Total Medical Costs Research Articles

Cytokine Release Syndrome and Neurological Event Management Resource Use and Costs Among Patients with Relapsed or Refractory Large B-Cell Lymphoma Who Received Second-Line Lisocabtagene Maraleucel Treatment in TRANSFORM and PILOT

Background:CAR T cell therapies are associated with cytokine release syndrome (CRS) and neurological events (NEs). Lisocabtagene maraleucel (liso-cel) is an autologous, CD19-directed, 4-1BB CAR T cell product administered at equal target doses of CD8 + and CD4 + CAR + T cells. There is limited published research on AE management-related health care resource utilization (HCRU) and costs in the second-line (2L) setting. The objective of this study was toestimate HCRU and costs for managing CRS and/or NEs after liso-cel administration among patients with R/R large B-cell lymphoma (LBCL) treated with liso-cel as 2L therapy in the TRANSFORM (NCT03575351) and PILOT (NCT03483103) studies. Methods: A microcosting methodology was used to assess CRS and/or NE management-related HCRU identified from pooled TRANSFORM and PILOT case report forms and to estimate associated costs among patients who experienced CRS or NEs after liso-cel administration. CRS or NEs were only included if the AE initiated within 90 days after the patient received liso-cel. HCRU categories captured the following: facility (eg, standard inpatient hospitalizations and ICU admissions and length of stay [LOS]), procedures (eg, dialysis and mechanical ventilation), diagnostics (eg, laboratory, imaging, and biopsy), and medications (eg, oncology supportive care, prophylactics, and other AE management). In the nonconcurrent and concurrent CRS/NE categories, events were classified per the highest grade event. HCRU by grade, per the study's management guidelines, were identified from onset of the AE through resolution. Lee criteria were used to determine CRS event grades (Lee DW, et al. Blood 2014), while the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.03, was used to determine NE grades. Unit costs from publicly available data sources (United States [US] Centers for Medicare & Medicaid Services, Healthcare Cost and Utilization Project, and IBM ® Micromedex ® RED BOOK ®) or published literature were applied to each HCRU after being adjusted to 2021 US dollars using the Consumer Price Index as needed. Analyses were stratified by grade and concurrency. Results: Among 150 patients treated with liso-cel, 92 (61%) experienced CRS and/or NEs, which were mostly grade ≤ 2 events (n = 76 [83%]). Most patients experienced CRS only (n = 34 [37%]) or NE only (n = 24 [26%]) that ranged in total median cost of $675 for grade 2 NE only to $35,181 for grade 2 CRS only (Figure). In the remaining patients, most experienced AEs concurrently (22/34 [65%]) vs nonconcurrent (12/34 [35%]) with total median costs ranging from $5018 for nonconcurrent grade ≤ 2 CRS/NE to $33,918 for concurrent grade ≥ 3 CRS/NE. Median total cost for grade ≥ 3 CRS/NE was equal to $24,219 versus $5312 for grade ≤ 2, reflecting an additional $18,907 or 356% increase in cost of grade ≥ 3 compared with grade ≤ 2. Facility and medications were the major contributors to CRS/NE management costs. Only 20% (18/92) of patients were hospitalized and 2% (2/92) of patients admitted to the ICU, with proportions higher among grade ≥ 3 CRS/NE than grade ≤ 2 (standard inpatient hospitalization: 6/16 [38%] vs 12/76 [16%]; ICU: 2/16 [13%] vs 0/76 [0%]; Table). Patients with grade ≥ 3 CRS/NE had a median total 4.5 days longer LOS than grade ≤ 2 (median [range], 9.5 [2-19] vs 5 [2-15], respectively). Some medication usage was also higher among patients with grade ≥ 3 CRS/NE compared with grade ≤ 2 (tocilizumab: 10/16 [63%] vs 26/76 [34%]; corticosteroids: 15/16 [94%] vs 39/76 [51%]; vasopressors: 1/16 [6%] vs 2/76 [3%]). No dialysis or mechanical ventilation was recorded for patients experiencing CRS/NE. Conclusions: Over half of patients with R/R LBCL experienced any-grade CRS and/or NEs after liso-cel administration in TRANSFORM and PILOT, and the majority of these (83%) were low grade. Resource use and costs for management of AEs among patients with less severe CRS/NEs were relatively minimal compared with patients who had more severe CRS/NEs (with the exception of a few outliers). In general, HCRU and costs increased with greater severity. These results are largely consistent to those for third-line-treated patients (Abramson JS, et al. Blood Adv 2021). Additionally, results presented here further support that CAR T cell therapies with low rates of CRS/NEs (and few events are of higher severity) have the potential to minimize AE management-related HCRU and costs among patients with LBCL.

Establishing Costs for Commercial Chimeric Antigen Receptor T-Cell (Tisagenlecleucel; Kymriah) in Children and Young Adult B-Cell Acute Lymphoblastic Leukemia; A Merged Analysis from the Prwcc and PHIS

Background: Chimeric antigen receptor (CAR) T cell therapy has achieved remarkable efficacy in children and young adult (CAYA) B-cell acute lymphoblastic leukemia (B-ALL). Nonetheless, this therapy is highly personalized, technically complex, and costly to manufacture. The USA FDA approved the first CAR T cell therapy (Kymriah) in Aug 2017, for relapsed/refractory CAYA B-ALL. The list price of Kymriah is $475,000, not accounting for costs related to delivery of care, inpatient hospitalization, toxicity management or follow-up. A half-decade of clinical experience has amassed since commercialization, yet financial analyses remain sparse. Here, we conduct the first study to understand costs for commercial CAR in CAYA B-ALL. Methods: Ten centers participating in both the Pediatric Real-world CAR Consortium (PRWCC) and Pediatric Health Information System (PHIS; Children's Hospital Association, Lenexa, KS) were eligible for study (08/2017-03/2020). Clinical data from the PRWCC database was merged with PHIS using age, diagnosis, center and lymphodepletion dates. Utilizing center and year specific charge-to-cost ratio, PHIS provided data for inpatient admission associated costs, but not outpatient care. For patients that were infused outpatient and subsequently admitted, only inpatient cost was available and analyzed for the first 60 days post-infusion. For patients that were infused inpatient, cost was calculated from the first day of admission for lymphodepletion or Kymriah infusion to 60 days post-infusion. The 60-day follow up was chosen as most of the clinical activity and toxicities occur within the 60 days post-infusion. Each patient was assigned a cost of $475,000 for Kymriah (list price). For the subset of patients who underwent allogeneic hematopoietic cell transplantation (alloHCT) following Kymriah, the median inpatient cost was assessed for 1-year post-alloHCT. Cost data was analyzed as medians and ranges. Univariable and multivariable logistic regression models were used to identify factors associated with the higher median cost associated with inpatient admissions. Results: 109 Kymriah-recipients were included. Patient characteristics are listed in Table 1. The incidence of grade 1-2 and ≥3 CRS was 42% and 23%, respectively, and grade 1-2 and ≥3 ICANS was 17% and 6%, respectively. Relapse/refractory disease at day 30 and 60 post-Kymriah infusion was 11% and 16%, respectively. AlloHCT was performed in 17 (16%) patients. Median time to alloHCT from Kymriah infusion was 148 days (36-354). The median number of admissions was 1 (0-5) and median length of all hospitalization was 18 days (0-69), 99% patients required inpatient admission. Thirty-six patients (33%) required intensive care unit (ICU) admission with a median ICU stay of 5 days (1-24). The median total cost (Kymriah + inpatient cost) per patient was $615,845 ($475,000-1,578,321). Breakdown of median total cost (excluding Kymriah) was: room/board $33,676 ($0-454,256), pharmacy $65,854 ($0-515,132), laboratory/pathology cost $10,496 ($0-201,900) and other cost $8,204 ($0-573,163). One-year median cost associated with inpatient admissions for alloHCT was $556,712 ($105,670-1,919,275), combined median cost associated with Kymriah + alloHCT was $1,263,316 ($696,768-2,404,447). Factors associated with higher inpatient cost were public insurance ($96,287, p=0.002); inpatient Kymriah infusion ($395,182, p<0.001); CRS grade≥3 ($342,176, p<0.001); ICANS grade ≥3 ($354,013, p=0.010); ICU stay ($346,737 p<0.001). Multivariable analysis demonstrated that only inpatient infusion of Kymriah significantly associated with higher cost (Table 2). Conclusion: In this cost analysis across CAYA receiving Kymriah, we describe the total inpatient treatment-associated cost, with inpatient infusion emerging as a main driver of cost. With increased clinical experience, outpatient infusions and early interventions to avoid high-grade toxicity and ICU-level care have become more common and potentially more cost-effective. Our data justifies efforts to deliver Kymriah in the outpatient setting, when safe and feasible, and to provide support systems to facilitate this. Additionally, Kymriah drug cost accounts for the bulk (73%) of the overall median cost, highlighting that efforts to lower drug costs may permit enhanced access globally.

