Borah, Bijan J.

Introduction: Teleneonatology (TN) allows remote neonatologists to provide real-time audio-video telemedicine support to community hospitals when neonates require advanced resuscitation or critical care. Currently, there are no published economic evaluations of U.S. TN programs. Objective: To evaluate the cost of TN from the perspective of the health care system. Methods: We constructed a decision tree comparing TN to usual care for neonates born in hospitals without a neonatal intensive care unit (NICU) who require consultation. Our outcome of interest was total cost per patient, which included the incremental cost of a TN program, the cost of medical transport, and the cost of NICU or non-NICU hospitalization. We performed threshold sensitivity analyses where we varied each parameter to determine whether the base-case finding reverted. Results: For neonates requiring consultation after birth in a hospital without a NICU, TN was less costly ($16,878) than usual care ($28,047), representing a cost-savings of $11,168 per patient. Sensitivity analyses demonstrated that at least one of the following conditions would need to be met for TN to no longer be cost saving compared to usual care: transfer rate with usual care <12% (base-case = 82%), TN reducing the odds of transfer by <8% (base-case = 52%), or TN cost exceeding $12,989 per patient (base-case = $1,821 per patient). Conclusions: Economic modeling from the health system perspective demonstrated that TN was cost saving compared to usual care for neonates requiring consultation following delivery in a non-NICU hospital. Understanding the cost savings associated with TN may influence organizational decisions regarding implementation, diffusion, and retention of these programs.

321 Background: KEYNOTE-564 demonstrated that adjuvant pembrolizumab after nephrectomy for high-risk clear cell renal cell carcinoma (RCC) decreased the risk of disease progression and – albeit with immature follow-up (2 years) – found a signal of improved overall survival as well. Herein, we used extrapolations from a Markov-model, accounting for the costs and toxicities of pembrolizumab relative to its efficacy, to investigate its utility at a population level. Methods: A decision-analytic Markov Model was used to conduct a cost-utility analysis of adjuvant pembrolizumab versus placebo after nephrectomy for high risk RCC, using data from KEYNOTE-564 to inform model probabilities. Transition probabilities not found in KEYNOTE-564, in addition to utility values, were extracted from the literature. Base case analyses were conducted with 5-year and 15-year time horizons (using extrapolations from 2-year outcomes), and 3-week time cycles. Primary outcomes were Quality-adjusted life years (QALYs), 2021 US Medicare costs, and Incremental cost-effectiveness ratios (ICERs). The willingness-to-pay threshold was set at $100,000/QALY. One-way sensitivity analyses were used to identify cost-effectiveness thresholds of individual parameters while probabilistic sensitivity analyses with 100,000 Monte-Carlo simulations were used to simultaneously vary all model inputs. Results: Pembrolizumab was associated with higher QALYs and costs relative to placebo (Table). Pembrolizumab was not cost-effective at a 5-year time horizon but was cost-effective at 15 years and beyond. One-way sensitivity analysis noted that pembrolizumab became cost-effective at 5-years if: 1) its administration cost was less than $5,064 (base = $10,278) or 2) if the 5-year risk of progression was 18.8% higher in placebo vs pembrolizumab (base = 9%). Using pembrolizumab’s reported hazard ratio of 0.68 for progression from KEYNOTE-564, we estimated that pembrolizumab would be cost-effective at 5-years for all patients with a Mayo Progression Free Survival Score of 10 or higher. Probabilistic sensitivity analysis found that pembrolizumab was cost-effective for 29% and 58% of microsimulations at 5 and 15 years, respectively. Conclusions: At current prices, adjuvant pembrolizumab was not cost-effective for all trial patients at a population level at 5-years after treatment but may be cost-effective for time horizons over 15 years. Instead, adjuvant pembrolizumab was found to be cost-effective only for the highest risk subsets of RCC at 5-years. Longer term trial data of progression-free survival and overall survival are necessary to confirm these extrapolations.[Table: see text]

