Botox; this way, when they come in, they only have to pay for the procedure fee.
Am I getting good results? In my practice: YES!!! Does everyone respond? No. Traditionally, I don’t recommend Botox unless migraine patients have had trouble tolerating traditional preventives like Topamax, Elavil, Inderal, Pamelor, and Depakote. Botox can be useful in the following scenarios:
- Migraineurs who suffer with headaches > 15 days/month and …
- Have trouble tolerating current available preventive medications OR
- Are not optimally responsive to their current preventive regimen
- Prefer to not take a daily preventive and like the convenience of simply coming in for a Botox injection every 3 months
The benefits of Botox are usually apparent in 2 weeks and in some cases, within 24 hours. For those who respond to Botox the benefits usually last for 3 months. Success for any migraine preventive, including Botox, is often measured as a greater than 50% improvement in both the quantity and quality of migraine headaches.
I am curious what most of you think of Botox. Feel free to respond to this blog and share your experience, positive or negative, with Botox.
Submitted by: Susan Hutchinson, M.D. , Director-Orange County Migraine & Headache Center
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"I had my first migraine when I was 12. I thought I was going blind, the spots in my vision all grouped together and everything went black. The pain was intense and felt like my head would crack open above my right eye." 
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I have been doing a lot of research on migraine therapies. I suffer with a migraine at least once or twice per week. I recently lost my job because of the amount of times that I have had to either leave work or call in sick. Truthfully I am surprised that my employer put up with it as long as they did. I am a Nurse and therefore have a great amount of responsibility on a day to day basis at work.
I have tried so many medications (preventative, etc.)…the last one being Amitriptyline. We started at 10 mg/day, then 20 mg and then 30mg and so on. The only thing I got out of that was un-wanted weight gain. My Doctor suggested trying Botox. At first I was reluctant but decided to go ahead with it when I could no longer function day to day. We only did the one side of my head (the side that has the most frequent pain) as a test run. We did this for two reasons…we didn’t know if it would work and the cost. In Canada medical treatments using Botox is being covered by some health benefits providers but ONLY for certain conditions (Hyperhidrosis, Bladder Disorder Treatment, Cervical Dystonia and Cerebral Palsy). At $10.00/unit that session was a cost of $300.00. It was “somewhat” worth it. I have had a few tension headaches in the weeks since and one migraine…on that side of my head. However, it would appear that they are now happening more frequently on the untreated side. I will be going back to do more but have no choice but to space it out some for financial reasons. I have filed a letter with my benefits provider (and my husband’s provider) along with a written letter from my Doctor. I have also sent them a detailed list of how much they have paid in the last year for my migraine medication. The cost of Maxalt (what I use now) to them in the last year has been just under $5000.00. I am able to show that I can save them money by using Botox instead. Not sure if this is going to work but it’s worth a shot.
***On a side note – I have also had some mild success with Cranial Sacral Therapy. Fortunately I am able to put it through my benefits as massage therapy.***
Some patients get incredible relief from the first time that Botox is injected; other patients get improved benefit from the 2nd and 3rd treatments. If someone has not experienced significant reduction in headache intensity and frequency after the 3rd treatment, then I would consider that individual a “Botox non-responder”. The current recommended amount is 155 units injected as 5 units in 31 individual sites.
I’m one of the fortunate migraine sufferers (if there is such a thing) who has been able to use Botox and have it covered by insurance. My neurologist notified me as soon as Botox was approved, then worked with my insurance provider to get coverage for it.
I’ve only done one round so far, but the results are promising. I did have one migraine and one mild tension headache in the last three weeks, but considering the alternative (daily migraines), I’m very hopeful. My neurologist had suggested that it usually takes three rounds of treatment before I would feel the full effects, and that with each of the first three treatments things would improve until I reached a plateau after the 3rd treatment. Have you found this to be true?
Also, you may want to be aware that Allergan has “Botox Reimbursement” Representatives that can help your provider in getting the prior authorization process handled in an efficient manner. It can be a hassle dealing with prior authorizations and insurance companies!
Thank you for your encouragement Dr Hutchinson, as well as the helpful information. I’m sure as I go through this I’ll be posting more about my own experience – or lack of it whichever way it goes
Ellen,
Many insurance companies are revising their coverage to now cover Botox if patients meet the criteria of chronic migraine and have failed traditional migraine preventive medications. Allergan Pharmaceutical (makes Botox) has a reimbursement program to help with getting Botox approved. The Website for this program is http://www.BOTOXReimbursementSolutions.com; the phone number is 1-800-44-BOTOX, Option 4. Going to this website or calling this number may help you or your provider with providing your insurance company with the information they need to get BOTOX covered for you. From my experience, insurance companies are now reversing previous denials of Botox in view of the FDA approval of Botox for chronic migraine. Don’t give up on trying Botox!
Thank you so much for telling us your perspective Dr Hutchinson. This is definitely something I’ve been waiting for a very long time to see.
Several years ago I was told that Botox was the next thing I needed to try, since I had failed everything else. This was pre-FDA-approval of course. When we learned the cost for a single treatment exceeded $1000 I returned home discouraged.
The good news as I saw it: There is still hope that something will help me. The bad news? How on earth am I ever going to be able to afford that?!
Like many Migraineurs I have several health problems. I am chronically ill and disabled at home, and my medical expenses are terribly high. Quitting my job because of my health issues was a huge impact on our family’s ability to survive financially. How would we be able to do this? The answer was simple: we couldn’t. Our insurance wouldn’t cover it and I was out in the cold.
I saw a pain management specialist who gave me 6 failed nerve blocks and told me I needed an occipital stimulator. “There’s nothing else I can offer you”.
So, begins a new year, and for us a new insurance plan. I am hoping to make some headway toward trying this. Do you have any advice as we proceed after the beginning of the year? Right now our insurance does not list Botox as something they will pay for. What can I do next? Where do I begin?
Do you have any words of advice for patients like me who have no other options? I have waited a long time for this day to arrive. I want to try Botox to see if it will help me, but I admit I am afraid of what it will do to me emotionally/mentally if once again I fail a treatment.