Uncategorized

New Monoclonal Antibodies Restrictions

In response to the rapid increase in utilization of therapeutic monoclonal antibodies (i.e. REGEN-COV) to treat COVID-19 infection, the department of Health and Human Services has placed these products 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 anticipated supply of these products will be lower than the current demand.

As such, the Kettering Health Pharmacy and Therapeutics Committee has approved changes to the REGEN-COV restrictions for both hospital and infusion center use. Below is a summary of changes:

  • Monoclonal antibody agents will no longer be utilized for COVID-19 post-exposure prophylaxis
  • Time since symptom onset shortened to 7 days (previously 10 days)
  • Use now requires pregnancy or 2 or more risk factors (previously 1 risk factor)
  • BMI risk factor increased to 35 kg/m2 (previously 25 kg/m2)

Changes to EPIC referral forms and order panels will be fully completed by the end of the week, however. We ask you order REGEN-COV based on the new restrictions beginning today, 9/20/2021. An updated paper copy of the referral form here is for your reference.

The complete list of the newly approved restrictions are as follows:

  1. Restricted to treatment only. Kettering Health 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

__ Pregnancy  

OR

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

__ Age ≥55 with COPD, Interstitial lung disease, cystic fibrosis, or pulmonary fibrosis

·        Requiring home O2 but at baseline flow rate

__ Age ≥55 with 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
September 20, 2021