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Colchicine, the old gout drug often cited as a cheap anti-inflammatory, hasn't been such a good deal since FDA approval, a study showed.

The inflation- and rebate-adjusted Medicaid price per pill jumped from $0.24 in 2008 to $4.20 after the FDA officially approved a branded form, Colcrys, through the agency's Unapproved Drug Initiative pathway in 2009.

As subsequent authorized generics emerged with only "marginally lower" prices, the price per pill actually rose further to $4.66 in 2015, reported Natalie McCormick, PhD, of Massachusetts General Hospital in Boston, and colleagues

"Accordingly, Medicaid spending on single-ingredient colchicine rose 2833%," they wrote, and "58% of this increase was attributable to price increases alone."

Their study used Medicaid and Medicare data files through 2017, when combined Medicaid and Medicare claims exceeded $340 million for colchicine.

"Colcrys's manufacturer, which conducted a 1-week trial (n=185), received 3 years' market exclusivity for treatment of acute gout, and the unapproved formulations were soon ordered off the market, resulting in a virtual monopoly," McCormick's group noted.

"Furthermore, Colcrys was granted patents for this centuries-old drug until 2029. Thus, although more than six independent generics have FDA approval to date, only authorized generics with price points set by brand-name companies are currently available to treat acute gout, pericarditis, and now potentially millions with myocardial infarction" following the COLCOT trial.

The issue could gain even more relevance as colchicine looks promising for severe COVID-19. The drug has been in the pragmatic RECOVERY trial that uncovered the survival benefit of dexamethasone.

"Only a fraction of an investment was required for Colcrys, a product that has provided no increased value and an unnecessary, long-term cost burden to the health care system," argued B. Joseph Guglielmo, PharmD, of the University of California San Francisco, in an . "The current study findings illustrate that we can never allow such an egregious case to take place again."

While it's too late for colchicine, the Trump administration announced on November 20 that it , citing the unintended consequences of allowing manufacturers to raise prices largely without market competition.

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