Background: The ACCORD-Lipid Trial’s finding that statin-fibrate combination therapy (CT) provides no incremental cardiovascular risk reduction in type 2 diabetese over statin monotherapy (MT) prompted FDA to issue a public communication on 11/9/2011 stating that fenofibrate may not reduce risk of heart attack or stroke. Yet, fibrate use continues unabated with over $1 billion in sales in the US that raises concern regarding the inconsistency in diffusion of scientific evidence into clinical practice. Critics of ACCORD findings maintain that ACCORD trial adopted flexible thresholds for qualifying HDL and triglyceride levels and that it left unanswered whether the effects of non-ACCORD statins or fibrates or combinations thereof will be different. By replicating the ACCORD-Lipid trial as closely as possible using 16-year longitudinal claims database from a large national health plan, our study seeks to compare the following ACCORD outcomes between CT and MT cohorts: (i) primary composite outcome of nonfatal MI, nonfatal stroke and cardiovascular death; (ii) secondary outcomes of all-cause mortality, expanded macrovascular outcome, major CAD events and CHF. Methods (Research Design, Data Source and Data Analysis Methods) : Retrospective claims analysis that included patients enrolled between 1995 and 2010 using ACCORD inclusion/exclusion criteria including type 2 diabetes patients aged 40 to 79 with baseline A1C≥7.5 and on statin. Patients in the two study cohorts, CT and MT, were required to have minimum of 1-year baseline and 90-day follow-up periods. Propensity score (PS) matching was used to adjust for patient baseline characteristics. T- and Chi-squared tests were used to assess differences in continuous and categorical covariates and Cox proportional hazard model was used to assess the hazard of study events. Results: The study included 6765 patients (CT=954; MT=5811) with a mean follow-up of 2.4 years. An average patient in the sample was a White male aged 57 years from the South. The two study cohorts differed in demographics (age, female, ethnicity, income categories), baseline lipids (HDL, LDL, triglyceride and HbA1c), and in numerous comorbid conditions. After 1-to-1 PS matching, baseline LDL, triglycerides and total cholesterol were similar but HDL (HbA1c) was higher (lower) in CT than in MT cohort (n=943 in each cohort). Most other baseline covariates were balanced. Unadjusted results showed that compared to MT, CT cohort had higher primary composite outcomes (62 vs 45), all-cause deaths (113 vs 105), macrovascular events (16 vs 9), major CAD (84 vs 59), nonfatal stroke (35 vs 33) and CHF (60 vs 51). Adjusted results show no difference in the rate of primary composite outcome (hazard rate or HR=1.44, p=0.09) and in secondary outcomes of macrovascular events (HR=1.61), all-cause mortality (HR=1.22), major CAD (HR=1.45), CHF (HR=1.24) and non-fatal stroke (HR=0.98) [all p>.05] Conclusion: The study results appear to confirm the non-significance of CT over MT in cardiovascular risk reduction among type 2 diabetes patients in a large US commercial health plan.

BackgroundThe objective of this randomized trial was to evaluate the short‐term effect of bilingual written and interpersonal education regarding mammographic breast density (MBD).MethodsLatinas aged 40 to 74 years who were presenting for screening mammography were recruited and randomized 1:1:1 to receive a letter with their mammogram and MBD results (usual care [UC]), a letter plus a brochure (enhanced care [ENH]), or a letter plus a brochure and telephonic promotora education (interpersonal care [INT]). Surveys were administered at enrollment (T0) and 2 weeks to 6 months after intervention delivery (T1). Differences were assessed with χ2, Kruskal‐Wallis, and McNemar tests and pairwise comparisons as appropriate. INT metrics and audio recordings were analyzed with descriptive statistics and qualitative content analysis.ResultsBetween October 2016 and October 2019, 943 of 1108 Latina participants (85%) completed both surveys. At T1, INT participants were more likely (P < .001) to report seeing their MBD results in the letter (70.2%) than UC (53.1%) or ENH participants (55.1%). The percentage of INT women who reported speaking with a provider about MBD (29.0%) was significantly greater (P < .001) than the percentage of UC (14.7%) or ENH participants (15.6%). All groups saw significant (P < .001) but nondifferential improvements in their knowledge of MBD as a masking and risk factor. In the INT group, the promotora delivered education to 77.1% of the 446 participants randomized to INT and answered questions at 28.3% of the encounters for an average of $4.70 per participant.ConclusionsAmong Latinas in a low‐resource setting, MBD knowledge may increase with written or interpersonal education, but with modest investment, interpersonal education may better improve MBD awareness and prompt patient‐provider discussions.

