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BackgroundYoung adults and other working-age adults with cancer are at risk for cancer-related financial toxicity (FT), including material hardships, depletion of coping resources, and psychological burden. This study compares FT domains in young adults (18-39years old) (YAs), other working-age adults (40-64years old), and older adults (≥65years old) receiving cancer care.MethodsA total of 311 adults were surveyed using the multi-domain Economic Strain and Resilience in Cancer instrument measuring FT (0-10 score indicating least to greatest FT; score ≥5 severe FT). Participants were receiving ambulatory care from March-September 2019. Associations of age with overall FT and material hardship, coping resource depletion, and psychological burden FT domains were tested using Kruskal-Wallis and χ2 tests and multivariable generalized linear models with gamma distribution.ResultsYAs (median age, 31.5years) comprised 9.6% of the sample; other working-age adults comprised 56.9%. Overall, material, coping, and psychological FT scores were worse in younger age adults versus older adults (P&nbsp

PURPOSE: Patients with cancer frequently encounter financial hardship, yet systematic strategies to identify at-risk patients are not established in care delivery. We assessed sensitivity of distress-based screening to identify patients with cancer-related financial hardship and associated care delivery outcomes. METHODS: A survey of 225 patients at a large cancer center assessed cancer-related financial hardship (0-10 Likert scale; highest quintile scores ≥ 5 defined severe hardship). Responses were linked to electronic medical records identifying patients’ distress screening scores 6 months presurvey (0-10 scale) and outcomes of missed cancer care visits and bad debt charges (unrecovered patient charges) within 6 months postsurvey. A positive screen for distress was defined as score ≥ 4. We analyzed screening test characteristics for identifying severe financial hardship within 6 months and associations between financial hardship and outcomes using logistic models. RESULTS: Although patients with positive distress screens were more likely to report financial hardship (odds ratio [OR], 1.21; 1.08-1.37; P < .001), a positive distress screen was only 48% sensitive and 70% specific for identifying severe financial hardship. Patients with worse financial hardship scores were more likely to miss oncology care visits within 6 months (for every additional point in financial hardship score from 0 to 10, OR, 1.28; 1.12-1.47; P < .001). Of patients with severe hardship, 72% missed oncology visits versus 35% without severe hardship ( P = .006). Patients with worse hardship were more likely to incur any bad debt charges within 6 months (OR, 1.32; 1.13-1.54; P < .001). CONCLUSION: Systematic financial hardship screening is needed to help mitigate adverse care delivery outcomes. Existing distress-based screening lacks sensitivity.

Introduction: BI-RADS category 4 is associated with a wide variability in probability of malignancy, ranging from 2 to 95% while biopsy-derived positive predictive value (PPV3) for this category’s lesions remains low at 21.1% in the US. A major fallout of these facts is that we have way very high false positive rate leading to too many unnecessary biopsies and their associated costs and emotional burden. We improved our in-house intelligent-augmented Breast cancer RISK calculator (iBRISK), an integrated deep learning (DL) based decision support app and assessed its performance in a multicenter IRB-approved study. Methods: We improved iBRISK by retraining the DL model with an expanded dataset of 9,700 patient records of clinical risk-factors and mammographic descriptors from Houston Methodist Hospital (HMH) and validated using another 1,078 patient records. These patients were all seen between March 2006 and December 2016. We assessed the model using blinded, independent retrospective BI-RADS 4 patients who had biopsies subsequently after mammography and seen January 2015 - June 2019 at three major healthcare institutions in Texas, USA: MD Anderson Cancer Center, the University of Texas Health Sciences Center at San Antonio, and HMH. We dichotomized and trichotomized the data to evaluate precision of risk stratification and probability of malignancy (POM) estimation translated into biopsy decision augmentation. The iBRISK score as a continuous predictor of malignancy and possible cost savings was also analyzed. Results: The multicenter validation dataset had 4,209 women, median age (interquartile) was 56 (45, 65) years. The use of iBRISK score as a continuous predictor of malignancy yielded an AUC of 0.97. Among “low” and “moderate” POM patients, only two out of 1,228 patients (0.16%) and 118 out of 1788 (6.6%) were malignant respectively. This translates to an even better precision when compared to newly introduced BI-RADS 4 subcategories 4A and 4B, with associated PPV3s of 7.6% and 22%, respectively. The “high” POM group had a malignancy rate of 85.9% (1,025/1,193). Estimated potential cost savings in the US was over $260 million. Conclusion: The iBRISK app demonstrated high sensitivity in malignancy prediction and can potentially be used to safely obviate biopsies in up to 50% of patients in low/moderate POM-groups. This would result in significant healthcare quality improvement, cost savings, and help reduce patient anxiety. Citation Format: Chika F. Ezeana, Tiancheng He, Tejal A. Patel, Virginia Kaklamani, Maryam Elmi, Erica Ibarra, Pamela M. Otto, Kenneth A. Kist, Heather Speck, Lin Wang, Joe Ensor, Ya-Chen T. Shih, Bumyang Kim, I-Wen Pan, David Spak, Wei T. Yang, Jenny C. Chang, Stephen T. Wong. A multicenter study validated an integrated deep learning model for precision malignancy risk assessment and reducing unnecessary biopsies in BI-RADS 4 cases. [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2023; Part 1 (Regular and Invited Abstracts); 2023 Apr 14-19; Orlando, FL. Philadelphia (PA): AACR; Cancer Res 2023;83(7_Suppl):Abstract nr 5698.

