Economic Outcomes In Patients Research Articles

Health outcomes and economic burden among patients with a COVID-19-associated hospitalization in the United States during the predominance of the XBB and JN.1 omicron lineages

Objective Conduct a comprehensive analysis of the health and economic outcomes of patients with a COVID-19-associated hospitalization in the US during the predominance of the XBB and JN.1 Omicron lineages. Methods This analysis used data from the PINC AI Healthcare Database (PHD) for all patients with a hospital admission date occurring between February 4, 2023, and February 29, 2024 with an ICD-10-CM code U07.1 “COVID-19” in any position. The data were used to estimate the mean and median length of stay (LOS), mean and median hospitalization cost, and proportion of patients that died in the hospital, by age and level of care (normal ward, intensive care [ICU], invasive mechanical ventilation [IMV]). Results LOS, hospitalization costs, and inpatient mortality increased with both the level of care and age. Patients not receiving ICU care had the shortest LOS, lowest inpatient mortality, and lowest hospitalization costs. LOS, hospitalization costs, and inpatient mortality were higher for those receiving ICU care and highest for those receiving IMV in the ICU. Within each level of care (normal ward, ICU without IMV, and ICU with IMV), the LOS, inpatient mortality, and hospitalization cost generally increased with age, indicating that older adults with COVID-19 required a longer recovery period, have a higher likelihood of death, and accrue higher costs. However, the proportion of pediatric patients with an ICU admission and/or IMV usage remained high. Limitations The PHD data may not be representative of all hospitalized patients in the US. Conclusions These findings suggest that COVID-19 continues to have severe and costly consequences in all age groups, but particularly for older adults including long LOS, ICU admission, need for IMV, mortality, and high hospital costs.

Treatment switching and associated economic outcomes in patients with plaque psoriasis treated with biologics: A retrospective analysis of German claims data 2016−2021

AbstractBackgroundBiologics are therapeutic options for the management of moderate−severe plaque psoriasis. Some patients need to switch biologic treatment to achieve satisfactory outcomes, which might have a considerable economic impact.ObjectivesWe assessed the characteristics and switch rates of patients with plaque psoriasis initiating biologic treatment and compared healthcare resource utilization (HCRU) and associated costs for switching and non‐switching.MethodsThis study was a retrospective claims‐based analysis comprising a 182‐day baseline period to identify patient characteristics and a 365‐day follow‐up to assess switch rates, HCRU and associated costs. Data covering claims activity from 2016 to 2021 in a representative sample of four million individuals with statutory insurance in Germany was used.ResultsWe identified 2565 patients with psoriasis initiating biologic treatment with anti‐IL‐17 (n = 1037), anti‐IL‐23 (n = 704), anti‐TNF‐α (n = 583) and anti‐IL‐12/23 (n = 241) agents. A total of 9.2% of patients switched therapy to another biologic during follow‐up, ranging from 4.9% (secukinumab) to 16.5% (etanercept). The probability of treatment switching was significantly lower in patients treated with risankizumab (p < 0.05) than in patients treated with other biologics except guselkumab (p = 0.14). HCRU and associated costs during the follow‐up were generally higher with a therapy switch (all‐cause: 32,263 ± 15,381€) than without (25,041 ± 12,090€). This applied to direct costs (outpatient services, hospitalization, drug treatment) and indirect costs (sickness benefits). Drug treatment accounted for the largest share of costs.ConclusionsTreatment switching is frequent in patients with moderate−severe plaque psoriasis initiating biologic therapy and is associated with increased HCRU and associated costs. As the probability that a switch occurs within 365 days after treatment initiation widely differs between biologic agents, further research is warranted to determine the underlying reasons for switching to help establish clinically and economically sound therapy sequences.

Dose escalation and associated economic outcomes in patients with psoriasis treated with biologics: A retrospective analysis of German health claims data.

In Germany, several biologic therapies are available for the treatment of moderate-to-severe plaque psoriasis, with the option of exceeding recommended dosages if standard dosing does not achieve a satisfactory treatment response. To examine dose escalation in patients with biologic-treated psoriasis and associated cost development for German statutory health insurance (SHI). We conducted a retrospective, non-interventional cohort study using German SHI health claims data from 2016 to 2021. Adult patients initiating biologic treatment were included in drug-specific cohorts. The odds for dose escalation, defined as the exceedance of the individually received daily dose over the maintenance dose recommended by the European product information, was compared between cohorts using multivariate logistic regression. The impact of dose escalation on SHI expenditures was analyzed with a generalized linear model. The relative frequency of dose escalation varied between cohorts (range 1.1% [risankizumab] to 42.9% [infliximab]). Compared to risankizumab-treated patients, the odds for dose escalation were statistically significantly (p < 0.05) higher in patients treated with all other biologic drugs except tildrakizumab. Patients with dose escalation during the maintenance phase accrued on average €6,473 more in direct healthcare costs to the SHI over a one-year period compared to those without dose escalation, with statistical significance (p < 0.05) after controlling for differences in covariates. Compared to patients treated with other biologics, dose escalation during the maintenance phase was lowest among risankizumab-treated patients. Dose escalation was associated with higher costs and thus a higher economic burden for the German SHI.

