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Background SARS-CoV-2 (COVID-19) virus is estimated to cost the United States (US) economy trillions of dollars over the next decade. Mass immunization has played a major role in reducing morbidity and mortality related to COVID-19 in the US, but the high-risk population remains vulnerable to developing severe COVID-19. A large clinical trial and several real-world evidence (RWE) studies have demonstrated the effectiveness of nirmatrelvir; ritonavir in reducing hospitalizations or death in high-risk patients. This study aimed to estimate the economic impact of using nirmatrelvir; ritonavir in a high-risk US population infected with COVID-19 as measured by reduction in hospitalizations and associated costs during a time of Omicron predominance. Methods An economic model was developed to estimatethe impact of nirmatrelvir; ritonavir in reducing hospitalizations and associated costs from a healthcare perspective. The model compared nirmatrelvir; ritonavir with no treatment in the outpatient setting among patients with mild-to-moderate COVID-19 at high-risk of progressing to severe disease as consistent with the EPIC-HR trial. Hospitalization rate reductions were derived from recent RWE studies conducted during the Omicron period while costs were gathered from the literature. A simulated population of 100,000 COVID-19 patients was modelled and was restricted to patients ≥12 years of age. Sensitivity analyses applied alternative model assumptions. Results Results from the model showed that treatment with nirmatrelvir; ritonavir was associated with fewer hospitalizations compared to no treatment, 3,269 vs 6,134 per 100,000 patients, respectively, with a reduction of 2,865 hospitalizations per 100,000 patients and an estimated cost savings of $133,754,359 per 100,000 patients ($152,634,256 for nirmatrelvir; ritonavir and $286,388,614 for no treatment). Varying the rate of hospitalization by 10% showed similar results. Conclusion Treatment with nirmatrelvir; ritonavir during the Omicron period could result in substantial cost savings due to reduction in hospitalizations. This is an important outcome measure that will help reduce the devastating economic burden that COVID-19 has imposed on the US health care system.

Nirmatrelvir (coadministered with ritonavir as PAXLOVIDTM) reduces the risk of COVID-19-related hospitalizations and all-cause death in individuals with mild-to-moderate COVID-19 at high risk of progression to severe disease. Ritonavir is coadministered as a pharmacokinetic enhancer. However, ritonavir may cause drug-drug interactions (DDIs) due to its interactions with various drug-metabolizing enzymes and transporters, including cytochrome P450 (CYP) 3A, CYP2D6, and P-glycoprotein transporters. To better understand the extent of DDIs (or lack thereof) of nirmatrelvir; ritonavir in a clinical setting, this study used real-world evidence (RWE) from the Optum Clinformatics Data Mart database to identify the top 100 drugs most commonly prescribed to US patients at high risk of progression to severe COVID-19 disease. The top 100 drugs were identified based on total counts associated with drugs prescribed to high-risk patients (i.e.,  ≥ 1 medical condition associated with an increased risk of severe COVID-19) who were continuously enrolled in the database throughout 2019 and had  ≥ 1 prescription claim. Each of the 100 drugs was then assessed for DDI risk based on their metabolism, excretion, and transport pathways identified from available US prescribing and medical literature sources. Seventy drugs identified were not expected to have DDIs with nirmatrelvir; ritonavir, including many cardiovascular agents, anti-infectives, antidiabetic agents, and antidepressants. Conversely, 30 drugs, including corticosteroids, narcotic analgesics, anticoagulants, statins, and sedatives/hypnotics, were expected to cause DDIs with nirmatrelvir; ritonavir. This RWE analysis is complementary to the prescribing information and other DDI management tools for guiding healthcare providers in managing DDIs. Graphical Abstract

Background Due to the coronavirus disease 2019 (COVID-19) pandemic in the United States (US), public health officials sought to reduce transmission. However, the psychosocial impact associated with COVID-19 has received less attention. This study describes psychosocial burden among adults diagnosed with COVID-19 and assesses the unique impact on those who had a COVID-19 hospitalization. Methods This cross-sectional retrospective study used 2021 US National Health and Wellness Survey (NHWS; N=75,098) data. NHWS is an annual web-based self-report survey of the US general adult population (aged ≥ 18 years). Results were weighted to reflect the population on age, gender, race/ethnicity, and education based on US Census. Among adults who self-reported a COVID-19 diagnosis, those with COVID-related hospitalization, emergency room (ER) visit/no hospitalization, and no hospitalization/no ER visit were descriptively compared on demographics, health characteristics, and psychosocial burden measures. Results Almost 16 million adults had a COVID-19 diagnosis in the past year; of these, 8% had a COVID-related hospitalization, and 6% had a COVID-related ER visit/no hospitalization. Compared to adults with no ER visit/no hospitalization or ER visit/no hospitalization, those with a hospitalization were more often male, college educated, and employed. Relative to those with no ER visit/no hospitalization, adults with a hospitalization were more often diagnosed, either pre- or post-COVID-19 diagnosis, with allergies (47% vs 38%), asthma (20% vs 11%), pain (37% vs. 25%), headache (25% vs 16%), migraine (27% vs 15%), type 2 diabetes (16% vs 10%), dry eye (25% vs 12%), and sleep apnea (15% vs 11%). Adults with a hospitalization had lower mental, physical, and general health-related quality of life, 2-3.4 times higher work/non-work impairment, and 2 times higher positive depression screen rate than those with no ER visit/no hospitalization. Conclusion US adults with a COVID-related hospitalization had higher psychosocial burden than those without a hospitalization on several domains. Accordingly, reducing COVID-related hospitalizations, particularly among the employed and those with comorbidities, will be vital to help mitigate this burden. Disclosures Wajeeha Ansari, MPH, Pfizer Inc.: Stocks/Bonds Florin Draica, MD, Pfizer Inc.: Stocks/Bonds Joanna Atkinson, MD, Pfizer Inc.: Stocks/Bonds Kathy Annunziata, MA, Pfizer: Advisor/Consultant|Pfizer: Employee of Cerner Enviza, which received funding from Pfizer to conduct and report on the study Martine C. Maculaitis, PhD, Cerner Enviza: Employee of Cerner Enviza, which received funding from Pfizer to conduct and report on the study. Amie Scott, MPH, Pfizer Inc.: Stocks/Bonds.