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Introduction: Paroxysmal nocturnal hemoglobinuria (PNH) is a rare blood disease associated with complications that increase morbidity, such as thrombosis and chronic kidney disease. Limited data exist regarding complications among treated patients outside of clinical trials, especially for patients treated with ravulizumab. Methods: This study leverages MarketScan claims data to examine the rate of complications in patients receiving PNH treatment. Patients with a diagnosis code of PNH [International Statistical Classification of Diseases and Related Health Problems (ICD-10) diagnosis code: D59.5] between October 2015 and December 2020, aged ≥ 18 on the date of diagnosis, who had a ≥ 6-month follow-up period of continuous enrollment and ≥ 1 PNH-indicated treatment on or after the first PNH diagnosis were included. Results: Among 211 patients diagnosed with PNH being treated with eculizumab or ravulizumab between October 2015 and December 2020, the most common complications were iron deficiency (20.4% of patients), arterial embolism and thrombosis (16.1%), and chronic kidney disease (11.8%). Overall, 44.1% of patients experienced ≥ 1 complication. Conclusion: The high number of patients with PNH receiving treatment who nevertheless experienced complications demonstrates significant unmet medical need. Further analysis with larger sample sizes and including newer therapies, such as pegcetacoplan and iptacopan, is required to fully understand the scope and magnitude of this unmet need. [ABSTRACT FROM AUTHOR]

AbstractObjectivesMethodsResultsConclusionThe healthcare burden of moderate asthma is not as well studied as severe asthma. This study used 2019 US claims data to characterize patients in Global Initiative for Asthma (GINA) steps 3 to 5 (moderate to severe) during the first 90 days of 2019.Patient characteristics, healthcare resource utilization and costs were described for all patients and GINA groups. Patients in GINA 3 accounting for the top 10% and 20% of asthma-related total costs were also analyzed.In the overall asthma population (N = 337 015), mean asthma-related healthcare cost per patient was $12 560; for GINA 3, 4 and 5, costs were $10 265, $12 923, and $22 601, respectively. For the GINA 3 top 10% and 20% cost subgroups, these expenditures were higher than for GINA 5 ($54 549 and $94 386, respectively), driven by outpatient and inpatient costs. The high-cost GINA 3 subgroups were older, more often female and had a higher comorbidity burden versus GINA 4 or 5. An exploratory analysis suggested that biologic initiation significantly increased costs in patients initially in GINA 3 (p < 0.0001), but significantly reduced costs in GINA 3 top 10% and 20% cost subgroups (both p < 0.01).Results indicate patients receiving GINA 3 treatment can have a high disease burden and may benefit from treatment with a biologic. [ABSTRACT FROM AUTHOR]

Purpose: Providers who treat patients with psoriasis are unevenly distributed across the United States, with more in urban than rural areas. This retrospective claims analysis characterized disparities in access to care for US patients with psoriasis using data from the STATinMED database. Materials and methods: Patients (≥18 years) had ≥1 claim with a psoriasis diagnosis and ≥1 claim for advanced psoriasis therapy (apremilast or biologics) between January 2015 and December 2019. Access to psoriasis care was determined using the proportion of patients with 0, 1–2, 3–4, or ≥5 providers in their local area. Results: Overall, 179,688 patients were included in the analysis, 80.0% in urban areas. The access ratio was highest for internal medicine physicians (97.1 per 1000 patients) and lowest for dermatologists (4.4 per 1000 patients) and family practice physicians (3.9 per 1000 patients). In urban areas, 41% of patients had access to ≥5 dermatologists versus 7% in rural areas. Whereas 2% of patients in urban areas sought care outside of their local area, 75% in rural areas did so. Use of advanced therapies was low in all states (<17%). Conclusion: Access to psoriasis-treating providers varied widely. Regardless of access, utilization of advanced treatments was low, suggesting the need for effective, easy-to-administer therapy. [ABSTRACT FROM AUTHOR]

ABSTRACT Aims/Introduction We aimed to explore the associations between income/employment status and diabetes care processes, health behaviors and health outcomes. Materials and Methods This cross‐sectional study used health insurance claims data between April 2021 and March 2022, and a questionnaire survey between December 2022 and January 2023 in Tsukuba City. The study analyzed the participants with diabetes (other than type 1) from those selected by stratified random sampling. We evaluated diabetes care processes, health behaviors and health outcomes by calculating weighted proportions among the groups. We also assessed the associations between income/employment status and these variables using multivariable modified Poisson regression models. Results Of the 264 identified participants, 161 (64.2%) were men and 168 (72.8%) were aged ≥65 years old. Compared with the low‐income groups, the high‐income group had a higher proportion of sodium–glucose cotransporter 2 inhibitors or glucagon‐like peptide‐1 receptor agonists use (adjusted risk ratio [aRR] 1.70, 95% confidence interval (CI) 1.07–2.72), a higher proportion of attendance to annual health checkups for ≥2 years (aRR 1.68, 95% CI 1.07–2.64) and a lower proportion of all‐cause hospitalization (aRR 0.15, 95% CI 0.04–0.48); additionally, the middle‐income group had a lower proportion of high total outpatient medical expenses (aRR 0.57, 95% CI 0.35–0.92). Compared to the no work time group, the full‐time work group had a lower proportion of exercise habits (aRR 0.59, 95% CI 0.35–0.99) and a higher proportion of good self‐reported health (aRR 2.08, 95% CI 1.22–3.55). Conclusions Several variables were associated with income/employment status. Policy intervention should focus on high‐risk groups identified by considering these associations.

Abstract Introduction The majority of metastatic renal cell carcinoma (mRCC) patients receive one or more VEGFR TKI agents, alone or in combination with an immune-oncology (IO) agent or an mTOR inhibitor. To date, the cost of adverse events (AEs) common to VEGFR TKIs has not been quantified. This study estimated the potential impact of differences in VEGFR TKI AE profiles on treatment cost efficiency in the relapsed/refractory (R/R) setting. Methods Patients with documented mRCC who were treated with VEGFR TKI therapies between Jan 2015 and Mar 2021 were identified using EMR. ICD-10 diagnosis codes were used to identify the first occurrence of each class effect AE. Patients were matched to 3rd party insurance claims, and costs associated to TKI AEs within 90 days of index event were captured. Average per patient AE cost data was calculated and applied to published incidence data to estimate regimen-specific AE total cost burden within a hypothetical commercial plan for mRCC patients undergoing treatment in the R/R setting. Results The highest total cost for AE management was attributed to lenvatinib and everolimus use at $13,303, followed closely by sunitinib at $13,092. Tivozanib treatment was associated with the lowest total cost of AE management at $7,523, driven by the relatively lower incidence of certain high-cost AEs. Conclusions The estimated costs of managing VEGFR TKI class-effect AEs were lowest with tivozanib, and highest with lenvatinib and everolimus, indicating potentially differential healthcare resource burden by TKI regimen. The use of tivozanib in the 3 L + mRCC setting suggests potential costs offsets when compared to other TKI regimens.

In clinical trials, once-daily oral tenofovir-based pre-exposure prophylaxis (PrEP) significantly reduced HIV-1 acquisition risk; however, this was highly dependent on medication adherence and persistence. We report clinical characteristics, PrEP usage patterns, first evidence of HIV-1, and associated risk factors among adults with commercial insurance using oral PrEP in the United States using health plan claims from the IQVIA PharMetrics® Plus database between January 1, 2015, and March 31, 2020, from individuals who newly initiated emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) or FTC/tenofovir alafenamide (TAF) for daily PrEP. Overall, 25,419 individuals were included (FTC/TDF, n = 24,232; FTC/TAF, n = 1187), with generally similar characteristics reported during the 6-month baseline period across cohorts. Mean follow-up length was 504 and 77 days for FTC/TDF and FTC/TAF, respectively, corresponding with the 2019 approval of FTC/TAF for PrEP. Similarly, mean PrEP use duration was 354 and 68 days for FTC/TDF and FTC/TAF, respectively. PrEP breaks (>90-day gap) were observed in 11.1% of individuals using FTC/TDF, with a mean break duration of 249 days; 20.0% of individuals using FTC/TDF and 7.3% using FTC/TAF had ≥1 sexually transmitted infection diagnosis during follow-up. From 6 to 12 months of follow-up, mean FTC/TDF proportion of days covered (PDC; 0.74 vs. 0.67) and persistence (70.2% vs. 57.4%) decreased; real-world PDC and persistence were lower than reported in globally conducted clinical trials. First evidence of HIV-1 was infrequent among individuals using FTC/TDF (0.6%), though 60.3% had PrEP on hand when HIV-1 definition was met; high-risk sexual behavior, syphilis, and gonorrhea were the most important risk factors. [ABSTRACT FROM AUTHOR]