Real-world clinical and economic outcomes for patients with advanced non-small cell lung cancer enrolled in a clinical trial following comprehensive genomic profiling via liquid biopsy.

Oncology clinical trial enrollment is strongly recommended for patients with cancer who are not eligible for established and approved therapies. Many trials are specific to biomarker-targeted therapies, which are typically managed as specialty pharmacy services. Comprehensive genomic profiling (CGP) of advanced cancers has been shown to detect biomarkers, guide targeted treatment, improve outcomes, and result in the clinical trial enrollment of patients, which is modeled to offset pharmacy costs experienced by US payers, yet payer policy coverage remains inconsistent. A common concern limiting coverage of CGP by payers is the potential of identifying biomarkers beyond guideline-recommended treatments, which creates a perception that insurance companies are being positioned to "pay for research." However, these biomarkers can increase clinical trial eligibility, and specialty pharmacy management may have an interest in maximizing the clinical trial enrollment of members. To investigate if clinical trial enrollment following liquid biopsy CGP for non-small cell lung cancer (NSCLC) is clinically and/or economically impactful from a payer claims perspective. Clinical and economic outcomes were studied using a real-world clinical genomic database (including payer claims data) from patients with NSCLC who enrolled in clinical trials immediately following liquid biopsy CGP (using Guardant360) and matched NSCLC patient controls also tested with liquid biopsy CGP. Real-world overall survival was significantly (log-rank P < 0.0001) better for patients enrolled in clinical trials with similar costs of care, albeit with more outpatient encounters among those enrolled compared with matched controls. The results, together with previous analyses, suggest that, in addition to the clinical benefits associated with targeted therapies directed by CGP and other testing approaches, payers and specialty pharmacy managers may consider clinical trial direction and enrollment as a clinical and economic benefit of liquid biopsy CGP and adopt this into coverage decision frameworks and formularies.

The Atrial FibriLlatiOn (FLOW-AF) Registry in the Middle East and North Africa: Patient Characteristics, Treatment Patterns and Outcomes.

Limited data on atrial fibrillation (AF) are available from the Middle East and North Africa region (MENA). The aim of the FLOW-AF registry was to evaluate the characteristics, treatment patterns, and clinical and economic outcomes ofpatients with newly diagnosed non-valvular atrial fibrillation (NVAF) in MENA. This multi-center, prospective, observational study (the FLOW-AF registry) enrolled patients newly diagnosed with NVAF across Egypt, Lebanon, Kingdom of Saudi Arabia, and United Arab Emirates. The data collection occurred at enrollment (baseline) and after 6- and 12-months (follow-up). Baseline data included demographics, AF characteristics, medical history, and anti-thrombotic treatment patterns. Clinical events, healthcare resource utilization, and direct costs were collected at follow-up. The study enrolled a total of 1418 patients (52.7% males and 47.3% females). The mean age of the patients was 64.5years and 90.6% were white. The mean (standard deviation) CHA2DS2-VASc and HAS-BLED risk scores were 2.7 (1.6) and 1.6 (1.2), respectively. Non-vitamin K antagonist oral anticoagulants, antiplatelet therapy, and vitamin K antagonists were prescribed to 65.8%, 16.4%, and 12.9% patients, respectively. During follow-up, the following rates of clinical outcomes were observed: bleeding events (1.7%), transient ischemic attack (1.7%), all-cause mortality (1.7%), stroke (0.6%), myocardial infarction (0.2%), and systemic embolism (0.08%). This MENA patient population was younger and had lower mean baseline CHA2DS2-VASc and HAS-BLED scores. The rates of clinical outcomes over 1-year in this study were low. Longer follow-up is required to comprehensively assess clinical outcomes in this patient population.

Clinical and economic burden of medicare beneficiaries with multiple myeloma and renal impairment: An observational study.

Evidence on real-world clinical and economic outcomes in patients with multiple myeloma (MM) and renal impairment (RI) is limited in the United States. This retrospective study aimed to generate an updated comprehensive assessment of the clinical and economic outcomes of MM patients with RI using the Medicare research identifiable files data with Part D linkage, which might assist in assessing the total clinical and socioeconomic burden of these high-risk and challenging-to-treat patients. Treatment patterns and clinical and economic outcomes in first line (1L) to fourth line (4L) therapy were described in Medicare beneficiaries (2012 to 2018) for MM patients with RI (RI MM cohort). For reference purposes, information on a general cohort of MM patients was generated and reported to highlight the clinical and economic burden of RI. Since the goal was to describe the burden of these patients, this study was not designed as a comparison between the 2 cohorts. Compared with the general MM cohort (n = 13,573), RI MM patients (24.9%) presented high MM-associated comorbidities. In the RI MM cohort, bortezomib-dexamethasone (45.7%), bortezomib-lenalidomide (18.6%), lenalidomide (12.3%), and bortezomib-cyclophosphamide (12.1%) were the most prevalent regimens in 1L; carfilzomib and pomalidomide were mostly received in 3L to 4L; and daratumumab in 4L. Across 1L to 4L, the RI MM cohort presented shorter median real-world progression-free survival (1L: 12.9 and 16.4 months) and overall survival (1L: 31.1 and 46.8 months) and higher all-cause healthcare resource utilization (1L incidence rate of inpatient days: 12.1 and 7.8 per person per year) than the general MM cohort. In the RI MM cohort, the mean all-cause total cost increased from 1L to 4L ($14,549-$18,667 per person per month) and was higher than that of the general MM cohort. RI MM patients presented higher clinical and economic burdens across 1L to 4L than the general MM patients in real-world clinical practice.

