Administrative Claims Analysis Research Articles

Healthcare costs and medical utilization patterns associated with painful and severe painful diabetic peripheral neuropathy.

Painful diabetic peripheral neuropathy (DPN) is a common complication in patients with diabetes. It is associated with a poor quality of life and high costs of care. This study investigated the impact of painful DPN on healthcare costs and resource utilization. This was a retrospective analysis of administrative claims of adult patients with diabetes (type 1 or 2) from Optum's de-identified Clinformatics® Data Mart Database. Patients were assigned to four cohorts by presence of DPN and pain severity, based on diagnoses and prescription patterns in a one-year baseline. All-cause and diabetes-associated costs were calculated for the year following the index DPN diagnosis. Risk factors associated with presence of severely painful DPN were evaluated. Relative to those without DPN, patients who had DPN without pain, painful DPN (PDPN), or severe PDPN incurred respective increases of $3,093, $9,349, and $20,887 in average annual all-cause costs. More than half of costs from painful/severe DPN were for prescriptions and inpatient hospitalization. Severe PDPN was associated with elevated odds of diabetic amyotrophy (OR: 8.09; 95% CI: 6.84-9.56), diabetic foot ulcers (OR: 6.54, 95% CI: 6.32-6.76), and loss of mobility (OR: 2.54, 95% CI: 2.48-2.60), among other complications. Painful DPN is associated with higher healthcare costs and resource utilization, and a greater risk of debilitating conditions that limit quality of life. Future research should focus on better treatment options and more aggressive pain management strategies to reduce the negative impacts of DPN.

Association Between Adherence, A1C Improvement, and Type of Continuous Glucose Monitoring System in People with Type1 Diabetes or Type2 Diabetes Treated with Intensive Insulin Therapy.

Use of continuous glucose monitoring (CGM) systems by people with diabetes is associated with improved glycemic outcomes, including lower glycated hemoglobin (A1C). Less is known about adherence to CGM systems, whether glycemic outcomes are impacted by levels of adherence, or whether adherence rates differ between types of CGM systems-intermittently scanned CGM (isCGM) or real-time CGM (rtCGM). A retrospective analysis of de-identified US administrative health claims and linked laboratory data was conducted using the Merative™ MarketScan® Research Database. The cohort included CGM-naïve people with type1 diabetes (T1D) or type2 diabetes treated with intensive insulin therapy (T2D-IIT) who initiated rtCGM or isCGM between August1, 2019 and March31, 2021 (defined as the index date). Adherence was calculated over a 12-month period using the proportion of days covered (PDC) with PDC ≥ 0.8 defined as adherent. A1C values were obtained within 6months of the index date. A total of 7669 individuals were identified. Subgroups included T1D using isCGM (n = 1578), T1D using rtCGM (n = 1244), T2D-IIT using isCGM (n = 3567), and T2D-IIT using rtCGM (n = 1280). After 12months, PDC was 0.71 (0.30)-0.72 (0.31) (mean(SD)) for T1D and T2D-IIT rtCGM users and 0.55 (0.34)-0.56 (0.34) for T1D and T2D-IIT isCGM users. The proportion of adherent users (PDC ≥ 0.8) was 56.8-59.7% for rtCGM users and 36.3-37.6% for isCGM users. Overall, regardless of diabetes type, the odds of adherence were over two times higher for rtCGM users compared to isCGM users. For those with available A1C information (T1D n = 213; T2D-IIT n = 346), independent of CGM type, adherence to CGM was associated with a greater reduction in A1C and more people reaching A1C targets of < 7.0% or < 8.0%. For people with T1D or T2D-IIT, higher adherence to CGM is associated with greater reductions in A1C, and higher adherence rates were observed with rtCGM systems than with isCGM systems.

Real-world onabotulinumtoxinA treatment patterns in patients with overactive bladder.

Utilization patterns of third-line onabotulinumtoxinA for overactive bladder (OAB) symptoms-including discontinuation and use of other therapeutic options during or after treatment-are not well understood. This retrospective analysis of administrative claims was designed to characterize the unmet need for OAB treatment. A retrospective claims analysis of Optum's deidentified Clinformatics® Data Mart Database (2009-2021) was performed among patients with diagnosis of OAB newly starting onabotulinumtoxinA injection (2015-2017). Study measures were evaluated during an 18-month pretreatment baseline and over a minimum of 36 months of follow-up. These included number of injections, days between injections, other measures of onabotulinumtoxinA utilization, use of second-line pharmacologic treatments, use of device and surgical treatment options, and complications. Of 2505 eligible patients, 535 (21.4%; 66.8 ± 13.3 y, 87.3% females) continued onabotulinumtoxinA throughout the study. The remaining 1970 (78.6%; 71.4 ± 11.6 y, 79.1% females) were considered discontinuers. Of continuers, 57% received ≥5 treatments. Of discontinuers, 84% received ≤2 treatments. Anticholinergics and β3-adrenoceptor agonist medication use declined in all patients from baseline to follow-up; however, the absolute reduction in the proportion with any medication fill was similar across continuers versus discontinuers (21% vs. 18%, p < 0.0001). Sacral neuromodulation was initiated by 15/535 (3%) of continuers and 137/1970 (7%) of discontinuers (p < 0.0001). No patients initiated percutaneous tibial neuromodulation. Early discontinuation of onabotulinumtoxinA therapy for OAB is common and most discontinuers do not receive alternative treatments. Providers have the opportunity to educate OAB patients with un- or undertreated symptoms regarding alternative options.

