Cost sharing for oral lenvatinib among commercially insured patients.

OBJECTIVE: To use a nationwide pharmaceutical claims database to evaluate cost-sharing trends for commercially insured patients with cancer who were prescribed lenvatinib (Lenvima). STUDY DESIGN: IBM MarketScan databases were used to evaluate lenvatinib costs for patients with employer-based commercial insurance, and for patients 65 years and older, Medicare claims for fee-for-service plans. METHODS: Patients were included if they had least 1 outpatient pharmaceutical claim for lenvatinib paid on a noncapitated basis from 2015 to 2019. Median and IQR costs were estimated and inflation adjusted to 2019 US$ for 30-day supplies and reported as total, insurance liability, coordination of benefits, and out-of-pocket costs. RESULTS: A total of 685 patients had at least 1 pharmaceutical claim for lenvatinib, which included patients with thyroid (n = 251; 36.6%), renal cell (n = 202; 29.5%), hepatocellular (n = 160; 23.4%), and endometrial (n = 48; 7.0%) cancer. The median (IQR) number of prescriptions per patient was 3 (2-7), and the median (IQR) total days of supply was 90 (45-210) days. The median (IQR) 30-day cost of lenvatinib was $17,253 ($15,597-$18,120). Median (IQR) 30-day insurance liability was $16,847 ($15,000-$17,981). Median (IQR) 30-day coordination of benefits was $0 ($0-$0). Median (IQR) 30-day patient out-of-pocket cost was $32 ($0-$100). However, the maximum 30-day out-of-pocket cost in our patient cohort was $12,538. CONCLUSIONS: In this cohort, insurance was liable for the majority of total lenvatinib drug costs, and 75% of patients paid $100 or less per month out of pocket. This information can be used by care teams to counsel insured patients. Health systems and drug manufacturers must identify patients with high out-of-pocket costs and provide convenient access to financial assistance programs so that patients are not forced to forgo the benefits of these drugs due to financial barriers. Value-based payment models and drug pricing reform are also needed to address underlying drivers of high drug costs.

Cost-effectiveness of lenvatinib plus pembrolizumab versus chemotherapy for recurrent mismatch repair-proficient endometrial cancer after platinum-based therapy.

OBJECTIVE: The recent Study 309-KEYNOTE-775 showed improved survival for lenvatinib plus pembrolizumab compared to chemotherapy in patients with recurrent endometrial cancer. We created a decision model to compare the cost-effectiveness of lenvatinib plus pembrolizumab in patients with recurrent mismatch repair-proficient (pMMR) endometrial cancer who had progressed after first-line chemotherapy. METHODS: A Markov model was created to simulate the clinical trajectory of 10,000 patients with recurrent pMMR endometrial cancer. The initial decision point in the model was treatment with ether lenvatinib plus pembrolizumab or chemotherapy (doxorubicin or dose-dense paclitaxel). Model probabilities, utility values and costs were derived with assumptions drawn from published literature. A cycle length of 3 months and a time horizon of 2 years was used. The effectiveness was calculated in terms of average quality adjusted life years (QALYs) gained. The primary outcome was incremental cost-effectiveness ratios (ICERs), expressed in 2020 US dollars/QALYs. One-way, two-way and probabilistic sensitivity analyses were performed. RESULTS: Chemotherapy was the least costly strategy at $66,693 followed by lenvatinib plus pembrolizumab ($193,590). Lenvatinib plus pembrolizumab resulted in more patients being alive at 2 years (lenvatinib plus pembrolizumab: 367, chemotherapy: 109). Chemotherapy was cost-effective compared with lenvatinib plus pembrolizumab (ICER: $164,493/QALYs). Lenvatinib plus pembrolizumab became cost-effective when its cost was reduced by $1553 per month (7.8% reduction). CONCLUSION: For patients with recurrent pMMR endometrial cancer Lenvatinib plus pembrolizumab is associated with greater survival but is more costly than chemotherapy. The cost of lenvatinib and pembrolizumab would have to be reduced by approximately 7% to be considered cost-effective.

Factors influencing willingness to participate in ophthalmic clinical trials and strategies for effective recruitment.

