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Changes in REGEN-COV Restrictions

Update: 10/20/2021

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. Kettering Health is constantly 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:

  1. One (1) risk factor is necessary to meet criteria for use (formerly two [2])

Changes to EPIC referral forms and order panels will be live today, 10/20/2021, at approximately 12:00 p.m. An updated paper copy of the referral form is attached for your reference.

The network will continue to reevaluate this decision at regular intervals and provide updates to these restrictions as appropriate.

The complete list of the newly approved restrictions as of 10/20/2021 are as follows:

  1. Restricted to treatment only. KH will no longer utilize for post-exposure prophylaxis (PEP).
  2. Patient must meet ALL the following criteria:
  • Positive test for SARS-CoV-2
  • Onset of symptoms within past 7 days
  • Patient is 18 years of age 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 last 6 months

AND

One 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

__ Pregnancy

October 20, 2021