Objectives This study sought to evaluate advanced psychometric properties of the 15-item Economic Strain and Resilience in Cancer (ENRICh) measure of financial toxicity for cancer patients. Methods We surveyed 515 cancer patients in the greater Houston metropolitan area using ENRICh from March 2019 to March 2020. We conducted a series of factor analyses alongside parametric and non-parametric item response theory (IRT) assessments using Mokken analysis and the graded response model (GRM). We utilized parameters derived from the GRM to run a simulated computerized adaptive test (CAT) assessment. Results Among participants, mean age was 58.49 years and 278 (54%) were female. The initial round factor analysis results suggested a one-factor scale structure. Negligible levels of differential item functioning (DIF) were evident between eight items. Three items were removed due to local interdependence (Q3>+0.4). The original 11-point numerical rating scale did not function well, and a new 3-point scoring system was implemented. The final 12-item ENRICh had acceptable fit to the GRM (p Conclusion These CAT and 4-item versions provide options for quick screening in clinical practice and low-burden assessment in research.

Supplemental material, Figure_Captions.rjf_online_supp for Factors Associated With Hospital Decisions to Purchase Robotic Surgical Systems by Chan Shen, Dian Gu, Roger Klein, Shouhao Zhou, Ya-Chen T. Shih, Thomas Tracy, David Soybel and Peter Dillon in MDM Policy & Practice

Supplemental material, SupplementaryTables.rjf_online_supp for Factors Associated With Hospital Decisions to Purchase Robotic Surgical Systems by Chan Shen, Dian Gu, Roger Klein, Shouhao Zhou, Ya-Chen T. Shih, Thomas Tracy, David Soybel and Peter Dillon in MDM Policy & Practice

Medical costs are often skewed to the right and heteroscedastic, having a sophisticated relation with covariates. Mean function regression models with low-dimensional covariates have been extensively considered in the literature. However, it is important to develop a robust alternative to find the underlying relationship between medical costs and high-dimensional covariates. In this paper, we propose a new quantile regression model to analyze medical costs. We also consider variable selection, using an adaptive lasso penalized variable selection method to identify significant factors of the covariates. Simulation studies are conducted to illustrate the performance of the estimation method. We apply our method to the analysis of the Medical Expenditure Panel Survey dataset.

5 Background: To provide a comprehensive evaluation of the trends in treatment pattern, total and out-of-pocket (OOP) costs of cancer care for in the period between 2-month before and 12-month after cancer diagnosis for the privately insured non-elderly adults diagnosed with female breast, colorectal, lung, or prostate cancer. These four cancers represent the four most prevalent cancers in the United States and the 14-month duration captures the most expensive care phase in the cost trajectory of cancer. Methods: We constructed incident cohorts using claims data from the Health Care Cost Institute between 2009 and 2016. We identified treatment modality (cancer-related surgery, systemic therapy, radiation, and other hospitalizations) and calculated associated total and OOP (sum of deductible, coinsurance, and copayment) costs from payment variables. For each cancer, we examined healthcare utilization and cost trends based on the year of diagnosis and conducted logistic regressions to assess the trend in utilization and generalized linear models to evaluate the trend in costs. All estimates are reported in 2020 US dollars. Results: The cohorts consisted of 105,255 breast, 23,571 colorectal, 11,321 lung, and 59,197 prostate cancer patients. Between 2009 and 2016, use of systemic therapy and radiation significantly increased, except for lung cancer. Cancer surgeries significantly increased for breast and colorectal cancer but decreased for prostate cancer, whereas hospitalizations for reasons other than cancer declined for all cancers (p < 0.001). Costs increased for nearly all treatment modalities except for systemic therapy in colorectal and radiation in prostate cancer. Total mean costs per patient had the largest increase in breast cancer (29%, $109,544 to $140,743), followed by lung (11%) and prostate (4%) cancer. Cost increase in colorectal cancer was not statistically significant (P = 0.089). Similar trends were found in median costs. Although not every cancer had significant increase in total costs over time, OOP costs increased > 15% for all cancers, with deductibles accounting for an increasingly proportion. Conclusions: Rising costs of cancer treatments, compounded with increasing cost-sharing increased OOP costs for privately insured, non-elderly cancer patients. Policy initiatives to mitigate financial hardship should consider cost containment as well as insurance reform.

Objectives The incidence of neuroendocrine tumors (NETs) has been steadily increasing. Racial differences in the incidence and survival are mostly unknown. This study examines the racial differences and the underlying causes. Methods We conducted a retrospective, population-based study using datasets from Surveillance, Epidemiology, and End Results (SEER) cancer registry and SEER data linked with Medicare claims (SEER-Medicare). We examined the incidence rates and the effects of patient demographics, clinical characteristics, and socioeconomic factors on survival. Results Of the 15,786 and 1731 cases from SEER and SEER-Medicare, 1991 and 163 were blacks, respectively. We found that blacks had higher NET incidence for all stages, with the largest difference noted in the local stage (4.3 vs 2.6 per 100,000 in whites). We found worse survival for distant-stage black patients, although they more often had clinical factors typically associated with better prognosis in NETs. However, they were also found to have significant unfavorable differences in socioeconomic and sociodemographic factors. Conclusions Blacks have higher incidence of NETs and worse survival compared with other races, especially whites. The influences of neighborhood socioeconomic, sociodemographic, and marital status suggest that social determinants, support mechanisms, and access to health care may be contributing factors.