MT15 Postoperative Clinical and Economic Outcomes of Patients With Reverse or Anatomic Total Shoulder Arthroplasty at One Year: A Retrospective, United States Hospital Billing Database Analysis

MT15 Postoperative Clinical and Economic Outcomes of Patients With Reverse or Anatomic Total Shoulder Arthroplasty at One Year: A Retrospective, United States Hospital Billing Database Analysis

Patient-reported outcomes and healthcare resource utilization in systemic lupus erythematosus: impact of disease activity

BackgroundLimited real-world data exists on clinical outcomes in systemic lupus erythematosus (SLE) patients by SLE Disease Activity Index 2000 (SLEDAI-2 K), hereafter, SLEDAI. We aimed to examine the association between SLEDAI score and clinical, patient-reported and economic outcomes in patients with SLE.MethodsRheumatologists from the United States of America and Europe provided real-world demographic, clinical, and healthcare resource utilization (HCRU) data for SLE patients. Patients provided self-reported outcome data, capturing their general health status using the EuroQol 5-dimension 3-level questionnaire (EQ-5D-3 L), health-related quality of life using the Functional Assessment of Chronic Illness Therapy (FACIT) and work productivity using the Work Productivity and Activity Impairment questionnaire (WPAI). Low disease activity was defined as SLEDAI score ≤ 4 and ≤ 7.5 mg/day glucocorticoids; patients not meeting these criteria were considered to have “higher” active disease. Data were compared between patients with low and higher disease activity. Logistic regression estimated a propensity score for SLE based on demographic and clinical characteristics. Propensity score matched analyses compared HCRU, patient-reported outcomes, income loss and treatment satisfaction in patients with low disease activity versus higher active disease.ResultsData from 296 physicians reporting on 730 patients (46 low disease activity, 684 higher active disease), and from 377 patients’ self-reported questionnaires (24 low disease activity, 353 higher active disease) were analyzed. Flaring in the previous 12 months was 2.6-fold more common among patients with higher versus low active disease. Equation 5D-3 L utility index was 0.79 and 0.88 and FACIT-Fatigue scores were 34.78 and 39.79 in low versus higher active disease patients, respectively, indicating better health and less fatigue, among patients with low versus higher active disease. Absenteeism, presenteeism, overall work impairment, and total activity impairment were 47.0-, 2.0-, 2.6- and 1.5-fold greater in patients with higher versus low disease activity. In the previous 12 months there were 28% more healthcare consultations and 3.4-fold more patients hospitalized in patients with higher versus low disease activity.ConclusionCompared to SLE patients with higher active disease, patients with low disease activity experienced better health status, lower HCRU, less fatigue, and lower work productivity impairment, with work absenteeism being substantially lower in these patients.

Postoperative revision, complication and economic outcomes of patients with reverse or anatomic total shoulder arthroplasty at one year: a retrospective, United States hospital billing database analysis

BackgroundData on the one-year postoperative revision, complication, and economic outcomes in a hospital setting after total shoulder arthroplasty (TSA) are sparse. MethodsA retrospective cohort study using the Premier Healthcare Database, a hospital-billing data source, evaluated one-year postoperative revision, complication, and economic outcomes of reverse (RTSA) and anatomic (ATSA) TSA for patients who underwent the procedure from 2015 until 2021. All-cause revisits, including revision-related events (categorized as either irrigation and débridement or revision procedures and device removals) and shoulder/non-shoulder complications were collected. The incidences and costs of these revisits were evaluated. Generalized linear models were used to evaluate the associations between patient characteristics and revision and complication occurrences and costs. ResultsAmong 51,478 RTSA and 34,623 ATSA patients (mean [standard deviation (SD)] ages RTSA 71.5 [8.1] years, ATSA 66.8 [9.0] years), one-year adjusted incidences of all-cause revisits, irrigation/débridement, revision procedures/device removals, and shoulder/non-shoulder complications were RTSA: 45.0% (95% confidence interval (CI): 44.6%-45.5%), 0.1% (95% CI: 0.1%-0.2%), 2.1% (95% CI: 2.0%-2.2%), and 17.8% (95% CI: 17.5%-18.1%) and ATSA: 42.3% (95% CI: 41.8%-42.9%), 0.2% (95% CI: 0.1%-0.2%), 1.9% (95% CI: 1.8%-2.1%), and 14.4% (95% CI: 14.0%-14.8%), respectively; shoulder-related complications were RTSA: 12.4% (95% CI: 12.1%-12.7%) and ATSA: 9.9% (95% CI: 9.6%-10.3%). Significant factors associated with a high risk of revisions and complications included, but were not limited to, chronic comorbidities and noncommercial insurance. Per patient, the mean (SD) total one-year hospital cost was $25,225 ($15,911) and $21,520 ($13,531) for RTSA and ATSA, respectively. Revision procedures and device removals were most costly, averaging $22,920 ($18,652) and $26,911 ($18,619) per procedure for RTSA and ATSA, respectively. Patients with revision-related events with infections had higher total hospital costs than patients without this event (RTSA: $60,887 (95% CI: $56,951-$64,823) and ATSA: $59,478 (95% CI: $52,312-$66,644)), equating to a mean difference of $36,148 with RTSA and $38,426 with ATSA. Significant factors associated with higher costs of revision-related events and complications included age, race, chronic comorbidities, and noncommercial insurance. ConclusionsNearly 45% RTSA and 42% ATSA patients returned to the hospital, most often for shoulder/non-shoulder complications (overall 17.8% RTSA and 14.4% ATSA, and shoulder-related 12.4% RTSA and 9.9% ATSA). Revisions and device removals were most expensive ($22,920 RTSA and $26,911 ATSA). Infection complications requiring revision had the highest one-year hospital costs (∼$60,000). This study highlights the need for technologies and surgical techniques that may help reduce TSA healthcare utilization and economic burden.

