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  1. Article ; Online: Substantial health and economic burden of COVID-19 during the year after acute illness among US adults not at high risk of severe COVID-19.

    Scott, Amie / Ansari, Wajeeha / Chambers, Richard / Reimbaeva, Maya / Mikolajczyk, Tomasz / Benigno, Michael / Draica, Florin / Atkinson, Joanna

    BMC medicine

    2024  Volume 22, Issue 1, Page(s) 47

    Abstract: Background: Patients recovering from SARS-CoV-2 infection and acute COVID-19 illness can experience a range of long-term post-acute effects. The potential clinical and economic burden of these outcomes in the USA is unclear. We evaluated diagnoses, ... ...

    Abstract Background: Patients recovering from SARS-CoV-2 infection and acute COVID-19 illness can experience a range of long-term post-acute effects. The potential clinical and economic burden of these outcomes in the USA is unclear. We evaluated diagnoses, medications, healthcare utilization, and medical costs before and after acute COVID-19 illness in US patients who were not at high risk of severe COVID-19.
    Methods: This study included eligible adults who were diagnosed with COVID-19 from April 1 to May 31, 2020, who were 18 - 64 years of age, and enrolled within Optum's de-identified Clinformatics® Data Mart Database for 12 months before and 13 months after COVID-19 diagnosis. Patients with any condition or risk factor placing them at high risk of progression to severe COVID-19 were excluded. Percentages of diagnoses, medications, healthcare utilization, and costs were calculated during baseline (12 months preceding diagnosis) and the post-acute phase (12 months after the 30-day acute phase of COVID-19). Data were stratified into 3 cohorts according to disposition during acute COVID-19 illness (i.e., not hospitalized, hospitalized without intensive care unit [ICU] admission, or admitted to the ICU).
    Results: The study included 3792 patients; 56.5% of patients were men, 44% were White, and 94% did not require hospitalization. Compared with baseline, patients during the post-acute phase had percentage increases in the diagnosis of the following disorders: blood (166%), endocrine and metabolic (123%), nervous system (115%), digestive system (76%), and mental and behavioral (75%), along with increases in related prescriptions. Substantial increases in all measures of healthcare utilization were observed among all 3 cohorts. Total medical costs increased by 178% during the post-acute phase. Those who were hospitalized with or without ICU admission during the acute phase had the greatest increases in comorbidities and healthcare resource utilization. However, the burden was apparent across all cohorts.
    Conclusions: As evidenced by resource use in the post-acute phase, COVID-19 places a significant long-term clinical and economic burden among US individuals, even among patients whose acute infection did not merit hospitalization.
    MeSH term(s) Adult ; Male ; Humans ; Female ; COVID-19/epidemiology ; SARS-CoV-2 ; Financial Stress ; Acute Disease ; COVID-19 Testing
    Language English
    Publishing date 2024-02-02
    Publishing country England
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 2131669-7
    ISSN 1741-7015 ; 1741-7015
    ISSN (online) 1741-7015
    ISSN 1741-7015
    DOI 10.1186/s12916-023-03235-5
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  2. Article ; Online: Real-World Evidence of the Top 100 Prescribed Drugs in the USA and Their Potential for Drug Interactions with Nirmatrelvir; Ritonavir.

    Gerhart, Jacqueline / Draica, Florin / Benigno, Michael / Atkinson, Jo / Reimbaeva, Maya / Francis, Domenick / Baillon-Plot, Nathalie / Sidhu, Gurinder Singh / Damle, Bharat D

    The AAPS journal

    2023  Volume 25, Issue 5, Page(s) 73

    Abstract: Nirmatrelvir (coadministered with ritonavir as ... ...

    Abstract Nirmatrelvir (coadministered with ritonavir as PAXLOVID
    MeSH term(s) Humans ; Ritonavir ; COVID-19 ; COVID-19 Drug Treatment ; Drug Interactions ; Cytochrome P-450 CYP3A ; Antiviral Agents/therapeutic use
    Chemical Substances nirmatrelvir and ritonavir drug combination ; Ritonavir (O3J8G9O825) ; Cytochrome P-450 CYP3A (EC 1.14.14.1) ; Antiviral Agents
    Language English
    Publishing date 2023-07-20
    Publishing country United States
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ISSN 1550-7416
    ISSN (online) 1550-7416
    DOI 10.1208/s12248-023-00832-3
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  3. Article ; Online: Substantial health and economic burden of COVID-19 during the year after acute illness among US adults at high risk of severe COVID-19.