1546 Background: The use of preoperative (pre-op) breast MRI remains controversial. Current practice may rely on patient characteristics and providers’ clinical judgment. This national study examined factors associated with pre-op breast MRI among women with newly diagnosed breast cancer (BC) and explored sources of variations. Methods: We applied the Nattinger algorithm to identify women with incident BC diagnosed between Mar 2008 and Dec 2018 from OPTUM Clinformatics database. Patients who had 26 months of full enrollment, 14 months before and 12 months after the first (index) BC surgery, and no pre-op radiotherapy were included. We defined pre-op MRI as patients who had an MRI between the date of BC diagnosis and date of index surgery. We conducted multivariable logistic regression models to examine factors associated with pre-op MRI and performed separate analyses for elderly (age > = 65) and non-elderly (age < 65) women. Results: 61,865 women (non-elderly: 27,309, elderly: 34,556) were included in the analysis. The crude rate of pre-op MRI increased from 7.4% in 2008 to 14.6% in 2018 (p-value

2017 Background: The prevention provision of Affordable Care Act (ACA) mandates private insurance to waive cost sharing for preventive services with grade A or B recommendations from the US Preventive Services Task Force. Although several professional societies have recommended augmenting screening mammography with MRI for women at high risk for breast cancer, the ACA prevention provision does not apply to screening MRI. This study examined the proportion of high-risk women having zero cost sharing associated with breast MRI for screening purposes and estimated out of pocket (OOP) costs as well as sources of variations. Methods: We identified women who underwent MRI and mammography for breast cancer screening from Marketscan database, 2009-2017. We quantified OOP costs as the sum of copayment, coinsurance, and deductible and defined zero cost sharing as having no OOP cost. We calculated the proportion of zero cost sharing for mammography and that for MRI and compared the time trend of each before and after ACA (enacted in 2010). We used multivariable logistic regression to examine factors associated with zero cost sharing for MRI use. We estimated OOP costs of MRI and examined cost variations by geographic regions or whether a woman had high deductible plans. Results: 25,232 women were included in the analysis. For screening mammography, the rate of zero cost sharing increased from 81% in 2009 to 91% in 2011 (post ACA) then 97% in 2017. For MRI, the rate was 41%, 37%, and 25%, respectively. The odds ratio (OR) of zero cost sharing for MRI screening was significantly lower for women with high deductible plans (OR = 0.65, 95% CI: 0.59-0.72) and for those resided in South (vs. Northeast) region (OR = 0.50, 95% CI: 0.46-0.53), after controlling for age, MSA, family breast cancer history, and year. OOP costs of MRI varied by region and insurance plan (Table); the mean OOP cost for women with high deductible plan were more than twice the mean cost for those in other plan types. Conclusions: With the financial protection under the ACA prevention provision applying to only screening mammography, many women at high risk for breast cancer are subject to high OOP costs for MRI screening. Those enrolled in high deductible plans and resided in the South are especially vulnerable financially. [Table: see text]

e19252 Background: Immune-checkpoint inhibitors (ICI) is a form of immunotherapy that “releases the brakes” on the immune cells to restore antitumor immunity and promote tumor cell death to treat cancer. In March 2011, the United States Food and Drug Administration (FDA) approved ipilimumab, the 1st ICI, to treat advanced-stage melanoma. Since December 2014, FDA successively approved another six ICIs: nivolumab, pembrolizumab, avelumab, durvalumab, cemiplimab, and atezolizumab. Beside melanoma, the treatment indications for these agents have been expanded to renal cell carcinoma, microsatellite instability (MSI)-high malignancies, small-cell lung cancer, non-small-cell lung cancer, and cutaneous squamous cell carcinoma. No study had examined the patterns and out-of-pocket (OOP) costs of ICI among cancer patients (pts) with private insurance. Methods: We used the IBM MarketScan Commercial Claims and Encounters database to document the uptake of ICI from 2011 to 2017. Using the Healthcare Common Procedure Coding System (HCPCS) codes, and national Drug code, we identified ICI claims among pts 18 to 64 years old. OOP cost for ICI was computed as sum of coinsurance, copayment, and deductible. To determine whether financial burden was higher for pts with high-deductible (HD) plans, we dichotomized pts’ insurance plan as HD vs. non-HD. Summary statistics was used to describe the patterns of ICI use. We used Wilcoxon Rank Sum test to compare the OOP by HD status. Results: The study cohort included 7,855 pts with 62,636 ICI claims of ipilimumab, nivolumab, pembrolizumab, avelumab, durvalumab, and atezolizumab between 2011 and 2017. The median age was 57 years and about 56.9% pts were male. Approximately 90% of pts used ICI as monotherapy, and the median number of claims per patient was 4. The most commonly used ICI was nivolumab (55.4%), accounting for about 90% of claims after 2014, followed by lpilimumab (24.6%), pembrolizumab (18.5%). Among the ICI pts, 17.2% enrolled in HD plans and 82.8% had non-HD plans. The median OOP for both HD and non-HD groups was $0, whereas the 3rd quartile of OOP was significantly higher for pts in HD plans ($556 vs. $26, P < 0.01). In addition, approximately 18.7% of pts (17.3% of pts in non-HD and 25.6% in HD plans) paid over $500 OOP per patient for ICI. Conclusions: The use of ICI was dramatically increased as more ICI agents were approved since 2015. Although more than 50% of pts had $0 OOP, possibly due to the out-of-pocket max provision in private insurance, pts with HD plans are especially susceptible to high financial burden of ICIs.

