The nation’s largest health payer and one of the most prominent American pharmaceutical companies partnered last month in a bid to determine if an experimental monoclonal antibody product recently authorized under emergency edict by the U.S. Food and Drug Administration (FDA) for the treatment of mild to moderate COVID-19 patients presently facing high risk for progressing to severe COVID-19 and/or hospitalization can safely and effectively help targeted populations in a pragmatic, real-world study. UnitedHealth Group (NYSE: UNH) and Eli Lilly and Company (NYSE: LLY) will jointly conduct this innovative study investigating the real world impact of bamlanivimab (LY-CoV555) versus a propensity-matched control in individuals that meet the EUA criteria. Targeting up to 500,000 participants (expectation that up to 5,000 patients will be infused at home with bamlanivimab), the study team will identify and treat a large, diverse population of high-risk individuals for COVID-19 with the Lilly monoclonal antibody under real-world conditions with a goal of reducing the severity of illness and hospitalizations. This study will draw upon both UnitedHealth Group’s UnitedHealthcare health benefits business as well as its Optum health services business to detect and treat high-risk symptomatic patients who test positive for COVID-19, including daily symptom tracking, in-home SARS-CoV-2 testing, and in-home infusion services. The study team will actually deliver the bamlanivimab to study patients via Optum-driven home infusions, supporting home-based quarantines, hence minimizing the spread of COVID-19. Importantly, this study seeks to address a major limitation right now with the emergency use authorization (EUA) monoclonal antibodies, which have been difficult to deliver in many treatment centers. The overall study is part of a collaborative partnership between OptumLabs, the scientific research arm of UnitedHealth Group, and Lilly to advance cutting-edge science, research, and solutions that will accelerate the progression of validated therapies into real world applications.
Why Monoclonal Antibodies During Vaccine Roll Out?
Not all individuals will be able to tolerate the COVID-19 vaccines, for example some individuals with severe allergies may be recommended by their doctors to avoid vaccines. Some high-risk individuals may need additional protection and various investigational therapies under development are designed for that reason. Moreover, the vaccine roll out under Operation Warp Speed at least until this point (start of the New Year), is considerably behind schedule.
Therefore, UnitedHealth Group and chief scientific officer Ken Ehlert was on the record, “Treatments like bamlanivimab offer a crucial early intervention against COVID-19 until vaccines are widely available.” Dr. Ehlert continued, “intercepting the disease before it escalates may help to keep people out of the hospital and reduce the overwhelming burden on the healthcare system. By bringing together UnitedHealth Group’s expertise in science, clinical research, and technology, with Lilly’s expertise in pharmaceutical development, we can responsibly and safely accelerate research on this new potential COVID-19 treatment.”
Capitalizing on ‘United in Research’
Under the study design, UnitedHealthcare Medicare Advantage members who meet the FDA-authorized criteria for treatment will be invited to volunteer for the study via United in Research, a UnitedHealth Group virtual community and technology platform for citizens scientists.
Set up under the Optum brand (a division under UnitedHealth Group) and managed by the giant payer’s Office of Human Research Affairs, United in Research was set up as a clinical trials matching portal during the COVID-19 pandemic for “citizen scientists” interested in participating in research. Declaring the COVID-19 “flipped healthcare on its head,” the portal is a calling for UnitedHealth beneficiaries and other patients (citizen scientists) seeking to contribute to the ongoing research targeting COVID-19.
Those participants who volunteers in an area where they can receive treatment will be directed to download Optum’s symptom-checking ProtectWell app and complete a daily questionnaire. Participants experiencing symptoms of COVID-19 will take an in-home SARS-CoV-2 test which they will self-administer and return. Those that are COVID-19 positive will receive outreach from an Optum Infusion Pharmacy nurse to schedule a home infusion treatment of bamlanivimab. The study will enroll up to 500,00 people, with at least 5,000 people expected to receive bamlanivimab therapy.
COVID-19 Drives Clinical Research as a Care Option
During the pandemic, UnitedHealth Group has leveraged its accumulating clinical knowledge, expertise and resources in the ongoing fight against SARS-CoV-2, the virus behind COVID-19. The payer is collaborating with pharma to test new types of diagnostics, drugs as well as life-saving equipment. They set up the UnitedHealth Group’s clinical research platform and virtual community known as “United in Research” to help accelerate enrollment in trial sites near member beneficiaries.
Collaboration with J&J ( Janssen)
As part of its ongoing COVID-19 research collaboration UnitedHealth Group recently inked a partnership with Johnson & Johnson and its Janssen Pharmaceutical Companies to share information about their Phase 3 COVID-19 vaccine candidate trial to members, customers, and employees to help meet enrollment goals, reported UnitedHealth Group recently.
Data-Driven Clinical Research as a Care Option
As part of this deal, UnitedHealth Group supports Janssen by identifying high risk populations—that is those more subject to risk from the pandemic—by analyzing de-identified health care data. This includes examining community infection rates and rates in select, at-risk beneficiaries.
Appreciating the importance of Phase 3 trials in combating the pandemic, Dr. Deneen Vojta, chief physician executive for UnitedHealth Group Research & Development reported “Phase 3 trials are a critical step toward ending this pandemic.” Dr. Vojta continued, “We are grateful for this opportunity to present information about the COVID-19 vaccine trial to people and communities we serve to help build a broad and diverse group of volunteers.”
What is Bamlanivimab?
TrialSite has chronicled the development of this monoclonal antibody developed in conjunction with University of British Columbia spinoff AbCellera and the National Institute of Allergy and Infectious Diseases (NIAID) as well as tirelessly working scientists from Lilly. The investigational product was approved under an EUA but was found not to be effective for hospitalized patients. Moreover, health systems have faced challenges in actually administering the therapy for a number of reasons. This interesting study can be considered an approach to get around real-world health delivery challenges.
The product’s background can be read here including safety issues.