Rates Of Healthcare Resource Utilization Research Articles

#1241 Healthcare resource utilisation in adults with chronic kidney disease by KDIGO categorisation in England: 2010-2019

Abstract Background and Aims Chronic kidney disease (CKD) is associated with high clinical burden for patients and substantial economic costs for healthcare systems. Detailed estimates of healthcare resource utilization (HCRU) for patients with CKD in the UK are limited, particularly by stage of CKD. This study assessed outpatient and non-elective inpatient HCRU by stage of CKD in England. Method This non-interventional study utilised data from primary care electronic health records from Clinical Practice Research Datalink (CPRD) AURUM and Hospital Episode Statistics (HES) admitted patient care (APC). Patients aged ≥18 years registered in CPRD with eligible linkage to HES between January 1, 2010 and December 31, 2019 with 2+ eGFR measurement during the period were identified. CKD was defined by eGFR <60 ml/min/1.73 m2 and/or presence of a uACR measurement ≥3 mg/mmol, both confirmed by a second measurement 90-365 days later. Start of follow-up (index) was set to the earliest date during the study period that CKD was confirmed. Follow-up for HCRU ended at earliest of death, administrative censoring, or 31st December 2019. Patients with end-stage kidney disease (eGFR <9 ml/min/1.73 m2) at index were excluded. Number of HCRU events for each HCRU category was estimated as rates per 1,000 person years (PY) for each calendar year based on cumulative number of events. Event rates were calculated as number of outcomes/total time at risk. Confidence intervals (95%) were calculated assuming a Poisson distribution. Age- and sex-adjusted rates were calculated to compare rates across CKD stages. Results Of 6.1 million adult patients meeting study inclusion criteria, 743,945 adults (12.2%) with CKD were identified. Mean age (SD) was 76.1 (11.5) years, 55.2% were female, and 89.8% White, contributing a total of 3,055,600 years of follow-up. Most (60.9%) patients had stage 3a CKD (eGFR 45-<59 ml/min/1.73 m2). Among patients with uACR measurements (44.4%), 48.0% were A1 (<3 mg/mmol), 44.4% A2 (3-30 mg/mmol), and 7.6% A3 (>30 mg/mmol). Overall, per 1000 PY, there were 24,763 primary care visits, 475 non-elective all-cause hospitalisations, 4,950 attended (722 unattended) outpatient visits, including 308 (43 unattended) outpatient nephrology visits and 368.1 attended (61.2 unattended) cardiology visits. For all HCRU categories, greater KDIGO risk category at index was associated with higher HCRU. For example, after age and sex adjustment, patients with CKD stage 3b had a mean of 0.53/PY non-elective all-cause hospitalisations compared to 0.77/PY for patients with CKD stage 4. Additionally, a mean of 5.18 outpatient visits per PY was observed for patients with CKD stage 3b, of which 0.91 were nephrology outpatient visits compared to 8.39 outpatient visits per PY for stage 4, of which 2.65 were nephrology outpatient visits. Generally, both lower eGFR and higher uACR were individually associated with higher HCRU. Conclusion This study demonstrates high HCRU for patients with CKD, with increasing rates of HCRU with lower kidney function and greater kidney damage. Patients with more advanced CKD contribute at a disproportionally higher rate of outpatient healthcare encounters and non-elective hospitalisations. Efforts to prevent the development and progression of CKD and improving clinical outcomes will reduce frequency and cost of HCRU.

Healthcare Resource Utilization and Economic Burden of Cytokine Release Syndrome and Neurotoxicity in Patients with Relapsed and Refractory Multiple Myeloma (RRMM) Receiving Idecabtagene Vicleucel in Earlier-Line Settings in the KarMMa-3 Clinical Trial

