Thao, Viengneesee

PURPOSE This national study was undertaken to determine screening mammography rates among transgender and gender diverse (TGD) individuals. METHODS TGD individuals and cisgender women who qualified to receive screening mammography based on American College of Radiology guidelines were identified in the longitudinal OptumLabs Data Warehouse. The primary end point was the percentage of patients who had high rates of screening (>75% recommended screenings). Multivariable analyses were conducted in a matched population of transgender men to cisgender women to identify and adjust for factors associated with high adherence. Individuals were matched at a 1:4 ratio (transgender men: cisgender women) on age, race/ethnicity, year of enrollment in their health care plan, and duration of follow-up. RESULTS This study focused on 10,478 TGD individuals (3,778 transgender men; 1,294 transgender women; 5,406 with gender dysphoria not meeting other TGD criteria, NMOT) and 6,218,369 cisgender women. For transgender men, transgender women, individuals with gender dysphoria NMOT, and cisgender women, high mammography rates were observed in 41.1% (95% CI, 39.5 to 42.6), 7.4% (95% CI, 6.0 to 8.8), 11.9% (95% CI, 11.0 to 12.7), and 38.3% (95% CI, 38.3 to 38.4), respectively ( P < .0001). When transgender men were compared with 15,112 matched cisgender women, an age-based differential association was observed between sex and high mammography rates (interaction P = .0003); compared with cisgender women, transgender men appeared more likely to manifest high rates of screening at age 40-49 years (odds ratios [ORs], 1.38 [95% CI, 1.28 to 1.50]; P < .0001) and 50-59 years (OR, 1.57 [95% CI, 1.35 to 1.81]; P < .0001) but not in the older age groups. CONCLUSION The relatively high rates of screening mammography in cisgender women and transgender men suggest clinicians are offering mammography to individuals who are at average or high breast cancer risk, as compared with cisgender women, and not to transgender women at low risk.

Purpose: A variety of care pathways are offered to females with chronic pelvic pain (CPP) and pelvic floor myofascial pain (PFMP), which may affect treatment outcomes. This study aims to compare care pathways and describe health care utilization and characteristics of patients with CPP and PFMP referred for physical therapy (PT) at a tertiary care center. Methods: A retrospective cohort analysis was conducted on females with CPP and PFMP referred for PT. Patients received PT, medication management, injection therapy, or a combination of treatments. We collected data on health care utilization, comorbidities of interest, and patient-reported outcome measures (PROMs). Wilcoxon rank-sum tests were used to compare patients with pre- and posttreatment PROM scores. Results: A total of 1172 patients were referred for PT treatment, but 19.5% (n = 229) did not attend any PT sessions, and only 18% (n = 211) of patients attended the recommended number of PT sessions. Comorbid urinary (48.5%, n = 569) and bowel dysfunction (43%, n = 512) were prevalent. Patients consulted with multiple providers. Most patients (57.1%, n = 669) utilized opioid medications. Less than 20% completed both pre-and posttreatment PROMs. Discussion: Care pathways vary widely for the treatment of PFMP. Low adherence to PT and a trend toward greater than 5 subspecialty appointments indicating higher health care utilization reflect the range of inconsistent patient experience likely affecting outcomes. Outcomes of care are uncharted territory. Optimal care pathways for CPP and PFMP need to be established, along with further investigation of PROMs, to determine which treatments result in effective outcomes that matter to patients.

Abstract Purpose Overuse of thyroid ultrasound (TUS) has contributed to rising thyroid cancer diagnoses and is projected to increase US healthcare costs from $1.5 billion to $3.5 billion by 2030. This study evaluated the healthcare cost of inappropriately ordered TUS in a national multicenter academic system. Methods This is a secondary cost analysis of a retrospective cohort study across 4 Mayo Clinic sites (Rochester, MN; Jacksonville, FL; Scottsdale, AZ; and the Midwest Mayo Clinic Health System). Adult patients (≥18 years) undergoing their first TUS between January 1, 2017, and December 31, 2021, with at least 1 year of follow-up were included. TUS indications were classified as appropriate or inappropriate using a guideline-based natural language processing algorithm. The primary outcome was a comparison of adjusted 1-year all-cause healthcare costs. A secondary analysis calculated the direct procedural costs of the inappropriate TUS cascade. Results Among 6984 patients (mean age 56 [SD 16.4]; 76.2% female; 90.9% White), 546 (7.8%) underwent TUS for inappropriate indications. These patients were younger (mean age 53.0 vs 56.3 years, P &lt; .0001) but otherwise demographically similar. Adjusted total healthcare costs over 90 days and 1 year were comparable: $4842 vs $5794 and $13 748 vs $14 257 for inappropriate vs appropriate TUS, respectively. The inappropriate TUS cascade, including an estimated 56 subsequent biopsies and 22 thyroidectomies, resulted in a minimum of $576 134 in direct procedural costs. Conclusion While adjusted total costs were similar, inappropriate TUS represents potentially avoidable spending and remains a viable target for cost-reduction strategies. Reducing low-value imaging remains a critical target for cost-saving interventions.

