Gout Drug Cost Increase Slows Doctors' Prescription Rates

Now that the Food and Drug Administration (FDA) decided to start regulating a drug commonly prescribed to treat gout, many patients will no longer be able to afford the medication.

The cost increase — 50 times the previous rate – has affected how often clinicians prescribe it. This outcome was examined in a recent study by lead author Aaron Kesselheim, MD, JD, MPH, associate professor of medicine at Harvard Medical School, and colleagues.

For years, multiple manufacturers made colchicine and it was on the market in the United States for just $0.09 per pill. However, with support from the FDA, one of the manufacturers did a small clinical trial to test the safety and effectiveness in 2007. When just a short course of the updated version proved to help the acute flares of gout, the FDA granted the manufacturer sole market rights. All unapproved versions of colchicine were ordered off of the marker by January 2011.

Although the FDA was aiming to strengthen regulations in order to protect against unapproved drugs, it comes at a cost — literally. The new version, Colcrys, prices in at nearly $5.00 per pill.

In addition to gout, the drug is also the primary treatment for familial Mediterranean fever, a rare inflammatory disease. The authors found that for patients with such diseases, their monthly prescription costs raised from $418 to $651.

“The way this case was handled has led to a potentially useful drug, colchicine, being prescribed to fewer patients, while there have also been substantial cost increases for those who do use it and no evidence of reductions in unsafe co-prescriptions," Kesselheim said in a news release.

Documented in the Journal of General Internal Medicine, the findings indicated an additional consequence due to the price jump. Since the regulations have been enforced, the likelihood of colchicine being prescribed within 30 days of a diagnosis decreased by 7.6% per month for familial Mediterranean fever patients and 0.5% for those with gout.

Not only are patients’ wallets taking a hit from the new approval, but a clear decrease in prescriptions are being written as a result.