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Cefaly Now Available Without a Prescription

You can now purchase a Cefaly Dual without a prescription. It’s currently $399 on the Cefaly website and has a 60-day trial period.

I have mixed feelings about Cefaly being available over-the-counter. Cefaly has brought at least some relief to many people I know. I also know others who have had a lasting worsening of their migraine attacks after using it. While that could be coincidental, headache specialists have told me that they’ve seen the same. My headache specialist told me that of all the devices, Cefaly is the only one he’s seen patients have a lasting worsening of symptoms with.

Early on, some providers recommended patients push through the increased pain for weeks to months to see if they would eventually notice an improvement. That’s when my specialist noticed the lasting increase in symptoms with his patients. The continued use through pain could very well be the problem—not the use itself—so a short-term trail may be just fine.

I don’t want to dissuade people from trying Cefaly—but do caution you to be mindful when doing so. Here are some recommendations for trying it:

  • Even though you don’t need a prescription, consult the health care provider who would have prescribed the device before you try it. Ask for their recommendations for safe use. Be sure to ask the questions that will help you feel comfortable using it.
  • Start on the lowest setting and see how you do. If you notice an improvement, try sticking at that level for a while to see if it’s enough before increasing the intensity. If you don’t notice an improvement, ease into an increase slowly.
  • If you notice a worsening of your symptoms when you use the device, don’t try to push through to see if things improve. Consult your health care provider instead. You may want to try it several times to be sure the device is the culprit and the worsening isn’t coincidence (which it very well could be), but that’s best to do under the supervision of a health care provider.

A friend shared the news of Cefaly’s OTC availability and mentioned that her implanted nerve stimulator experience was a nightmare. She said that experience has made her cautious about trying anything that might make her worse. Similarly, my nerve stimulator implant also made me aware that the things we try to improve our health can instead exacerbate our symptoms. I’m sure I am more cautious than most people—I got that way out of experience and fear of worsening my already tenuous health.

So take what I say here with a grain of salt if you need to. I don’t want to scare anyone, but do recommend an abundance of caution when trying Cefaly.

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Regular TENS Unit Instead of Cefaly?

Cefaly“Can I use a regular TENS unit instead of Cefaly?” I’ve been asked this questions so many times that I know others are curious and haven’t asked. I can’t give you a direct yes or no, but here’s what I’ve seen headache specialists say about it.

Writing for the American Headache Society, headache specialist Brian Plato, D.O, says, “It should be noted that “regular” TENS units should not be used in place of the Cefaly.” He does not explain why.

Headache specialist Alexander Mauskop, M.D., said in a comment on my Migraine.com post about Cefaly, “My patients haven’t had much success with Cefaly. To save them money, I suggest that they try a regular TENS unit, which can costs as little as $50. It is not as cool-looking or convenient, but it offers more options in adjusting the current, frequency of stimulation and duration.”

Dr. Mauskop wrote on his blog that he was unsure whether Cefaly has an advantage over a regular TENS unit. He speculates that Cefaly could be better because of its convenience and that the current “may have specific frequency, strength and wave shape, which provides better relief. However, an electrical engineer could easily hook up the Cefaly unit to a monitor and figure out and publicize these settings.” (To my knowledge, no one has done this.)

Many patients point out in forums that their doctors and the instructions with their TENS units say not to use them on your head. One said that a regular TENS unit may be too strong for the forehead.

That’s all I can tell you. I cannot give a direct recommendation either way. Even if I could, I don’t have enough information to form a solid opinion. My best advice is to talk to your doctor about it.

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Cefaly Insurance Coverage Update

“Is Cefaly covered by insurance?” is the question I’ve been asked most since the device was approved. The answer is probably not, but your insurance company may cover it as they would any TENS unit.

Cefaly does not currently have a procedure code (also called a CPT code), which is required for an insurance company to cover any medical device or procedure. A company representative told me FDA approval is the first step in the long process of getting a CPT code. They expect it to be one to two years before Cefaly has a code.

Hope is not lost! Some migraineurs have found that their insurance companies will cover Cefaly the way they would any TENS unit using an established code for those devices. Google tells me those are E0720 for a two-lead device and E0730 for a four-lead device. The problem? Cefaly only has one lead, which may trip up some insurance companies.

