Ideally, such a circumstance would exert pressure on those operating the system to find a way to address the root causes of the failure to reach more vulnerable patients. allocation of mAb therapies to identify how referrals relocated through the allocation process and what proportion of patients who were offered and received mAb therapies were socially vulnerable. == Results == Notwithstanding multiple operational difficulties, the reserve system for allocation of mAb therapy worked as intended to enhance the quantity of socially vulnerable patients who were offered and received mAb therapy. A significantly higher proportion of patients offered mAb therapy were socially vulnerable (27.0%) than would have been the case if the infusion visits had been allocated using a pure lottery system without a vulnerable reserve (19.8%), and a significantly higher proportion of patient who received infusions were socially vulnerable (25.3%) PKI-402 than would have been the case if the infusion visits had been allocated using a real lottery system (17.6%) == Interpretation == Our health system experience demonstrates that a reserve system with a lottery for tiebreaking is a viable way to distribute scarce therapeutics when enhancing access for certain groups is desirable. Key Words:allocation, COVID-19, ethics, lottery, monoclonal antibodies Abbreviations:EUA, emergency use authorization; mAb, monoclonal antibody; MGB, Mass General Brigham; SVI, Social Vulnerability Index == Graphical Abstract == FOR EDITORIAL COMMENT, SEEPAGE 2005 In November 2020, the Food and Drug Administration issued emergency use authorizations (EUAs) for two monoclonal antibodies (mAbs)bamlanivimab and the dual-antibody cocktail casirivimab plus imdevimabfor the treatment of outpatients with moderate to moderate COVID-19 at high risk of developing severe disease.1,2The EUAs authorized use of the mAbs within 10 days of symptom onset for patients Rabbit Polyclonal to Bax (phospho-Thr167) with one or more of several risk factors including age 65 years and BMI 35 kg/m2. The initial EUAs for bamlanivimab and casirivimab plus imdevimab were based on modest data from phase 2 clinical trials that suggested that mAb therapy might reduce hospitalization, ED visits, or other medical visits in patients with moderate to moderate COVID-19 if given early in the course of the disease.3,4Phase 3 trial data supporting the benefits of mAb therapy subsequently were documented in press releases.5,6The Food and Drug Administration issued an EUA for the dual antibody cocktail bamlanivimab plus etesevimab on February 9, 2021.7 The mAbs, which are delivered by IV infusion, initially were distributed by the federal government directly PKI-402 to says. It was unclear at the outset to what extent supplyboth product and infusing capacitywould be sufficient to satisfy demand for mAb therapy. The prospect of scarcity, along with the many logistical difficulties of patients with a contagious disease reaching infusion sites, led to concern that patients who loved socioeconomic advantages and easy access to health care would receive mAbs disproportionately. This was of particular concern given the disproportionate impact of COVID-19 on communities of color and other socially vulnerable populations.8 In this setting, the Commonwealth of PKI-402 Massachusetts issued guidance detailing how mAbs should be allocated in the event of scarcity9with a stated goal of promoting equitable access for socially vulnerable patients. The guidance specified that patients who met age criteria, BMI criteria, or both should be prioritized over patients who met other EUA criteria. It further provided that patients with a Centers for Disease Control and Prevention Social Vulnerability Index (SVI)10of PKI-402 more than the 50th percentile, patients who lived in towns or cities with the highest quartile of COVID-19 incidence in the Commonwealth, or both should receive priority for 20% of the infusion spots over and above their share from the remaining 80% (an over-and-above reserve). The Massachusetts guidance further specified that, if there were more patients within a given priority group than available infusion slots, a PKI-402 lottery should decide which patients within the priority group were assigned the slots. The 20% reserve size for socially vulnerable patients in the Massachusetts guidance was based on data suggesting that people from a.