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Provider Portal - Prevention and Treatment

Overview

This site provides additional information to healthcare providers regarding COVID-19 therapeutics. This information is not for the general public; for general information, please visit the community page on prevention and treatments.
 

Prevention and Treatment of COVID-19

There are now multiple prevention and treatment options authorized by the FDA for emergency use:

To learn how to access and administer monoclonal antibodies for post-exposure prophylaxis or treatment, please see the Access and Administration below.

These products are not substitutes for vaccination against COVID-19. FDA has authorized three vaccines to prevent COVID-19 and serious clinical outcomes caused by COVID-19, including hospitalization and death.

Pre-Exposure Prevention

What Is Pre-Exposure Prevention (PrEP) And How Does It Work?
PrEP medicines are designed to proactively protect certain individuals from COVID-19 infection prior to exposure.

These medicines use monoclonal antibodies (laboratory-made proteins that mimic the immune system's ability to fight off harmful pathogens) to block the COVID-19 virus' attachment and entry into human cells.

What Medicines Are Available?
In the United States, AstraZeneca's Evusheld (tixagevimab co-packaged with cilgavimab and administered together) is the only product currently authorized for pre-exposure prevention.

Who is Eligible for COVID-19 PrEP?
Evusheld is only authorized for adults and pediatric individuals (12 years of age and older weighing at least 40 kilograms [about 88 pounds]) who are not currently infected with COVID-19 virus and who have not recently been exposed to an individual infected with COVID-19.

The authorization also requires that individuals either:

  • have moderate to severely compromised immune systems and may not mount an adequate immune response to COVID-19; or
  • are recommended to not receive vaccination against COVID-19.

What Are the Side Effects of PrEP?
Possible side effects of Evusheld include: allergic reactions (including anaphylaxis), cardiac events, bleeding at the injection site, headache, fatigue and cough. 
 
How Can I Obtain PrEP Products to Treat My Patients?
Due to limited supply of Evusheld, product will only be stocked in certain locations across the Commonwealth. You may contact covidtherapeutics@pa.gov to ask questions regarding how to obtain Evusheld.

How Is PrEP Administered?
Evusheld is administered as two intramuscular injections given in immediate succession.

Post-Exposure Prevention

What Is Post-Exposure Prophylaxis (PEP, or Post-Exposure Prevention) and How Does It Work?
PEP medicines are designed to proactively protect certain individuals who have been exposed to the COVID-19 virus from infection.

These medicines use monoclonal antibodies (laboratory-made proteins that mimic the immune system's ability to fight off harmful pathogens) to block the COVID-19 virus' attachment and entry into human cells.
 
What PEP Medicines Are Available?
In the United States, there are two products with emergency use authorizations (EUA) from the FDA for post-exposure prophylaxis:

Who Is Eligible for PEP?
REGEN-COV and bam/ete are authorized in individuals who are:

  • at high risk for progression to severe COVID-19, including hospitalization or death, and
  • not fully vaccinated or are not expected to mount an adequate immune response to complete COVID-19 vaccination (for example, people with immunocompromising conditions, including those taking immunosuppressive medications), and
    • have been exposed to an individual infected with COVID-19 consistent with close contact criteria per Centers for Disease Control and Prevention (CDC), or
    • are at high risk of exposure to an individual infected with COVID-19 because of occurrence of COVID-19 infection in other individuals in the same institutional setting (for example, nursing homes or prisons)

High risk reasons for more serious symptoms include:

  • Age ≥ 65 years
  • Obesity or being overweight based on Centers for Disease Control and Prevention clinical growth charts
  • Pregnancy
  • Chronic kidney disease
  • Diabetes
  • Immunosuppressive disease or immunosuppressive treatment
  • Heart or circulatory conditions such as heart failure, coronary artery disease, cardiomyopathies, and possibly high blood pressure
  • Chronic lung diseases including COPD, asthma, interstitial lung disease, cystic fibrosis, and pulmonary hypertension
  • Sickle cell disease
  • Neurodevelopmental disorders such as cerebral palsy
  • Having a medical device

Given supplies of these products are significantly limited, it may be prudent for providers to determine whether providing prophylaxis to exposed, but non-COVID-positive individuals constitutes the most effective utilization of a scarce resource.

