Updated: Dec. 30, 2021

There are multiple therapeutic treatment options available, under emergency use authorization from the U.S. Food and Drug Administration, for the care of COVID-19 patients both inside and outside of the hospital setting. These therapeutics are for individuals who are moderate to high risk for progressing to severe disease, including hospitalization or death. The Centers for Disease Control and Prevention provided guidance in underlying medical conditions that are associated with a higher risk for severe COVID-19 disease and a list of moderate and severe immunocompromising conditions. Each individual therapeutic treatment provides more specific guidance in their EUA.

There may be logistical or supply chain constraints that make it impossible to offer the available therapeutics to all eligible patients, making triage necessary. When this is the case, the NIH COVID-19 Treatment Guidelines Panel suggests prioritizing the following.

• • treatment of COVID-19 patients over post-exposure prophylaxis patients
  • treatment of COVID-19 unvaccinated patients with clinical risk factors for severe illness and vaccinated individuals who are not expected to mount an adequate immune response
  • the use of Evusheld as preexposure prophylaxis for severely immunocompromised individuals over moderately compromised individuals
  • for monoclonal antibody therapies, the panel-based prioritization is based on four key elements: age, vaccination status, immune status and clinical risk factors

Monoclonal Antibodies

Monoclonal antibodies are laboratory-made proteins that mimic the immune system’s ability to fight off harmful pathogens such as viruses.¹ “Monoclonal antibodies are basically antibodies that will attach to the spike protein of the SARS-CoV-2 virus (the virus that causes COVID-19). What it does is once it attaches to that spike protein, the virus cannot attach itself to the cells, thereby limiting the spread of the infection and preventing it from progressing further.”²

There currently are three therapies — bamlanivimab, casirivimab and imdevimab, and sotrovimab — that have an EUA from the FDA for treatment of COVID-19.

When the Omicron variant reaches 80% in the region based upon CDC NOWCAST data, bamlanivimab and casirivimab and imdevimab no longer will be available for allocation as they currently are not proven to be efficacious to this variant. Sotrovimab remains a viable mAb treatment option against the Omicron variant.

How do I request allocation for these treatment options?

Currently available for weekly allocation through the DHSS ordering portal COVID-19 Therapeutics Weekly Request. Orders are due by 5 p.m. on Mondays.

Is there a usage reporting requirement?

These therapeutics usages must be reported weekly into TeleTracking. Sotrovimab reporting remains a work in progress.

How do I report adverse events?

To report negative side effects of prescription drugs to the FDA, visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Can we charge for this treatment?

Medicare Monoclonal Antibody COVID-19 Infusion Program Instruction — Updated: Dec. 3, 2020

Oral Antivirals

Currently, there are two oral antivirals available for allocation through DHSS: molnupiravir and Paxlovid. To be added to the list of providers considered for allocation, complete this form to be submitted to the DHSS review team to facilitate onboarding to the Health Partner Ordering Portal.

How do I request allocation for oral antivirals?

Currently available for allocation through the DHSS ordering portal COVID-19 Therapeutics Weekly Request on a two-week cycle. Orders are due by 5 p.m. on Mondays.

Are there usage reporting requirements?

Yes, therapeutics usage must be reported into HPOP daily.

Preexposure Prophylaxis

There is one treatment option available for preexposure prophylaxis for immunocompromised and immunosuppressed individuals not expected to mount an adequate response to the COVID-19 vaccine, Evusheld. Supply is extremely limited and not anticipated to be available to all individuals who may qualify. To request being added to the DHSS list of providers considered for allocation, complete this form to be submitted to the DHSS review team to facilitate onboarding to the Health Partner Ordering Portal.

How do I request allocation for Evusheld?

Currently available for allocation through the DHSS ordering portal COVID-19 Therapeutics Weekly Request on a two-week cycle. Orders are due by 5 p.m. on Mondays.

Are there usage reporting requirements?

Yes, therapeutics usage must be reported into HPOP daily.

Who can receive this treatment?

For emergency use as preexposure prophylaxis for prevention of COVID-19 in adults and pediatric individuals (12 years of age and older weighing at least 40 kg):

• Who are not currently infected with SARS-CoV-2 and who have not had a known recent exposure to an individual infected with SARS-CoV-2 and
  • Who have moderate to severe immune compromise due to a medical condition or receipt of immunosuppressive medications or treatments and may not mount an adequate immune response to COVID-19 vaccination or
  • For whom vaccination with any available COVID-19 vaccine, according to the approved or authorized schedule, is not recommended due to a history of severe adverse reaction (e.g., severe allergic reaction) to a COVID-19 vaccine(s), and/or COVID-19 vaccine component(s).

How is this treatment provided?

The dosage of Evusheld in adults and pediatric individuals (12 years of age and older weighing at least 40 kg) is 150 mg of tixagevimab and 150 mg of cilgavimab administered as two separate consecutive intramuscular injections. Treatments should be repeated every six months.

Resources:

• FDA Letter of EUA Authorization
• Health Care Provider Fact Sheet
• Patients, Parents and Caregivers Fact Sheet
• FAQs on the EUA for Evusheld