Abstract Background Yttrium-90 ibritumomab tiuxetan [(90)Y-IT; Zevalin] is a radio-immunoconjugate (RIC) which targets CD20. This study evaluates the utilization and cost-effectiveness of (90)Y-IT in the first line treatment for patients with previously untreated low-grade FL (UFL) and marginal zone lymphoma (UMZL) treated at our institution with (90)Y-IT. Methods We utilized the Advanced Text Explorer (ATE) and the Lymphoma SPORE databases to identify two groups of patients with UFL, WHO grade 1-2, and UMZL who received treatment with either (90)Y-IT or bendamustine plus rituximab (BR) at Mayo Clinic Cancer Center between January 2003 and December 2019. We excluded all patients who had &gt;25% bone marrow involvement with lymphoma for the BR group as this was a requirement for (90)Y-IT treatment. Inverse propensity weighting was utilized to balance the groups for baseline patients and disease characteristics. We use progression-free survival (PFS) as a denominator for the cost effectiveness/utilization evaluation. We identified meaningful and retrospectively measurable outcomes to compare between the groups. we extracted the following data; number of clinic visits in the first year after therapy, emergency room visits, number of hospital admissions, number of hospitalization days, numbers of days on the floor and ICU, number of infections, number of neutropenic fever hospitalizations, number of C-difficile events, number of blood products transfusions, overall use of growth factors due to therapy induced neutropenia, average number of times a growth factor was used, and the number of therapeutic use days. We defined days of therapeutic use as the number of days a treatment was administered on. We also calculated the average cost of the induction treatment when utilizing either (90)Y-IT or BR. The therapeutic cost included only the cost of the medications/therapies and their administration. Results Our cohort consists of a total of 143 patients - 64% (92/143) received BR and 36% (51/143) received (90)Y-IT (see Table-1 for clinical characteristics).The median follow-up from the time of therapeutic administration for the (90)Y-IT group was 5.3 years (95% CI; 4.2, 6.2) with one death and 4.7 years (95% CI; 3.9, 4.9) for the BR group with 6 deaths. The ORR was 100% in (90)Y-IT group with 94% achieving complete response (CR) while ORR in the BR group was 98% with 95% achieving CR. Rituximab maintenance was utilized in 33% of BR patients compared to only 6% in patients who received (90)Y-IT, p=0.002. After utilizing inverse propensity weighting (Figure-1), 5 years PFS was 76% for the (90)Y-IT group and 75% for the BR group, p=0.63 (Figure-2). We evaluated the average treatment effect of (90)Y-IT compared to BR on utilization outcomes, Table-2. (90)Y-IT required an average of 4.5 clinic visits less within the first year after treatment compared to BR group, p&lt;0.001. (90)Y-IT patients had an average of 10 days less of therapeutic use days compared to the BR group, p&lt;0.001. Patienta had similar admission rates to the hospital in both groups. However, when patients were admitted to the hospital in the first year after treatment, those who received (90)Y-IT spent an average of 1.5 days less in the hospital compared to the BR group, p=0.046. The overall use of growth factors was 40% less in the (90)Y-IT group as compared to the BR group, p&lt;0.001. The therapeutic cost of induction of (90)Y-IT was 54% less than that of 6 cycles of BR. Transformation to a high grade of lymphoma was seen in 4 patients in the BR group and 2 patients in the (90)Y-IT group. There was only one case of myelodysplastic syndrome in the BR group and none in the (90)Y-IT group. Conclusion Radio-immunoconjugate therapy with (90)Y-IT is a very convenient and cost-effective treatment for low-grade UFL and UMZL. This is especially important amidst the COVID-19 pandemic as it requires less contact with the health system with decreased number of therapeutic days, clinic visits, use of growth factors and number of hospitalization days. The cost of the therapeutic agents and their administration was also significantly lower for the (90)Y-IT which could help reducing the burden on the health system. Figure 1 Figure 1. Disclosures Cerhan: Regeneron Genetics Center: Other: Research Collaboration; Genentech: Research Funding; Celgene/BMS: Other: Connect Lymphoma Scientific Steering Committee, Research Funding; NanoString: Research Funding. Tun: Mundipharma, Celgene, BMS, Acrotech, TG therapeutics, Curis, DTRM: Research Funding; Gossamer Bio, Acrotech: Consultancy. OffLabel Disclosure: We are describing the use of Yttrium-90 ibritumomab tiuxetan in the first line setting in comparison to the bendamustine plus rituximab which is the standard of care