AIM: To explore the factors influencing individuals' willingness to participate in ophthalmic clinical trials. METHODS: A questionnaire survey was conducted from January to April 2021 among patients and their family members at Zhongshan Ophthalmic Center, Sun Yat-sen University, in Guangzhou, China. The survey gathered data on respondents' willingness, demographic and socioeconomic profiles, as well as their reasons and concerns regarding engagement in clinical trials. RESULTS: Of the 1078 residents surveyed (mean age 31.2±13.1y; 65.8% females) in Guangzhou, 749 (69.5%) expressed a willingness to participate in future ophthalmic clinical trials. Specific characteristics associated with greater willingness included a younger age, lower annual income, higher education, prior participation experience, previous ophthalmic treatment, and a better understanding of clinical trials. With the exception of age, these characteristics were significantly linked to a higher willingness. The primary barrier to participation, expressed by 64.8% of those willing and 54.4% of those unwilling, was "Uncertain efficacy". In terms of motivations, the willing group ranked "Better therapeutic benefits" (35.0%), "Professional monitoring" (34.3%), and "Trust in healthcare professionals" (33.1%) as their top three reasons, whereas the unwilling participants indicated "Full comprehension of the protocol" (46.2%) as the key facilitator. CONCLUSION: This study reveals a substantial willingness to participate in ophthalmic clinical trials and demonstrates the predictive role of demographic and socioeconomic factors. Variations in motivators and concerns between willing and unwilling participants highlight the significance of tailored recruitment strategies. Importantly, the need for and trust in healthcare professionals stand out as powerful motivations, underscoring the importance of enhancing physician-patient relationships, adopting patient-centered communication approaches, and addressing individualized needs to improve accrual rates.

Recommendations and guidelines for endoscope reprocessing: Current position statement of digestive endoscopic society of Taiwan.

Reprocessing of gastrointestinal (GI) endoscopes and accessories is an essential part of patient safety and quality control in GI endoscopy centers. However, current endoscopic reprocessing guidelines or procedures are not adequate to ensure patient-safe endoscopy. Approximately 5.4 % of the clinically used duodenoscopes remain contaminated with high-concern microorganisms. Thus, the Digestive Endoscopy Society of Taiwan (DEST) sets standards for the reprocessing of GI endoscopes and accessories in endoscopy centers. DEST organized a task force working group using the guideline-revision process. These guidelines contain principles and instructions of step-by-step for endoscope reprocessing. The updated guidelines were established after a thorough review of the existing global and local guidelines, systematic reviews, and health technology assessments of clinical effectiveness. This guideline aims to provide detailed recommendations for endoscope reprocessing to ensure adequate quality control in endoscopy centers.

Correlations between China's socioeconomic status, disease burdens, and pharmaceuticals and personal care product levels in wastewater.

The presence of pharmaceutical and personal care products (PPCPs) in domestic wastewater can potentially indicate socioeconomic status and disease burdens. However, current knowledge is limited to the correlation between specific pharmaceuticals and diseases. This study aims to explore the associations between socioeconomic status, disease burdens, and PPCP levels in domestic wastewater at a national level. Samples from 171 wastewater influents across China were used to measure PPCPs, and the per capita consumption of PPCPs was calculated. Results showed that the 31 targeted PPCPs were widely present in wastewater with varying occurrence characteristics. The mean consumption levels of different PPCPs varied greatly, ranging from 0.03 to 110723.15 µg/d/capita. While there were no significant regional differences in the overall pattern of PPCP consumption, 22 PPCPs showed regional variations between Northern China and Southern China. PPCPs with similar usage purposes exhibited similar distribution patterns. Disease burden (70.1%) was the main factor affecting most PPCP consumption compared to socioeconomic factors (26.4%). Through correlation analyses, specific types of PPCPs were identified that were highly associated with socioeconomic status and disease burdens, such as hypertension-bezafibrate, brucellosis-quinolones, sulfonamides, hepatitis-triclosan, triclocarban, socioeconomic development-fluoxetine, and people's living standards-gemfibrozil. Despite some uncertainties, this study provides valuable insights into the relationship between PPCPs in domestic wastewater and socioeconomic status and human health.

Mapping the global, regional, and national burden of diarrheal diseases attributable to unsafe water.