Challenges in building radiotherapy capacity: A longitudinal study evaluating eight years of the Brazilian radiotherapy expansion plan

BackgroundIn 2012, the Brazilian government launched a radiotherapy (RT) expansion plan (PER-SUS) to install 100 linear accelerators. This study assesses the development of this program after eight years. MethodsOfficial reports from the Ministry of Health (MoH) were reviewed. RT centres projects status, timeframes, and cost data (all converted to US dollars) were extracted. The time analysis was divided into seven phases, and for cost evaluation, there were five stages. The initial predicted project time (IPPT) and costs (estimated by the MoH) for each phase were compared between the 18 operational RT centres (able to treat patients) and 30 non-operational RT centres using t-tests, ANOVA, and the Mann-Whitney U. A p-value < 0.05 indicates statistical significance. ResultsA significant delay was observed when comparing the IPPT with the overall time to conclude each 48 RT centres project (p < 0.001), with considerable delays in the first five phases (p < 0.001 for all). Moreover, the median time to conclude the first 18 operational RT centres (77.4 months) was shorter compared with the 30 non-operational RT centres (94.0 months), p < 0.001. The total cost of 48 RT services was USD 82,84 millions (mi) with a significant difference in the per project median total cost between 18 operational RT centres, USD1,34 mi and 30 non-operational RT centres USD2,11 mi, p < 0.001. All phases had a higher cost when comparing 30 non-operational RT centres to 18 operational RT centres, p < 0.001. The median total cost for expanding existing RT centres was USD1,30 mi versus USD2,18 mi for new RT services, p < 0.0001. ConclusionAfter eight years, the PER-SUS programs showed a substantial delay in most projects and their phases, with increased costs over time. Policy summaryOur findings indicate a need to act to increase the success of this plan. This study may provide a benchmark for other developing countries trying to expand RT capacity.

Cost per Responder Analysis of Patients with Lenalidomide-Refractory Multiple Myeloma Who Received Cilta-Cel from the Cartitude-4 Trial

Introduction: Ciltacabtagene autoleucel (cilta-cel) is a chimeric antigen receptor-T cell (CAR-T) immunotherapy approved for patients with relapsed or refractory multiple myeloma (RRMM). In the phase 3 trial, CARTITUDE-4 (NCT04181827), cilta-cel demonstrated better efficacy than physician's choice (daratumumab plus pomalidomide and dexamethasone [DPd] or pomalidomide plus bortezomib and dexamethasone [PVd]) with an overall response rate (ORR) of 84.6% versus 67.3% and ≥complete response (CR) of 73.1% versus 21.8% (San-Miguel et al. New Engl J Med. 2023). The present analysis assessed the value of cilta-cel and physician's choice treatments within the CARTITUDE-4 trial from a US combined commercial and Medicare payer perspective using a novel cost per responder (CPR) model that incorporates efficacy and total treatment costs. Methods: A CPR analysis was conducted from a mixed payer perspective (67.7% commercial, 23.3% Medicare), comparing the direct medical cost per patient receiving cilta-cel versus physician's choice (87% DPd and 13% PVd, per distribution in the trial) over 25.4 months, the maximum observed period for the physician's choice arm in the CARTITUDE-4 trial. The model was developed using progression-free survival (PFS), overall survival (OS), time to next treatment, CR, stringent CR (sCR), and ORR endpoints from the CARTITUDE-4 trial to inform health status. A standard parametric approach was taken to extrapolate the PFS and OS beyond the trial period for each arm for analysis scenarios with longer follow-up. Resource use and costs associated with the administration process for each treatment were included: apheresis, bridging therapy, pre-conditioning treatment, infusion, drug acquisition, other medications (infection prophylaxis, antihistamine, and antipyretic), and monitoring (eg, labs, vital sign assessment, hematologist visit) for CAR-T; drug acquisition, administration, other medications, and monitoring for physician's choice. The base case assumed CAR-T infusion was entirely administered in the inpatient setting, and an additional scenario was included that considered the outpatient infusion setting (70% inpatient and 30% outpatient). Costs of managing grade 3 to 4 AEs and grade 1 to 4 AEs for cytokine release syndrome (CRS) and neurotoxicity were included. Costs of subsequent therapies were assigned following disease progression, and costs of terminal care were also considered upon death events. Model outcomes included total cost per treated patient, total cost per complete responder, and cost per month in PFS compared between cilta-cel and physician's choice of therapy. All costs were adjusted to 2023 US dollars based on the consumer price index for medical care. Results: The total cost (PFS and post-progression survival [PPS] combined) per treated patient was estimated as $693,009 for cilta-cel and $1,028,444 for physician's choice over 25.4 months. Total estimated costs per treated patient were lower for cilta-cel than physician's choice during PFS and PPS separately ($581,108 vs $765,169 and $111,901 vs $263,275, respectively). Treatment acquisition and subsequent treatment costs are key drivers of the total costs during PFS and PPS, respectively ($451,318 and $103,101 for cilta-cel; $726,356 and $249,005 for physician's choice). Total cost per complete responder was estimated to be lower for cilta-cel compared with physician's choice ($948,029 vs $4,717,634) (Figure). Total estimated cost per month in PFS was $30,814 for cilta-cel versus $58,113 for physician's choice (Figure). Scenario analysis with a lower percentage of patients receiving CAR-T infusion in inpatient settings led to lower cost per complete responder and lower cost per month in PFS for cilta-cel (70% inpatient and 30% outpatient, $940,431 and $30,520, respectively). Conclusions: Overall, cilta-cel offers substantial clinical and economic benefit for patients with RRMM. The CPR analysis of data from CARTITUDE-4 estimated that, for patients with RRMM, cost per complete responder, and cost per month in PFS for cilta-cel were remarkably lower compared to physician's choice (DPd or PVd). Treatment acquisition and subsequent treatment costs appear to be key drivers for total direct medical costs.

