Evusheld

Evusheld

Frequently Asked Questions About Evusheld

On 12/08/2021, the FDA issued an Emergency Use Authorization (EUA) for the medication Evusheld (tixagevimab/cilgavimab). Evusheld is a long-acting monoclonal antibody (mAb) therapy used for prevention, also known as pre-exposure prophylaxis (PrEP) of COVID-19 in adults and children >12 years and weighing at least 40kg (88 lbs), with certain high-risk, immunocompromised conditions.

A physician will determine whether Evusheld is an appropriate treatment and when an individual will receive the medication. There is a very limited supply of Evusheld and is being distributed in limited amounts to most health systems. It is believed that over 95% of eligible patients receive care through one of these health care systems. Eligible individuals not affiliated with one of these health care systems will still be able to access Evusheld by contacting their health care provider. It is important to remember that this medication is not a substitute for the COVID-19 vaccine. Evusheld may be given two weeks following vaccination.

How does Evusheld Work?

  • Unlike other mAb medications used for COVID-19, Evusheld is not a treatment for COVID-19. Instead, it is given as a preventative medication to those that have significant immune disorders or for the few people who have experienced a severe reaction to the vaccination and are unable to receive additional vaccinations.
  • It works by keeping the SARS-CoV-2 virus that causes COVID-19 from entering the cells of the body, preventing illness.

How do I know if I am a candidate for Evusheld?

You may be a candidate for Evusheld if you:

  • Are moderate to severely immunocompromised, and MAY not develop an adequate immune response to COVID-19 vaccination.
  • Are undergoing chemotherapy or other treatments that may depress the immune system.
  • Have undergone organ transplant and are taking immunosuppressant therapy.
  • Have undergone CAR-T-cell or stem cell transplant within two years.
  • Have moderate to severe immunocompromise due to a medical condition such as DiGeorge Syndrome, Wiskott-Aldrich syndrome, etc.
  • Have advanced or untreated HIV infection (CD4 cell counts of <200; AIDS-defining illness, or symptomatic HIV).
  • Are being treated with high dose corticosteroids such as prednisone (20 mg a day or more).

Who should not receive Evusheld?

People who have the following should not receive Evusheld:

  • Currently infected with COVID-19. Evusheld is not authorized for treatment once infected.
  • Post exposure prophylaxis (PEP), or prevention, of COVID-19 in persons who have been exposed to someone with SARS-CoV-2.
  • A substitute for vaccination in individuals who are eligible for COVID-19 vaccination.

How is Evusheld Administered and What are the Side Effects?

  • A physician will determine whether an individual is eligible for Evusheld, as well as when and where the medication should be given.
  • Evusheld is given by 2 intramuscular injections.
  • Repeat injections should be given 6 months later for continued prevention of COVID-19 while the virus remains in circulation.
  • Reported side effects include hypersensitivity to the medication, bleeding from the injection site, headache, fatigue, and nausea.

Further information for patients and caregivers can be found at: Fact Sheet for Patients, Parents and Caregivers Emergency Use Authorization (EUA) of EVUSHELD™ (tixagevimab copackaged with cilgavimab) for Coronavirus Disease 2019 (COVID 19)

I appear to meet the eligibility criteria for Evusheld but my health care provider tells me I can't receive the medication at this time. Why?

Evusheld is currently in extremely short supply with the demand being much greater than what we have been allocated. Because of this the State of Michigan has had to establish priority eligibility criteria in which individuals who are at higher risk are offered the medication before those at lower risk. Even with these priority criteria, there is an inadequate supply of the medication to provide all high-risk patients the medication at once. Health care systems have established ethically based processes to make Evusheld available to people as supplies permit and in in an equitable and fair manner.

How much will Evusheld cost me?

Currently, Evusheld is provided by the federal government at no charge to you. Health care providers administering Evusheld may bill insurance providers for the cost of administering the medication. Patients should not experience out-of-pocket costs.

How can I access Evusheld if I am not affiliated with one of the health care systems that have Evusheld?

Contact your Michigan health care provider. Evusheld can be made available through MDHHS to independent hospitals and other health care providers not affiliated with one of these health care systems. Your healthcare provider can contact MDHHS with any questions.