Background: Diarrheal diseases are major contributors to deaths. Data on global and country-specific levels and trends of diarrheal diseases resulting from unsafe water are essential for policymakers to allocate resources. Aims: This study aimed to describe the global, regional, and national spatiotemporal burden of diarrheal diseases resulting from unsafe water exposure. Methods: According to the Global Burden of Disease (GBD) 2019 dataset, deaths, disability-adjusted life years (DALYs) of diarrheal diseases, and their age-standardized rates (ASRs) were analyzed by age and sex in 204 countries and territories. Moreover, the average annual percentage change (AAPC) was estimated by a log-linear regression model to reflect the time trend. The association between ASR of diarrheal diseases due to unsafe water and socio-demographic index (SDI) levels was also analyzed. Results: From 1990 to 2019, the number of deaths and DALYs of diarrheal diseases resulting from unsafe water decreased by 50 and 59%, respectively. Moreover, the ASR of deaths and DALYs also decreased during the study period, with AAPCs of -3.69 (95% CI [95% confidence interval]: -3.91 to -3.47) and - 3.66 (95% CI: -3.8 to -3.52), respectively. High diarrheal diseases resulting from unsafe water occurred mainly in low SDI regions and Africa. Males exhibited greater diarrheal deaths attributable to unsafe water than females, which was contrary to the condition in terms of DALYs. The age-specific burden of diarrheal deaths attributable to unsafe water is concentrated in children younger than 5 years. The AAPCs of the ASR of both deaths and DALYs showed a strong negative correlation with the SDI levels. Conclusion: The current study indicated that the global burden of unsafe water exposure-related diarrheal diseases decreased from 1990 to 2019 and varied significantly according to age, sex, and geographical location. Effective health promotion and health communication strategies and policies should be adopted to prevent and control diarrheal diseases resulting from unsafe water exposure.

Strategies to Guide Preemptive Waitlisting and Equity in Waittime Accrual by Race/Ethnicity.

BACKGROUND: Use of eGFR to determine preemptive waitlisting eligibility may contribute to racial/ethnic disparities in access to waitlisting, which can only occur when the eGFR falls to ≤20 ml/min per 1.73 m 2 . Use of an alternative risk-based strategy for waitlisting may reduce these inequities ( e.g. , a kidney failure risk equation [KFRE] estimated 2-year risk of kidney failure) rather than the standard eGFR threshold for determining waitlist eligibility. Our objective was to model the amount of preemptive waittime that could be accrued by race and ethnicity, applying two different strategies to determine waitlist eligibility. METHODS: Using electronic health record data, linear mixed models were used to compare racial/ethnic differences in preemptive waittime that could be accrued using two strategies: estimating the time between an eGFR ≤20 and 5 ml/min per 1.73 m 2 versus time between a 25% 2-year predicted risk of kidney failure (using the KFRE, which incorporates age, sex, albuminuria, and eGFR to provide kidney failure risk estimation) and eGFR of 5 ml/min per 1.73 m 2 . RESULTS: Among 1290 adults with CKD stages 4-5, using the Chronic Kidney Disease Epidemiology Collaboration equation yielded shorter preemptive waittime between an eGFR of 20 and 5 ml/min per 1.73 m 2 in Black (-6.8 months; 95% confidence interval [CI], -11.7 to -1.9), Hispanic (-10.2 months; -15.3 to -5.1), and Asian/Pacific Islander (-10.3 months; 95% CI, -15.3 to -5.4) patients compared with non-Hispanic White patients. Use of a KFRE threshold to determine waittime yielded smaller differences by race and ethnicity than observed when using a single eGFR threshold, with shorter time still noted for Black (-2.5 months; 95% CI, -7.8 to 2.7), Hispanic (-4.8 months; 95% CI, -10.3 to 0.6), and Asian/Pacific Islander (-5.4 months; -10.7 to -0.1) individuals compared with non-Hispanic White individuals, but findings only met statistical significance criteria in Asian/Pacific Islander individuals. When we compared potential waittime availability using a KFRE versus eGFR threshold, use of the KFRE yielded more equity in waittime for Black ( P = 0.02), Hispanic ( P = 0.002), and Asian/Pacific Islander ( P = 0.002) patients. CONCLUSIONS: Use of a risk-based strategy was associated with greater racial equity in waittime accrual compared with use of a standard single eGFR threshold to determine eligibility for preemptive waitlisting.

Timeliness of diagnostic evaluation for postmenopausal bleeding: A retrospective cohort study using claims data.

