Reductions in Use of Colchicine after FDA Enforcement of Market Exclusivity in a Commercially Insured Population

J Gen Intern Med. 2015 Nov;30(11):1633-8. doi: 10.1007/s11606-015-3285-7. Epub 2015 Apr 9.


Background: A brand-name version of colchicine (Colcrys) was introduced after its manufacturer conducted a clinical trial in acute gout patients, leading to higher prices for this drug.

Objective: We analyzed the impact of the new single-source colchicine product on prescribing and patient health spending as well as incidence rates of potentially dangerous concomitant use of clarithromycin and cyclosporine after formal FDA approval.

Design/participants: We conducted a retrospective cohort study of UnitedHealth-affiliated enrollees newly diagnosed with gout or FMF.

Main measures: Among gout and FMF patients separately, we assessed linear trends in colchicine prescriptions, prescription drug costs, and total health care costs from 2009 to September 2010 (market exclusivity announced) compared to January 2011 (market exclusivity enforced) through 2012. Next, we estimated trends in co-prescription within 15 days of clarithromycin, azithromycin (indicated on the Colcrys label for use in place of clarithromycin), and cyclosporine.

Key results: Among gout patients, before Colcrys' market exclusivity, the odds of receiving colchicine within 30 days of gout diagnosis increased 1.4 %/month (OR: 1.014, 95 % CI: 1.011-1.018). Following FDA action, the odds decreased by 0.5 %/month (OR: 0.995, 95 % CI: 0.992-0.999) (p < 0.001). Similarly, among FMF patients, odds of initiating colchicine changed from an increase of 2.8 %/month to a decrease by 7.6 %/month (p = 0.01). Patients receiving colchicine 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). Incidence rates of colchicine/clarithromycin co-prescription before and after FDA action did not change, while co-prescription of colchicine/cyclosporine increased after introduction of Colcrys [-0.75 monthly change in patients (95 % CI: -1.07, -0.43) vs. 0.13 (95 % CI: -0.16, 0.42), p < 0.001].

Conclusions: The FDA's actions were associated with a reduction in colchicine initiation and an increase in patient spending. By contrast, we did not observe any association with improvements in avoidance of potentially dangerous co-prescriptions.

Publication types

  • Research Support, N.I.H., Extramural
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Anti-Bacterial Agents / therapeutic use
  • Clarithromycin / therapeutic use
  • Colchicine / economics
  • Colchicine / therapeutic use*
  • Drug Approval
  • Drug Costs / statistics & numerical data
  • Drug Costs / trends
  • Drug Interactions
  • Drug Prescriptions / statistics & numerical data
  • Drug Utilization / statistics & numerical data
  • Drug Utilization / trends*
  • Economic Competition
  • Familial Mediterranean Fever / drug therapy
  • Female
  • Gout / drug therapy*
  • Gout / economics
  • Gout Suppressants / economics
  • Gout Suppressants / therapeutic use*
  • Health Care Costs / statistics & numerical data
  • Health Care Costs / trends
  • Humans
  • Insurance, Health
  • Male
  • Middle Aged
  • Retrospective Studies
  • United States
  • United States Food and Drug Administration


  • Anti-Bacterial Agents
  • Gout Suppressants
  • Clarithromycin
  • Colchicine