Eli Lilly is set to shift its COVID-19 monoclonal antibody therapy from contract to commercial sales later this month, the Indianapolis-based drugmaker said Thursday.

The drug, bebtelovimab, is expected to become commercially available for purchase starting the week of August 15. Until now, it has been distributed through government contracts, as have most of the other COVID-19 vaccines and treatments.

Bebtelovimab would likely become the first coronavirus vaccine or treatment to make such a switch. As such, it would be an important test case for several reasons.

As the sole antibody-based outpatient drug whose efficacy has been found to hold up against the Omicron variant, bebtelovimab is a significant weapon in the pandemic armamentarium. States and territories, hospitals and other providers will be able to access it via a sole distributor prior to the anticipated depletion of the U.S. government’s supply, Lilly said. That date, according to a report in The Wall Street Journal, could arrive as early as the week of August 22, once June’s shipment of about 150,000 doses peters out.

Like other drugmakers, Lilly has sold bebtelovimab and its other antibody treatments by contracting with the federal government, which in turn has made them available for free to patients in the U.S. But with congressional pandemic funding having run out in the spring, the government is no longer able to purchase it.

Bebtelovimab’s pivot will also mark an early test of the accessibility of coronavirus treatments and vaccines on the commercial market. Indeed, with the government no longer footing the bill, the distribution shift could mean access issues for the uninsured – a disturbing proposition amid a rise in serious COVID-19 case counts and hospitalizations. 

A spokesman for the Department of Health and Human Services told the Journal that HHS has worked with Lilly to ensure there is no break in availability to different jurisdictions across the country and healthcare providers. The organizations are also working to ensure uninsured, low-income people can get the drug, and Lilly expects the monoclonal antibody will be covered by Medicare and Medicaid. 

According to the Journal report, absent a congressional breakthrough on reauthorizing COVID-19 funding, other treatments and vaccines are expected to join bebtelovimab in jumping to the commercial market. That could happen after a vaccine booster campaign now scheduled for as soon as mid-September.

Lilly announced Q2 earnings Thursday, reporting declines in revenue and net income.