Healthcare Resource Utilization Data Research Articles

Informal care time and costs of dementia care in Benin (West Africa).

Dementia is a growing global health challenge, with significant socioeconomic implications. This study examined the informal care duration and related costs along with the total cost of care for older individuals with dementia in Benin, West Africa, providing insights into a region with limited dementia research. We conducted a cost-of-illness study in Benin. Both hospital and community recruitments were used to enroll adults aged ≥ 60 years and their primary caregivers. Structured questionnaire and validated tools were used to collect the demographic, clinical, healthcare resource utilization data as well as informal care duration. Replacement costs approach was performed to valuate informal care time. Official exchange rates from the World Bank were used to convert costs from local currency to purchasing power parities dollars (PPP$). Data from 135 individuals with varying dementia stages revealed that dementia places substantial caregiving demands, predominantly on women who provide up to eight hours of daily care. In 2021, the mean annual cost of dementia care was estimated to be PPP$2,399.66 ± 2,057.07. Informal care represented a significant portion of dementia expenses, up to 92% of the total care costs in this study. Policy interventions are urgently needed to address the dementia-care challenges in Benin, especially because economic transitions and educational advancements may reduce the availability of informal caregivers. This emphasizes the vital role of informal caregivers and underscores the need of implementing dementia policies to support families facing the evolving challenges of dementia care.

A Cost-Utility Analysis of Add-On Cannabidiol Versus Usual Care Alone for the Treatment of Seizures Associated with Tuberous Sclerosis Complex in England and Wales.

The aim of this study was to evaluate the cost effectiveness of plant-derived highly purified cannabidiol (Epidyolex® in the UK; 100mg/mL oral solution) as an add-on treatment to usual care for the management of treatment-refractory seizures associated with tuberous sclerosis complex (TSC) in patients aged ≥2 years. A cohort-based model was developed using a National Health Service perspective and lifetime horizon. Health states were based on weekly seizure frequency and seizure-free days, utilizing patient-level data from the GWPCARE6 trial (ClinicalTrials.gov identifier: NCT02544763). Two independent regression models were applied to individual patient-level data to predict seizure-free days and seizure frequency. Healthcare resource utilization data were sourced from a Delphi panel, and patient and caregiver health-related quality of life values were elicited using vignettes valued by the general public. Outcomes relating to TSC-associated neuropsychiatric disorders were modeled with costs and quality-adjusted life-years sourced from published literature. In the base case, compared with usual care alone, 12mg/kg/day cannabidiol was associated with an incremental cost-effectiveness ratio (ICER) of £23,797. The National Institute for Health and Care Excellence disease severity modifier reduced the ICER to £19,831. Probabilities of cost effectiveness at willingness-to-pay thresholds of £20,000 and £30,000 were 30% and 52%, respectively, for the base case and 39% and 66%, respectively, for the disease severity modifier. Results were robust to sensitivity and scenario analyses. At 12mg/kg/day and an ICER threshold of £20,000-£30,000, we provide evidence for the cost effectiveness of add-on cannabidiol treatment for patients with TSC-associated seizures aged ≥2 years who are refractory to current treatment.

Postinfusion Monitoring Health Care Resource Utilization and Costs By Site of Care Among Inpatients and Outpatients with Relapsed or Refractory Large B-Cell Lymphoma Who Received Second-Line Treatment with Lisocabtagene Maraleucel in the TRANSFORM and PILOT Clinical Trials