Objective: Despite the growing emphasis on healthcare costs, limited data address this aspect of care within the vestibular schwannoma (VS) literature. We sought to determine which strategy confers the lowest lifetime cost and greatest quality-adjusted life-years (QALYs) for patients with small- to medium-sized sporadic VS tumors. Study Design: A Markov model was created to determine the most cost-effective management algorithm. Tumor characteristics, magnetic resonance imaging surveillance schedule, treatment outcomes, and health-related quality of life values were derived from previously published data. Cost estimates were based on CMS Fee Schedule reimbursement rates. Setting: Economic Evaluation Service within the Kern Center for the Science of Healthcare Delivery. Patients: Patients diagnosed with small- to medium-sized sporadic VS. Interventions: Upfront microsurgery following diagnosis, upfront radiosurgery following diagnosis, observation with microsurgery reserved for observed tumor growth, and observation with radiosurgery reserved for observed tumor growth. Results: Across patient ages at time of diagnosis ranging from 18 to 70 years, observation with subsequent radiosurgery used for tumor growth was the most cost-effective management algorithm while upfront microsurgery was the least. When presented with a hypothetical 50-year-old patient, the strategy with the lowest lifetime cost and highest QALYs was observation with subsequent radiosurgery reserved for tumor growth ($32,161, 14.11 QALY), followed by observation with microsurgery reserved for tumor growth ($34,503, 13.94 QALY), upfront radiosurgery ($43,456, 14.02 QALY), and lastly, upfront microsurgery ($47,252, 13.60 QALY). Sensitivity analyses varying mortality rates, estimated costs, health-related quality of life, and progression to nonserviceable hearing demonstrated consistent ranking among treatments. Conclusions: When considering initial management of small- and medium-sized sporadic VSs, neither lifetime cost nor QALYs support upfront microsurgery or radiosurgery, even for younger patients. Initial observation with serial imaging, reserving radiosurgery or microsurgery for patients exhibiting tumor growth, confers the greatest potential for optimized lifetime healthcare cost and QALY outcomes.

INTRODUCTION: Minimally invasive tests for Barrett's esophagus (BE) detection have raised the prospect of broader nonreflux-based testing. Cost-effectiveness studies have largely studied men aged 50 years with chronic gastroesophageal reflux disease (GERD) symptoms. We evaluated the comparative cost effectiveness of BE screening tests in GERD-based and GERD-independent testing scenarios. METHODS: Markov modeling was performed in 3 scenarios in 50 years old individuals: (i) White men with chronic GERD (GERD-based); (ii) GERD-independent (all races, men and women), BE prevalence 1.6%; and (iii) GERD-independent, BE prevalence 5%. The simulation compared multiple screening strategies with no screening: sedated endoscopy (sEGD), transnasal endoscopy, swallowable esophageal cell collection devices with biomarkers, and exhaled volatile organic compounds. A hypothetical cohort of 500,000 individuals followed for 40 years using a willingness to pay threshold of $100,000 per quality-adjusted life year (QALY) was simulated. Incremental cost-effectiveness ratios (ICERs) comparing each strategy with no screening and comparing screening strategies with each other were calculated. RESULTS: In both GERD-independent scenarios, most non-sEGD BE screening tests were cost effective. Swallowable esophageal cell collection devices with biomarkers were cost effective (<$35,000/QALY) and were the optimal screening tests in all scenarios. Exhaled volatile organic compounds had the highest ICERs in all scenarios. ICERs were low (<$25,000/QALY) for all tests in the GERD-based scenario, and all non-sEGD tests dominated no screening. ICERs were sensitive to BE prevalence and test costs. DISCUSSION: Minimally invasive nonendoscopic tests may make GERD-independent BE screening cost effective. Participation rates for these strategies need to be studied.

PURPOSE: The goal of this study was to assess the impact of an interdisciplinary remote patient monitoring (RPM) program on clinical outcomes and acute care utilization in cancer patients with COVID-19. METHODS: This is a cross-sectional analysis following a prospective observational study performed at Mayo Clinic Cancer Center. Adult patients receiving cancer-directed therapy or in recent remission on active surveillance with polymerase chain reaction–confirmed SARS-CoV-2 infection between March 18 and July 31, 2020, were included. RPM was composed of in-home technology to assess symptoms and physiologic data with centralized nursing and physician oversight. RESULTS: During the study timeframe, 224 patients with cancer were diagnosed with COVID-19. Of the 187 patients (83%) initially managed in the outpatient setting, those who did not receive RPM were significantly more likely to experience hospitalization than those receiving RPM. Following balancing of patient characteristics by inverse propensity score weighting, rates of hospitalization for RPM and non-RPM patients were 2.8% and 13%, respectively, implying that the use of RPM was associated with a 78% relative risk reduction in hospital admission rate (95% CI, 54 to 102; P = .002). Furthermore, when hospitalized, these patients experienced a shorter length of stay and fewer prolonged hospitalizations, intensive care unit admissions, and deaths, although these trends did not reach statistical significance. CONCLUSION: The use of RPM and a centralized virtual care team was associated with a reduction in hospital admission rate and lower overall acute care resource utilization among cancer patients with COVID-19.

