Résumé
Objectives: The COVID pandemic has imposed significant direct medical cost and resource use burden on healthcare systems. This study described the patient demographic and clinical characteristics, healthcare resource utilization and costs associated with acute COVID in adults in England. Method(s): This population-based retrospective study used linked primary care (Clinical Practice Research Datalink, CPRD, Aurum) and secondary care (Hospital Episode Statistics) data to identify: 1) hospitalized (admitted within 12 weeks of a positive COVID-19 PCR test between August 2020 and March 2021) and 2) non-hospitalized patients (positive test between August 2020 and January 2022 and managed in the community). Hospitalization and primary care costs, 12 weeks after COVID diagnosis, were calculated using 2021 UK healthcare reference costs. Result(s): We identified 1,706,368 adult COVID cases. For hospitalized (n=13,105) and non-hospitalized (n=1,693,263) cohorts, 84% and 41% considered high risk for severe COVID using PANORAMIC criteria and 41% and 13% using the UKHSA's Green Book for prioritized immunization groups, respectively. Among hospitalized cases, median (IQR) length of stay was 5 (2-7), 6 (4-10), 8 (5-14) days for 18-49 years, 50-64 years and >= 65 years, respectively;6% required mechanical ventilation support, and median (IQR) healthcare costs (critical care cost excluded) per-finished consultant episode due to COVID increased with age (18-49 years: 4364 (1362-4471), 50-64 years: 4379 (4364-5800), 65-74 years: 4395 (4364-5800), 75-84 years: 4473 (4364-5800) and 85+ years: 5800 (4370-5807). Among non-hospitalized cases, older adults were more likely to seek GP consultations (13% of persons age 85+, 9% age 75-84, 7% age 65-74, 5% age 50-64, 3% age 18-49). Of those with at least 1 GP visit, the median primary care consultation total cost in the non-hospitalized cohort was 16 (IQR 16-31). Conclusion(s): Our results quantify the substantial economic burden required to manage adult patients in the acute phase of COVID in England.Copyright © 2023
Résumé
Objectives: This analysis was conducted to develop a comprehensive list of ICD-10 CM codes for underlying conditions identified by the CDC as being associated with high-risk of developing severe COVID-19 and assessed the consistency of these codes when applied to large US based datasets. Method(s): The comprehensive list of ICD 10-CM codes for CDC-defined high-risk underlying conditions were mapped from CDC references and FDA Sentinel code lists. These codes were subsequently applied to Optum's de-identified Clinformatics Data Mart Database (claims) and the Optum de-identified Electronic Health Record (EHR) database across 3 years (2018, 2019 and 2020) among continuously enrolled subjects >= 12 years of age to determine the performance and consistency in identifying these high-risk underlying conditions annually over these years. Result(s): A total of 10,276 ICD-10 codes were mapped to 21 underlying conditions. Within the claims data, 62.7% of subjects >= 12 years had >= 1 CDC-defined high-risk condition (excluding age) with 26.6% of patients >= 65 years while in the EHR data 38% had >= 1 high-risk underlying condition (excluding age) with 14.4% >= 65 years. These results were similar and consistent in both datasets across all years. Patients aged 12-64 years in the claims data had a higher rate of >=1 high risk underlying condition relative to the EHR data, 49.3% and 34%, respectively. The top 5 conditions among the >= 65 were identical across both databases: hypertension, immunocompromised status, heart conditions, diabetes (type 1 or 2), and overweight/obesity. The top 5 conditions among the 12-64 age group were also similar among the databases and included: immunocompromised status, hypertension, overweight/obesity, smoking (current or former), and mental health conditions. Conclusion(s): These findings present a comprehensive list of codes that can be used by researchers, clinicians and policy makers to identify and characterize patients that may be at high-risk for severe COVID-19 outcomes.Copyright © 2023
Résumé
Objectives: Clinical Practice Research Datalink (CPRD) Aurum contains primary care electronic health records, including vaccinations and nearly complete capture of SARS-CoV-2 PCR test results between August 2020-March 2022. Our objective was to build code lists to define a cohort of persons diagnosed with COVID in England using routinely collected health data. Method(s): Persons aged 1 year or older were indexed on first COVID diagnosis from August 1, 2020 - January 31, 2022. We developed SNOMED code lists to define high risk of severe disease: 1) National Health Service's (NHS) list of highest risk conditions;2) PANORAMIC trial inclusion criteria;3) UK Health Security Agency (UKHSA) clinical risk groups. COVID vaccinations were defined as of December 1, 2021 using medical and product codes. Code lists were developed using wildcard search terms which were reviewed by multiple independent reviewers, and