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Monoclonal antibodies (mAbs) are highly effective in treating mild to moderate COVID-19 among nonhospitalized patients.1 Given limited supply, federal guidelines prioritize patients at higher risk of progression to hospitalization or mortality from COVID-19, with risk factors including age and comorbid conditions.2,3 Antibodies were initially allocated to states by the federal government,4 then distributed through suppliers in 2021.5 We assessed how the limited supply of mAb therapy was allocated to patients at highest risk of severe disease.
We used a 100% sample of outpatient, emergency department, and laboratory claims for fee-for-service Medicare beneficiaries with a new COVID-19 diagnosis or confirmed exposure between November 2020 (first month of mAb availability) and August 2021. Beneficiaries hospitalized or deceased within 7 days of COVID-19 diagnosis, who were less likely to have mild to moderate disease and be eligible for mAb therapy, were excluded. We identified mAb infusions with Current Procedural Terminology codes (Q0239, Q0243-7, M0239, M0243-8) and classified COVID-19 diagnosis using International Classification of Diseases, Ninth Revision codes U07.1, B97.29, and Z20.828 (exposure to confirmed COVID-19). Among nonhospitalized patients with a COVID-19 diagnosis, we compared rates of mAb receipt by age, sex, race and ethnicity, Medicaid eligibility, region, number of chronic conditions, reason for Medicare eligibility, and selected conditions associated with severe COVID-19. We performed multivariable logistic regression to estimate odds ratios, with statistical significance defined as a 95% confidence interval that does not include 1.0, for receipt of mAbs controlling for the patient characteristics listed above. We also compared rates of mAb treatment by state. Analyses were performed using SAS version 9.4 (SAS Institute Inc). This study was approved and informed consent was waived by the Dartmouth College institutional review board.
From November 2020 to August 2021, 1 902 914 fee-for-service Medicare beneficiaries had a diagnosis of COVID-19 and were not hospitalized or deceased within 7 days of diagnosis. Of these, 7.2% received mAb therapy (Table). The likelihood of receiving mAb therapy was higher among those with fewer chronic conditions (23.2% of beneficiaries with 0 chronic conditions vs 6.3%, 6.0%, and 4.7% with 1-3, 4-5, and ≥6 chronic conditions, respectively; adjusted odds ratio, 7.43 [95% CI, 7.21-7.66] for 0 vs ≥6). Patients receiving treatment were also less likely to be Black (6.2% vs 7.4% of non-Hispanic white patients; adjusted odds ratio, 0.77 [95% CI, 0.75-0.79]) or dually enrolled in Medicaid (4.6% vs 8.1%, adjusted odds ratio 0.74 [95% CI, 0.72-0.75]). Unadjusted mAb therapy rates were lower for older beneficiaries (6.7% of ≥85-year-old vs 7.8% of 65- to 74-year-old beneficiaries), but after adjustment, being aged 85 years or older was associated with higher odds of mAb therapy (adjusted odds ratio, 1.42 [95% CI, 1.39-1.45]).
Rhode Island and Louisiana administered mAb therapy to the highest proportion of nonhospitalized patients with COVID-19 (24.9% and 21.2%), while Alaska and Washington administered mAb therapy to the lowest proportion (1.1% and 0.7%) (Figure). States in the South had the highest rates of mAb therapy (10.6% of beneficiaries) vs the lowest rates in states in the West (2.9%) (Table).
Among nonhospitalized Medicare beneficiaries with a COVID-19 diagnosis between November 2020 and August 2021, only 7.2% received mAb therapy. In many cases, patients at the highest risk of severe disease were the least likely to receive mAb therapy. There was also extreme variation geographically.
These findings suggest that use of mAb therapy for mild to moderate COVID-19 failed to reach the highest-risk patients across and within states. There are multiple potential explanations for these results. Higher-risk patients may have had difficulty navigating the multiple steps needed to receive mAbs, from receipt of a timely COVID-19 diagnosis to referral and scheduling an infusion within 10 days. In addition, mAb supply may have been low or less used by clinicians in some regions of the country. Policy that explicitly prioritizes high-risk patients may be needed for equitable distribution of COVID-19 therapeutics.
Limitations of this analysis include the use of Medicare fee-for-service data, which may not generalize to other populations, including Medicare Advantage enrollees. This analysis did not account for patient vaccination status or observed disease severity, which could influence clinicians’ choice to give mAb therapy.
Accepted for Publication: January 22, 2022.
Published Online: February 4, 2022. doi:10.1001/jama.2022.1243
Créditos: Comité científico Covid