State/territory-coordinated Distribution System
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Why is HHS transitioning to a new distribution process for COVID-19 monoclonal antibody therapeutics?
The increased incidence of the Delta variant of SARS-CoV-2 caused a substantial surge in the utilization of monoclonal antibody (mAb) drugs, particularly in areas of the country with low vaccination rates. HHS is committed to helping ensure consistent availability of these critical drugs for current and future patients in all geographic areas of the country. As such, we updated the distribution process for mAbs to assure fairness and efficiency.
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How will COVID-19 monoclonal antibody therapeutics be distributed under the updated system?
The updated process is a state/territory-coordinated distribution system similar to that used to distribute mAb product from November 2020 – February 2021. HHS firmly believes a state and territory-coordinated distribution system will help maintain equitable distribution, both geographically and temporally, across the country - providing states and territories with consistent, fairly-distributed supply over the coming weeks
Under this system, HHS determines the weekly amount of mAb product available to each state and territory. Subsequently, state and territorial health departments then determine which sites in their jurisdictions receive product and how much.
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What formula or equation will be used to determine the weekly amount of products each state and territory receives?
HHS will first determine a state or territory’s proportion of the country’s total COVID-19 hospitalizations and confirmed cases, using a weighted average of these two numbers.
This percentage is equal to that state or territory’s portion of the total amount of mAb products available for a given distribution week.
State/territory calculated amounts may be reduced if a state or territory’s projected utilization is less than their calculated amount. Utilization of mAb product is reported each week through the HHSProtect TeleTracking data collection platform by administration sites, health departments, or other entities.
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Can states and territories receive additional product above their calculated amount?
At this time, states and territories are not able to receive additional product above their weekly calculated amounts. It should be noted that the weekly distribution amounts are determined based on case burden and utilization within jurisdictions.
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Will HHS buy more COVID-19 monoclonal antibody therapeutics products?
Yes; HHS is considering all available options for procuring additional product.
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Will HHS transition back to the regular direct ordering process? If so, when?
HHS will continue to monitor product utilization rates, COVID-19 case burden, and overall availability of monoclonal antibody therapeutics to determine when we will shift back to the normal direct ordering process.
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What data is required for reporting into HHSProtect and how often is it reported?
Sites are required to report utilization of product and stock on hand each week to HHS through their state/territorial health department or directly to the HHSProtect TeleTracking data collection system.
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Where can I find additional information about COVID-19 monoclonal antibody therapeutics?
Please visit phe.gov/mAbs and CombatCOVID.hhs.gov to learn more about mAbs and to find useful resources for healthcare providers and patients.