    Scott, Amie / Ansari, Wajeeha / Khan, Farid / Chambers, Richard / Benigno, Michael / Di Fusco, Manuela / McGrath, Leah / Malhotra, Deepa / Draica, Florin / Nguyen, Jennifer / Atkinson, Joanna / Atwell, Jessica E

    BMC medicine

    2024  Volume 22, Issue 1, Page(s) 46

    Abstract: Background: Post-COVID conditions encompass a range of long-term symptoms after SARS-CoV-2 infection. The potential clinical and economic burden in the United States is unclear. We evaluated diagnoses, medications, healthcare use, and medical costs ... ...

    Abstract Background: Post-COVID conditions encompass a range of long-term symptoms after SARS-CoV-2 infection. The potential clinical and economic burden in the United States is unclear. We evaluated diagnoses, medications, healthcare use, and medical costs before and after acute COVID-19 illness in US patients at high risk of severe COVID-19.
    Methods: Eligible adults were diagnosed with COVID-19 from April 1 to May 31, 2020, had ≥ 1 condition placing them at risk of severe COVID-19, and were enrolled in Optum's de-identified Clinformatics
    Results: The cohort included 19,558 patients (aged 18-64 y, n = 9381; aged ≥ 65 y, n = 10,177). Compared with baseline, patients during the post-acute phase had increased percentages of blood disorders (16.3%), nervous system disorders (11.1%), and mental and behavioral disorders (7.7%), along with increases in related prescriptions. Overall, there were substantial increases in inpatient and outpatient healthcare utilization, along with a 23.0% increase in medical costs. Changes were greatest among older patients and those admitted to the intensive care unit for acute COVID-19 but were also observed in younger patients and those who did not require COVID-19 hospitalization.
    Conclusions: There is a significant clinical and economic burden of post-COVID conditions among US individuals at high risk for severe COVID-19.
    MeSH term(s) Adult ; Humans ; United States/epidemiology ; COVID-19/epidemiology ; Post-Acute COVID-19 Syndrome ; Financial Stress ; Acute Disease ; COVID-19 Testing ; SARS-CoV-2 ; Retrospective Studies
    Language English
    Publishing date 2024-02-01
    Publishing country England
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 2131669-7
    ISSN 1741-7015 ; 1741-7015
    ISSN (online) 1741-7015
    ISSN 1741-7015
    DOI 10.1186/s12916-023-03234-6
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  4. Article ; Online: Real-world retrospective analysis of patient characteristics, healthcare resource utilization, costs, and treatment patterns among unvaccinated adults with COVID-19 diagnosed in outpatient settings in the United States.

    Scott, Amie / Chambers, Richard / Reimbaeva, Maya / Atwell, Jessica / Baillon-Plot, Nathalie / Draica, Florin / Tarallo, Miriam

    Journal of medical economics

    2022  Volume 25, Issue 1, Page(s) 287–298

    Abstract: Aims: This retrospective analysis of the Optum Clinformatics Data Mart database evaluated US patient characteristics, healthcare resource utilization (HCRU), costs, and treatment patterns among unvaccinated adults with outpatient-diagnosed COVID-19 to ... ...

