C19 Therapies Request Form

Message from Health and Human Services: We know this is a very challenging time, and we appreciate your continued partnership. As you may know, the increased incidence of the Delta variant of SARS-CoV-2 caused a substantial surge in the utilization of monoclonal antibody drugs, particularly in areas of the country with low vaccination rates. We are committed to helping ensure the consistent availability of these critical drugs for current and future patients in all geographic areas of the country. On September 13, HHS transitioned from the direct ordering process for mAbs to a state-coordinated distribution system, similar to that used from November 2020 – February 2021. We fully recognize that state/territorial health departments know where to send needed products in their areas. Transitioning to a state-coordinated distribution system will give health departments maximum flexibility to get these critical drugs where they are needed most. As of Monday, September 13, 2021: Administration sites will no longer order mAb directly from AmerisourceBergen. HHS will determine each state's weekly amount of mAb products based on COVID-19 case burden and mAb utilization. State health departments subsequently identify which sites in their respective jurisdictions receive the product and the amount each site receives. HHS will determine weekly distribution amounts for each state based on weekly reports of new COVID-19 cases and hospitalizations in addition to data on inventories and use submitted in HHSProtect. State Health Departments will determine where the product goes in their jurisdictions. HHS will continue to monitor product utilization rates, COVID-19 case burden, and overall availability of mAbs to determine when a shift back to the normal direct ordering process may be possible. For questions on contacting your state department of health, please contact Covid19.Therapeutics@hhs.gov.

Name of Requestor*

Requestor Email*

Prior mAB Receipt from AmerisourceBergen?*

Have you received any monoclonal anti-body before from AmerisourceBergen either via HHS Allocation, State Allocation, or direct ordering?

Select

Class of Trade / Type of Facility*

Use of these mAB is limited to the following class of trades. By selecting one of these you attest to meeting the class of trade criteria.

Select

Eligibility

At this time direct ordering is only available for sites who meet the Class of Trade category. Please contact C19therapies@amerisourcebergen.com for assistance.

The COVID therapies ordered through this site have been authorized by FDA for the emergency uses described in the applicable Emergency Use Authorization for each therapy. The therapies are authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of such therapy, unless the authorization is terminated or revoked sooner. By checking the box below, you attest and certify that (i) your organization will use the ordered therapy only as authorized pursuant to the therapy’s applicable Emergency Use Authorization, (ii) your organization (or provider if an LoA is provided) will adhere to the administration requirements of the Emergency Use letter of authorization, and (iii) that your selection for site class of trade/type of facility is accurate.

Accept*

ABC/ASD Account

If you have a known or preferred ABC account, please provide to expedite the ordering and shipping process. The account number should look like 1000XXXXX or 01000XXXXX .

Board of Pharmacy (BoP) License

BoP Expiry Date

LoA form if no Board of Pharmacy License

Please provide a copy of your state board of pharmacy license for your site, if applicable. If you do not have a BOP license, provide a copy of the state medical license for the administrating physician. If the address on the physician’s license does not match the shipping address for your site, please complete a LOA form. The license information on the form must match EXACTLY what appears on the license. For all Florida physician licenses, please complete a Declaration of Intention form. Blank LoA Form: https://drive.google.com/file/d/1ZqnEPqzXeQJ_xDIq7rN6H-ChWYsS9fY8/view?usp=sharing Florida Only, blank DOI form: https://drive.google.com/file/d/1nXG8391qnidYB55Jy2ZtBiBX3N14AQ59/view?usp=sharing Instructions to complete the LOA or DOI: https://docs.google.com/presentation/d/1mK4P5p_NN37Cwru04jXsc9l6TbTQt0oC/edit?usp=sharing&ouid=105987537352460271906&rtpof=true&sd=true

Drag and drop files here or

Shipment Site Name*

Shipment Site Address*

Note this address must match what is on the Board of Pharmacy License and our prior mAB shipping records.

Shipment Site City*

Shipment Site State*

Select or enter value

Shipment Site Zip*

C19 Therapy*

Select

Patient Courses*

Please provide the number of patient courses you wish to order. We are supporting order sizes of 12 patient courses and orders of quantities of 24 (full case). We will be rounding up all orders to 12, or quantities of 24. Every order is going through HHS review. This should not discourage you from ordering what you need for 1 week's worth of anticipated need. The HHS approval process is done by ABC and may delay your order 2-3 days due to the backlog. THIS IS BEING ENFORCED automatically. You will not have communication stating your quantity ordered is less than what you requested if HHS determines not to approve all of your order. IMPORTANT: If you need to order more than 100 courses please do so, if you have any questions about ordering please contact us at c19therapies@amerisourcebergen.com

Need By Date*

Please indicate the date needed. Note those that have existing accounts that any orders received after 5PM EDT will not get processed for next day delivery; Friday orders will ship for Monday delivery. Sites that require new accounts will have an additional 2-3 day delay in placing initial order, assuming all provided information is accurate. Please plan accordingly if you do not currently have an ABC/ASD account.

Weekly Usage

Please enter roughly how many courses you are using every week. If you are having a surge please enter your previous weeks usage if it is above average.

On Hand Inventory

Please enter your current on hand inventory.

Please select one or both options for how you will be using Regeneron-Cov:

Post Exposure Prophylaxis (PEP) in vulnerable persons

Active Covid 19 infection in high risk individuals with mild to moderate symptoms

Please select one or both options for how you plan to administer Regeneron-Cov

Via Infusion

Via Subcutaneous administration

Primary Contact Name*

Primary Contact Phone #*

Primary Email*

Additional Comments

Provide any shipping information (such as "attn: pharmacy).

Required Utilization Reporting

To improve availability of treatments for Monoclonal Antibody (mAb) therapies for patients with COVID-19 across the nation, the federal government requires entities receiving shipments of mAb treatments to provide weekly reports of mAb treatments administered and stock on hand through one of the following reporting mechanisms: Should you have any questions regarding this update in ordering and distribution procedures, please email the Federal COVID-19 Response Team at COVID19therapeutics@hhs.gov. If you are NOT a hospital or health system and require a TeleTracking account to report mAb utilization data please email hhs-protect@teletracking.com. If you are a health system and have questions on therapeutic reporting, please go here: https://www.hhs.gov/sites/default/files/covid-19-faqs-hospitals-hospital-laboratory-acute-care-facility-data-reporting.pdf First-time users will receive enrollment and reporting instructions in an e-mail from protect-noreply@hhs.gov with the subject line of “Invitation: HHS TeleTracking COVID-19 Portal.” This email provides step-by-step instructions to access the Portal for the first time. If you do not receive an email in the next 48 hours, please contact TeleTracking’s Technical Support at hhs-protect@teletracking.com.

Emergency Use Authorization

For information and requirements about EUA use of these mABs, please visit here: https://www.phe.gov/emergency/events/COVID19/investigation-MCM/Pages/default.aspx

Product Guidebook Links

Regeneron: https://www.regeneroneua.com/Content/pdf/treatment-covid19-eua-guide-book.pdf Lilly: https://www.covid19.lilly.com/assets/pdf/bam-ete/lilly-antibodies-playbook.pdf

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