Aims/Introduction: We aimed to explore the associations between income/employment status and diabetes care processes, health behaviors and health outcomes. Materials and Methods: This cross‐sectional study used health insurance claims data between April 2021 and March 2022, and a questionnaire survey between December 2022 and January 2023 in Tsukuba City. The study analyzed the participants with diabetes (other than type 1) from those selected by stratified random sampling. We evaluated diabetes care processes, health behaviors and health outcomes by calculating weighted proportions among the groups. We also assessed the associations between income/employment status and these variables using multivariable modified Poisson regression models. Results: Of the 264 identified participants, 161 (64.2%) were men and 168 (72.8%) were aged ≥65 years old. Compared with the low‐income groups, the high‐income group had a higher proportion of sodium–glucose cotransporter 2 inhibitors or glucagon‐like peptide‐1 receptor agonists use (adjusted risk ratio [aRR] 1.70, 95% confidence interval (CI) 1.07–2.72), a higher proportion of attendance to annual health checkups for ≥2 years (aRR 1.68, 95% CI 1.07–2.64) and a lower proportion of all‐cause hospitalization (aRR 0.15, 95% CI 0.04–0.48); additionally, the middle‐income group had a lower proportion of high total outpatient medical expenses (aRR 0.57, 95% CI 0.35–0.92). Compared to the no work time group, the full‐time work group had a lower proportion of exercise habits (aRR 0.59, 95% CI 0.35–0.99) and a higher proportion of good self‐reported health (aRR 2.08, 95% CI 1.22–3.55). Conclusions: Several variables were associated with income/employment status. Policy intervention should focus on high‐risk groups identified by considering these associations. [ABSTRACT FROM AUTHOR]

Introduction: The majority of metastatic renal cell carcinoma (mRCC) patients receive one or more VEGFR TKI agents, alone or in combination with an immune-oncology (IO) agent or an mTOR inhibitor. To date, the cost of adverse events (AEs) common to VEGFR TKIs has not been quantified. This study estimated the potential impact of differences in VEGFR TKI AE profiles on treatment cost efficiency in the relapsed/refractory (R/R) setting. Methods: Patients with documented mRCC who were treated with VEGFR TKI therapies between Jan 2015 and Mar 2021 were identified using EMR. ICD-10 diagnosis codes were used to identify the first occurrence of each class effect AE. Patients were matched to 3rd party insurance claims, and costs associated to TKI AEs within 90 days of index event were captured. Average per patient AE cost data was calculated and applied to published incidence data to estimate regimen-specific AE total cost burden within a hypothetical commercial plan for mRCC patients undergoing treatment in the R/R setting. Results: The highest total cost for AE management was attributed to lenvatinib and everolimus use at $13,303, followed closely by sunitinib at $13,092. Tivozanib treatment was associated with the lowest total cost of AE management at $7,523, driven by the relatively lower incidence of certain high-cost AEs. Conclusions: The estimated costs of managing VEGFR TKI class-effect AEs were lowest with tivozanib, and highest with lenvatinib and everolimus, indicating potentially differential healthcare resource burden by TKI regimen. The use of tivozanib in the 3 L + mRCC setting suggests potential costs offsets when compared to other TKI regimens. [ABSTRACT FROM AUTHOR]

Respiratory syncytial virus (RSV) is a leading cause of lower respiratory tract infection (LRTI) in infants and young children worldwide. Using routine statutory health insurance claims data including patients from all regions of Germany, we investigated the health-care resource use and costs associated with RSV prophylaxis with palivizumab in Germany. In the database, infants from the birth cohorts 2015–2019 eligible for palivizumab immunization were identified using codes of the 10th revision of the International Classification of Diseases (ICD-10). Health-care resource use and costs related to immunization were determined by inpatient and outpatient administrations. Over the study period, only 1.3% of infants received at least one dose of palivizumab in their first year of life. The mean number of doses per immunized infant was 4.6. From a third-party payer perspective, the mean costs of palivizumab per infant who received at least one dose in the first year of life was €5,435 in the birth cohorts 2015–2019. Despite the substantial risk of severe RSV infection, we found low rates of palivizumab utilization. Novel preventive interventions, featuring broader indications and single-dose administration per season, contribute to mitigating the burden of RSV disease across a more extensive infant population.

Background: People with multiple sclerosis (pwMS) are at risk of concurrently using multiple central nervous system (CNS)-active drugs, yet the prevalence of CNS-active polypharmacy remains unmeasured in pwMS. Objective: The objective is to measure the prevalence of CNS-active polypharmacy in pwMS. Methods: This serial, cross-sectional study measured CNS-active polypharmacy in people with MS in the United States from 2008 to 2021 using insurance claims data. CNS-active polypharmacy was defined as the concurrent prescription of ⩾3 CNS-active drugs for >30 continuous days. CNS-active drugs included antidepressants, antiepileptics, antipsychotics, benzodiazepines, nonbenzodiazepine benzodiazepine receptor agonist hypnotics, opioids, and skeletal muscle relaxants. Results: The number of subjects included at each time point ranged from 23,917 subjects in 2008 to 55,797 subjects in 2021. In 2021, subjects with CNS-active polypharmacy were more likely to be 46–65 years of age and have CNS-related comorbidities compared to those without CNS-active polypharmacy. From 2008 to 2021, the age-adjusted prevalence of CNS-active polypharmacy among female subjects increased from 19.8% (95% confidence interval (CI) = 19.1–20.4) to 26.4% (95% CI = 25.9–26.8) versus 15.9% (95% CI = 14.8–17.0) to 18.6% (95% CI = 17.9–19.2) in male subjects. Conclusion: The prevalence of CNS-active polypharmacy has increased among people with MS with a growing disparity by sex. [ABSTRACT FROM AUTHOR]

Frailty is an important predictor of mortality, health care costs and utilization, and health outcomes. Validated measures of frailty are not consistently collected during clinical encounters, making comparisons across populations challenging. However, several claims-based algorithms have been developed to predict frailty and related concepts. This study compares performance of three such algorithms among Medicare beneficiaries. Claims data from 12-month continuous enrollment periods were selected during 2014–2016. Frailty scores, calculated using previously developed algorithms from Faurot, Kim, and RAND, were added to baseline regression models to predict claims-based outcomes measured in the following year. Root mean square error and area under the receiver operating characteristic curve were calculated for each model and outcome combination and tested in subpopulations of interest. Overall, Kim models performed best across most outcomes, metrics, and subpopulations. Kim frailty scores may be used by health systems and researchers for risk adjustment or targeting interventions. [ABSTRACT FROM AUTHOR]

Abstract Background X-linked myotubular myopathy (XLMTM) is a rare, life-threatening congenital disease, which is not well-defined. To our knowledge, no studies characterizing the XLMTM disease burden have been conducted in Brazil. We identified and described patients with suspected XLMTM using administrative claims data from the Brazilian public healthcare system. Methods Data from 2015 to 2019 were extracted from the DATASUS database. As no XLMTM-specific ICD-10 code was available, a stepwise algorithm was applied to identify patients with suspected XLMTM by selecting male patients with a congenital myopathies code (G71.2), aged

Abstract Background Hypoparathyroidism (HP) is a rare endocrine disease commonly caused by the removal or damage of parathyroid glands during surgery and resulting in transient (tHP) or chronic (cHP) disease. cHP is associated with multiple complications and comorbid conditions; however, the economic burden has not been well characterized. The objective of this study was to evaluate the healthcare resource utilization (HCRU) and costs associated with post-surgical cHP, using tHP as a reference. Methods This analysis of a US claims database included patients with both an insurance claim for HP and thyroid/neck surgery between October 2014 and December 2019. cHP was defined as an HP claim ≥ 6 months following surgery and tHP was defined as only one HP claim

Background Hypoparathyroidism (HP) is a rare endocrine disease commonly caused by the removal or damage of parathyroid glands during surgery and resulting in transient (tHP) or chronic (cHP) disease. cHP is associated with multiple complications and comorbid conditions; however, the economic burden has not been well characterized. The objective of this study was to evaluate the healthcare resource utilization (HCRU) and costs associated with postsurgical cHP, using tHP as a reference. Methods This analysis of a US claims database included patients with both an insurance claim for HP and thyroid/ neck surgery between October 2014 and December 2019. cHP was defined as an HP claim≥6 months following surgery and tHP was defined as only one HP claim<6 months following surgery. The cHP index date was the first HP diagnosis claim following their qualifying surgery claim, whereas the tHP index date was the last HP diagnosis claim following the qualifying surgery claim. Patients were continuously enrolled at least 1 year pre- and post-index. Patients’ demographic and clinical characteristics, all-cause HCRU, and costs were descriptively analyzed. Total allcause costs were calculated as the sum of payments for hospitalizations, emergency department, office/clinic visits, and pharmacy. Results A total of 1,406 cHP and 773 tHP patients met inclusion criteria. The average age (52.1 years cHP, 53.5 years tHP) and representation of females (83.2% cHP, 81.2% tHP) were similar for both groups. Neck dissection surgery was more prevalent in cHP patients (23.6%) than tHP patients (5.3%). During the 1–2 year follow-up period, cHP patients had a higher prevalence of inpatient admissions (17.4%), and emergency visits (26.0%) than the reference group -tHP patients (14.4% and 21.4% respectively). Among those with a hospitalization, the average number of hospitalizations was 1.5-fold higher for cHP patients. cHP patients also saw more specialists, including endocrinologists (28.7% cHP, 15.8% tHP), cardiologists (16.7% cHP, 9.7% tHP), and nephrologists (4.6% cHP, 3.3% tHP). Conclusion This study demonstrates the increased healthcare burden of cHP on the healthcare system in contrast to patients with tHP. Effective treatment options are needed to minimize the additional resources utilized by patients whose HP becomes chronic. [ABSTRACT FROM AUTHOR]