How Can I Obtain Products to Treat My Patients?
To learn how to gain access to Evusheld, please see Access and Administration below.

You can find all locations for post-exposure prevention medicines at Therapeutics Distribution | HHS Protect Public Data Hub.

How Is PEP Administered?
Regeneron's REGEN-COV (casirivimab plus imdevimab) and Eli Lilly's bamlanivimab plus etesevimab (bam/ete) are administered through a one-time intravenous (IV) infusion. The infusion takes about one hour to complete, and you must stay at the infusion center for another hour to be monitored for allergic reactions or other side effects. REGEN-COV may also be administered via subcutaneous injection.

What Are the Side Effects of These Medicines?
Allergic reactions can occur during and after infusion with these medicines, and infusion of these medicines may cause brief pain, bleeding, bruising of the skin, soreness, swelling, and possible infection at the infusion site.

The most common side effects for Eli Lilly's bamlanivimab plus etesevimab are:

  • Fever
  • Difficulty breathing
  • Rapid/slow heart rate
  • Tiredness
  • Weakness
  • Confusion

The most common side effects for Regeneron's REGEN-COV are:

  • Nausea
  • Vomiting
  • Hyperglycemia
  • Pneumonia

Potential side effects of sotrovimab include anaphylaxis and infusion-related reactions, rash, and diarrhea.

These are not all the possible side effects of these medicines. Serious and unexpected side effects may occur.

COVID-19 Treatments

What Are COVID-19 Treatments and How Do They Work?
Treatment for COVID-19 is designed to protect certain individuals who test positive for COVID-19 from progressing to more severe infections.

There are multiple treatment options for COVID-19 infections. Oral antiviral medications are pills that can be taken at home, while monoclonal antibodies are administered through a one-time intravenous (IV) infusion.

Oral Antiviral Medications

What Oral Antivirals Are Available for Treatment of COVID-19?
In the United States, there are two oral antiviral medications with emergency use authorizations (EUA) from the FDA for treatment of COVID-19. Please visit the webpages below for complete information about these products.

Who is Eligible to Receive Oral Antivirals?
Molnupiravir is authorized for the treatment of mild-to-moderate COVID-19 in adults:

  • who have tested positive for COVID-19
  • who are at high risk for progression to severe COVID-19, including hospitalization or death, and

Paxlovid is authorized for the treatment of mild-to-moderate COVID-19 in adults and pediatric individuals (12+ years of age and weighing at least 40 kg [88 pounds]) who:

  • who have tested positive for COVID-19
  • who are at high risk for progression to severe COVID-19, including hospitalization or death, and

High risk reasons for more serious symptoms include:

  • Age ≥ 65 years
  • Obesity or being overweight based on Centers for Disease Control and Prevention clinical growth charts
  • Chronic kidney disease
  • Diabetes
  • Immunosuppressive disease or immunosuppressive treatment
  • Heart or circulatory conditions such as heart failure, coronary artery disease, cardiomyopathies, and possibly high blood pressure
  • Chronic lung diseases including COPD, asthma, interstitial lung disease, cystic fibrosis, and pulmonary hypertension
  • Sickle cell disease
  • Neurodevelopmental disorders such as cerebral palsy
  • Having a medical device

How Can I Obtain Products to Treat My Patients?
To learn how to gain access to treatments, please see the Access and Administration below.

How Are Oral Antivirals Administered?
Molnupiravir is administered as 4 capsules every 12 hours for 5 days. It is important that patients complete the full 5 days of treatment with molnupiravir, even if they feel better.

Paxlovid consists of 2 medicines: nirmatrelvir and ritonavir. Patients should take 2 tablets of nirmatrelvir (150 mg) with 1 tablet of ritonavir (100 mg) by mouth twice daily (in the morning and in the evening) for 5 days. For each dose, all 3 tablets should be taken at the same time.
 
