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June 30, 2020

HHS will buy 500,000 treatment courses of remdesivir for U.S. hospitals

Daily Briefing

    HHS on Monday announced it entered an agreement to acquire large supplies of remdesivir—the most promising experimental treatment for Covid-19 so far—for U.S. hospitals, as cases of the new coronavirus in the United States reached more than 2.6 million and regional surges prompted state officials to roll back reopening plans.

    US new coronavirus cases surpass 2.6M, deaths top 126K

    The announcement comes as U.S. officials as of Tuesday morning reported 2,604,900 cases of the new coronavirus—up from 2,564,600 cases as of Monday morning.

    New cases have now grown for more than a week and have surpassed the epidemic's previous peak.

    Data from the New York Times shows that 35 states—Alabama, Alaska, Arizona, Arkansas, California, Colorado, Delaware, Florida, Georgia, Hawaii, Idaho, Illinois, Iowa, Kansas, Kentucky, Louisiana, Maine, Michigan, Mississippi, Missouri, Montana, Nevada, New Mexico, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Washington, West Virginia, Wisconsin, and Wyoming—saw their average daily numbers of newly reported cases rise over the past 14 days.

    Despite the surge in cases, some states are proceeding with their reopening plans. For example, bars remain open in Georgia, Louisiana, Nevada, and South Carolina.

    But in other states, officials are reevaluating their reopening plans—and considering whether to roll back their decisions to allow non-essential businesses to operate. For example, Arizona Gov. Doug Ducey (R) on Monday announced the state will close bars, gyms, movie theaters, nightclubs, and water parks for 30 days because of recent spikes in cases. The governors of California, Florida, and Texas also have ordered bars to close. On Monday, California Gov. Gavin Newsom (D) warned that the state would continue to roll back reopening plans if new coronavirus cases continue to spike.

    "The bottom line is: We're doing this because we have seen an increase in the spread of this virus," Newsom said. "We need to take further steps and that’s exactly what we did this weekend."

    State officials are also considering other strategies to slow the spread of the new coronavirus. For instance, Kansas Gov. Laura Kelly (D) on Monday ordered state residents to wear masks in public spaces.

    Meanwhile, the New York Times' data shows that the average daily numbers of newly reported cases over the past two weeks remained mostly stable in Guam, Puerto Rico, and 13 states: Connecticut, Indiana, Massachusetts, Minnesota, Nebraska, New Hampshire, New Jersey, New York, North Carolina, North Dakota, South Dakota, Vermont, and Virginia.

    But the national spikes in new coronavirus cases have prompted officials in these states to reconsider their reopening plans, too. New Jersey Gov. Philip Murphy (D) said he is "indefinitely" postponing the state's plan to restart indoor dining, and New York Gov. Andrew M. Cuomo (D) said state officials are now evaluating whether New York City can safely resume indoor dining and that he would announce a decision on Wednesday.

    Washington, D.C., and two states—Maryland and Rhode Island—saw their average daily numbers of newly confirmed cases decrease over the past 14 days, according to the New York Times' data.

    As of Tuesday morning, officials had reported a total of 126,161 U.S. deaths linked to the new coronavirus—up from 125,814 deaths reported as of Monday morning.

    HHS strikes agreement with Gilead for 500K treatment courses of remdesivir

    As America's coronavirus epidemic resurgences, HHS on Monday announced that it had reached an agreement to secure more than 500,000 treatment courses of Gilead Sciences' remdesivir for U.S. hospitals.

    HHS and state health departments will use hospitalization and inpatient data to allocate remdesivir to hospitals across the country based on need through September. Gilead said, "[O]nce supplies are less constrained" after September, "HHS will no longer manage allocation."

    Gilead will ship the drug to AmerisourceBergen, which will deliver remdesivir to hospitals. HHS said shipments will occur biweekly.

    HHS and Gilead said the supplies of remdesivir will be sold directly to hospitals for $3,120 per treatment course—or $520 per vial—for patients with private insurance. For patients with government-sponsored insurance, Gilead said, remdesivir's price will be set at $2,340 per treatment course, or $390 per vial.

    According to the Institute for Clinical and Economic Review (ICER), a nonprofit that calculates fair prices for medications, Gilead's price for remdesivir's falls within a cost-effective range for insurers.

    ICER estimated Gilead could charge as little as $1,600 per regimen to recuperate its costs and up to $5,080 per regimen to remain cost-effective for insurances, given that the drug could help patients recover faster and leave hospitals sooner.

    Gilead CEO Daniel O'Day in an interview said remdesivir on average would reduce hospital costs by $12,000 per patient, citing data showing that patients who took remdesivir were discharged from the hospital four days sooner and that each day of hospitalization costs $3,000.

    "Gilead made a responsible pricing decision based on the evidence we have today," ICER President Steven D. Pearson said in a written statement on Monday. But "if further data do[es] not show a clear mortality benefit for remdesivir, then the price of the drug should be dramatically reduced."

    HHS to renew Covid-19 public health emergency

    Separately, an HHS spokesperson on Monday in a tweet announced that HHS plans to extend its Covid-19 public health emergency, which is scheduled to expire on July 25.

    HHS spokesperson Michael Caputo in a tweet said, "[HHS] expects to renew the Public Health Emergency due to COVID-19 before it expires. We have already renewed this PHE once."

    The renewal will extend the designation by 90 days, and allow several payment policies and regulatory adjustments connected to the designation to stay in place (Hackett, Healthcare Finance News, 6/29; Kolata, New York Times, 6/29; Walker, Wall Street Journal, 6/29; Hellmann, The Hill, 6/29 [1]; Lupkin, "Shots," NPR, 6/29; Zaveri, New York Times, 6/29; Hellmann, The Hill, 6/29 [2]; Klar, The Hill, 6/29; Luna, Los Angeles Times, 6/29; Cohrs, Modern Healthcare, 6/29; New York Times, 6/3).

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