Background:CAR T cell therapy administration is often in an inpatient (IP) setting due to the possibility of severe AEs after infusion. Lisocabtagene maraleucel (liso-cel) is an autologous, CD19-directed, 4-1BB CAR T cell product administered at equal target doses of CD8 + andCD4 + CAR + T cells. Outpatient (OP) administration of liso-cel is feasible given trial-demonstrated low rates of grade ≥ 3 AEs that require hospitalization, including cytokine release syndrome and neurological events (Bachier CR, et al. J Clin Oncol 2020). Follow-up care in the OP setting may differ from that in an IP setting and may offer an opportunity to reduce AE management-related health care resource utilization (HCRU) and costs; limited data is published on this topic. Thus, this study assessed postinfusion monitoring HCRU and costs by site of care (ie, IP/OP) among patients with R/R large B-cell lymphoma (LBCL) treated with liso-cel as second-line (2L) therapy in TRANSFORM (NCT03575351) and PILOT (NCT03483103) clinical trials. Methods: A microcosting methodology was used to assess postinfusion monitoring-related HCRU identified from pooled TRANSFORM and PILOT case report forms and to estimate associated costs (excluding liso-cel acquisition costs) by site of care using a 6-month time frame, beginning on the liso-cel infusion date. HCRU data were analyzed in the 6 months after infusion, including facility (eg, number of standard IP and ICU hospitalizations and length of stay [LOS]), procedures (eg, dialysis or intubation/mechanical ventilation), diagnostics (eg, imaging or laboratory tests), and medication use (eg, tocilizumab or corticosteroids). Unit costs were then applied to each HCRU. Unit costs were assessed from the health care system perspective, derived from publicly available databases (eg, United States [US] Centers for Medicare & Medicaid Services, Healthcare Cost and Utilization Project, and IBM ® Micromedex ® RED BOOK ®) or peer-reviewed literature, and adjusted to 2021 US dollars using the medical component of the Consumer Price Index. Patients were considered OP if discharged on the day of infusion or at the end of the observation period. Results: Among 150 patients treated with liso-cel, 111 (74%) were infused as IPs and 39 (26%) as OPs. Estimated median 6-month total postinfusion monitoring costs were $55,253 in the IP setting and $17,505 in the OP setting, reflecting a reduction of $37,748 for OP site of care (Figure). Among patients cared for in the OP setting who required subsequent hospitalization (19/39 [49%]), the median total LOS was 7 days shorter than patients cared for in the IP setting who required hospitalization (105/111 [95%]) (OP: 7 days [range, 1-33] vs IP: 14 days [range, 1-164]). Facility costs, especially hospitalizations, were the largest contributor to overall median 6-month costs in both the IP setting ($40,501; 73%) and the OP setting ($5697; 33%). The majority of total costs occurred in Month 1 postinfusion for patients in both settings. For patients receiving care in the IP setting, 78% ($42,864) of median costs were incurred within the first month after infusion; for OPs, 36% ($6295) of median costs were incurred within Month 1. Patients in the IP setting had higher rates of key HCRU than in the OP setting, respectively, for the following: standard IP hospitalizations (105/111 [95%] vs 19/39 [49%]), ICU admissions (10/111 [9%] vs 0/39 [0%]), any tocilizumab use (32/111 [29%] vs 5/39 [13%]), and any corticosteroid use (54/111 [49%] vs 17/39 [44%]). Patients in the OP setting had higher rates compared with the IP setting, respectively, for office visits (37/39 [95%] vs 87/111 [78%]) and intubation (2/39 [5%] vs 0/111 [0%]). Conclusions: Among patients with R/R LBCL treated with liso-cel in the 2L TRANSFORM and PILOT trials, estimated median 6-month postinfusion costs were 68% lower for patients cared for in the OP versus IP setting. These results are consistent with a previous analysis of patients treated with liso-cel in the third-line setting (Palomba ML, et al. Leuk Lymphoma 2021); and thus, further support that OP postinfusion monitoring and care may allow health care systems to optimize HCRU and costs for patients with LBCL who receive CAR T cell therapy.

Health Care Resource Utilization (HCRU) and Cost of Management of Cytokine Release Syndrome (CRS) and Neurological Events (NEs) in Patients with R/R Follicular Lymphoma (FL) Receiving Lisocabtagene Maraleucel (liso-cel) in the TRANSCEND FL Study

Background: Adverse events (AEs) such as CRS and NEs of varying severity have been associated with CAR T cell therapies, including liso-cel, an autologous, CD19-directed, 4-1BB CAR T cell product administered at equal target doses of CD8 + and CD4 + CAR + T cells. Liso-cel has previously demonstrated clinically meaningful responses in patients with R/R FL in the phase 2 TRANSCEND FL study (NCT04245839). In addition, previous research among patients with large B-cell lymphoma has suggested an acceptable safety profile with few grade ≥ 3 CRS/NEs, and safety data from TRANSCEND FL are in line with this larger dataset. However, there is limited to no research published on estimates of HCRU and costs related to the management of CRS/NEs among liso-cel-treated patients with FL. This analysis evaluated HCRU and estimated costs of managing CRS/NEs by grade and concurrency for patients with R/R FL who received liso-cel treatment in the TRANSCEND FL study. Methods: Retrospective analyses were conducted for liso-cel-treated patients with R/R FL (second line or later) who experienced CRS/NEs within 90 days after infusion using patient-level HCRU data from the TRANSCEND FL study databases. HCRU captured included facility (standard inpatient [IP] and ICU hospitalizations), length of stay (LOS), diagnostics (eg, laboratory and imaging), procedures (eg, dialysis and mechanical ventilation), and medications (eg, oncology supportive care, prophylactics, and other AE management). Costs of managing CRS/NEs were estimated using a microcosting methodology in which 1) HCRU from the time of AE onset through resolution was identified and 2) the most recently available unit costs sourced from public databases or literature (US Centers for Medicare and Medicaid Services, Healthcare Cost and Utilization Project, and IBM ® Micromedex ® RED BOOK ®) were applied to each HCRU and adjusted to 2023 US dollars using the Consumer Price Index. Analyses were stratified by AE grade and concurrency of events (CRS or NEs only, nonconcurrent CRS and NEs, and concurrent CRS and NEs). Patients with nonconcurrent and concurrent CRS/NEs were categorized by the highest-grade event experienced. Results: CRS only occurred in 59/130 (45%) patients, NEs only occurred in 4/130 (3%), and CRS and/or NEs occurred in 79/130 (61%). Of the 79 patients who experienced CRS and/or NEs, 75 (95%) were grade ≤ 2 and 4 (5%) were grade 3; no grade 4 or 5 CRS/NEs were observed. Most CRS/NEs were experienced as a single event (63/79 [80%]). Patients who experienced CRS and/or NEs had a median (range) age of 60 (23‒78) years and were predominantly male (51/79 [65%]). Estimated median management costs ranged from $20,306 (grade 1 CRS only) to $50,400 (grade 3 CRS or NEs; Figure). The largest contributor to median management costs across CRS/NE categories was facility HCRU. Key HCRU and total LOS (standard IP hospitalization and ICU stay days among hospitalized patients) are shown in the Table. Almost all patients (78/79 [99%]) had a standard IP hospitalization, and only 1 patient (1%) with a grade 3 CRS only event was admitted to the ICU. Median (range) total LOS for IP/ICU admission was 1.5 days longer among patients with grade 3 versus grade ≤ 2 CRS and/or NEs (5.5 [3‒8] days vs 4 [1‒14] days). Although there were very few grade 3 events (n = 4) to assess, patients with grade 3 versus grade ≤ 2 CRS and/or NEs also had higher rates of utilization for some medications (eg, tocilizumab: 3/4 [75%] vs 28/75 [37%]; corticosteroids: 4/4 [100%] vs 19/75 [25%]). Conclusions: While most patients with R/R FL treated with liso-cel in the TRANSCEND FL study experienced treatment-emergent CRS and/or NEs, they were almost all of low severity (grade ≤ 2) and experienced as single events. Management costs for CRS/NEs, primarily related to facility HCRU, increased with greater AE severity and concurrency. The additional median cost for a patient with grade 3 versus grade ≤ 2 CRS or NEs was $22,586, representing an 88% increase in cost; however, this finding must be considered in the context of the small number of overall grade 3 events (n = 4) and ICU admissions (n = 1). CAR T cell therapies with few associated higher severity AEs provide a potential option to optimize resource use and costs for the management of CRS/NEs in patients with FL.