HomeCare, a magazine for the home medical equipment industry, says that to have a TENS unit covered for chronic pain, your doctor must submit a statement of medical necessity and “must determine that the patient is likely to derive significant therapeutic benefit from continuous use of the unit over a long period of time. The physician’s records must document a reevaluation of the patient at the end of the trial period and indicate how often the patient used the TENS unit, the typical duration of use each time and the results.” Unfortunately, the article also says TENS units are rarely considered medically necessary for headache disorders. (This is general industry information. What you encounter with your insurance company may be different.)

Don’t give up without checking with your own insurance company. Enough migraineurs have received positive responses that it’s worth a try. Please let us know if you have success and, if possible, which code your insurance company is using.

Update on Cefaly availability: As of April 9, 2014, the order page of Cefaly’s U.S. website says, “Order intakes on hold for a week because of limitation in the supply chain.” This notice apparently went up today, so I hope that means you’ll be able to order from them next week. I’ll keep an eye on the site and let you know if anything changes.

April 15, 2014: Cefaly has removed the “not currently taking orders” notification from their website. They appear to now be shipping previously ordered products and taking new orders.

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Cefaly Availble in the US, Insurance Coverage

If you’re in the US, you can now order a Cefaly from Cefaly.us. The device itself is $295 (plus $29 for shipping) and a three-pack of electrodes is $25. You must send a copy of your prescription before they will send your order. Devices will be delivered beginning the first week of April.

Here’s what Cefaly’s FAQs currently say about insurance coverage:

Cefaly is not currently reimbursable via the social security system and therefore is not listed in the catalogue of approved medical devices. However it is becoming increasingly apparent that certain health insurance companies and mutual funds are partially funding this treatment and may do so on a case-by-case basis.

We therefore advise that you write to your insurer or health care in order to ask them if they will help you with the cost of Cefaly. Explain your migraine problem and the benefits that the device brings you. Make sure you to attach a prescription along with a copy of the invoice to your letter.

Translated: Your insurance company might reimburse you, but probably not. Sending your insurance company a letter with your receipt, as the Cefaly website recommends, is unlikely to work out in your favor. If insurance coverage is imperative for you, contact your insurance company before purchasing the device. They may refuse to cover it at all or they may allow you to submit an appeal for coverage. Be sure to ask if having your doctor send a letter of medical necessity will increase the chance that they’ll cover it.

April 8, 2014: Check Cefaly Insurance Coverage Update for current information.

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FDA Approves Cefaly for Migraine Prevention

Cefaly

(i can’t believe I’m posting a selfie with a Cefaly.)

The FDA has approved the Cefaly for migraine prevention in the U.S., according to an announcement from the agency yesterday. Purchasing details aren’t available yet, but it shouldn’t be too long since it is already being manufactured for other countries. It will be available by prescription, which I expect means it will also be covered by insurance. You can order one now at Cefaly.us. The device itself is $295 and a pack of three electrodes costs $25. You must send them your prescription before they will ship your order. I don’t know what this means for eventual insurance coverage.

Here’s an excerpt from the FDA’s press release that describes the studies the approval was based on:

The agency evaluated the safety and effectiveness of the device based on data from a clinical study conducted in Belgium involving 67 individuals who experienced more than two migraine headache attacks a month and who had not taken any medications to prevent migraines for three months prior to using Cefaly, as well as a patient satisfaction study of 2,313 Cefaly users in France and Belgium.

The 67-person study showed that those who used Cefaly experienced significantly fewer days with migraines per month and used less migraine attack medication than those who used a placebo device. The device did not completely prevent migraines and did not reduce the intensity of migraines that did occur.

The patient satisfaction study showed that a little more than 53 percent of patients were satisfied with Cefaly treatment and willing to buy the device for continued use. The most commonly reported complaints were dislike of the feeling and not wanting to continue using the device, sleepiness during the treatment session, and headache after the treatment session.

Neither of these studies are new and still have the limitation of being short-term, but I’ll reiterate that it’s worth trying out. Even more so now that you won’t have the additional expense of ordering it from Canada and your insurance may pay for it. I’ll keep you posted on it’s availability.

Here’s my experience with it, including a detailed description of what it feels like: