SummarySince the beginning of the Public Health Emergency (PHE), manufacturers have been developing monoclonal antibodies (mAbs) and other treatment modalities to prevent and treat COVID-19.
Despite the clinical utility of these treatments, issuance of Emergency Use Authorizations (EUAs) by the FDA, and direct purchase by the U.S. government with no patient out-of-pocket (OOP) cost-sharing for patients, utilization of mAbs has been below expectations.
mAbs Are 1 of the Few Options for Treating COVID-19
The Food & Drug Administration has issued three Emergency Use Authorizations (EUAs) for investigational mAb therapies indicated for the therapeutic treatment of mild-to-moderate COVID-19 in adult and pediatric patients. Additionally, manufacturers are testing COVID-19 mAb utility for pre-exposure prophylaxis (PrEP) to prevent the virus from infecting the individual and post-exposure prophylaxis (PEP) in those who have a known exposure. The US government has purchased more than 1 million doses of COVID-19 mAbs that are provided at no cost to patients to reduce COVID-19 treatment burden on hospitals and healthcare systems. On November 9, 2020, the Department of Health and Human Services Office of the Assistant Secretary for Preparedness and Response (HHS-ASPR) released a phased allocation and distribution plan for these mAbs, which establishes weekly allocation based on a state’s share of confirmed COVID-19 cases nationally, as well as the total number of hospitalized patients over a 7-day period. HHS-ASPR emphasized their commitment to “the equitable and efficient distribution” of mAb treatments with the goal of “reaching as many patients as possible.”
Uptake Has Not Met Expectations
Despite federal and state investment, mAb uptake has not met expectations. Considerably low utilization of mAbs has created a gap between the number of doses being allocated to states and the number of doses administered to patients. Operation Warp Speed Chief Advisor Moncef Slaoui stated on December 16, 2020, that only 5–20% of delivered mAb doses had actually been administered to mild-to-moderate COVID-19 patients. This low utilization rate may be attributable to a myriad of issues, including infusion logistical challenges, a lack of patient and provider education, and the speed of disease progression.
COVID-19 mAbs are administered via infusion in the outpatient setting, meaning many hospitals cannot administer these treatments in their infusion centers due to the risk of exposing other patients who are receiving infusions for other conditions. To limit contact between infected and non-infected patients, hospitals must sequester patients within infusion centers or use different hospital space in order to safely treat infected patients. Additionally, many of these existing infusion centers do not have the capacity to treat the sheer volume of COVID-infected patients.
Provider and patient education can play a key role in driving utilization rates. While vaccine hesitancy continues to pose challenges for COVID-19 vaccine uptake, most of the general public is unfamiliar with mAb treatments. A lack of education may be leading some patients to refuse treatment, despite facing zero cost-sharing for these therapies. Provider efforts to increase awareness of mAb therapies have not bolstered interest either, despite many hospitals providing treatment hotlines and attempting to share knowledge via media engagement. It also may be important to consider potential delays in provider adoption of new therapies into standards of care. Traditionally, it takes an average of 17 years for research evidence to reach clinical practice. This traditional time lag may be playing a role in low mAb utilization during the rapidly changing PHE, despite availability.
COVID-19 mAbs must be administered within a specific window of disease progression, which may additionally limit use. Patients receive infusions early after symptoms onset. If patients are hospitalized or require oxygen to treat their disease, they are ineligible to receive mAbs. Due to the way COVID-19 presents and develops, many individuals may not be aware they have the virus or may feel like they have their mild-to-moderate symptoms under control and may not seek treatment until their symptoms have progressed into a more severe form and thus may be ineligible for mAb use. These challenges may be deterring patients from seeking treatment for COVID; for instance, the University of Pittsburgh Medical Center reported that 20–25% of eligible patients are declining to receive the mAb as their symptoms have subsided or they have reconsidered treatment.
Most COVID-19 mAbs Are Administered in Assisted Living Facilities
Using Inovalon provider clearinghouse data, Avalere conducted an analysis of COVID-19 mAb utilization over the 2 months following the FDA’s issuance of the first mAb EUA. Clearinghouse data represents approximately 5–7% of the Medicare fee-for-service population and is based on a convenience sample. Avalere evaluated available mAb utilization claims data across 18 reporting states.
Following the issuance of the EUAs on November 9 and November 21, there were 737 COVID-19 mAb claims across the 18 states with data available (183 claims in November, 554 in December). When examining sites of care, 67% of these reported mAbs were administered in assisted living facilities (Figure 1). The limited data available across 18 states may suggest low mAb utilization in many states. mAb uptake analysis may yield clearer results via a month-over-month comparison of mAb uptake as the PHE progresses.
Home infusion may be an attractive site of care for COVID-19 infected patients with mild-to-moderate disease that do not require hospitalization but are required to self-quarantine. The National Home Infusion Association (NHIA) recently published recommendations to the acting administrator of the Centers for Medicare and Medicaid Services (CMS) calling for greater access and promotion of home infusion for COVID-19 mAbs. One specific recommendation called for the CMS to assess the reimbursement rates that are paid by Medicare for the infusion of mAbs. The CMS has issued 3 infusion codes for the mAbs recently approved under EUA (M0239, M0243, M0245) with reimbursement set at $309.60. The NHIA concluded that this level of reimbursement is not adequate to support providers who may consider delivering these products in the home setting.
Opportunities to Expand Use of COVID-19 mAbs
The US government’s purchase of more than a million doses of COVID-19 mAbs has established mAbs as a viable treatment option in the fight against COVID-19 that may reduce disease burden and morality. However, low utilization of these therapies suggests that structural barriers and lack of education may be rendering this investment less effective and limiting patient access to viable COVID-19 therapies. To address this issue, stakeholders might consider the following:
- Educating patients and providers on the potential benefits of COVID-19 mAbs. In conjunction with vaccine education, these efforts may address hesitancy and increase patient confidence. It may be critical to draw provider attention to data supporting mAbs as effective therapies in order to combat the lag that often occurs between translational research of a therapy and provider uptake of said therapy.
- Supporting state and federal legislation that expands access to mAbs. Currently, distribution and access to mAb products vary across states. This variability may present barriers to care for those who would benefit from a mAb treatment.
- Garnering more data to demonstrate broader use of mAbs. This may increase patient access. To date, mAbs have received EUAs based on clinical demonstration of efficacy in a relatively small portion of COVID-infected patients. With the generation of broader data, the use COVID-19 mAbs may expand, including use in prophylactic (PrEP and PEP) settings.
- Continuing to advance access to home infusion for COVID-19 mAb treatments. This can increase the size of the population able to receive treatment. Consideration of adequate reimbursement rates for mAb infusion will be critical to home infusion access.
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