7083 Background: Studies assessing wastage of discarded weight (WT)-based cancer drugs (can-RX) derived their estimates from Medicare Average Sales Prices + 6% mark-up. With higher mark-ups, financial impact of discarded can-RX can be much higher in private insurance market. In addition, no study has examined the financial burden for patients(pts) even though they are subject to out-of-pocket payment (OOP) of the discarded RX. This study fills in these important knowledge gaps. Methods: We obtained the list of WT-based can-RX from the 2017 Centers for Medicare and Medicaid Services Part B Discarded Drug Units Report and gathered information on package size and recommended dose from IBM Micromedex. We identified pts who received WT-based can-RX from 2017 MarketScan data and linked to MarketScan Health Risk Assessment to obtain WT and height for a subset of pts. For each claim, we derived the recommended dose based on pt’s RX and his/her WT or body surface area (calculated from WT and height) and estimated the % of discarded dose. We quantified OOP as the sum of deductible, copayment, and coinsurance, and classified pts’ insurance by their enrollment to high-deductible (HD) plans. For claim-level analysis, we applied beta regression (for fractional outcomes) to determine factors associated with % discarded while accounting for within pts correlations. Covariates were age group (grp) ( < 50, 50-59, > = 60), WT grp ( < 150, 150-199, > = 200lb), HD plan (yes/no), region, cancer type, and can-RX. For pt-level analysis, we calculated the amount payers and pts spent on all and discarded can-RX in 2017 and compared OOP b/t pts in HD and non-HD plans. Results: Of 27,883 claims of WT-based can-RX, the median discarded % was 0.10 (mean 0.19, SD = 0.21). In addition to can-RX and cancer type, significantly higher discarded % was found in the lowest WT grp (0.03, P < 0.001, vs. WT > = 200lb) and significantly lower % was found in the middle age grp (-0.01, P = 0.02 vs. age < 50). Of 1963 pts, 778 (40%) had HD plans. Payments by payers (NETPAY) and pts (OOP) for total and discarded can-RX and the comparison b/t HD and non-HD plans are shown in Table. Conclusions: Payers incurred substantial financial burden from discarded can-RX. While OOP costs were modest for most privately insured pts, 5.3% of pts (~8% in HD plans) paid > $400 for discarded RX. [Table: see text]

Background. Robotic surgical systems are expensive to own and operate, and the purchase of such technology is an important decision for hospital administrators. Most prior literature focuses on the comparison of clinical outcomes between robotic surgery and other laparoscopic or open surgery. There is a knowledge gap about what drives hospitals’ decisions to purchase robotic systems. Objective. To identify factors associated with a hospital’s acquisition of advanced surgical systems. Method. We used 2002 to 2011 data from the State of California Office of Statewide Health Planning and Development to examine robotic surgical system purchase decisions of 476 hospitals. We used a probit estimation allowing heteroscedasticity in the error term including a set of two equations: one binary response equation and one heteroscedasticity equation. Results. During the study timeframe, there were 78 robotic surgical systems purchased by hospitals in the sample. Controlling for hospital characteristics such as number of available beds, teaching status, nonprofit status, and patient mix, the probit estimation showed that market-level directly relevant surgery volume in the previous year (excluding the hospital’s own volume) had the largest impact. More specifically, hospitals in high volume (>50,000 surgeries v. 0) markets were 12 percentage points more likely to purchase robotic systems. We also found that hospitals in less competitive markets (i.e., Herfindahl index above 2500) were 2 percentage points more likely to purchase robotic systems. Limitations. This study has limitations common to observational database studies. Certain characteristics such as cultural factors cannot be accurately quantified. Conclusions. Our findings imply that potential market demand is a strong driver for hospital purchase of robotic surgical systems. Market competition does not significantly increase the adoption of new expensive surgical technologies.

Background The concomitant use of tyrosine kinase inhibitors (TKIs) and proton pump inhibitors (PPIs) is a significant concern because of potential drug-drug interaction that reduces TKI absorption, thus potentially reducing the effectiveness of TKIs. The objective of this study was to evaluate the prevalence and predictors of concomitant TKI-PPI receipt and its impact on survival and therapy discontinuation in older adults with cancer. Methods This retrospective study used linked Surveillance, Epidemiology, and End Results-Medicare data for the years 2007 through 2012. In total, 12,538 patients with lung cancer, renal cell cancer, chronic myelogenous leukemia, liver cancer, or pancreatic cancer were included. The primary exposure variable was concomitant receipt of TKI-PPI, defined as at least 30 days of PPI use in the first 90 days from the start of the TKI (exposure period). The outcomes measured were overall survival and discontinuation of therapy in 90 days and 1 year after the end of the exposure period. Cox proportional-hazards regression with inverse probability of treatment weighting was used to evaluate the association between exposure and outcome. Results The overall prevalence of TKI-PPI receipt was 22.7%. Predictors that were associated with increased use included polypharmacy and prior PPI receipt. TKI-PPI use decreased survival in 90 days (hazard ratio, 1.16; 95% confidence interval, 1.05-1.28) and in 1 year (hazard ratio, 1.10; 95% confidence interval, 1.04-1.18) but was not associated with discontinuation. Conclusions Nearly 1 in 4 older adults with cancer who receive TKIs also receive PPIs concomitantly, and concomitant use is associated with an increased risk of death. Concerted efforts to manage medications are needed to identify and reduce the receipt of PPIs when TKIs are initiated.