Longer milestone-free time in IV edaravone–treated vs non–IV edaravone-treated patients with amyotrophic lateral sclerosis: An administrative claims analysis

Longer milestone-free time in IV edaravone–treated vs non–IV edaravone-treated patients with amyotrophic lateral sclerosis: An administrative claims analysis

Treatment Patterns and Adverse Event-Related Hospitalization Among Patients with Epidermal Growth Factor Receptor (EGFR)-Mutated Metastatic Non-small Cell Lung Cancer After Treatment with EGFR Tyrosine Kinase Inhibitor and Platinum-Based Chemotherapy Regimens.

Epidermal growth factor receptor-tyrosine kinase inhibitors (EGFR TKIs) are established first-line treatments among patients with metastatic non-small cell lung cancer harboring EGFR-sensitizing mutations. Upon EGFR TKI resistance, there are scant data supporting a standard of care in subsequent lines of therapy. We aimed to characterize real-world treatment patterns and adverse events associated with hospitalization in later lines of therapy. This retrospective analysis of administrative claims included adults with metastatic non-small cell lung cancer who initiated a next line of therapy (index line of therapy) following EGFR TKI and platinum-based chemotherapy discontinuation on/after 1 November, 2015. Treatment regimens and adverse event rates during the index line of therapy were described. Among 195 eligible patients (median age: 59 years; female: 60%), the five most common index line of therapy regimens were immune checkpoint inhibitor monotherapy (29%), EGFR TKI monotherapy (21%), platinum-based chemotherapy (19%), non-platinum-chemotherapy (13%), and EGFR TKI combinations (9%). The overall median (95% confidence interval) time to discontinuation of the index line of therapy was 2.8 (2.1-3.2) months. Common adverse events associated with hospitalizations included infection/sepsis, pneumonia/pneumonitis, and anemia (2.9, 2.8, and 2.0 per 100 person-months, respectively). Among EGFR TKI-resistant patients who discontinued platinum-based chemotherapy, the duration of the next line of therapy was short, treatment was highly variable, and re-treatment with EGFR TKIs and platinum-based regimens was common, suggesting a lack of standard of care in later lines. Adverse event rates associated with hospitalization were high, especially among platinum-treated patients. These results underscore the unmet need for new therapies in a later line of treatment to reduce the clinical burden among patients in this population.

Impact of adherence to disease modifying therapies on long-term clinical and economic outcomes in multiple sclerosis: A claims analysis of real-world data.

Multiple sclerosis (MS) is a chronic neurodegenerative inflammatory disease that requires long-term commitment to treatment for optimal outcomes. A variety of disease-modifying therapies (DMTs) are now available that reduce relapses and delay disease progression in people with MS. However, adherence remains a significant issue, with a variety of mental, physical, and emotional factors contributing to non-adherence. In a large number of studies, non-adherence has been associated with worse clinical outcomes (relapses and disease severity), a higher economic burden, and loss of work productivity. However, many of these studies were short-term (1-2 years) or cross-sectional studies; thus, more data are needed on the long-term clinical and economic impacts of DMT non-adherence. The objective of this study was to determine the longer-term impact of adherence to DMTs on disease activity and healthcare resource utilization (HCRU) in people with MS. The study hypothesis was that non-adherence to DMTs would be associated long-term with worse clinical outcomes and a higher economic burden. A retrospective administrative claims analysis of the US MarketScan® Commercial database (2011-2017) in individuals (18-65 years) with MS (based on International Classification of Disease coding) was conducted. Adherence was classified by proportion of days covered (PDC) ≥0.8 and non-adherence by PDC <0.8; sensitivity analyses helped further categorize as moderately (PDC ≥0.6-<0.8) or highly (PDC <0.6) non-adherent. Cohorts were matched using propensity score matching. Time to first relapse, annualized relapse rate (ARR), time to use of assistive devices (cane/walker or wheelchair), and annual HCRU (inpatient, emergency room [ER], outpatient, and MRI visits and costs) were compared between cohorts. 10,248 MS cases were identified; 58% met adherence criteria, and 42% met non-adherence criteria. Mean follow-up from diagnosis or first DMT claim was 5.3 years. Adherent individuals had a longer time to first relapse (hazard ratio [HR] 0.83; 95% confidence interval [CI]: 0.77-0.90; p<0.0001), a lower ARR (0.13vs. 0.18, respectively; rate ratio [RR] 0.75 [95% CI: 0.71-0.79]; p<0.0001), and longer lag times to cane/walker use (HR 0.79 [95% CI: 0.66-0.94]; p=0.0067) and wheelchair use (HR 0.68 [95% CI: 0.55-0.83]; p=0.0002) than non-adherent individuals. Adherent individuals had fewer annual inpatient and ER visits and lower total costs than those who were non-adherent (p<0.0001). Sensitivity analyses showed that differences in disease activity and HCRU were generally more pronounced between matched adherent and highly non-adherent pairs than between matched adherent and moderately non-adherent pairs. Significant differences in MS disease activity and HCRU were observed based on adherence to DMTs. Our study underscores the negative impact of non-adherence to DMTs on long-term clinical and economic outcomes in MS.

