Important Updates Regarding Monoclonal Antibody Therapeutics Distribution for COVID-19

The following update is from the Florida Board of Medicine:

On Monday, September 13, 2021, the U.S. Department of Health and Human Services (HHS) transitioned from a direct ordering process to a state/territory-coordinated distribution system similar to that used for the distribution of monoclonal antibodies (mAbs) from November 2020 to February 2021.

HHS will determine the weekly amount of mAb products each state and territory receives based on COVID-19 case burden and mAb utilization. State and territorial health departments will subsequently identify which sites in their respective jurisdictions receive product as well as the amount each site receives.

As of Monday, September 13, 2021:

• Administration sites no longer order directly from AmerisourceBergen (ABC).
• Weekly distribution amounts for each state/territory will be determined by HHS based on weekly reports of new COVID-19 cases and hospitalizations in addition to data on inventories and use submitted to the federal government.
• State/Territorial Health Departments will determine where product goes in their jurisdictions.

For more information regarding the distribution of monoclonal antibody therapeutics, please visit the HHS website.

Florida's monoclonal antibody distribution process is as follows:

All pending orders have been cancelled and the new process will be used for any new orders. For existing sites, please use the below link to make a request each week by 5:00 p.m. on Tuesdays. Note that ABC stated it may take up to two days before all orders are shipped. Delivery time is usually two days after shipping, but you can track your order with the information below. Your request will reflect the inventory needed to administer doses for one week.

You will need to continue reporting your inventory into HHS Protect each Wednesday as well.

The State has been given a weekly allocation which may adjust depending on the usage and inventory you report into HHS Protect. Since we are on allocation, your order may be adjusted.

Order link for existing sites currently receiving product - https://fdoh.readyop.com/fs/4cNI/577f

For new sites that have never received mAbs for outpatient use, use the below link to start registration with ABC. Someone from the covid.therapeutics@flhealth.gov mailbox will follow up with you: https://fdoh.readyop.com/fs/4cNG/08dd

Please see further updates from ABC below.

HHS-Protect account information

For all questions about an HHS-Protect account, reach out directly to HHS.

If you do not have an account, you can register for one by visiting https://teletracking.protect.hhs.gov. Keep your ABC account number handy. If you are unsure if you have an HHS-Protect account please contact TeleTracking's Technical Support at hhs-protect@teletracking.com for assistance. If you already have an HHS-Protect account please continue to submit your weekly reporting every Wednesday as this information helps inform allocations.

Florida's monoclonal antibody distribution process is as follows:

If your state Department of Health allocates to your site, you will receive an email notification from ABC that advises of your allocation quantity and shipping status.

1. If you have ABC Order access (our online ordering system), you will be able to view tracking under your order history. For access to ABC Order please contact customersystemssupport@amerisourcebergen.com.
2. You can also use this tracking tool to locate your allocation.

Sotrovimab

Sotrovimab is an additional mAb authorized for use under an Emergency Use Authorization (EUA) for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death.

Sotrovimab is not offered through the federal allocation process at this time and is only available through ABC during the EUA period approved by the FDA. Sotrovimab is approved for infusion in appropriate patients as defined in the Sotrovimab Fact Sheet for Healthcare Providers.

Glaxosmithkline (GSK), with guidance from the National Infusion Center Association, has developed an in-depth resource entitled Detailed Guide for the Use of Sotrovimab.

Ordering from ABC

Sotrovimab is available for customers to purchase directly with ABC as the sole Specialty Distributor during the Emergency Use Authorization period. Customers can purchase directly by:

Placing purchase order through the customer ordering portal at abcorder.amerisourcebergen.com, calling ABC Customer Service at 1-800-746-6273 Monday through Thursday 7:00 AM to 6:30 PM, and Friday 7:00 AM to 6:00 PM CT or placing the purchase order through any of the ABC ordering platforms. Customers may search by product name, material item number, or NDC. For new customers, please call ABC Customer Service or email c19therapies@amerisourcebergen.com

Please allow 1 to 2 days for product arrival following order placement. For new customers, please allow up to 2 days for the initial order following receipt of the required customer documentation. For any additional information regarding orders, product availability, or access/log-in information, please email c19therapies@amerisourcebergen.com or contact ABC’s Customer Service Department.

Sites will be required to:

• Provide ABC with a Board of Pharmacy license or physician letter of authorization if not already on file
• Attest to their designated class of trade and that they will administer Sotrovimab according to terms of the FDA-issued EUA

Additional information

• Product availability may be subject to established criteria for minimum and maximum amounts based on previous orders and utilization history
• GSK and ABC will ensure that the authorized labeling (e.g., Fact Sheets) will accompany the authorized Sotrovimab. Please see most current Fact Sheet for Healthcare Providers and Fact Sheet for Patients, Parents and Caregivers
• GSK and ABC will ensure that appropriate storage and cold chain is maintained until the product is delivered to healthcare facilities and/or healthcare providers