The incidence and prevalence of neuroendocrine tumors (NETs) are continually increasing. While it is known that NET symptoms often predate diagnosis, their prevalence and impact on resource utilization and costs are largely unknown. We identified 9,319 elderly patients diagnosed with NETs between 1/2003 and 12/2011 from the Surveillance, Epidemiology and End Results (SEER)-Medicare. We examined the patients’ conditions potentially associated with NET, resource utilization and costs during the year before diagnosis. We found that NET patients were more likely to have diagnoses of hypertension (63.8% vs. 53.3%), abdominal pain (22.2% vs. 7.6%), heart failure (11.7% vs. 8.0%), diarrhea (5.8% vs. 1.8%), peripheral edema (5.4% vs. 3.8%) and irritable bowel syndrome (1.2% vs. 0.5%) compared to the non-cancer control group. They also had much higher resource utilization including number of outpatient visits (mean: 22.1 vs. 17.2), percentage with ER visits (20.9% vs. 11.6%), and hospitalizations (28.4% vs. 17.0%). Similarly, NET patients incurred significantly higher total (mean: $14602 vs. $9464), outpatient (mean: $5987 vs. $4253), and inpatient costs (mean: $8615 vs. $5211). This first population-based study on the pre-diagnosis symptoms and healthcare utilization found that NET patients were more likely to have certain conditions and incur higher resource utilizations and costs.

8 Background: Clinical trials are an important therapeutic option for cancer patients. Although financial burden in cancer treatment is well-described, the financial burden associated with clinical trials is not well understood, especially for patients with lower socioeconomic status. Methods: We conducted a survey regarding economic burden and financial toxicity among cancer patients on Phase I clinical trials for at least 1 month. Financial Toxicity Score (FTS) was assessed using the validated COmprehensive Score for Financial Toxicity (COST) survey (scale 0-44, lower scores indicating worse financial toxicity). Patients also reported monthly out of pocket (OOP) medical and non-medical expenses. Results: Of 147 consecutive patients approached, 105 agreed to participate; median age = 60y; 62% female; 49% had annual income < $60K; 50% lived < 300 miles from the clinic; 34% required air travel; 41% had Medicare, 50% had employer sponsored insurance. Median FTS = 20, with interquartile range of 12.5. Median monthly OOP costs for non-medical expenses was $985, and for medical expenses was $475. Median total monthly OOP costs was $1695. Compared to patients in the highest quartile of FTS, a significantly lower % of patients in the lowest (worst) quartile of FTS had incomes > $60K (27% v. 77%, P < 0.001), and a significantly higher % were unemployed or not working outside the home (54% v. 12%, P = 0.001), and incurred higher than expected medical (39% vs. 12%, P = 0.025) and non-medical (64% vs. 15%, P = 0.003) expenses. Compared with patients for whom medical costs were not much higher than expected, a significantly higher % of patients with medical costs much higher than expected were non-White (77% v. 46%, P = 0.004) and unemployed/not working outside the home (46% v. 19%, P = 0.009). Conclusions: Among cancer patients participating on clinical trials, economic burden is high and financial toxicity is disproportionally higher in patients with lower income. OOP costs can be substantial and are often unexpected for patients.

e18383 Background: Clinical trials are an important therapeutic option for cancer patients. Although financial burden in cancer treatment is well-described, the financial burden associated with clinical trials is not well understood, especially for patients with lower socioeconomic status. Methods: We conducted a survey regarding economic burden and financial toxicity among cancer patients on Phase I clinical trials for at least 1 month. Financial Toxicity Score (FTS) was assessed using the validated COmprehensive Score for Financial Toxicity (COST) survey (scale 0-44, lower scores indicating worse financial toxicity). Patients also reported monthly out of pocket (OOP) medical and non-medical expenses. Results: Of 147 consecutive patients approached, 105 agreed to participate; median age = 60y; 62% female; 49% had annual income < $60K; 50% lived < 300 miles from the clinic; 34% required air travel; 41% had Medicare, 50% had employer sponsored insurance. Median FTS = 20, with interquartile range of 12.5. Median monthly OOP costs for non-medical expenses was $985, and for medical expenses was $475. Median total monthly OOP costs was $1695. Compared to patients in the highest quartile of FTS, a significantly lower % of patients in the lowest (worst) quartile of FTS had incomes > $60K (27% v. 77%, P < 0.001), and a significantly higher % were unemployed or not working outside the home (54% v. 12%, P = 0.001), and incurred higher than expected medical (39% vs. 12%, P = 0.025) and non-medical (64% vs. 15%, P = 0.003) expenses. Compared with patients for whom medical costs were not much higher than expected, a significantly higher % of patients with medical costs much higher than expected were non-White (77% v. 46%, P = 0.004) and unemployed/not working outside the home (46% v. 19%, P = 0.009). Conclusions: Among cancer patients participating on clinical trials, economic burden is high and financial toxicity is disproportionally higher in patients with lower income. OOP costs can be substantial and are often unexpected for patients.

Medical cost data are often skewed to the right and heteroscedastic, having a nonlinear relation with covariates. To tackle these issues, we consider an extension to generalized linear models by assuming nonlinear associations of covariates in the mean function and allowing the variance to be an unknown but smooth function of the mean. We make no further assumption on the distributional form. The unknown functions are described by penalized splines, and the estimation is carried out using nonparametric quasi-likelihood. Simulation studies show the flexibility and advantages of our approach. We apply the model to the annual medical costs of heart failure patients in the clinical data repository (CDR) at the University of Virginia Hospital System.