Characteristics associated with receipt of treatment among patients diagnosed with chronic hepatitis C virus.

Although current guidelines recommend that nearly all patients with chronic hepatitis C virus (HCV) infection receive treatment, a substantial proportion remain untreated. We conducted an administrative claims analysis to provide real-world data on treatment patterns and characteristics of treated versus untreated patients among individuals with HCV in the United States. Adults with an HCV diagnosis from 01 July 2016 through 30 September 2020 and continuous health plan enrolment for 12 months before and ≥1 month after the diagnosis date were identified in the Optum Research Database. Descriptive and multivariable analyses were conducted to evaluate the association between patient characteristics and the rate of treatment. Of 24,374 patients identified with HCV, only 30% initiated treatment during follow-up. Factors associated with increased rate of treatment included younger age versus age 75+ (hazard ratio [HR] 1.50-1.83 depending on age group), commercial versus Medicare insurance (HR 1.32), and diagnosis by a specialist versus a primary care physician (HR 2.56 and 2.62 for gastroenterology and infectious disease or hepatology, respectively) (p < .01 for all). Several baseline comorbidities were associated with decreased rate of treatment, including psychiatric disorders (HR 0.87), drug use disorders (HR 0.85) and cirrhosis (HR 0.42) (p < .01 for all). These findings highlight existing HCV treatment inequities, particularly among older patients and those with psychiatric disorders, substance use disorders or chronic comorbidities. Targeted efforts to increase treatment uptake in these populations could mitigate a considerable future burden of HCV-related morbidity, mortality and healthcare costs.

EE213 Long COVID-19 Associated with 5-Fold Increase in Total Medical Costs and Greater Use of Inpatient and Outpatient Services Compared to Non-Long COVID-19: An Analysis of Real-World Data

Assess real-world evidence data on the prevalence and impact of long COVID (LC) to establish a baseline for the value of potential therapeutic interventions. This study was a retrospective, longitudinal analysis of administrative claims from multiple payer channels spanning 4/1/2020-6/30/2022. Inclusion criteria: 1) ICD-10-CM diagnosis code of COVID-19 (U07.1) on or after 4/1/2020 (COVID-19 diagnosis date=index date), 2) 18+ years of age on index, and 3) at least -365/+30 days of continuous plan enrollment surrounding index. Employing a conservative LC definition, patients were classified as LC if they presented at least 1 claim ≥ 28 days following the index date which included both a COVID-19 diagnosis and ≥1 of 8 LC-related symptoms. LC and non-LC patients were compared on demographics, COVID-19 symptoms, healthcare utilization, and medical costs. Descriptive statistics were presented for outcomes, and bivariate tests of significance were used to assess differences between cohorts. Of 4,938,801 medically attended COVID-19 patients meeting inclusion criteria, 386,153 (7.8%) qualified as LC. The LC patients were older (Mean(SD) = 67.0(19.0) vs. 51.0(20.7)), were more likely to be female (65.1% vs. 60.4%), were in poorer health (Deyo-Charlson Comorbidity Index=3.51(3.24) vs. 1.47(2.45)), and presented greater baseline total medical expenditures ($39,769($60,401) vs. $15,275($35,640); p < 0.0001). On index, LC patients had a higher rate of LC-related symptoms, and in the 180-day post-index period, LC patients incurred increased total medical costs ($38,874($54,098) vs. $7,319($18,439); p < 0.001) and greater use of inpatient and outpatient medical services. Patients with LC presented elevated rates of symptoms and incurred 5-fold greater medical costs post-index compared to non-LC patients. This study is one of the first to longitudinally quantify the cost and symptom burden of LC in a real-world setting and helps to establish a baseline for the value of potential therapeutic interventions.

