Boston—A centuries-old drug that shows promise as a preventive agent after myocardial infarction and now is being investigated to lower inflammation in COVID-19 cases presents a cautionary tale about rapidly rising drug prices in the United States, according to a recent research letter.

The article in JAMA Internal Medicine points out that the recent Colchicine Cardiovascular Outcomes Trial (COLCOT) suggested that colchicine could be repurposed for cost-effective, secondary prevention after myocardial infarction. That study determined that low-priced generics, at about $0.30/pill, were available worldwide.

The problem, according to authors from Massachusetts General Hospital and Harvard Medical School, is that the prices were much, much higher in the U.S.

“Colchicine, which predated the U.S. Food and Drug Administration (FDA), had been available in unregulated/unapproved forms, for less than $0.50/pill, until the first FDA-regulated product, Colcrys, entered in 2009 at a drastically higher price ($5.00/pill), upending the marketplace,” according to the research letter. “Under the guidance of the FDA’s Unapproved Drug Initiative, 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.”

In addition, the authors point out, Colcrys was granted patents for this centuries-old drug until 2029, adding, “Thus, although more than 6 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.”

To examine colchicine prices from 2008 to 2017, the researchers looked at national Medicaid and Medicare drug-spending data.

Results indicate that, in 2017, spending on Medicare and Medicaid claims for single-ingredient colchicine exceeded $340 million. For example, the authors write, inflation-adjusted and rebate-adjusted Medicaid unit prices rose from $0.24/pill in 2008 (unapproved formulations) to $4.20/pill in 2011 (Colcrys only) and peaked at $4.66/pill in 2015 (Colcrys plus authorized generics). They add that Medicare prices had similar jumps from 2012 through 2017.

An issue was that authorized generics entered the market in 2015 but were priced only slightly lower than the brand-name medications and still considerably higher than the previous, unapproved formulations, researchers emphasize, although prescribing of lower-priced probenecid-colchicine ($0.66/pill in 2017) remained stable throughout.

A consequence was that Medicaid spending on single-ingredient colchicine rose 2,833%, with 58% of the increase attributable to price increases alone. The authors compared the $32.2 million in 2017 to just $2.1 million if prices had remained at pre-Colcrys levels.

“Public spending on colchicine has grown exponentially, mainly from ongoing price increases after Colcrys’s approval and market exclusivity, potentially limiting millions of U.S. patients from affording its benefits as a long-term therapy for gout or after myocardial infarction,” the authors conclude.

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