The next step in the fight against COVID-19 is here.
Shore Integrative Health is providing Monoclonal Antibody Therapy for both treatment AND prophylaxis post-exposure. According to the U.S. Food & Drug Administration (FDA), monoclonal antibody treatments have proven to reduce viral levels and improve symptoms in non-hospitalized COVID patients.
Monoclonal antibodies developed to treat COVID-19 target the spike protein, which corona-virus (SARS-CoV-2) uses to enter the host cells. By binding to the spike protein, a monoclonal antibody can help prevent the virus from infecting human cells.
Monoclonal antibody therapy is a combination of casirivimab and imdevimab (more widely known as Regeneron). mAbs treatment can reduce COVID-19 symptoms, hospitalization, or emergency room visits when administered as soon as possible after exposure or within 10 days of symptom onset.
At this time, Shore Integrative Health is administering Casirivimab and Imdevimab (REGEN-COV) only as In-home treatment because of our space constraints and staff/patient safety at our pharmacy.
Fact sheet for patients about Regen-Cov
Decharger La Ficha Técnica para Patientes para REGEN-COV
Who is Eligible for Monoclonal Antibody Treatment?
To be eligible, individuals must meet all of the following criteria:
1) Treatment of Mild-to-moderate COVID-19 with positive results of direct SARS-CoV-2
be 12 years or older;
weigh at least 88 lbs;
be at high risk for progressing to severe COVID-19 (see high-risk list below);
have tested positive for COVID-19 or been exposed to a positive case;
be within 10 days of symptom onset (ideally as soon as possible after diagnosis, even if symptoms are not too bad); AND
not be receiving oxygen therapy.
High risk includes any of the following:
65 years or older;
Chronic kidney disease;
Heart or lung disease;
BMI of 25 or greater;
Pregnancy;
Diabetes;
Sickle cell disease;
Neurodevelopmental disorders (for example, cerebral palsy);
Having a medical-related technological dependence (for example, tracheostomy, gastrostomy, or positive pressure ventilation (not related to COVID 19); OR
Other medical conditions or factors (for example, race or ethnicity) that may also place individual patients at high risk for progression to severe COVID-19.
2) Post-exposure prophylaxis of COVID-19 in individuals who are at high risk for progression to severe COVID-19, including hospitalization or death, and are:
not fully vaccinated OR who are not expected to mount an adequate immune response to complete SARS-CoV-2 vaccination (e.g., individuals with
immunocompromising conditions, including those taking immunosuppressive medications) AND
– have been exposed to an individual infected with SARS-CoV-2 consistent with close contact criteria per Centers for Disease Control and Prevention (CDC) OR
– who are at high risk of exposure to an individual infected with SARS-CoV-2 because of occurrence of SARS-CoV-2 infection in other individuals in the same institutional setting.
Who should NOT receive Monoclonal Antibody Treatment?
Mabs may be associated with worse clinical outcomes when administered to hospitalized patients with COVID-19 requiring a high flow of oxygen or mechanical ventilation. Under the terms of the EUA mAbs are not authorized for use in patients who meet any of the following:
Are hospitalized due to COVID-19
Require oxygen therapy due to COVID-19
Require an increase in baseline oxygen flow rate due to COVID-19 in those on chronic oxygen therapy due to underlying non-COVID-19 related comorbidity.
What is the cost of treatment?
There is no cost to patients as medications are made available to our center at no charge. Shore Integrative Health can bill the patient’s insurance carrier for the administration/visit fee to the patient’s insurance, but Soleil Pharmacy can not bill patients.
For uninsured patients, the federal HRSA COVID-19 Coverage Assistance Fund was developed to reimburse providers for COVID-19 treatments, including monoclonal antibody therapy. See this link for more information: https://www.hrsa.gov/coviduninsuredclaim