The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) outbreak posed impact on healthcare. This study evaluated the effect of SARS-CoV-2 outbreak on the outpatient visits of patients with type 2 diabetes and determined the most affected groups. We analyzed Taiwan's National Health Insurance data, including 1,922,702 patients diagnosed with type 2 diabetes from 2018 to 2021. Group-based trajectory modelling identified four distinct outpatient visit patterns, namely, consistently high (Group 1, 74.2%), low-to-high (Group 2, 8.1%), high-to-low (Group 3, 6.0%) and consistently low (Group 4, 11.7%) utilization. Logistic regression was used to analyze correlations between trajectory types and patients' demographics and health statuses. Group 3 members had higher odds of being male [adjusted odds ratio (aOR) = 1.04, 95% confidence interval (CI) 1.03-1.05] and earning below 20,000 New Taiwan Dollar monthly (aOR = 1.29, 95% CI 1.26-1.31) than those in Group 1. However, they were less likely to be under 80 years old (aOR = 0.70-0.97), from lower median family income regions (aOR = 0.81-0.89) or possess a Charlson Comorbidity Index score > 2 (aOR = 0.67, 95% CI 0.66-0.68). Patients with lower income in affluent areas displayed the highest likelihood of falling into Group 3. Patients with type 2 diabetes and low income from wealthy areas were vulnerable during the pandemic. This result emphasizes the need to target resources and support for this subgroup during such crises. [ABSTRACT FROM AUTHOR]

Abstract Introduction This retrospective cohort study (GSK213737) aimed to characterize treatment patterns, healthcare resource utilization (HCRU), and costs in patients with lupus nephritis (LN) initiating immunosuppressant therapy in clinical practice in Germany, to better understand the full picture of the real-world burden of LN. Methods Adult patients with LN who initiated mycophenolate mofetil (MMF), intravenous cyclophosphamide (CYC), azathioprine (AZA), tacrolimus, cyclosporin A, or rituximab therapy in 2011–2017 (index therapy) were identified from the Betriebskrankenkassen German Sickness Fund database. Treatment patterns, including immunosuppressant discontinuations, and therapy switches, were assessed (maximum follow-up 4 years). Corticosteroid use, HCRU, and total economic costs were also evaluated. HCRU and costs were compared with matched controls (individuals without systemic lupus erythematosus [SLE]/LN matched by age, sex, and baseline Charlson Comorbidity Index). Results Among 334 patients with LN, the median (interquartile range) duration of index immunosuppressant therapy use was 380.5 (126, 1064) days. Of those patients with 4 years complete enrollment, 70.8% had ≥ 1 discontinuation and 28.8% switched therapy. While most patients (71.2%) received only one immunosuppressant, gaps in treatment were common. After 1 year of follow-up, 41.6% of patients had a prednisone-equivalent corticosteroid dose of ≥ 7.5 mg/day. Patients with LN had greater HCRU use for most categories assessed and increased mean total costs per person-year versus controls (€15,115.99 versus €4,081.88 in the first year of follow-up). Conclusions This real-world analysis demonstrated the considerable burden of immunosuppressant-treated LN in Germany, with a high rate of discontinuations, frequent use of high-dose corticosteroids, and substantial HCRU/costs.

Abstract Introduction Psoriasis (PsO) is associated with the development of psoriatic arthritis (PsA). Patients with PsO often experience pre-PsA musculoskeletal (MSK) symptoms, leading to potential structural damage and substantial disease burden with impact on function. The objective of this study is to describe prevalence rates and evidence of MSK symptoms, including incidence of comorbid PsA diagnosis, in patients newly diagnosed with PsO and identify factors associated with PsA diagnosis. Methods This retrospective analysis included administrative claims from the Optum Research Database for adult patients with a new PsO diagnosis between January 2008 and February 2019. Eligible patients had ≥ 2 claims for PsO on unique dates, were aged ≥ 18 years at the date of the first claim with a diagnosis of PsO (index date), and had continuous enrollment with medical and pharmacy coverage for 12 months before (baseline period) and ≥ 12 months following the index date. Primary outcomes were incidence of comorbid PsA diagnosis, prevalence of MSK symptoms other than PsA, and evidence of MSK symptoms collected at baseline and assessed in 12-month intervals through 60 months. Results Of the 116,203 patients with newly diagnosed PsO, 110,118 were without baseline comorbid PsA. High prevalence rates of MSK symptoms among patients with only PsO were seen at baseline (47.1%), 12 months (48.2%), and 60 months (82.1%). Patient age, baseline MSK symptoms, and baseline MSK symptom–related healthcare utilization were associated with increased hazard of a PsA diagnosis. Conclusion Increased prevalence rates of MSK symptoms and burden are experienced by patients newly diagnosed with PsO through 60 months of follow-up. Several baseline factors were associated with increased risk of PsA diagnosis.

Introduction: This retrospective cohort study (GSK213737) aimed to characterize treatment patterns, healthcare resource utilization (HCRU), and costs in patients with lupus nephritis (LN) initiating immunosuppressant therapy in clinical practice in Germany, to better understand the full picture of the real-world burden of LN. Methods: Adult patients with LN who initiated mycophenolate mofetil (MMF), intravenous cyclophosphamide (CYC), azathioprine (AZA), tacrolimus, cyclosporin A, or rituximab therapy in 2011–2017 (index therapy) were identified from the Betriebskrankenkassen German Sickness Fund database. Treatment patterns, including immunosuppressant discontinuations, and therapy switches, were assessed (maximum follow-up 4 years). Corticosteroid use, HCRU, and total economic costs were also evaluated. HCRU and costs were compared with matched controls (individuals without systemic lupus erythematosus [SLE]/LN matched by age, sex, and baseline Charlson Comorbidity Index). Results: Among 334 patients with LN, the median (interquartile range) duration of index immunosuppressant therapy use was 380.5 (126, 1064) days. Of those patients with 4 years complete enrollment, 70.8% had ≥ 1 discontinuation and 28.8% switched therapy. While most patients (71.2%) received only one immunosuppressant, gaps in treatment were common. After 1 year of follow-up, 41.6% of patients had a prednisone-equivalent corticosteroid dose of ≥ 7.5 mg/day. Patients with LN had greater HCRU use for most categories assessed and increased mean total costs per person-year versus controls (€15,115.99 versus €4,081.88 in the first year of follow-up). Conclusions: This real-world analysis demonstrated the considerable burden of immunosuppressant-treated LN in Germany, with a high rate of discontinuations, frequent use of high-dose corticosteroids, and substantial HCRU/costs. [ABSTRACT FROM AUTHOR]

Purpose: To describe medication adherence and persistence of HIV PrEP overall and compare between sex and age groups of commercially insured individuals in the United States. Methods: We conducted a national retrospective cohort study of the Merative MarketScan Claims Database from 2011 to 2019 to describe adherence and persistence of PrEP overall and compared between sex and age groups. High adherence was defined as ≥80% of proportion of days covered and persistence was measured in days from initiation to the first day of a 60‐day treatment gap. Results: A total of 29 689 new PrEP users identified. Overall adherence was high (81.9%; 95% confidence interval [CI]: 81.5%–82.3%). Females were more adherent than males (adjusted odds ratio [aOR] 1.87; 95% CI: 1.50–2.34), while those ≥45‐years were less adherent than individuals <45‐years (aOR 0.87: 95% CI: 0.81–0.93). More than half of individuals discontinued therapy within the first year (median 238.0 days; interquartile range 99.0–507.0 days). Females were less persistent than males (hazard ratio [HR] 1.49; 95% CI: 1.34–1.65), and people ≥45‐years old were more persistent (i.e., lower risk of discontinuation) than those <45‐years (HR 0.43; 95% CI: 0.33–0.55). Conclusions: These findings show adherence to daily PrEP is high among commercially insured individuals but the majority still discontinue in the first year. Future research should investigate what factors influence PrEP discontinuation among this population and ways to reduce barriers to therapy maintenance to ensure the population‐level benefits of PrEP treatment. [ABSTRACT FROM AUTHOR]

Aims: To compare all-cause claims associated with the LATERA Absorbable Nasal Implant and surgical repair of nasal vestibular stenosis in patients with nasal valve collapse. Methods: This retrospective cohort study utilized data from STATinMED RWD Insights. A defined set of HCPCS, ICD-10-CM and CPT codes were used to identify patients with ≥1 claim for a LATERA procedure, and patients with ≥1 claim for surgical repair between June 1, 2015– March 31, 2023. Patients with continuous capture for at least 12 months before and at least 6 months after the index date were selected. The index date was defined as earliest date of encounter for a LATERA or surgical repair procedure. Inverse probability of treatment weighting (IPTW) was used to ensure balance between cohorts. Descriptive analyses were provided for all claims data using standard summary statistics. All-cause claims were assessed during the baseline, index date, and follow-up period. Chi-squared tests and independent sample t-tests were used to assess differences in cohorts for categorical and continuous variables, respectively. Results: The study population included 5,032 LATERA patients and 26,553 surgical repair patients. During the baseline and follow-up periods, the matched cohorts exhibited similar all-cause claims. On the index date, LATERA patients incurred lower claims vs. surgical repair, likely due to LATERA's ability to be implanted in the physician office setting. LATERA patients and surgical repair patients mean (SD) total costs were $9,612 [$14,930] vs $11,846 [$17,037] (p ≤ 0.0001), respectively. Conclusions: Treatment with the LATERA Absorbable Nasal Implant is a potentially cost saving option for payers on the index date compared to traditional surgical repair in patients with nasal valve collapse due to the ability to be performed in the office. All-cause claims were similar in the baseline and follow-up periods. When performed with concomitant procedures, all-cause claims during follow-up were similar between groups. [ABSTRACT FROM AUTHOR]

