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Underused Covid Therapy Gets Boost in Nursing Homes From HHS

Dec. 29, 2020, 10:45 AM

A promising but underused Covid-19 therapy is heading to more high-risk nursing home patients under a new initiative bringing together home infusion providers and long-term care pharmacists.

The new Health and Human Services Department effort is dubbed “SPEED,” or “Special Projects for Equitable and Efficient Distribution.” It’s designed to help states and local governments identify and provide monoclonal antibody therapies to Covid-19 patients in non-hospital settings, like nursing homes, assisted living facilities, and federally qualified health centers.

By enlisting infusion providers and long-term care pharmacists to help locate facilities that need these therapies, SPEED could help lower Covid hospitalizations and spur wider take-up of the treatments, which have been underutilized with Covid vaccines winning emergency authorization.

Laboratory-made monoclonal antibodies mimic the immune system’s ability to repel dangerous pathogens, like viruses. They are designed to bind to the spike protein of the SARS-CoV-2 virus, which blocks it from attaching to and infecting human cells.

Additional SPEED initiatives are being explored for “state/local correctional facilities, dialysis centers, and other settings,” John T. Redd, chief medical officer in the HHS’ Office of the Assistant Secretary for Preparedness and Response, said in a recent email announcing the program to state and local health officials.

The department didn’t respond to questions in time for publication.

In November, the FDA issued separate emergency use authorizations for monoclonal antibody therapies made by Eli Lilly & Co. and Regeneron. Both infusion therapies are designed to treat Covid-19 patients with mild to moderate symptoms who are at high risk for developing a severe case or of being hospitalized. This includes patients age 65 and older and those of any age with certain chronic medical conditions like diabetes, hypertension, or heart and lung diseases.

President Donald Trump received the Regeneron therapy during his initial hospital visit after developing Covid-19 in October. The emergency use authorizations estimate the treatments can reduce the risk of Covid hospitalizations from 10% to 3% in high-risk patients.

Supplies Limited

U.S. hospitals will have received only about 56,000 patient courses of the Regeneron therapy cocktail by Jan. 5, 2021, even though 117,154 patient courses have been allocated, according to HHS data.

Of the nearly 415,000 doses of Lilly’s antibody therapy to be allocated by Jan. 5, only 234,653 are expected to be delivered by that date, the HHS reports.

While neither monoclonal therapy is authorized to be administered to hospitalized Covid-19 patients, most doses have so far gone mainly to hospitals where they’re administered during observational visits, often at infusion clinics located near hospital emergency rooms, said Chad Worz, executive director and CEO of the American Society of Consultant Pharmacists.

But with limited space and hospital staff to manage the therapies during the ongoing surge, the doses have sat largely unused, Worz said.

“So HHS recognized pretty quickly that it wasn’t getting deployed and it was starting to stockpile in acute care centers,” Worz said. “So they reached out to the National Home Infusion Association. And then they reached out us.”

The American Society of Consultant Pharmacists represents roughly 500 long-term care pharmacies that service the prescription needs of about 75% of all nursing home patients. Since Dec. 17, ASCP has helped 275 long-term care pharmacies get 10,000 doses of the Lilly therapy that will go to nursing home residents, Worz said.

“We’ve developed a pretty manual kind of Excel spreadsheet way of pharmacies saying ‘here’s how much we have, here’s how much we used, here’s how much we think we’ll need for the next week,’” Worz said. “And we’re doing that through HHS in the short term until states—that are pretty overwhelmed with everything else, including vaccines—can step back into that role of allocating the doses to the right locations.”

Requirements for Treatment

Like the federal government, states have also had difficulty finding non-hospital entities that can administer the therapy, said Connie Sullivan, president and CEO of the National Home Infusion Association. The emergency use authorization requires that monoclonal therapy providers be able to treat patients who have adverse reactions to the infusion therapy.

“But states don’t have existing relationships with home infusion providers, so they don’t know enough about these products, really, to facilitate access, in any other way other than just sending them to the hospitals, which is what has been happening.” Sullivan said. “So we’re trying to help identify providers that we know can do this type of therapy, and get them product, outside of the state allocation process.”

Sullivan’s group has helped identify 150 long-term care pharmacies that could dispense the therapies in nursing homes. In the first week of the effort, these pharmacies received 560 vials. In the second week, it was nearly 2,000, Sullivan said. The effort launched the week of Dec. 14.

Infusion providers typically administer medications in patients’ homes. But the government pays only $310 to administer the monoclonal infusion, Sullivan said. That wouldn’t cover the actual cost to do the one-hour, in-home therapy and one-hour monitoring that follows, Sullivan said.

Instead, home infusion providers have offered to provide nursing support—and even administer the therapy themselves—in smaller nursing homes and assisted living facilities with no medical staff, Sullivan said. Administering the therapy to multiple patients at the same time creates more favorable “economies of scale,” Sullivan said.

To contact the reporter on this story: Tony Pugh in Washington at tpugh@bloomberglaw.com

To contact the editors responsible for this story: Fawn Johnson at fjohnson@bloombergindustry.com; Andrew Childers at achilders@bloomberglaw.com

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