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Botox Approval for Chronic Migraine: What Does this Mean?

Botox 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?

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:

  1. Migraineurs who suffer with headaches > 15 days/month and …
  2. Have trouble tolerating current available preventive medications OR
  3. Are not optimally responsive to their current preventive regimen
  4. 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

This article represents the opinions, thoughts, and experiences of the author; none of this content has been paid for by any advertiser. The Migraine.com team does not recommend or endorse any products or treatments discussed herein. Learn more about how we maintain editorial integrity here.

Comments

  • Dr Hutchinson author
    7 years ago

    Not everyone gets results in 2 weeks. In addition, some patients do not respond at all and are considered Botox “non-responders”. Also, for some patients, the 2nd or 3rd Botox injection is more effective than the first. Overall, the response rate for patients that feel Botox helps is about 85% in my practice. I have spoken with other headache providers who agree with an approximate 85% response rate.

  • stacysillen
    7 years ago

    Results were NOT seen in 2 weeks like your article states! I was in a lot of pain for a year’s worth of shots (4x/yr). By then I had about given up on shots working for me-and then they did! When I do get an aura or a headache they just don’t rise to the level of what I had sadly become used to when my migraines turned chronic. My headach specialist says botox kind of “dampens down the fire” that is migrains. She switched me to Dysport because it’s cheaper, I haven’t noticed any difference.

  • stacysillen
    7 years ago

    No difference in how well it works.

  • antamyers
    7 years ago

    I am currently getting botox injections every 8 weeks my most recent was 9-5-12 and it was my third session. The first round didn’t do much and I had severe neck pain and loss of muscle control in my neck, my right eye lid also drooped badly. With the second session we decided not to do the neck injections so the neck pain and muscle control did not happen again and he moved upward above the eye some so my eye did not droop as bad. On the third session I have not had any eye drooping or neck pain I do however have pain at the injection sites and a headache for about a week after the sessions, but normally I am migraine frr for up to three weeks prior to my next dose. I was also taking Topomax as a prevenative, but was taken off of that due to the developement of chronic kidney stones so I have noticed wanting to get a migraine easier without being on that. So I guess I can say that the botox has worked for me for now I had migraines daily for at least 2 years that were not stopped by anything else.

  • Dr Hutchinson author
    7 years ago

    The side-effects of Botox include some pain at the injection sites for 3-4 days but this can be helped by putting ice on the areas of discomfort. The treatment would be expected to help relax tight muscles as well as prevent migraines so I would hope for you that Botox can reduce your myofascial pain in your neck and shoulders.

  • lulabelle
    7 years ago

    My neurologist is proposing Botox for me. In addition to migraine I have fibromyalgia and am very hypersensitive to meds. I have had occipital nerve blocks, and they help, but also cause several days of tenderness before they take effect. I am curious what the side effects of Botox are like? The last thing I need is to risk a flare in my fibro pain and allodynia. Anyone cam tell me what the initial side effects are like? Do things get worse before they get better? Anyone also have fibro – does this treatment help with mayofascial pain in neck and shoulders? Thanks!

  • Teresa Tribble
    7 years ago

    I go this after noon for my injections and I’am a little nervous but I sure hope it works I’m so sick of these headaches controlling my life. I told my sister the other day I was getting Botox and I also threw this little line in. I said, I might not feel good however I will be looking good :0) I really do wish the best from this treatment……

  • Sarah Estep Preo
    7 years ago

    Botox has been the best relief in 11 yrs… its not 100%, but instead of agonizing pain, it’s more nagging that PRN pain meds can ACTUALLY work on.

  • Carolyn Neumann Skidmore
    7 years ago

    Botox worked for me. I have intractible chronic migraines and fibromyalgia for over 40 years. I had daily headaches. I have had my 6th round of botox and within 2 weeks I was headache free. Last time I went for four months headache free. My only problem is headaches for about three weeks after injections and a muscle relaxant helps for those few weeks. I feel like a new human being. My neurologist from Barnes in St. Louis is pleased. I had tried over thirty drugs, pain clinics, physical therapy, everything. I recommend Botox highly.

  • Daisy Pagan
    7 years ago

    My son is having his first treatment with Botox on 4/19/12. I hope he gets results and can get his life back.

  • Yolanda Pagan
    7 years ago

    Seguro que yes. Todo va a estar bien,,,,Confia en Dios

  • Dayna Haines
    7 years ago

    I have had three rounds of 100 units of Botox and it has helped! It has essentially gotten rid of the muscle tension caused by the chronic migraime. At one time I could not turn my head due to muscle spasms. That is completely gone! Not even 9 weeks of massage came close to doing this. I still have the “typical” migraime shooting, stabbing and sloshy brain pain, bit the muscle tension is gone, gone, gone!