Red Blood Cell Transfusion Dependence Is Associated with Greater Healthcare Resource Utilization, Higher Medical Cost, and Poorer Prognosis in Patients with Lower-Risk Myelodysplastic Syndromes: A 28-Year Retrospective Observation Study Result

Myelodysplastic syndromes (MDS) encompass a heterogeneous group of myeloid neoplasms characterized by cytopenia due to inefficient hematopoiesis, with a considerable risk of progression to acute myeloid leukemia (AML) or early mortality. In lower-risk MDS (LR-MDS) patients, anemia and its associated complications have been the focus of clinical attention. A significant portion of these patients eventually develop red blood cell transfusion dependence (RBC TD), which has been linked to a poorer prognosis. Given the limited efficacy of available treatments in reducing RBC TD, most patients face increased risks of chronic anemia and various complications. Moreover, RBC TD is known to be associated with reduced overall survival (OS) and leukemia-free survival (LFS). This study aimed to assess the impact of RBC TD on the socioeconomic burden and clinical prognosis of LR-MDS patients, utilizing an electronic medical records (EMR) database spanning nearly 30 years of MDS patient data. This retrospective observational study examined adult MDS patients (≥ 18 years of age) treated at Samsung Medical Center in the Republic of Korea. Eligible patients were diagnosed with MDS between Sep 1, 1994, to Apr 1, 2022 (index period), with the observation period spanning from Sep 1, 1994, to Sep 1, 2022. Baseline assessments included estimation of revised international prognostic scoring system (IPSS-R) scores, categorizing patients with very low, low or intermediate risks as lower-risk MDS (LR-MDS). TD was defined as the occurrence of any 16-week period with RBC transfusion of ≥ 2 units per 8 weeks, without consecutive 56-day period without transfusion. Healthcare resource utilization (HCRU), medical costs, and prognosis indicators including overall survival (OS) and AML-free survival (AFS) were analyzed and compared between patients who experiencing TD and those not (non-TD). Out of 831 MDS patients, 349 (42.0%) were classified as lower-risk at baseline. Among LR-MDS patients, 29.5% (103/349) experienced TD while 23.3% (194/831) experienced TD in the entire study population. The median age at diagnosis of MDS was 63 (ranging from 18 to 89), and 65.3% (543/831) were male. In LR-MDS patients, there were no significant differences in either baseline age (61 vs 63, P=0.16) or gender (71.8% vs 61.0% males, P=0.053) between TD and non-TD groups. However, TD group exhibited significantly higher median erythropoietin (EPO) level than non-TD group (290.5U/L vs. 112U/L, P&amp;lt;0.001) among LR-MDS patients with available baseline serum EPO levels (76 TD and 178 non-TD). Among the 76 TD LR-MDS patients with baseline serum EPO levels, 51 (67.1%) exhibited &amp;gt; 200U/L, which is considered a clinical threshold for erythropoiesis-stimulating agent (ESA) treatment. As shown in Table 1, RBC TD was consistently associated with greater HCRU and higher medical costs, especially in LR-MDS patients. TD LR-MDS patients had higher rates of outpatient department and emergency room visits (15676 vs. 8303 visits and 587 vs. 328 visits per 1000 person-years [PY], respectively), and increased hospitalizations (709 vs. 456 per 1000 PY), with longer hospital stays (13343 vs. 8272 days per 1000 PY). Furthermore, TD LR-MDS patients required over four-times of packed RBC units than non-TD patients (31107 vs. 7073 units per 1000 PY). Consequently, TD LR-MDS patients incurred higher total medical cost than their non-TD counterpart (13.5 million vs. 6.1 million USD per 1000 PY). Median OS (58.4 months vs. 103.1 months) and AFS (52.7 months vs. 102.7 months) were both significantly shorter in the TD group compared to the non-TD group among LR-MDS patients, while the differences in OS and AFS did not reach the level of significance in the entire study population (Table 1 and Figure 1). Notably, median OS after the first documented RBC TD event was 33.8 months (95% confidence interval: 24.7-58.5 months) in LR-MDS patients. The findings of this study indicate that RBC TD can be a strong predictor of increased HCRU and medical costs, as well as decreased OS and AFS over a 20-year period following the initial diagnosis of LR-MDS. Given that a majority of LR-MDS patients experiencing TD may not be eligible for ESA treatment due to elevated EPO levels exceeding 200U/L, and the use of cytotoxic agents is not usually recommended for these patients, these results highlight a substantial unmet need for alternative treatment options to address RBC TD in LR-MDS patients.

Facility-Related Healthcare Resource Utilization (HCRU) for Patients Treated with Idecabtagene Vicleucel (Ide-Cel, bb2121) in a Real-World (RW) Setting: A Single-Center Experience

