Dexamethasone's swift rise as a COVID-19 treatment has U.S. drug suppliers struggling to keep up.
Hospitals in U.S. regions hard hit by COVID-19 are ramping up use of the well-known steroid, Reuters reports. And group drug purchaser Vizient, which supplies meds to about half of U.S. hospitals, confirmed that surge: It's seen a 610% increase in calls for the steroid in hospitals across the country.
So far, those calls haven't been answered as often as Vizient member hospitals would like, either. They're receiving 54% of their dexamethasone orders now, down from 97% on the day dexamethasone's breakthrough COVID-19 data were announced, Vizient said.
It doesn't help that the stepped-up demand hit when injectable dexamethasone was already on the FDA's shortages list.
So where does that leave doctors, and more importantly, severely ill patients who are looking to the drug's promise in severe COVID-19? "What we're hearing from our members right now is that they are able to treat patients who do require dexamethasone," vice president of Vizient's pharmaceutical solutions, Steven Lucio, said. "The concern is, can the market continue to sustain this?"
According to the FDA, injectable dexamethasone has been in low-supply since February of last year, with drugmaker AuroMedics' doses on backorder until later this summer, and Hikma's stores completely tapped out—both well before the COVID-19 developments. The good news? Mylan, Somerset Pharmaceuticals and Fresenius Kabi still have doses to spare.
German drugmaker Fresenius SE's Kabi unit—the U.S.' biggest supplier of the steroid—was quick to voice confidence in its current dexamethasone stores and has pledged to scale up production in three U.S. factories to meet new demand, according to Reuters.
Dexamethasone, which has been in use since the 1960s to treat inflammatory diseases and cancer, is also listed as a "high impact" drug on Vizient's essential medicines list. This means the drug supplier can seek alternatives if its stores run dry, though it warned those alternative drugs may be less clinically desirable and more finicky to use.
Dexamethasone stole the spotlight last week when Oxford University researchers announced that the drug had slashed death rates in COVID-19 patients on ventilators by 35% and 20% for those on oxygen. Patients were given daily 6mg doses of dexamethasone over 10 days, delivered orally or by IV. Even with the data awaiting peer review, the drug scored a swift nod from the U.K. government, which authorized the drug in hospitalized COVID patients hours after the data reveal.
U.S. physicians were quick to voice skepticism though, fearing a repeat of hydroxychloroquine's troubled rise and fall in COVID-19. Doctors hoped that the widely available steroid could provide a cost-effective alternative to the sparse treatment options on offer for COVID patients, but they needed to see more data first.
Then, on Tuesday, researchers unveiled preprint data on the drug, further confirming its success in severely ill patients. The data had analysts speculating whether dexamethasone would usurp Gilead Sciences' remdesivir as the new standard treatment in COVID-19, but more trials pitting the drugs against each other—and in combination—are needed to show how the two compare.
Still, the world looks ready to accept another potentially life-saving COVID treatment, and demand in U.S. hospitals proves it, even if the data is incomplete. Drug pricing watchdogs at the Institute for Clinical and Economic Review (ICER) even warned that a fair price for remdesivir might drop if dexamethasone passes peer review. Analysts, ICER said, advised that dexamethasone might force Gilead's antiviral to take a back seat.
Of course, dexamethasone only has value as a standard treatment if it's readily available for hospitals to use, and drugmakers may need to step up to make that happen.