EE333 Assessment of Medically-Attended COVID-19 Patient Risk Profiles and Health Care Resource Utilization (HCRU) and Costs in the U.S.

To assess healthcare costs for medically attended COVID-19 (MAC) patients vs. matched controls not presenting with COVID-19, to serve as a baseline for the value of potential therapeutics. This study was a retrospective analysis of administrative claims from multiple payer channels spanning 4/1/2020 to 6/30/2022 (Wuhan strain through omicron clinical variants). Inclusion criteria: 1) ICD-10-CM diagnosis code of COVID-19 (U07.1; index date), 2) 18+ years of age on index, and 3) at least -365/+30 days of continuous enrollment surrounding index. Baseline comorbid conditions were assessed, along with the proportion of patients presenting as high-risk for developing severe COVID-19 per CDC guidelines. HCRU and costs were assessed during the 180-day period following index, and were compared between a subset of MAC and non-MAC controls matched directly on age, gender, and baseline Deyo-Charlson Comorbidity Index (DCI). Descriptive statistics were presented for all outcomes, and bivariate tests of significance were used to assess differences between cohorts. A total of 5,746,432 COVID-19 patients met all study inclusion criteria. Patients with MAC had a mean DCI score of 1.79±2.69, with 26.0% of patients presenting a DCI score ≥ 3, and with 49.7% qualifying as at high-risk for complications per the CDC guidelines. MAC patients also presented significantly greater ER visits (0.62±1.42 vs. 0.24±0.85), hospitalizations (0.28±0.66 vs. 0.09±0.38), and total medical costs ($13,011±$28,382 vs. $5,083±$15,061; ps < 0.001) compared to non-MAC controls. A key feature of COVID-19 is higher costs and HCRU related to complications for patients with comorbidities. This study demonstrated that patients with comorbidities are more likely to experience complications and incur greater costs associated with ER visits, hospitalization, and other medical services. These data serve as a baseline for assessing the value of therapeutics that lower the risk of mild COVID-19 progressing to more severe disease.

Longer Milestone-Free Time in Patients With Amyotrophic Lateral Sclerosis Treated With IV Edaravone vs Not Treated With IV Edaravone: Results From a US Administrative Claims Analysis (S14.007)

<h3>Objective:</h3> To estimate time-to-progression milestones in IV edaravone–treated vs non–IV edaravone-treated patients with ALS in a real-world setting. <h3>Background:</h3> Intravenous (IV) edaravone was US Food and Drug Administration-approved in May 2017 based on a slowing of functional decline in patients with amyotrophic lateral sclerosis (ALS). Information on real-world outcomes in patients with ALS treated with IV edaravone is limited. <h3>Design/Methods:</h3> This retrospective observational analysis included patients with ALS who were continuously enrolled in Optum’s de-identified Clinformatics® Data Mart database between August 8, 2017, and September 30, 2021. Propensity score matching (1:1) identified IV edaravone–treated patients (cases) and non–IV edaravone-treated patients (controls) matched for covariates: age, race, geographic region, gender, pre-index disease duration (period between the first claim for ALS diagnosis and the first claim for IV edaravone [cases] or August 2017 [controls]), insurance, cardiovascular disease history, riluzole prescription, gastrostomy tube placement, artificial nutrition, noninvasive ventilation, and all-cause hospitalization. Milestones were defined according to the Healthcare Common Procedure Coding System and included the use of canes/walkers/wheelchairs (M1); artificial nutrition (M2); noninvasive ventilation (M3); invasive ventilation/speech-generating devices (M4); and hospice (M5). Difference between cases and controls in cause-specific restricted mean time lost (RMTL) was estimated to examine IV edaravone benefit. <h3>Results:</h3> Cases (n=360) were matched to controls (n=360); mean age in years (SD) was 62.9 (10.2) and 62.8 (10.2) in cases and controls, respectively. In the post-index period, differences in RMTL (95% CI) in months indicate longer milestone-free time in cases than controls: 2.50 (0.93–4.07), 4.30 (2.88–5.72), 2.92 (1.56–4.28), 4.12 (3.00–5.23), and 2.33 (1.31–3.34) for M1, M2, M3, M4, and M5, respectively. <h3>Conclusions:</h3> This analysis describes the time to milestones in patients with ALS treated with IV edaravone in a real-world setting. This information may be useful to payers and clinicians in evaluating use of IV edaravone. <b>Disclosure:</b> Malgorzata Ciepielewska has received personal compensation for serving as an employee of Mitsubishi Tanable Pharma America . Jeffrey Zhang has received personal compensation for serving as an employee of Princeton Pharmatech. Jeffrey Zhang has received stock or an ownership interest from CalciMedica. Ying Liu has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for MPTA. Dr. Hagan has received personal compensation for serving as an employee of Mitsubishi Tanabe Pharma America.

