Kettering Health will stop all treatments of bamlanivimab/etesevimab or REGEN-COV treatment on Thursday January 6, 2022, at approximately 5 p.m.
This decision is based on the increasing omicron prevalence (estimated >90%) and data indicating they are unlikely to retain activity against the omicron variant.
The Kettering Health COVID Infusion Center will stop taking referrals for bamlanivimab/etesevimab and REGEN-COV effective immediately.
Kettering Health COVID Infusion Center will begin accepting referrals for sotrovimab treatment to eligible patients. Treatment is not guaranteed at this time due to limited inventory.
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.
The following is the approved criteria for sotrovimab use:
Patient must meet ALL of the following criteria:
Positive test for SARS-CoV-2
Onset of symptoms within the past 7 days
Patient is 18 years of age or older
Patient does not require supplemental oxygen
There is no increase in baseline oxygen needs
The patient has not received Regen-COV or bamlanivimab/etesevimab within the past 6 months
AND
One (1) of the following risk factors:
Pregnancy
Patients who are within 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 An updated EPIC referral form will be live today (1/5/2022). Please utilize the attached referral form in the interim if you have patients that may qualify for sotrovimab therapy.