In 2019, there were two branded formulations of colchicine and generic colchicine was being manufactured by more than six companies, yet the unit cost was over $4.74. The cost of branded colchicine was $7.03.
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Explore This IssueSeptember 2021
The unit cost of probenecid-colchicine over this entire study period remained at approximately $0.70.
A total of 21 drugs received approvals from 2008–17 under the Unapproved Drugs Initiative, and two were granted exclusivity under the Orphan Drug Act. Eight of the 21 were self-administered agents, including morphine sulfate, oxycodone hydrochloride and atropine sulfate eye drops. Competition amongst manufacturers of these products was significantly reduced, and although not as remarkable as colchicine, several products saw an increase in unit price.30
In November 2020, the FDA decided to terminate the Unapproved Drug Initiative. In a report by the U.S. Department of Health and Human Services and the FDA, it stated several reasons for such an action. In addition to raising the costs of several drugs, including colchicine, the market exclusivity provided under the Unapproved Drugs Initiative created shortages of various drugs.
The report added that the majority of the drugs approved under this initiative were supported by literature reviews and bioequivalence to older drugs, with very little added in terms of new clinical trial evidence.
As a consequence, the cessation of this initiative will likely reduce the burden on American taxpayers and increase access to these drugs.35 It is presently unclear what will replace the Unapproved Drug Initiative.
Colchicine is one of the oldest remedies still in use today, with the potential for multiple indications. The anti-inflammatory and anti-fibrotic effects it confers, with a relatively favorable safety profile, make it an ideal drug for several rheumatic and non-rheumatic conditions. Although the cost of this very old drug remains inexplicably high, it is being investigated for several rheumatic and non-rheumatic conditions.
Ibrahem Salloum, MD, is a hospitalist and assistant professor (clinician-educator) with the Department of Medicine, Division of Hospital Medicine at the Warren Alpert School of Medicine, Brown University, Providence, R.I. He provides inpatient care at The Miriam Hospital in Providence and has an interest in caring for patients with rheumatic diseases.
Deepan S. Dalal, MD, MPH, has been a faculty member in the Department of Medicine, Rheumatology Section at the Warren Alpert School of Medicine for the past five years. He sees patients in the general rheumatology clinic at Brown Medicine Patient Center and has a special interest in musculoskeletal ultrasound. He focuses on health services and outcomes research and is particularly interested in geriatric patients suffering from inflammatory arthritis.