Objective To use more precise measures of which hospitals are electronically connected to determine whether health information exchange (HIE) is associated with lower emergency department (ED)-related utilization. Materials and Methods We combined 2018 Medicare fee-for-service claims to identify beneficiaries with 2 ED encounters within 30 days, and Definitive Healthcare and AHA IT Supplement data to identify hospital participation in HIE networks (HIOs and EHR vendor networks). We determined whether the 2 encounters for the same beneficiary occurred at: the same organization, different organizations connected by HIE, or different organizations not connected by HIE. Outcomes were: (1) whether any repeat imaging occurred during the second ED visit; (2) for beneficiaries with a treat-and-release ED visit followed by a second ED visit, whether they were admitted to the hospital after the second visit; (3) for beneficiaries discharged from the hospital followed by an ED visit, whether they were admitted to the hospital. Results In adjusted mixed effects models, for all outcomes, beneficiaries returning to the same organization had significantly lower utilization compared to those going to different organizations. Comparing only those going to different organizations, HIE was not associated with lower levels of repeat imaging. HIE was associated with lower likelihood of hospital admission following a treat-and-release ED visit (1.83 percentage points [−3.44 to −0.21]) but higher likelihood of admission following hospital discharge (2.78 percentage points [0.48-5.08]). Discussion Lower utilization for beneficiaries returning to the same organization could reflect better access to information or other factors such as aligned incentives. Conclusion HIE is not consistently associated with utilization outcomes reflecting more coordinated care in the ED setting. [ABSTRACT FROM AUTHOR]

Of those patients diagnosed with generalized pustular psoriasis (GPP) in Japan, approximately 30% have a prior psoriasis vulgaris (PsV) diagnosis. Therefore, understanding factors associated with a GPP diagnosis is essential for early diagnosis of GPP in patients with PsV. This retrospective cohort study was conducted to identify associated factors for GPP diagnosis in patients with PsV. Eligible patients with two confirmed diagnoses of PsV with/without a confirmed GPP diagnosis (International Classification of Disease 10th revision codes L40.0 and L40.1, respectively) were identified from the Japanese Medical Data Center database (JMDC) (July 1, 2005–January 31, 2019). Weighted logistic regression was used to identify associated factors (based on recorded comorbidities) between the PsV only and PsV with GPP cohorts. Odds ratios (ORs) of ≥1.5, associated with a high probability of a GPP diagnosis, were reported for factors with ≥5 patients/cohort. The time from event to GPP diagnosis was evaluated. The highest associated factor for GPP diagnosis was psoriatic arthritis (OR 20.2, 95% confidence interval [CI] 17.06–23.92, P < 0.0001), which also had the shortest time from event to GPP diagnosis (median 119 days). Other comorbidities associated with GPP diagnosis were other psoriasis, tonsillitis, and sinusitis. Treatments associated with GPP diagnosis included systemic corticosteroids (OR 2.19, 95% CI 1.98–2.43, P < 0.0001; median time from treatment initiation to GPP diagnosis 180 days). Other associated treatments (other immunosuppressants, interleukin [IL]‐17 or IL‐23 inhibitors, and phototherapy) had a delay of ≥1 year from treatment initiation to GPP diagnosis. Back pain, headache, and fever were also identified as associated with a GPP diagnosis. Patients with PsV requiring systemic therapies are more likely to receive a GPP diagnosis than those not requiring systemic treatment. These data will help identify patients with PsV at high risk of developing GPP and potentially support early GPP diagnosis. [ABSTRACT FROM AUTHOR]

Abstract Background Insurance claims data have been used to inform an understanding of Lyme disease epidemiology and cost of care, however few such studies have incorporated post-treatment symptoms following diagnosis. Using longitudinal data from a private, employer-based health plan in an endemic US state, we compared outpatient care utilization pre- and post-Lyme disease diagnosis. We hypothesized that utilization would be higher in the post-diagnosis period, and that temporal trends would differ by age and gender. Methods Members with Lyme disease were required to have both a corresponding ICD-9 code and a fill of an antibiotic indicated for treatment of the infection within 30 days of diagnosis. A 2-year ‘pre- diagnosis’ period and a 2-year ‘post-diagnosis period’ were centered around the diagnosis month. Lyme disease-relevant outpatient care visits were defined as specific primary care, specialty care, or urgent care visits. Descriptive statistics examined visits during these pre- and post-diagnosis periods, and the association between these periods and the number of visits was explored using generalized linear mixed effects models adjusting for age, season of the year, and gender. Results The rate of outpatient visits increased 26% from the pre to the post-Lyme disease diagnosis periods among our 317-member sample (rate ratio = 1.26 [1.18, 1.36], p

Abstract Aims/Introduction Regular screening for diabetic retinopathy is essential. This study aimed to show the process and current situation of diabetic retinopathy screening prescribed by physicians (internists) and ophthalmologists for Japanese patients with diabetes. Materials and Methods This retrospective cohort study used data from the Japanese National Database of Insurance Claims between April 2016 and March 2018. Ophthalmology visits and fundus examinations are defined using specific medical procedure codes. The proportion of ophthalmology visits for patients with diabetic medication and for fundus examination among those who visited ophthalmologists was calculated in the fiscal year 2017. A modified Poisson regression analysis was carried out to identify factors associated with retinopathy screening. Similarly, quality indicators by prefectures were also calculated. Results Among 4,408,585 patients receiving diabetic medications (57.8% men, 14.1% insulin use), 47.4% visited the ophthalmology department and 96.9% of those underwent fundus examination. Regression analysis showed that female sex, older age, insulin use, medical facilities with Japan Diabetes Society certification and large medical facilities were predictors of fundus examination. By prefecture, the ophthalmology consultation rate and the fundus examination ranged 38.5–51.0% and 92.1–98.7%, respectively. Conclusions Less than half of the patients who were prescribed antidiabetic medication by their physicians visited an ophthalmologist. However, most of the patients who visited an ophthalmologist had a fundus examination carried out. A similar tendency was noted for each prefecture. It is essential to reaffirm the necessity of recommending ophthalmologic examinations to physicians and healthcare professionals who care for patients with diabetes.

Grace Wang,1 Louie Lu,1 Laura S Gold,2 Jeannie F Bailey3 1Clinical Research, Hinge Health, Inc, San Francisco, CA, USA; 2Clinical Learning, Evidence and Research Center, University of Washington, Seattle, WA, USA; 3Orthopaedic Surgery, University of California, San Francisco, CA, USACorrespondence: Grace Wang, Senior Director of Clinical Research, Hinge Health, Inc, 455 Market Street, Floor 7, San Francisco, CA, 94105-2437, USA, Tel +1 415 900-3997, Email grace.wang@hingehealth.comBackground: In-person, conservative care may decrease opioid use for chronic musculoskeletal (MSK) pain, but the impact of digitally delivered conservative care on opioid use is unknown. This study examines associations between a digital MSK program and opioid initiation and prescriptions among opioid naive adults with chronic MSK pain.Methods: This observational study used commercial medical and pharmacy claims data to compare digital MSK program members to matched physical therapy (PT) patients. Outcomes were any opioid prescriptions and opioid prescriptions per 100 participants within the 12-months after starting a digital MSK program. After propensity-score matching, we conducted multivariate regression models that controlled for demographic, comorbidity, and baseline MSK healthcare use.Results: The study included 4195 members and 4195 matched PT patients. For opioid initiation, 7.89% (95% Confidence Interval [CI]: 7.07%, 8.71%) of members had opioid prescriptions within 12 months after starting the digital MSK program versus 13.64% (95% CI: 12.60%, 14.67%) of matched PT patients (p < 0.001). Members had significantly fewer opioid prescriptions (16.73 per 100 participants; 95% CI: 14.11, 19.36) versus PT patients (22.36 per 100 participants; 95% CI: 19.99, 24.73). Members had lower odds (OR: 0.52, 95% CI: 0.45, 0.60) of initiating opioids and significantly fewer prescriptions per 100 participants (beta: − 6.40, 95% CI: − 9.88, − 2.93) versus PT patients after controlling for available confounding factors.Conclusion: An MSK program that delivers conservative care digitally may be a promising approach for decreasing opioid initiation among individuals with chronic MSK pain given the limitations of the observational design and matching on only available covariates.Keywords: musculoskeletal pain, telemedicine, telerehabilitation, opioid, claims analysis

Abstract Introduction Apremilast, the first oral targeted treatment for moderate to severe psoriasis, is associated with diarrhea, nausea, and vomiting, which have contributed to treatment discontinuation. This study describes early apremilast discontinuation rates in patients with psoriasis, including a cohort with gastrointestinal (GI) comorbidities, and associated characteristics. Methods This retrospective cohort study used IBM® (now Merative™) MarketScan® commercial and Medicare claims data to identify adults with psoriasis who filled their first apremilast prescription between September 1, 2014 and March 31, 2020. Discontinuation was defined as a gap of > 30 days after exhausting the days’ supply of a prescription fill. The GI comorbidity cohort included patients with ≥ 1 claim for inflammatory bowel disease (IBD), irritable bowel syndrome (IBS), or other GI comorbidity during the study period. Results Discontinuation rates were high, regardless of previous biologic treatment or GI comorbidities. Among all patients, 25.5% discontinued within 60 days and 56.4% discontinued within 180 days. Patients who discontinued were more likely to be younger, female, and have IBD, Crohn’s disease, or a mental health disorder. At 180 days, patients who used biologics previously were more likely to discontinue than biologic-naive patients. Patients with IBD discontinued at a greater rate than those without IBD at 60 days (30.3% vs 24.4%; P = 0.018) and 180 days (63.6% vs 57.2%; P = 0.026). Differences in discontinuation rates were minimal between GI comorbidity groups; patients with IBS discontinued at numerically higher rates than those without IBS. Conclusions High rates of early discontinuation were observed for patients with and without GI comorbidities. Early discontinuation, whether attributable to poor tolerability or effectiveness, suggests the need for additional oral treatment options.