    Abstract Aims: This retrospective analysis of the Optum Clinformatics Data Mart database evaluated US patient characteristics, healthcare resource utilization (HCRU), costs, and treatment patterns among unvaccinated adults with outpatient-diagnosed COVID-19 to quantify US economic burden.
    Materials and methods: The index event was the earliest outpatient diagnosis of confirmed COVID-19 from May 1 to December 10, 2020. Patients had 12 months' continuous enrollment before and were followed for ≥60 days after index date until insurance dis-enrollment or study end.
    Results: 236,589 patients had outpatient-diagnosed COVID-19 (7,692 with and 228,897 without subsequent COVID-19-related inpatient admission >48 h post-diagnosis). The median age was 51 years (≥65 years, 30.0%); 72.4% had ≥1 risk factor. Patients with versus without subsequent inpatient admission were more often male, older, Black/Hispanic, and had comorbidities/risk factors. With a median follow-up of 162 days, patients had a median of 1 COVID-19-related outpatient visit (with inpatient admission, 5 outpatient visits). Those with inpatient admission had a median of 1 COVID-19-related inpatient visit (median length of stay [LOS], 6 days), 33.3% were admitted to intensive care (median LOS, 8 days), 8.4%, 7.1%, and 13.3% received invasive mechanical ventilation, noninvasive mechanical ventilation, and supplemental oxygen, respectively; 13.5% experienced readmission. Inpatient mortality was 6.0% (0.3% for nonhospitalized patients). Antithrombotic therapy, antibiotics, corticosteroids, and remdesivir use increased among patients with inpatient admission versus without. Median total COVID-19-related non-zero medical costs were $208 for patients without inpatient admission (with inpatient admission, $39,187).
    Limitations: Results reflect the circulating SARS-CoV-2 and treatment landscape during the study period. Requirements for continuous enrollment could have biased the population. Cost measurements may have included allowed (typically higher) and charge amounts.
    Conclusions: Given the numbers of the US population who are still not fully vaccinated and the evolving epidemiology of the pandemic, this study provides relevant insights on real-world treatment patterns, HCRU, and the cost burden of outpatient-diagnosed COVID-19.
    MeSH term(s) Adult ; COVID-19 ; Delivery of Health Care ; Health Care Costs ; Humans ; Male ; Middle Aged ; Outpatients ; Retrospective Studies ; SARS-CoV-2 ; United States
    Language English
    Publishing date 2022-01-31
    Publishing country England
    Document type Journal Article
    ZDB-ID 2270945-9
    ISSN 1941-837X ; 1369-6998
    ISSN (online) 1941-837X
    ISSN 1369-6998
    DOI 10.1080/13696998.2022.2037917
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  5. Article ; Online: Budget impact of oral nirmatrelvir/ritonavir in adults at high risk for progression to severe COVID-19 in the United States.

    Sandin, Rickard / Veenstra, David L / Vankelegom, Mathilde / Dzingina, Mendwas / Sullivan, Sean D / Campbell, David / Ma, Cuiying / Harrison, Cale / Draica, Florin / Wiemken, Timothy Lee / Mugwagwa, Tendai

    Journal of managed care & specialty pharmacy

    2023  Volume 29, Issue 12, Page(s) 1290–1302

    Abstract: Background: Nirmatrelvir/ritonavir (NMV/r) is indicated for the treatment of mild-to-moderate COVID-19 in adults who are at high risk for progression to severe COVID-19. NMV/r has also been authorized for emergency use by the US Food and Drug ... ...

