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Drug Regulations Tied to Fewer Prescriptions of Effective Gout Medication

FDA actions led to 50-fold increase in price of colchicine

“Well intentioned, but costly and potentially problematic.” That’s how researchers describe the end result of a decision by the FDA to regulate colchicine, a drug used to treat gout, among other ailments. Fewer patients are now taking it, and it has come at a cost to their wallets, says study leader Dr. Aaron Kesselheim of the Harvard Medical School. The findings were published in the Journal of General Internal Medicine.

Colchicine had been sold at low cost for many years in the U.S. It is widely used to treat gout and is the primary treatment for the rare inflammatory disease familial Mediterranean fever (FMF). The availability of colchicine on the U.S. market predated the FDA’s regulatory authority to ensure the safety and effective use of prescription drugs, and numerous manufacturers made the medication, selling it for approximately $0.09 per pill.

In 2007, with the FDA’s encouragement, one of these manufacturers conducted a small clinical trial demonstrating the safety and efficacy of a short course of the drug in managing acute flares of gout. The FDA approved this manufacturer’s version, granting sole market rights and ordering all unapproved versions off the market by January 2011. Exclusive rights for at least 7 years were also granted for its use to treat FMF, although no new studies were done on its effectiveness to treat this disease. The manufacturer of the new version, called Colcrys, sold the drug for about $5.00 per pill.

To gauge the effect of these market changes, Kesselheim and his colleagues conducted a retrospective cohort study of approximately 217,000 commercially insured patients. Between 2009 and 2012, these patients were all newly diagnosed with either gout or FMF.

Before the market exclusivity of Colcrys, the odds of receiving colchicine within 30 days of a gout diagnosis increased 1.4% per month. After the FDA action, the odds decreased by 0.5% per month (P  < 0.001). Similarly, among FMF patients, the odds of initiating colchicine decreased by 7.6% per month after an increase of 2.8% per month (P  =  0.01) before the FDA action. Patients receiving colchicine also experienced increases in average monthly prescription drug costs ($418 vs. $651; P  < 0.001) and health care costs ($3,406 vs. $3,534; P  < 0.001).

The FDA’s justifications for approving Colcrys included new warnings in the drug’s label about the potentially lethal risks of co-prescribing colchicine with the antibiotic clarithromycin. But Kesselheim and his colleagues found no change in the rates of the coprescriptions of these two drugs, or in the coprescription of colchicine with the transplant- rejection medication cyclosporine, another potentially deadly combination.

Kesselheim and his team say that although the FDA’s attempts to strengthen its regulatory oversight related to unapproved drugs are laudable, they have come at a price to those who need colchicine. “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 coprescriptions,” Kesselheim said.

Sources: Medical Xpress; April 9, 2015; and JGIM; April 9, 2015.

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