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Changes in REGEN-COV Restrictions

As you are aware, the Department of Health and Human Services has placed therapeutic monoclonal antibodies (i.e. REGEN-COV) to treat COVID-19 infection on a state-administered allocation.

The Ohio Department of Health will allocate supply weekly to hospitals and health systems based on case count and supply availability. The Network is regularly reviewing restrictions of COVID-19 treatments based on supply chain considerations, patient volume, and current literature.

Based on estimated allocation, current usage, and provider feedback, the Kettering Health Pharmacy and Therapeutics Committee (P&T) have approved changes to the REGEN-COV restrictions for both hospital and infusion center use. Below is a summary of changes:

Removed age qualifier from pulmonary risk factors (previously ≥ 55 years of age)

Removed age qualifier from cardiovascular risk factors (previously ≥ 55 years of age)

Added “Asthma” as a pulmonary risk factor

Changes to EPIC referral forms and order panels will be live today, 9/30/2021, at approximately noon. An updated paper copy of the referral form is attached for your reference.

The Network will continue to re-evaluate this decision at regular intervals and provide updates to these restrictions as appropriate.

The complete list of the newly approved restrictions as of 9/30/2021 are as follows:

Restricted to treatment only. Kettering Health will no longer utilize for post-exposure prophylaxis (PEP).

Patient must meet ALL the following criteria:

  • Positive test for SARS-CoV-2
  • Onset of symptoms within past 7 days
  • Patient is 18 years old or older.
  • Not requiring supplemental oxygen
  • No increase in baseline oxygen requirements for those patients on baseline O2 from a non-COVID-19 comorbidity
  • No prior administration of REGEN-COV or bamlanivimab/etesevimib within the past 6 months.

AND

Two of the following risk factors:

__ Age ≥ 65

__ BMI ≥ 35

__ Chronic Kidney Disease (stage 4 and above, ESRD)

__ Diabetes Mellitus on insulin therapy or oral hypoglycemics

__ COPD, Asthma, Interstitial Lung Disease, Cystic Fibrosis, or Pulmonary Fibrosis

__ Hypertension, Coronary Artery Disease or Congestive Heart Failure

__ Immunosuppressive Condition

  • Solid organ transplant, advanced HIV, active chemotherapy, ESLD
  • Use of biologic agents for treatment of underlying disease: TNF alpha inhibitor for RA or Crohn’s, chronic high dose steroids

OR

__ Pregnancy 

Click here for the document order form.

September 30, 2021