Introduction: Psoriasis (PsO) is associated with the development of psoriatic arthritis (PsA). Patients with PsO often experience pre-PsA musculoskeletal (MSK) symptoms, leading to potential structural damage and substantial disease burden with impact on function. The objective of this study is to describe prevalence rates and evidence of MSK symptoms, including incidence of comorbid PsA diagnosis, in patients newly diagnosed with PsO and identify factors associated with PsA diagnosis. Methods: This retrospective analysis included administrative claims from the Optum Research Database for adult patients with a new PsO diagnosis between January 2008 and February 2019. Eligible patients had ≥ 2 claims for PsO on unique dates, were aged ≥ 18 years at the date of the first claim with a diagnosis of PsO (index date), and had continuous enrollment with medical and pharmacy coverage for 12 months before (baseline period) and ≥ 12 months following the index date. Primary outcomes were incidence of comorbid PsA diagnosis, prevalence of MSK symptoms other than PsA, and evidence of MSK symptoms collected at baseline and assessed in 12-month intervals through 60 months. Results: Of the 116,203 patients with newly diagnosed PsO, 110,118 were without baseline comorbid PsA. High prevalence rates of MSK symptoms among patients with only PsO were seen at baseline (47.1%), 12 months (48.2%), and 60 months (82.1%). Patient age, baseline MSK symptoms, and baseline MSK symptom–related healthcare utilization were associated with increased hazard of a PsA diagnosis. Conclusion: Increased prevalence rates of MSK symptoms and burden are experienced by patients newly diagnosed with PsO through 60 months of follow-up. Several baseline factors were associated with increased risk of PsA diagnosis. Plain Language Summary: A Study to Look at Symptoms of Muscles, Joints, and Bones in Patients with Psoriasis and Whether They Can Predict a Diagnosis of Psoriatic Arthritis Psoriasis is an inflammatory skin disease that results in areas of significant itchiness, pain, and scaling, and ultimately decreases patient quality of life. Psoriasis affects approximately 2–4% of the general US population and 1.3–2.2% of the UK population. Some patients with psoriasis may experience musculoskeletal symptoms and may go on to develop psoriatic arthritis. The goal of this study was to determine the frequency of patients with psoriasis who experienced complaints of musculoskeletal pain prior to and/or following their psoriasis diagnosis, and whether these were associated with further probability of developing psoriatic arthritis. Using a large US-based database with data from approximately 115,000 patients with newly diagnosed psoriasis, we determined the percentage of newly diagnosed psoriasis patients with existing musculoskeletal pain complaints within 12 months of their initial diagnosis. We found that 47% of newly diagnosed patients had previous musculoskeletal pain complaints, with joint pain, back pain, and overall fatigue representing the most common forms. Notably, psoriasis patients with previous joint pain were approximately 50% more likely to develop psoriatic arthritis compared with patients with no previous joint pain. Furthermore, patients with previous other forms of arthritis were nearly twice as likely to develop psoriatic arthritis. This study provides additional support that existing musculoskeletal pain in patients with newly diagnosed psoriasis may predict the potential future onset of psoriatic arthritis. These findings will help guide primary care physicians, dermatologists, and rheumatologists in understanding the importance of earlier detection of psoriatic arthritis to provide more appropriate care. [ABSTRACT FROM AUTHOR]

This study aimed to describe the healthcare resource utilization (HCRU) and healthcare costs associated with systemic lupus erythematosus (SLE) management in China from the patient's and the payer's perspective. HCRU and medical costs (2017 US dollar [USD]) between January 1 and December 31, 2017, were extracted from the national medical insurance claims database, China Health Insurance Research Association (consisting of claims from all public health insurance schemes in China), for adults with ≥ 1 SLE-related claim. The main analysis group comprised all adults with an SLE diagnosis and claim during 2017 (overall group); the annual subgroup (SLE diagnosis and claim in January 2017) informed annual HCRU and costs. The overall group consisted of 3645 adults with ≥ 1 SLE-related claim. Outpatient visits constituted 86.9% of healthcare visits. SLE-related healthcare outpatient costs were USD 433 per outpatient, and inpatient costs were USD 2072 per inpatient. Medication costs accounted for 75.0% (USD 42/56) of total costs for outpatient visits and 44.3% (USD 456/1030) for inpatient hospitalizations. Notably, 35.4% of patients had a severe SLE flare; mean SLE-related cost per severe flare was USD 1616. HCRU and costs were similar in the annual subgroup. Female sex, SLE flares, tertiary hospitals, renal involvement, and utilization of anti-infective drugs were associated with higher SLE-related patient costs. SLE in China is associated with considerable HCRU and medical costs, especially for patients experiencing severe SLE flares. Preventing organ involvement, infections, flares, and associated hospitalizations may reduce the burden on patients and healthcare providers in China. • Despite the profound impact of systemic lupus erythematosus (SLE) and SLE flares on patients and healthcare systems, there are limited costing studies available. In China, there have been no claims database studies to estimate the economic burden of SLE. This large study of 3645 adult patients helps to address this paucity of data both in China and globally. • This study demonstrated that, in Chinese patients, SLE is associated with considerable healthcare and medical costs, especially for patients experiencing hospitalizations or severe flares. • Reducing disease activity and preventing severe flares and associated hospitalizations may reduce the burden for patients and healthcare providers in China. [ABSTRACT FROM AUTHOR]

Introduction: Apremilast, the first oral targeted treatment for moderate to severe psoriasis, is associated with diarrhea, nausea, and vomiting, which have contributed to treatment discontinuation. This study describes early apremilast discontinuation rates in patients with psoriasis, including a cohort with gastrointestinal (GI) comorbidities, and associated characteristics. Methods: This retrospective cohort study used IBM® (now Merative™) MarketScan® commercial and Medicare claims data to identify adults with psoriasis who filled their first apremilast prescription between September 1, 2014 and March 31, 2020. Discontinuation was defined as a gap of > 30 days after exhausting the days' supply of a prescription fill. The GI comorbidity cohort included patients with ≥ 1 claim for inflammatory bowel disease (IBD), irritable bowel syndrome (IBS), or other GI comorbidity during the study period. Results: Discontinuation rates were high, regardless of previous biologic treatment or GI comorbidities. Among all patients, 25.5% discontinued within 60 days and 56.4% discontinued within 180 days. Patients who discontinued were more likely to be younger, female, and have IBD, Crohn's disease, or a mental health disorder. At 180 days, patients who used biologics previously were more likely to discontinue than biologic-naive patients. Patients with IBD discontinued at a greater rate than those without IBD at 60 days (30.3% vs 24.4%; P = 0.018) and 180 days (63.6% vs 57.2%; P = 0.026). Differences in discontinuation rates were minimal between GI comorbidity groups; patients with IBS discontinued at numerically higher rates than those without IBS. Conclusions: High rates of early discontinuation were observed for patients with and without GI comorbidities. Early discontinuation, whether attributable to poor tolerability or effectiveness, suggests the need for additional oral treatment options. [ABSTRACT FROM AUTHOR]

The European Union (EU) is in search of a new narrative to create a sense of common purpose, but it is unclear around which values that narrative should be built. To analyse how different narratives resonate in Europe's public spheres, this article presents a novel dataset based on claims analysis of newspaper articles from Germany, France, Italy, Spain, Poland and Denmark between 2012 and 2019 on the issues of migration, the Economic and Monetary Union (EMU), trade and counterterrorism. Descriptive and logistic regression analyses show how different frames have been used for various policy agendas. This reveals considerable variation, but comparatively low levels of explained variance. Europe's public spheres can thus be described as a 'justification jungle', where many actors use a range of arguments to back up diverging political demands. This poses a formidable obstacle to any single narrative of European integration. [ABSTRACT FROM AUTHOR]

Aim: Patients with Rett syndrome (RTT) experience gastrointestinal (GI) manifestations. This study aimed to describe the prevalence of GI manifestations and the associated medical costs in patients with RTT in the USA. Patients & Methods: The study combined an insurance claims database analysis with a survey of 100 physicians experienced in RTT management. Results: GI manifestations affected 43.0% of 5940 patients, with increased prevalence in pediatric patients (45.6%) relative to adult patients (40.2%). Annualized mean medical cost of managing GI manifestations was $4473. Only 5.9–8.2% of neurologists and pediatricians ranked GI symptom management among the five most important treatment goals. Conclusion: Patients with RTT experience a high burden of GI manifestations, which translate to considerable medical costs. Importantly, the prevalence of GI manifestations was likely underestimated in this study, as only those symptoms which resulted in a healthcare encounter were captured.