OP21 COVID-19 morbidity/mortality and vaccination against SARS-CoV-2 in patients with Inflammatory Bowel Disease in Poland: Nationwide Data

Abstract Background According to the international recommendations, patients with inflammatory bowel disease (IBD) should be vaccinated against SARS-CoV-2 at the earliest opportunity to do so. The aim of this study was to assess the morbidity and mortality from COVID-19 in the adult IBD population in Poland with respect to their vaccination status. Methods We conducted a retrospective analysis of administrative health claims collected by the National Health Fund, the sole public payer in Poland. We identified adult IBD patients as of December 31th, 2021 who had at least two or more records with K50 or K51 code and two or more prescriptions for IBD drugs reimbursed or else intestinal surgery preceding the record. The vaccination status in 2021 was assessed using the database maintained by the Ministry of Health. We examined the vaccination process against SARS-CoV-2 among IBD patients along with morbidity and mortality from COVID-19. We conducted a Cox proportional hazard model analysis to determine the hazard ratio of SARS-CoV-2 infection, hospitalization and death in respect to the vaccination status during the autumn wave of the COVID-19 pandemic (October–December 2021). Results As of December 31th, 2021 there were 93 068 adult patients diagnosed with IBD. The vaccination rate in IBD patients was significantly higher than in the general population of Poland (72.1% vs 63.8%; p&amp;lt;0.001) and grew with age, reaching the top value among those aged 70-79 years (88.2%) [Figure 1]. 87 353 IBD patients were included into the Cox proportional hazard analysis of autumn pandemic wave, during which there were 4 042 registered COVID-19 cases in IBD population. The peak value of a weekly average of incidence rate of COVID-19 was lower for vaccinated IBD patients (7.4/10000) than for unvaccinated ones (13.0/10000). The risk of being infected was significantly lower for vaccinated IBD patients (HR 0.53; 95%CI 0.5-0.57; p&amp;lt;0.001). The cumulative risk of being positively tested for COVID-19 shows Figure 2. The most notable protective effect of vaccination against SARS-CoV-2 was found in patients aged 60-69 years (HR 0.47; 95%CI 0.39-0.55) and in those aged 80 years and above (HR 0.44; 95%CI 0.32-0.63). The risk of hospitalization due to COVID-19 was also significantly lower among the vaccinated IBD patients (HR 0.48; 95%CI 0.31-0.74, p&amp;lt;0.0001). The risk of death due to COVID-19 was more than 3 times decreased in vaccinated IBD patients in comparison to the remaining IBD population (HR 0.29, 95%CI 0.17-0.43, p&amp;lt;0.001) [Table 1]. Conclusion Adult patients with IBD were more likely to get vaccinated against SARS-COV-2 than adults in the general population of Poland. The vaccination significantly decreased the risk of the infection, hospitalization and death due to COVID-19.

Anorexia in Medicare Fee-for-Service Beneficiaries: A Claims-Based Analysis of Epidemiology and Mortality

ObjectivesLoss of appetite in older adults can lead to malnutrition, weight loss, frailty, and death, but little is known about its epidemiology in the United States (US). The objective of this study was to estimate the annual prevalence and incidence of anorexia in older adults with Medicare fee-for-service (FFS) health insurance.DesignRetrospective and observational analysis of administrative health insurance claims data.SettingThis study included Medicare FFS claims from all settings (eg, hospital inpatient/outpatient, office, assisted living facility, skilled nursing facility, hospice, rehabilitation facility, home).ParticipantsThis study included all individuals aged 65 to 115 years old with continuous Medicare FFS medical coverage (Parts A and/or B) for at least one 12-month period from October 1, 2015, to September 30, 2021 (ie, approximately 30 million individuals each year).InterventionNot applicable.MeasurementsAnorexia was identified using medical claims with the ICD-10 diagnosis code “R63.0: Anorexia”. This study compared individuals with anorexia to a control group without anorexia with respect to demographics, comorbidities using the Charlson Comorbidity Index (CCI), Claims-based Frailty Index (CFI), and annual mortality. The annual prevalence and incidence of anorexia were estimated for each 12-month period from October 1, 2015, to September 30, 2021.ResultsThe number of individuals with anorexia ranged from 317,964 to 328,977 per year, a mean annual prevalence rate of 1.1%. The number of individuals newly diagnosed with anorexia ranged from 243,391 to 281,071 per year, a mean annual incidence rate of 0.9%. Individuals with anorexia had a mean (±standard deviation) age of 80.5±8.7 years (vs 74.9±7.5 years without anorexia; p<.001), 64.4% were female (vs 53.8%; p<.001), and 78.4% were White (vs 83.2%; p<.001). The most common CCI comorbidities for those with anorexia were chronic pulmonary disease (39.4%), dementia (38.3%), and peripheral vascular disease (38.0%). Median (interquartile range [IQR]) CCI with anorexia was 4 [5] (vs 1 [3] without anorexia; p<.001). The annual mortality rate among those with anorexia was 22.3% (vs 4.1% without anorexia; relative risk 5.49 [95% confidence interval, 5.45–5.53]).ConclusionApproximately 1% of all adults aged 65–115 years old with Medicare FFS insurance are diagnosed with anorexia each year based on ICD-10 codes reported in claims. These individuals have a higher comorbidity burden and an increased risk of annual mortality compared to those without a diagnosis of anorexia. Further analyses are needed to better understand the relationship between anorexia, comorbidities, frailty, mortality, and other health outcomes.

