Can you spare 102,930 dimes?

by Joel on March 28, 2006

102,930 dimes, or $10,293 a year is how much the anti-narcolepsy medicine costs that I began taking in January. Xyrem, sponsored by Orphan Medical, with a chemical name sodium oxybate or gamma hydroxybutyrate, was approved for prescribing in late 2002 by the U.S. Food and Drug Administration. It had to also be approved by each state’s legislature as well, and Oklahoma’s was one of the very last to do so, in the fall of 2005.

How did a $2,500/year drug end up costing so much? The short answer is that generic street versions have been employed in “date rape.” The longer answer includes other factors, including the fact that sodium oxybate is a naturally occurring substance in the body (in far, far smaller quantities) that needed a means of patent protection to entice a company, any company, into manufacturing the medicine. Sodium oxybate was declared an orphan drug under the 1986 Orphan Drug Act passed during the Reagan administration. The act has been a God-send for the development of many cures or treatments that were otherwise not economically feasible. Further, the U.S. narcoleptic population is relatively small, numbering perhaps between 250,000 to 400,000. Thus the demand was potentially limited. (Despite that the manufacturer’s application as amended only covered the condition of narcolepsy with cataplexy or narcolepsy without cataplexy but also excessive daytime sleepiness, the FDA chose not to prohibit off-label use.)

In approving the distribution of Xyrem, the FDA mandated that the drug would not be available in local pharmacies, but only through one central mail order pharmacy (Express Scripts was designated), with the medicine sent by overnight courier and the patient signing for it in person. The FDA also requires that both patient and doctor complete an education program about the drug.

Behind the limited distribution is the fear, not entirely unreasonable, that local pharmacy distribution posed too great a risk for conversion to illegal use. Under the current program, the physician faxes the scrip to the Xyrem Success Program, which then turns it over to the pharmacy upon proof that the safegaurd regulations have been complied with.

Interestingly, however, the FDA may have passed on one of the best safeguards, and that is to limit the drug to treatment of the condition of narcolepsy, for which it was developed in the first place. Narcolepsy is such a serious, debilitating sleep disorder that those who have it are more likely to not only really need the medicine but to be so appreciative as to faithfully comply with the terms. Indeed, any patient who “loans” their Xyrem to someone else and gets caught can find that the drug’s classification has instantly become “Schedule I, illegal for all purposes.”

It is not that I begrudge others who have serious disorders of excessive daytime sleepiness, or that I oppose for all time trials for things such as chronic fatigue syndrome. Rather, I don’t want anything to risk Xyrem’s future availability. Many law enforcement officials and families of illegal sodium oxybate victims fought hard against Xyrem’s legalization. Most opponents were sincere, although some were unhinged zealots and a few grossly exaggerated the dangers of the drug.

I myself had to wait 12 years beyond the time a neurologist first recommended the medicine for me. So, while I would empathize with others who might have to wait, securing the safe use and distribution of the drug is vital to its continued availability.

I’m not sure yet exactly how much of the medicine is going to be covered by my insurance; I hope a lot, as I’ve so far been paying for it entirely out of my own pocket. I also hope the price drops over time, not just for my sake but because even though there are income-tested assistance programs for the uninsured, it is likely that many will go without a valuable medicine due to its high cost.

So, can you spare 102,930 dimes. Not literally. One way or the other, my expense will be taken care of. I’d like to point out, though, that Xyrem is one drug that even most drug companies would admit would never have been developed if left entirely to the free market system. It really took federal involvement to provide the needed incentives.

{ 7 comments… read them below or add one }


Beth 03.29.06 at 2:26 pm

Joel, this is fascinating, and I’m glad to hear that, despite the cost, you’re finally getting the treatment you need. I’ve suffered from CFS for over ten years now, and it seems there’s really nothing that can be done to alleviate it significantly as things stand. I hope, as you say, that they manage to bring the price of Xyrem down and that it continues to be used responsibly.

So, having been awake for an amazing five hours, my head’s full of cotton wool and I’m now heading back to bed - goodnight, everyone!


Joel 03.30.06 at 6:18 am


Nice to hear from you. Xyrem is being used experimentally to treat CFS. I have no idea of the results, to date, though. The thought is that in many people, CFS is so bad because sleep architecture is off. Also, some people claim that the Austrian-made drug milnacipran is helpful to CFS.


Beth 03.30.06 at 12:06 pm

Good to know, Joel, thanks. I’m trying to persuade my GP to send me to some kind of specialist, since I have some mild symptoms of narcolepsy as well and would really like to rule out any sleep-related disorder as a factor in the CFS. My dad is narcoleptic, though he refuses to be treated properly for it, and it’s quite scary to watch.


mr skin 11.04.06 at 9:59 pm

I believe that Chronic Fatigue is more of a psychological illness that a physical one. When the mind is suffering it comes through in physical form.


Anonymous 03.08.07 at 2:47 pm

Don’t be stupid mr skin.


ES 11.11.07 at 1:05 am

I have been taking sodium oxybate in a clinical trial for fibromyalgia and also have cfs. I noticed a difference almost immediately. I must say I was quite skeptical when I started, but surprise surprise, I could actually wake up in the mornin and I actually felt like I slept. I am only 25 and I have had fm/cfs for 11-12 years. I cannot believe how good I feel. I can walk, I can think, I can concentrate, I can form sentences, I do not hurt or ache like I used to. It had come to the point I could barely work. I had started to lose hope that I would ever feel well. I am just so amazed at this “drug” and what it does for me. I have had almost no side effects. and what I had was very minor and went away within 3-4 days. I am nervous that I will not be able to continue after the trial because my insurance doesn’t cover and wow it seems to be so expensive.


Brad 12.02.10 at 9:02 pm

why does it cost so much?

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