Effectiveness and economic outcomes in patients undergoing laparoscopic radical prostatectomy with a new surgical shear with an integrated energy system: A retrospective study based on a tertiary hospital database in China

ObjectiveThis study aimed to demonstrate a new surgical shear with an integrated energy system (Harmonic ACE®+7) value by determining its effectiveness and economic outcomes compared with conventional ultrasonic shears (CUSs) in a real-world setting. MethodsThis was a retrospective study of adults with prostate cancer undergoing laparoscopic radical prostatectomy with the ACE®+7 shear or CUSs between August 2019 and April 2021 at Shanghai Ruijin Hospital (the headquarters and Luwan Center in China). Demographic and diagnosis information, intraoperative and postoperative clinical outcomes, and total and categorical costs were collected. Propensity score matching was performed to form the study population for each clinical group. Data were compared between the two groups using t-test and Chi-squared test. ResultsThe ACE®+7 was associated with a lower mean number of hemostatic clips used per surgery compared with CUSs (12.8 vs. 19.8, p<0.001), a moderate but not significant difference in mean postoperative drainage duration (6.6 [standard deviation, SD 2.2] days vs. 7.9 [SD 4.1] days, p=0.082), a reduction on mean total drainage volume (275.5 [SD 374.3 mL vs. 492.9 [SD 1495.0] mL, p=0.321), and a lower average rate of postoperative hemostatic drug usage (16.0% vs. 52.0%, p<0.001). There was no significant difference in total costs between the ACE®+7 and CUS groups. ConclusionThis study provides real-world data demonstrating that the ACE®+7 shear with an integrated energy system improves clinical outcomes compared with CUSs and can offer cost savings for hospitals and health systems. Using the ACE®+7 during laparoscopic radical prostatectomy allows physicians to help their patients achieve better outcomes and not spend additional money.

Clinical and Economic Outcomes of Patients with Osteoporosis Undergoing Spine Fusion Surgery in Japan.

Spinal fusion surgery with instrumentation is a treatment of choice for many spinal disorders; however, there is little data related to factors associated with early and late outcomes, especially among patients with poor bone quality (e.g., osteoporosis). We conducted this study to characterize the epidemiology and outcomes of patients undergoing spinal fusion surgery with instrumentation in Japan, especially in patients with poor bone quality and those needing additional fixation methods. This retrospective observational study used real-world health insurance claims data from the Japanese Medical Data Vision. Adult patients undergoing an index spinal fusion procedure from April 1, 2010, to September 30, 2017, with procedural details, length of stay (LOS), total in-hospital costs, spine-related reoperation, all-cause readmission, and postoperative complications recorded. Data were summarized descriptively overall, by osteoporosis status, and additional fixation method used, and were analyzed in bivariate analyses. Multivariate logistic and linear regressions were used to explore associations between covariates and variables of interest. A total of 22,932 patients (mean age, 67.3 years; 51.2% male) met the study criteria and were included. A total of 5,288 (23.0%) patients had osteoporosis, and 2,507 (10.9%) needed additional fixation methods; these patients were older, more frequently female, and had higher Elixhauser comorbidity index scores. Osteoporosis and additional fixation use were also associated with longer LOS, higher hospital costs, and higher rates of complications. Patients with osteoporosis and those needing additional fixation methods have a higher risk for procedural and postoperative complications, reoperation, longer LOS, and higher total hospital costs.

The Impact of Systemic Lupus Erythematosus Flares on Clinical and Economic Outcomes: The CHAMOMILE Claims Database Study in Germany.