The economic burden of renal cell carcinoma (RCC) came into sharp focus when the UK National Institute for Health and Clinical Excellence (NICE) denied coverage (later reversed) of sunitinib for metastatic RCC. In the first of two articles that provide updated reviews and analyses of the economic burden of RCC, we conducted an updated literature review of RCC-related economic studies. We performed a literature search of PubMed, EMBASE and the Cochrane Library for English-language studies published from 1 January 2000 to 15 June 2010. We also performed a separate search for related studies in the Health Technology Assessment (HTA) reports published by the National Institute for Health Research HTA Programme in the UK. Identified articles were classified into three categories: cost studies, cost-effectiveness/cost-utility studies and cost-of-illness studies. All cost estimates were normalized to &dollar;US, year 2009 values. We identified 20 articles, including six cost, six cost-utility and eight cost-of-illness studies. In general, the studies found new surgical techniques, such as laparoscopic partial nephrectomy, to be potentially cost saving (in the range of &dollar;US181-5842). Targeted agents, such as bevacizumab, sunitinib, sorafenib and temsirolimus, were associated with higher lifetime costs (&dollar;US8537-72 254) and were not always considered to be cost effective by authors of the cost-effectiveness studies included in this review (incremental cost-effectiveness ratio &lsqb;ICER&rsqb;: &dollar;US49 959-272 418 per QALY). The literature reported annual estimates of the US economic burden of RCC between &dollar;US0.60 billion and &dollar;US5.19 billion, with per-patient costs of &dollar;US16 488-43 805. RCC is associated with substantial economic burden, although the estimates are wide ranging. Comparisons of the estimates across studies were hindered by variations in study methodology, choice of database and the associated timeframe, and limitations inherent to each database. More research is needed to assess the quality of the economic studies of RCC and to understand why the estimated costs differ across studies.

Introduction: The economic burden of renal cell carcinoma (RCC) came into sharp focus when the UK's National Institute for Health and Clinical Excellence denied coverage (later reversed) of sunitinib for metastatic RCC. Following an updated review of RCC-related economic studies, we supplemented the costs of RCC reported in the literature with estimates from the latest US databases that capture the utilization of several newly approved targeted agents. Method: We conducted analyses using the 1991-2007 SEER (Surveillance, Epidemiology and End Results)-Medicare and 1996-2007 MarketScan Commercial Claims and Encounter (CCAE) and Medicare Supplemental databases, and based our estimates on a prevalent cohort of patients with RCC or kidney cancer constructed from each database. All cost estimates were normalized to &dollar;US, year 2009 values. The incremental costing approach was applied to estimate the annual cost of RCC by treatment phases using a prevalent cohort of patients with RCC identified from the 2005 SEER-Medicare database. We used the method of extended estimation equations to estimate the impact of patients' use of targeted therapies on the annual costs of RCC, while controlling for confounding factors such as patients' age, sex, tumour characteristics, co-morbidity and geographic regions. The method was applied to two elderly cohorts of RCC patients identified from the SEER-Medicare and the MarketScan Medicare Supplemental databases and a non-elderly cohort of patients with RCC identified from the MarketScan CCAE database. Results: Compared with the cost of treating an elderly, non-cancer patient in the matched sample, the average cost of treating an elderly patient with RCC was &dollar;US11 169 (95% CI 10 683, 11 655) more per year, based on our analyses of the latest SEER-Medicare data. The annual cost to treat patients with RCC who received targeted therapies was 3- to 4-fold greater than the cost to treat patients with RCC who received other therapies. Results from the multivariate analysis showed that, after controlling for potential confounders, the annual medical cost was &dollar;US31 000-65 000 higher for RCC patients treated with targeted therapies, with the largest increase observed among the non-elderly patients. Conclusion: The economic burden of RCC is likely to grow with an increasing use of targeted therapies. Future research is needed to understand the impact of various forces on the economic burden of RCC, such as increased disease incidence, use of minimally invasive surgical techniques and more prevalent adoption of emerging targeted therapies.

e18732Background: The concomitant use of tyrosine-kinase-inhibitors(TKI) and proton-pump-inhibitors(PPI) is a concern due to potential drug-drug interaction that reduces TKI absorption, thus potent...

e18718Background: The prices of targeted oral cancer medications have increased sharply over the last decade. We aim to assess off-label use of everolimus and associated factors among non-elderly c...

4092 Background: The incidence and prevalence of neuroendocrine tumors (NETs) are continually increasing. While it is known that NET symptoms often predate diagnosis, the prevalence of these symptoms and the impacts on resource utilization and costs are largely unknown. Methods: We identified 12,052 elderly patients diagnosed with NET between 1/2003 and 12/2011 by ICD-O-3 codes from the Surveillance, Epidemiology and End Results (SEER)-Medicare database with continuous Medicare Parts A and B enrollment during the one year before NET diagnosis. We used propensity score matching to identify a group of comparable elderly patients from a non-cancer Medicare cohort. We captured patients’ potentially relevant conditions (defined as > 1 indicative claim), resource utilization and costs from patients’ medical claims during the year before diagnosis. We examined a) resource utilization in terms of number of outpatient visits, percentage of patients having any emergency room (ER) visits and hospitalizations, and b) health care costs including inpatient, outpatient and total costs. We used chi-square test for categorical variables and Mann-Whitney U test for continuous variables. Results: NET patients were more likely to have diagnoses of diarrhea (8% vs. 2%), abdominal pain (37% vs. 8%), irritable bowel syndrome (1.5% vs. 0.6%), hypertension (72% vs. 55%), heart failure (16% vs. 8%), and peripheral edema (7% vs. 4%) compared to the non-cancer control group. They also had much higher resource utilization including number of outpatient visits (mean: 27.25 vs. 18.45); and percentage with ER visits (64% vs. 36%), and hospitalizations (66% vs. 34%). Similarly, NET patients incurred significantly higher total (mean: $32924 vs. $10048), outpatient (mean: $8869 vs. 4580), and inpatient costs (mean: $24055 vs. $10048). All p < 0.001. Conclusions: To the best of our knowledge, this is the first population-based study to examine potentially relevant pre-existing symptoms, resource utilization and healthcare costs before NET diagnosis. NET patients were more likely to have certain conditions and incurred higher resource utilizations and costs in the year preceding diagnosis of NET.

