The pandemic has highlighted the challenge health care providers face in translating new scientific findings to actual patient care. The integration of COVID-19 monoclonal antibody treatment is a good example of this challenge.
Frustration at a Local Hospital
In a year of difficult days, my mom came home from work one evening in March especially frustrated in her efforts to arrange care for a COVID-19 positive patient. She is a nurse practitioner caring for patients in the greater Worcester area. My mom explained to me that she had seen a patient that day who was a candidate for the COVID-19 monoclonal antibody treatment. But her hospital did not have this treatment available.
The COVID-19 monoclonal antibodies are synthetic antibodies that bind to the spike protein of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and block the virus from invading human cells. This new treatment could reduce the risk of progression to severe disease if it is administered early enough to high-risk outpatients with mild disease.
She searched the Massachusetts Department of Health COVID-19 treatment locator site. After finding an available location, she called the site to understand how to order the treatment for her patient. She was unable to order the monoclonal antibodies through her electronic medical record, because no order set was available. The whole process took hours.
Listening to her story, I realized that health care providers have been acting as mediators during this pandemic. They have had to interpret breaking research findings, navigate government emergency authorization and lead implementation. As a pre-med student, I wondered what caused such delays in the uptake of this novel treatment.
Current Recommendations for Monoclonal Antibodies in Outpatient Settings
Two COVID-19 monoclonal antibody treatments, casirivimab-imdevimab and sotrovimab, are currently available under the U.S. Food and Drug Administration (FDA) Emergency Use Authorization (EUA).
The data from EUA suggested that casirivimab-imdevimab reduced COVID-19 related hospitalizations and death. Most recently, sotrovimab showed an 85% reduction in progression to more severe illness, while maintaining activity against new variants first reported in the United Kingdom, South Africa, Brazil, New York, California, and India. It was granted EUA in May 2021.
Both the National Institutes of Health (NIH) and Infectious Diseases Society of America (IDSA) recommend the COVID-19 monoclonal antibody treatments for outpatients with mild to moderate COVID-19, who are at high risk of progression to severe disease.
Slow Uptake of COVID-19 Monoclonal Antibody Treatment
Despite the EUA and recommendations, the U.S. Department of Health and Human Services (HHS) reported in January 2021 that only 25% of the available COVID-19 monoclonal antibody treatments were being used. This slow uptake was due to both limited provider awareness and the logistical challenges unique to COVID-19 monoclonal antibody treatment. Hospitals must request their treatment doses from the federal government, so provider knowledge and comfort, and the health care system’s capacity to deliver the treatment all are major factors in the adoption of the treatment.
Since the beginning of the pandemic, rapidly changing recommendations have contributed to information overload and confusion for providers. For example, FDA originally issued the EUA for bamlanivmab alone in November 2020. Then bamlanivimab-etesvimab therapy received an EUA in February 2021. These are based on the interim analysis of the clinical trials without waiting for the final analysis.
However, due to the increasing prevalence of a variant resistant to bamlanivmab, FDA revoked the EUA for bamlanivmab in April 2021. HHS paused the distribution of bamlanivmab-etesevimab in June 2021. Although IDSA still suggests bamlanivmab-etesevimab in their guideline from June 2021, the latest NIH guidelines updated in July 2021 recommended against bamlanivmab-etesevimab. These frequent changes of EUA and guidelines lead to confusion and hesitation from providers considering use of these treatments.
Providers also need to know where and how to refer patients for monoclonal antibody treatment. Slow implementation of clinical decision support tools, such as an electronic health record order set, present additional hurdles. Embedding these tools in providers’ existing workflows would provide much-needed guidance to providers. And it would facilitate safe and informed decision-making in the time frame required to optimize the benefits of treatment.
Logistical Challenges Are Amplified During a Pandemic
Even for providers, like my mother, who are aware of the current guidelines, logistical challenges present significant hurdles. First, COVID-19 patients must receive monoclonal antibodies within 10 days of illness onset to be effective. Since COVID-19 test results can take 24-48 hours or longer, many patients cannot capitalize on this treatment.
Second, patients receive monoclonal antibodies through an IV. This is a process that often takes more than 60 minutes. And afterward patients receive monitoring for at least an hour. Together, this results in a very lengthy process. While lengthy treatments are not uncommon in medicine, quickly generating sufficient staffing can be a challenge.
Finally, monoclonal antibody patients receive treatment separately from others to minimize the spread of infection. This means hospitals offering COVID-19 monoclonal antibodies require the dedicated space and staff (often in an outpatient setting) to safely provide this treatment. As a result, only a limited number of hospitals offer COVID-19 monoclonal antibody treatments on their premises.
Increasing COVID-19 Monoclonal Antibody Treatment Uptake
In an attempt to increase COVID-19 monoclonal antibody uptake, the HHS launched a website that allows both patients and providers to locate potential sites for antibody treatment. Initially, only 22 states and territorial health departments opted to participate in the project. Presently, monoclonal antibody therapeutic treatments are shipped nationwide. HHS has taken steps to further improve access to the treatment by offering home infusion through Coram, the pharmacy and infusion care division of CVS Health.
These approaches may be helpful to minimize transportation and monetary barriers that may disproportionally hinder those in rural or impoverished areas. However, these efforts will not be effective until providers have the tools they need to stay up-to-date. They must also be able to connect their patients efficiently to these treatments, ideally ordering and referring using EHRs.
As a daughter of a health care worker and a college student poised to enter the medical field, I have learned the potential barriers to adoption of the novel treatments. I see the need for faster and clearer communication of rapidly evolving scientific findings and clinical guidelines among stakeholders. And we must do this without overwhelming frontline providers. Those working in policy can help by establishing strategies to rapidly integrate scientific findings to ensure the best care to all.
Juliette Carreiro