BACKGROUND: Postmenopausal bleeding (PMB) is a common gynecologic condition. Although it can be a sign of uterine cancer, most patients have benign etiology. However, research on quality of diagnostic evaluation for PMB has been limited to cancer patients. To extend this research, we examined the timeliness of diagnostic evaluation for PMB among patients with benign conditions. METHODS: Using the 2008-2019 MarketScan Research Databases, we identified 499176 patients (456741 with commercial insurance and 42435 with Medicaid insurance) who presented with PMB but did not have gynecologic cancer. For each patient, we measured the time from their PMB reporting to the date of their first diagnostic procedure. The association between patient characteristics and time to first diagnostic procedure was examined using Cox proportional hazards models (for the overall sample and then stratified by insurance type). RESULTS: Overall, 54.3% of patients received a diagnostic procedure on the same day when they reported PMB and 86.6% received a diagnostic procedure within 12 months after reporting PMB. These percentages were 39.4% and 77.1%, respectively, for Medicaid patients, compared to 55.7% and 87.4%, respectively, for commercially insured patients (p<0.001 for both). Medicaid patients had an 18% lower rate of receiving a diagnostic procedure at any given time point than commercially insured patients (adjusted hazard ratio = 0.82, 95% CI: 0.81-0.83). Meanwhile, older age and non-gynecologic comorbidities were associated with a lower rate whereas concomitant gynecologic conditions and recent use of preventive care were associated with a higher rate of receiving diagnostic procedures. Analysis stratified by insurance type identified additional risk factors for delayed diagnostic procedures (e.g., non-metropolitan versus metropolitan location for commercially insured patients and Black versus White race for Medicaid patients). CONCLUSION: A sizable proportion of patients did not receive prompt diagnostic evaluation for PMB. Both clinical and non-clinical factors could affect timeliness of evaluation.

A critical review on quantitative evaluation of aqueous toxicity in water quality assessment.

Conventional chemical techniques have inherent limitations in detecting unknown chemical substances in water. As a result, effect-based methods have emerged as a viable alternative to overcome these limitations. These methods provide more accurate and intuitive evaluations of the toxic effects of water. While numerous studies have been conducted, only a few have been applied to national water quality monitoring. Therefore, it is crucial to develop toxicity evaluation methods and establish thresholds based on quantifying toxicity. This article provides an overview of the development and application of bioanalytical tools, including in vitro and in vivo bioassays. The available methods for quantifying toxicity are then summarized. These methods include aquatic life criteria for assessing the toxicity of a single compound, comprehensive wastewater toxicity testing for all contaminants in a water sample (toxicity units, whole effluent toxicity, the potential ecotoxic effects probe, the potential toxicology method, and the lowest ineffective dilution), methods based on mechanisms and relative toxicity ratios for substances with the same mode of action (the toxicity equivalency factors, toxic equivalents, bioanalytical equivalents), and effect-based trigger values for micropollutants. The article also highlights the advantages and disadvantages of each method. Finally, it proposes potential areas for applying toxicity quantification methods and offers insights into future research directions. This review emphasizes the significance of enhancing the evaluation methods for assessing aqueous toxicity in water quality assessment.

Survival analysis and probability density function of switching heroin model.

We study a switching heroin epidemic model in this paper, in which the switching of supply of heroin occurs due to the flowering period and fruiting period of opium poppy plants. Precisely, we give three equations to represent the dynamics of the susceptible, the dynamics of the untreated drug addicts and the dynamics of the drug addicts under treatment, respectively, within a local population, and the coefficients of each equation are functions of Markov chains taking values in a finite state space. The first concern is to prove the existence and uniqueness of a global positive solution to the switching model. Then, the survival dynamics including the extinction and persistence of the untreated drug addicts under some moderate conditions are derived. The corresponding numerical simulations reveal that the densities of sample paths depend on regime switching, and larger intensities of the white noises yield earlier times for extinction of the untreated drug addicts. Especially, when the switching model degenerates to the constant model, we show the existence of the positive equilibrium point under moderate conditions, and we give the expression of the probability density function around the positive equilibrium point.

Motor Assessment With the STEGA iPad App to Measure Handwriting in Children.