Introduction: Adverse events (AE), such as cytokine release syndrome (CRS) and neurological toxicity (NT), have been associated with chimeric antigen receptor (CAR) T cell therapies. Idecabtagene vicleucel (ide-cel, bb2121), a B-cell maturation antigen-directed CAR T cell therapy, demonstrated deep and durable responses in triple-class exposed (TCE) patients (pts) with RRMM in the pivotal, single-arm, open-label phase 2 KarMMa (3 prior lines of therapy [LOTs]; NCT03361748) (Munshi NC, et al. NEJM 2021;384:705-716) and superior progression-free survival with ide-cel vs standard regimens in the phase 3 KarMMa-3 trial (2-4 prior LOTS; NCT03651128) (Rodríguez-Otero P, et al. NEJM 2023;388:1002-1014). Healthcare resource utilization (HCRU) and costs associated with CRS/NT management were estimated previously for pts receiving ide-cel in the KarMMa trial (McGarvey N, et al. Value Health 2023;26:S89) and suggested low rates of severe (grade ≥ 3) CRS/NT following ide-cel infusion and higher HCRU and costs with increasing AE severity. To further assess resource and economic burden associated with care of treatment-emergent AEs, this analysis evaluated HCRU and estimated cost of CRS/NT management among pts treated with ide-cel in earlier-line settings in the KarMMa-3 study. Methods: In this retrospective study, case report forms from the KarMMa-3 clinical trial database among pts experiencing a CRS and/or NT event that initiated within 90 days post ide-cel infusion were assessed. Pt-level HCRU data, including hospitalizations and length of hospital stay (LOS) (standard inpatient [IP], intensive care unit [ICU] days), diagnostics (eg, lab work, imaging), procedures (eg, dialysis, intubation), and medications (eg, oncology supportive care, prophylactics, other AE management) were identified from CRS/NT onset through resolution. AE management costs were estimated using a micro-costing methodology in which unit costs sourced from public databases or literature (eg, United States Centers for Medicare and Medicaid Services, Healthcare Cost and Utilization Project, IBM ® Micromedex ® RED BOOK ®) were adjusted to 2022 US dollars (USD) using the Consumer Price Index and applied to each HCRU identified. Results: Of 225 pts treated with ide-cel in the KarMMa-3 trial, 203 (90.2%) experienced any grade CRS and/or NT event. Pts experiencing a CRS/NT event had a mean (standard deviation [SD]) age of 61.9 (8.9) years and most were male (123/203 [60.6%]), White (138/203 [68.0%]), and non-Hispanic or Latino (138/203 [68.0%]). The majority (187/203 [92.1%]) of pts experienced less severe CRS/NT events (grade ≤ 2), which resolved quicker and relatively few pts (16/203 [7.9%]) had a more severe (grade ≥ 3) event, which took longer to resolve. Among pts who received ide-cel, the estimated median cost of AE management ranged from USD 17,124 (CRS only grade 1) to USD 181,552 (nonconcurrent CRS or NT grade ≥ 3) (Figure 1). Additional median costs for a pt with a grade ≥ 3 CRS/NT event was USD 31,045 higher than a grade ≤ 2 CRS/NT event. Across AE categories, the main contributors to CRS/NT management were facility costs, namely standard IP hospitalizations and ICU stays. Almost all pts (202/203 [99.5%]) had a standard IP hospitalization; 3.9% (8/203) had an ICU stay (Table 1). The trial protocol required a stay of ≥ 15 days post infusion unless admitted to the ICU; some hospitalization days recorded during the AE overlapped with the protocol-required stay. ICU admissions were more common among pts with CRS/NT grade ≥ 3 (7/16 [43.8%]) than those with grade ≤ 2 (1/187 [0.5%]). Median (range) total LOS was 10 days longer among pts with grade ≥ 3 (14.5 [2-84] days) than those with grade ≤ 2 (4 [1-34] days) CRS/NT. Pts with grade ≥ 3 CRS/NT had higher rates of HCRU than those with grade ≤ 2 for several interventions, such as medications (eg, tocilizumab + corticosteroids: 13/16 [81.3%] vs 63/187 [33.7%]), diagnostics (eg, imaging: 14/16 [87.5%] vs 48/187 [25.7%]), and procedures (eg, dialysis:3/16 [18.8%] vs 0/187 [0%]). Conclusions: Most pts with RRMM treated with ide-cel in the KarMMa-3 trial experienced a CRS and/or NT event, however, few were of high severity (grade ≥ 3). HCRU and costs for CRS/NT increased with AE severity and management. CAR T cell therapies associated with lower-severity AEs and planned interventions to prevent higher-grade AEs may provide an opportunity to better manage HCRU and costs.

Understanding the long-term impact of incident osteoporotic fractures on healthcare utilization and costs in Korean postmenopausal women.

To evaluate healthcare resource utilization (HCRU) and costs of care over 5 years after the incident osteoporotic fractures (OF) in postmenopausal women. We used data from the National Health Insurance Service databases 2011-2018. Women aged ≥ 50 years with incident OF (OF group) were matched to women without OF (non-OF group). HCRU (inpatient, outpatient, and emergency room [ER] visits) and costs of care (inpatient, outpatient, and ER visits) during the 5-year follow-up period were derived after propensity score matching (PSM). Additionally, we identified women with subsequent fractures within the first 2 years after the incident OF. After PSM, 47,238 OF and 134,813 non-OF women were identified. HCRU rates and costs of care were highest in the first year after OF and decreased substantially, but remained higher in the OF group during the entire follow-up period. The increase in cumulative HCRU rates over 5 years was highest in inpatient admissions with ER visits (138% higher in OF vs non-OF). The cumulative total costs over 5 years were 73% higher in the OF group than in the non-OF group, which was mostly driven by inpatient costs. Trends were similar for women with subsequent fractures, but they generally showed higher HCRU and costs than those in the total OF group. OF imposes a substantial and sustained economic burden on women, resulting in an approximately twofold increase in the cumulative cost over 5 years compared to women without fracture, which highlights the need for early diagnostics and treatment of osteoporosis.

Treatment Patterns and Healthcare Resource Use in Medicare Beneficiaries with Parkinson's Disease.

Studies on real-world treatment patterns and long-term economic burden of Parkinson's disease (PD) have been limited. To assess treatment patterns, healthcare resource utilization (HRU), and costs associated with PD symptoms and treatment-related adverse events (AEs) among Medicare beneficiaries in the United States. A 100% Medicare Fee-For-Service data (2006-2020) of patients with PD were analyzed. PD treatment patterns were described for the subset of patients who had no previously observed PD treatments or diagnoses (ie, the incident cohort). HRU and healthcare costs associated with PD symptoms were assessed for all patients with PD (ie, the overall cohort) and that associated with treatment-related AEs were assessed for the subset of patients who received PD treatments after PD diagnosis (ie, the active treatment cohort), using longitudinal models with repeated measures. Overall, 318,582 patients were included (mean age at PD diagnosis: 77.4 years; 53.3% female). Among patients in the incident cohort (N=214,829), 51.1% initiated levodopa monotherapy and 5.9% initiated dopamine agonists (DAs) monotherapy as first-line treatment. The proportion of incident patients treated with DAs and other PD therapies generally increased from post-diagnosis years 1 to 10. The median time from diagnosis to PD treatment initiation was 2.0 months; the median time to treatment discontinuation was the longest with levodopa (18.7 months), followed by DAs (9.5 months). In the overall cohort, PD symptoms, especially motor symptoms and severe motor symptoms, were associated with significantly higher rates of HRU and costs. In the active treatment cohort (N=234,298), treatment-related AEs were associated with significantly higher rates of HRU and medical costs. While levodopa is still the mainstay of PD management, considerable heterogeneity exists in real-world treatment patterns. Overall, PD symptoms and AEs were associated with significantly higher HRU and healthcare costs, suggesting unmet medical needs for PD treatments with better tolerability profiles.