inclusion/exclusion was determined by consensus. All lists for diagnoses were reviewed by a UK physician. Result(s): We identified 2,257,907 people diagnosed in primary care with COVID;46% were male and mean age was 34 years, comparable to governmental data for the same period reporting 47% of cases in England were male and mean age was 34 years. We identified 12% at high risk of severe disease using the NHS definition, 31% using the PANORAMIC trial criteria, and 10% using the UKHSA clinical risk groups. Among adults, 86.1% had >=1 and 80.2% had >=2 COVID vaccine doses (2% and 0.2% lower than official reports, respectively). Conclusion(s): This cohort represented the age and sex distribution of COVID cases, and the COVID vaccination coverage, in England through January 2022. Definitions were built using reproducible methods that can be leveraged for future work. The high capture of COVID vaccinations supports the use of this cohort to examine clinical and societal benefits of COVID vaccination in England.Copyright © 2023
Résumé
Objectives: Clinical Practice Research Datalink (CPRD) Aurum captures primary care electronic healthcare records for ~28% of the population in England. From August 2020-;March 2022, all SARS-CoV-2 polymerase chain reaction (PCR) tests performed were reported back to the patient's general practitioner (GP), making the CPRD a closed system uniquely positioned to answer COVID research questions. Method(s): We defined persons with COVID as those recorded in primary care with a positive PCR test from August 1, 2020-March 31, 2021. We required continuous registration with their GP practice for >=365 days prior to diagnosis to establish comorbid conditions, and eligibility for linkage to Hospital Episode Statistics (HES) Admitted Patient Care data. Hospitalizations for COVID were defined as persons admitted with a primary diagnosis of COVID (ICD-10-CM U07.1) within 12 weeks of the initial primary care diagnosis record. Result(s): Our cohort included 535,453 persons diagnosed in primary care with COVID, with 2% later hospitalized. The hospitalized group was 57% male, 42% current/former smokers, 35% obese46% with a Charlson Comorbidity Index >1 and 98% had never received any COVID vaccine. Hospitalizations increased with age;<0.1% of patients aged 1-17, 1% aged 18-49, 4% aged 50-64, 9% aged 65-74, 13% aged 74-84, and 11% of COVID cases aged >=85 were hospitalized. Persons living in socially disadvantaged areas were overrepresented in the hospitalized cohort (25% in the Index of Multiple Deprivation's most deprived quintile). Conclusion(s): Consistent with other studies, hospitalized COVID patients were disproportionately those with male sex, smoking history, high body mass index, comorbidity and unvaccinated status. Hospitalizations were more common with age, and for individuals living in socially and economically deprived communities. Understanding the demographic and clinical characteristics of this cohort can help contextualize future work describing healthcare resource utilization and costs, as well as the impact of vaccines, associated with COVID in England.Copyright © 2023
Résumé
BACKGROUND: Paxlovid (nirmatrelvir/ritonavir) has received a US Emergency Use Authorization for patients >=12 years with mild-to- moderate COVID-19 at high-risk of progression to severe disease. DDI studies conducted with Paxlovid implicate the PK enhancer ritonavir as the main perpetrator of DDIs. Ritonavir is a potent inhibitor of CYP3A4, CYP2D6, and P-gp. The Paxlovid Fact Sheet1 identifies contraindicated drugs and those with a potentially important interaction. METHOD(S): A retrospective analysis was conducted using RWE from the Optum Clinformatics Data Mart. Patients were identified based on CDC criteria for high-risk COVID-19 and confirmed continuous insurance enrollment from Jan 1 to Dec 31, 2019 with >=1 prescription claim. Excluding non-drug claims (e.g., vaccines), the top 100 drugs were selected and ranked based on total patient counts. DDI potential with Paxlovid was evaluated using US Prescribing and DailyMed Information or relevant literature for each drug. RESULT(S): Of the top 100, 70 drugs are not expected to have a DDI with Paxlovid. These drugs are eliminated unchanged in urine, cleared by enzymes other than CYP3A4 or CYP2D6, are not P-gp substrates, or are cleared by multiple pathways. The remaining 30 drugs expected to have a DDI are represented in the Paxlovid Fact Sheet. The top four drug classes expected to interact with Paxlovid include corticosteroids, narcotic analgesics, anticoagulants, and statins. One drug, simvastatin, is contraindicated. The mechanism of interaction with Paxlovid, or lack thereof, will be presented in detail for each drug. CONCLUSION(S): Paxlovid DDI management is important to ensure the right patients receive this antiviral. This analysis provides an understanding of Paxlovid interactions with the top 100 drugs likely to be used in high-risk COVID-19 patients and serves as an additional DDI management resource.