1530 Background: Regular breast cancer screening reduces mortality. The American College of Radiology (ACR) recommends annual screening mammography for asymptomatic, average risk 1) transgender and gender diverse (TGD) men (individuals assigned female sex at birth but identify as men) age 40+ and with residual breast tissue and 2) TGD women (individuals assigned male sex at birth but identify as women) age 40+ and on gender-affirming hormone therapy for 5+ years. This nationwide study investigated screening mammography in TGD individuals. Methods: Four cohorts were identified with complex algorithms of medical and pharmacy data in the OptumLabs Data Warehouse, a longitudinal, administrative insurance claims database that includes patients with commercial insurance and Medicare Advantage: 1) TGD men, 2) TGD women, 3) individuals with gender dysphoria not meeting other TGD criteria (NMOT), and 4) cisgender women -- all of whom met ACR screening criteria. The primary endpoint was the percentage of individuals with high adherence, defined as completing >75% of recommended screenings; comparisons were made across the cohorts (Chi-square test). Multivariable logistic regression was used to compare adherence between TGD men and cisgender women with adjustment for demographics and with 1:4 matching (on race/ethnicity, age group, year of healthcare plan enrollment, and duration of follow-up). Results: 10,478 TGD individuals (3,778 TGD men; 1,294 TGD women; and 5,406 with gender dysphoria NMOT) and 6,218,369 cisgender women were identified. For TGD men, TGD women, individuals with gender dysphoria NMOT, and cisgender women, high adherence was observed in 41.1% (95% confidence interval (CI): 39.5, 42.6%); 7.4% (95% CI: 6.0, 8.8%); 11.9% (95% CI: 11.0, 12.7%); and 38.3% (95% CI: 38.3, 38.4%), respectively, p < 0.0001. No screening ever in these same populations was observed in 23.6% (95% CI: 22.2, 24.9%); 81.3% (95% CI: 79.2, 83.4%), 72.8% (95% CI: 71.6, 74%), and 35.9% (95% CI: 35.8, 35.9%), respectively, p < 0.0001. When TGD men were matched and compared to 15,112 cisgender women, a differential association was observed between gender and high adherence by age group (p < 0.0001); compared to cisgender women, the likelihood of high adherence in TGD men ages 40-49 (n = 2,472), 50-59 (n = 852), 60-69 (n = 320), and 70+ (n = 134) were as follows: odds ratios (OR‘s): 1.38 (95% CI: 1.28, 1.50), p < 0.0001; 1.57 (95% CI: 1.35, 1.81), p < 0.0001; 0.812 (95% CI: 0.619, 1.065), p = 0.1316; and 1.277 (95% CI 0.835, 1.951), p = 0.2595, respectively. Conclusions: This study found that TGD men manifest relatively high adherence to screening mammography, whereas TGD women and individuals with gender dysphoria NMOT manifest low adherence. Future research should focus on improving breast cancer screening in these underserved populations.

