Purpose: 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). Patients and Methods: 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 >= 1 hospitalization 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. Results: 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 >= 1 hospitalization, 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. Conclusion: 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.

Abstract Background Adrenomyeloneuropathy (AMN) is a neurodegenerative disease phenotype of X-linked adrenoleukodystrophy (ALD), resulting in progressive myeloneuropathy causing spastic paraparesis, sensory ataxia, and bowel/bladder symptoms. We conducted a retrospective cohort study using two large administrative databases to characterize mortality and the burden of illness in adult men with AMN in the US. Results Healthcare resource use was assessed using a national commercial insurance claims database (2006–2021). Males with AMN ages 18–64 years and no evidence of cerebral ALD or other peroxisomal disorders were included and 1:4 matched on demographic characteristics to individuals without AMN. All study participants were followed for as long as observable. Patients with AMN were also identified in the Medicare Limited Dataset (2017–2022); mortality and age at death were compared with all Medicare enrollees. We identified 303 commercially insured men with AMN. Compared with non-AMN, individuals with AMN had significantly more inpatient hospital admissions (0.44 vs. 0.04 admissions/patient/year), outpatient clinic (8.88 vs. 4.1 visits/patient/year), outpatient hospital (5.33 vs. 0.99 visits/patient/year), and home healthcare visits (4.66 vs. 0.2 visits/patient/year), durable medical equipment claims (0.7 vs. 0.1 claims/patient/year), and prescription medication fills (18.1 vs. 5.4 fills/patient/year) (all p < 0.001). Average length-of-stay per hospitalization was also longer in AMN (8.88 vs. 4.3 days; p < 0.001). Rates of comorbidities were significantly more common in AMN compared to controls, including peripheral vascular disease (4.6% vs. 0.99%), chronic pulmonary disease (6.3% vs. 2.6%), and liver disease (5.6% vs. 0.88%), all p < 0.001. Among individuals age < 65 with Medicare disability coverage, mortality rates were 5.3x higher for adult AMN males (39.3% vs. 7.4%) and the age at death significantly younger (47.0 ± 11.3 vs. 56.5 ± 7.8 years), both p < 0.001. Among Medicare beneficiaries ages ≥ 65 mortality rates were 2.2x higher for men with AMN vs. those without AMN (48.6% vs. 22.4%), p < 0.001. Conclusion AMN imposes a substantial and underrecognized health burden on men, with higher healthcare utilization, greater medical comorbidity, higher mortality rates, and younger age at death.

Objective: To quantify healthcare resource use (HRU) and mortality associated with adrenomyeloneuropathy (AMN) in X-linked Adrenoleukodystrophy (ALD). Background: AMN is a neurodegenerative disease caused by mutations in ABCD1 resulting in progressive myeloneuropathy causing spastic paraparesis, sensory ataxia, loss of mobility, incontinence, and sexual dysfunction. AMN's impact on HRU and mortality is unknown. Design/Methods: HRU was assessed using commercial insurance claims from IQVIA's PharMetrics Plus database (1/01/2006–6/30/2021). The AMN cohort comprised men 18–64y with ≥1 inpatient or ≥2 outpatient claims containing an AMN diagnosis (ICD-10-CM: E71.52x; ICD-9-CM 277.86) and no evidence of childhood cerebral adrenoleukodystrophy or other peroxisomal disorders. AMN patients were 1:4 matched and compared to non-AMN individuals. Separately, mortality rates and age at death were assessed in the Medicare Limited Dataset (all ages). Results: We identified 303 AMN men with mean age 35.1±13.8y, followed for average 29 months. Per year, AMN men had greater inpatient admissions (0.39 vs. 0.04); outpatient clinic (8.76 vs. 4.11), hospital (5.32 vs. 0.88) and home healthcare visits (4.57 vs. 0.24); and more durable medical equipment claims (0.70 vs. 0.13). Length-of-stay (8.78 vs. 4.32 days) was longer in AMN and they utilized more prescription medications (18.1 vs 5.4 pharmacy fills/year) than non-AMN. Comorbidities were more common in AMN compared to controls, including peripheral vascular disease (4.6%), chronic pulmonary disease (6.3%), and liver disease (5.6%). Mortality rates among male AMN Medicare enrollees were 5.3x higher for ages 18–64y (39.3% vs. 7.4%) and 2.2x for ≥65y (48.6% vs. 22.4%), both p<0.001). Age at death was younger for male AMN enrollees 18–64y (47.0±11.3 vs. 56.5±7.8, p<0.001). Conclusions: AMN imposes a substantial and previously under-recognized health burden for men with ALD, including more medical comorbidities, more healthcare use, higher mortality rates, and, in some subgroups, younger age at death. Further research to fully elucidate these findings is needed. Disclosure: Dr. Bonkowsky has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Bluebird bio. Dr. Bonkowsky has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Neurogene. Dr. Bonkowsky has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Passage Bio. Dr. Bonkowsky has received personal compensation in the range of $0-$499 for serving as a Consultant for Takeda. Dr. Bonkowsky has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Autobahn. Dr. Bonkowsky has received stock or an ownership interest from Orchard. The institution of Dr. Bonkowsky has received research support from NIH. An immediate family member of Dr. Bonkowsky has received intellectual property interests from a discovery or technology relating to health care. Dr. Bonkowsky has received publishing royalties from a publication relating to health care. Ms. Healey has received personal compensation for serving as an employee of PrecisionHEOR. Naomi Sacks has nothing to disclose. Ms. McLin has received personal compensation for serving as an employee of Precision Medicine Group. Philip Cyr has received personal compensation for serving as an employee of PRECISIONheor. Eileen Sawyer has received personal compensation for serving as an employee of uniQure Inc. Eileen Sawyer has received stock or an ownership interest from uniQure Inc. Dr. Stephen has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for SwanBio Therapeutics. The institution of Dr. Stephen has received research support from Sanofi. Dr. Stephen has received research support from National Institutes of Health. An immediate family member of Dr. Eichler has received personal compensation for serving as an employee of UpToDate. Dr. Eichler has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for SwanBio Therapeutics. Dr. Eichler has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Alnylam. Dr. Eichler has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Origin Biosciences. Dr. Eichler has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Orchard Therapeutics. Dr. Eichler has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Autobahn Therapeutics. Dr. Eichler has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Bluebird Bio. Dr. Eichler has received personal compensation in the range of $500-$4,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for UpToDate. Dr. Eichler has received stock or an ownership interest from SwanBio Therapeutics. The institution of Dr. Eichler has received research support from Bluebird Bio. The institution of Dr. Eichler has received research support from Minoryx Therpeutics. The institution of Dr. Eichler has received research support from Sio Therapeutics. Dr. Eichler has received intellectual property interests from a discovery or technology relating to health care.

BACKGROUND: Diabetic peripheral neuropathy, a common comorbidity of diabetes, is a neurodegenerative disorder that targets sensory, autonomic, and motor nerves frequently associated with painful diabetic neuropathy (PDN). PDN carries an economic burden as the result of reduced work and productivity. A recent multicenter randomized controlled trial, SENZA-PDN (NCT03228420), assessed the impact of high-frequency (10 kHz) spinal cord stimulation (SCS) on pain relief. The effects of high-frequency SCS on health care resource utilization and medical costs are not known. OBJECTIVE: To evaluate the effect of high-frequency (10 kHz) SCS on health care resource utilization (HRU) and medical costs in patients with PDN using data from the SENZA-PDN trial. METHODS: Participants with PDN were randomly assigned 1:1 to receive either 10 kHz SCS plus conventional medical management (CMM) (SCS treatment group) or CMM alone (CMM treatment group). Patient outcomes and HRU up to the 6-month follow-up are reported here. Costs (2020 USD) for each service was estimated based on publicly available Medicare fee schedules, Medicare claims data, and literature. HRU metrics of inpatient and outpatient contacts and costs are reported as means and SDs. Univariate and bivariate analyses were used to compare SCS and CMM treatment groups at 6 months. RESULTS: At 6-month follow up, the SCS arm experienced approximately half the mean rate of hospitalizations per patient compared with the CMM treatment group (0.08 vs 0.15; P = 0.066). The CMM treatment group's total health care costs per patient were approximately 51% higher compared with the SCS treatment group (equivalent to mean annual cost per patient of $9,532 vs $6,300). CONCLUSIONS: Our analysis of the SENZA-PDN trial indicates that the addition of 10 kHz SCS therapy results in lower rates of hospitalization and consequently lower health care costs among patients with PDN compared with those receiving conventional management alone.

Noninfectious pulmonary complications (NIPC) after allogeneic hematopoietic stem cell transplantation (alloHSCT), including bronchiolitis obliterans syndrome (BOS), cause significant morbidity and mortality, but their impact on health care resource utilization (HRU) and costs is unknown. This longitudinal retrospective study quantified the economic burden of NIPC and BOS in alloHSCT patients using commercial claims data from the IQVIA PharMetrics Plus database. Study patients were aged 0 to 64 years and underwent alloHSCT between 1 January 2006 and 30 September 2018, and were observable 12 months before and up to 5 years after index alloHSCT. NIPC patients were identified using International Classification of Disease (ICD) diagnosis codes. Outcomes were mean per patient HRU (inpatient admissions, outpatient office, hospital visits, and prescription medications) and costs paid by insurers in each post-transplant year. Among 2162 alloHSCT patients, 254 developed NIPCs, and 155 were propensity score (PS)-matched to non-NIPC patients. The year following transplantation, NIPC patients had significantly higher inpatient admission rates (3.8 +/- 3.2 vs non-NIPC: 2.6 +/- 2.4; P < .001) and higher total costs ($567 870 vs $412 400; P = .07), reflecting higher costs for inpatient admissions ($452 475 vs $300 202; P = .06). Among those observable for more years, costs remained higher for NIPC patients, reflecting significantly higher inpatient admission rates in the first 3 years following transplant. Subanalysis of patients with diagnoses likely reflective of BOS were consistent with these findings. AlloHSCT patients who developed NIPC had higher health care resource utilization and incurred higher costs compared with alloHSCT patients who did not develop NIPC following transplant.

Aims Chronic lung allograft dysfunction (CLAD), a common complication of lung transplantation, is the leading cause of death for lung transplant recipients. While data on lung transplant costs are available, the impact of CLAD on healthcare resource use (HRU) and cost is not well understood. The primary objective was to quantify the HRU and costs of CLAD in the US using real-world data. Methods A longitudinal retrospective analysis was performed of commercial claims data from the IQVIA PharMetrics Plus database for patients aged 18-64 who underwent lung transplantation between January 1, 2006 and September 30, 2018. Lung transplantation was identified using International Classification of Disease and Common Procedure Terminology procedure codes. Patients studied were observable for at least 12 months before and after transplantation. Patients who developed CLAD were identified using novel, diagnosis codes for incident lung disease at least one year following transplantation. Descriptive analyses were conducted to assess the study's outcomes prior to and following a CLAD diagnosis. All-cause HRU and costs, the study's primary outcomes, leading up to and following CLAD diagnosis were calculated. Results Among 129 transplant patients who developed CLAD, healthcare costs were substantially higher in the year following diagnosis ($198,113), compared to the year leading to diagnosis ($85,276). Inpatient admissions were responsible for most costs in years 1 and 2 following diagnosis ($99,372 and $83,348 respectively). Drug costs were higher in the 12 months post-index, compared to the 12 months pre-index ($3,600 vs $2,527). Limitations Claims data do not include clinical data, have limits determining loss of follow-up, and do not provide granularity to determine disease severity. Also, there is no ICD-10-CM code specific to CLAD or BOS. Conclusions CLAD after lung transplant is associated with substantial HRU and costs. Further work is needed to develop interventions that reduce this impact.

BACKGROUND:Paroxysmal supraventricular tachycardia (PSVT) encompasses a range of heart rhythm disorders leading to rapid heart rates. By virtue of its episodic nature, diagnosing PSVT is difficult and estimating incidence and prevalence on a population level is challenging. The objective of this study was to estimate the incidence and prevalence of PSVT in the United States (US) in contemporary practice.METHODS AND RESULTS:An observational retrospective longitudinal study using claims, enrollment, and demographic data from the IBM MarketScan® Commercial Research database (age < 65) and the Medicare Limited Data Set (age ≥ 65) from 2008 to 2016. Patients with a PSVT diagnosis code (ICD-9: 427.0; ICD-10: I47.1) on ≥2 outpatient, ≥1 emergency room, or ≥1 inpatient visit were considered as having PSVT. Patients with atrial fibrillation/atrial flutter (AF/AFL) were excluded from the initial analysis given the potential for misclassification. Incidence was estimated by assessing diagnoses made during year 5 of continuous enrollment. Finally, a sensitivity analysis was performed by including patients with both PSVT and AF/AFL diagnoses. Period prevalence and incidence rate were estimated to be 332.9 (323.2-342.9) and 57.8 (52.8-63.3) per 100 000 individuals, respectively, when excluding patients with AF/AFL. Projected to the 2018 US Census, prevalence and incidence are 1.26 million (1.21-1.30 million) and 188,981 (172,891-206,943), respectively. Including patients with AF/AFL, the prevalence may increase to 479.7 (467.9-491.8) with an incidence of 93.4 (86.9-100.5) per 100 000 individuals or a prevalence of 2.06 million (2.01-2.12 million).CONCLUSIONS:Approximately 1 in 300 people in the US had PSVT with the highest rates in older and female patients.

BACKGROUND: Several nonpharmacologic and pharmacologic treatments are available for the management of knee osteoarthritis (OA)-related pain and for improving functionality; however, clinical guideline recommendations vary on their use. OBJECTIVE: To compare the treatment patterns in a real-world setting versus the guideline recommendations for the treatment of newly diagnosed patients with knee OA. METHODS: This retrospective analysis used data from the electronic health records of the Geisinger Health System between January 1, 2010, and December 2018 to identify adults with newly diagnosed knee OA who had not received previous therapy with intra-articular corticosteroids, opioids, intra-articular hyaluronic acid, or prescription nonsteroidal anti-inflammatory drugs (NSAIDs). Eligible patients were evaluated for the mutually exclusive treatment categories after diagnosis, including prescription NSAIDs, intra-articular corticosteroids, intra-articular hyaluronic acid (specifically an intra-articular bioengineered hyaluronic acid), opioids, physical therapy, bracing, and total knee arthroplasty. These 7 treatment categories were evaluated for utilization patterns in the real-world setting. RESULTS: A total of 8776 patients with a new diagnosis of knee OA were identified; 88.2% of them received 1 of the 7 evaluated treatments. The most frequently prescribed first treatment was intra-articular corticosteroids (26%), followed by opioids (17.6%), and intra-articular bioengineered hyaluronic acid (14.9%). The most often prescribed second treatment was opioids (15.8%), followed by physical therapy (14%), NSAIDs (11.8%), and intra-articular bioengineered hyaluronic acid (9.6%). Of note, 22.9% of the patients received only 1 evaluated therapy during the study period and did not receive a second treatment. CONCLUSIONS: Real-world treatment patterns in patients with newly diagnosed knee OA indicate that prescribers are using the spectrum of the available therapies that, at times, are different from the current treatment guideline recommendations.

BACKGROUND: In X-linked myotubular myopathy (XLMTM), mutations in the MTM1 gene result in absence or dysfunction of myotubularin, a protein required for normal development, maintenance, and function of skeletal muscle. Extreme muscle weakness results in severe respiratory failure that is fatal for approximately half of XLMTM-affected children by age 18 months. Most surviving patients require invasive mechanical ventilation, feeding tubes, and wheelchairs for mobility, due to profoundly impaired motor function. Little is known about the costs of care for this rare disease. Currently, there are no approved therapies for XLMTM. OBJECTIVE: To quantify the direct medical costs and health care resource utilization (HRU) incurred by XLMTM patients and paid by commercial insurers. METHODS: A retrospective, longitudinal study was conducted using the IQVIA PharMetrics Plus commercial database of adjudicated claims for more than 140 million individuals with commercial insurance coverage in the United States. An algorithm based on demographic information, diagnosis and procedure codes, and medications was used to identify XLMTM patients younger than aged 2 years during the study period from January 1, 2006, through September 30, 2018. All-cause direct medical costs and HRU during each month were calculated. Costs were grouped as inpatient hospital admissions (including the intensive care unit or neonatal intensive care unit [NICU]); emergency department visits; outpatient services (outpatient hospital visits, office visits, physician/provider office visits, ambulatory surgeries and procedures, laboratory tests, and imaging tests); and prescription medications. Monthly costs and HRU over time were stratified by age and use of mechanical ventilation. RESULTS: 49 patients met the study criteria. All had at least 1 inpatient hospital admission, and 36 (73%) had at least 1 NICU stay. All patients received ventilation at some time during the study period, including 40 (82%) treated with invasive ventilation. Mean monthly per patient direct medical costs were highest in the first year of life ($74,831), including costs for inpatient admissions ($69,025), outpatient services ($5,266), and prescription medication ($540). Mean monthly costs were lower in the second, third, and fourth years of life ($23,207, $ 13,044, and $9,440, respectively). When annualized, these all-cause monthly medical costs totaled $897,978 per patient in the first year of life and nearly $ 1.5 million total for patients who survived the first 4 years of life. Costs were consistently highest when patients were receiving invasive ventilation and lowest when they were not receiving ventilation (i.e., before they started on ventilator support). CONCLUSIONS: This direct health care cost and HRU analysis demonstrates the substantial economic burden associated with XLMTM. Costs are highest in the first year of life and are particularly significant for patients receiving invasive ventilation.

Background Bronchiolitis obliterans syndrome (BOS) is an obstructive airway disease of the lungs that affects 5.5 to 14.8% of allogeneic hematopoietic stem cell transplant (allo-HSCT) patients. One of its defining clinical manifestations is a decline in Forced expiratory volume in 1 second (FEV1) in the presence of airflow obstruction, as quantified by spirometry and other lung function tests. Prompt diagnosis through lung function testing may improve outcomes, but lung function testing rates following allo-HSCT have not been examined. This study analyzed lung function testing rates before and after allo-HSCT in the US. Methods Data sources for this longitudinal retrospective study were the IQVIA PharMetrics Plus commercial database and the Medicare Limited Dataset, both with enrollment, demographic and medical claims data for individuals in the US. Study patients had at least one claim with a Common Procedure Terminology (CPT) or International Classification of Diseases (ICD), 9th and 10th revision, procedure code, or an International Code of Disease (ICD-9 or ICD-10) for allo-HSCT, following a 6-month period with no evidence of transplantation. Commercially insured patients were limited to age 0y to <65y because those ≥65y are likely to have primary coverage through Medicare. The study period was 1/1/06 - 9/30/18 for commercially insured, and 1/1/10 -12/31/18 for Medicare patients. Lung function tests were identified using CPT and ICD procedure codes. Outcome measures were the percent of patients receiving testing each year, and the mean annual number of tests per patient. All measures were calculated for patients receiving at least one lung function test of any kind, and for specific tests: spirometry, lung diffusion capacity, and plethysmography/lung function volume. McNemar tests were conducted to assess whether the percent of patients with any lung function testing was significantly different in year 3, compared with years 1 and 2. ANOVA tests assessed whether mean testing rates were significantly different in the three post-transplant years. All tests of significance were conducted at an alpha level of .05. Results Among 2,187 commercially insured and 1,864 Medicare patients, a minority (41%) received at least one lung function test in the first year following transplantation. Among those who survived more than one year, the percentage with any lung function test declined over time, with 42% (Commercial) and 40% (Medicare) receiving any tests in year 2 and 31% (Commercial) and 26% (Medicare) in year 3 (Commercial p=.61; Medicare p<.05). The proportions of patients receiving specific tests further declined over the study period, including spirometry, with 41% (Commercial) and 34% (Medicare) of all patients receiving spirometry in year 1 and 38% (Commercial) and 36% (Medicare) in year 2, but only 28% (Commercial) and 24% (Medicare) receiving spirometry tests in year 3 (Commercial p<.05; Medicare p=.12). The mean annual number of tests administered per patient also declined. Rates of spirometry, which were 0.73±1.1 (Commercial) and 0.55±0.9 (Medicare) in year 1 and 0.66±1.2 (Commercial) and 0.55±0.9 (Medicare) in year 2 declined to 0.46±1.1 (Commercial) and 0.34±0.7 (Medicare) in year 3 (Commercial p<.05; Medicare p<.05). Rates of lung diffusion capacity and plethysmography/lung function volume testing also declined, with significantly fewer tests per patient in year 3, compared with years 1 and 2 (all p<0.05) (Table). Conclusion Morbidity and mortality from BOS remain high in allo-HSCT patients, but only a minority of patients receive lung function testing in the first year, and even fewer receive testing in year 3 following allo-HSCT. The mean number of tests per patient is significantly lower for all patients in year 3, compared with years 1 and 2, suggesting that annual testing frequency also decreases over time. This decrease is evident in commercially insured patients in the second year post-transplant, and is greatest for all patients in the third year post transplant, when patients remain at risk of BOS. Declines in testing may lead to a delayed or missed diagnosis of BOS. Increased and sustained monitoring of allo-HSCT patients could lead to earlier detection of BOS and earlier intervention and treatment. Disclosures No relevant conflicts of interest to declare.

INTRODUCTION: Clostridioides difficile infection (CDI), especially recurrent CDI (rCDI), is associated with high morbidity and resource utilization, imposing significant burden on the US healthcare system. This study evaluated the association of rCDI with medical procedures, complications, and medication use after an index CDI episode. METHODS: We performed a retrospective analysis of commercial claims data from the IQVIA PharMetrics Plus™ database for patients aged 18–64 years with CDI episodes requiring inpatient stay with CDI diagnosis code (ICD-9-CM 008.45; ICD-10-CM A04.7, A04.71, A04.72) or an outpatient medical claim for CDI plus a CDI treatment. We considered index CDI episodes from 1/1/2010 to 6/30/2017, including only those patients who were observable 6 months a priori and 12 months after the index episode. Each CDI episode was followed by a 14-day claim-free period after the end of treatment to distinguish rCDI from continuous CDI. rCDI was defined as another CDI episode within an 8-week window immediately after the claim-free period. Medication use, procedures, and complications were calculated over 12 months and stratified by number of rCDI episodes. RESULTS: 46,571 patients with an index CDI episode were included, of whom 3,129 (6.7%) experienced 1 rCDI, 472 (1.0%) experienced 2 rCDI, and 134 (0.3%) had 3 or more rCDI episodes. Mean (SD) age was 47.4 (12.7) years, and 62.4% were female (similar across rCDI groups; Table 1). Mean baseline Charlson Comorbidity Index (CCI) scores were 1.15, 1.54, 1.83, and 2.29 for those with no rCDI, 1 rCDI, 2 rCDI, and 3+ rCDI episodes, respectively. Vancomycin was the most commonly prescribed antibiotic during follow-up (Table 2). Follow-up prescription rates of metronidazole decreased with increasing rCDI episodes. In the 12-month follow up, sepsis occurred in 16.5% of patients with no rCDI, 27.3% with 1 rCDI, 33.1% with 2 rCDI, and 43.3% with 3+ rCDI episodes; subtotal colectomy or diverting loop ileostomy was performed as a follow-up procedure for 4.6%, 7.3%, 8.9%, and 10.4% of patients, respectively, in the four study groups (Figure 1). CONCLUSION: There appears to be a stepwise increase in number of rCDI episodes associated with increasing baseline CCI score. During the 12 months after index CDI episode, the frequency of sepsis and colectomy increased in parallel to the number of CDI recurrences. Prevention of rCDI is an important step to reduce the burden of such complications.

Abstract Background Clostridioides difficile infection (CDI), especially recurrent CDI (rCDI), is associated with high morbidity and resource use and imposes a significant burden on the US healthcare system. The objective of this study was to evaluate the burden of rCDI on healthcare resource utilization. Methods A retrospective study analyzed commercial claims data from patients aged 18–64 years old in the IQVIA PharMetrics Plus™ database. CDI episodes required an inpatient stay with CDI diagnosis code (ICD-9-CM 008.45; ICD-10-CM A04.7, A04.71, A04.72), or an outpatient medical claim with CDI diagnosis code plus a CDI treatment, and index episodes occurred from January 1, 2010 to June 30, 2017. Only patients who were observable 6 months before and 12 months after the index CDI episode were included. Each CDI episode was followed by a 14-day claim-free period after the end of treatment. rCDI was defined as another CDI episode within an 8-week window immediately after the claim-free period. Number of CDI and rCDI episodes, healthcare resource use, and costs were calculated over 12-month follow-up and stratified by number of rCDI episodes. Costs were adjusted to 2018 dollars. Results 46,571 patients with an index CDI episode were included, with 3,129 (6.7%) who had 1 rCDI, 472 (1.0%) who had 2 rCDI, and 134 (0.3%) who had 3+ rCDI episodes. Mean age was 47.4 years, and 62.4% were female. In the 12-month follow-up, the mean (SD) numbers of inpatient visits were 1.4 (2.1) for those with no rCDI, 2.7 (3.4) for those with 1 rCDI, 3.7 (3.9) for those with 2 rCDI, and 5.8 (6.0) for those with 3+ rCDI episodes. Emergency department (ED) visits had a similar trend, with mean (SD) number of visits of 1.5 (3.5), 2.5 (6.0), 3.7 (7.0), and 4.6 (13), respectively for the four study groups. All-cause costs after the index CDI were $71,980 for those with no rCDI, $131,953 for those with 1 rCDI, $180,574 for those with 2 rCDI, and $207,733 for those with 3+ rCDI. Conclusion CDI and rCDI are associated with substantial healthcare resource utilization and direct medical costs. During the 12 months after an index CDI episode, the number of inpatient admissions and ED visits increased substantially for patients with an rCDI episode. Direct medical costs for patients with rCDI also increased with number of recurrences. Disclosures All authors: No reported disclosures.

Background Bronchiolitis obliterans syndrome (BOS), also known as respiratory chronic Graft versus Host Disease (cGvHD), is an obstructive airway disease of the lungs following alloHSCT that has significant morbidity and mortality. BOS is characterized by T-cell mediated inflammation and fibrosis of bronchiolar walls that reduces the diameter of the bronchioles resulting in progressive and irreversible airflow obstruction. BOS is a well described complication following lung transplant and can also be a complication following alloHSCT, with similar histopathology and clinical symptoms. There is currently no approved therapy for the treatment of BOS. While data on alloHSCT costs are available (Milliman 2017; Broder et al., 2017), little is known about the impact of BOS on healthcare resource use (HRU) and costs in alloHSCT. The aim of this study is to quantify the economic burden of BOS in alloHSCT patients. Methods We performed a retrospective analysis of commercial claims data from the IQVIA PharMetrics Plus™ database for patients aged 0-64 who were treated with alloHSCT from 1/1/2007 to 9/30/2017. Patients were observable 12 months before and after index alloHSCT. Those who developed BOS were identified using International Classification of Disease (ICD) diagnosis codes (ICD-9: 491.8, 491.9, 515, 516.34, 561.8; ICD-10: J41.8, J42, J84.09, J84.89, J84.115) and propensity score matched to identify patients who did not develop BOS after alloHSCT. We calculated mean annual per patient rates of hospitalizations, tests and treatments for BOS, as well as costs in the follow-up year for inpatient admissions, Emergency Department (ED) and non-ED outpatient visits, and prescription medications. Costs for the index HSCT were included in the first follow-up year costs. All analyses were repeated for the subset of patients observable in the second post-alloHSCT year. The effect of BOS was estimated as the difference in HRU and costs between the matched BOS and non-BOS alloHSCT patients. Results We identified 161 alloHSCT patients with commercial insurance coverage who developed BOS. A majority were male (60%). Mean age was 51.0 yrs (+/- SD: 12.13); a small proportion (2%) were under age 18. We also identified 161 matched alloHSCT patients who did not develop BOS. More BOS patients were diagnosed with leukemias or lymphomas compared with non-BOS patients (94% vs. 84%) in the pre-alloHSCT year, and more had pulmonary disease (asthma or COPD; 24% vs. 16%). No other differences were statistically significant at p>0.05. In the year following alloHSCT, BOS patients had higher mean per patient annual numbers of inpatient admissions (3.9 [+/- SD: 3.3] vs. 2.6 [+/- SD: 2.5]). More BOS patients received lung function testing, including spirometry (60% vs. 42%), and more were treated with ventilation, oxygen therapy or pulmonary rehabilitation (61% vs. 39%). Costs were higher for BOS patients ($560,048 vs. $408,764), with inpatient costs responsible for most of this difference ($446,622 vs. $300,146). Lung function test costs were over 3 times as high for BOS patients ($35,744 vs. $10,192) and lung function treatment costs 2.5 times as high ($31,761 vs. $7,994). Costs for patients observable in the second post-alloHSCT year were considerably lower, as the costs for the initial alloHSCT costs were reflected in the first year expenditures. Nonetheless, costs remained higher for BOS patients ($72,829 vs. $43,665), with higher inpatient, outpatient and prescription drug costs and HRU (Table, Figure). Conclusion AlloHSCT patients who develop BOS in the U.S. have higher rates of hospitalization and have more lung function tests and treatments, compared with alloHSCT patients with no diagnosis of BOS in the first 1-2 years post-alloHSCT. These higher rates of healthcare service use are accompanied by mean annual per patient costs that are $151,000 higher in the first post-alloHSCT year. Disclosures Sacks: Breath Therapeutics Inc.: Other: Employee of Precision Health Economics (PHE). PHE received funding from Breath Therapeutics for this research. . Healey:Breath Therapeutics Inc.: Other: Employee of Precision Health Economics (PHE). PHE received funding from Breath Therapeutics for this research. . Cyr:Breath Therapeutics Inc.: Other: Employee of Precision Health Economics (PHE). PHE received funding from Breath Therapeutics for this research. . Batt:Breath Therapeutics Inc.: Other: Scientific Adviser to Precision Health Economics (PHE). PHE receieved funding from Breath Therapeutics for this research.. Henig:Breath Therapeutics Inc.: Employment.