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Anyone, 5 years of age and older, is eligible to receive the COVID-19 vaccine. Find your nearest vaccination location at vaccines.gov.

COVID-19 Outpatient Treatment

To search for locations offering Monoclonal Antibody Treatment, go to https://covid.infusioncenter.org/

Overview of Monoclonal Antibody Treatment and Oral Medications for COVID-19 Made Available Under Emergency Use Authorization for Non-Hospitalized Patients

Monoclonal antibody therapy is a prevention as well as treatment option for mild to moderate COVID-19 illness for non-hospitalized people and is a way to lower the chance of progression to severe illness or hospitalization. IDPH continues to encourage health care providers, such as primary care offices, outpatient clinics, urgent care centers, infusion centers, dialysis centers, home health services, and hospitals, to assess their capabilities to provide this treatment to their patients quickly after they have been identified as having COVID-19 and are determined to be high-risk for severe illness or hospitalization.

Monoclonal antibodies are laboratory-made proteins that mimic the immune system’s ability to fight off harmful viruses and bacteria which can cause disease. Currently there are three monoclonal antibody therapies approved for use under an Emergency Use Authorization, for non-hospitalized patients.

Bamlanivimab plus Etesevimab (Bam/Ete)

Bamlanivimab and etesevimab should be administered together under Emergency Use Authorization (EUA) 094. Specifically, the EUA now authorizes the use of bamlanivimab and etesevimab, administered together, only in states, territories, and U.S. jurisdictions in which recent data shows the combined frequency of variants resistant to bamlanivimab and etesevimab administered together is less than or equal to 5%. As of August 2021, IL is one such state where we can use bamlanivimab/etesevimab. It will not work against the Omicron variant but can still be used in regions where Omicron is not very prevalent.

Casirivimab/Imdevimab (REGEN)

On November 21, 2020, Regeneron Pharmaceuticals, Inc. received an Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for the investigational treatment cocktail consisting of 2 monoclonal antibodies, casirivimab and imdevimab. The EUA allows healthcare providers to administer casirivimab/imdevimab to non-hospitalized patients with confirmed COVID-19 who are experiencing mild to moderate symptoms and are at high-risk for severe symptoms and hospitalization. It can also be used to prevent COVID-19 once you are exposed, especially if you are unvaccinated. It will not work against the Omicron variant but can still be used in regions where Omicron is not very prevalent.

Sotrovimab (SOT)

On May 26, 2021 GlaxoSmithKline LLC received an Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for their COVID-19 treatment called Sotrovimab (SOT). SOT is 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. Administration of SOT is by intravenous use only. It has activity against the Omicron variant and is available through intravenous infusion sites and services across the state.

The U.S. Department of Health and Human Services, Office of the Assistant Secretary for Preparedness and Response (HHS/ASPR) will oversee allocation of thesetherapeutic and coordinate its distribution.

HHS will taper off allocating monoclonal antibodies Bam/Ete and REGEN-COV for outpatient treatment of COVID-19 based on the growing prevalence of Omicron variant cases. All facilities using those products may continue using doses on hand if they have not had any Omicron variant cases identified in their area of practice. Sotrovimab (intravenous) has been made available for allocation here in Illinois. We have been allocated 3288 courses of Sotrovimab available for distribution until Jan 3, 2022. Omicron has been detected in several counties in IL. Sites requesting mAb and therapeutics have been notified of the counties involved . Sites that have mAb doses of Bam/Ete and REGEN-COV and are NOT in these counties, please continue to use the doses you have on hand. If you are in these above mentioned counties, please consider sharing doses of Bam/Ete and REGEN-COV with facilities in other counties.

Paxlovid

Paxlovid (nirmatrelvir co-packaged with ritonavir) is an oral medication therapy consisting of two 150mg capsules of nirmatrelvir and one 100 mg capsule of ritonavir (3 pills total) taken twice a day for 5 days to treat COVID-19 in those above the age of 12 years or 40 kg who are at high risk of progressing to severe disease. Therapy must be started within 5 days of developing COVID-19 symptoms. Illinois will receive 2040 courses of Paxlovid in the first release from HHS. We anticipate receiving allocations from HHS on a two-week cycle schedule. Requests for Paxlovid on the Health Partner Ordering Portal (HPOP) opened on 12/22 with shipping to begin the week of 12/27.

Molnupiravir

Molnupiravir is an oral antiviral now authorized for the treatment of mild to moderate COVID-19 in adults age 18 years and older, who are at high risk for progressing to severe COVID-19 and for whom alternative COVID-19 treatment options are not accessible or clinically appropriate. It is administered as four 200 mg capsules taken orally every 12 hours for five days, for a total of 40 capsules. Therapy must be started within 5 days of developing symptoms. Molnupiravir is not authorized for use in those under the age of 18 years, or for pregnant or lactating women due to the possibility of fetal harm. Illinois has been allocated 9540 courses of molnupiravir this cycle. Requests for Molnupiravir on HPOP begins on 12/23 with shipping to begin on 12/29.