ABSTRACT Background Multiple outpatient therapies have been developed for COVID‐19 in high‐risk individuals, but solid organ transplant (SOT) recipients were not well represented in controlled clinical trials. To date, few comparative studies have evaluated outcomes between outpatient therapies in this population. Methods We performed a retrospective cohort study using de‐identified administrative claims data from OptumLabs Data Warehouse. Patients were included if they were age ≥ 18 years, diagnosed with COVID‐19 between January 2022 and December 2023, and underwent SOT prior to COVID‐19. The primary outcome was 30‐day hospitalization. Stabilized inverse probability of treatment weighting was used to account for potential confounding variables. Results 4192 SOT recipients with COVID‐19 were identified. 1403 received an outpatient COVID‐19 therapy, including anti‐spike monoclonal antibodies ( N = 748, 53.3%), molnupiravir ( N = 327, 23.3%), ritonavir‐boosted nirmatrelvir ( N = 217, 15.5%), or remdesivir ( N = 141, 10.0%). In weighted analysis compared to no treatment, anti‐spike monoclonal antibodies (hazard ratio [HR] 0.39, 95% confidence interval [CI] 0.28–0.55; p < 0.001), molnupiravir (HR 0.56, 95% CI 0.36–0.89; p = 0.013), and nirmatrelvir (HR 0.47, 95% CI 0.25–0.89; p = 0.020) were associated with reduced hospitalization risk, while remdesivir (HR 1.00, 95% CI 0.50–1.98; p = 0.992) was not. Hospitalization rates were similar between the treatment agents, apart from remdesivir showing a higher risk compared to anti‐spike monoclonal antibodies. Conclusions Outpatient COVID‐19 therapies were largely associated with improved outcomes among SOT recipients. These treatment agents showed similar rates of 30‐day hospitalization, except for remdesivir. The choice of outpatient COVID‐19 therapy in SOT recipients should primarily account for patients’ individual circumstances and drug‐drug interactions rather than differential therapeutic efficacy. image

8051 Background: The National Comprehensive Cancer Network (NCCN) currently recommends the use of Atezolizumab, Nivolumab, Osimertinib, and Pembrolizumab in the perioperative management of non-small cell lung cancers (NSCLC) and esophageal cancers (EC). As the therapeutic landscape evolves, we aim to evaluate the cost implications of these guidelines for eligible patients in the United States. Methods: The Medicare Part B payment allowance limits of each medication were ascertained except Osimertinib for which an approximate wholesale acquisition cost (WAC) was reported due to privately administered Medicare Part D coverage. Using national data and published literature, we estimated the annual incidence of patients with newly diagnosed EC and NSCLC who would be eligible for surgery combined with neoadjuvant and/or adjuvant immune and targeted therapy. We applied the estimated cost of the medication based on dosing and duration of treatment, which spanned 1 year for all but adjuvant Osimertinib, which spanned 3 years. Using these data, the cost per patient and the total cost for an incident cohort were estimated. Results: We estimated that 8,602 patients with newly diagnosed EC would be eligible for adjuvant Nivolumab; the cost to treat one patient was $248,529, and the cost to treat one incident cohort was approximately $2 billion (Table). We estimated that 50,409 patients with NSCLC will meet the criteria for neoadjuvant Nivolumab with a total cost of three cycles of $32,894 per patient and $1.7 billion per cohort. Among NSCLC patients who may undergo resection and qualify for adjuvant therapy (Stage IB – IIA with high-risk features or IIB-IIIA), 85,063 patients are anticipated to be EGFR-negative and treated with adjuvant Atezolizumab or Pembrolizumab. Treatment costs range from $178,584 – $197,320 per patient with up to $16 billion cost per cohort. The cost to treat one patient with adjuvant Osimertinib was $556,720, and the cost to treat one incident cohort was close to $10 billion. In total, the cost to treat an incident cohort of eligible operable thoracic malignancies could exceed $30 billion. Conclusions: Neoadjuvant and adjuvant immune and targeted therapy in operable thoracic patients is associated with a significant cost burden. Prospective large-scale studies are needed to assess cost-effectiveness, particularly given the paucity of superior overall survival data with these agents. [Table: see text]

PURPOSE BMT CTN 1102 was a phase III trial comparing reduced-intensity allogeneic hematopoietic cell transplantation (RIC alloHCT) to standard of care for persons with intermediate- or high-risk myelodysplastic syndrome (MDS). We report results of a cost-effectiveness analysis conducted alongside the clinical trial. METHODS Three hundred eighty-four patients received HCT (n = 260) or standard of care (n = 124) according to availability of a human leukocyte antigen–matched donor. Cost-effectiveness was calculated from US commercial and Medicare perspectives over a 20-year time horizon. Health care utilization and costs were estimated using propensity score–matched cohorts of HCT recipients in the OptumLabs Data Warehouse (age 50-64 years) and Medicare (age 65 years and older). EuroQol 5 Dimension (EQ-5D) surveys of trial participants were used to derive health state utilities. RESULTS Extrapolated 20-year overall survival for those age 50-64 years was 29% for HCT (n = 105) versus 13% for usual care (n = 44) and 31% for HCT (n = 155) versus 12% for non-HCT (n = 80) for those age 65 years and older. HCT was more effective (+2.36 quality-adjusted life-years [QALYs] for age 50-64 years and +2.92 QALYs for age 65 years and older) and more costly (+$452,242 in US dollars (USD) for age 50-64 years and +$233,214 USD for age 65 years and older) than usual care, with incremental cost-effectiveness ratios of $191,487 (USD)/QALY and $79,834 (USD)/QALY, respectively. For persons age 50-64 years, there was a 29% chance that HCT was cost-effective using a willingness-to-pay (WTP) threshold of $150K (USD)/QALY and 51% at a $200K (USD)/QALY. For persons age 65 years and older, the probability was 100% at a WTP >$150K (USD)/QALY. CONCLUSION Among patients age 65 years and older with high-risk MDS, RIC HCT is a high-value strategy. For those age 50-64 years, HCT is a lower-value strategy but has similar cost-effectiveness to other therapies commonly used in oncology.