CYP2D6 Substrate Dispensing Among Patients Dispensed Mirabegron: An Administrative Claims Analysis.

Overactive bladder (OAB) is characterized by the presence of bothersome urinary symptoms. Pharmacologic treatment options for OAB include anticholinergics and β3-adrenergic agonists. Use of β3-adrenergic agonists may result in similar treatment efficacy with a decreased side effect profile compared with anticholinergics because high anticholinergic burden is associated with cardiovascular and neurologic side effects. However, the β3-adrenergic agonist mirabegron, one of two approved drugs within this class, is a moderate cytochrome P450 (CYP) 2D6 inhibitor, and coadministration of drugs that are CYP2D6 substrates with mirabegron may lead to adverse drug effects. The aim of this study was to quantify how often CYP2D6 substrates were dispensed in patients receiving mirabegron among adults of any age and among those ≥ 65 years of age. In this retrospective descriptive analysis, a deidentified administrative claims database in the United States, IQVIA PharMetrics® Plus, was used to identify dispensing claims for CYP2D6 substrates and mirabegron from November 2012 to September 2019. Prevalence of CYP2D6 substrate dispensing was assessed in patients dispensed mirabegron among all adults ≥ 18 years old and additionally among a cohort of those ≥ 65 years old. Patient baseline profiles at the time of mirabegron and CYP2D6 substrate codispensing and at the time of mirabegron dispensing were compared. CYP2D6 substrates were categorized as those with the potential for increased risk of QT prolongation, with anticholinergic properties, with narrow therapeutic index (NTI), contraindicated or having a black box warning when used with CYP2D6 inhibitors, or used for depression or other psychiatric disease. Dispensing data and patient profiles were summarized descriptively. Overall, 68.5% of adults ≥ 18 years old dispensed mirabegron had overlapping dispensings for one or more CYP2D6 substrate; 60.6% and 53.6% had overlapping dispensings for CYP2D6 substrates with anticholinergic properties or risk of QT prolongation, respectively. CYP2D6 substrates with NTI, contraindicated with CYP2D6 inhibitors, or for psychiatric use were codispensed in 17.7%, 16.6%, and 38.0% of adult mirabegron users, respectively. Mirabegron users receiving one or more concurrent CYP2D6 substrate were more likely to be older, have more comorbidities and baseline polypharmacy, and have increased healthcare resource utilization compared with those without concurrent CYP2D6 substrates. Commonly codispensed CYP2D6 substrates included hydrocodone, oxycodone, tramadol, metoprolol, and tamsulosin. Findings were similar for patients in the older cohort (≥ 65 years old), with 72.1% receiving overlapping CYP2D6 substrates. Codispensing of CYP2D6 substrates, especially those with anticholinergic properties or risk of QT prolongation, was common among adults and older adults receiving mirabegron. Results highlight the need for improved awareness of CYP2D6 substrate prescribing among patients receiving pharmacologic treatment for OAB that inhibits the CYP2D6 pathway.

Factors associated with receipt of second-line recurrent or metastatic cervical cancer treatment in the United States: A retrospective administrative claims analysis

PurposeContemporary, real-world data on eligible patients receiving treatment following progression on first-line (1L) recurrent or metastatic cervical cancer (r/mCC) therapy are needed to inform treatment algorithms and identify potential gaps in the r/mCC care continuum. MethodsThis study estimated the prevalence and predictors of second-line (2L) r/mCC therapy among 1L-treated patients using the 2015–2020 IBM MarketScan® commercial claims database. Women ≥ 18 years diagnosed with cervical cancer and treated with first-line systemic therapies were identified and followed for 12 months from their 1L therapy end date. Women with claims for a new therapy after 60 days but no later than 365 days from the end of 1L treatment were identified as those who progressed and received 2L therapy for r/mCC. Descriptive statistics examined baseline cohort characteristics and multivariable logistic regression model examined the factors associated with receiving 2L treatment. ResultsWe identified 384 1L-treated patients with r/mCC with ≥ 12 months of follow-up post-1L treatment. During follow-up, over half (51.0 %) of the 1L-treated r/mCC patients received 2L treatment. Patients from the South and Midwest had a lower likelihood of receiving 2L treatment compared with those living in the Northeast (adjusted odds ratio [aOR] = 0.43; 0.23–0.84) and (aOR = 0.52; 0.28–0.95, respectively). Patients not treated with bevacizumab in 1L were also less likely to receive 2L therapy (aOR = 0.65; 0.43–0.99). ConclusionAdditional research and targeted outreach efforts are needed to understand geography-, population-, or practice-specific barriers impacting access to 2L therapy among patients with r/mCC.

