Building a case for Xyrem for FMS

badlydrawnboy · Joined: 02 Oct 2005 Posts: 42

I am preparing to battle with my insurance company in the hope that they will reimburse me for Xyrem as a treatment for fibromyalgia. In preparation for this, I've created a summary of clinical studies and research supporting the use of Xyrem for FMS.

I chose only to draw from studies published in peer-reviewed journals. Some of them are small, open-label trials, but many are larger, controlled studies.

I hope that this may be of benefit to you. If anyone has suggestions for improvement or things to add, please pass them along and I'll integrate them into the document.

Download the PDF here: http://chriskresser.com/misc/xyremfms.pdf

Best,
Chris

Perchance Dreamer · Joined: 31 Mar 2006 Posts: 138

Hi, Chris. Have you already tried to get Xyrem approved and been denied by your insurance company?

The reason I ask is that I've had Xyrem through 3 different insurance companies through the years. I know at least one of them had a written policy that they wouldn't approve drugs for off-label uses. I've always easily gotten it approved anyway. I don't have narcolepsy or cataplexy (sp?), which, as far as I know, are currently the only officially sanctioned uses.

badlydrawnboy · Joined: 02 Oct 2005 Posts: 42

I have Health Net HMO insurance. The first time I had my Xyrem presecription filled in '05, they denied any coverage and I had to pay the full price out-of-pocket. I'm just assuming the same thing will happen now (still waiting to hear back from the Xyrem people today).

My experience with them is that they categorically deny any off label prescriptions and/or referrals to specialists outside of their network. My primary care doc told me that she can't stand Health Net because they are so difficult to deal with. I've heard the same thing from other doctors and patients.

May I ask where you are, and what insurance companies you've had?

Thanks,
Chris

Perchance Dreamer · Joined: 31 Mar 2006 Posts: 138

Hey, Chris. I'm in Austin, and my insurance companies have been United Health Care, Blue Cross, and Aetna.

Maybe they've never fussed because we've always done PPO instead of HMO.

I wish you luck with your insurance company. I don't know why it's taking so long for Xyrem to get approved for fibro. It's been in the works for a long time.

Perchance Dreamer · Joined: 31 Mar 2006 Posts: 138

Hi, Chris. I'm curious.

Seroquel is off label for insomnia. Would your insurance company have approved that? If so, it seems they wouldn't have an excuse to deny Xyrem off label.

So many drugs are used off label such as Trazodone and Klonopin. Yet there are scads of people on these drugs. Maybe the companies mainly balk at the exceedingly expensive off-label drugs.

badlydrawnboy · Joined: 02 Oct 2005 Posts: 42

Good question regarding the Seroquel. I imagine they don't worry as much since it's not that expensive as a drug. But when it comes to new, patented drugs that are expensive they either don't cover it at all or my co-pay is outrageous.

I'd much rather be on a PPO. I used to be, in fact, but that isn't an option where I'm working now. And I doubt I'd be able to get private insurance because of my "pre-existing" conditions. I have a friend with a very painful neurological disorder who cannot get insurance, because she didn't have any coverage at the time she developed the disorder. She could qualify for "disaster" insurance through the state of California, but that would only cover emergencies and none of her doctor's visits or medications. It's really an absolute crime how our "disease-care" system is set up.

We'll see how it goes. My PCP referred me to a sleep specialist for a sleep study consultation, and hopefully, a sleep study. If it turns out I do have an alpha intrusion sleep disorder, and I can get this new sleep doc to support me, I'll have a fairly strong case for Xyrem reimbursement. This is all a bit of the cart being in front of the horse, though, since I'm not completely sure I'll be able to get Xyrem to work for me. But it's the most promising med I've tried, and I can't afford to keep experimenting with it to the tune of $300+/month.

Chris

Perchance Dreamer · Joined: 31 Mar 2006 Posts: 138

It would be great if you could get a sleep study. I had one about 1 1/2 years ago and will have another soon.

Mine showed alpha intrusions, REM cycle in the wrong phase of the sleep cycle, and frequent, unexplained arousals (not the good kind). My sleep doctor said it's like someone wakes me up every 90 seconds all through the night.

I'm still doing well on Trazodone (although I still wake once or twice during the night) and will use it with the sleep study. I'll be interested because Traz. is supposed to have a positive effect on deep-stage sleep although not as much as Xyrem, of course.

I've done so many things in the meantime--biofeedback brainwave training, Alpha-Stim, pROSHI, and neurotransmitter and hormone precursors--that I won't really know how much improvement is due to these alternative treatments and how much is due to Traz. It doesn't really bother me, though. I've come a long way since I was sleeping zero to 1 hour a night.

Press for the sleep study and let us know the results.

badlydrawnboy · Joined: 02 Oct 2005 Posts: 42

I'm glad trazodone is giving you some relief. I tried it and felt like an absolute zombie the next day.

My appt. with the sleep doc is in 2.5 weeks, then who knows how long I'll wait for a sleep study. In the meantime, I'm going to try Remeron (which I've had some success with in the past) and Xyrem and see if I can't figure something out.

Best,
Chris

Irishvamp7587 · Joined: 17 Jul 2009 Posts: 94 Location: Pennsylvania

Badlydrawn boy - I was so excited to see you had a link with information to back up why xyrem is good for fibro but the link doesn't work, I guess since it was from awhile ago. I'm going to see my dr on Weds and if he even knows what it is, I'm sure he won't be supportive. I wanted to get information like what you described but I'm so tired and can barely think straight and I need all my extra energy to take care of my baby. I hope you get this and can get back to me soon. Thanks.

FibroFog · Joined: 27 Jun 2006 Posts: 51

sleeplessinmidwest · Joined: 23 Sep 2009 Posts: 22 Location: MO

Hi. Jazz Pharma just finished clinical trials on Phase III for fibromyalgia with good numbers - just this month (Oct 2009). I just got diagnosed with FM. Previous diagnosis was for insomnia and my insurance (cigna) denied coverage of xyrem at my dose due to off label use. I hope to get approved in appeal with the Fibro diag with this clinical trials results.

xyrem has changed my life back into the 8-5 world. I really pray that they get fda approval.

FibroFog · Joined: 27 Jun 2006 Posts: 51

sleeplessinmidwest · Joined: 23 Sep 2009 Posts: 22 Location: MO

Fibrofog: Cigna approved 2 bottles, which is 20 days dose for me. That's what I'm taking now. I didn't get the letter that said that I was no approved to take the drug before I ordered the 2 bottles. I hope they can't come back on me as they didn't inform me beforehand, and they approved the amount. I'm not going to start going in debt to get the xyrem so I'll have to go back to the best I can expect with the other sleep meds until the FDA approves xyrem for FMS.

sleeplessinmidwest · Joined: 23 Sep 2009 Posts: 22 Location: MO

badlydrawnboy: what are the peer reviewed articles for xyrem for fibro? Can you give me info for them? I need 2 to appeal to my insurance for xyrem.

Jazz has just finished their Phase III clinical trials on xyrem for fibro with some really good numbers. It's only a matter of time before they get FDA approval. You can find that info here: http://jazzpharmaceuticals.com/chunk.php?content_id=27&id=83#jzp6

sleepless

FibroFog · Joined: 27 Jun 2006 Posts: 51

sleeplessinmidwest,

How was Xyrem's sleep effects different for you than all the other sleep meds you've tried? You said it has changed your life in ways other sleep meds have been unable to touch.

I am just curious because any fibro expert knows that the other sleep meds either disrupt deep sleep further, or alter the sleep architecture in other ways. But one thing for certain is that no other med reduces alpha wave intrusions like Xyrem.