  • Dayna Haines
    7 years ago

    Please excuse the type-o’s. My spell corrector has taken over and the window is so small I can’t see what I have typed 😉

  • Kathy Hack Rumsby
    7 years ago

    Botox has worked wonders for me as well. The injections hurt me a lot, but I am willing to do it in order to experience less headaches. My headaches have been reduced by at least 50%. I

  • Pat Fisher
    7 years ago

    I have just gotten approval for the Botox procedure and expect for the botox vials to be paid for after the fact. It seems with my newest insurance they had a pharmacy to contact but they no longer carry Botox. So I will apy for the medication up front and hope they pay later. It will be worth every penny. When I think about all the money I have spent on meds that didn’t work, any success will be wonderful. It is good to see that this has worked for many of you. I too, clench my teeth and wear a guard at night. I have cracked at tleast three teeth in the past. I’ll update after my appt on 2/14.

  • stacysillen
    7 years ago

    I have to pay a co=pay, something like $145.00 every 3 months.

  • Jennifer Oddo
    7 years ago

    I had Botox injections about 3 times. While I found the effects where amazing, they were short lived. After waiting about 2 weeks for it to kick in, the relief only lasted about 3 weeks; this left me with about 6 to 7 more weeks of waiting for the next round of injections.

  • Marissa Joy D'Aleo
    7 years ago

    I have had three rounds of “Nerve Block” and “Trigger Point” injections, all of which have exacerbated my chronic migraines. I am now under review for Botox. Have any of you had similar experiences? Will the Botox only worsen the problem (if any MDs are reading, I’d appreciate input).

  • Deborah Wisehart Wilton
    7 years ago

    I had to quit getting them after about 7 yrs. of treatment because my insurance said they decided to quit covering it. They didn’t bother to inform me, I found out after I had 3 treatments that weren’t being paid for. I went back and forth from Mayo Clinic to Blue Cross. Mind you, I was still having daily migraines. Then they sent me to collections and my credit got ruined. When I finally came to realize they covered one half of the treatment and not the other. Then, I talked to supervisors and they agreed on both sides that it didn’t make sense. Finally a year and a half later, they covered it! They did nothing to fix my credit for their mistake. People with dailly migraines or chronic migraines get walked on. I took Topamax and ever since I took it, I can’t remember things, I’m always late to things….it TOTALLY SCREWED UP MY LIFE! I would like to go back to getting botox injections but I’m terrified I will experience the same thing with my insurance company!

  • Lori Hilliard
    7 years ago

    I’ve had three rounds of Botox so far. The first two rounds were like a miracle; my husband told people that it has literally changed our lives. We no longer had to plan activities around my headaches. I was thrilled! The third round didn’t work as well. About six weeks after the treatment, I began to get cluster headaches that kept coming back. The pain was not nearly as severe, but three weeks into them, my neurologist gave me nerve blocks to get through the holidays.

    In two weeks, I’ll go in for the next round of Botox, hoping that it will continue to work. Does anyone know if the effect of Botox starts to wear off after you’ve used it for a while?

  • JodyStern
    7 years ago

    I have had the exact same situation as you. I have had about 4 rounds so far but have noticed that the last two have not been as effective. I have had a couple of bad migraines and am back to having a headache pretty much 5 days a week it seems. Really frustrating.

  • Kristie Roy Perrin
    7 years ago

    I have been having Botox injections for 3 years and I can tell a HUGE difference. I was having migraines almost daily and now it is only 2-3 unless it raines then I have a migraine however long the weather is bad.

  • Ireland Meeuwse
    7 years ago

    can I say goodbye to Sapphyre tomorrow? I sent her my cell number in her message box. I am leaving thursday morning.

  • Sandy McCarthy Brooks
    8 years ago

    I meet the qualifications to receive botox but I’m on an injectable anticoagulant. Do I need to stop it for the botox treatment? I have received my clot dr’s ok to get the botox as long as I don’t have to stop my anticoagulant. I have received other therapies which involved greater than 50 injections and I didn’t stop it. What do you think?

  • Anne Marie Regan Eliopoulos
    8 years ago

    Good luck!

  • Teri Robert
    8 years ago

    Sandy, I have no idea if you need to stop your anticoagulant. I wouldn’t think so, but really, the only person who can safely answer this is the doctor who’s going to administer the Botox. Good luck! Hope the Botox works well for you.