What Are the Side Effects of Oral Antivirals?
Common side effects of molnupiravir are diarrhea, nausea, and dizziness.
 
Paxlovid is contraindicated in patients with a history of clinically significant hypersensitivity reactions [e.g., toxic epidermal necrolysis (TEN) or Stevens-Johnson syndrome] to its active ingredients (nirmatrelvir or ritonavir) or any other components of the product.

Potential side effects of Paxlovid include, but are not limited to:

  • Liver problems
    • Signs and symptoms of liver problems include loss of appetite, yellowing of the skin and the whites of the eyes (jaundice), dark-colored urine, pale-colored stools and itchy skin, or stomach area (abdominal) pain
  • Resistance to HIV Medicines
  • Altered sense of taste
  • Diarrhea
  • High blood pressure
  • Muscle aches

Monoclonal Antibodies

What Monoclonal Antibodies Are Available for Treatment of COVID-19?
In the United States, there are three monoclonal antibody products with emergency use authorizations (EUA) from the FDA for treatment of COVID-19:

Please note that early data indicates that sotrovimab may be the only currently available monoclonal antibody that remains efficacious against the Omicron variant of COVID-19.Opens In A New Window

Who is Eligible to Receive Monoclonal Antibodies?
Patients may be eligible for monoclonal antibody treatments if they:

  • Have tested positive for COVID-19
  • Are experiencing mild or moderate symptoms of COVID-19
  • Experienced their first symptoms of COVID-19 in the last 10 days (optimally before 7 days; earlier intervention likely leads to better results)
  • Are at high risk for having more serious symptoms of COVID-19 and/or going into the hospital

High risk reasons for more serious symptoms include:

  • Age ≥ 65 years
  • Obesity or being overweight based on Centers for Disease Control and Prevention clinical growth charts
  • Pregnancy
  • Chronic kidney disease
  • Diabetes
  • Immunosuppressive disease or immunosuppressive treatment
  • Heart or circulatory conditions such as heart failure, coronary artery disease, cardiomyopathies, and possibly high blood pressure
  • Chronic lung diseases including COPD, asthma, interstitial lung disease, cystic fibrosis, and pulmonary hypertension
  • Sickle cell disease
  • Neurodevelopmental disorders such as cerebral palsy
  • Having a medical device

How Can I Obtain Monoclonal Antibodies to Treat My Patients?
To learn how to gain access to treatments, please see the Access and Administration below.

You can find all locations for monoclonal antibody treatments at Therapeutics Distribution | HHS Protect Public Data Hub.
 
How Are Monoclonal Antibodies Administered?
Regeneron's REGEN-COV (casirivimab plus imdevimab), Eli Lilly's bamlanivimab plus etesevimab (bam/ete), and GSK's sotrovimab are administered through a one-time intravenous (IV) infusion. The infusion takes about one hour to complete, and you must stay at the infusion center for another hour to be monitored for allergic reactions or other side effects. Although infusion is the recommended form of administration for treatment, REGEN-COV may also be administered via subcutaneous injection.
 
What Are the Side Effects of Monoclonal Antibodies?
Allergic reactions can occur during and after infusion with these medicines, and infusion of these medicines may cause brief pain, bleeding, bruising of the skin, soreness, swelling, and possible infection at the infusion site.

The most common side effects for Eli Lilly's bamlanivimab plus etesevimab are:

  • Fever
  • Difficulty breathing
  • Rapid/slow heart rate
  • Tiredness
  • Weakness
  • Confusion

The most common side effects for Regeneron's REGEN-COV are:

  • Nausea
  • Vomiting
  • Hyperglycemia
  • Pneumonia

Potential side effects of sotrovimab include anaphylaxis and infusion-related reactions, rash, and diarrhea.

These are not all the possible side effects of these medicines. Serious and unexpected side effects may occur.

Access and Administration

Evusheld for Pre-Exposure Prophylaxis (PrEP)
Due to limited supply of Evusheld, product will only be stocked in certain locations across the Commonwealth, which can be found here: COVID-19 Public Therapeutic Locator | HealthData.gov. If you have specific inquiries about obtaining Evusheld, you can get in touch with one of these locations using the information found here. You may also contact covidtherapeutics@pa.gov to ask questions regarding how to obtain Evusheld.
 
