OBJECTIVES: The US FDA authorized for emergency use three monoclonal antibody (Mab) and two oral treatments for mild/moderate COVID-19. Future access to and reimbursement will rely on value assessment. This study applies a patient-informed value element framework for future patient-centered value assessment of mild/moderate COVID therapies.

METHODS: We searched PubMed [December 21, 2021] to identify relevant publications using the string: “(mild OR moderate) AND (COVID OR coronavirus 2019 OR COVID19) AND (bamlanivimab OR estesevimab OR sotrovimab OR casirivimab OR imdevimab OR REGN-COV2) OR (paxlovid) OR (molnupiravir)”. Publications in 2020 or later that discussed mild/moderate COVID-19 were included. We abstracted information relevant to treatment effects and costs and clinical and humanistic outcomes. We mapped positive and negative treatment attributes to the patient-informed value element framework domains (treatment effects, access, cost, life impact, and social impact).

RESULTS: Of the 140 papers identified, 34 met inclusion criteria. For Mabs, positive aspects are treatment effects (i.e., recovery time, long permissible window from symptom onset to treatment initiation, few/no drug-drug interactions), access (i.e., ease of coordination between providers and infusion centers), and cost (i.e., affordability-currently free of charge). Negative aspects are life impact (i.e., missed work/school due to >3 hours for infusion appointments), treatment effects (i.e., viral resistance, no safety data for pediatric/pregnant women), access (i.e., limited availability, transportation/distance to infusion centers), and costs (i.e., infusion-related out-of-pocket costs). For oral therapies, positive aspects are treatment effects (i.e., rapid clinical improvement, low risk of hospitalization/death, resistance to viral variants), access (i.e., home administration), and cost (i.e., affordability). Negative aspects include treatment effects (i.e., duration of treatment, viral resistance if non-adherent, pill burden, mutagenicity/teratogenicity concerns) and access (i.e., limited supply).

CONCLUSIONS: Potential impacts on productivity and patient costs suggest that therapies for mild/moderate COVID-19 should be assessed with evaluations that include the patient-informed value elements.