e18016 Background: The use of targeted oral cancer medications has increased significantly since 2001. Everolimus, an mTOR inhibitor was first approved for cancer treatment by FDA as second line for patients with advanced renal cancer. Subsequently it has been approved for advanced pancreatic neuroendocrine tumor (NET) in 2011 and breast cancer in 2012 respectively. Off-label use is common in oncology practice. The objective of this study is to assess prescription trends, especially off-label use of everolimus, among non-elderly cancer patients with private insurance in the United States from 2009 to 2014. Methods: Data from the MarketScan database were analyzed. Between 2009 to 2014, 4,728 cancer patients with at least one everolimus prescription were included in the analyses. The diagnosis which incurred the most recently to the initial everolimus use in each calendar year was recorded. Off-label use was defined as using everolimus by all of the cancer types except of renal cancer in 2009-2014, NET in 2011-2014 and breast cancer in 2012-2014. Results: The number of patients received everolimus has increased significantly from 243 in 2009 to 1,194 in 2014. The most common diagnoses associated with everolimus use were breast cancer (42%), followed by renal cancer (24%), and NET (7%). Off-label use of everolimus increased from 29% in 2009 to 47% in 2011 then decreased to 23% in 2014. The 3 most common diagnoses associated with off-label use of everolimus were secondary malignancies (30.7%), breast cancer (10.4%) and liver cancer (5%) in 2009-2011, compared to secondary malignancies (47.3%), brain cancer (4.2%) and lung cancer (3.9%) in 2012-2014. The off-label use in female has decreased significantly from 32% in 2009 to 19% in 2014 (p = 0.03). There was no statistical difference in off-label use of everolimus by geographic region. Conclusions: Analyses of MarketScan data suggest off-label use of everolimus is common among US cancer patients, especially in lung, liver and brain cancer and secondary malignancies after the approved indication was expanded to breast cancer in 2012. Further research of the factors associated with off-label use of everolimus and its economic implication is needed.

There is conflicting evidence for the role of statins in the primary prevention of colorectal cancer (CRC). We conducted a case control study (N=357,702) in the non-elderly adult US population (age=18-64 years) with the primary objective to examine the association between CRC and statin use.MarketScan® databases were used to identify patients with CRC. A case was defined as having an incident diagnosis of CRC. Up to ten individually matched controls (age, sex, region and date of diagnosis) were selected per case. Statin exposure was assessed by prescription tracking in the 12 months prior to the index date. Conditional logistic regression was used to adjust for multiple potential confounders and calculate adjusted odds ratios (AOR).The mean age of participants was 54 years; 52% males and 48% females. In a multivariable model, any statin use was associated with 26% reduced odds of CRC (AOR, 0.74, 95% confidence interval (CI), 0.72-0.77, p0.001). Age-stratified analyses showed a stronger effect of statins on CRC in participants aged 55 years or younger (AOR, 0.67, 95% CI, 0.63-0.71, p0.001) than in participants aged above 55 years (AOR, 0.79, 95% CI, 0.76-0.82, p0.001); the age-by-statin interaction was statistically significant (p0.001). The dose-response analyses performed with simvastatin only showed a trend towards significance between the duration of simvastatin exposure and odds of developing CRC (p=0.06).Statins appears to reduce the risk of CRC in non-elderly US population. Chemoprevention with statin might be more effective in non-elderly US population.

There has been a rapid increase in the use of targeted oral anticancer medications (OAMs) in the past decade. As OAMs are often expensive, economic consideration play a significant role in the decision to prescribe, receive or cover them. This paper performs a systematic review of costs or budgetary impact of targeted OAMs to better understand their economic impact on the healthcare system, patients as well as payers. We present our review in a summary table that describes the method and main findings, take into account multiple factors, such as country, analytical approach, cost type, study perspective, timeframe, data sources, study population and care setting when we interpret the results from different papers, and discuss the policy and clinical implications. Our review raises a concern regarding the role of sponsorship on findings of economic analyses as the vast majority of pharmaceutical company-sponsored studies reported cost advantages toward the sponsor's drugs.

