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:
- 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
How much has your migraine disease changed or evolved over time?