Health care resource utilization in 3L + patients with chronic phase chronic myeloid leukemia receiving asciminib or bosutinib

ObjectivesTo assess and compare health care resource utilization (HCRU) rates of asciminib and bosutinib at the Week 24, Week 48, and Week 96 cutoffs among 3 L + patients with chronic myeloid leukemia in chronic phase (CML-CP) in the randomized ASCEMBL trial.MethodsPatients in the ASCEMBL trial (Clinicaltrials.gov: NCT03106779) were randomized to receive asciminib 40 mg twice daily (n = 157) or bosutinib 500 mg once daily (n = 76). At each scheduled visit, investigators conducted HCRU assessment on hospitalization, emergency room visit, general practitioner visit, specialist visit and urgent care visit; duration and type of hospitalization for the hospitalized patients; and reasons for HCRU. The number of patients with HCRU, rate of HCRU per patient-year, and length of hospital stay by ward type were compared at Week 24, Week 48, and Week 96 analyses.ResultsLower proportions of patients receiving asciminib versus bosutinib used any resources including hospitalizations, emergency room visits, general practitioner visits, specialist visits, and urgent care visits (23.6% versus 36.8%, 26.1% versus 39.5%, and 28.6% versus 42.6% at Week 24, Week 48, and Week 96 analyses, respectively). After normalizing for treatment exposure, rates of HCRU for any resource per patient-year were significantly lower for asciminib versus bosutinib: 0.25 (95% CI: 0.18–0.34) versus 0.80 (95% CI: 0.55–1.16) at the Week 24 analysis, 0.20 (95% CI: 0.15–0.27) versus 0.47 (95% CI: 0.32–0.66) at the Week 48 analysis, and 0.17 (95% CI: 0.12–0.22) versus 0.40 (95% CI: 0.27–0.55) at the Week 96 analysis. Among the hospitalized patients, mean length of hospital stay was lower for asciminib than bosutinib for most wards at all three timepoints.ConclusionsIn the ASCEMBL trial, asciminib-treated patients with CML-CP in 3 L + maintained lower resource utilization compared to bosutinib over the long-term.

Economic and Clinical Burden of Herpes Zoster Among Patients With Inflammatory Bowel Disease in the United States.

Patients with ulcerative colitis (UC) or Crohn's disease (CD) are at increased risk of herpes zoster (HZ); however, relevant cost and healthcare resource utilization (HCRU) data are limited. We estimated HCRU (hospitalization, emergency department [ED], and outpatient visits) and costs in patients with UC or CD, with and without HZ, using administrative claims data (October 2015-February 2020). HCRU and costs (2020 US dollars) were compared at 1 month, 1 quarter, and 1 year after the index date, using propensity score adjustment and generalized linear models. In total, 20 948 patients were included: UC+/HZ+ (n = 431), UC+/HZ- (n = 10 285), CD+/HZ+ (n = 435), and CD+/HZ- (n = 9797). Patients with HZ had higher all-cause HCRU rates and all-cause total healthcare costs relative to those without HZ. In the first month, adjusted incidence rate ratios (aIRRs) for hospitalizations and ED visits for patients with UC and HZ compared with UC alone were 2.87 (95% confidence interval [CI], 1.93-4.27) and 2.66 (95% CI,1.74-4.05), respectively; for those with CD and HZ, aIRRs were 3.34 (95% CI, 2.38-4.70) and 3.31 (95% CI, 2.32-4.71), respectively, compared with CD alone (all P < .001). Adjusted cost differences in UC and CD cohorts with HZ over the first month were $2189 and $3774, respectively, chiefly driven by higher inpatient costs. The incremental impact on HCRU and costs in cohorts with HZ predominantly occurred during the first quarter following diagnosis. HZ is associated with increased HCRU and costs in patients with UC and CD, especially shortly after diagnosis.

Healthcare Resource Utilization Among Patients With Activated PI3Kδ Syndrome in the United States: A Real-world Assessment by Patient Age

ImportanceDespite the known morbidity associated with activated PI3Kδ syndrome (APDS), little is understood about the healthcare resource utilization (HRU) attributable to this condition. ObjectiveTo describe HRU and treatment patterns of patients with APDS by age group (≤11 and ≥12 yrs). MethodsPatients with APDS were identified via genetic testing and tokenized to the Symphony Health Integrated Dataverse database comprising medical/pharmacy claims (10/1/2015–3/31/2021). HRU rates (hospitalizations, emergency room [ER], outpatient, and other visits) per person-year, main reason for HRU visit, and treatment patterns were assessed from the start of patients’ clinical activity to the earliest of end of clinical activity or data availability (observation period). ResultsOf 31 patients with APDS identified, 14 were ≤11 yrs and 17 were ≥12 yrs. The mean±SD observation period was 3.9 ±2.1 and 5.2 ± 1.8 yrs, respectively; mean age was 3.9 ± 2.7 and 29.4 ± 13.1 yrs, respectively. Common clinical manifestations in ≤11 yrs included lymphoproliferation (71.4%), fever (64.3%), allergy (57.1%), otitis media (50.0%), diarrhea (21.4%), and lymphoma (7.1%). Common clinical manifestations in ≥12 yrs included sinusitis (58.8%), bronchitis (58.8%), allergy (47.1%), diarrhea (23.5%), and lymphoma (17.6%). Outpatient visit rates were high overall; ER visits and hospitalization rates were low in both groups, whereas other visit rates were high in ≥12 yrs (Figure 1). Immunoglobulin replacement therapy (IRT)-related HRU accounted for 14.4% and 17.9% of outpatient visits in ≤11 yrs and ≥12 yrs, respectively, and 36.6% and 34.3% of other visits in ≤11 yrs and ≥12 yrs, respectively. Reasons for outpatient visits included enlarged lymph nodes and otitis media in ≤11 yrs and long-term drug therapy, common variable immunodeficiency, and acute sinusitis in ≥12 yrs. IRT was used by 42.9% and 70.6% in ≤11 yrs and ≥12 yrs, respectively. Antibiotic, corticosteroid, and mTor inhibitors were used by 92.9% and 88.2%, 78.6% and 76.5%, and 21.4% and 11.8% in ≤11 yrs and ≥12 yrs, respectively; no rituximab use was observed. [Display omitted] ConclusionsAPDS presents with various complex clinical manifestations requiring intervention. Among patients analyzed, outpatient and other visits were the most commonly used healthcare resources and were often associated with respiratory disease and immunodeficiency management. To our knowledge, this is the first study to assess HRU among patients with APDS using administrative claims data.