CHAMOMILE (CHaracteristics and impact of flares on clinicAl and econoMic OutcoMes In patients with systemic Lupus Erythematosus [SLE]) examined how flares in the year of SLE diagnosis impact future disease activity and damage, productivity, healthcare resource utilization (HCRU), and costs in patients with SLE in Germany. CHAMOMILE was a retrospective cohort study of adults with an SLE diagnosis in the German Sickness Fund Database from 1July 2010 to 31December 2013. Patients were classified according to their greatest flare severity during the baseline year (none, mild, or moderate/severe). The number and severity of flares were assessed annually over 5-8.5 follow-up years, along with SLE organ/system damage, treatments, work disability, and HCRU metrics. Of 2088 patients (84.6% female; mean age [standard deviation] 51.4 [16.1] years; mean follow-up 6.8 [2.1] years), 34.3% (n = 716) were flare-free, 29.8% (n = 622) had mild flares, and 35.9% (n = 750) had moderate/severe flares at baseline. Baseline flare severity was related to future flares: rates during follow-up were higher in patients with moderate/severe baseline flares compared with those with mild or no baseline flares (89.6 vs 78.5 and 44.2 flares/100 patient years, respectively). Overall, 80.2% (n = 1675) of patients received glucocorticoids at least once during baseline and follow-up. Patients' HCRU was generally greatest in their baseline year. Costs were highest in patients with moderate/severe baseline flares. Baseline flare severity provided insight into a patient's disease course and the clinical and economic burden of SLE over time, highlighting the ramifications of uncontrolled disease for patients with SLE.

Impact of Demographics and Insurance Coverage on Schizophrenia Treatment and Healthcare Resource Utilization Within an Integrated Healthcare System.

Little is known about the impact of health disparities on antipsychotic treatment and healthcare resource utilization (HRU) among patients with schizophrenia. The objective of this analysis is to examine treatment patterns and HRU by age, race/ethnicity, and insurance coverage among patients with schizophrenia in an integrated delivery network (IDN). This cross-sectional study used electronic health record data from MedStar Health, an IDN in the Baltimore-Washington, DC, area. Patients were aged ≥18 years and had ≥2 outpatient encounters or ≥1hospitalization with a diagnosis of schizophrenia between January 1, 2017 and March 31, 2021. Outcomes assessed included oral antipsychotic prescriptions, long-acting injectable antipsychotic (LAI) utilization, hospitalizations, emergency department (ED) visits, and outpatient visits. Analyses compared subgroups based on age, race/ethnicity (non-Hispanic Black, non-Hispanic White, and other), and type of insurance coverage at index (Medicare, Medicaid, and other) during 12 months of follow-up. A total of 78.1% of patients had ≥1 prescription for an antipsychotic and 69.1% received ≥1 second-generation antipsychotic. Second-generation long-acting injectables (SGA LAI) were utilized by 9.0% of patients, with the elderly and Medicaid beneficiaries having the lowest SGA LAI utilization. Overall, 61.7% of patients had ≥1hospitalization, 56.4% had ≥1 outpatient visit, and 50.5% had ≥1 ED visit. Hospitalizations and ED visits were most common in those 18 to 24 years of age and in Medicaid beneficiaries, whereas outpatient visits were more common for the elderly and Medicare beneficiaries. At the population level, the results indicate widespread underprescription/underutilization of antipsychotics that have been shown to improve clinical and economic outcomes in patients with schizophrenia, particularly SGA LAI. Within specific subpopulations, disparities in treatment selection and HRU were observed, suggesting the need for increased attention to at-risk groups to ensure consistent quality of care regardless of age, race/ethnicity, or insurance coverage.

Economic and clinical burden of managing transfusion-dependent β-thalassemia in the United States

AimsTo describe clinical complications, treatment use, healthcare resource utilization (HCRU), and costs among patients with transfusion-dependent β-thalassemia (TDT) in the United States.Materials and methodsMerative MarketScan Databases were used to identify patients with β-thalassemia between 1 March 2010, and 1 March 2019. Patients were eligible for inclusion with ≥1 inpatient claim or ≥2 outpatient claims for β-thalassemia and ≥8 red blood cell transfusions (RBCTs) during any 12-month period after and including the date of the first qualifying β-thalassemia diagnosis code. Matched controls consisted of individuals without β-thalassemia. Clinical and economic outcomes of patients were assessed during ≥12 months of follow-up, defined as the period from the index date (i.e. the first RBCT) to either the end of continuous enrollment in benefits, inpatient death, or 1 March 2020.ResultsOverall, 207 patients with TDT and 1035 matched controls were identified. Most patients received iron chelation therapy (ICT) (91.3%), with a mean of 12.1 (standard deviation [SD] = 10.3) ICT claims per-patient-per-year (PPPY). Many also received RBCTs, with a mean of 14.2 (SD = 4.7) RBCTs PPPY. TDT was associated with higher annual ($137,125) and lifetime ($7.1 million) healthcare costs vs. matched controls ($4183 and $235,000, respectively). Annual costs were driven by ICT (52.1%) and RBCT use (23.6%). Patients with TDT had 7-times more total outpatient visits/encounters, 3-times more prescriptions, and 33-times higher total annual costs than matched controls.LimitationsThis analysis may underestimate the burden of TDT, as indirect healthcare costs (e.g. absenteeism, presenteeism, etc.) were not included. Results may not be generalizable to patients excluded from this analysis, including those with other types of insurance or without insurance.ConclusionsPatients with TDT have high HCRU and direct healthcare costs. Treatments that eliminate the need for RBCTs could reduce the clinical and economic burden of managing TDT.

Clinical and Economic Outcomes in Patients With Metastatic Urothelial Carcinoma Receiving First-Line Systemic Treatment (the IMPACT UC I Study).

The IMPACT UC I study assessed real-world treatment patterns, outcomes, healthcare resource utilization (HCRU), and costs in patients with metastatic urothelial carcinoma (mUC) receiving first-line (1L) systemic treatment after the FDA approval of 1L immune checkpoint inhibitor (ICI) monotherapy. This retrospective study used 100% Medicare fee-for-service claims from 1/1/2015 to 6/30/2019 to identify patients aged ≥18 years diagnosed with UC with evidence of metastatic disease, continuously enrolled for 6 months before and after initial diagnosis. Patients were grouped by 1L treatment: cisplatin-containing chemotherapy, carboplatin-containing chemotherapy, ICI monotherapy, or nonplatinum-containing therapy. Unadjusted time on 1L treatment (TOT), overall survival (OS), HCRU, and total healthcare costs were analyzed. Of 18 888 patients with mUC, 8630 (45.7%) had received identified 1L systemic treatment; platinum-containing chemotherapy was the most common (cisplatin-containing chemotherapy, 37.6%; carboplatin-containing chemotherapy, 30.2%). Cisplatin- and carboplatin-containing chemotherapy had the shortest time-to-treatment initiation (median, 1.7-3.0 months) and longest TOT (median, 4.0-4.3 months). Median OS was longest with cisplatin-containing chemotherapy (20.0 months) and shortest with ICI monotherapy (7.6 months). Cisplatin- and carboplatin-containing chemotherapy were associated with highest HCRU; total healthcare costs were approximately 2-fold higher with ICI monotherapy vs other 1L treatments ($10 359 vs $5042-$5709 per patient per month). 1L platinum-containing chemotherapy resulted in the longest median OS and highest HCRU, whereas 1L ICI treatment had the shortest median OS and the highest costs. Over 50% of patients diagnosed with advanced UC (aUC) received no systemic therapy, highlighting the importance of optimal 1L treatment decisions in aUC.

Pharmacist-Driven Dosing Services and Pharmaceutical Care Increase Probability of Teicoplanin Target Concentration Attainment and Improve Clinical and Economic Outcomes in Non-Critically Ill Patients.

Pharmacist-driven (PD) dosing and monitoring services have been shown to improve the clinical and economic outcomes in patients treated with different antibiotics, other than teicoplanin. This study investigates the impact of PD dosing and monitoring services on the clinical and economic outcomes of non-critically ill patients receiving teicoplanin treatment. A single-center retrospective study was conducted. Patients were divided into the PD group and the non-PD (NPD) group. Primary outcomes included the achievement of target serum concentration, and a composite endpoint of all-cause mortality, intensive care unit (ICU) admission, and sepsis or septic shock development during hospitalization or within 30days of hospital admission. The cost of teicoplanin, overall medication cost, and total cost during hospital stay were also compared. A total of 163 patients from January to December 2019 were included and assessed. Seventy patients were assigned to the PD group and 93 to the NPD group. The PD group had a higher percentage of patients reaching the target trough concentration (54% versus 16%, p < 0.001). Around 26% of the patients in the PD group and 50% of the patients in the NPD group met the composite endpoint during their hospital stay (p = 0.002). The PD group exhibited a significantly lower incidence of sepsis or septic shock, shorter hospital stays, reduced drug costs, and lower total expenses. Our study demonstrates that pharmacist-driven teicoplanin therapy can improve the clinical and economic outcomes for non-critically ill patients. https://www.chictr.org.cn ; identifier, ChiCTR2000033521.

Cannabis use disorder is associated with shorter length of stay and increased home discharge after primary total joint arthroplasty: a propensity-weighted analysis

IntroductionIncreased legalization of cannabis use across the United States has been correlated with increased cannabis use in the clinical setting. However, little is known regarding the characteristics and postoperative outcomes after primary joint arthroplasty (TJA) for patients with cannabis use disorder (CUD).MethodsThis retrospective cohort study used data from the National Inpatient Sample of patients undergoing primary TJA between 2006 to 2015. Patients were grouped based on presence of concomitant CUD. Patient demographic characteristics and outcome data between groups were analyzed. Propensity score methodology was used to compare immediate in-hospital complications and economic outcomes.ResultsA total of 8,740,798 TJAs were included. The prevalence of CUD increased nearly five-fold from 0.05% to 0.26% during this time (P < 0.0001). CUD patients were significantly younger, more likely to be male, most frequently of non-Hispanic Black race, and had higher rates of Medicaid insurance. Patients with CUD had a significantly shorter length of hospital stay (3.04 vs. 3.24 days, P = 0.0297), while incurring significantly higher daily ($22,614 vs. $17,955, P < 0.0001) and total charges during admission ($58,507 vs. $50,924, P < 0.0001), compared to patients without CUD. When compared with the control group, CUD was associated with significantly greater odds of home discharge (odds ratio (OR): 1.45, P = 0.0007), and significantly lower odds of rehab discharge (OR: 0.70, P = 0.0013). There were no differences in overall complication profile or in the vast majority of individual in-hospital complications between groups.ConclusionWhile CUD is correlated to shorter length of stay and increased home discharge after TJA, it does not show a strong effect on complications in an inpatient postoperative setting. It is important for clinicians to appreciate the demographic profile and expected clinical and economic outcomes for patients with CUD undergoing TJA, particularly in the context of evolving laws surrounding cannabis use.