Introduction: Ide-cel is a B-cell maturation antigen (BCMA)-directed chimeric antigen receptor (CAR) T cell therapy associated with deep and durable responses and improved quality of life among triple-class exposed (TCE) patients with relapsed/refractory multiple myeloma (RRMM) (Munshi NC, et al. N Engl J Med 2021;384:705-716; Delforge M, et al. Blood Adv 2022;6:1309-1318). An analysis of 2-year post-infusion facility-related HCRU (fHCRU) associated with ide-cel treatment in the phase 2 KarMMa clinical trial (NCT03361748) found that most facility costs were incurred within the first month following infusion where the median hospital length of stay (LOS) was 19.5 days which included the clinical trial requirement of hospitalization for monitoring and 20% of the patients had intensive care unit (ICU) stays (McGarvey N, et al. Blood 2022;140(suppl 1):10947-10948). In this study, we estimated fHCRU and associated costs for patients with TCE RRMM receiving ide-cel in RW clinical practice. Methods: This was a retrospective chart review of adults (≥ 18 years of age) with TCE RRMM who received an ide-cel infusion in RW clinical practice at H. Lee Moffitt Cancer Center, Tampa, FL, USA from May 25, 2021 to December 27, 2022. Costs were estimated using a two-step micro-costing methodology. Unit costs were sourced from public databases or literature, adjusted to 2022 US dollars and then applied to fHCRU. Patient characteristics and fHCRU were characterized using descriptive statistics, and the distribution of fHCRU was examined by key characteristics using Wilcoxon rank sum or chi-square tests. fHCRU and total facility costs included LOS and ICU stays obtained from the National Inpatient Sample and peer-reviewed literature, inflated to 2022 US dollars (USD); LOS days included readmissions. Unit costs (2022) were applied to post-index hospitalizations at the rate of USD 3001.80 per inpatient day and USD 9351.52 per ICU day. Results: A total of 109 patients were included. Median age was 65 years, 61% were male, 67% were non-Hispanic White, 14% had extramedullary disease, and 28% had high-risk cytogenetics. Patients had a median (range) of 6.0 (4.0-13.0) prior lines of MM therapy; 75% and 30% of patients were triple- and penta-class refractory, respectively. Median (range) follow-up was 9.2 months (0.2-24.4). Any grade cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) occurred in 82% and 17% of patients, respectively. Moderate or worse CRS and ICANS (grade ≥ 2) occurred in 19% and 10% of patients, respectively. A total of 71% of patients received tocilizumab, 34% received steroids, and 2% received anakinra for toxicity management. Only 26% of patients would have been eligible for the KarMMa trial. In the overall cohort, median LOS was 8.0 days (interquartile range [IQR], 7.0-10.0) and total median hospital costs were USD 24,014 (IQR, USD 21,013-30,018). Five (5%) patients had an ICU stay (median 8.0 days; IQR, 8.0-12.0) with total median costs of USD 76,252 (IQR, USD 76,252-114,378). fHCRU was comparable when analyzed by extramedullary disease, high-risk cytogenetics, penta-class refractory status, age at infusion (&amp;lt; 65 vs ≥ 65 years), and KarMMa clinical trial eligibility criteria ( P &amp;gt; 0.05). LOS and total costs were significantly lower among those with grade &amp;lt; 2 versus grade ≥ 2 CRS (both P &amp;lt; 0.05) or ICANS (both P &amp;lt; 0.01). Patients with more severe toxicity (grade ≥ 2) had a longer median LOS (CRS: 9 vs 8 days, P = 0.017; ICANS: 14 vs 8 days, P = 0.0026, respectively), were more likely to have an ICU stay (CRS: 24% vs 0%, P &amp;lt; 0.001; ICANS: 36% vs 1%, P &amp;lt; 0.001, respectively), and had higher median hospital costs (CRS: USD 27,016 vs USD 24,014, P = 0.0069; ICANS: USD 51,031 vs USD 24,014, P = 0.002, respectively) than patients with less severe toxicity (grade &amp;lt; 2) (Figure). Conclusion: This is the first study to characterize fHCRU and associated costs for patients with TCE RRMM who received ide-cel in a RW single-center practice. Median LOS was only 8 days and few patients (5%) had an ICU stay. fHCRU and associated costs were higher among patients who experienced moderate or worse CRS and neurologic toxicity. A limitation of this study is that fHCRU does not consider drug costs, including that of ide-cel. Additional studies with larger sample sizes and detailed cost analyses are needed to further quantify RW HCRU and pre-infusion and post-infusion costs in this patient population.

Health Care Resource Utilization (HCRU) and Cost of Management of Cytokine Release Syndrome (CRS) and Neurological Events (NEs) in Patients with R/R CLL/SLL Receiving Lisocabtagene Maraleucel (liso-cel) Treatment in the TRANSCEND CLL 004 Study

Background:Liso-cel is an autologous, CD19-directed, 4-1BB CAR T cell product administered at equal target doses of CD8 + and CD4 + CAR + T cells, which is currently being evaluated for treatment of patients with R/R CLL/SLL in the TRANSCEND CLL 004 study (NCT03331198). Initial study results suggested that a single infusion induced CRs or remission in patients with R/R CLL/SLL and had a manageable safety profile, with low to moderate incidence of severe CRS and NEs (Siddiqi T, et al. Lancet 2023). While the clinical consequences of CRS/NEs associated with CAR T cell therapies are well understood, limited data are available on the cost of management of these AEs. This analysis evaluated HCRU and estimated costs of managing CRS/NEs by grade in patients with R/R CLL/SLL who received liso-cel treatment in TRANSCEND CLL 004. Methods: Case report forms were analyzed from the trial database, capturing patient-level HCRU related to the management of CRS/NEs. Only patients that received liso-cel at a dose level of 100 × 10 6 CAR + T cells (dose level 2 [DL2]) and subsequently experienced treatment-emergent CRS and/or NEs were included in this study. Treatment-emergent AEs were defined as those initiated within a 90-day period of liso-cel administration. Costs for management of CRS/NEs were estimated using microcosting methodology. Relevant HCRU observed from the day of AE onset through resolution that was associated with the management of CRS/NEs per protocol management guidelines was identified; unit costs sourced from public databases were applied to each HCRU. Included HCRU categories were: facility (standard inpatient admission, ICU stay), diagnostics (laboratory, imaging), medications (tocilizumab, corticosteroids, vasopressors), and procedures (dialysis, intubation). Cost analyses were conducted from the United States (US) health care system perspective and adjusted to 2023 US dollars. Unit costs were obtained from the US Centers for Medicare &amp; Medicaid Services Hospital Outpatient Prospective Payment System, laboratory and physician fee schedules, IBM ® Micromedex ® RED BOOK ®, and literature. Descriptive statistical analyses stratified by AE severity grade and type of AE experienced were performed. Results: Ninety-four of 108 (87%) patients who received liso-cel at DL2 experienced CRS and/or NEs; 68 (72%) were grade ≤ 2 and 26 (28%) were grade ≥ 3. Overall, 44 (47%) patients had CRS only, 1 (1%) had NEs only, and 49 (52%) experienced both CRS and NEs. The study sample had a mean (standard deviation) age of 64.5 y (7.9) and were predominantly male (69%), White (84%), and non-Hispanic or Latino (90%). HCRU and total length of stay (LOS; the sum of inpatient and ICU stay days) are shown in the Table. All patients had an inpatient stay. ICU admissions only occurred among patients who experienced both CRS and NEs (10/49 [20%]) and were more common among patients with grade ≥ 3 (29%) compared with grade ≤ 2 (12%) AEs. Among patients who had an ICU admission, the median duration of an ICU stay was 5 days. Median total LOS increased with increasing AE severity for patients who had CRS only (grade 1, 5 days; grade 2, 9 days; grade 3, 15 days) and for patients who experienced both CRS and NEs (grade ≤ 2, 12 days; grade ≥ 3, 15 days). Overall, 68% and 62% of patients received tocilizumab and corticosteroids, respectively. Patients with grade ≥ 3 CRS and/or NEs had higher rates of utilization of medications, diagnostics, and procedures than those with grade ≤ 2 (Table). Additionally, patients who experienced both CRS and NEs had higher rates of utilization across all HCRU categories compared with those who experienced CRS or NEs only (Table). Estimated median management costs for CRS or NEs ranged from $14,638 (CRS only grade 1) to $46,802 (experienced both CRS and NEs with CRS or NEs grade ≥ 3) (Figure). Facility-related costs were the largest contributor to median total costs. Conclusions: While most patients treated with liso-cel at DL2 in TRANSCEND CLL 004 experienced CRS and/or NEs, they were primarily of low severity. HCRU and associated costs for management of CRS and/or NEs after liso-cel infusion increased with AE severity.Although everyone in this study required hospitalization, ICU admissions were rare and only observed among patients who experienced both CRS and NEs. Overall, costs of managing CRS and/or NEs were modest.