IMPORTANCE: Handwriting and the fine motor control (hand and fingers) underlying it are key indicators of numerous motor disorders, especially among children. However, current assessment methods are expensive, slow, and subjective, leading to a lack of knowledge about the relationship between handwriting and motor control. OBJECTIVE: To develop and validate the iPad precision drawing app Standardized Tracing Evaluation and Grapheme Assessment (STEGA) to enable rapid quantitative assessment of fine motor control and handwriting. DESIGN: Cross-sectional, single-arm observational study. SETTING: Academic research institution. PARTICIPANTS: Fifty-seven typically developing right-handed children ages 9 to 12 yr with knowledge of cursive. OUTCOMES AND MEASURES: Predicted quality, measured as the correlation between handwriting letter legibility (Evaluation Tool of Children's Handwriting-Cursive [ETCH-C]) and predicted legibility (calculated from STEGA's 120 Hz, nine-variable data). RESULTS: STEGA successfully predicted handwriting (r2 = .437, p < .001) using a support vector regression method. Angular error was the most important aspect of STEGA performance. STEGA was much faster to administer than the ETCH-C (M = 6.7 min, SD = 1.3, versus M = 19.7 min, SD = 5.2). CONCLUSIONS AND RELEVANCE: Assessment of motor control (and especially pen direction control) may provide a meaningful, objective way to assess handwriting. Future studies are needed to validate STEGA with a wider age range, but the initial results indicate that STEGA can provide the first rapid, quantitative, high-resolution, telehealth-capable assessment of the motor control that underpins handwriting. What This Article Adds: The ability to control pen direction may be the most important motor skill for successful handwriting. STEGA may provide the first criterion standard for the fine motor control skills that underpin handwriting, suitable for rehabilitation research and practice.

Usefulness of the Visual Cognitive Assessment Test in Detecting Mild Cognitive Impairment in the Community.

BACKGROUND: A delay in the detection of mild cognitive impairment (MCI) in the community delays the opportunity for early intervention. Accurate tools to detect MCI in the community are lacking. The Visual Cognitive Assessment Test (VCAT) is a visual based cognitive test useful for multilingual populations without the need for translation. OBJECTIVE: Here, we evaluate the usefulness of VCAT in detecting MCI in a community population in Singapore. METHODS: We recruited 301 participants from the community who completed a detailed neuropsychological assessment and 170 of them completed a 3T magnetic resonance imaging (MRI) brain scan. We performed a receiver operating characteristics analysis to test the diagnostic performance of VCAT compared to Montreal Cognitive Assessment (MoCA) in distinguishing MCI from cognitively normal (CN) by measuring area under the curve (AUC). To test for the association of VCAT with structural MRI, we performed a Pearson's correlation analysis for VCAT and MRI variables. RESULTS: We recruited 39 CN and 262 MCI participants from Dementia Research Centre (Singapore). Mean age of the cohort was 63.64, SD = 9.38, mean education years was 13.59, SD = 3.70 and majority were women (55.8%). VCAT was effective in detecting MCI from CN with an AUC of 0.794 (95% CI 0.723-0.865) which was slightly higher than MoCA 0.699 (95% CI 0.621-0.777). Among subjects with MCI, VCAT was associated with medial temporal lobe atrophy (ρ = -0.265, p = 0.001). CONCLUSIONS: The VCAT is useful in detecting MCI in the community in Singapore and may be an effective measure of neurodegeneration.

Racial disparities in diagnostic evaluation of uterine cancer among Medicaid beneficiaries.

BACKGROUND: To inform reasons contributing to Black-White disparity in early diagnosis of uterine cancer, we compared the quality of diagnostic evaluation received by Black vs White patients with abnormal uterine bleeding (AUB) ultimately diagnosed with uterine cancer. METHODS: Using 2008-2019 MarketScan Multi-State Medicaid Database, we identified Black (n = 858) and White (n = 1749) patients with uterine cancer presenting with AUB. Quality of diagnostic evaluation was measured by delayed diagnosis (>1 year after AUB reporting), not receiving guideline-recommended diagnostic procedures, delayed time to first diagnostic procedure (>2 months after AUB reporting), number of diagnostic procedures received, and number of evaluation and management visits for AUB. The association between race and quality indicators was examined by multivariable regressions adjusting for patient characteristics. RESULTS: Black patients were more likely than White patients to experience delayed diagnosis (11.3% vs 8.3%, P = .01; adjusted odds ratio [OR] = 1.71, 95% confidence interval [CI] = 1.27 to 2.29) or to not receive guideline-recommended diagnostic procedures (10.1% vs 5.0%, P < .001; adjusted OR = 1.94, 95% CI = 1.40 to 2.68). Even when they did receive recommended diagnostic procedures, Black patients were more likely than White patients to experience delay in time to the first diagnostic procedure (adjusted OR = 1.46, 95% CI = 1.09 to 1.97). In addition, Black patients underwent more evaluation and management visits for AUB before getting diagnosed compared with White patients (adjusted mean ratio = 1.13, 95% CI = 1.04 to 1.23). CONCLUSIONS: Black and White patients with uterine cancer differed in the quality of diagnostic evaluation received. Improving equity in this area may help reduce Black-White disparity in stage at diagnosis.

