Colchicine, a drug primarily used to treat gout, is an old drug. Very old. Extracts from the plant it comes from, colchicum, have been used in gout treatment for thousands of years. In pill form as colchicine, it’s been on the market in the United States since the 19th century and predates the Food and Drug Administration. A few years ago, the company that makes one brand of the drug, Colcrys, obtained FDA approval for their version, and the exclusive rights to sell it in the United States for three years. Who cares? Reader Nick does. He works in retail, isn’t wealthy, and the colchicine he takes twice a day for a serious medical condition shot up in cost from about $20 per month to closer to $400.
While colchicine is a prescription drug, it was “grandfathered” in and never evaluated and approved by the FDA since the government agency came into existence in 1938. URL Pharma, the manufacturer of Colcrys, performed randomized, controlled trials to test the drug, gained FDA approval for it as a gout treatment, and was rewarded with what they call “market exclusivity” in the biz: their version is the only one you can buy in the United States for the next three years.
That brings us back to Nick. He writes:
Hello, I have a major complaint about the doctor-prescribed medicine Colchicine. I am a 22 year old male in generally good health, however I was diagnosed three years ago with a medical condition known as Pericarditis, which is an inflammation of the sack around my heart. When this condition flares up I am tremendous pain and usually have to be admitted to the hospital. The only thing that helps me is the prescription drug Colchicine which I have to take twice a day, every day, for potentially the rest of my life as there is no cure for my type of Pericarditis outside of having my rib-cage cracked open and getting a bunch of junk scraped out.
For the past three years I have been getting my prescription for about $20 – $30 dollars a month. Now imagine my surprise when I tried to get my prescription refilled yesterday, only to find out that the pills now cost $390 dollars! Even with my health insurance and all the coupon vouchers the pharmacist could give me I would still have to pay $150 dollars out of my pocket! This is insane! …
I support myself, work at a chain store, and barely have enough to scrape by as it is. How can they possibly expect somebody like me to afford this every single month? A drug that literally has saved my life! A drug that I *need* to take for the rest of my life!
This situation has prompted a lot of discussion among doctors, but that doesn’t help Nick pay his bills right now. Fortunately, the manufacturers of pricey drugs sometimes have options for patients who can’t afford them. If you’re on a drug that you’re struggling to pay for, it’s always worth checking the manufacturer’s web site or calling the company, especially when you’re uninsured or underinsured.
In Nick’s case, his best option is probably URL Pharma’s voucher program. It’s supposed to bring the co-pay for insured patients down to $15: a huge relief for Nick if it turns out that he’s eligible.
Incentives for Drug Development — The Curious Case of Colchicine [New England Journal of Medicine] (subscription required)
Colchicine’s Other Indication — Effect of FDA Action [New England Journal of Medicine]
Colcrys Patient Assistance Initiatives [Official site]