Nationwide Analysis of Characteristics and Outcomes of Patients with Heparin Induced Thrombocytopenia Admitted for Treatment of COVID-19

Introduction: Heparin is used for both therapeutic anticoagulation and thromboprophylaxis in admitted with COVID-19. However, multiple studies have shown an increased risk of heparin induced thrombocytopenia (HIT) among hospitalized patients with COVID-19. We conducted a large nationwide study to determine the impact of HIT on hospitalization outcomes among patients with COVID-19. Methods: The National Inpatient Sample Database (NIS) was interrogated using the appropriate International Classification of Diseases (1CD) 10 codes to determine hospitalizations for COVID-19 in 2020. The Data was then subclassified into cases with and without HIT. Chi square test and Mann Whitney U test were used to compare categorical and continuous variables, respectively. Subsequently, 1:1 propensity score matching (PSM) using the nearest neighbor with a match tolerance of zero was performed to match the two groups for patient demographics, and comorbidities. The primary endpoint was the difference in all-cause mortality. Other secondary endpoints included common hospitalization complications like acute myocardial infarction (AMI), deep vein thrombosis (DVT), pulmonary embolism (PE), and respiratory failure requiring mechanical ventilation (MV). We also performed a cost analysis to determine the differences in cost and length of stay. A p value of &amp;lt;0.05 was considered significant. All statistical methods were performed using SPSS Version 28.0. Results: A total of 1,678,995 weighted hospitalizations for COVID-19 were recorded in 2020. Among these 1745 (0.1%) had concurrent HIT. COVID-19 patients with HIT were more likely to be male (65.3% vs 52.0; p&amp;lt;0.01) and black (21.6% vs 19.1%, p&amp;lt;0.01). More patients with HIT had comorbid conditions compared to patients without HIT, most notably history of cerebrovascular disease (9.7% vs 5.2%), chronic kidney disease (35.5% vs 20.4%), congestive heart failure (21.8% vs 17.4%), diabetes mellitus (26.4% vs 23.2%), metastatic cancer (2.6% vs 1.1%), and obesity (34.7% vs 26.2%) (all p&amp;lt;0.01). PSM was used to match 1080 cases with HIT to 1080 without HIT. Hospitalizations with HIT had higher odds of all-cause mortality (Odds Ratio [OR] = 7.54, 95% confidence interval [CI]: 6.07-9.36; p&amp;lt;0.01). Patients with HIT also had higher odds of AMI (OR = 1.45, 95% CI: 1.03-2.04; p&amp;lt;0.01), DVT (OR = 6.65, 95% CI: 4.69-9.42; p&amp;lt;0.01), PE (OR = 4.45, 95% CI: 3.04-6.51, p&amp;lt;0.01), and MV (OR = 12.66, 95% CI: 10.22-15.69; p&amp;lt;0.01). COVID-19 patients with HIT also had a higher median LOS (21.0 vs 6.00 days, p&amp;lt;0.01), and median total cost of hospitalization ($272,000 vs $45,600, p&amp;lt;0.01) (Figure 1). Conclusion: Our nationwide study suggests HIT as an independent risk factor for poor hospitalization outcomes including death among patients admitted with COVID-19. Early recognition and prompt cessation of heparin related products can help prevent catastrophic thrombotic complications.

Economic burden of Thalassemia treatment: An analysis from the Vietnam Social Security perspective.

Thalassemia is a genetic disorder that significantly impacts the health and well-being of individuals in Vietnam. This study aimed to assess the economic burden of Thalassemia treatment in Lam-Dong Province from the perspective of the Vietnam Social Security and to develop a model to forecast these costs. This study analyzed the medical records of all 288 health-insured Thalassemia patients who received treatment in Lam-Dong Province from 2019-2021. The annual economic burden was calculated as the total direct medical cost of treatment per patient over one year. Bayesian Model Averaging (BMA) was utilized to forecast economic burdens. The best fit model was selected based on evaluation criteria including the R2 value, the Bayesian information criterion (BIC), and posterior model probabilities. The study found that the average annual economic burden of Thalassemia treatment was VND 9,947,000 (±6,854,000), equivalent to approximately USD 426.7 (±294.0), with blood transfusions being the main contributor to costs (63%). Using BMA, the best fit model to forecast economic burdens included variables including patient age, sex, and length of hospitalization, with age being the key factor with the greatest impact on the increase in economic burden. These findings provided important information for policymakers in Vietnam, as they highlighted the significant economic burden of Thalassemia treatment in the country. By developing a model to forecast these costs, policymakers can make informed decisions on how to allocate resources and support individuals with Thalassemia and their families.

1585. The Annual Cost per Newly Virally-Suppressed Person with HIV in Those Starting Long-Acting Injectable Antiretroviral Therapy with Detectable Viremia in a Safety-Net Clinic in San Francisco

Abstract Background Long-acting injectable cabotegravir/rilpivirine (CAB/RPV-LA) holds promise to effectively treat people with HIV (PWH) who are unable to achieve or maintain viral suppression on oral antiretroviral therapy (ART). Methods We employed standard micro-costing techniques to identify the resources and associated annual costs to provide CAB/RPV-LA to those initiating it with detectable viremia at San Francisco General Hospital’s Ward 86 clinic, accounting for q4week vs. q8week injections. Through structured interviews with service providers and administrators, we elicited the time in minutes for each staff member to perform each task, using mid-points for ranges. Person-minutes were applied to the personnel compensation rate to derive the total personnel cost per person. One-time costs required for CAB/RPV-LA initiation were distributed over 29.3 years, the expected average duration of treatment. We used the Medi-Cal reimbursement rate for the cost of CAB/RPV-LA and a literature-based estimate of other medical care costs of treating people with viral suppression to derive the total variable cost of CAB/RPV-LA treatment from the payer’s perspective. This result was adjusted by the viral suppression success rate at Ward 86 (96.5%) to derive the cost per new virally-suppressed PWH. We deducted the cost of standard ART and medical care to derive the incremental cost per additional virally suppressed PWH. Costs were adjusted to 2022 dollars. Results The annual variable cost of providing CAB/RPV-LA was $36,511, $35,252 for CAB/RPV-LA medication and $1,259 for other variable costs, mainly personnel. Including other medical care costs yielded a total annual medical care cost of $43,945 per newly virally-suppressed person. Deducting the cost of standard care, $42,276, from this sum suggests an incremental annual variable cost for CAB/RPV-LA of $1,668 per newly virally-suppressed person. If the cost of CAB/RPV-LA were reduced slightly, e.g. to 90% of current cost, CAB/RPV-LA would generate net savings of $1,985. Table 1 Annual Cost of Providing CAB/RPV-LA and Cost per Newly Suppressed Person with HIV Conclusion We found that the additional cost per newly-suppressed PWH was $1,668. CAB/RPV is likely to be highly cost-effective for this population. Modest reductions in CAB/RPV-LA price could render it cost-saving from a health care payer perspective. Disclosures Jonathan Colasanti, MD, MSPH, DKB MED LLC: Honoraria|Prime Education LLC: Advisor/Consultant Katerina Christopoulos, MD, MPH, Gilead Sciences: Advisor/Consultant

Costs and Outcomes of Total Joint Arthroplasty in Medicare Beneficiaries Are Not Meaningfully Associated with Industry Payments.