Background: Insurance claims data have been used to inform an understanding of Lyme disease epidemiology and cost of care, however few such studies have incorporated post-treatment symptoms following diagnosis. Using longitudinal data from a private, employer-based health plan in an endemic US state, we compared outpatient care utilization pre- and post-Lyme disease diagnosis. We hypothesized that utilization would be higher in the post-diagnosis period, and that temporal trends would differ by age and gender. Methods: Members with Lyme disease were required to have both a corresponding ICD-9 code and a fill of an antibiotic indicated for treatment of the infection within 30 days of diagnosis. A 2-year 'pre- diagnosis' period and a 2-year 'post-diagnosis period' were centered around the diagnosis month. Lyme disease-relevant outpatient care visits were defined as specific primary care, specialty care, or urgent care visits. Descriptive statistics examined visits during these pre- and post-diagnosis periods, and the association between these periods and the number of visits was explored using generalized linear mixed effects models adjusting for age, season of the year, and gender. Results: The rate of outpatient visits increased 26% from the pre to the post-Lyme disease diagnosis periods among our 317-member sample (rate ratio = 1.26 [1.18, 1.36], p < 0.001). Descriptively, care utilization increases appeared to persist across months in the post-diagnosis period. Women's care utilization increased by 36% (1.36 [1.24, 1.50], p < 0.001), a significantly higher increase than the 14% increase found among men (1.14 [1.02, 1.27], p = 0.017). This gender difference was mainly driven by adult members. We found a borderline significant 17% increase in visits for children < 18 years, (1.17 [0.99, 1.38], p = 0.068), and a 31% increase for adults ≥ 18 years (1.31 [1.21, 1.42], p < 0.001). Conclusions: Although modest at the population level, the statistically significant increases in post-Lyme diagnosis outpatient care we observed were persistent and unevenly distributed across demographic and place of service categories. As Lyme disease cases continue to grow, so will the cumulative prevalence of persistent symptoms after treatment. Therefore, it will be important to confirm these findings and understand their significance for care utilization and cost, particularly against the backdrop of other post-acute infectious syndromes. [ABSTRACT FROM AUTHOR]

Functional impairment predicts mortality and health care utilization. However, validated measures of functional impairment are not routinely collected during clinical encounters and are impractical to use for large-scale risk-adjustment or targeting interventions. This study's purpose was to develop and validate claims-based algorithms to predict functional impairment using Medicare Fee-for-Service (FFS) 2014–2017 claims data linked with post-acute care (PAC) assessment data and weighted to better represent the overall Medicare FFS population. Using supervised machine learning, predictors were identified that best predicted two functional impairment outcomes measured in PAC data—any memory limitation and a count of 0–6 activity/mobility limitations. The memory limitation algorithm had moderately high sensitivity and specificity. The activity/mobility limitations algorithm performed well in identifying beneficiaries with five or more limitations, but overall accuracy was poor. This dataset shows promise for use in PAC populations, though generalizability to broader older adult populations remains a challenge. [ABSTRACT FROM AUTHOR]

Aims/Introduction: Regular screening for diabetic retinopathy is essential. This study aimed to show the process and current situation of diabetic retinopathy screening prescribed by physicians (internists) and ophthalmologists for Japanese patients with diabetes. Materials and Methods: This retrospective cohort study used data from the Japanese National Database of Insurance Claims between April 2016 and March 2018. Ophthalmology visits and fundus examinations are defined using specific medical procedure codes. The proportion of ophthalmology visits for patients with diabetic medication and for fundus examination among those who visited ophthalmologists was calculated in the fiscal year 2017. A modified Poisson regression analysis was carried out to identify factors associated with retinopathy screening. Similarly, quality indicators by prefectures were also calculated. Results: Among 4,408,585 patients receiving diabetic medications (57.8% men, 14.1% insulin use), 47.4% visited the ophthalmology department and 96.9% of those underwent fundus examination. Regression analysis showed that female sex, older age, insulin use, medical facilities with Japan Diabetes Society certification and large medical facilities were predictors of fundus examination. By prefecture, the ophthalmology consultation rate and the fundus examination ranged 38.5–51.0% and 92.1–98.7%, respectively. Conclusions: Less than half of the patients who were prescribed antidiabetic medication by their physicians visited an ophthalmologist. However, most of the patients who visited an ophthalmologist had a fundus examination carried out. A similar tendency was noted for each prefecture. It is essential to reaffirm the necessity of recommending ophthalmologic examinations to physicians and healthcare professionals who care for patients with diabetes. [ABSTRACT FROM AUTHOR]

The idea of post-factual politics has become increasingly relevant for describing current political and societal developments. Though research on the topic has been blooming, we lack a common framework and systematic tool to map and analyze post-truth communication. Therefore, our paper advances the adaptation of claims-making for the analysis of how actors relativize the truth and use discourses of untruthfulness to attack their opponents, constructing their own versions of reality. We extend the affinity between populism and post-truth to conceptualize truth contestation in two aspects: (1) the antagonistic anti-elite constructions of accusations of creating and spreading false information and lies, (2) the emphasis on emotionality and negativity over facts and expertise. Building on a communication-centered approach to populism, we define key content and stylistic characteristics of post-truth claims to study the contestation of truth in political communication in a systematic way. Taking the Twitter communication of Donald Trump as a prime example, we illustrate the employability of our approach via a pilot study on the longest period of shutdown in US history (22 December 2018–25 January 2019). As a result, we introduce claims analysis as an approach that can be usefully adapted to study post-truth discourses. [ABSTRACT FROM AUTHOR]

Background Since Food and Drug Administration approval of brentuximab vedotin in combination with cyclophosphamide, doxorubicin, and prednisone (A + CHP) as initial therapy for previously untreated CD30-expressing peripheral T-cell lymphoma (PTCL), there has been limited research on real-world patient characteristics, treatment patterns, and clinical outcomes. Methods We retrospectively analyzed claims of patients with PTCL treated with frontline A + CHP or CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone) using the Symphony Health Solutions database. Adults with International Classification of Diseases-9/10 PTCL diagnosis codes who initiated A + CHP or CHOP between November 2018 and July 2021 were included. A 1:1 propensity score matching analysis was performed that adjusted for potential confounders between groups. Results A total of 1344 patients were included (A + CHP, n = 749; CHOP, n = 595). Before matching, 61% were men; median age at index was 62 (A + CHP) and 69 (CHOP) years. The most common A + CHP-treated PTCL subtypes were systemic anaplastic large cell lymphoma (sALCL; 51%), PTCL-not otherwise specified (NOS; 30%), and angioimmunoblastic T-cell lymphoma (AITL; 12%); the most common CHOP-treated subtypes were PTCL-NOS (51%) and AITL (19%). After matching, similar proportions of patients treated with A + CHP and CHOP received granulocyte colony-stimulating factor (89% vs. 86%, P = .3). Fewer patients treated with A + CHP received subsequent therapy than CHOP overall (20% vs. 30%, P  < .001) and specifically with the sALCL subtype (15% vs. 28%, P  = .025). Conclusions Characteristics and management of this real-world PTCL population who were older and had a higher comorbidity burden than that in the ECHELON-2 trial demonstrate the importance of retrospective studies when assessing the impact of new regimens on clinical practice. [ABSTRACT FROM AUTHOR]

Carol Bazell,1 Michael Pollack,2 Alejandro P Comellas,3 Sanjay Sethi,4 Maggie Alston,1 Bruce Pyenson,1 Dane Hansen,1 Melissa Caplen,1 Anthony Staresinic,2 John Styczynski,2 Norbert Feigler2 1Milliman, New York, NY, USA; 2BioPharmaceuticals, US Medical Affairs, AstraZeneca, Wilmington, DE, USA; 3Department of Internal Medicine, University of Iowa Carver College of Medicine, Iowa City, IA, USA; 4Department of Medicine, University at Buffalo Jacobs School of Medicine and Biomedical Sciences, Buffalo, NY, USACorrespondence: Michael Pollack, BioPharmaceuticals, US Medical Affairs, AstraZeneca, 1800 Concord Pike, Wilmington, DE, 19850, USA, Tel +1 302 886 1253, Email michael.pollack1@astrazeneca.comPurpose: We analyzed population-level administrative claims data for Medicare fee-for-service (FFS) beneficiaries to provide insights on systemic oral corticosteroid (OCS) use patterns and associated health conditions and acute events among patients newly diagnosed with chronic obstructive pulmonary disease (COPD).Background: COPD is a progressive inflammatory disease of the lungs, characterized by acute exacerbations that may lead to increased mortality. Short courses of systemic corticosteroids (SCS) are recommended to reduce recovery time from exacerbations, although SCS use has been associated with increased risk of adverse events.Methods: This study used 2013– 2019 Medicare 100% FFS research identifiable files, which contain all Medicare Parts A, B, and D paid claims incurred by 100% of Medicare FFS beneficiaries. Descriptive statistics for patients newly diagnosed with COPD were analyzed, including OCS use, select health conditions and acute events, and COPD exacerbations. Statistical models were used to analyze the relationship between the incidence of select health conditions and events and cumulative OCS dosage.Results: Of Medicare FFS patients newly diagnosed with COPD, 36% received OCS in the 48 months following diagnosis, and 38% of OCS episodes lasted longer than the recommended 5– 7 days. Patients had a variety of health conditions or acute events in the 24-month period prior to new COPD diagnosis, such as hypertension, depression/anxiety, type 2 diabetes, or osteoporosis, that could heighten the risks of OCS use. Patients treated with > 1000 mg of prednisolone equivalent OCS in the 48 months following COPD diagnosis had a higher incidence of new conditions or events, including cardiovascular disease, heart failure, hypertension, obesity, dyspepsia, infections, and depression/anxiety, than patients with no OCS use.Conclusion: These results highlight the potential risks of OCS in COPD treatment, including prolonged use among complex Medicare patients, and reinforce the importance of preventive treatment strategies and therapy optimization early in the disease course.Keywords: chronic obstructive pulmonary disease, systemic corticosteroids, SCS, OCS, COPD exacerbations, claims analysis

