Monoclonal Antibodies are Available for Tennessee Physicians’ Offices


September 15, 2021

Nashville, TN — Recently, the Tennessee Department of Health (TDoH) alerted medical practices about the availability of monoclonal antibodies to treat Covid-19 positive individuals meeting necessary criteria in an effort to provide rapid therapy to those in need and decrease pressure on hospitals.

This week, the US Department of Health and Human Services (HHS) announced an update to the distribution process for monoclonal antibodies, which are effective in preventing hospitalization among people with mild to moderate Covid-19, due to the substantial surge in placed orders and utilization of the drugs for the outpatient treatment of Covid-19.

TMA Board of Trustees Chairman Jamie Cates, MD, a Cookeville-based primary care physician and owner of Satellite Med, said the treatments provide significant benefit up to 10 days in most cases. However, they cannot be given after that time period under current recommendations.

“We have seen hundreds of our patients that were ready to slip into the abyss have their symptoms reversed within days or hours after receiving the monoclonal antibodies,” said Cates. “We are really seeing this therapy save lives.

“If we get the monoclonal antibodies started within the first five days our patients usually do very well. The problem is educating the public through their physicians’ offices to have them come in as soon as possible to be tested. If the test is positive, we want them to see their primary care physician to make a decision about their treatment.”

HHS has transitioned from a process by which administration sites could directly order product from the distributor to a state/territory-coordinated distribution system. Transitioning to a state/territory-coordinated distribution system gives health departments maximum flexibility to get monoclonal antibodies where they are needed most. HHS will determine the weekly amount of monoclonal antibody products each state and territory receive based on nationwide criteria applied equally across all jurisdictions. Additional information is available here.

The treatment has been available through US Food and Drug Administration (FDA) Emergency Use Authorization (EUA) since November 2020. The one outpatient monoclonal antibody treatment currently available is a cocktail of two monoclonal antibodies casirivimab and imdevimab (REGEN-COV) by Regeneron. It is preferred to be administered through intravenous (IV) infusion, but is also authorized for administration subcutaneously if arrangement of IV infusion would delay treatment.

The EUA includes the criteria for use, and appropriate storage and preparation of the monoclonal antibody treatment. Below are the links to the FDA EUA fact sheets for health care providers, and patients and parents/caregivers.

REGEN-COV (casirivimab and imdevimab) by Regeneron:
FACT SHEET FOR HEALTH CARE PROVIDERS: EUA OF REGEN-COVTM (casirivimab andimdevimab)
FACT SHEET FOR PATIENTS AND PARENTS/CAREGIVERS: EUA OF COVID-19 CONVALESCENT PLASMA FORTREATMENT OF HOSPITALIZED PATIENTS WITH COVID-19

The federal government purchased the current stock of monoclonal antibodies authorized for outpatient use, which was initially provided through state health department allocations. Since March 2021, there has been plentiful supply and casarivimab/imdevimab has been requested directly from the federally-contracted wholesaler. Click here to acquire the monoclonal antibodies.

“Its effectiveness against the Delta variant has been tremendous. I cannot think of one product that has worked better to save lives than the monoclonal antibodies,” said Cates. “We need to have as many physicians’ offices as possible get in the order line so they can get the product as soon as possible.”

The monoclonal antibody treatment has been shipped to more than 140 sites in Tennessee. The state has asked physicians to assist with the administration of the treatment to those patients meeting the criteria. If health care providers are unable to administer the therapy to a patient and require referral the TDH has made a listing of sites available.

Casirimab/imdevimab (REGEN-COV®) is supplied to requesting providers and administered to patients free of charge. The administration fee may be reimbursed. Information on reimbursement from the Centers for Medicare & Medicaid Services (CMS) is available here.

Additional information and frequently asked questions concerning monoclonal antibody therapeutics may be found here.

Questions regarding this overall program may be directed to Calita Richards, Director of Pharmacy, Tennessee Department of Health, at calita.richards@tn.gov.