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Study: FDA actions reduced Colcrys use, increased costs for patients with gout
The approval of Colcrys in July 2009 and its market exclusivity that followed created higher costs and reduced use of or delayed access to colchicine products for patients with gout, according to researchers.
The researchers studied the Optum Research Database of more than 13 million beneficiaries of UnitedHealth insurance plans and identified 216,640 individuals newly diagnosed with gout, among whom 630 were included as a result of a familial Mediterranean fever (FMF) diagnosis. Patients’ mean age was 52 years, and 76% of the patients were men.
Before the FDA order that granted market exclusivity to Colcrys (colchicine, Takeda) as a single-source provider of colchicine to U.S. patients with gout or FMF, the odds of receiving colchicine within 30 days of diagnosis increased by 1.4% each month. After the FDA action, the odds of receiving colchicine within 30 days of diagnosis decreased by 0.5% each month. The odds of receiving initial treatment with colchicine between September 2010 and January 2011 decreased by 16% in adjusted and unadjusted models, according to the researchers.
The odds of receiving colchicine in patients newly diagnosed with FMF increased each month by 2.8% before the FDA action and decreased by 7.6% per month following the decision.
Monthly drug costs among all patients averaged $418 between January 2009 and September 2010 and increased to $651 between January 2011 and December 2012.
Additionally, the researchers reported there was no association with improvements in the avoidance of potentially dangerous co-prescriptions observed as a result of the FDA order. - by Shirley Pulawski
Disclosure: The researchers report no relevant financial disclosures.