Oral Antivirals (Paxlovid and Molnupiravir) for COVID-19 Treatment
There are a limited number of pharmacies that currently have these products. These pharmacies can be found using the links below or through this locator: COVID-19 Public Therapeutic Locator | HealthData.gov. You may want to contact the pharmacy to determine availability of the product before submitting the prescription.

Monoclonal Antibodies (mAbs) for Post-Exposure Prophylaxis and Treatment
Step 1: Determine your plan and suitability to provide mAbs.
Providers should understand the clinical conditions under which mAbs should be administered, which are highlighted in the EUAs for each product: REGEN-COV, sotrovimab, and bam/ete. Providers must have or develop the capacity to outreach to and serve members of the eligible population, as facilities receiving these products must commit to following the EUA.

Additionally, providers should consider the staffing and space requirements for administration of mAbs. All products are authorized to be administered via IV infusion, which may take up to 70 minutes per patient; REGEN-COV is also authorized for administration as a subcutaneous injection. Supplies and materials required to administer the infusion are not included with the products ordered. Providers must also be able to monitor for and treat post-administration reactions, including anaphylaxis and should have plans and protocols in place for the administration of epinephrine and activation of Emergency Medical Services.

Step 2: For new Providers - enroll in the AmerisourceBergen Portal.
If you are already receiving product, your account has already been established and you can proceed to step 3.
All providers receiving allocations must have an account established in the AmerisourceBergen (ASB) ordering portal. Providers can fill out the required documentation here. All sites will need a valid Board of Pharmacy license OR both a provider's license and a signed Letter of Affiliation. These documents must be uploaded through ASB's smartsheet portal. AmerisourceBergen does vet every site against individual state requirements to ensure compliance with local state regulations and laws. Please note that it may take up to five business days for ASB to enroll your site and allow the department to place orders.

Step 3: Submit your weekly request to the Department.
Requests for products should be submitted to the department using this form by 12:00 p.m. each Monday. Currently, the Department of Health is responsible for making allocation determinations to provider facilities based on total allocations assigned to each state. Requests may be reduced depending on the total quantity of product allocated to Pennsylvania, the total quantity of product requested by providers, and the current inventory and demand levels for each provider.

Step 4: Receive confirmation of your order and await delivery.
The department will provide a confirmation email of each requesting provider's allocation, typically on Tuesday afternoons. This confirmation will include the total quantity of product that has been assigned to your facility and provide you with confirmation that the order for your facility has been placed with ASB.

Please note that once the order is placed with ASB, it may take up to one week before products are shipped, meaning that a request submitted to the department on Monday and processed to ASB on Tuesday may not be delivered until the following Wednesday or Thursday. This delay in shipping is outside of the control of the department, and the department has no visibility on when products will be shipped. ASB does provide both the department and the provider an emailed tracking number within 24 hours of the product being shipped. However, facilities should plan internally for potential delays in receipt of product, even after a successful submission of the order.

Step 5: Administer product and report utilization.
All providers who administer monoclonal antibodies must ensure compliance with the EUA for the product being utilized and should ensure that patients meet all eligibility criteria established by the FDA. Additionally, we want to remind providers that weekly state allocations are determined in part by data on inventories and utilization submitted by providers to HHS Protect. Failure of Pennsylvania's providers to efficiently use the product and report utilization to HHS may reduce the total overall quantity of monoclonal antibodies allocated to Pennsylvania.  For additional information on reporting requirements, please visit the HHS Public Health Emergency site for Reporting Utilization of COVID-19 Therapeutics.

Where Should I Refer Patients if I Cannot Administer Monoclonal Antibodies?
There are several locations within the Commonwealth that have the ability to administer monoclonal antibodies. Please visit Therapeutics Distribution | HHS Protect Public Data Hub for more information about these locations.

If you have any questions, contact our logistics team at HOC_LOG@pa.gov