Effects of hyperbaric oxygen therapy on clinical and economic outcomes in patients with deep second-degree burns

Introduction: Deep second-degree burn injuries are the most challenging situations for the burn surgeon in the treatment of adult cases. While waiting for spontaneous closure increases the risk of hypertrophic scar and keloid, early excision and grafting pose the risk of donor site wound and permanent color differences. Unlike many studies in the literature, the current study was planned in a way to minimize factors other than burn wounds to investigate the effect of adding hyperbaric oxygen (HBO2) therapy to conventional treatment in deep second-degree burn wounds. Material and Method: This prospective observational study included patients with burn injuries who underwent conventional treatment alone and those who underwent conventional plus HBO2 treatment performed by a single experienced surgeon and who met the study criteria. Results: Thirty-eight patients completed the study. Mean burned total body surface area (TBSA) was. 9.22 Å}3 43% (range 5% to 20%). There was no difference between the two groups in terms of age, burned TBSA, and burn etiology. The need for surgery and grafting was lower in patients who received HBO2 in addition to conventional treatment (p=0.003 and p=0.03, respectively). The patients in the HBO2 group had a shorter hospital stay, and their wounds epithelialized in a shorter time (p=0.169 and p&lt;0.001, respectively). They also had a higher satisfaction level and lower treatment cost (p=0.03 and p=0.36, respectively). Discussion: The results of this prospective study, in which co-factors were eliminated, showed that adding HBO2 to the conventional treatment of deep second-degree burns had a significant positive effect on patient outcomes, as well as reducing treatment costs.

A Systematic Literature Review of Clinical and Economic Outcomes for Patients with Paroxysmal Nocturnal Hemoglobinuria in Clinical Trials and Real-World Settings

Purpose: The purpose of this study was to systematically identify and evaluate published literature reporting clinical and economic outcomes associated with paroxysmal nocturnal hemoglobinuria (PNH) across clinical trials and real-world settings. Background: PNH is a rare, acquired hematopoietic stem cell disorder characterized by abnormal hemolysis of red blood cells.1,2 This complement-mediated hemolysis results in low hemoglobin [Hb] and high lactate dehydrogenase [LDH] levels, as well as symptoms including fatigue, dyspnea, pain, and hemoglobinuria.1-5 Patients frequently require costly hospitalizations and transfusions.4-10 Various measures of clinical response are used to assess treatment effectiveness and prognosis for patients with PNH, including laboratory values and transfusion dependence, but they are not consistently reported. This systematic literature review (SLR) describes clinical and economic outcomes reported in clinical trials and real-world/observational studies. Methods: Publications were collected through systematic searches for English language studies in MEDLINE, Embase, and Cochrane libraries with no date restriction, supplemented by abstracts and associated posters from recent major conferences (2020-2021). Studies were screened for relevance by two researchers independently, with disagreements adjudicated by a third reviewer. Studies were screened at 2 levels (title/abstract and full-text) using pre-specified criteria. Clinical trials and observational studies reporting clinical response (transfusion frequency, Hb levels, LDH levels, or reticulocyte counts), healthcare resource utilization, or costs were included in this descriptive analysis. This SLR is registered with PROSPERO (CRD42022314640). Results: Among 1607 unique publications following de-duplication, 105 studies with samples of at least 25 patients reported clinical response outcomes of interest. This included 29 clinical trials and 76 studies in real-world settings. Across these studies, methods of measuring clinical response varied: 12/29 clinical trials and 23/76 observational studies reported mean or median Hb during follow-up. These values were 11/29 and 15/76 for mean or median LDH and 4/29 and 6/76 for mean or median reticulocyte count, respectively. Mean Hb levels and mean LDH levels were the most commonly reported measures. Mean Hb levels at baseline ranged from 6.8-11.1 g/dL for patients in clinical trials and from 8.0-11.4 g/dL for patients in observational studies. Mean LDH levels ranged from 228-2293.3 U/L for patients in clinical trials and from 518-3880 U/L for patients in real-world studies. During study follow-up, mean Hb levels ranged from 7.6-12.8 g/dL and 6.8-11.9 g/dL for patients in clinical trials and real-world studies, respectively. Mean LDH levels during study follow-up periods ranged from 189-2419 U/L and 246.29-1555.45 U/L for patients in clinical trials and real-world studies, respectively. At study completion, mean and median Hb levels were <12.3 g/dL in all studies reporting values (n=35), with the exception of 1 clinical trial. Similarly, mean and median LDH levels were >225 U/L in 25/26 studies. Reticulocyte counts during study follow-up were only reported in 10 studies. Limited data were available describing the economic burden associated with PNH. Only 3 studies reported direct costs, with total direct costs ranging from $88,251-$624,911 and PNH-related costs estimated to be $13,220. The proportion of patients who required at least 1 transfusion remained high, ranging from 4-100%. Discussion and Conclusions: The Severe Aplastic Anemia Working Party of the European Society for Blood and Marrow Transplantation recently proposed clinical response classification based on Hb level (for complete response: ≥12 g/dL), LDH level (≤1.5 x the upper limit of normal), absolute reticulocyte count (≤150,000/µL), and transfusion requirements (none).11 This SLR has identified considerable gaps and inconsistencies in the reporting of these outcomes. Available data reflect persistently low Hb levels and high LDH levels across both clinical trial and real-world study publications, with outcomes in real-world studies suggesting most patients have at best partial response to available treatment. These laboratory values, along with continued transfusion dependence, underscore the sustained clinical and economic burden of PNH. Figure 1View largeDownload PPTFigure 1View largeDownload PPT Close modal