Introduction The Blood and Marrow Transplant Clinical Trials Network 1102 study (BMT CTN 1102, NCT02016781) was a multicenter, biologic assignment trial, where patients aged 50-75 with intermediate-2 or high risk de novo myelodysplastic syndrome (MDS) were assigned to reduced-intensity allogeneic hematopoietic cell transplantation (alloHCT) or best supportive care (non-alloHCT) based on donor availability. A parallel economic evaluation was performed alongside BMT CTN 1102. Here, we report on the financial impact of the treatment protocol on patients using a prospective cost diary study conducted within the trial. Methods BMT CTN 1102 enrollees were offered the option to participate in the parallel cost diary study at the same time of primary study enrollment. The cost diary survey instrument, comprised of 19 questions, covered the domains of out-of-pocket (OOP) costs of healthcare and financial hardship indicators. Surveys were distributed at 1- (1M), 7- (7M), and 19-months (19M) after enrollment. Study participants were grouped by actual treatment received, rather than group assignment. Responses were analyzed using univariate Fisher's exact and Wilcoxon rank sum tests for association. Results Out of 216 enrollee invitations, 138 patients (64%) returned at least one survey. Total completed surveys at the 1M, 7M, and 19M timepoints were 103 (39%), 93 (35%), and 71 (27%), respectively. 50 (36%) completed only one survey, while 41 (39%) completed surveys at all three timepoints. Of all respondents, median age was 67.7 years (IQR: 64.8-70.3), 88 (64%) were male, 128 (93%) white, and 126 (91%) were non-Hispanic. Among respondents of the 1M, 7M and 19M surveys, 82 (80%), 78 (84%), 65 (92%) received alloHCT, respectively. Mean OOP costs by category are presented in Table 1. While alloHCT patients experienced higher OOP costs compared to non-alloHCT patients across all categories (outpatient services, prescription medications, and accommodations for healthcare), none of the comparisons were statistically significant. However, total OOP costs were significantly higher among alloHCT patients at 1 and 7 months (mean over past 30 days, 1M: $889 vs. $217, p=0.046; 7M: $678 vs. $349, p=0.03; 19M: $328 vs. $103, p=0.15). Financial hardship indicators are presented in Table 2. While alloHCT patients experienced greater financial hardship compared to non-alloHCT patients across all categories (mobilized reserve funds, borrowed money to pay for care, developed debt due to care), none of the comparisons were statistically significant. However, alloHCT patients were significantly more likely to experience at least one of these factors of financial hardship at 7 months (1M: 38% vs. 19%, p=0.13; 7M: 42% vs. 13%; p=0.04; 19M: 37% vs. 0%, p=0.08). Discussion Patients with MDS who received alloHCT incurred substantially more OOP costs overall compared to patients who did not receive alloHCT, most notably for accommodations related to alloHCT. Similarly, alloHCT patients were more likely to develop financial hardship, including mobilizing reserve funds, borrowing money, and developing debt. These findings demonstrate that treatment-related OOP expenditures associated with alloHCT are substantial and may pose significant burdens for some populations receiving alloHCT. Financial navigation and assistance, which have been shown to help patients address cost burden in solid tumor settings, should be considered for MDS patients prior to alloHCT. Small final sample sizes limited our analyses significantly; further research into OOP costs and financial hardship among larger cohorts of alloHCT patients are necessary to confirm these findings. Acknowledgement Support for this study was provided by grants #U10HL069294 and #U24HL138660 to the Blood and Marrow Transplant Clinical Trials Network from the National Heart, Lung, and Blood Institute and the National Cancer Institute. The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH.