New research from the University of Minnesota (UMN) School of Public Health (SPH), the Minnesota Department of Health (MDH), the UMN Center for Bioethics, UMN Health Sciences Technology, and Hennepin Healthcare traces the development, implementation, and health outcomes of Minnesota’s system for distributing monoclonal antibodies (mAbs) during the COVID-19 pandemic. According to the new study, published in Frontiers in Public Health, Minnesota’s online platform equitably connected over 31,000 patients to care during its operation, successfully distributing a potentially life-saving treatment to those most eligible to receive treatment — regardless of their connection to a healthcare system.
Before the development and distribution of COVID-19 vaccines, monoclonal antibodies were considered one of the most effective and widely used therapies to reduce the risk of progression to severe COVID, especially for high-risk patients. In November 2020, the U.S. Department of Health and Human Services (HHS) purchased mAbs from pharmaceutical manufacturers and distributed them to each state, territory, and federal partner to distribute to clinics and hospitals across the state.
As the supply of mAbs was very limited, concerns arose about scarcity and the need for a process to efficiently and ethically allocate mAbs. While many states adopted a decentralized approach to distribute these drugs to their residents — resulting in a patchwork of methods with mixed success in reaching patients at highest risk — Minnesota used a more centralized strategy. The state’s approach took the form of an online platform called the Minnesota Resource Allocation Platform (MNRAP), which facilitated access to mAbs when supplies were sufficient, and when supplies ran low, managed the allocation of resources by prioritizing those most at risk for hospitalization or death.
MNRAP was developed through a collaborative process between the Minnesota Department of Health, the University of Minnesota, and 116 private healthcare administration sites across the state. The Minnesota COVID Ethics Collaborative and MDH’s Science Advisory Team also participated in MNRAP’s development in an advisory capacity. To ensure that mAbs were equitably distributed during periods of particular demand and scarcity, MNRAP used a three-stage tiered allocation system to determine eligibility for clinic referrals and treatment.
By analyzing the health outcomes of the people who interacted with MNRAP between February 2021 and July 2022, the study found:
- After excluding those with COVID reinfections, 5.7% of participants were hospitalized and 0.7% died.
- There was a statistically significant difference in hospitalizations for people who did not receive a referral through MNRAP versus those who did receive a referral (5.2% for unreferred versus 6.1% for referred), because those who received referrals were at much higher clinical risk than those that did not.
- Vaccination conferred a substantially larger protection against hospitalization and death than did a referral for mAbs, but among unvaccinated users that did not get a referral, chances of hospitalization increased by 4.1 percentage points.
“In just a year and a half, MNRAP connected over 30,000 Minnesotans battling COVID-19 with monoclonal antibodies, regardless of whether they had a usual source of care.” said JP Leider, SPH associate professor, lead author of the study, and UMN lead on the MNRAP project. “While vaccination proved to be the most protective against severe clinical outcomes, it appears monoclonal antibodies helped protect unvaccinated individuals against particularly bad outcomes.”
“Minnesota continues to be an innovator and leader in finding ways to distribute vital resources to people in an equitable and ethical way,” says Alexandra Waterman, medical surge coordinator at MDH. “Our partnership with the University of Minnesota is vital to this groundbreaking work. MNRAP was the only system we knew of that could ensure demand was evenly spread among treatment sites and could prioritize those most at risk of severe illness to receive treatment.”
“Clinical risk factors should drive allocation decisions, not a patient’s individual circumstances—such as access to health care or the resources and ability to navigate a complicated health system,” says Debra DeBruin, director of the UMN Center for Bioethics. “Experience nationwide—documented in countless news articles about patients calling dozens of providers or needing to `be connected` to find appointments—suggested patients might have had uneven access to this critical resource. That is exactly what MNRAP was designed to avoid.”