Samantha Tomicki,1 Gabriela Dieguez,1 David DeStephano,1 Melody Chang,2 Paul Cockrum3 1Milliman, Inc, New York, NY, USA; 2American Oncology Network, Fort Meyers, FL, USA; 3Ipsen Biopharmaceuticals, Inc, Cambridge, MA, USACorrespondence: Gabriela Dieguez, Milliman, Inc, 463 7th Avenue, 19th Floor, New York, NY, 10018 USA, USA, Tel +1 917 903 3670, Email Gabriela.Dieguez@milliman.comPurpose: Compare total cost of care (TCOC) for commercially-insured patients with metastatic pancreatic cancer receiving FDA-approved/NCCN Category 1 preferred regimens in community oncology or hospital outpatient settings.Patients and Methods: We used the 2016– 2019 MarketScan® and Milliman Consolidated Health Cost Guidelines Sources Database (CHSD) administrative claims data to compare utilization of healthcare services and expenditures for commercially-insured patients receiving chemotherapy in community oncology or hospital outpatient settings. We identified patients with metastatic pancreatic cancer using ICD-10 diagnosis codes in 2016– 2019 MarketScan® and Milliman Consolidated Health Cost Guidelines Sources Database files. Patients were assigned to cohorts based on where they received the plurality of chemotherapy services: community oncology or hospital outpatient settings. Total cost of care (TCOC) and healthcare resource utilization metrics were calculated per line of therapy (LOT) for patients receiving similar chemotherapy regimens in each cohort, and differences between cohorts were evaluated using t-testing and chi-squared statistical methods.Results: Although cohorts had similar demographics, chemotherapy regimen use, and length of therapy, the mean TCOC among all patients receiving chemotherapy in hospital outpatient settings was 41% higher compared to community oncology settings. Median TCOC was 35% higher in hospital outpatient settings than in community oncology settings. Mean admissions and readmissions per beneficiary were 7% and 16% higher, respectively, for thse treated in hospital outpatient versus community oncology settings. We observed no differences in the use of emergency department or hospice care between the cohorts.Conclusion: Our study indicates that patients receiving chemotherapy at community oncology centers are associated with better or equivalent outcomes and lower costs than patients receiving the same regimen in a hospital outpatient setting.Keywords: chemotherapy, reimbursement, 340B, claims analysis

Stronger European Union (EU) competencies come with greater media presence, according to existing cross-sectional comparisons. While presence comes with the power to influence public discourse, we know little about how it affects the overall tone of public discourse. This article investigates the effect of the empowerment of EU institutions on media presence and the tone of debate in the EU. It does this through an original claims analysis of newspaper articles in Germany, France, Italy, Spain, Denmark, and Poland during the height of the Euro crisis (2011–2012), the Greek bailout crisis (2015), and the Italian budget crisis (2018). EU media presence indeed increases following empowerment. However, this does not result in a more pro-European debate, because pro-European national voices are crowded out. While this does not affect the desirability of austerity, it does harden Eurosceptic public discourse. [ABSTRACT FROM AUTHOR]

Anuja Roy,1 Andrew Peterson,2 Nick Marchant,1 Jose Alvir,3 Rahul Bhambri,4 Jason Lynn,4 Darrin Benjumea,5 Sapna Prasad,6 Alex O’Brien,6 Yong Chen,7 Jason Kemner,8 Bhash Parasuraman8 1Global HEOR, Patient & Health Impact, Rare Diseases BU, Pfizer Inc, New York, NY, USA; 2Department of Pharmacy Practice/Pharmacy Administration, University of the Sciences, Philadelphia, PA, USA; 3Statistical Research and Data Science Center Global Product Development, Pfizer Inc, New York, NY, USA; 4Medical Affairs, Pfizer Inc, New York, NY, USA; 5Evidence Strategy, Genesis Research, Hoboken, NJ, USA; 6Clarify Insights Services, Clarify Health Solutions, New York, NY, USA; 7Rare Disease, Pfizer Inc, Collegeville, PA, USA; 8Patient & Health Impact, Pfizer Inc, Collegeville, PA, USACorrespondence: Anuja Roy, Global HEOR, Patient & Health Impact, Rare Diseases BU, Pfizer Inc, New York, NY, USA, Email Anuja.Roy@pfizer.comIntroduction: Transthyretin amyloid cardiomyopathy (ATTR-CM) is a serious, underrecognized condition, which leads to heart failure and early mortality if left untreated. Until recently, heart transplantation was the only treatment for ATTR-CM. Regulatory approval of tafamidis transformed treatment for patients. In the phase 3 Transthyretin Amyloidosis Cardiomyopathy Clinical Trial (ATTR-ACT), which established the safety and efficacy of tafamidis, medication adherence was high with 97.2% of patients taking ≥ 80% of scheduled doses. Evidence of real-world adherence to cardiology drugs demonstrates low adherence and suboptimal outcomes; however, real-world adherence to tafamidis has not been investigated. The main objective of this study was to describe adherence patterns of patients filling tafamidis in the Symphony Health database.Methods: This retrospective analysis of the Symphony Health Solutions claims database used secondary adherence measures, including modified medication possession ratio (MPRm), days between fills adherence rate, and compliance rate, to assess adherence patterns of 2020 patients filling tafamidis free acid 61-mg capsules or tafamidis meglumine 4x20-mg capsules from June 1, 2019 to August 31, 2020.Results: Patients receiving a tafamidis formulation had characteristics consistent with the expected patient population; 71.6% were aged 75– 84 years, 83.2% were male, and the highest proportion resided in the Northeast region (30.5%) of the United States. Adherence for tafamidis was high, as 75% to 100% of the patients across subgroups met or exceeded the commonly defined adherence threshold of 80%. Median number of refills ordered and received was six refills per patient. Most patients received refills with no gap (n=1633) or a gap < 30 days (n=1267/1317 patients). Adherence was high across follow-up time, sex, and age subgroups. Adherence varied by geographic region, with the Northeast being significantly higher than the Midwest (mean MPRm 94.41% vs 88.21%, p=0.0007).Conclusion: These results provide evidence that real-world adherence to tafamidis in patients with ATTR-CM is high.Keywords: claims analysis, amyloidosis, cardiomyopathy, transthyretin amyloid, adherence

#MeToo has raised public awareness on issues of sexual harassment and misconduct at an unprecedented scale, nurturing hopes for sustainable change also in terms of gender equality. We use the concept of politicization to assess the potential for change which #MeToo might have induced in the broader print media discourse on gender equality issues. We analyse Australia as an arguably difficult case due to its conservative political and media system, thus offering political activism rather dire prospects of public resonance. We assess a total of two years of media coverage in the eight largest newspapers (October 2016 – September 2018), combining automated content analysis with manual claims analysis. Our results speak to the societal debate on gender equality as well as the potential of online social movements to change mainstream discourses and social realities. [ABSTRACT FROM AUTHOR]

