SUPPLY AND SCALE OF EFFORT Product Allocation and Supply Lilly has committed to manufacturing up to 1,000,000 vials of bamlanivimab in 2020, with 100,000 doses available to ship within days of authorization. Additionally, Lilly has reached an agreement with the U.S. government to supply 300,000 vials within the first two months after Emergency Use Authorization (EUA) with the option to purchase an additional 650,000 vials through June 2021. Bamlamivimab will be allocated to each state by the Federal Government. Upon EUA, the Federal Government will begin allocating to states immediately and thereafter on a weekly basis. Weekly allocations to state and territorial health departments will be proportionally based on confirmed hospitalizations and COVID-19 cases in each state and territory over the previous seven days, based on data hospitals and state health departments enter into the HHS Protect data collection platform. State Health Authorities will then allocate to individual sites of care within their jurisdiction. If you would like more information about the allocation process or would like to be considered for product allocation, please contact your state health department directly. Scaling Operations The time duration to administer a 700mg/20mL dose of bamlanivimab is 60 minutes at the infusion rate of 200mL/hr (20mL bamlanivimab/180mL 0.9% sodium chloride) for both infusion pumps and gravity infusion. Treatment also requires a post-infusion observation period. It is clinically recommended to monitor patients during infusion and observe patients for at least 1 hour after infusion is complete. Sites of care should follow local requirements when determining appropriate observation periods. If patients will occupy chairs for infusion during this period, rather than a post-treatment monitoring area, planning must account for this time as well. The number of chairs for infusion can be scaled along with the hours of operation to determine the size of the infusion site of care. Infusion sites of care should take into account time for patient intake, IV preparation, infusion and post-infusion observation when determining potential capacity. For example, in Lilly’s monoclonal antibody clinical trial settings, Lilly found a single infusion could take between 165–225 minutes to complete from patient intake to discharge. See Appendix A for more information. The above values could be used to determine a rough approximation of the number of infusion sites of care that may be needed per region. A region can easily modify the number based on changing the capacity assumptions with the various infusion sites of care. Depending on the dispersion of the population in a region, the region may choose to size some infusion sites of care larger than others. Lilly Bamlanivimab Antibody Playbook | 11 PP-BM-US-0024
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