Potential Miracle Treatment Promoted by Feds for SNFs

COVID-19 monoclonal antibodies are now widely available for use by skilled nursing facilities  — and early results show promise, according to long-term care pharmacy leaders. Kimberly Marselas, writing for McKnight's Long-term Care News outlined the great news in her article, A potential ‘miracle’? Feds push monoclonal antibody treatments toward SNFs.  The following is an annotated reprint of her excellent article.

The Department of Health and Human Services’ (DHS) Project SPEED, or Special Projects for Equitable and Efficient Distribution, aims to get monoclonal treatment to COVID patients in non-hospital settings with priority populations, including nursing homes and assisted living facilities [some links added]. It goes beyond an earlier pilot spearheaded by CVS Health that targeted nursing homes and patients at home in seven cities with rapidly rising COVID rates.

The program is now open to any licensed pharmacy, said Chad Worz, PharmD, CEO and executive director of the American Society of Consultant Pharmacists, during an online update last week. He said LTC pharmacies around the country are beginning to add the therapeutic drugs, which mimic the body’s natural immune response, to their formularies.

As word spreads about availability, Worz expects increasing demand from skilled nursing providers who see antibodies as a way of mitigating COVID symptoms and preventing hospitalizations.

On the same webinar, T.J. Griffin, R.Ph., senior vice president of long-term care operations and chief pharmacy officer at PharMerica, said he is working closely with two nursing homes in Chicago and San Antonio that have used antibodies on a total of 70 patients since the program’s launch.

“The medical directors of both places have called it a miracle,” Griffin said. “So far, none of these patients have gone back to the hospital.”

Because most clinical data on monoclonal antibodies comes from hospitals, there’s not much evidence about its success in nursing home residents. But Griffin said he is working to gather and report information to HHS, and urged others to document and share patient responses.

Use protected during public health emergency

One pharmacist on the call noted a facility he worked with declined to administer the antibodies, citing liability concerns. But Worz said federal PREP Act protections would apply to skilled facilities that administer them safely and effectively and monitor for anaphylactic shock.

Arnold Clayman, ASCP’s vice president of pharmacy practice and government affairs, said infusion could be handled by staff members with an infusion license where required. Non-skilled facilities, or those without nurses to spare, could also tap into a separate program being led by the National Home Infusion Association in 46 states and Washington, D.C.

To date, only bamlanivimab, widely known as BAM, has been made available to LTC pharmacies. But Worz is also advocating for doses of Regeneron’s version, which requires pharmacists to compound casirivimab and imdevimab.

Both types of monoclonal antibodies received Emergency Use Authorization in mid-November with initial shipments sent to hospitals. But many said they were simply too busy treating severe COVID cases to deliver the outpatient therapy. As of late December, just 20% of the available antibodies had been used.

“That’s the reason they’re pushing it to long-term care, because (HHS) saw stockpiling in hospitals,” Worz said.

Wider use covered by CMS

Pharmacies can order for weekly delivery, or arrange for an emergency shipment in the case of a known outbreak, but Worz said HHS is tracking inventory to ensure the potentially life-saving product doesn’t continue to sit unused.

Medicare and Medicaid coverage of the use of monoclonal antibody therapy for COVID-19 treatments extends to beneficiaries in nursing homes at no cost during the public health emergency.

AMDA — The Society for Post-Acute and Long-Term Care Medicine, which initially expressed skepticism about the efficacy of antibody treatments in nursing homes because of a lack of data, has now partnered with ASCP to assist with Project Speed.

John Redd, M.D., MPH, chief medical officer, Office of the Assistant Secretary for Preparedness and Response at HHS, previously told McKnight’s that medical directors and physicians who care for long-term care patients are “crucial” to expanded delivery of the antibody treatment.

“We intend to engage them with every phase of the rollout,” he said.  “This therapeutic is intended to treat patients with COVID-19 risk factors who are early in their disease, which includes the majority of residents of long-term care facilities.”