Introduction/Background Patients with atopic dermatitis (AD) may be at an increased risk for a range of malignancies, including lymphoma.1 However, real-world data characterizing malignancy risk among US patients with AD remain limited. Objective To evaluate the risk of malignancy excluding non-melanoma skin cancer (NMSC) in patients with AD compared to individuals without AD and to those with rheumatoid arthritis (RA). Additionally, these analyses were repeated in a subgroup of patients with moderate-to-severe disease to evaluate the effect of disease activity on cancer risk. Methods This retrospective observational claims-based study utilized the Optum Clinformatics Data Mart. Eligible patients were aged ≥18 years with a diagnosis of AD or RA during the study period (March 2017–December 2019). Diagnosis was determined using International Classification of Diseases (ICD)-9 or ICD-10 codes for AD (≥2 claims for AD or ≥1 claim for AD with asthma and/or hay fever, food allergies, allergic rhinitis, or eczema) and RA (≥2 claims ≥ 7 days apart and filled by a rheumatologist). Receipt of advanced systemic therapy during the follow-up period was used as a proxy for disease severity in patients with AD (dupilumab only) and RA. Patients with AD were matched 1:1 with non-AD controls based on age (±1 year), sex, and cohort entry date. Follow-up occurred until study end, disenrollment, death, or occurrence of an adverse event of interest. Malignancies excluding NMSC were identified based on 2 separate ICD diagnosis codes ≥30 days apart in an inpatient or outpatient setting. For each comparative analysis, the risk of malignancy excluding NMSC was calculated using a multivariable-adjusted Cox proportional hazards model with results reported as an adjusted hazard ratio (aHR). Results This analysis included 391,753 patients with AD (7136 with moderate-to-severe AD) and 97,455 patients with RA (35,846 with moderate-to-severe RA). The matched non-AD cohort included 381,221 patients and the matched non-AD cohort for moderate-to-severe disease included 7134 patients. The mean (SD) age at cohort entry date was lower for patients in the AD and matched non-AD controls than those in the RA cohort (58.0 [18.8] years for AD, 58.1 [18.8] years for non-AD controls, and 67.0 [13.6] years for RA). Median (IQR) follow-up was 1093 (490–1492) days for AD, 995 (357–1552) days for non-AD controls, and 1190 (484–1773) days for RA. The incidence of malignancies excluding NMSC per 100 patient-years (95% CI) was 2.18 (2.15, 2.21) for AD, 2.38 (2.35, 2.41) for non-AD controls, 3.32 (3.25, 3.38) for RA, 2.43 (2.18, 2.69) for moderate-to-severe AD, and 2.57 (2.47, 2.67) for moderate-to-severe RA. The risk of malignancies excluding NMSC (aHR [95% CI]) was lower for AD vs matched non-AD controls (0.92 [0.90, 0.93]; P <.001) and for moderate-to-severe AD vs their matched non-AD controls (0.76 [0.63, 0.91]; P <.01). Although the risk of malignancies excluding NMSC (aHR [95% CI]) was lower in patients with AD vs RA (0.97 [0.94, 0.99]; P =.03), there was no significant difference in risk for patients with moderate-to-severe AD vs moderate-to-severe RA (1.06 [0.95, 1.18]; P =.28). Among patients with AD, the risk of malignancies excluding NMSC (aHR [95% CI]) was greater among patients who were older (1.04 [1.04, 1.04]; P <.001) and those with a history of any type of malignancy excluding NMSC and including recurrence (12.76 [12.32, 13.22]; P <.001), cardiovascular disease (1.12 [1.07, 1.17]; P <.01), smoking (1.15 [1.11, 1.19]; P <.01), asthma (1.05 [1.01, 1.08]; P <.01), or chronic liver disease (1.16 [1.10, 1.22]); P <.01). Conclusions Patients with AD demonstrated a lower risk of malignancy excluding NSMC vs matched controls without AD. This lower risk was also observed in patients with moderate-to-severe AD vs their matched non-AD controls and in patients with AD vs RA. [ABSTRACT FROM AUTHOR]

• Discontinuation rates of all initial DOACs used were high. • Non-persistence was lower with apixaban versus VKAs, rivaroxaban and dabigatran. • Only a minority of those who discontinued a given OAC switched to another one. Direct oral anticoagulants (DOACs) were developed as an alternative to vitamin K antagonists (VKAs) and are commonly used for stroke prevention in patients with non-valvular atrial fibrillation (NVAF). Unlike VKAs, DOACs do not require Internal Normalized Ratio (INR) monitoring, but regular intake is as important for effective anticoagulation. This study examined treatment persistence among patients receiving oral anticoagulants (OACs) for NVAF. Within the French healthcare claims database (SNDS), we assessed and compared the rates of non-persistence (≥ 30-day treatment gap) among patients with NVAF initiating an OAC between January 2014 and December 2016. The time-to-event of non-persistence was computed and plotted using a cumulative incidence function accounting for the competing risk of mortality. After adjusting on confounding factors, the risk for non-persistence was compared between apixaban and each other OACs using a Cox proportional hazard model, or Fine and Gray models. In a cohort of 321,501 OAC-naive patients with NVAF, the cumulative incidence of non-persistence at 12 months considering competing risk was 44.3%, 31.0%, 41.3% and 46.8% for VKAs, apixaban, rivaroxaban and dabigatran, respectively. Median therapy duration before non-persistence ranged between 70 and 121 days. Non-persistence was lower with apixaban compared with VKAs (HR = 0.63, 95%CI = [0.62–0.64]), rivaroxaban (HR = 0.71, 95%CI = [0.70–0.73]), and dabigatran (HR = 0.60, 95%CI = [0.59–0.62]). In this nationwide observational study, non-persistence rates of oral anticoagulant treatment were high in patients treated for NVAF. Apixaban-treated patients seem to experience lowest discontinuation rates 12 months after treatment initiation compared to patients treated with any other OAC. [ABSTRACT FROM AUTHOR]

Aims: The objective of this analysis was to describe longitudinal adherence with recommended urinary incontinence (UI) evaluation and treatment guidelines over a 2‐year period in patients newly diagnosed with stress (SUI) or mixed UI (MUI), and average 2‐year cost associated with initial treatment. Methods: A retrospective claims analysis using the IBM MarketScan database was conducted. Women diagnosed with SUI/MUI between July 1, 2014 and June 30, 2016 were identified using the International Classification of Diseases (ICD) 9 and 10 codes for SUI or MUI. Newly diagnosed SUI/MUI patients who did not have a UI‐related diagnosis for at least 1 year before their index date were assessed. Results: 103 813 patients with newly diagnosed SUI or MUI were identified. Of those, 96.15% (99 821/103 813) received an initial evaluation in accordance with professional guidelines (e.g., patient history, physical examination, urinalysis). Only 6.8% (5086/74 925) and 7.7% (2229/28 888) of patients with SUI and MUI, respectively, received a first‐line behavioral treatment (e.g., pelvic floor muscle exercises, bladder training), according to guidelines. The 2‐year average UI‐related medical costs associated with guideline adherence for SUI were $5770.93 ± $9454.81 and for MUI, $4416.16 ± $7401.53. Nonadherence was observed in 59.2% (44 382/74 925) of SUI and 64.1% (18 530/28 888) of MUI patients. Two‐year average UI‐related medical costs for the nonadherent group were $8568.00 ± $11 275.52 for SUI and $6986.66 ± $10 765.55 for MUI, significantly more than the adherent group (p < 0.0001). Conclusion: The majority of SUI or MUI patients do not receive a documented behavioral intervention as their first‐line treatment, which is a recommendation by professional society guidelines. This was found to affect the cost burden for payers; those that were nonadherent had significantly higher costs 2‐year postindex. [ABSTRACT FROM AUTHOR]

Aims: To examine the incidence of interventions for diabetic retinopathy and serious limb complications and to elucidate the patient attributes related to the incidence of each intervention based on real-world claims data from Japan. Materials and methods: A retrospective longitudinal study design involving a 9 year (2009–2018) claims database obtained from the JMDC Inc. Patients with type 2 diabetes aged 20–74 years taking antidiabetic medications were divided into two groups: "patients with newly initiated antidiabetic medication" (Group 1, n = 47,201) and "patients with continuing antidiabetic medication" (Group 2, n = 82,332). The incidence rate for each intervention was analyzed. We also divided Group 1 into the former and latter periods and investigated temporal changes. Results: The incidences of the first retinopathy intervention (laser photocoagulation, vitrectomy, or intraocular injection), vitrectomy, and lower-limb amputations in Group 1 were 7.46, 2.37, and 0.31 /1000 person-years, respectively. Those in Group 2 were about 1.2–1.5 times higher. Older age, insulin use, and being dependents rather than insured persons were associated with a higher incidence in both groups after adjustment. While the incidence of the interventions for retinopathy hardly changed during the observation period, that of lower-limb amputations decreased by 40%, with less statistical significance (p = 0.11). Conclusions: We showed the incidences of the first retinopathy interventions and lower-limb amputations and their secular trends in patients with diabetes, stratified by whether the antidiabetic medication was newly initiated or not. Older age, insulin use, and being dependents were risk factors of these interventions for diabetic complications. [ABSTRACT FROM AUTHOR]

Medicaid claims are an important, but underutilized source of data for neonatal health services research in the United States. However, identifying live births in Medicaid claims data is challenging due to variation in coding practices by state and year. Methods of identifying live births in Medicaid claims data have not been validated, and it is not known which methods are most appropriate for different research questions. The objective of this study is to describe and validate five approaches to identifying births using Medicaid Analytic eXtract (MAX) from 45 states (2006–2014). We calculated total number of MAX births by state-year using five definitions: (1) any claim within 30 days of birth date listed in personal summary (PS) file, (2) any claim within 7 days of PS birth date, (3) live birth ICD-9 in inpatient or other therapies file, (4) live birth ICD-9 code in inpatient file, (5) live birth ICD-9 in inpatient file with matching PS birth date. We then compared the number of MAX births by state and year to expected counts using outside data sources. Definition 1 identified the most births (14,189,870) and was closest to total expected count (98.3%). Each definition produced over- and underestimates compared to expected counts for given state-years. Findings suggest that the broadest definition of live births (Definition 1) was closest to expected counts, but that the most appropriate definition depends on research question and state-years of interest. [ABSTRACT FROM AUTHOR]