U.S. Renal Care to Administer IV Monoclonal Antibody Therapy in Dialysis Clinics to Confirmed COVID‐19 Patients
Therapy Could Dramatically Reduce Hospitalizations for High-Risk Dialysis Patient Population
PLANO, Texas – U.S. Renal Care (USRC), a leading provider of dialysis services caring for more than 26,000 individuals living with kidney disease, announced it will obtain and distribute the monoclonal antibody therapy, Bamlanivimab, to its patients recently diagnosed with COVID-19. USRC obtained the therapy from Operation Warp Speed, Project SPEED, and will administer the drug to medically stable COVID-19 positive patients with mild to moderate disease in their outpatient dialysis facilities. USRC is among the first national dialysis organizations to offer this therapy.
“Our internal data is consistent with data from CMS that demonstrates extraordinarily high rates of hospitalization for Medicare beneficiaries with end-stage kidney disease who contract Covid-19,” said Mary Dittrich, MD, FASN, Chief Medical Officer, USRC. “Having the ability to administer monoclonal antibody therapy to high-risk, COVID-19 positive patients in our clinics -- where they already receive dialysis care three times a week – may reduce hospitalizations and save lives.”
Manufactured by Eli Lilly and distributed by AmerisourceBergen, Bamlanivimab has received emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) for the treatment of mild to moderate COVID-19 for non-hospitalized patients aged 12-years-old and above. The therapy must be given as an intravenous (IV) infusion as soon as possible after a positive COVID-19 test and within ten days of symptom onset.
Data from the Blocking Viral Attachment and Cell Entry with SARS-CoV-2 Neutralizing Antibodies (BLAZE) trial recently published in the New England Journal of Medicine showed a substantial reduction in hospitalizations for high-risk patients who received this drug within the recommended time frame. The BLAZE trial is an ongoing clinical trial to evaluate the efficacy and safety of Bamlanivimab for patients with recently diagnosed mild or moderate COVID-19.
“Our dialysis patients who are at high-risk for contracting COVID-19 and ending up in the hospital if they do, are ideally suited for this intervention,” said Oladipo Adeniyi, MD, Medical Director at USRC Gallup in New Mexico. “Dr. Dittrich and USRC have shown incredible leadership and foresight by working with the team at Operation Warp Speed and our physician partners to ensure that this therapy is an option for these patients under our care.”
AmerisourceBergen will initially ship Bamlanivimab to 16 USRC clinics in the following eight states: California, Georgia, Hawaii, Maryland, New Mexico, Ohio, South Carolina and Texas. The locations were chosen, among other factors, based on the prevalence of COVID-19 infection rates in these communities. After the initial roll-out, USRC will review the efficacy and tolerability of the therapy and work with nephrologists to expand distribution to its clinics nationwide.
“During the pandemic, it is vitally important to lead with innovation to keep our patients safe and ensure they receive uninterrupted care. This includes reducing hospital admissions by providing access to cutting-edge therapeutic options for our COVID-19 positive patients that they might otherwise not receive,” Dr. Dittrich concluded. “We look forward to working with the entire kidney care community to expand patient access to this potentially life-saving therapy.”