Monoclonal Antibody Use in Post-Acute and Long-Term Care: A Call to Action

To the Editor:

Older adults, specifically those residing in nursing homes, recently experienced the most significant increase in COVID-19 cases and death in the United States.¹ Monoclonal antibody (mAb) treatments are the only currently available outpatient antiviral treatment available for COVID-19.² MAb awareness, access, and administration remain significant challenges in post-acute and long-term care (PALTC) facilities. We provide tools and strategies to address these challenges.

Studies of SARS-CoV-2 mAb demonstrate outcomes relevant to PALTC residents. Administration of the casirivimab-imdevimab mAb cocktail to decrease SARS-CoV-2 viral load reduces risk of hospitalizations and deaths from mild to moderate cases of COVID-19 by 70% and decreases symptoms by 4 days.³ When given as postexposure prophylaxis, casirivimab-indevimab has been associated with an 81% reduced risk of symptomatic infections in household contacts of individuals with COVID-19.⁴ Bamlanivimab-ertesevimab has shown a 45% reduced risk of COVID-19 for nursing home and assisted living residents when used as postexposure prophylaxis.⁵ Ultimately, reducing COVID-19 outbreaks and COVID-19-related hospitalization is critically important given the known risk of mortality and challenges of hospitalization for residents in PALTC.

Of great concern is that effective immunity to COVID-19 by mRNA vaccination among nursing home residents has declined significantly since emergence of the Delta variant.⁶ Simultaneously, although use of mAb for COVID-19 was initially low, at times reaching fewer than 30% of eligible patients, utilization of mAb for treatment or postexposure prophylaxis increased in August 2021.⁷ Then, as of September 13, 2021, the Department of Health and Human Services transitioned from a direct ordering process by health care facilities to a state- and territory-coordinated distribution system. This shift has significantly increased barriers to mAb access in PALTC.

In this rapidly evolving paradigm, it remains imperative to make mAb treatment available for appropriate PALTC residents when indicated. Offering the treatment in place circumvents the need for transportation from the PALTC community to an outpatient infusion center and potential transmission of COVID-19 to all those in the path to the infusion center and back. However, PALTC communities have difficulty with access to mAb; cumbersome protocols for ordering mAb; lack of familiarity with preparation and administration of mAb, such as not being aware of a subcutaneous administration option; and feeling unprepared to monitor for adverse effects. Providers often lack awareness of the clinical indications and feel unprepared to place orders for this new treatment.

Action-oriented resources are necessary to support rapid implementation of mAb in PALTC (Table 1 ). The Colorado Society for Post-acute and Long-term Care Medicine collaborates with local partners, including the mAb Colorado research team of the Colorado Clinical and Translational Sciences Institute, University of Colorado, and the Colorado Department of Public Health and Environment (CDPHE), to increase awareness and uptake of mAb. Current tools and strategies to improve appropriate use of mAb in PALTC residents include the following:

• -Authorization for treatment of patients with COVID-19 or postexposure prophylaxis using intravenous or subcutaneous delivery methods by the Food and Drug Administration Emergency Use Authorization for COVID-19 mAb cocktails⁸
• -Public health guidance by CDPHE that all nonhospitalized residential care facility residents who are diagnosed with COVID-19 be evaluated to determine eligibility for mAb⁹
• -PALTC provider education to promote knowledge of clinical uses of mAb (eg, multistakeholder webinars)
• -Distribution of user-friendly treatment protocols tailored to PALTC settings, in coordination with long-term care pharmacies
• -Facility-based protocols to help PALTC nursing staff identify appropriate candidates for mAb therapy for treatment or postexposure prophylaxis in a PALTC resident
• -Standing orders of mAb by local pharmacies to facilitate efficient prescribing
• -Toolkits for PALTC nursing staff demonstrating administration for intravenous or subcutaneous delivery routes, scripts for shared decision making, and monitoring algorithms for adverse effects.

Table 1.

SARS-CoV-2 Monoclonal Antibody Administration Resources for Post-Acute and Long-Term Care Facilities

	National	State-Level Example
FDA Emergency Use Authorizations	ASPR PHE: COVID-19 Monoclonal Antibody Therapeutics page: https://www.phe.gov/emergency/events/COVID19/therapeutics/Pages/default.aspx	NA
Public Health Guidance	ASPR PHE: Important Updates: Monoclonal Antibody Therapeutics: https://www.phe.gov/emergency/events/COVID19/therapeutics/Pages/default.aspx NIH COVID-19 Treatment Guidelines: https://www.covid19treatmentguidelines.nih.gov/therapies/	CDPHE Residential Care Facility Comprehensive Mitigation Guidance: https://cdphe.colorado.gov/health-facility-covid-19-response/residential-care-strike-team/guidance-by-facility-type
PALTC provider education	AMDA webinar (September 22, 2021): https://paltc.org/amda-update-covid-19	CMDA Webinar (September 13, 2021): https://youtu.be/dp3nATnTuLc
Treatment protocols and standing orders for mAb, in coordination with long-term care pharmacies	AMDA Best Practices for Use of Monoclonal Antibodies to Treat COVID-19 in PALTC (August 31, 2021) https://paltc.org/sites/default/files/Best%20Practices%20for%20Use%20of%20Monoclonal%20Antibodies%20to%20Treat%20COVID_8_31-21.pdf	Contact long-term care pharmacy
Nursing staff protocols to help identify appropriate candidates for mAb therapy	AMDA App: mAb Treatment Eligibility Tool: https://paltc.org/amda-update-covid-19	Contact long-term care pharmacy
Toolkits for intravenous or subcutaneous delivery routes, and monitoring algorithms for adverse effects	HHS Playbook, Federal Response to COVID-19 Monoclonal Antibody Clinical Implementation Guide: https://www.phe.gov/emergency/events/COVID19/investigation-MCM/Documents/USG-COVID19-Tx-Playbook.pdf	Contact long-term care pharmacy

AMDA, The Society for Post-Acute and Long-Term Medicine; ASPR PHE, Office of the Assistant Secretary for Preparedness and Response Public Health Emergency; CMDA, Colorado Society for Post-acute and Long-term Care Medicine; NA, not applicable.

Coordinated preparation, advocacy, and action to implement this new mAb treatment are required to reduce the devastating effects of COVID-19 in PALTC. We urge state and regional public health officials, health care systems, individual organizations, and PALTC providers and staff to use the information provided in this letter to prepare for the use of mAb now so that all appropriate PALTC patients receive this life-saving treatment.