Background/Purpose:

Although colchicine has been used in the management of gout for decades, it had never undergone the formal approval process by the Food and Drug Administration (FDA). In 2006 the FDA announced its Unapproved Drugs Initiative. This initiative encouraged manufacturers of colchicine to study the safety and efficacy of their product, and to formally apply for FDA approval.  In 2009 one brand name colchicine became the sole FDA approved colchicine product in the United States.  In 2010 all unapproved colchicine products were removed from the market. With the availability of only one colchicine product, the cost increased significantly. Each pill was estimated to be 50 times more expensive. Concerns were raised that this price increase would result in decreased access for patients with gout who need colchicine. The inability to afford, and therefore utilize colchicine, could result in more frequent and prolonged flares of gout. Patients with acute gout often present to an emergency department (ED) or rheumatology office for treatment.  The number of visits to the ED and rheumatology outpatient office by gout patients may correlate with gout flares.

Methods:

A retrospective cohort study comparing the number of patients presenting to the ED and outpatient rheumatology practice at our institution was compared during two distinct time periods: January 1, 2008 to December 31, 2008 when unapproved inexpensive colchicine was still available, and January 1, 2012 to December 31, 2012 when only one approved more expensive colchicine was available. A diagnostic code search was performed for ICD-9 codes 274.0, 274.01, and 274.9 as the primary diagnosis. The total number of visits for both gout and non-gout diagnoses in each time period and setting were calculated for comparison.

Results:

The number of visits to the ED for gout was 73 out of 85,500 total ED visits in 2008. This increased to 91 out of 122,200 total ED visits in 2012. This was not found to be statistically significant.  In the rheumatology outpatient setting there were 225 gout visits out of a total of 7,827 total office visits in 2008. This decreased to 112 out of 10,377 total office visits in 2012. In this patient population there was a statistically significant lower incidence of gout in 2012 compared to 2008 with a risk ratio of 2.66 (95% CI 2.13-3.33, p-value <0.0001).  Combining ED visits and outpatient rheumatology there was again a statistically lower incidence of gout presentations in 2012 compared to 2008 with a risk ratio of 2.08 (95% CI 1.74-2.49, p-value <0.0001).  These findings suggest it was about twice as likely to present with gout in 2008 compared to 2012.

Conclusion:

There have been concerns that a significant increase in cost would reduce access to colchicine for patients with gout resulting in possibly more frequent and prolonged flares of gout.  Our study did not show an increase in ED utilization by patients with gout during the period of increased cost, and outpatient rheumatology visits actually decreased. This may in fact be partially due to the availability of newer medications for the long-term management of gout.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/the-effect-of-the-formal-approval-of-colchicine-on-utilization-of-emergency-department-and-rheumatology-outpatient-services-by-patients-with-gout/