A Retrospective Analysis of Prophylactic G-CSF Biosimilar and Originator Administrative Claims over Time Among Patients with Non-Hodgkin Lymphoma

A Retrospective Analysis of Prophylactic G-CSF Biosimilar and Originator Administrative Claims over Time Among Patients with Non-Hodgkin Lymphoma

WITHDRAWN: Factors associated with receipt of second-line recurrent or metastatic cervical cancer treatment in the United States: A retrospective administrative claims analysis

Contemporary, real-world data on eligible patients receiving treatment following progression on first-line (1L) recurrent or metastatic cervical cancer (r/mCC) therapy are needed to inform treatment algorithms and identify potential gaps in the r/mCC care continuum. This study estimated the prevalence and predictors of second-line (2L) r/mCC therapy among 1L-treated patients using the 2015-2020 IBM MarketScan® commercial claims database. Women≥18years diagnosed with cervical cancer and treated with first-line systemic therapies were identified and followed for 12months from their 1L therapy end date. Women with claims for a new therapy after 60days but no later than 365days from the end of 1L treatment were identified as those who progressed and received 2L therapy for r/mCC. Descriptive statistics examined baseline cohort characteristics and multivariable logistic regression model examined the factors associated with receiving 2L treatment. We identified 384 1L-treated patients with r/mCC with≥12months of follow-up post-1L treatment. During follow-up, over half (51.0%) of the 1L-treated r/mCC patients received 2L treatment. Patients from the South and Midwest had a lower likelihood of receiving 2L treatment compared with those living in the Northeast (adjusted odds ratio [aOR]=0.43; 0.23-0.84) and (aOR=0.52; 0.28-0.95, respectively). Patients not treated with bevacizumab in 1L were also less likely to receive 2L therapy (aOR=0.65; 0.43-0.99). Additional research and targeted outreach efforts are needed to understand geography-, population-, or practice-specific barriers impacting access to 2L therapy among patients with r/mCC.

Clinical and economic burden of chronic rhinosinusitis with nasal polyposis: A U.S. administrative claims analysis.

Background: Limited data exist on the clinical and economic burden of chronic rhinosinusitis with nasal polyposis (CRSwNP). Objective: To describe patient characteristics, health-care resource utilization (HCRU), and health-care costs among patients with CRSwNP with and without comorbid asthma (primary analysis) and with surgical management of nasal polyps (secondary analysis). Methods: This was a retrospective study of patients diagnosed with CRSwNP conducted using administrative claims data from January 1, 2013, through March 31, 2019. Study outcomes were assessed over a 2-year follow-up. Results were stratified by baseline asthma status (primary analysis) and presented separately for patients with surgically managed CRSwNP (secondary analysis). Results: The primary analysis included 10,999 patients with CRSwNP (2649 with asthma, 8350 without asthma). Patients with versus without asthma had higher medication use, HCRU, and all-cause medical costs (mean ± standard deviation $34,667 ± $42,234 versus $27,122 ± $45,573; p < 0.001) across the full follow-up period. CRSwNP-related medical costs were significantly higher for patients with versus without asthma in year 2 of follow-up. In the surgical management analysis (n = 4943), most categories of medication use and CRSwNP-related HCRU declined from baseline levels during follow-up, and CRSwNP-related pharmacy costs in year 2 were less than half of baseline levels. Conclusion: Patients diagnosed with CRSwNP and asthma had a greater burden of illness than those without asthma. Higher CRSwNP-related medical costs in year 2 of follow-up for patients with asthma may indicate worsening symptoms over time. Among patients with surgically managed CRSwNP, HCRU and costs increased in year 1 of follow-up but decreased below baseline levels in year 2, potentially reflecting improved symptom severity.