Deep learning-based automatic left atrial appendage filling defects assessment on cardiac computed tomography for clinical and subclinical atrial fibrillation patients.

Rationale and objectives: Selecting region of interest (ROI) for left atrial appendage (LAA) filling defects assessment can be time consuming and prone to subjectivity. This study aimed to develop and validate a novel artificial intelligence (AI), deep learning (DL) based framework for automatic filling defects assessment on CT images for clinical and subclinical atrial fibrillation (AF) patients. Materials and methods: A total of 443,053 CT images were used for DL model development and testing. Images were analyzed by the AI framework and expert cardiologists/radiologists. The LAA segmentation performance was evaluated using Dice coefficient. The agreement between manual and automatic LAA ROI selections was evaluated using intraclass correlation coefficient (ICC) analysis. Receiver operating characteristic (ROC) curve analysis was used to assess filling defects based on the computed LAA to ascending aorta Hounsfield unit (HU) ratios. Results: A total of 210 patients (Group 1: subclinical AF, n = 105; Group 2: clinical AF with stroke, n = 35; Group 3: AF for catheter ablation, n = 70) were enrolled. The LAA volume segmentation achieved 0.931-0.945 Dice scores. The LAA ROI selection demonstrated excellent agreement (ICC ≥0.895, p < 0.001) with manual selection on the test sets. The automatic framework achieved an excellent AUC score of 0.979 in filling defects assessment. The ROC-derived optimal HU ratio threshold for filling defects detection was 0.561. Conclusion: The novel AI-based framework could accurately segment the LAA region and select ROIs while effectively avoiding trabeculae for filling defects assessment, achieving close-to-expert performance. This technique may help preemptively detect the potential thromboembolic risk for AF patients.

Small vessel disease burden predicts functional outcomes in patients with acute ischemic stroke using machine learning.

AIMS: Our purpose is to assess the role of cerebral small vessel disease (SVD) in prediction models in patients with different subtypes of acute ischemic stroke (AIS). METHODS: We enrolled 398 small-vessel occlusion (SVO) and 175 large artery atherosclerosis (LAA) AIS patients. Functional outcomes were assessed using the modified Rankin Scale (mRS) at 90 days. MRI was performed to assess white matter hyperintensity (WMH), perivascular space (PVS), lacune, and cerebral microbleed (CMB). Logistic regression (LR) and machine learning (ML) were used to develop predictive models to assess the influences of SVD on the prognosis. RESULTS: In the feature evaluation of SVO-AIS for different outcomes, the modified total SVD score (Gain: 0.38, 0.28) has the maximum weight, and periventricular WMH (Gain: 0.07, 0.09) was more important than deep WMH (Gain: 0.01, 0.01) in prognosis. In SVO-AIS, SVD performed better than regular clinical data, which is the opposite of LAA-AIS. Among all models, eXtreme gradient boosting (XGBoost) method with optimal index (OI) has the best performance to predict excellent outcome in SVO-AIS. [0.91 (0.84-0.97)]. CONCLUSIONS: Our results revealed that different SVD markers had distinct prognostic weights in AIS patients, and SVD burden alone may accurately predict the SVO-AIS patients' prognosis.

Opportunistic Salpingectomy at the Time of Laparoscopic Cholecystectomy for Ovarian Cancer Prevention: A Cost-effectiveness Analysis.