Epidemiology and patient journey of Rett syndrome in the United States: a real-world evidence study

BackgroundRett syndrome (RTT) is a neurodevelopmental disorder that almost exclusively affects females and is associated with high clinical burden. However, literature characterizing the real-world journey of patients with RTT is limited. This study provided an overview of the epidemiology, patient characteristics, clinical manifestations, healthcare resource utilization (HRU), costs, and treatment patterns of patients with RTT in the US.MethodsIQVIA™ Medical Claims Data and Longitudinal Prescription Data (11/01/2016–10/31/2019) were used to identify female patients with RTT, with the first observed diagnosis defined as the index date. Annual incidence and prevalence of RTT were assessed over the entire study period; clinical manifestations, all-cause and RTT-related HRU and costs, and treatment patterns were evaluated during the observation period—from the index date to end of clinical activity or end of data availability, whichever occurred first. Results were further stratified into pediatric (< 18 years) and adult (≥ 18 years) subgroups.ResultsIn 2019, prevalence and incidence of RTT was 0.32 and 0.23 per 10,000 enrollees, respectively. Among 5,940 female patients (pediatric: 3,078; adult: 2,862) with mean observation period of 2.04 years, the most prevalent clinical manifestations were neurological disorders (72.8%), gastrointestinal/nutritional disorders (41.9%), and orthopedic disorders (34.6%). The incidence rate of all-cause HRU was 44.43 visits per-patient-per-year and RTT-related HRU comprised 47% of all-cause HRU. Mean all-cause healthcare costs were $40,326 per-patient-per-year, with medical costs driven by home/hospice care visits, therapeutic services, outpatient visits, and inpatient visits. RTT-related healthcare costs comprised 45% of all-cause healthcare costs. The most prevalent supportive therapy and pharmacologic agent were feeding assistance (37.9%) and antiepileptic drugs (54.8%), respectively. Trends were similar by subgroup; although, rates of HRU were generally higher among pediatric patients relative to adult patients (all-cause: 52.43 and 35.86, respectively), which translated into higher mean healthcare costs (all-cause: $45,718 and $34,548, respectively).ConclusionsPatients with RTT have substantial disease burden, including prevalent clinical manifestations, high rates of HRU and annual healthcare costs, and reliance on pharmacologic and supportive therapies. These findings underscore the unmet need for effective therapies to target the multifactorial manifestations of RTT.

Burden of Comorbidities and Healthcare Resource Utilization Among Medicaid-Enrolled Extremely Premature Infants

Background: The effect of gestational age (GA) on comorbidity prevalence, healthcare resource utilization (HCRU), and all-cause costs is significant for extremely premature (EP) infants in the United States. Objectives: To characterize real-world patient characteristics, prevalence of comorbidities, rates of HCRU, and direct healthcare charges and societal costs among premature infants in US Medicaid programs, with respect to GA and the presence of respiratory comorbidities. Methods: Using International Classification of Diseases, Ninth/Tenth Revision, Clinical Modification codes, diagnosis and medical claims data from 6 state Medicaid databases (1997-2018) of infants born at less than 37 weeks of GA (wGA) were collected retrospectively. Data from the index date (birth) up to 2 years corrected age or death, stratified by GA (EP, ≤28 wGA; very premature [VP], &gt;28 to &lt;32 wGA; and moderate to late premature [M-LP], ≥32 to &lt;37 wGA), were compared using unadjusted and adjusted generalized linear models. Results: Among 25 573 premature infants (46.1% female; 4462 [17.4%] EP; 2904 [11.4%] VP; 18 207 [71.2%] M-LP), comorbidity prevalence, HCRU, and all-cause costs increased with decreasing GA and were highest for EP. Total healthcare charges, excluding index hospitalization and all-cause societal costs (US dollars), were 2 to 3 times higher for EP than for M-LP (EP $74 436 vs M-LP $27 541 and EP $28 504 vs M-LP $15 892, respectively). Conclusions: Complications of preterm birth, including prevalence of comorbidities, HCRU, and costs, increased with decreasing GA and were highest among EP infants during the first 2 years in this US analysis.

Burden of Comorbidities and Healthcare Resource Utilization Among Medicaid-Enrolled Extremely Premature Infants.

Background: The effect of gestational age (GA) on comorbidity prevalence, healthcare resource utilization (HCRU), and all-cause costs is significant for extremely premature (EP) infants in the United States. Objectives: To characterize real-world patient characteristics, prevalence of comorbidities, rates of HCRU, and direct healthcare charges and societal costs among premature infants in US Medicaid programs, with respect to GA and the presence of respiratory comorbidities. Methods: Using International Classification of Diseases, Ninth/Tenth Revision, Clinical Modification codes, diagnosis and medical claims data from 6 state Medicaid databases (1997-2018) of infants born at less than 37 weeks of GA (wGA) were collected retrospectively. Data from the index date (birth) up to 2 years corrected age or death, stratified by GA (EP, ≤28 wGA; very premature [VP], >28 to <32 wGA; and moderate to late premature [M-LP], ≥32 to <37 wGA), were compared using unadjusted and adjusted generalized linear models. Results: Among 25 573 premature infants (46.1% female; 4462 [17.4%] EP; 2904 [11.4%] VP; 18 207 [71.2%] M-LP), comorbidity prevalence, HCRU, and all-cause costs increased with decreasing GA and were highest for EP. Total healthcare charges, excluding index hospitalization and all-cause societal costs (US dollars), were 2 to 3 times higher for EP than for M-LP (EP $74 436 vs M-LP $27 541 and EP $28 504 vs M-LP $15 892, respectively). Conclusions: Complications of preterm birth, including prevalence of comorbidities, HCRU, and costs, increased with decreasing GA and were highest among EP infants during the first 2 years in this US analysis.

EE427 Annual Cost Savings From the Use of Empagliflozin Over DPP4I in Select Asia-Pacific Countries – Estimates Based on the Emprise East Asia Study

The recently published findings of the EMPRISE East Asia study that looked at patients with type 2 diabetes mellitus (T2DM) in Japan, South Korea, and Taiwan demonstrated that empagliflozin treatment was associated with lower inpatient care needs and other healthcare resource utilization (HRU) than dipeptidyl peptidase-4 inhibitors (DPP4i) in routine clinical practice. The aim of this analysis was to estimate the annual costs savings arising from the reduction in the rates of HRU arising from the use of empagliflozin over DPP4i in select Asia-Pacific countries (Australia, Indonesia, Malaysia, Philippines, Thailand and Vietnam) based on the EMPRISE East Asia study findings.

Real-World Effectiveness and Economic Impact Associated with Chimeric Antigen Receptor T-Cell Therapy Among Older Patients with Relapsed/Refractory Diffuse Large B-Cell Lymphoma in US

Introduction: Chimeric antigen receptor (CAR) T-cell therapy has changed the treatment landscape of relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL). However, there are still limited real-world evidence of survival outcomes from CAR T-cell therapy in older patients with DLBCL. The aim of the study was to examine the outcomes and economic impact among older patients with DLBCL receiving CAR T-cell therapy in a real-world setting in the United States. Methods: Using administrative medical and pharmacy claims from the 100% Medicare Fee-for-Service database, older patients (≥65) with at least one inpatient or two outpatient claims with a diagnosis of DLBCL between 4/1/2016 and 12/1/2020, followed by at least one claim for the administration of CAR T-cell therapy between 1/1/2018 and 12/31/2020 were selected. Patients with evidence of clinical trial participation were excluded. Bridging therapies were reported based on the presence of therapy in the 4-week period preceding the infusion. Outcomes included progression-free survival (PFS) and overall survival (OS). The initiation of any subsequent treatment was used as a proxy for progression. Additionally, healthcare resource utilization (HrU) and total costs within the 90-day period following the infusion were examined among patients with ≥90 days of enrollment post-infusion. The proportion of patients receiving inpatient care, emergency room (ER) services, and outpatient services post CAR T-cell therapy, were reported by location of CAR T-cell therapy administration (inpatient vs. outpatient). Descriptive analyses included means, medians, and standard deviations (SD) for continuous variables, and frequencies and proportions for categorical variables. PFS and OS were analyzed using Kaplan-Meier curves, calculated from infusion date, and tested for significance using the Log-Rank test. Select analyses were further stratified by age category (65-69; 70-74; 75+ years). Results: A total of 551 patients with R/R DLBCL receiving CAR T-cell therapy were included, with mean age of 72.2 and 173 patients (31.4%) aged ≥ 75. A total of 262 patients (47.5%) received bridging therapy (Table 1). The oldest patients (≥75) had shorter median PFS (160 days) and OS (403 days), compared to patients aged 70-74 who had median PFS (379 days) and OS (603 days) and patients aged 65-69 who had a median PFS (194 days) and OS (518 days) (Figure 1). The 12-month failure rate based on PFS was highest in patients aged ≥ 75 at 66%, compared to patients aged 70-74 at 48% and patients aged 65-69 at 57% (p = 0.001). The majority of patients received CAR T-cell infusion in an inpatient setting (n=456, 82.8%), with an average length of stay 21.4 days. Within 90 days following infusion, 28.7% of patients who received CAR T-cell therapy in an inpatient setting presented a re-hospitalization, 30.3% had an ER visit, and all patients had ≥1 outpatient visit, with a mean of 17.4 outpatient visits. Among patients who received CAR T-cell therapy in an outpatient setting, 41.8% were hospitalized later, 31.6% had an ER visit, and all patients had ≥1 outpatient visit, with a mean of 19.0 outpatient visits. Similar HrU rates were observed across age groups, except hospitalization rate, which was lowest among patients with age ≥ 75. Total median cost within 90 days from the infusion date (inclusive of CAR T-cell infusion) was $352,572 and was similar across all age groups (Table 1). Conclusion: This study is one of the largest real-world studies to date of patients with R/R DLBCL receiving CAR T-cell therapy leveraging Medicare claims data. Older patients in this study appeared to have shorter PFS and OS compared to clinical trials, with the worst outcomes observed in patients aged 75+. Similar costs within the 90-day period post CAR T-cell therapy were observed across age groups, and intensive use of HrU was noted. The results provide important reference to consider real-world healthcare utilization and cost effective treatment approaches in older patients with R/R DLBCL. Figure 1View largeDownload PPTFigure 1View largeDownload PPT Close modal

Reductions in acute medication use and healthcare resource utilization in patients with chronic migraine: a secondary analysis of a phase 3, randomized, double-blind, placebo-controlled study of galcanezumab with open-label extension (REGAIN)

Aims To analyze secondary objectives of the REGAIN study related to acute headache medication use and healthcare resource utilization (HCRU) in patients with chronic migraine treated with galcanezumab, a monoclonal antibody to calcitonin gene-related peptide. Methods Adults with chronic migraine (N = 1,113) were randomized (2:1:1) and treated with double-blind monthly injections of placebo, galcanezumab-120 mg, or galcanenzumab-240 mg for 3 months, followed by a 9-month open-label extension with 120 or 240 mg/month galcanezumab. Headache and medication information was collected by daily eDiary. HCRU was reported for the 6 months before randomization, monthly thereafter, and converted to rate per 100-patient-years. Results At baseline, 63–64% of patients met criteria for acute headache medication overuse. At Month 3, incidence of headache medication overuse in the galcanezumab groups (33% and 33%) was significantly lower than in the placebo group (46%, both p < .001) and was 16% and 23% in the previous-galcanezumab groups at Month 12. From a baseline of 14.5 to 15.5, reduction in mean number of monthly migraine headache days with acute headache medication use was also significantly greater in the galcanezumab groups at Month 3 (−4.2 and −4.9) than in placebo (−2.6, both p < .001), with reductions of −6.8 and −7.6 in the previous-galcanezumab groups at Month 12. Migraine-specific HCRU rates decreased for all groups, with no significant between-group differences at Month 3. At Month 12, in the two previous-galcanezumab groups, emergency room visits decreased by 58% and 75%, hospital admissions by 100%, and healthcare professional visits by 54% and 67%. Limitations Only 3 months of double-blind, placebo-controlled data, a longer HCRU recall period for baseline than postbaseline, and patients receiving care in the clinical trial itself, may limit generalizability. Conclusions Treatment with galcanezumab resulted in significant reductions in headache medication overuse and migraine headache days requiring acute medication use, with notable reductions in migraine-specific HCRU.

Single-Inhaler Triple Therapy in Patients with Advanced COPD: Bayesian Modeling of the Healthcare Resource Utilization Data and Associated Costs from the IMPACT Trial.

ObjectivesIn the IMPACT trial (NCT02164513), triple therapy with fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) showed clinical benefit compared with dual therapy with either FF/VI or UMEC/VI in the treatment of chronic obstructive pulmonary disease (COPD). We used data from IMPACT to determine whether this translated into differences in COPD-related healthcare resource utilization (HRU) costs in a United Kingdom (UK) setting.MethodsIn a within-trial analysis, individual patient data from the IMPACT intention-to-treat (ITT) population were analyzed to estimate rates of COPD-related HRU with FF/UMEC/VI, FF/VI, or UMEC/VI. A Bayesian approach was applied to address issues typically encountered with this kind of data, namely data missing due to early study withdrawal, subjects with zero reported HRU, and skewness. Rates of HRU were estimated under alternate assumptions of data being missing at random (MAR) or missing not at random (MNAR). UK-specific unit costs were then applied to estimated HRU rates to calculate treatment-specific costs.ResultsUnder each MNAR scenario, per patient per year (PPPY) rates of COPD-related HRU were lowest amongst those patients who received treatment with FF/UMEC/VI compared with those receiving either FF/VI or UMEC/VI. Although absolute HRU rates and costs were typically higher for all treatment groups under MNAR scenarios versus MAR, final economic conclusions were robust to patient withdrawals.ConclusionsPPPY rates were typically lower with FF/UMEC/VI versus FF/VI or UMEC/VI.

Changes in acute headache medication use and health care resource utilization: Results from a randomized, double-blind, placebo-controlled clinical trial evaluating galcanezumab in adults with treatment-resistant migraine (CONQUER).

BACKGROUND: Patients with migraine, particularly with multiple prior preventive treatment failures, often have high rates of acute headache medication use and are at risk for overuse (acute or symptomatic headache medication use between 10 and 15 days per month [depending on the medication] for > 3 months). Furthermore, these patients have greater health care resource utilization (HCRU). OBJECTIVE: To examine acute headache medication use and HCRU with galcanezumab compared with placebo in a population with multiple prior migraine preventive treatment failures. METHODS: In the 3-month double-blind phase, patients with episodic or chronic migraine and treatment failures to 2 to 4 standard-of-care migraine preventive categories (lack of effectiveness or safety/tolerability) received galcanezumab 120 mg/month (following a 240-mg loading dose) or placebo; an optional 3 month open-label phase followed. Acute headache medication use (monthly days with acute headache medication utilization) was self-reported daily. The change from baseline in monthly days with acute headache medication used a mixed-model repeated measures analysis. HCRU was reported at baseline (for the previous 6 months) and at monthly visits. Migraine-related HCRU rates were evaluated in the total population per 100 patient-years. RESULTS: Of the 462 patients (galcanezumab n=232, placebo n=230), baseline mean days/month of acute headache medication was 12.3; 44.8% had acute headache medication overuse. Across months 1-3, least squares (LS) mean reductions in acute headache medication use were greater for the galcanezumab group (4.2) compared with placebo (0.9); the LS mean difference was 3.4 (95% CI = 2.7-4.1; P < 0.0001). Greater reductions in the galcanezumab group were observed as early as month 1; statistical separation continued at months 2 and 3 (all P < 0.0001). During the open-label phase, reductions from baseline ranged from 4.7 to 5.3 days and were similar in patients who transitioned from placebo to patients continuing galcanezumab. Reductions from baseline of migraine-specific health care visits (double-blind phase) were numerically greater with galcanezumab than placebo (215.5 vs 155.3). Patients switching to galcanezumab had reductions (212.9 days) similar to patients continuing galcanezumab (222.6 days). Migraine-specific emergency department visits decreased by two-thirds at month 3 in the galcanezumab group compared with nearly no reduction in the placebo group that experienced a similar reduction during the open-label phase. For both groups, migraine-specific hospitalizations were less than 2 per 100 patient-years. CONCLUSIONS: These results demonstrate that galcanezumab has the potential to reduce acute headache medication use and overuse and HCRU in patients with prior migraine preventive treatment failures. DISCLOSURES: Data were presented in part as a poster presentation at the 14th European Headache Congress (European Headache Federation), Virtual Meeting, July 3-5, 2020. Dr Ambrosini is on the advisory board for Eli Lilly and Company and received honorarium from Teva, Novartis, and Eli Lilly and Company. Dr Estemalik is on the advisory boards for Eli Lilly and Company, Lundbeck, and Allergan and the speakers' bureau for Teva, Lundbeck, Eli Lilly and Company, Allergan, and Biohaven. He received consulting fees from Eli Lilly and Company, Teva, Lundbeck, and Allergan and support for attending meetings and/or travel from Eli Lilly and Company, Allergan, Biohaven, Teva, and Lundbeck. Dr Pascual received research support from Instituto de Salud Carlos III, Ministry of Economy, Spain. He was also on advisory boards for Allergan, Amgen-Novartis, Eli Lilly and Company, and Stendhal and received consulting fees or honoraria from Allegan, Eli Lilly and Company, Novartis-Amgen, and Teva. Dr Rettiganti is an employee of Eli Lilly and Company and/or one of its subsidiaries, Indianapolis, IN. She is also a minor stock and restricted stockholder of Eli Lilly and Company. Mr. Stroud and Ms. Day are employees of Eli Lilly and Company and/or one of its subsidiaries, Indianapolis, IN. Dr Ford is an employee of and holds stock of Eli Lilly and Company and/or one of its subsidiaries, Indianapolis, IN. She also received support for attending meetings and/or travel from Eli Lilly and Company.

Real-world treatment patterns and clinical outcomes in patients with AML in Japan who were ineligible for first-line intensive chemotherapy

Acute myeloid leukemia (AML) predominantly affects elderly adults, and its prognosis worsens with age. Treatment options for patients in Japan ineligible for intensive chemotherapy include cytarabine/aclarubicin ± granulocyte colony-stimulating factor (CA ± G), azacitidine (AZA), low-dose cytarabine (LDAC), targeted therapy, and best supportive care (BSC). The country's aging population and the evolving treatment landscape are contributing to a need to understand treatment pathways and associated outcomes. This retrospective chart review evaluated outcomes in patients across Japan with primary/secondary AML who were ineligible for intensive chemotherapy and began first-line treatment or BSC between 01/01/2015 and 12/31/2018. The primary endpoint was overall survival (OS); secondary endpoints included progression-free survival (PFS) and healthcare resource utilization (HRU). Of 199 patients (58% > 75years), 121 received systemic therapy (38 CA ± G, 37 AZA, 7 LDAC, 39 other) and 78 received BSC. Median OS was 5.4, 9.2, 2.2, 3.8, and 2.2months for CA ± G, AZA, LDAC, other systemic therapy, and BSC, respectively; median PFS was 3.4, 7.7, 1.6, 2.3, and 2.1months, respectively. HRU rates were uniformly high, with > 80% patients hospitalized in each cohort. The poor clinical outcomes and high HRU among Japanese AML patients who are ineligible for intensive chemotherapy highlight an unmet need for novel therapies.

Healthcare resource utilization and costs 2 years pre- and post-lumbar spine surgery for stenosis: a national claims cohort study of 22,182 cases

BACKGROUND CONTEXTImproved understanding of the pre- and postoperative trends in costs and healthcare resource utilization (HCRU) is needed to better inform patient expectations and aid in the development of strategies to minimize the significant healthcare burden associated with lumbar spine surgery. PURPOSEExamine the time course of costs and HCRU in the 2 years preceding and following elective lumbar spine surgery for stenosis in a large national claims cohort. STUDY DESIGN/SETTINGRetrospective analysis of an administrative claims database (IBM® Marketscan® Research Databases 2007–2015). PATIENT SAMPLEAdult patients undergoing elective primary single-level lumbar surgery for stenosis with at least 2 years of continuous health plan enrollment pre- and postoperatively. OUTCOME MEASURESFunctional measures, including monthly rates of HCRU (15 categories), monthly gross covered payments (including payments made by the health plan and deductibles and coinsurance paid by the patient) overall, by HCRU category, and by spine versus non-spine-related. METHODSAll available patients were utilized for analysis of HCRU. For analysis of payments, only patients on noncapitated health plans providing accurate financial information were analyzed. Payments were converted to 2015 United States dollars using the medical care component of the consumer price index. Trends in payments and HCRU were plotted on a monthly basis pre- and post-surgery and assessed with regression models. Relationships with demographics, surgical factors, and comorbidities were assessed with multivariable repeated measures generalized estimating equations. RESULTSMedian monthly healthcare payments 2 years prior to surgery were $275 ($22, $868). Baseline HCRU at 2 years preoperatively was stable or only gradually rising (office visits, prescription drug use), but began an increasingly steep rise in many categories 6 to 12 months prior to surgery. Monthly payments began an increasingly steep rise 6 months prior to surgery, reaching a peak of $1,402 ($634, $2,827) in the month prior to surgery. This was driven by an increase in radiology, office visits, PT, injections, prescription medications, ER encounters, and inpatient admissions. Payments dropped dramatically immediately following surgery. Over the remainder of the 2 years, the median total payments declined only slightly, as a continued decline in spine-related payments was offset by gradually increased non-spine related payments as patients aged. By 2 years postoperatively, the percentage of patients using PT and injections returned to within 1% of the baseline levels observed 2 years preoperatively; however, spine-related prescription medication use remained elevated, as did other categories of HCRU (radiology, office visits, lab/diagnostic services, and also rare events such as inpatient admissions, ER encounters, and SNF/IRF). Patients with a fusion component to their surgeries had higher payments and HCRU preoperatively, and this did not resolve postoperatively. Variations in payments and HCRU were also evident among plan types, with patients on comprehensive medical plans—predominantly employer-sponsored supplemental Medicare coverage—utilizing more inpatient, ER, and inpatient rehabilitation & skilled nursing facilities. Patients on high-deductible plans had fewer payments and HCRU across all categories; however, we are unable to distinguish whether this is because they used fewer of these services or if they were paying for these services out of pocket without submitting to the payer. By 2 years postoperatively, 51% of patients had no spine-related monthly payments, while 33% had higher and 16% had lower monthly payments relative to 2 years preoperatively. CONCLUSIONSThis is the first study to characterize time trends in direct healthcare payments and HCRU over an extended period preceding and following spine surgery. Differences among plan types potentially highlight disparities in access to care and plan-related financial mediators of patients’ healthcare resource utilization.

Healthcare Resource Utilization and Costs of Rivaroxaban Versus Warfarin Among Nonvalvular Atrial Fibrillation Patients with Obesity and Diabetes.

IntroductionNonvalvular atrial fibrillation (NVAF) is associated with a substantial economic burden, particularly in patients with comorbid conditions. This study compared healthcare resource utilization (HRU) and costs of rivaroxaban and warfarin in patients with NVAF, obesity, and diabetes.MethodsA de-identified healthcare claims database was used to identify adult patients newly initiating rivaroxaban or warfarin and having at least one medical claim with a diagnosis of AF, obesity determined by validated algorithm, and at least one claim with a diagnosis of diabetes or for antidiabetic medication from December 2011 to March 2020. Propensity score matching was used to balance the treatment cohorts on the basis of demographics and baseline characteristics. All-cause and NVAF-related HRU rates and costs were compared between treatments using rate ratios, and mean cost differences were calculated on a per patient per year (PPPY) basis.ResultsA total of 9999 matched pairs of patients with NVAF, obesity, and diabetes were identified in the rivaroxaban and warfarin cohorts. Rate ratios of all-cause HRU were significantly reduced with rivaroxaban versus warfarin in all healthcare settings evaluated, except emergency room visits. The greatest impact was on physician office visits followed by hospital outpatient and inpatient visits. NVAF-related HRU was significantly lower for rivaroxaban versus warfarin in all care settings. Consistent with these findings, the length of hospital stay was significantly reduced by approximately 4 days among all patients for both all-cause and NVAF-related hospitalizations in the rivaroxaban cohort compared with the warfarin cohort. Rivaroxaban was associated with reductions in all-cause total healthcare costs by more than $5000 PPPY and NVAF-related medical costs by approximately $1100 PPPY.ConclusionIn comparison with warfarin, rivaroxaban reduced HRU and costs, particularly hospital inpatient and outpatient visits and physician office visits, in patients with NVAF and comorbidities of obesity and diabetes.Supplementary InformationThe online version contains supplementary material available at 10.1007/s13300-021-01161-4.

Burden of illnessandoutcomes in second-line large B-cell lymphoma treatment: real-world analysis of Medicare beneficiaries.

Aims:To characterize elderly large B-cell lymphoma patients who progress to second-linetreatment to identify potential unmet treatment needs. Patients & methods: Retrospective USA cohort study, patients receiving second-lineautologous stem cell transplant (SCT)preparative regimen ('ASCT-intended') versus those who did not; stratified furtherinto those who received a stem cell transplantand those who did not. Primary outcomes were: healthcare resource utilization, costs andadverse events. Results: 1045 patients (22.0%) were included intheASCT-intended group, 23.3% of whom received SCT (5.1% of entire second-line population). Non-SCT patients were older andhad more comorbiditiesand generally higher rates of healthcare resource utilization and costs. Conclusion: Elderly second-line large B-cell lymphoma patients incurred substantial costs and a minority received potentially curative SCT, suggesting significant unmet need.

CML-353: Health Care Resource Utilization (HCRU) with Asciminib and Bosutinib among Patients with Chronic Myeloid Leukemia in Chronic Phase (CML-CP) Previously Treated with ≥2 Tyrosine Kinase Inhibitors (TKIs): Results from the Multicenter, Open-Label Phase 3 ASCEMBL Trial

Objective: To investigate HCRU among CML-CP patients who received asciminib or bosutinib after previously being treated with ≥2 TKIs in a clinical trial setting. Design: ASCEMBL enrolled adults with CML-CP who had previously been treated with ≥2 TKIs. Patients were randomized in a 2:1 ratio to receive asciminib 40 mg twice daily (n=157) or bosutinib 500 mg once daily (n=76). Data were collected while on randomized treatment for the following HCRU categories: hospitalizations, emergency hospital visits, general practitioner visits, specialist visits, and urgent care visits. The reasons (adverse events, CML, and other) for accessing services were also captured. The number of patients in each arm with any HCRU, by category, was calculated and used to estimate rates per patient-year. Main Outcomes Measures: Median exposure to treatment; number of patients with HCRU, by category; rate of HCRU per patient-year. Results: As of the 25 May 2020 cut-off, the median duration of exposure was 43.4 and 29.2 weeks in the asciminib and bosutinib arms, respectively. In the asciminib arm, 24.2% (n=38) had HCRU compared to 36.8% (n=28) of those who received bosutinib, corresponding to rates per person-year of 0.32 and 0.80. The percentage of patients (and rates per person-year) with HCRU by category for asciminib and bosutinib were 14.0% (0.16) versus 18.4% (0.32) for hospitalizations, 1.9% (0.02) versus 5.3% (0.08) for emergency hospital visits, 4.5% (0.05) versus 6.6% (0.11) for general practitioner visits, 10.8% (0.13) versus 13.2% (0.24) for specialist visits, and 0% (0) versus 5.3% (0.08) for urgent care visits. A higher percentage of patients treated with bosutinib compared to asciminib required hospitalization (7.9% [n=6] versus 1.9% [n=3]) or a visit to a hospital emergency department (2.6% [n=2] versus 1.3% [n=2]) due to adverse events related to therapy. Length of stay in the hospital was also generally higher with bosutinib compared to asciminib, regardless of ward type (e.g., mean/median number of days: 10.2/6.5 versus 9.2/6.0 in general wards, 19.0/19.0 versus 13.0/5.0 in intensive care units, and 12.0/12.0 versus 7.3/3.0 in other care units). Conclusions: These results suggest that HCRU may be lower for CML-CP patients treated with asciminib compared with bosutinib.