    Abstract Background: Nirmatrelvir/ritonavir (NMV/r) is indicated for the treatment of mild-to-moderate COVID-19 in adults who are at high risk for progression to severe COVID-19. NMV/r has also been authorized for emergency use by the US Food and Drug Administration for the treatment of mild-to-moderate COVID-19 in pediatric patients (aged 226512 years and weighing at least 40 kg) who are at high risk for progression to severe COVID-19. Understanding the budget impact of introducing NMV/r for the treatment of adults with COVID-19 is of key interest to US payers.
    Objective: To estimate the annual budget impact of introducing NMV/r in a US commercial health plan setting in the current Omicron COVID-19 era.
    Methods: A budget impact model was developed to assess the impact of NMV/r on health care costs in a hypothetical 1-million-member commercial health insurance plan over a 1-year period in the US population; clinical and cost inputs were derived from published literature with a focus on studies in the recent COVID-19 era that included vaccinated population and predominance of the Omicron variant. In the base-case analysis, it was assumed the only effect of NMV/r was a reduction in incidence (not severity) of hospitalization or death; its potential effect on post-COVID conditions was assessed in a scenario analysis. Outcomes included the number of hospitalizations, total cost, per patient per year (PPPY) costs, and per member per month (PMPM) costs. Sensitivity and scenario analyses were conducted to assess uncertainty around key model inputs.
    Results: An estimated 29,999 adults were eligible and sought treatment with oral antiviral for COVID-19 over 1 year. The availability of NMV/r was estimated to reduce the number of hospitalizations by 647 with a total budget impact of $2,733,745, $91 PPPY, and $0.23 PMPM. NMV/r was cost saving when including post-COVID conditions with a -$1,510,780 total budget impact, a PPPY cost of -$50, and a PMPM cost of -$0.13. Sensitivity analyses indicated results were most sensitive to the risk of hospitalization under supportive care, risk of hospitalization with NMV/r treatment and cost of NMV/r.
    Conclusions: Treatment with NMV/r in the current COVID-19 era is estimated to result in substantial cost offsets because of reductions in hospitalization and modest budget impact to potential overall cost savings.
    MeSH term(s) Adult ; Humans ; United States/epidemiology ; Child ; Ritonavir/therapeutic use ; COVID-19 ; COVID-19 Drug Treatment ; SARS-CoV-2 ; Budgets
    Chemical Substances nirmatrelvir (7R9A5P7H32) ; Ritonavir (O3J8G9O825)
    Language English
    Publishing date 2023-12-06
    Publishing country United States
    Document type Journal Article
    ISSN 2376-1032
    ISSN (online) 2376-1032
    DOI 10.18553/jmcp.2023.29.12.1290
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  6. Article ; Online: Cost-Effectiveness of Oral Nirmatrelvir/Ritonavir in Patients at High Risk for Progression to Severe COVID-19 in the United States.

    Carlson, Josh / Foos, Volker / Kasle, Adam / Mugwagwa, Tendai / Draica, Florin / Lee Wiemken, Timothy / Nguyen, Jennifer L / Cha-Silva, Ashley / Migliaccio-Walle, Kristen / Dzingina, Mendy

    Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research

    2023  Volume 27, Issue 2, Page(s) 164–172

    Abstract: Objectives: Nirmatrelvir/ritonavir (NMV/r) is an orally administered antiviral indicated for the outpatient treatment of patients with mild-to-moderate COVID-19 at high risk for disease progression to severe illness. We estimated the cost-effectiveness ... ...

    Abstract Objectives: Nirmatrelvir/ritonavir (NMV/r) is an orally administered antiviral indicated for the outpatient treatment of patients with mild-to-moderate COVID-19 at high risk for disease progression to severe illness. We estimated the cost-effectiveness of NMV/r versus best supportive care for patients with mild-to-moderate COVID-19 at high risk for progression to severe illness from a US health sector perspective.
    Methods: A cost-effectiveness model was developed using a short-term decision-tree (1 year) followed by a lifetime 2-state Markov model (alive and dead). The short-term decision-tree captured costs and outcomes associated with the primary infection and healthcare utilization; survivors of the short-term decision-tree were followed until death assuming US quality-adjusted life years (QALYs), adjusted in the short-term for survivors of mechanical ventilation. Baseline rate of hospitalization and NMV/r effectiveness were taken from an Omicron-era US real-world study. Remaining inputs were informed by previous COVID-19 studies and publicly available US sources. Sensitivity analyses were conducted for all model inputs to test the robustness of model results.
    Results: NMV/r was found to decrease COVID-19 related hospitalizations (-0.027 per infected case) increase QALYs (+0.030), decrease hospitalization costs (-$1110), and increase total treatment cost (+$271), resulting in an incremental cost-effectiveness ratio of $8931/QALY. Results were most sensitive to baseline risk of hospitalization and NMV/r treatment effectiveness parameters. The probabilistic analysis indicated that NMV/r has a >99% probability of being cost-effective at a $100 000 willingness-to-pay threshold.
    Conclusions: NMV/r is cost-effective vs best supportive care for patients at high risk for severe COVID-19 from a US health sector perspective.
    MeSH term(s) Humans ; United States/epidemiology ; Ritonavir/therapeutic use ; Cost-Benefit Analysis ; COVID-19/epidemiology ; COVID-19 Drug Treatment ; Lactams ; Leucine ; Nitriles ; Proline
    Chemical Substances Ritonavir (O3J8G9O825) ; nirmatrelvir (7R9A5P7H32) ; Lactams ; Leucine (GMW67QNF9C) ; Nitriles ; Proline (9DLQ4CIU6V)
    Language English
    Publishing date 2023-12-02
    Publishing country United States
    Document type Journal Article
    ZDB-ID 1471745-1
    ISSN 1524-4733 ; 1098-3015
    ISSN (online) 1524-4733
    ISSN 1098-3015
    DOI 10.1016/j.jval.2023.11.003
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  7. Article ; Online: The impact of vaccination and outpatient treatment on the economic burden of Covid-19 in the United States omicron era: a systematic literature review.