Clinical and Economic Outcomes in Patients with Transfusion-Dependent β-Thalassemia and Patients with Sickle Cell Disease with Recurrent Vaso-Occlusive Crises Receiving Hematopoietic Stem Cell Transplants in the United States

Background: Transfusion-dependent β-thalassemia (TDT) and sickle cell disease (SCD) are inherited blood disorders caused by mutations in the β-globin gene, resulting in abnormal, reduced, or absent expression of hemoglobin. TDT is characterized by ineffective red blood cell production that leads to chronic anemia, need for regular red blood cell transfusions (RBCTs), and organ complications. SCD is characterized by sickle-shaped red blood cells that cause vaso-occlusive crises (VOCs), hemolysis, and end-organ damage. Hematopoietic stem cell transplant (HSCT) is currently the only curative option for patients with TDT and patients with SCD. There is limited research on the frequency and outcomes of HSCT in these two patient populations. This study describes the economic and clinical outcomes for a combined population of patients with TDT and patients with SCD with recurrent VOCs who received HSCTs in the United States. Methods: This retrospective cohort study used administrative claims from the MerativeTM Commercial, Medicare, and Multi-State Medicaid Databases to identify patients with ≥1 inpatient or ≥2 outpatient claims for β-thalassemia or SCD between March 1, 2010, and March 1, 2019. Eligible patients with TDT were required to have ≥8 discrete RBCTs in any 12-month period on or after the date of the earliest qualifying β-thalassemia claim. At least 3 days between service dates of RBCT claims were required to be considered discrete RBCTs. Patients with TDT were required to have 1 year of continuous enrollment after their first transfusion to be included. Eligible patients with SCD with recurrent VOCs were required to have ≥2 diagnosed VOCs per year in any 2 consecutive years after and including the first qualifying SCD claim. A VOC was defined as inpatient or outpatient claim of acute chest syndrome, priapism, SCD crisis, or splenic sequestration; at least 3 days between VOC claims were required to be considered discrete VOCs. Eligible patients with SCD with recurrent VOCs were required to have 24 months of continuous enrollment before the second VOC in the second consecutive year and 12 months of continuous enrollment after. Patients with TDT and patients with SCD who met the above criteria and received an HSCT were included in the analysis set. Patients receiving HSCT were identified utilizing relevant procedure codes. The index date was the date of transplant. Patients were followed from the index date to the earliest of end of enrollment, death, or end of study period (March 1, 2020). Demographics were assessed at the index date, and clinical complications, healthcare resource utilization, and costs were descriptively summarized in the post-index period. Costs were based on paid amounts of adjudicated claims and patient cost-sharing and included costs in the 10 days before the index date to account for pre-transplant healthcare services associated with the transplant. Results: Two hundred thirty-four and 3500 patients met the criteria for TDT and SCD with recurrent VOCs, respectively, for a total of 3734 patients. Of that total, 62 patients (1.66%) underwent a transplant and were therefore included in the analysis cohort. Mean patient age at the index date was 12.6 years, and 46.8% were female. A proportion of transplant patients experienced graft versus host disease (GvHD) (37/62; 59.7%), unspecified HSCT complications (33/62; 53.2%), or bone marrow transplant rejection or failure (6/62; 9.7%) post-transplant. Average length of stay for the index HSCT admission was 42 days; in the first year post-transplant, patients averaged 58.3 days in the hospital. Total costs in the first 100 days and 1 year post-transplant were $442,752 and $623,301, respectively. Inpatient costs accounted for 93.7% and 88.7% of costs at 100 days and 1 year, respectively. Conclusions: This retrospective cohort study suggests that only a small proportion of patients with TDT and patients with SCD with recurrent VOCs receive HSCTs. Many patients who undergo transplants experience clinical complications, including graft failure and GvHD, and substantial economic burden. Given the limited utilization and potential safety risks of HSCT, additional curative treatment approaches are needed for patients with TDT and patients with SCD with recurrent VOCs.