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April 22, 2015
Regulation of Colchicine Lowers Usage, Raises Costs
Boston—The decision by the FDA to regulate colchicine 8 years ago may have been well-intentioned but, according to a new study, has had an unfavorable unintended consequence: Fewer patients are taking the drug, primarily used to treat gout, and those that do are bearing much greater expense. The study, published recently in the Journal of General Medicine, notes that the price went up from about 9 cents per pill before regulation—colchicine was on the market prior the FDA gaining regulatory authority to assure the safety and efficacy of prescription drugs—to about $5 per pill. The investigation was led by researchers from Brigham and Women’s Hospital and the Harvard Medical School. Background information in the report notes that colchicine, which also is the primary treatment for a rare inflammatory disease called familial Mediterranean fever, was sold at low cost by numerous manufacturers for many years in the U.S. In 2007, however, the FDA encouraged one of the manufacturers to conduct 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 that manufacturer’s version, which was branded as Colcrys, granting sole market rights and ordering all unapproved versions off the market by January 2011. Exclusive rights for at least seven years were also granted for the drug’s use to treat familial Mediterranean fever, although no new studies were done on its effectiveness to treat this disease, according to the study. Seeking to determine the impact of the market changes, the researchers conducted a retrospective cohort study of nearly 217,000 commercially insured patients who had been newly diagnosed with either gout or familial Mediterranean fever between 2009 and 2012. Results indicate that the odds of a familial Mediterranean fever patient being prescribed colchicine within 30 days of receiving such a diagnosis dropped by 7.6% per month after the regulations were put in place, while the odds for gout sufferers dropped by 0.5% per month. The average patients’ monthly total prescription bills rose from $418 to $651, the authors note. While one of the FDA’s stated concerns in regulating colchicine was the potentially lethal risk of coprescribing colchicine with the antibiotic clarithromycin, the researchers found no change in the rates of coprescriptions of these two drugs, or coprescription of colchicine with the transplant rejection medication cyclosporine, another potentially deadly combination. “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,” the authors conclude. |
U.S. Pharmacist Social Connect
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