1 Manager Message Map: OUTPATIENT SARS-CoV-2 Monoclonal Antibodies – Tip Sheet - PowerPoint Presentation

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Manager Message Map: OUTPATIENT SARS-CoV-2 Monoclonal Antibodies – Tip Sheet

Background

SARS-CoV-2 monoclonal antibody (MAB) treatments have been approved by the FDA for Emergency Use Authorization (EUA). Casirivimab- imdevimab is the only MAB that will be infused in the outpatient setting at Main Line Health to treat COVID-19 at this time.Monocolonal antibodies are administered via a single intravenous infusion or subcutaneously based on patient criteria (repeat dose for ongoing expsosure availableClinical benefit: reduced symptoms and the risk of hospitalization or ED visits in high-risk patients.The main risk is allergic/hypersensitivity reaction in <1% of patients

Referral Process and Links to Register Patient

Provider informs patient of their positive test result (PCR or antigen test).Patients who consent and meet inclusion criteria, are then referred.If necessary, based on availability of medication and infusion resources, patients will be allocated the medications via weighted lottery based. Patients and referring providers of eligible patients selected to receive the medication will be contacted within 2 business days of referral.Complete PHYSICIAN / PROVIDER referral document & submit. No patient will be contacted prior to approval or receipt of COMPLETE referral. For MLH providers: Go to the following links to request that your patient be considered for the monoclonal antibody treatment. Adult Monoclonal Antibody for COVID-19 Request Formhttps://ncv.microsoft.com/RSj4etvQQkPediatric Monoclonal Antibody for COVID-19 Request Formhttps://ncv.microsoft.com/yXTjwQ9H0gExternal Providers:Access the document(s) https://www.mainlinehealth.org/conditions-and-treatments/conditions/covid-19/testing-and-care/monoclonal-antibody-therapyPrint the document to register (Adult / Pediatric patients)Complete the entire documentSubmit via the fax number provided on the document (484-227-9028) or email MABCOVID19@mlhs.org.

Q&A

Criteria: Inclusion and Exclusion

Updated August 2021

INCLUSION Criteria (

within 10 days of symptom onset and +COVID result)Older age (example >65 years)BMI >25Diabetes Chronic Kidney DiseaseSickle cell diseasePregnancyImmunosuppressive disease or immunosuppressive treatment Cardiovascular disease (including congenital heart disease) or HTNChronic lung disease (i.e. COPD, asthma [mod-severe], interstitial lung disease, cystic fibrosis and pulmonary hypertension).Neurodevelopmental disorders (i.e. cerebral palsy) or other conditions that confer medical complexity (i.e. genetic or metabolic syndromes and severe congenital anomalies)Have a medical-related technological dependence (i.e. tracheostomy, gastrostomy, or positive pressure ventilation [not related to COVID-19])Social determinants of health which have been shown to independently negatively impact survival from COVID-19 * See CDC website: Health Equity Considerations and Racial and Ethnic Minority Groups | CDCPediatric BMI / 12-17 y.o.:BMI ≥85th percentile for their age and gender based on CDC growth charts, https://www.cdc.gov/growthcharts/clinical_charts.htmThe triage team requires a complete referral, including a COVID-19 test (+PCR/antigen test/rapid) validated prior to scheduling a patient for therapy. A referring provider or PCP is responsible for submitting the test.* The mAB triage team will not reach out to the patient until ready to schedule. *Life expectancy, zip code and occupation is for weighted lottery is necessary (not an exclusion). GOAL: administer drugs as soon as possible, within 10 days of symptom onset. Treatment is offered at the MLH Urgent Care in Wynnewood.Monoclonal Antibody EXCLUSION CriteriaNot authorized for use in patients who are:hospitalized due to COVID-19require oxygen therapy due to COVID-19require an increase in baseline oxygen flow rate due to COVID-19

EUA Update August 2021:

Post-Exposure Prophylaxis (select one in each category):

*

Centers for Disease Control and Prevention (CDC)

defined as

anyone who was within 6 feet of an infected person for a total of 15 minutes or more.

Patient is not fully vaccinated

OR

Patient is not expected to mount an adequate immune response to a complete vaccination (immuno-incompetent)

AND

Patient exposed to an individual infected with COVID-19 consistent with close contact criteria per CDC

OR

Patient is high risk of exposure to an individual infected with COVID-19 because of occurrence in other individuals in the same institutional setting (i.e., nursing home resident)

Monoclonal Antibody Therapy for COVID-19: Regen-COV

Casirivimab-imdevimab

(Regen-COV) continues to be offered at Main Line Health, Urgent Care, in Wynnewood. Regeneron, Regen-COV

, dosing update for prophylaxis:In addition, for patients who have received initial infusion and require subsequent repeat dosing by SC/IV infusion once every 4 weeks for the duration of ongoing exposure will be offered.Medication administration (IV/SC):Intravenous route is STRONGLY recommendedSubcutaneous is an ALTERNATE route of administration WHEN intravenous infusion is not feasible and would lead to a delay in treatmentRequire 1 hour post infusion monitoringETA Monday August 23rd, 2021 (new form / referral document, procedure launch)2