Epidemiología de las enfermedades valvulares aórticas no reumáticas en España, 2003-2018

Introduction and objectivesThe impact of therapeutic improvements in nonrheumatic aortic valve disease (NRAVD) has been assessed at the patient level but not in the whole population with the disease. Our objective was to assess temporal trends in hospitalization rates, treatment and fatality rates in patients with a main or secondary NRAVD diagnosis. MethodsRetrospective analysis of administrative claims from patients hospitalized with a main or secondary NRAVD diagnosis between 2003 and 2018 in Spain. Time trends in age- and sex-standardized hospitalization and procedure rates, baseline characteristics and case fatality rates by diagnosis type were assessed by Poisson regression and joinpoint analysis. ResultsHospital admissions in patients with NRAVD increased from 69 213 in 2003 to 136 185 in 2018. The crude in-hospital fatality rate increased from 6.7% to 8.7% (IRR, 1.015; 95%CI, 1.012-1.018; P <.001) without changes after adjustment. Adjusted fatality rates decreased in patients with a main NRAVD diagnosis (5.5% to 3.5%; IRR, 0.953; 95%CI, 0.942-0.964) but increased in those with a secondary diagnosis (8.0% to 8.8%; IRR, 1.005; 95%CI, 1.002-1.009). Aortic valve replacements increased from 10.5 to 17.1 procedures per 100 000 population (IRR, 1.033; 95%CI, 1.030-1.037), mainly driven by transcatheter procedures (IRR, 1.345; 95%CI, 1.302-1.389). ConclusionsHospitalizations in patients with NRAVD are increasing, with most being secondary diagnoses. The use of aortic valve replacement is increasing with a reduction in fatality rates but only in patients with a main diagnosis.

Intravenous edaravone treatment in ALS and survival: An exploratory, retrospective, administrative claims analysis

SummaryBackgroundWe aimed to evaluate overall survival in US patients with amyotrophic lateral sclerosis (ALS) treated with intravenous (IV) edaravone compared with those not treated with IV edaravone in a real-world setting.MethodsThis exploratory retrospective comparative effectiveness observational analysis included patients with ALS who were enrolled in an administrative claims database from 8 August 2017 to 31 March 2020. Propensity score matching identified IV edaravone-treated patients (cases) and non-edaravone-treated patients (controls) matched for covariates: age, race, geographic region, sex, pre-index disease duration, insurance, history of cardiovascular disease, riluzole prescription, gastrostomy tube placement, artificial nutrition, noninvasive ventilation, and all-cause hospitalisation. For cases, the index date was the date of the first claim for IV edaravone. For controls, it was the date IV edaravone was available (8 August 2017). The effect of IV edaravone on all-cause mortality was estimated with shared frailty Cox regression analysis.Findings318 cases were matched to 318 controls. In both groups, 208 patients (65.4%) had a history of riluzole prescription. As of 31 March 2021, there were 155 deaths (48.7%) among the cases and 196 among the controls (61.6%). Median overall survival time was 29.5 months with edaravone and 23.5 months without, respectively, and the risk of death was 27% lower in cases than in controls (HR, 0.73; 95% CI, 0.59–0.91; p=0.005).InterpretationIn this real-world analysis, IV edaravone treatment in a large predominantly riluzole-treated US cohort was associated with prolonged overall survival compared with not using IV edaravone. Data from adequately powered RCTs are needed to support this finding.FundingFunded by Mitsubishi Tanabe Pharma America.

The Divergence Between Hospital Charges and Reimbursements For Primary 1-2-level Lumbar Fusion Has Increased Over Time: A Medicare Administrative Claims Analysis.

A retrospective cohort study was performed for patients undergoing 1-2-level lumbar fusion (1-2LF) from 2005 to 2014 using an administrative claims database. The objective of this study was to determine changes in: (1) annual charges; (2) annual reimbursement rates; and (3) annual difference (charges minus reimbursements) in patients undergoing 1-2LF. With implementation of value-based care in orthopaedics, coupled with the rise in number of patients undergoing 1-2LF, understanding the discordance in hospital charges and reimbursements is needed. The difference in hospital charges to reimbursements specifically for 1-2LF for degenerative disc disease has not been studied. A Medicare administrative claims database was queried for patients undergoing primary lumbar fusion using ICD-9 procedural code 81.04-81.08. Patients specifically undergoing 1-2LF were filtered from this cohort using ICD-9 procedural code 81.62. The query yielded 547,067 patients who underwent primary 1-2LF. Primary outcomes analyzed included trends in charges, reimbursement rates, and net difference in cost over time and per annual basis. Linear regression evaluated the change in costs over time with a P -value less than 0.05 considered significant. From 2005 to 2014, total charges increased from $6,085,838,407 to $19,621,979,956 and total reimbursements increased from $1,677,764,831 to $4,656,702,685 (all P <0.001). Per patient charges increased 92.10% from 2005 to 2014 for patients undergoing primary 1-2LF from $129,992 to $249,697 ( P <0.001). Similarly, an increase in reimbursement per patient of 65.35% from $35,836 to $59,258 ( P <0.001) was noted. The annual difference in charges to reimbursements increased 102.26% during the study interval from $94,155 to $190,439 ( P <0.001). Per patient charges and reimbursements both increased over the study period; however, charges increased 30% more than reimbursements. Further breakdown of hospital, surgeon, and anesthesiologist reimbursements for 1-2LF is needed. Level III.