e18862 Background: Hematopoietic cell transplantation (HCT) is a medically complicated, expensive and resource intensive medical technology. High health care costs are usually associated with high Out-of-Pocket (OOP) costs. In this population-based study, using deidentified administrative claims data from OptumLabs Data Warehouse, we describe total and patient level costs for one-year pre and post HCT and describe the characteristics of those with top 25% cost. Methods: Patients who had undergone an autologous or allogeneic HCT in 2015 to 2019 and had continuous health plan coverage for one year prior and post the index date-the date of the first claim for HCT, were included. We examined total costs, patient paid (OOP) and plan paid costs for one year before and after HCT. We also examined inpatient, outpatient, and pharmacy costs for the one year before and after the HCT. Logistic regression models examined factors including age, gender, race/ ethnicity, Charlson comorbidity index, geographic region and costs in the year prior to HCT (baseline costs) for their association with high total costs and high OOP costs (top 25%). Results: A total of 3,346 patients (2,344 commercial plan (CPE) and 1,002 under Medicare Advantage plan (MAPE) enrollees) were included in the study. Median one year post HCT costs for CPE was $ 612,517 (IQR 413,348- 960,456) and for MAPE was $ 521,000 (IQR 347,388-736,685). Median one year post HCT OOP costs were $ 5,407 (IQR 1,584 -10,000) in CPE and $7,199 (IQR 3,485 -16,396) in MAPE group. 625 subjects in the CPE and 253 subjects in MAPE group had overall costs in the top 25%. Median baseline costs were $482,107 vs. $846,943 in the low vs. high cost group in CPE and $278,656 vs. $343,633 in MAPE. There was a low correlation between OOP costs and overall costs (r = 0.17 for CPE and 0.15 for MAPE; p < 0.05). Younger age (OR for age 0.98; p < 0.001) and higher baseline costs (OR1.89; p < 0.001) predicted top 25% total costs post HCT in the CPE group. Not being African American (OR for African American 0.5; p = 0.02) and higher baseline costs (OR 1.07; p < 0.001) predicted top 25% total costs post HCT in MAPE group. Age (OR 0.97; p < 0.001), not being African American (OR 0.5; p = 0.001) and high baseline costs (OR 1.44; p < 0.001) also predicted higher OOP costs in the CPE group. The only factor that was associated with lower likelihood of OOP costs in top 25% in MAPE group was being Hispanic (OR 0.6; p = 0.004). Conclusions: HCT is an expensive treatment modality. High costs prior to HCT are associated with high post HCT costs both for patients on commercial and Medicare Advantage plan. The magnitude of correlation between patient level and total costs was low, likely due to differences in benefit plan. A careful assessment of benefits and costs of HCT is needed for providing high-value care and allow optimum allocation of the finite resources while minimizing patient level financial burden.

1503 Background: Patients with cancer and COVID-19 are at risk for poor clinical outcomes. An established multi-site remote patient monitoring (RPM) service was rapidly adapted to support a novel, interdisciplinary COVID-19 program for outpatient management of patients at high-risk for severe illness. The goal of this study was to assess the impact of the RPM program on clinical outcomes and acute care utilization in cancer patients diagnosed with COVID-19. Methods: This is a cross-sectional analysis following a multi-site prospective observational study performed at Mayo Clinic Cancer Center (MCCC). All adult patients with active cancer – defined as currently receiving cancer-directed therapy or in recent remission on active surveillance – and PCR-confirmed SARS-CoV-2 infection between March 18 and July 31, 2020 were included. RPM was comprised of in-home technology to assess symptoms and physiologic data with centralized nurse and physician oversight. Results: During the study timeframe 224 cancer patients were diagnosed with COVID-19 at MCCC. Initial management included urgent hospitalization (within 48 hours of diagnosis) in 34 patients (15%). Of the remaining 190 patients (85%) initially managed in the outpatient setting, those who did not receive RPM were significantly more likely to experience hospitalization than those receiving RPM (OR 3.6, 95% CI 1.036 to 12.01, P = 0.044). Following balancing of patient characteristics by inverse propensity weighting, rates of hospital admission for RPM and non-RPM patients were 3.1% and 11% respectively, implying that RPM was associated with an 8% reduction in hospital admission rate (-0.077; 95% CI: -0.315 to -0.019, P = 0.009). Use of RPM was also associated with lower rates of prolonged hospitalization, ICU admission, and mortality, though these trends did not reach statistical significance. Conclusions: In the midst of a global pandemic associated with inpatient bed, ventilator, and PPE shortages, the RPM program provided an effective strategy for outpatient clinical management and was associated with decreased rates of hospitalization, ICU admission, and mortality in cancer patients with COVID-19. This care model enabled simultaneous opportunity to mitigate the increased risks of exposure, transmission, and resource utilization associated with conventional care.