OBJECTIVE: To perform a cost-effectiveness analysis to examine the utility and effectiveness of OS performed at the time of elective cholecystectomy [laparoscopic cholecystectomy (LAP-CHOL)]. SUMMARY BACKGROUND DATA: OS has been adopted as a strategy to reduce the risk of ovarian cancer in women undergoing hysterectomy and tubal sterilization, although the procedure is rarely performed as a risk reducing strategy during other abdominopelvic procedures. METHODS: A decision model was created to examine women 40, 50, and 60 years of age undergoing LAP-CHOL with or without OS. The lifetime risk of ovarian cancer was assumed to be 1.17%, 1.09%, and 0.92% for women age 40, 50, and 60 years, respectively. OS was estimated to provide a 65% reduction in the risk of ovarian cancer and to require 30 additional minutes of operative time. We estimated the cost, quality-adjusted life-years, ovarian cancer cases and deaths prevented with OS. RESULTS: The additional cost of OS at LAP-CHOL ranged from $1898 to 1978. In a cohort of 5000 women, OS reduced the number of ovarian cancer cases by 39, 36, and 30 cases and deaths by 12, 14, and 16 in the age 40-, 50-, and 60-year-old cohorts, respectively. OS during LAP-CHOL was cost-effective, with incremental cost-effectiveness ratio of $11,162 to 26,463 in the 3 age models. In a probabilistic sensitivity analysis, incremental cost-effectiveness ratio for OS were less than $100,000 per quality-adjusted life-years in 90.5% or more of 1000 simulations. CONCLUSIONS: OS at the time of LAP-CHOL may be a cost-effective strategy to prevent ovarian cancer among average risk women.

Dostarlimab for recurrent mismatch repair-deficient endometrial cancer: A cost-effectiveness study.

OBJECTIVE: Patients with recurrent endometrial cancer treated with carboplatin and paclitaxel whose disease progresses have few effective treatment options. Based on promising clinical trial data, the anti-programmed cell death 1 (anti-PD-1) antibody dostarlimab was recently granted accelerated approval for endometrial cancer by the US Food and Drug Administration. We developed a decision model to examine the cost-effectiveness of dostarlimab for patients with progressive/recurrent deficient mismatch repair (dMMR) endometrial cancer whose disease has progressed with first-line chemotherapy. DESIGN: Cost-effectiveness study. POPULATION: Hypothetical cohort of 6000 women with progressive/recurrent dMMR endometrial cancer. METHODS: The initial decision point in the Markov model was treatment with dostarlimab, pembrolizumab or pegylated liposomal doxorubicin (PLD). Model probabilities, and cost and utility values were derived with assumptions drawn from published literature. Effectiveness was estimated as average quality-adjusted life years (QALYs) gained. One-way, two-way and probabilistic sensitivity analyses were performed to vary the assumptions across a range of plausible values. MAIN OUTCOME MEASURES: The primary outcome was the incremental cost-effectiveness ratio (ICER). RESULTS: Pegylated liposomal doxorubicin (PLD) was the least costly strategy, at $55,732, followed by dostarlimab ($151,533) and pembrolizumab ($154,597). Based on a willingness-to-pay threshold of $100,000/QALY, PLD was cost-effective compared with dostarlimab, with an ICER of $331,913 per QALY gained for dostarlimab, whereas pembrolizumab was ruled out by extended dominance (less effective, more costly), compared with dostarlimab. In one-way sensitivity analyses, dostarlimab was cost-effective when its cost was reduced to $4905 (52% reduction). These results were robust in a variety of sensitivity analyses. CONCLUSIONS: Dostarlimab is associated with greater survival compared with other treatments for women with recurrent dMMR endometrial cancer. Although the agent is substantially more costly, dostarlimab became cost-effective when its cost was reduced to $5489 per cycle.

Economic evaluation of margetuximab vs. trastuzumab for pretreated ERBB2-positive advanced breast cancer in the US and China.