Prior studies have demonstrated that industry payments affect physician prescribing patterns, but their effect on orthopaedic surgical costs is unknown. This study examines the relationship between industry payments and the total costs of primary total joint arthroplasty, as well as operating room cost, length of stay, 30-day mortality, and 30-day readmission. Open Payments data were matched across a 20% sample of Medicare-insured patients undergoing primary elective total hip arthroplasty (THA) (n = 130,872) performed by 7,539 surgeons or primary elective total knee arthroplasty (TKA) (n = 230,856) performed by 8,977 surgeons from 2013 to 2015. Patient, hospital, and surgeon-specific factors were gathered. Total and operating room costs, length of stay, mortality, and readmissions were recorded. Multivariable linear and logistic regression models were used to identify the risk-adjusted relationships between industry payments and the primary and secondary outcomes. In this study, 96.7% of THA surgeons and 97.4% of TKA surgeons received industry payments. After multivariable risk adjustment, for each $1,000 increase in industry payments, the total costs of THA increased by $0.50 (0.003% of total costs) and the operating room costs of THA increased by $0.20 (0.003% of total costs). Industry payments were not associated with TKA cost. Industry payments were not associated with 30-day mortality after either THA or TKA. Higher industry payments were independently associated with a marginal decrease in the length of stay for patients undergoing THA (0.0045 days per $1,000) or TKA (0.0035 days per $1,000) and a <0.1% increase in the odds of 30-day readmission after THA for every $1,000 in industry payments. The median total THA costs were $300 higher (p < 0.001), whereas the median TKA costs were $150 lower (p < 0.001), for surgeons receiving the highest 5% of industry payments. These surgical procedures were more often performed in large urban areas, in hospitals with a higher number of beds, with a higher wage index, and by more experienced surgeons and were associated with a 0.4 to 1-day shorter length of stay (p < 0.001). Although most arthroplasty surgeons received industry payments, a minority of surgeons received the majority of payments. Overall, arthroplasty costs and outcomes were not meaningfully impacted by industry relationships. Prognostic Level III . See Instructions for Authors for a complete description of levels of evidence.

Progestin primed ovarian stimulation using dydrogesterone from day 7 of the cycle onwards in oocyte donation cycles: a longitudinal study

Does a progestin-primed ovarian stimulation (PPOS) protocol with dydrogesterone from cycle day 7 yield similar outcomes compared with a gonadotrophin-releasing hormone (GnRH) antagonist protocol in the same oocyte donors? This retrospective longitudinal study included 128 cycles from 64 oocyte donors. All oocyte donors had the same type of gonadotrophin and daily dose in both stimulation cycles. The primary outcome was the number of cumulus-oocyte complexes (COC) retrieved. The number of COC retrieved (mean ± SD 19.7 ± 10.8 versus 19.2 ± 8.3; P = 0.5) and the number of metaphase II oocytes (15.5 ± 8.4 versus 16.2 ± 7.0; P = 0.19) were similar for the PPOS and GnRH antagonist protocols, respectively. The duration of stimulation (10.5 ± 1.5 days versus 10.8 ± 1.5 days; P = 0.14) and consumption of gonadotrophins (2271.9 ± 429.7 IU versus 2321.5 ± 403.4 IU; P = 0.2) were also comparable, without any cases of premature ovulation. Nevertheless, there was a significant difference in the total cost of medication per cycle: €898.3 ± 169.9 for the PPOS protocol versus €1196.4 ± 207.5 (P < 0.001) for the GnRH antagonist protocol. The number of oocytes retrieved and number of metaphase II oocytes were comparable in both stimulation protocols, with the advantage of significant cost reduction in favour of the PPOS protocol compared with the GnRH antagonist protocol. No cases of premature ovulation were observed, even when progestin was started later in the stimulation.

Medical care costs according to the stage and subtype of breast cancer in a municipal setting: a case study of Hachioji City, Japan

BackgroundIt is important to assess whether the early detection of breast cancer affects medical care costs. However, research remains scant on the actual medical care costs associated with breast cancer treatment in Japan. This study aimed to determine the medical care costs of breast cancer treatment based on its stage using national health insurance claims data.MethodsThis was an observational study including patients with breast cancer who had undergone breast cancer treatment, as defined by the disease name and related treatment codes. Between August 2013 and June 2016, patients who underwent surgical treatment without axillary lymph node dissection and other radical treatment were classified as the curable group, while those who underwent palliative treatment were classified as the non-curable group. Patients were further stratified by subtype. The total and treatment-specific medical care costs for the five years were calculated using the national health insurance claims data of Hachioji City between August 2013 and May 2021.ResultsThe mean total medical care costs for the curable and non-curable groups for the 5 years were JPY 3958 thousand (standard deviation 2664) and JPY 8289 thousand (8482), respectively. The mean medical care costs for specific breast cancer treatment for the curable and non-curable groups were JPY 1142 (728) thousand and JPY 3651 thousand (5337), respectively. Further, human epidermal growth factor receptor 2 + , Hormone + patients had the highest mean cost over the 5 years.ConclusionsThe results suggest that the early detection of breast cancer may reduce medical care costs at the patient level.

Economic cost of patients with trisomy 13, 18, and 21 in a tertiary hospital in Thailand.

The purpose of this study was to determine direct and indirect costs of patients with trisomy (T) 13, 18, and 21 in Thailand. Direct medical costs were obtained from Siriraj Informatics and Data Innovation Center (SiData+), Faculty of Medicine, Siriraj Hospital, and indirect costs were estimated using a human capital approach. About 241 patients with T21 had outpatient care visits and 124 patients received inpatient care. For T13 and T18, five and seven patients were analyzed for outpatient and inpatient cares, respectively. For patients with T13, T18, and T21 receiving outpatient care, total annual mean direct medical costs ranged from 183.2 USD to 655.2 USD. For inpatient care, average yearly direct medical costs varied between 2,507 USD to 14,790 USD. The mean and median increased with age. In outpatient care, costs associated with drugs and medical devices were a major factor for both T13 and T21 patients, whereas laboratory costs were substantial for T18 patients. For inpatient care, costs of drug and medical devices were the greatest for T13 patients, while service fee and operation costs were the highest for T18 and T21 patients, respectively. For outpatient care, adult patients with congenital heart disease (CHD) had significantly higher mean annual direct medical costs than those without CHD. However, all adult and pediatric patients with CHD receiving inpatient care had significantly higher costs. Patients with T13, T18, and T21 had relative lifetime costs of 22,715 USD, 11,924 USD, and 1,022,830 USD, respectively.

Cost Analysis of Remote Cardiac Rehabilitation Compared With Facility-Based Cardiac Rehabilitation for Coronary Artery Disease

Remote cardiac rehabilitation (RCR) represents a promising, noninferior alternative to facility-based cardiac rehabilitation (FBCR). The comparable cost of RCR in US populations has yet to be extensively studied. The purpose of this prospective, patient-selected study of traditional FBCR versus a third-party asynchronous RCR platform was to assess whether RCR can be administered at a comparable cost and clinical efficacy to FBCR. Adult insured patients were eligible for enrollment after an admission for a coronary heart disease event. Patients selected either FBCR or Movn RCR, a 12-week telehealth intervention using an app-based platform and internet-capable medical devices. Clinical demographics, intervention adherence, cost-effectiveness, and hospitalizations at 1-year after enrollment were assessed from the Highmark claims database after propensity matching between groups. A total of 260 patients were included and 171 of those eligible (65.8%) received at least 1 cardiac rehabilitation session and half of the patients chose Movn RCR. The propensity matching produced a sample of 41 matched pairs. Movn RCR led to a faster enrollment and higher completion rates (80% vs 50%). The total medical costs were similar between Movn RCR and FBCR, although tended toward cost savings with Movn RCR ($10,574/patient). The cost of cardiac rehabilitation was lower in those enrolled in Movn RCR ($1,377/patient, p=0.002). The all-cause and cardiovascular-related hospitalizations or emergency department visits in the year after enrollment in both groups were similar. In conclusion, this pragmatic study of patients after a coronary heart disease event led to equivalent total medical costs and lower intervention costs for an asynchronous RCR platform than traditional FBCR while maintaining similar clinically important outcomes.

Care pathways of sepsis survivors: sequelae, mortality and use of healthcare services in France, 2015–2018

BackgroundIndividuals who survive sepsis are at high risk of chronic sequelae, resulting in significant health-economic costs. Several studies have focused on aspects of healthcare pathways of sepsis survivors but comprehensive, longitudinal overview of their pathways of care are scarce. The aim of this retrospective, longitudinal cohort study is to identify sepsis survivor profiles based on their healthcare pathways and describe their healthcare consumption and costs over the 3 years following their index hospitalization.MethodsThe data were extracted from the French National Hospital Discharge Database. The study population included all patients above 15 years old, with bacterial sepsis, who survived an incident hospitalization in an acute care facility in 2015. To identify survivor profiles, state sequence and clustering analyses were conducted over the year following the index hospitalization. For each profile, patient characteristics and their index hospital stay and sequelae were described, as well as use of care and its associated monetary costs, both pre- and post-sepsis.ResultsNew medical (79.2%), psychological (26.9%) and cognitive (18.5%) impairments were identified post-sepsis, and 65.3% of survivors were rehospitalized in acute care. Cumulative mortality reached 36.6% by 3 years post-sepsis. The total medical cost increased by 856 million € in the year post-sepsis. Five patient clusters were identified: home (65.6% of patients), early death (12.9%), late death (6.8%), short-term rehabilitation (11.3%) and long-term rehabilitation (3.3%). Survivors with early and late death clusters had high rates of cancer and primary bacteremia and experienced more hospital-at-home care post-sepsis. Survivors in short- or long-term rehabilitation clusters were older, with higher percentage of septic shock than those coming back home, and had high rates of multiple site infections and higher rates of new psychological and cognitive impairment.ConclusionsOver three years post-sepsis, different profiles of sepsis survivors were identified with different mortality rates, sequels and healthcare services usage and cost. This study confirmed the importance of sepsis burden and suggests that strategies of post-discharge care, in accordance with patient profile, should be further tested in order to reduce sepsis burden.

Comparative analysis of using atezolizumab vs. durvalumab in combination with platinum-containing chemotherapy in adult patients with advanced small cell lung cancer

Background. In recent decades, a course of chemotherapy with etoposide (EP) and platinum preparations (сarboplatinum, CP) has been recommended as a standard first-line treatment option in patients with advanced small cell lung cancer (SCLC), but with the advent of new immunological drugs, immune checkpoint inhibitors, approaches to therapy have changed. Based on randomized clinical trials, courses combining traditional platinum-containing chemotherapy with inhibitors of programmed death-ligand 1 (PD-L1) atezolizumab (ATZ) or durvalumab (Durv) have been included in many clinical recommendations for oncologists.Objective: to evaluate the clinical and cost-effectiveness of using ATZ and Durv as first-line therapy in advanced SCLC adult patients within the Russian healthcare system.Material and methods. The model of treatment of advanced SCLC adult patients in conditions of the healthcare system of the Russian Federation included the most popular options for first-line immunochemotherapy: CP/EP + ATZ and CP/EP + Durv courses. Pharmacoeconomic cost-effectiveness analysis, sensitivity analysis of the selected model to changes in its initial parameters, budget impact analysis were carried out.Results. The total medical costs for CP/EP + ATZ course (2,310,546.07 rubles) were significantly lower than for the CP/EP + Durv course (4,081,833.98 rubles). With comparable costs for the treatment of complications (426,175.17 and 407,704.50 rubles, respectively), the cost of Durv exceeded ATZ by 94.8%. When conducting a cost-effectiveness analysis, the advantage was retained by the CP/EP + ATZ course, the cost-effectiveness ratios for which amounted to 187,849.27 rubles per month of patient's life and 444,335.78 rubles per month of patient's life without progression (for CP/EP + Durv, 316,421.24 and 800,359.60 rubles, respectively). When choosing the CP/ET + ATZ strategy, the savings will be 128,571.96 rubles per month of life and 356,023.82 rubles per month of life without progression. Sensitivity analysis demonstrated the stability of the developed model: to increase in the price of the CP/EP + ATZ course up to +68%; to decrease in overall survival with the course of CP/EP + ATZ up to –40%; to decrease in progression-free survival with the course of CP/EP + ATZ to –44%. Budget impact analysis showed that with a possible cohort size of 4,448 people an increase in the proportion of patients receiving CP/EP + ATZ course from 70% to 90% will reduce budget costs by 1,575,737,725.38 rubles per year, which will allow additional treatment of 681.9 advanced SCLC patients per year (+15.3%).Conclusion. The use of ATZ combined with standard platinum-containing chemotherapy in advanced SCLC adult patients as the first-line therapy is clinically and cost-effective strategy within the Russian healthcare system, as it allows to reduce therapy costs compared to Durv and treat more SCLC patients, which fully corresponds to the target indicators of the federal program “Oncology”.

Abstract 15363: Equivalent Total Medical Costs Between Remote Cardiac Rehabilitation and Facility-Based Cardiac Rehabilitation

Purpose: Remote cardiac rehabilitation (RCR) represents a promising, non-inferior alternative to facility-based cardiac rehabilitation (FBCR). The comparable cost of RCR in US populations has not been previously studied. The purpose of this prospective, patient-selected study of traditional FBCR vs. a 3 rd party RCR platform was to assess whether RCR can be administered at comparable cost and clinical efficacy to FBCR. Methods: Adult insured patients were eligible for enrollment following an admission for a coronary event. Patients selected either FBCR or Movn RCR, a 12-week telehealth intervention using an app-based platform and internet-capable medical devices. Clinical demographics, intervention adherence, cost-effectiveness, and hospitalizations at 1-year post-enrollment were assessed from the Highmark claims database following propensity matching between groups. Results: A total of 260 patients were included, and 171 (65.8%) of those eligible received at least one cardiac rehab session, half of those choosing Movn RCR. Propensity matching produced a sample of 41 matched pairs between FBCR and RCR groups. Movn RCR led to quicker program initiation and higher completion rates (80% vs. 50%). Total medical costs were similar between Movn RCR and FBCR, though tended toward cost savings with Movn RCR ($10,574/patient). Cost of cardiac rehabilitation was lower in those enrolled in Movn RCR ($1377/patient, p=0.002). All-cause and cardiovascular-related hospitalizations or ED visits in the year following enrollment in both groups were similar. Conclusions: This pragmatic study of patients after a coronary event led to equivalent total medical costs and lower intervention costs for an RCR platform when compared to traditional FBCR while maintaining similar clinically important outcomes.

Ultrasound-guided manual vacuum aspiration (USG-MVA) with cervical preparation for early pregnancy loss: A cost-effectiveness analysis.

Approximately one in four women will experience a miscarriage in their lifetime. Ultrasound-guided manual vacuum aspiration (USG-MVA) is an ideal outpatient surgical treatment alternative to traditional surgical evacuation. We aimed to examine the cost-effectiveness of US-MVA with cervical preparation for treatment of early pregnancy loss from the perspective of public healthcare provider of Hong Kong. A decision-analytic model was designed to simulate outcomes in a hypothetical cohort of patients with early pregnancy loss on four interventions: (1) US-MVA, (2) misoprostol, (3) surgical evacuation of uterus by dilation and curettage (surgical evacuation), and (4) expectant care. Model inputs were retrieved from published literature and public data. Model outcome measures were total direct medical cost and disutility-adjusted life-year (DALY). Base-case model results were examined by sensitivity analysis. The expected DALYs (0.00141) and total direct medical cost (USD736) of US-MVA were the lowest of all interventions in base-case analysis, and US-MVA was the preferred cost-effective option. One-way sensitivity analysis showed that the misoprostol group became less costly than the US-MVA group if the evacuation rate of misoprostol (base-case value 0.832) exceeded 0.920. In probabilistic sensitivity analysis, At the willingness-to-pay (WTP) threshold of 49630 USD/DALY averted (1x gross domestic product per capita of Hong Kong), the US-MVA was cost-effective in 72.9% of the time. US-MVA appeared to be cost-saving and effective for treatment of early pregnancy loss from the perspective of public healthcare provider of Hong Kong.

Estimating Transfusion-Related Medical Costs and Associated Time Burden in Patients with Myelofibrosis: A Comparison of Momelotinib Vs Ruxolitinib Based on Simplify-1

Introduction: Myelofibrosis (MF) is a myeloproliferative neoplasm characterized by splenomegaly, debilitating symptoms, and bone marrow fibrosis. Transfusion-dependent (TD) anemia is present in one-quarter of patients (pts) with MF at diagnosis and becomes more common over time. Transfusion dependence imposes a high cost burden on healthcare systems, with annual total medical costs up to 9 times higher for TD pts than for non-TD pts (Gerds A, et al. ASH 2022. Abstract 1729). Momelotinib (MMB) is a Janus kinase (JAK) 1/JAK2/activin A receptor type 1 inhibitor that has demonstrated symptom, spleen, and anemia benefits in pts with MF across 3 phase 3 trials. Evidence in JAK inhibitor-naive pts comes from SIMPLIFY-1 (NCT01969838), a randomized, double-blind, phase 3 trial of MMB vs ruxolitinib (RUX). Eligible pts had International Prognostic Scoring System high-risk or intermediate-2-risk MF, or intermediate-1-risk MF associated with symptomatic splenomegaly, hepatomegaly, or anemia (hemoglobin &amp;lt;10 g/dL) and/or unresponsiveness to available non-JAK inhibitor therapy. MMB was associated with higher red blood cell (RBC) transfusion independence rates (66.5% vs 49.3%), lower transfusion dependence rates (30.2% vs 40.1%), and fewer RBC units transfused (median of zero units/month vs 0.4 units/month) compared with RUX by week 24. This study estimated the projected differences between MMB and RUX in total medical costs as well as cost and time burden associated with outpatient transfusion visits, based on results from SIMPLIFY-1, in all pts with MF and separately in those aged ≥65 years. Methods: Analyses were based on transfusion status (TD, transfusion independent [TI], or transfusion requiring [TR]) and mean rates of outpatient transfusion visits over 24 weeks in SIMPLIFY-1. TD was defined as ≥4 RBC units transfused or hemoglobin &amp;lt;8 g/dL in the prior 8 weeks, TI was defined as no RBC transfusions and all hemoglobin ≥8 g/dL in the prior 12 weeks, and TR was defined as being neither TD nor TI. Projected cost offsets for MMB relative to RUX were calculated based on observed transfusion status and rates over 24 weeks from SIMPLIFY-1 combined with cost estimates for TD vs TI/TR from the IBM MarketScan Database used to inform commercial health plans. Projected time savings were calculated similarly using transfusion rates from SIMPLIFY-1 and previously reported time burden estimates for transfusion visits in pts with TD β-thalassemia (Knoth RL, et al. EHA2022. Poster P1741). For pts aged ≥65 years, individual pt data from SIMPLIFY-1 and cost estimates from the Medicare fee-for-service database were used instead. Results: Based on the IBM MarketScan Commercial Database, projected average annual total medical cost savings based on week 24 transfusion status with MMB vs RUX were $20,215 per pt with baseline TD status and $23,991 per pt with baseline TI/TR status. Fewer outpatient transfusion visits with MMB vs RUX resulted in projected annual savings of $25,704 per pt with baseline TD status and $12,083 per pt with baseline TI/TR status. Among pts with baseline TD status, projected annual time savings in transfusion visits for MMB vs RUX (147 vs 253 hours) totaled 106 hours per pt (42 hours, preparation and waiting; 50 hours, transfusion and recovery; 15 hours, travel), a 42% reduction for MMB vs RUX. In the subgroup analysis that focused on pts aged ≥65 years, based on the Medicare fee-for-service database, projected average annual total medical cost savings with MMB vs RUX were $11,102 per pt with baseline TD status and $17,373 per pt with baseline TI/TR status. Fewer outpatient transfusion visits with MMB vs RUX resulted in projected annual savings of $28,826 per pt with baseline TD status and $18,255 per pt with baseline TI/TR status. Among pts aged ≥65 years with baseline TD status, projected annual time savings in transfusion visits accounted for MMB vs RUX (160 vs 279 hours) totaled 119 hours per pt (47 hours, preparation and waiting; 56 hours, transfusion and recovery; 16 hours, travel), a 43% reduction for MMB vs RUX. Conclusions: Reductions in transfusion dependence and transfusion visits for MMB vs RUX were associated with projected healthcare system savings in transfusion costs and transfusion-related time burden in JAK inhibitor-naive pts with MF, including in subgroup analyses of pts aged ≥65 years.