Health care providers are required to discuss the risks and benefits of all the above products and engage in shared decision making, based on the data in the emergency use authorization (EUA) factsheets. Health care providers are required to provide the EUA patient factsheets to the recipients of these products and ensure that they comprehend the information in those factsheets.

All COVID-19 therapeutics require a prescription from a provider. Please do not present to the pharmacy without a prescription.

These medications are FREE from the federal government and allotted weekly to every two weeks to the State of Illinois.

These medications are in VERY short supply and so those at the highest risk for COVID-19 complications will get prioritized. However, given the number of cases in IL, even those in the highest risk category may not all be able to receive this medication and pharmacies will be dispensing on a first come first serve basis.

Those who are diagnosed with COVID-19 and are at high risk for developing serious illness from it should discuss alternatives such as Molnupiravir if other therapeutics are not available, in order to expedite the decision making process at pharmacies.

Facilities interested in providing Paxlovid or Molnupiravir and any pending antiviral or novel therapeutic, need to go to the COVID-19 Antiviral Survey and fill it out indicating they would like to participate. Further instructions will follow to get you set up in that portal. Facilities are REQUIRED to report utilization of these products DAILY in the HPOP portal. This impacts the allocation for the entire state. Facilities that do not comply with this requirement may impact their future allocations.

Given the scarcity of these medications, IDPH strongly recommends limiting use of therapeutics for the following highest priority patients as below:

  • Those living in long term care facilities
  • Those above the age of 65 years
  • Those with an active immunocompromising condition as described here:
    • Active treatment for solid tumor and hematologic malignancies
    • Receipt of solid-organ transplant and taking immunosuppressive therapy
    • Receipt of chimeric antigen receptor (CAR)-T-cell or hematopoietic stem cell transplant (within 2 years of transplantation or taking immunosuppression therapy)
    • Moderate or severe primary immunodeficiency (e.g., DiGeorge syndrome, Wiskott-Aldrich syndrome)
    • Advanced or untreated HIV infection (people with HIV and CD4 cell counts <200/mm3, history of an AIDS-defining illness without immune reconstitution, or clinical manifestations of symptomatic HIV)
    • Active treatment with high-dose corticosteroids (i.e., ≥20 mg prednisone or equivalent per day when administered for ≥2 weeks), alkylating agents, antimetabolites, transplant-related immunosuppressive drugs, cancer chemotherapeutic agents classified as severely immunosuppressive, tumor-necrosis (TNF) blockers, and other biologic agents that are immunosuppressive or immunomodulatory (e.g., B-cell depleting agents)

Additional consideration may be given to the following group if there are additional doses to allocate:

  • Those 50 years and over with at least one additional risk factor OR above the age of 12 years with at least 2 additional risk factors for progression to severe COVID-19 disease as described here and as below:
    • Cancer
    • Cerebrovascular disease
    • Chronic kidney disease
    • Chronic lung diseases limited to:
      • Interstitial lung disease
      • Pulmonary embolism
      • Pulmonary hypertension
      • Bronchopulmonary dysplasia
      • Bronchiectasis
      • COPD (chronic obstructive pulmonary disease)
    • Chronic liver diseases limited to:
      • Cirrhosis
      • Non-alcoholic fatty liver disease
      • Alcoholic liver disease
      • Autoimmune hepatitis
    • Diabetes mellitus, type 1 and type 2
    • Heart conditions (such as heart failure, coronary artery disease, or cardiomyopathies)
    • Mental health disorders limited to:
      • Mood disorders, including depression
      • Schizophrenia spectrum disorders
    • Obesity (BMI ≥30 kg/m2)
    • Pregnancy and recent pregnancy
    • Smoking, current and former
    • Tuberculosis

It is critically important for the clinical community to use evidence based clinical judgement in triaging use of these products. Clinicians may exercise further discretion based on any additional factors they deem important to the triaging of this product, as long as it is limited to the EUA. This restriction is expected to ease if we receive larger allocations that would render any restriction unnecessary.

Note: A request does not guarantee the amount or type of mAb requested will be provided or that the request will be approved. Priority will be based on areas of the state with the greatest need.

Pre-Exposure Prophylaxis to prevent COVID-19

Evusheld (tixagevimab co-packaged with cilgavimab) is an intramuscular injectable monoclonal antibody combination which has been approved for use in PRE-exposure prophylaxis for those who are unable to receive nor respond well to vaccines i.e. those on immunosuppressive medications or those with immunosuppressive conditions. It is unclear, at this point in time, if the activity against the Omicron variant will be sufficient to provide protection from COVID-19 infection. IL has been allocated 1872 courses of Evusheld in the first release from HHS.

Given its limitation for use in those with immunosuppressive conditions, Evusheld will be distributed to hospitals that offer specialized services such as oncology, rheumatology etc. Providers in the community who also care for such populations may refer to these centers for access to Evusheld. A prescription from the specialist clinician managing their immunosuppressive condition (eg. Oncologist or Rheumatologist) will be required in order to ensure that this limited resource is disbursed judiciously for those with the greatest need.

Given the limited doses available, we strongly recommend specialists managing these conditions develop their own ethical prioritization framework for those meeting criteria per the EUA. Medical conditions or treatments that may result in moderate to severe immune compromise and an inadequate immune response to COVID-19 vaccination include but are not limited to:

  • Active treatment for solid tumor and hematologic malignancies
  • Receipt of solid-organ transplant and taking immunosuppressive therapy
  • Receipt of chimeric antigen receptor (CAR)-T-cell or hematopoietic stem cell transplant (within 2 years of transplantation or taking immunosuppression therapy)
  • Moderate or severe primary immunodeficiency (e.g., DiGeorge syndrome, Wiskott-Aldrich syndrome)
  • Advanced or untreated HIV infection (people with HIV and CD4 cell counts <200/mm3, history of an AIDS-defining illness without immune reconstitution, or clinical manifestations of symptomatic HIV)
  • Active treatment with high-dose corticosteroids (i.e., ≥20 mg prednisone or equivalent per day when administered for ≥2 weeks), alkylating agents, antimetabolites, transplant-related immunosuppressive drugs, cancer chemotherapeutic agents classified as severely immunosuppressive, tumor-necrosis (TNF) blockers, and other biologic agents that are immunosuppressive or immunomodulatory (e.g., B-cell depleting agents)

Allocation decisions should not be based on:

  • Race; ethnicity; gender; gender identity; sexual orientation or preference; religion; citizenship or immigration status; or socioeconomic status (this does not limit consideration of factors such as race or ethnicity in clinical prognostication, if data indicates that such factors are associated with heightened risks of progression to severe COVID-19).
  • Ability to pay.
  • Age as a criterion in and of itself (this does not limit consideration of a patient’s age in clinical prognostication if data indicates that age is associated with heightened risks of progression to severe COVID-19).
  • Disability status or comorbid condition(s) as a criterion in and of itself (this does not limit consideration of a patient’s physical condition in clinical prognostication if data indicates that disability is associated with heightened risks of progression to severe COVID-19).
  • Predictions about baseline life expectancy beyond the current episode of care (i.e., life expectancy if the patient were not facing the current crisis), unless the patient is imminently and irreversibly dying or terminally ill, with life expectancy under six months (e.g., eligible for admission to hospice).
  • First-come, first-served, because this approach tends to provide advantage to privileged populations.
  • Judgments that some people have greater quality of life than others
  • Judgments that some people have greater social value than others

Facilities interested in providing Evusheld and any pending antiviral or novel therapeutic, need to go to the COVID-19 Antiviral Survey and fill it out indicating they would like to participate. Further instructions will follow to get you set up in that portal. Facilities are REQUIRED to report utilization of these products DAILY in the HPOP portal. This impacts the allocation for the entire state. Facilities that do not comply with this requirement may impact their future allocations.

For questions about Monoclonal Antibody Therapy please email DPH.MABTherapy@illinois.gov.

Providers Seeking Information about the Allocation and Distribution Process

On Monday, September 13, 2021, the U.S. Department of Health and Human Services (HHS) moved from direct ordering by monoclonal antibody administration sites, to requiring orders for monoclonal antibody (mAb) to go through the state.

The current model for distributing mAb in the country is HHS allocates quantity of mAb to each state. In Illinois, IDPH is tasked with allocating those available doses around the state to sites that request mAb. The allocation cycles are set by HHS and on the first Monday of each allocation cycle HHS releases the allocation of each mAb product that will be available to each state. IDPH compiles the requests and begins making allocations on Wednesday. A separate shipping company AmerisourceBergen handles the direct shipment of product from their warehouses to the requesting sites as allocated by IDPH. Below is information that requesting sites can use for clarification and requesting.

  • Sites wishing to administer mAb need to make sure they are set up with AmerisourceBergen to receive shipments: AmerisourceBergen New Site Form
  • Sites MUST report inventory and usage on TeleTracking as part of the HHS mAb program: TeleTracking
  • Locations then use the IDPH mAb Request form to submit request for a specific allocation cycle and type of mAb: IDPH mAb Request Form

Providers, If you need help getting set up please email DPH.MABTherapy@illinois.gov

Related Resources about Monoclonal Antibody Treatments