Objective: To assess the economic evaluation of margetuximab plus chemotherapy over trastuzumab plus chemotherapy for women with pretreated ERBB2-positive advanced breast cancer in the United States (US) and China. Methods: Based on the SOPHIA trial, a three-state Markov model was developed to compare the cost and efficacy of margetuximab to trastuzumab for previously treated women with ERBB2-positive advanced breast cancer. The model inputs were derived from existing literature and the US life table. Primary outcomes included lifetime costs in US dollars, quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratio (ICER). Deterministic and probabilistic sensitivity analyses were conducted to evaluate the impact of uncertainty. Results: The base case analyses demonstrated that margetuximab plus chemotherapy had an increasing cost of $68,132 and $20,540 over trastuzumab plus chemotherapy in the US and China, respectively, with a gain of 0.11 and 0.09 QALYs both favored margetuximab. The ICERs for two treatment strategies were $260,176 in the US and $630,777 in China, resulting in a poor cost-effectiveness at their respective threshold of willingness to play. One-way sensitivity analyses showed that the results to be most sensitive to the price of margetuximab and that of trastuzumab. And an 11 and 82% price reduction of margetuximab would make this regimen cost-effective in the US and China, respectively. Conclusion: In the US and China, margetuximab plus chemotherapy is not likely to be cost-effective for women with pretreated ERBB2-positive advanced breast cancer, whereas price reduction effectively improves insufficient cost-effectiveness.

Pregnancy costs with commercial insurance.

BACKGROUND: Costs for obstetrical care may be increasing for both patients and insurers. OBJECTIVE: To examine predictors of and trends in the cost of medical care during pregnancy. STUDY DESIGN: We performed a study of pregnancies from 2009 to 2019 covered by commercial insurance resulting in term, singleton delivery hospitalizations and included in the MarketScan database. The analysis categorized pregnancies based on whether delivery occurred via cesarean versus vaginal delivery and whether pre-gestational diabetes or chronic hypertension was present. We estimated inflation-adjusted total medical costs from 273 days before through 42 days after delivery hospitalization discharge. The analysis evaluated costs for inpatient services, outpatient services, and outpatient drugs separately and trended these costs over the study period. The analysis dichotomized total medical costs into insurer liability versus out-of-pocket patient costs. The study used quantile regression models fit separately to evaluate costs for vaginal and cesarean delivery including demographic and medical characteristics. RESULTS: The analysis included 1,952,432 pregnancies covered by commercial insurance. From 2009 to 2019, median total medical costs increased from $14,091 (IQR $11,122-$18,417) to $19,645 (IQR $14,676-$27,959) with median inpatient costs increasing 36% and median outpatient costs increasing 43%. Out-of-pocket costs rose 65% for inpatient services and 120% for outpatient services. Median total pregnancy costs were higher for women with chronic hypertension (median $22,268, IQR $16,809-$30,901, p < .01), pregestational diabetes (median $20,786, IQR $15,702-$28,714, p < .01), and cesarean delivery (median $20,098, IQR $15,748-$26,889 versus median $14,904, IQR $11,728-$19,785 for vaginal delivery, p < .01). In adjusted analyses, chronic hypertension, diabetes, and cesarean delivery were associated with increased median total costs. CONCLUSION: Total and out-of-pocket medical costs for maternity care are increasing among commercially insured patients. Chronic hypertension, pregestational diabetes, and cesarean delivery are important predictors of costs.

Intravesical Therapy Compared to Radical Cystectomy Among Patients With Non-Muscle Invasive Bladder Cancer Requiring Additional Treatment After Induction BCG.

BACKGROUND: Many patients with recurrent high-risk non-muscle invasive bladder cancer after intravesical bacillus calmette-guerin (BCG) face a difficult decision between radical cystectomy (RC) or salvage intravesical therapy (IVT). We sought to determine if there is a difference in overall survival RC and IVT after previous treatment with BCG. METHODS: We performed a retrospective cohort study of patients with Ta, T1, and Tis bladder cancer treated with induction BCG in the SEER-Medicare dataset from 2000 to 2015. We used a proportional hazards regression model to compare differences in survival between patients having RC and IVT. We adjusted for confounding using a propensity score and stratified our analysis according to timing of treatment and stage at diagnosis. RESULTS: We identified 3940 patients who received either IVT (79%) or RC (21%) following induction BCG. Among patients treated within 12 months of BCG, there was no significant difference in survival between RC and IVT (HR 0.92, 95% CI 0.81-1.04) and 17% of patients having early IVT ultimately required RC. Among patients treated at least 12 months after BCG, RC was associated with worse survival than IVT (HR 1.19, 95% CI 1.06-1.35) and 10% of patients having late IVT ultimately required RC. CONCLUSION: Among patients with bladder cancer who required additional treatments after induction BCG, we did not observe a difference in overall survival between IVT and RC within 12 months of starting BCG. While RC remains the gold-standard for high risk recurrent NMIBC after BCG, bladder preservation with IVT may be appropriate for well-selected patients.