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Updated Criteria for Oral COVID-19 Medications

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What follows are updates to our now loosened criteria regarding oral COVID-19 medications. Please read the updates (highlighted below) in context with the entirety of our current criteria. 

Due to limited supply and complex eligibility requirements, Kettering Health is restricting the prescribing of oral COVID-19 therapies at this time. Instead of directly prescribing the medication, prescribers will need to place a referral so patients can appropriately be screened, the most appropriate oral therapy be selected, and patients be appropriately counseled regarding the medication.

Treatment is not guaranteed at this time due to limited inventory. Kettering Health currently has received a very limited supply of Paxlovid (nirmatrelvir/ritonavir) and molnupiravir. As supplies of specific products change, an Epic BPA that fires when the referral order is placed will indicate availability.

Referral orders are processed hourly from 7 a.m. to 7 p.m. every day including weekends. Once a referral is processed, KPN pharmacy services will coordinate with our retail pharmacies and the patient to get the medication to the patient in the timeliest fashion. Depending on the time of the order, availability, and patient location, patients may be given the option to pick up at a network pharmacy or have the medication delivered.

The Kettering Health Pharmacy and Therapeutics Committee (P&T) referenced the National Institute of Health (NIH) Statement on Patient Prioritization for Outpatient Therapies (Statement on Patient Prioritization for Outpatient Therapies | COVID-19 Treatment Guidelines (nih.gov)) to determine patient treatment eligibility.

For Paxlovid, the patient must meet the following criteria plus one of the risk factors below:

  • Patient has tested positive for SARS-CoV-2.
  • Patient is > 12 years old.
  • Patient is > 40 kg.
  • Patient’s eGFR is > 30 mL/min.
  • Patient’s symptoms started within the past 5 days.
  • Patient is not on a contraindicated medication listed in the EUA.

For Molnupiravir, the patient must meet the following criteria plus one of the risk factors below:

  • Patient has tested positive for SARS-CoV-2
  • Patient is >18 years old.
  • Patient’s symptoms started within the past 5 days.
  • Patient is not pregnant or breastfeeding.

One (1) of the following risk factors:

  • Pregnancy
  • Patients who are within one (1) year of receiving B-cell depleting therapies (riTUXimab, ocrelizumab, ofatumumab, ibritumomab tiuxetan, obinutuzumab, belimumab)
  • Patients receiving Bruton tyrosine kinase inhibitors (ibrutinib, acalabrutinib, zanubrutinib)
  • Chimeric antigen receptor T-cell recipients (CAR T-Cell Therapy) (Idecabtagene Vicleucel, Brexucabtagene Autoleucel, Axicabtagene Ciloleucel, Axicabtagene Ciloleucel)
  • Post-hematopoietic cell transplant recipients who have chronic graft versus host disease or who are taking immunosuppressive medications for another indication
  • Patients with hematologic malignancies who are on active therapy
  • Lung transplant recipients
  • Patients who are within 1 year of receiving a solid-organ transplant (other than lung transplant)
  • Solid-organ transplant recipients with recent treatment for acute rejection with T- or B-cell depleting agents
    • T-cell depleting agents: antithymocyte globulin (ATG), alemtuzumab
    • B-cell depleting agents: riTUXimab, ocrelizumab, ofatumumab, ibritumomab tiuxetan, obinutuzumab, belimumab
  • Patients with severe combined immunodeficiencies
  • Patients with untreated HIV who have a CD4 T lymphocyte cell count < 50 cells/mm3
  • Unvaccinated patients who are 75 years and older
  • Unvaccinated patients who are 65 and older with one of the following risk factors:
    • Diabetes
    • BMI > 25
    • Chronic lung disease (including asthma)
    • Chronic Kidney Disease
    • Current smoker
    • Immunosuppressive disease or treatment
    • Cardiovascular disease (including hypertension)
    • Sickle cell disease
    • Neurodevelopmental disorders
    • Active cancer
    • Medically related technological dependence
January 12, 2022
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