    Pierre, Vicki / Draica, Florin / Di Fusco, Manuela / Yang, Jingyan / Nunez-Gonzalez, Solange / Kamar, Joanna / Lopez, Santiago / Moran, Mary M / Nguyen, Jennifer / Alvarez, Piedad / Cha-Silva, Ashley / Gavaghan, Meghan / Yehoshua, Alon / Stapleton, Naomi / Burnett, Heather

    Journal of medical economics

    2023  Volume 26, Issue 1, Page(s) 1519–1531

    Abstract: Aims: To identify and synthesize evidence regarding how coronavirus disease 2019 (COVID-19) interventions, including vaccines and outpatient treatments, have impacted healthcare resource use (HCRU) and costs in the United States (US) during the Omicron ... ...

    Abstract Aims: To identify and synthesize evidence regarding how coronavirus disease 2019 (COVID-19) interventions, including vaccines and outpatient treatments, have impacted healthcare resource use (HCRU) and costs in the United States (US) during the Omicron era.
    Materials and methods: A systematic literature review (SLR) was performed to identify articles published between 1 January 2021 and 10 March 2023 that assessed the impact of vaccination and outpatient treatment on costs and HCRU outcomes associated with COVID-19. Screening was performed by two independent researchers using predefined inclusion/exclusion criteria.
    Results: Fifty-eight unique studies were included in the SLR, of which all reported HCRU outcomes, and one reported costs. Overall, there was a significant reduction in the risk of COVID-19-related hospitalization for patients who received an original monovalent primary series vaccine plus booster dose vs. no vaccination. Moreover, receipt of a booster vaccine was associated with a lower risk of hospitalization vs. primary series vaccination. Evidence also indicated a significantly reduced risk of hospitalizations among recipients of nirmatrelvir/ritonavir (NMV/r), remdesivir, sotrovimab, and molnupiravir compared to non-recipients. Treated and/or vaccinated patients also experienced reductions in intensive care unit (ICU) admissions, length of stay, and emergency department (ED)/urgent care clinic encounters.
    Limitations: The identified studies may not represent unique patient populations as many utilized the same regional/national data sources. Synthesis of the evidence was also limited by differences in populations, outcome definitions, and varying duration of follow-up across studies. Additionally, significant gaps, including HCRU associated with long COVID and various high-risk populations and cost data, were observed.
    Conclusions: Despite evidence gaps, findings from the SLR highlight the significant positive impact that vaccination and outpatient treatment have had on HCRU in the US, including periods of Omicron predominance. Continued research is needed to inform clinical and policy decision-making in the US as COVID-19 continues to evolve as an endemic disease.
    MeSH term(s) Humans ; COVID-19/prevention & control ; Financial Stress ; Post-Acute COVID-19 Syndrome ; Outpatients ; Vaccination ; Vaccines
    Chemical Substances Vaccines
    Language English
    Publishing date 2023-11-27
    Publishing country England
    Document type Systematic Review ; Journal Article ; Review
    ZDB-ID 2270945-9
    ISSN 1941-837X ; 1369-6998
    ISSN (online) 1941-837X
    ISSN 1369-6998
    DOI 10.1080/13696998.2023.2281882
    Database MEDical Literature Analysis and Retrieval System OnLINE

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