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COVID-19 Monoclonal Antibody Therapies
General Information for Health Care Professionals
Stanford Health Care is providing COVID-19 monoclonal antibody (mAb) therapies to eligible patients, whether within or outside of the Stanford Health Care system, in accordance with the Food & Drug Administration (FDA) Emergency Use Authorization (EUA) criteria.
For questions, please contact us at
DL-SHC-Pharmacy-COVID@stanfordhealthcare.org
At present, Stanford Health Care offers casirivimab/imdevimab (CASIM).
Stanford Health Care reserves the right to select the monoclonal antibody for infusion based on medication supply and clinical data available at the time of referral.
Are you a patient?
General Information for Health Care Professionals
Stanford Health Care is providing COVID-19 monoclonal antibody (mAb) therapies to eligible patients, whether within or outside of the Stanford Health Care system, in accordance with the Food & Drug Administration (FDA) Emergency Use Authorization (EUA) criteria.
At present, Stanford Health Care offers casirivimab/imdevimab (CASIM).
Stanford Health Care reserves the right to select the monoclonal antibody for infusion based on medication supply and clinical data available at the time of referral.
Are you a patient?
For questions, please contact us at
DL-SHC-Pharmacy-COVID@stanfordhealthcare.org
Confirming Patient Eligibility
Stanford Health Care Modified* Emergency Use Authorization Criteria for mAbs
- Must be an adult >18 years of age** AND
- Have positive direct SARS CoV-2 viral testing AND
- Be symptomatic with onset within the previous 10 days (symptoms include at least one of the following: fever, cough, sore throat, malaise, headache, muscle pain, gastrointestinal symptoms, or shortness of breath with exertion) AND
- Meet one or more of the following criteria:
- BMI >30 kg/m2
- Chronic kidney disease
- Diabetes mellitus
- Immunosuppressive disease/therapy — this does not include:
- HIV alone with CD4 >200 CD4+ T cells/mm3
- Prednisone or prednisone equivalent <20 mg daily for <3 weeks
- Age >= 65 years
- Age >= 55 years and one or more of the following:
- Cardiovascular disease
- hypertension
- Chronic obstructive pulmonary disease/other chronic respiratory disease
* Differences from the FDA EUA criteria are bolded
** Stanford Health Care does not provide therapy to pediatric patients. Please contact the on-call Pediatric Infectious Disease team at 650-497-8000 for therapy inquiries in patients less than 18 years of age.
Referral Process Overview
Step 1: Familiarize Yourself
- At present, Stanford Health Care is providing casirivimab/imdevimab. Stanford Health Care reserves the right to select the monoclonal antibody for infusion based on medication supply and clinical data available at the time of referral.
- Review the Stanford Health Care Modified Emergency Use Authorization Criteria for mAbs.
Step 2: Educate the Patient
- Inform the patient that COVID-19 mAbs are unapproved therapies but are authorized for use under Emergency Use Authorization. Click here for information that may assist in explaining EUA to patients.
- Discuss the risks, benefits, and alternatives to monoclonal antibody therapies with patients by reviewing the EUA mAbs Fact Sheet for Patients, Parents, and Caregivers and providing a copy of this document, when possible.
- Inform the patient that COVID-19 vaccination should be deferred for at least 90 days after receiving monoclonal antibody therapy.
Step 3: Refer the Patient
- If the patient is interested in pursuing therapy, please submit a referral using this link.
- The referral will be screened to ensure that the patient is eligible for therapy. You will receive an email response within 24 hours of submission of a referral with a determination.
- If approved, the patient will be contacted via phone to schedule an appointment and will receive detailed information about what to expect.
- If denied, you will be informed of the reason for denial in the email communication.
Step 1: Familiarize Yourself
- At present, Stanford Health Care is providing casirivimab/imdevimab. Stanford Health Care reserves the right to select the monoclonal antibody for infusion based on medication supply and clinical data available at the time of referral.
- Review the Stanford Health Care Modified Emergency Use Authorization Criteria for mAbs.
Step 2: Educate the Patient
- Inform the patient that COVID-19 mAbs are unapproved therapies but are authorized for use under Emergency Use Authorization. Click here for information that may assist in explaining EUA to patients.
- Discuss the risks, benefits, and alternatives to monoclonal antibody therapies by reviewing the EUA mAb Fact Sheet for Patients, Parents, and Caregivers and providing a copy of this document, when possible.
- Inform the patient that COVID-19 vaccination should be deferred for at least 90 days after receiving monoclonal antibody therapy.
Step 3: Refer the Patient
- If the patient is interested in pursuing therapy, please submit a referral using this link.
- The referral will be screened to ensure that the patient is eligible for therapy. You will receive an email response within 24 hours of submission of a referral with a determination.
- If approved, the patient will be contacted via phone to schedule an appointment and will receive detailed information about what to expect. If denied, you will be informed of the reason for denial in the email communication.
Step 4: Ordering & Documentation
- Co-sign the EPIC Therapy Plan that is routed to your In Basket prior to the patient's infusion.
- Write a note in the patient's chart using the dotphrase ".MABTHERAPY" to capture all mandatory EUA elements.
Step 5: Follow-up & Reporting
- Contact the patient 24 hours post-infusion to determine if the patient experienced an adverse reaction. If so, submit a report to the following:
- FDA MedWatch
- Manufacturer
- Regeneron Pharmaceuticals (CASIM)
- Email: medical.information@regeneron.com, Phone: 1-844-734-6643, Fax: 1-888-876-2736
- Eli Lilly and Company, Global Patient Safety (BAM/ETE)
- Email: mailindata_gsmtindy@lilly.com, Phone: 1-855-545-5921, Fax: 1-317-277-0853
- Enter a SAFE Event (Stanford Health Care-privileged providers only)
- Eli Lilly and Company, Global Patient Safety (BAM/ETE)
- Email: medical.information@regeneron.com, Phone: 1-844-734-6643, Fax: 1-888-876-2736
- Regeneron Pharmaceuticals (CASIM)
Resources for Health Care Providers
RESOURCE
Casirivimab/imdevimab EUA FAQs
Food & Drug Administration