Becker's Hospital Review

53 FINANCE CMO / CARE DELIVERY Invoking Defense Production Act for COVID-19 vaccines causing shortages of some drugs By Maia Anderson T he federal government has invoked the Defense Production Act sev- eral times to boost the development and production of COVID-19 vaccines, but directing so many drugmaker resources toward vac- cines is causing some drug shortages, NPR reported March 13. Horizon Therapeutics said in December that its thyroid drug Tepezza would likely be in shortage because its contract manufacturer, Catalent, has been directed under the act to process and package COVID-19 vac- cines instead of making the drug, according to NPR. The drugmaker's CEO, Tim Walbert, said in a Feb. 1 Facebook video: "We've heard from many of you. We understand the urgency to resume or start treatment." He added that Horizon is working with the FDA to figure out alternative manufacturing methods, NPR reported. Pfizer also sent a letter to hospitals telling them they may experience short-term supply shortages "due to increased vaccine production," ac- cording to NPR. The shortages may affect cleocin phosphate, an antibi- otic; Depo-Medrol, a steroid; and depo-testosterone and testosterone cypionate, used to treat hormonal problems and some breast cancers, NPR reported. n UK variant is deadlier than other strains, research suggests By Mackenzie Bean A study published March 15 in Nature offered more evidence that the U.K. coronavirus variant B.1.1.7 is not only more transmissi- ble than other strains, but may also be deadlier. Researchers analyzed data on more than 2.2 million positive COVID-19 tests collected in community-based settings in England between Sep. 1, 2020, and Feb. 14, 2021. The presence or absence of the U.K. variant could be identified in about 51 percent of samples. Based on 4,945 deaths with a known U.K. variant status, researchers es- timated that the 28-day death risk associated with the variant was 55 percent higher than other strains after adjusting for such factors as age, sex and testing date. Researchers estimated this figure was closer to 61 percent for the whole study cohort. The findings come five days after a separate study published in The BMJ found patients ages 30 and older infected with the U.K. variant had a 64 per- cent higher death risk than those infected with previously circulating strains. However, both research teams noted the absolute 28-day mortality risk was still low for most populations, according to CIDRAP News. Both studies also focused on less than 10 percent of total deaths recorded in England during the study periods, so the findings may not be transfer- able to other settings or age groups. n cer patients in the state, it became clear that even with those creative scheduling efforts, our capacity would still be far inadequate. So then we went to our urgent care leadership and asked if we could train the urgent care nurses to prepare the treatment and manage these infusions. And they said absolutely. at engagement was awesome. We then filled in the gaps around the infusion centers with urgent care sites in geographically strategic locations that would serve high COVID-19 density places. By doing that, we were able to open 17 infusion sites, which essentially covered the majority of a popula- tion corridor representing about 2.5 million people. is meant no one would have to drive more than 60 minutes to get to an infusion site. In most cases it was much shorter than that. Q: What do you think has been key to In- termountain's successful rollout? BW: We've been participating in the clinical trial that led to the authorization of these treatments, so we were able to get some familiarity of how the infusions work even before they were authorized by the FDA. e other thing that was helpful was the fact that we were already doing clinical trials in outpatient COVID-19 populations. Because of our research participation, we had already developed a platform for identifying patients who were at higher risk and would stand to benefit from treatments de- signed to prevent hospitalization. I think two factors gave us confidence. One, that we could appropriately match the drug supply and in- fusion capacity that we did have to the patients who were most likely to benefit. And two, that we already had the framework to do that because of our partici- pation in clinical research. Q: Do you have any insights on how well the treatment appears to be working in your patient population? BW: When we started this program, we paired it with a planned approach to do research analysis to understand how well they work. We recognized that while FDA-authorized, these antibody treat- ments are still technically investigational, and we have an incomplete understanding of their safety and effectiveness. As of March 11, Intermountain alone has delivered 1,000 treatments. We have now treated enough pa- tients that we have a large enough sample to do a meaningful analysis. So we are just now starting to do that analysis. I can speak to some very prelim- inary numbers right now. Of the patients who re- ceive infusions, about 4.5 percent of them end up being hospitalized. By our estimation, we are target- ing a population that normally would be hospital- ized at a rate of at least 10 percent to 15 percent. So very preliminarily, we expect that this treatment is indeed preventing hospitalization, and we are anx- ious to have a more robust analysis with adjustment for other factors that will help us and others know even better in a real-world setting how well this actually works. n

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