The FDA issues an emergency use authorization (EUA) for Eli Lilly’s coronavirus disease 2019 (COVID-19) treatment; insurance waivers for COVID-19–related costs are starting to expire; new data update convalescent plasma’s indication.
Monoclonal antibody combination bamlanivimab plus etesevimab has been granted an emergency use authorization (EUA) by the FDA for use among patients testing positive for SARS-CoV-2, the virus that causes coronavirus disease 2019 (COVID-19). This indication is for mild to moderate cases among patients 12 years and older who weigh at least 40 kg (88 lb), for adults 65 years and older, or individuals with certain chronic conditions. During a 29-day follow-up, just 1 intravenous infusion of the combination was shown to greatly reduce mortality and hospitalization rates. Bamlanivimab previously received an EUA in November as a solo treatment for COVID-19.
At the start of the COVID-19 pandemic, many insurance companies waived all patient-related costs, but those payment-free days are ending for some, reports Los Angeles Times. For example, Blue Shield of California’s waivers expire at the end of February; Cigna’s in 5 days, February 15; and Blue Cross Blue Shield Association, at the end of May. At the crux of this issue is self-funded/employer-funded plans, for which the waivers were voluntary—most waivers don’t cover these plans—and some of which do not have out-of-pocket patient spending limits.
New trial data have led the FDA to update its original EUA from August 2020 on the use of convalescent plasma to treat patients with COVID-19. The revised guidance will permit only the use of high-titer convalescent plasma, restrict its use to hospitalized patients early in the disease course, and eliminates the use of low-titer convalescent plasma, which has been shown ineffective. This EUA also includes approvals for 9 tests to evaluate anti–SARS-CoV-2 antibody levels in potential plasma donations.