Ordering and Distribution
- Why is the U.S. Department of Health and Human Services (HHS) transitioning to a new distribution process for COVID-19 monoclonal antibody therapeutics?
The increased incidence of the Delta variant of COVID-19 caused a substantial surge in the utilization of monoclonal antibody (mAb) drugs, particularly in areas of the country with low vaccination rates. The U.S. Department of Health and Human Services (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.
- 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 to 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.
- 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 Health Partner Order Portal (HPoP) and HHSProtect TeleTracking data collection platforms by administration sites, health departments, or other entities.
- 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.
- 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.
- 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 HPoP and HHS through their state/territorial health department.
Washington State Provider Support
Providers who would like to receive, dispense, and treat individuals with COVID-19 can requested federally purchased and state allocated COVID-19 therapeutics (monoclonal antibodies and oral antivirals).
Sites that wish to request an allocation of COVID-19 therapeutics must establish a Healthcare Partner Order Portal (HPoP) account to submit allocation requests, as well as receive and track shipments.
For HPoP access, please download and complete the New HPoP Therapeutics User Form and send the complete document to the Washington Department of Health Medical Countermeasures Team at firstname.lastname@example.org. Once submitted, providers will be contacted within 24-48 hours to finalize the onboarding process.
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- What is HPoP, and is it mandatory for state/territorial health departments to use this system?
HPoP is the Health Partner Order Portal therapeutics ordering portal for all federally allocated COVID-19 Therapeutics. All jurisdictional partners must use this system to order Evusheld, Paxlovid, Molnupiravir, Sotrovimab and Bebtelovimab, as well as satisfy the daily reporting requirements for these products.
- I am provider and have requested an allocation for COVID-19 therapeutics, but I have not heard back from my request or received any product to my site.
Due to the high demand of COVID-19 therapeutics and the limited supply, not all request for COVID-19 therapeutics can be processed. Additionally, not all orders can be fulfilled as requested, and many sites who order products might receive a reduced amount from their original request.
- I am a provider receiving COVID-19 therapeutics, and I am experiencing technical issues. Who do I contact for support?
Program Help Needed Email/Action HPoP
Logging into the system
email@example.com Password resets Use the “I forgot my password…” link on the sign-in screen
Elevated HPoP troubleshooting
HPOP-Therapeutics@hhs.gov Therapeutics Program General questions COVID19.Therapeutics@hhs.gov Tiberius Website protect-ows.hhs.gov Accounts and access issues Tiberiusfirstname.lastname@example.org AmerisourceBergen Orders and shipping C19therapies@amerisourcebergen.com
- My order in HPoP shows it is “On Hold.” What does that mean?
This indicates an order that has been completed by the partner (WA DOH) but the provider does not have an AmerisourceBergen (ASD) account listed in the system. These orders are flagged for ASD review. ASD will log into HPoP, look at the provider information and then update the ASD account number in HPoP. After updating the ASD account number the order will flip to Distributed/Transmitted.
- How often and where do I report COVID-19 Therapeutics usage in HPoP?
Reporting requirements for all COVID-19 therapeutics are daily by 11:59pm PST time. To report Evusheld. bvebtelovimab, paxlovid and molnupiravir go to the "Therapeutic Inventory" provider page in HPoP and enter daily your courses administered and courses available. For Sotrovimab, report utilization using HHS Protect. If you are experiencing additional issues, please contact email@example.com.
- My distribution of therapeutics was lost or destroyed in transit. Can it be replaced?
Yes. If your distribution of therapeutic products was lost or destroyed in transit, please contact HHS at COVID19Therapeutics@HHS.gov for assistance.
- What should be done with bam/ete and REGEN-COV?
- Product return is not recommended; any returned product has to be destroyed
- COVID-19 environment remains dynamic
- Products may be effective against future variants
- If you have storage concerns or challenges:
- Consider transferring product to another location/site in region or health system
- If product must be returned:
- For bam/ete, see The Lilly Return Goods Procedure; detailed guidance can be found at: https://www.lillytrade.com/
- For REGEN-COV, call 844-734-6643
Note: Reconstituted (diluted) product should not be returned and should be treated as waste per your facility's SOP.
- What is the mAbs Calculator?
The mAbs Calculator is a free, data-informed decision support tool that is based on a comprehensive simulation framework provided by ASPR and Johns Hopkins University. The mAbs Calculator can be used to inform staffing decisions and resource investments needed for COVID-19 monoclonal antibody therapeutic infusion sites.
Simply enter your state's Physical Capacity, Patient Arrival Process, Check-in Process and a few more details and you will receive useful information for your infusion site.
- What current monoclonal antibody treatment and oral antivirals are effective against the Omicron variant?
Updated information on mAbs and effectiveness against Omicron can be found on the U.S. Department of Health & Human Services Side-by-Side Overview of Outpatient Therapies Authorized for Treatment of Mild-Moderate COVID-19 page.
- What resources are available to help health care providers talk to patients about mAbs for COVID-19?
The Washington State Department of Health (DOH) encourages health care providers to speak with eligible individuals about mAb therapeutics. Resources to assist with the discussion can be found in this Talking With Patients fact sheet from the Combat COVID website (PDF).
- How can mAbs Therapeutics be administered?
COVID-19 therapeutics can be administered two ways:
- IV infusion (mAbs): One-time intravenous infusion, which takes approximately 16 minutes to an hour, followed by a one hour monitoring period.
- Subcutaneous injection (mAbs): Delivered through four separate injections in one visit. The injections are followed by a one hour monitoring period.
- What are some approaches to administering mAbs to individuals in non-hospital settings, such as skilled nursing facilities or assisted living facilities?
mAbs can be administered in non-hospital settings, including skilled nursing facilities, acute care facilities, and long-term care facilities. Effective approaches include:
- What is post-exposure prophylaxis (PEP)?
Post-exposure prophylaxis (PEP) is any preventive medical treatment started after exposure to a pathogen to prevent infection from occurring. PEP is not a substitute for vaccination against COVID-19.
- What mAbs serve as PEP for COVID-19 and who is eligible to receive them?
Pre-exposure Prophylaxis (PrEP) is authorized for those individuals who are not currently infected with the SARS-CoV-2 virus and who have not been exposed to an individual infected with SARS-CoV-2. The authorization also requires individuals either have:
- Moderate to severely compromised immune systems due to a medical condition or due to taking immunosuppressive medications or treatments and may not mount an adequate immune response to COVID-19 vaccination (examples of such medical conditions or treatments can be found in the fact sheet for healthcare providers) or;
- A history of severe adverse reactions to a COVID-19 vaccine and/or component(s) of those vaccines, therefore vaccination with an available COVID-19 vaccine, according to the approved or authorized schedule, is not recommended.
There is one product that has been granted Emergency Use Authorization by the FDA.
- Tixagevimab/Cilgavimab (EVUSHELD) - these work by supplying antibodies to resist breakdown in cells. This is administered as an intramuscular injection.
For more information about using mAbs as PEP for COVID-19, see the REGEN-COV emergency use authorization fact sheet.