Estimation of Postinfusion Resource Use and Total Costs of Care for Patients with R/R Follicular Lymphoma (FL) Receiving Lisocabtagene Maraleucel (liso-cel) in the TRANSCEND FL Study

Background: Liso-cel, an autologous, CD19-directed, 4-1BB CAR T cell product administered at equal target doses of CD8 + and CD4 + CAR + T cells, has previously demonstrated clinically meaningful responses in patients with R/R FL in the global phase 2 TRANSCEND FL study (NCT04245839). Limited evidence is published on estimates of health care resource utilization (HCRU) and cost of postinfusion care among patients with large B-cell lymphoma (LBCL) treated with liso-cel (Palomba ML, et al. Leuk Lymphoma 2021), and no evidence is currently available for patients with R/R FL. This analysis evaluated postinfusion HCRU and estimated cost of care across a 6-month period among patients treated with liso-cel in the TRANSCEND FL study. Methods: In this retrospective analysis, patient-level HCRU data from the TRANSCEND FL study database, including hospitalizations and length of hospital stay (LOS) for the entire hospitalization period postinfusion (standard inpatient [IP] and ICU days), diagnostics (eg, laboratory work and imaging), procedures (eg, dialysis and intubation), and medications (eg, oncology supportive care, prophylactics, and other AE management), were analyzed from the day of liso-cel infusion through 6 months of follow-up. Postinfusion costs (not including the cost of liso-cel) were estimated using a microcosting methodology in which HCRU in the 6-month period was identified and unit costs sourced from public databases or literature (adjusted to 2023 US dollars [USD] using the Consumer Price Index) were applied to each HCRU. Facility costs were sourced from the Healthcare Cost and Utilization Project National Inpatient Sample (2020) databases (Dasta JF, et al. Crit Care Med 2005), and the US Centers for Medicare and Medicaid Services (CMS) Hospital Outpatient Prospective Payment System (OPPS; 2023). Diagnostic and procedure costs were obtained from the CMS OPPS (2023), clinical laboratory fee schedule (2023), physician fee schedule (2023), durable medical fee schedule (2023), and Dasta 2005. Medication cost data were obtained from IBM ® Micromedex ® RED BOOK ® (2023) using wholesale acquisition cost and were uniformly applied across sites of care. Average total cost by month after liso-cel infusion was calculated among patients with ongoing status in that month. Patients censored due to data cutoff were excluded. Results: A total of 130 patients were treated with liso-cel in the TRANSCEND FL study, primarily in the fourth-line setting (45.4%). These patients had a median (range) age of 60 (23‒80) years and were predominantly male (83/130 [63.8%]) and White (69/130 [53.1%]); 45 (34.6%) had unknown race. Among patients who received liso-cel infusions, the estimated mean 6-month postinfusion total cost of care was $89,516 (Figure 1). Most 6-month costs ($77,088 [86.1%]) were incurred in Month 1 after infusion and were primarily driven by facility costs ($66,683 [74.5%]), namely standard IP hospitalization and ICU stays. HCRU and LOS (including standard IP hospitalization and ICU days) are shown in Table 1. Almost all patients were hospitalized in the standard IP setting (128/130 [98.5%]). Few patients were admitted to the ICU (4/130 [3.1%]), and 3/130 (2.3%) had an emergency department visit. Median (range) hospitalization time was 14 (3‒45) days for standard IP and 5 (3‒7) days for ICU stays. Some patients received corticosteroids (30/130 [23.1%]) or tocilizumab (31/130 [23.8%]), and few required intravenous immunoglobulin (11/130 [8.5%]), vasopressors (4/130 [3.1%]), lumbar puncture (2/130 [1.5%]), or mechanical ventilation (1/130 [0.8%]). No patients received dialysis. Conclusions: The majority of costs in the 6-month period after liso-cel infusion among patients with R/R FL in the TRANSCEND FL study were incurred in Month 1 and were facility related (IP and ICU hospitalizations and LOS). These findings, consistent with those previously reported for patients with LBCL treated with liso-cel, support that a single infusion of liso-cel is associated with significantly less HCRU and costs after the initial treatment period in the first month.