  • Joy Perez
    8 years ago

    Interesting. My Dr is recommending Botox as the next step in my treatment. We’ll see how it works, though it will be a few months before I can get them. In the meantime, I got nerve blocks in the back of my head and Magnesium injections thru IV. Day #4 without ANY pain in head and it feels AMAZING. This is after having some sort of headache daily for the last 9 months or so, with a day or two of relief occasionally. And, the days that were more manageable, I still had some sort of pain in my head. I can honestly say that now I have no pain and it feels great! BUT, I am wondering how long this will last. We’ll see. Botox is next, I guess.

  • Eric Romers
    8 years ago

    It will be interesting to see if this treatment works. I have not suffered from migraines but I recently saw a few stories on news mags like The Journal with Joan Lunden and CNN that were talking about the number of people who deal with chronic migraines and the effects it has on their lives. It sounds horrible. Hopefully this treatment will have the capability of helping some people.

  • Thomas M. Lewis
    8 years ago

    I had a migraine the very next day after treatment.

  • Thomas M. Lewis
    8 years ago

    I did not respond very well to treatment.

  • Migraine.com
    8 years ago

    Sorry to hear that, Thomas… thanks for sharing your experience!

  • Elaine Gross
    8 years ago

    I’ve had three treatments so far. The first one totally eliminated the head pain, of course it doesn’t eliminate the other symptoms of migraine. Since then the treatments haven’t been as effective, but it’s certainly better than no Botox. I’m due for my next shots October 1st, and I’m now starting to feel pain in my occipital nerves, which is one of the most painful migraines I experience.

  • Migraine.com
    8 years ago

    Elaine – Please let us know how it goes after your treatment on October 1st!

  • Tammy Trantales Costello
    8 years ago

    Botox has been like a magic wand for me! I suffered from chronic migraines and had to cancel countless events due to them. I tried 6 different migraine medicatIons. Not even one worked for me. My neurologist said I was a perfect candidate for Botox. As migraineurs know, we will try just about anything for relief. I highly recommend Botox injections.

  • Migraine.com
    8 years ago

    Thanks for sharing, Tammy! We’re happy to hear Botox is working for you

  • Marsha DeGennaro
    8 years ago

    side effect of wrinkle eraser..priceless…:)

  • Melissa Treff
    8 years ago

    I have received 3 treatments of Botox this year. The first was 50 units, the 2nd 100 units and the most recent was 155 units. So far, no results. At my next treatment, we will use 195 units.

  • Melissa Treff
    8 years ago

    I will say, the wrinkles do not appear to be a problem at all!! 😀

  • Jessica Dunn
    8 years ago

    You must not have ANY wrinkles.. 😛

  • Vaughan Haier
    8 years ago

    Hi I am about to have my 3rd treatment of botox 100 units only. I have given the recommended 31 injections sites to my Dr but there is not enough to do all the sites. Is it best to dilute it further or miss some of the injection sites. Personally I want to have all the sites covered.

  • Renee Starkey
    8 years ago

    I had my dermatologist inject Botox into my forehead, between my eyes and temples. The results are dramatic! Now I am waiting to see a neurologist for a consultation about Botox in the rest of my head. I would like to know WHY my muscles tense up all the time, and migraines thrown in there for good measure, but my docs don’t seem to know. Or really care. One Neurologist said if I responded good to the injections in the forehead that I would be a good candidate to have the injections in my head, neck and shoulders.

  • Deborah Marble Huebler
    7 years ago

    Hey, did you ever go back for the other injections? I, too, have tense muscles ALL the time. I also clench my jaws constantly, even during the day, and it causes bad headaches and is ruining my teeth. Just wondering if you tried it and how it went. And how much it cost!!

  • Carrie Johnstone
    8 years ago

    I agree

  • christine
    8 years ago

    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.***

  • Dr Hutchinson author
    8 years ago

    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.

  • chipdooley
    7 years ago

    Do those sites happen to be were wrinkles form or more, I don’t know how to ask not thing to clearly, do the shots go were there is more fat/mussel or is it were there is just skin. I don’t know if this makes since. Were do the shot go. I had blockers injected up under my skull buy neck and I could not move for 2 weeks almost and the pain was so intense for over a month and i can’t go through that again

  • Lori in PA
    8 years ago

    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?

  • stacysillen
    7 years ago

    Yes, true for me, Almost a year…

  • Dr Hutchinson author
    8 years ago

    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!

  • Ellen Schnakenberg
    8 years ago

    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 🙂

  • Dr Hutchinson author
    8 years ago

    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!

  • Ellen Schnakenberg
    8 years ago

    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.

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