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.

Post-infusion Costs Associated with Idecabtagene Vicleucel Treatment for Patients with Relapsed/Refractory Multiple Myeloma in the KarMMa Trial.

Patients with triple-class exposed relapsed/refractory multiple myeloma (RRMM) have poor outcomes with substantial healthcare costs. Idecabtagene vicleucel (ide-cel), a B-cell maturation antigen (BCMA)-directed chimeric antigen receptor (CAR) T cell therapy, showed deep, durable responses in patients with RRMM in the pivotal phase 2 KarMMa trial (NCT03361748). Healthcare resource utilization (HCRU) and costs were estimated for ide-cel-treated patients in the KarMMa trial. Post-infusion costs were estimated based on HCRU data, including facility care, diagnostics, medications, and procedures. Length of stay (LOS) was extracted for inpatient and intensive care unit (ICU) care. All patients had a 14-day post-infusion inpatient stay per trial protocol. Analyses were conducted for patients treated in the United States (US), who received the ide-cel target dose of 450×106 CAR+T cells and assuming a 7-day inpatient stay. Overall, 128 patients received ide-cel and were included in this analysis. Mean age was 60years, 59% were men, and 81% were white. Mean total LOS was 23.9days. Total estimated costs over 24months post-infusion were US$115,614 per patient, driven by facility costs (75%; $86,385). Most costs were incurred in the first month (58%; $67,259). The scenario analysis assuming a 7-day inpatient stay showed estimated 24-month costs of $92,294. For the 54 (42%) patients who received ide-cel high dose, total costs over 24months were $113,298 per patient. Extrapolation of costs based on HCRU data from patients receiving single-infusion of ide-cel in the KarMMa trial showed substantially reduced HCRU and costs over 2years after initial treatment. Most costs were incurred during the first month after ide-cel infusion, likely attributable to the 14-day inpatient stay required by the trial protocol. These findings suggest a nominal, incremental monthly cost of care immediately after treatment, which may be lower in routine clinical practice.

Cost Effectiveness of Concurrent Midurethral Sling at the Time of Prolapse Repair: Results From a Randomized Controlled Trial

ABSTRACT After pelvic reconstructive surgery for pelvic organ prolapse, postoperative stress urinary incontinence (SUI) commonly occurs, which leads many women to choose to have a midurethral sling placed at the time of surgery, even in cases without symptomatic preoperative urinary incontinence. Approximately 27.3% of women with a sling had de novo SUI despite this intervention. Full evaluation of the societal and economic implications brought by a midurethral sling placement attempting to prevent postoperative de novo SUI at the time of a pelvic reconstructive surgery have yet to be evaluated. This study aimed to evaluate the 1-year cost-effectiveness of a midurethral sling in the prevention of SUI at the time of prolapse surgery. This assessment was a randomized controlled trial based on patient resource utilization and patient-reported effectiveness. Study data were obtained via the OPUS randomized clinical trial, which was performed through the Pelvic Floor Disorders Network (a cooperative agreement network sponsored through the National Institute of Child Health and Human Development). A total of 337 women with anterior vaginal prolapse and without SUI symptoms set to undergo treatment from May 2007 to January 2011 were included in the study. Patients were randomly assigned to receive either sham incisions or a midurethral sling during vaginal prolapse surgery. Follow-up occurred at 3, 6, and 12 months postsurgery, with surveys, physical examinations, and medical history. Cost data were collected, and overall health utility in quality-adjusted life-years (QALYs) was calculated. Secondary outcomes were urinary incontinence-specific quality of life and cases of urinary incontinence, as defined by bothersome incontinence symptoms and positive cough stress tests. Initial surgical procedures and subsequent urinary incontinence-related health care were all used for recording health care sector costs. Total costs for study participants were collected via health care resource utilization data, including office visits, additional surgical procedures, and related procedures. The incremental cost-effectiveness ratio was the difference between the sham incision and midurethral sling groups in mean cost, divided by difference in mean QALYs. Data for health care resource utilization were collected during the trial period. Questionnaires at baseline, 3, 6, 9, and 12 months were used to collect other costs. At 1 year, one-way sensitivity analysis was performed for assessing the varying effectiveness of midurethral slings at 1 year, by noting the urinary incontinence-associated patient costs and by using varied QALY for the sling group. Results were taken from a study population of 337 women who underwent randomization to be included in the analysis of cost-effectiveness. No great variance of characteristics existed between groups. One year after surgery, a lower rate of urinary incontinence existed for those in the midurethral sling group. Notably, QALYs were not statistically different between midurethral sling and sham incision groups at baseline, but at 12 months, there was an improvement in both the UDI stress subscale and an overall reduction in the Incontinence Severity Index for the midurethral sling group. In conclusion, although prophylactic midurethral sling placements during vaginal prolapse surgery does reduce the rate of de novo SUI, based on this analysis of date from the OPUS trial, it is not a cost-effective intervention. The decision to place a sling in this setting is often driven by cost savings on the patient side, whereas midurethral sling health care costs are higher than when sling is not done.

Cost-effectiveness of ticagrelor plus aspirin versus aspirin in acute ischaemic stroke or transient ischaemic attack: an economic evaluation of the THALES trial

ObjectiveTHALES demonstrated that ticagrelor plus aspirin reduced the risk of stroke or death but increased bleeding versus aspirin during the 30 days following a mild-to-moderate acute non-cardioembolic ischaemic stroke (AIS)...

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.

Impact of Electronic Chronic Pain Questions on patient-reported outcomes and healthcare utilization, and attitudes toward eCPQ use among patients and physicians: prospective pragmatic study in a US general practice setting.

The Electronic Chronic Pain Questions (eCPQ) has been developed to help healthcare providers systematically capture chronic pain data. This study evaluated the impact of using the eCPQ on patient-reported outcomes (PROs) and healthcare resource utilization (HCRU) in a primary care setting, and patient and physician perceptions regarding use of, and satisfaction with, the eCPQ. This was a prospective pragmatic study conducted at the Internal Medicine clinic within the Henry Ford Health (HFH) Detroit campus between June 2017 and April 2020. Patients (aged ≥18 years) attending the clinic for chronic pain were allocated to an Intervention Group to complete the eCPQ in addition to regular care, or a control group to receive regular care only. The Patient Health Questionnaire-2 and a Patient Global Assessment were assessed at baseline, 6-months, and 12-months study visits. HCRU data were extracted from the HFH database. Telephone qualitative interviews were conducted with randomly selected patients and physicians who used the eCPQ. Two hundred patients were enrolled, 79 in each treatment group completed all 3 study visits. No significant differences (p > 0.05) were found in PROs and HCRU between the 2 groups. In qualitative interviews, physicians and patients reported the eCPQ as useful, and using the eCPQ improved patient-clinician interactions. Adding the eCPQ to regular care for patients with chronic pain did not significantly impact the PROs assessed in this study. However, qualitative interviews suggested that the eCPQ was a well-accepted and potentially useful tool from a patient and physician perspective. By using the eCPQ, patients were better prepared when they attended a primary care visit for their chronic pain and the quality of patient-physician communication was increased.

#4026 ECONOMIC EVALUATION OF ANAEMIA OF CHRONIC KIDNEY DISEASE (CKD): A SYSTEMATIC LITERATURE REVIEW AND MODEL CONCEPTUALISATION

Abstract Background and Aims Anaemia is a common complication of chronic kidney disease (CKD), affecting up to 53.4% of patients with Stage 5 CKD compared to 8.4% of patients with Stage 1 CKD [1]. Anaemia of CKD is associated with increased risk of cardiovascular events and death, increased healthcare resource utilisation (HRU), and reduced health-related quality of life (HRQoL) [2]. Established treatments for anaemia of CKD include erythropoiesis-stimulating agents (ESAs) [1,2]; however, hypoxia-inducible factor prolyl hydroxylase inhibitors (HIF-PHIs), targeting both erythropoietin production and iron metabolism (the two key mechanisms of anaemia of CKD), are an emerging class of agents in this indication [3]. The cost and HRQoL burden associated with anaemia of CKD treatment is not well characterised.1 Thus, we conducted a systematic literature review (SLR) to evaluate published economic models (including the cost inputs, time horizon, subgroups, and clinical assumptions used) and HRU data in patients with anaemia of CKD. Findings of the SLR will help guide future economic model development and inform economic evaluation strategies as part of health technology assessment submissions to support daprodustat, an HIF-PHI under development for use in both dialysis-dependent and non-dialysis-dependent patients. Method Relevant publications were identified using structured searching of MEDLINE, Embase, MEDLINE In-Process, Cochrane Controlled Trials Register, and the Cochrane Database of Systematic Reviews from database inception to 10 April 2022 using disease- (e.g. CKD, chronic kidney failure, anaemia) and economic-associated (e.g. economics, economic evaluation, quality-adjusted life-years, model structure) search terms. Additional supplemental searches (conference proceedings [2016–2021], grey literature, and bibliographies) were conducted. Studies were assessed for inclusion or exclusion by two independent reviewers, with any discrepancies resolved by a third reviewer. Objectives were to determine the structure of any published economic models and the availability of health utility data in patients with anaemia and additional complications of CKD, and to examine what cost inputs, time horizons, subgroups, and clinical assumptions are used to inform economic modelling. Results From 1397 citations identified in the searches, 40 primary studies were included in the final analysis. Review of the data revealed an established approach for modelling the ESA cost-effectiveness (i.e. a Markov model with health states defined according to CKD treatment received or anaemia status): most studies were conducted from a North American or European perspective, time horizons varied, and reporting of cycle length was poor. Only one economic evaluation included an HIF-PHI model: given the different mechanisms of action of ESAs and newer treatments, a modelling strategy focused mainly on a Markov approach may not be the most optimal way of assessing cost-effectiveness in anaemia of CKD where HIF-PHIs are used. Considerations of modelling factors that could influence cost-effectiveness of HIF-PHIs are shown in Fig. 1. While existing models typically only stratified patient populations according to age (&amp;lt;65 vs &amp;gt;65 years), for appropriate modelling of treatment effectiveness, the impact of prior treatments (including response to prior ESAs) was also considered. As in every model, comorbidities may also have a role in effect modification and this impact will need to be considered in economic models of anaemia of CKD treatment. Due to the natural history of anaemia in CKD, innovative modelling techniques that retain the Markov approach and which account for respective haemoglobin levels, CKD stage, and potential kidney transplantation should be incorporated into the economic evaluation (Fig. 2). Conclusion Adjustment of existing models using the approaches described may provide more reliable estimates of treatment efficacy in a highly heterogenous population of patients with anaemia of CKD.

Treatment patterns and outcomes in patients with metastatic synovial sarcoma in France, Germany, Italy, Spain and the UK.

Aim: Describing the treatment patterns, outcomes by line of treatment (LOT), and healthcare resource utilization (HCRU) in patients with metastatic synovial sarcoma (mSS). Patients & methods: In this descriptive, non-interventional, retrospective cohort study, physicians from five European countries reported on patients with recent pharmacological treatment for mSS. Results: Among 296 patients with mSS, 86.1, 38.9 and 8.4% received 1 LOT (1L), 2 LOTs (2L) and 3+ LOTs (L3+), respectively. Common regimens were doxorubicin/ifosfamide-based (37.4%) for 1L and trabectedin-based for 2L (29.7%). For 1L, median time to next treatment was 13.1 and 6.0months for living and deceased patients, respectively. Median OS was 22.0, 6.0 and 4.9months in all patients, 2L and 3L, respectively. HCRU data showed median one inpatient hospital admission, 3days in hospital and four outpatient visits yearly. Conclusion: This large-scale study documents high unmet needs in patients previously treated for mSS and for more effective therapies.

Alzheimer’s Disease Linkage to Evidence (AD-LINE) Study Early Results: Linking Real-World Claims Data to Phase III GRADUATE Study of Gantenerumab (P7-6.009)

<h3>Objective:</h3> We sought to demonstrate a first-of-its-kind successful linkage of real-world Medicare claims data from the Centers for Medicare &amp; Medicaid Services to data from the GRADUATE I and II phase III clinical trials of gantenerumab, and to understand differences in healthcare resource utilization (HCRU) in participants with early symptomatic AD. <h3>Background:</h3> The detailed clinical and patient-reported outcomes data typically collected in clinical trials are often missing a broader, more holistic understanding of HCRU and costs, particularly before and after the clinical trial. <h3>Design/Methods:</h3> AD-LINE is a non-interventional cohort study of Medicare patients with early symptomatic AD who were enrolled in the GRADUATE pivotal trials. Participants consented to combine existing (including year preceding GRADUATE entry) and future medical claims with clinical trial data. HCRU was examined for the year preceding their baseline trial visit. <h3>Results:</h3> In total, 111 GRADUATE participants were included in AD-LINE. Mean age was 75.1 years (SD: 5.5); 67 participants (60.4%) were female. At baseline, 55 participants (49.5%) had MCI-AD and 56 (50.5%) had mild AD dementia. This early proof-of-concept linkage analysis includes data from the GRADUATE baseline visit and Medicare claims through December 2019 (latest currently available). Excluding 2020 clinical trial entrants, there were 79 patients; of those, 78 were continuously enrolled in Medicare Parts A/B and 46 were not in a health maintenance organization (HMO) in the preceding year. Sample size and data availability will increase as more Medicare claims and GRADUATE study data become available. Initial results show that in the year preceding GRADUATE trial entry, these 46 AD-LINE patients had an average of 4.09 outpatient visits. <h3>Conclusions:</h3> AD-LINE is the first study to successfully link large phase III clinical trial and real-world claims data. Linking trial data with HCRU data may provide critical information for payers and population health decision makers. <b>Disclosure:</b> Chris Wallick has nothing to disclose. Howard Fillit has nothing to disclose. The institution of Prof. Tcheremissine has received research support from Eli Lilly . The institution of Prof. Tcheremissine has received research support from Genentech/Roche. The institution of Prof. Tcheremissine has received research support from Janssen . The institution of Prof. Tcheremissine has received research support from Athira Pharma. Dr. Abbass has received personal compensation for serving as an employee of Genentech. Carmen Ng has received personal compensation for serving as an employee of Genentech. Carmen Ng has stock in Roche. Tu My To has received personal compensation for serving as an employee of Genentech. Tu My To has received stock or an ownership interest from Genentech. Sheila Seleri has received personal compensation for serving as an employee of Genentech, a member of the Roche group. Sheila Seleri has received stock or an ownership interest from Genentech, a member of the Roche group.

Healthcare Resources Utilization throughout the Last Year of Life after Acute Myocardial Infarction.

Healthcare resource utilization (HRU) peaks in the last year-of-life, and accounts for a substantial share of healthcare expenditure. We evaluated changes in HRU and costs throughout the last year-of-life among AMI survivors and investigated whether such changes can predict imminent mortality. This retrospective analysis included patients who survived at least one year following an AMI. Mortality and HRU data during the 10-year follow-up period were collected. Analyses were performed according to follow-up years that were classified into mortality years (one year prior to death) and survival years. Overall, 10,992 patients (44,099 patients-years) were investigated. Throughout the follow-up period, 2,885 (26.3%) patients died. The HRU parameters and total costs were strong independent predictors of mortality during a subsequent year. While a direct association between mortality and hospital services (length of in-hospital stay and emergency department visits) was observed, the association with ambulatory services utilization was reversed. The discriminative ability (c-statistics) of a multivariable model including the HRU parameters for predicting the mortality in the subsequent year, was 0.88. In conclusion, throughout the last year of life, hospital-centered HRU and costs of AMI survivors increase while utilization of ambulatory services decrease. HRUs are strong and independent predictors of an imminent mortality year among these patients.

Epidemiology and healthcare resource utilization in atopic dermatitis in Colombia: A retrospective analysis of data from the National Health Registry from 2015 to 2020

Introduction: Atopic dermatitis, also known as eczema or atopic eczema, is a chronic inflammatory skin disorder characterized by the presence of pruritus accompanied by itching. In Colombia, epidemiological and healthcare resource utilization information regarding this pathology is limited. Objective: To describe atopic dermatitis epidemiological characteristics and healthcare resource utilization patterns in Colombia. Material and methods: A retrospective database study using real-world data obtained from the national claims database SISPRO (Sistema de Información para la Protección Social) for the 2015-2020 period was carried out. Sociodemographic (age, and health services delivery), epidemiological (incidence, prevalence, and comorbidities), and healthcare resource utilization data were extracted from the SISPRO database. Results: The epidemiological results showed increased incidence and prevalence of atopic dermatitis in Colombia in the 2018-2019 period compared to 2015-2017. Accordingly, the number of medical consultations (particularly with specialists), the number of procedures, and the number of hospitalizations of patients with atopic dermatitis increased. Topic and systemic corticoids were the most frequently prescribed drugs. Conclusions: Diagnoses of atopic dermatitis in Colombia increased with a concomitant increase in healthcare resource utilization during 2015-2020, which was possibly slowed down by the arrival of the Covid-19. This study may help physicians gaining a better understanding of the disease, improving atopic dermatitis patient management.

Cost effectiveness of ultrasound-guided long peripheral catheters in difficult vascular access patients.

Peripheral intravenous catheter (PIVC) placement is a routinely performed invasive procedure in hospital settings with an unacceptably high failure rate that can result in significant costs. This investigation aimed to determine the cost-effectiveness of using long peripheral catheters (LPC) versus standard short peripheral catheters (SPC) in the difficult vascular access (DVA) population. A secondary analysis was performed of a randomized control trial that compared a 20-gauge 4.78 cm SPC to a 20-gauge 6.35 cm SPC for the endpoint of survival. This study assessed cost-effectiveness of the comparative interventions. Costs associated with increased hospitalization length of stay due to PIVC failure, including labor, materials, equipment, and treatment delays were estimated by utilizing healthcare resource utilization data. Cost-effectiveness of the LPC was analyzed through the incremental cost-effectiveness ratio, the cost-effectiveness acceptability curve, and the incremental net benefit. A sensitivity analysis was conducted to evaluate the robustness of the results during the time interval of PIVC insertion. Among the 257 patients, the average total cost for therapy was lower in the LPC group compared to the SPC group ($400 vs $521; mean difference -$121, 95% bootstrapped CI -$461 to $225). A marginally significant absolute difference of complication averted was found for LPC versus SPC (10.8%, p = 0.07). The estimated incremental cost-effectiveness ratio (ICER) for LPC as compared with SPC was -$1123 (95% bootstrapped CI -$8652 to $5964) per complication averted. In a willingness to pay (WTP) analysis, as WTP = $0, the incremental net benefit (INB) $121 was positive, indicating LPC was less costly. Analysis of PIVCs that survived ⩽48 h (n = 134) demonstrated a lower average total cost for therapy among the LPC group ($418 vs $531; mean difference -$113, 95% bootstrapped CI -$507 to $282). Forty-seven of 66 (71.2%) LPCs did not experience a complication, compared with 37 of 68 (54.4%) SPCs, resulting in a significant absolute difference of complication adverted of 16.8% (p = 0.04). In addition, with a positive slope, the INB $113 was positive as WTP = $0, indicating LPC was estimated to be cost-effective. When using ultrasound guidance for vascular access, LPCs are potentially a cost-effective strategy for reducing PIVC complications in DVA patients compared to SPCs. Given this finding, ultrasound-guided LPCs should be routinely considered as first-line among the DVA population in order to improve their overall care and wellbeing.

Cost-effectiveness analysis of cardiac implantable electronic devices with reactive atrial-based antitachycardia pacing.

Reactive atrial-based anti-tachycardia pacing (rATP) in pacemakers (PMs) and cardiac resynchronization therapy defibrillators (CRT-Ds) has been reported to prevent progression of atrial fibrillation, and this reduced progression is expected to decrease the risk of complications such as stroke and heart failure (HF). This study aimed to assess the cost-effectiveness of rATP in PMs and CRT-Ds in the Japanese public health insurance system. We developed a Markov model comprising five states: bradycardia, post-stroke, mild HF, severe HF, and death. For devices with rATP and control devices without rATP, we compared the incremental cost-effectiveness ratio (ICER) from the payer's perspective. Costs were estimated from healthcare resource utilisation data in a Japanese claims database. We evaluated model uncertainty by analysing two scenarios for each device. The ICER was 763 729 JPY/QALY (5616 EUR/QALY) for PMs and 1,393 280 JPY/QALY (10 245 EUR/QALY) for CRT-Ds. In all scenarios, ICERs were below 5 million JPY/QALY (36 765 EUR/QALY), supporting robustness of the results. According to a willingness to pay threshold of 5 million JPY/QALY, the devices with rATP were cost-effective compared with control devices without rATP, showing that the higher reimbursement price of the functional categories with rATP is justified from a healthcare economic perspective.

469. Healthcare Resource Utilization (HRU) among Hospitalized Patients (Pts) with Candidemia (C) and Invasive Candidiasis without Candidemia (IC) Who Received Definitive Treatment with an Echinocandin (EC) Across United States (US) Hospitals

Abstract Background Guidelines recommend ECs as preferred agents for C/IC. Although studies demonstrate that the ECs are safe and effective for the treatment of pts with C/IC, there are scant HRU data among hospitalized adult pts who received an EC for C/IC. This study sought to describe current EC use patterns and outcomes for C/IC across US hospitals. Methods A retrospective, multi-centered observational study was performed using the Premier Healthcare Database (1/2016-4/2019). Inclusion criteria: hospitalized; age ≥ 18 years, presence of Candida sp. on clinical culture consistent with C/IC; and received ≥3 days of an EC between -2 days of index culture to discharge. Pts were stratified by presence of C/IC. Baseline characteristics and treatment patterns (EC received, receipt of EC in relation to index culture, and EC duration) were assessed. Outcomes: discharge status (in-hospital death vs discharge location), hospital length of stay (LOS) post index culture, and hospital costs (overall and component costs) post index culture. Results 1,865 pts met study criteria. The mean (SD) age was 58.9 (19), 48% were female, mean (SD) Charlson Comorbidity Index was 3.4 (2.7) and 55% resided in the ICU at index culture. The most common Candida sp. were C. albicans (37%), C. glabrata (28%), C. parapsilosis (11%), and C. tropicalis (10%). Most pts had C (66%). Baseline characteristic and treatment patterns were largely similar between C/IC pts except for Candida sp., EC received, and EC duration (Table). Mean HRU was greater in pts with IC vs C (Table and Figure). No differences in HRU were observed in pts who died vs survived. In-hospital mortality was higher in pts with C vs IC. Most pts with C/IC received additional medical care post-discharge and pts with IC vs C were more likely to be discharged to a home health agency. Conclusion Hospital costs associated with C/IC are substantial, with most attributable to room and board costs. In-hospital mortality was considerable for pts with C/IC and many pts with C/IC required additional medical care in a long-term care facility or with a home health agency post-discharge. New treatment options are needed to mitigate the costs and outcomes associated with daily receipt of EC for pts with C/IC. Disclosures Thomas Lodise, Jr., Pharm.D., PhD, BioFire Diagnostics: Grant/Research Support|cidara: Advisor/Consultant|cidara: Honoraria|Entasis: Grant/Research Support|Merck: Advisor/Consultant|Merck: Grant/Research Support|Paratek: Advisor/Consultant|Shionogi: Advisor/Consultant|Spero: Advisor/Consultant|Venatrox: Advisor/Consultant Kevin W. Garey, PharmD, MS, Acurx: Grant/Research Support|cidara: Advisor/Consultant|cidara: Grant/Research Support|Paratek: Grant/Research Support|Seres Health: Grant/Research Support|Summit: Grant/Research Support Brian H. Nathanson, Ph.D., cidara: Grant/Research Support|Merck: Advisor/Consultant|Merck: Grant/Research Support.

EPH33 Assessing the Validity of English Linked Routine Healthcare Resource Utilisation Data in the Investigation of Triple Therapy Effectiveness (INTREPID Trial)

EPH33 Assessing the Validity of English Linked Routine Healthcare Resource Utilisation Data in the Investigation of Triple Therapy Effectiveness (INTREPID Trial)