To determine factors that influence radical prostatectomy (RP) operative times. Operative time assessment is inherent to defining surgeon learning curves and evaluating quality of care.Population-based observational cohort study using USA Surveillance, Epidemiology, and End Results (SEER)-Medicare linked data of men diagnosed with prostate cancer during 2003-2007 who underwent robot-assisted radical prostatectomy (RARP, 3458 men) and retropubic RP (RRP, 6993) through to 2009. We obtained median operative time using anaesthesia administrative data for RP and used median regression to assess the contribution of patient, surgeon, and hospital factors to operative times.The median RARP operative time decreased from 315 to 247 min from 2003 to 2008-2009 (P0.001), while the median RRP operative time remained similar (195 vs 197 min, P = 0.90). In adjusted analysis, RARP vs RRP (parameter estimate [PE] 70.9; 95% confidence interval [CI] 58, 84; P0.001) and obesity (PE 15; 95% CI 7, 23; P0.001) were associated with longer operative times while higher surgeon volumes were associated with shorter operative times (P0.001). RPs performed by surgeons employed by group (parameter estimate [PE] -22.76; 95% CI -38, -7.49; P = 0.004) and non-government (PE -35.59; 95% CI -68.15, -3.03; P = 0.032) vs government facilities and non-profit vs government hospital ownership (PE -21.85; 95% CI -32.28, -11.42; P0.001) were associated with shorter operative times.During our study period, RARP operative times decreased by 68 min while RRP operative times remained stagnant. Higher surgeon volume was associated with shorter operative times, and selective referral or improved efficiency to the level of high-volume surgeons would net almost $15 million (USA dollars) in annual savings.

6531Background: Tyrosine kinase inhibitors (TKIs) have transformed chronic myeloid leukemia (CML) from a deadly cancer to chronic disease. While these drugs dramatically improve survival, non-adher...

6519Background: Although communicating costs of treatment with patients is important for high-quality care, a lack of data on cost has been a major hindering factor. This is especially concerning f...

4097Background: Functional neuroendocrine tumors (NETs) secrete bioactive amines and cause carcinoid syndrome, with its incumbent symptom burden of flushing and diarrhea. However, the frequency of ...

6536Background: Access to cancer drugs used off-label is considered vital to the treatment of many cancer patients. Yet policymakers are concerned that use of drugs in this way may drive up health ...

6625Background: High costs of oncology drugs have threatened the affordability of cancer care. Previous research using data from privately insured non-elderly cancer patients (pts) showed that both...

Background The purpose of this study is to evaluate the risk factors and the prevalence of thromboembolic events (TEEs) in breast cancer patients. Patients and methods This is a retrospective cohort study using the Surveillance, Epidemiology, and End Results-Medicare database. Breast cancer patients diagnosed from 1992 to 2005 ≥66 years old were identified. International Classification of Diseases, Ninth Revision, and Healthcare Common Procedure Coding System codes were used to identify TEEs within 1 year of the breast cancer diagnosis. Analyses were conducted using descriptive statistics and logistic regression. Results A total of 89 841 patients were included, of them 2658 (2.96%) developed a TEE. In the multivariable analysis, males had higher risk of a TEE than women [odd ratio (OR) = 1.57; confidence interval (CI) 1.10–2.25] and blacks had higher risk than whites (OR = 1.20; CI 1.04–1.40). Compared with stage I patients, patients with stage II, III and IV had 22%, 39% and 98% increase, respectively, in risk. Placement of central catheters (OR = 2.71; CI 2.43–3.02), chemotherapy treatment (OR = 1.66; CI 1.48–1.86) or treatment with erythropoiesis-stimulating agents (ESAs) (OR = 1.33; CI 1.33–1.52) increase the risk. Other significant predictors included comorbidities, age, receptor status, marital status and year of diagnosis. Similar estimates were seen for pulmonary embolism, deep vein thromboembolism and other TEEs. Conclusions In total, 2.96% of patients in this cohort developed a TEE within 1 year from breast cancer diagnosis. Stage, gender, race, use of chemotherapy and ESAs, comorbidities, receptor status and catheter placement were associated with the development of TEEs.

BACKGROUND. Hypothyroidism is a potential complication after radiation therapy (RT) when treatment fields include the thyroid. The authors assessed risk of hypothyroidism in breast cancer patients who were receiving RT to a supraclavicular field, which typically includes a portion of thyroid. METHODS. The authors identified 38,255 women (aged >65) without history of hypothyroidism from the Surveillance, Epidemiology, and End Results (SEER)-Medicare cohort diagnosed with stage 0-III breast cancer from 1992–2002 and 111,944 cancer-free controls. The authors compared hypothyroidism incidence among irradiated patients with 4 + positive lymph nodes (4 + LN, surrogate for supraclavicular RT) and no positive nodes (0 LN, surrogate for no supraclavicular RT), nonirradiated patients, and controls. Proportional hazards models tested associations of LN, RT, and breast cancer status with hypothyroidism. RESULTS. The 5-year incidence of hypothyroidism was identical (14%) in irradiated patients with 4 + LN, 0 LN, and nonirradiated patients (P = .52). After adjusting for sociodemographic and clinical characteristics, hypothyroidism risk was not increased in irradiated patients with 4 + LN versus 0 LN (hazard ratio(HR) = 1.04; 95% confidence interval (CI), 0.89–1.23). However, all patients, regardless of RT status, were more likely to be diagnosed with hypothyroidism compared with cancer-free controls (HR = 1.21; 95% CI, 1.17–1.25). CONCLUSIONS. Development of hypothyroidism is fairly common in older breast cancer survivors. Although supraclavicular irradiation does not appear to amplify risks, further studies on the role of routine thyroid function monitoring in all breast cancer patients regardless of treatment status may be warranted, given the excess risks compared with the general population. Cancer 2008. ©2008 American Cancer Society.

6597 Background: Studies documenting high costs of cancer drugs often focus on targeted therapies as a whole without differentiating between oral and intravenous agents; such distinction is importa...

392 Background: Octreotide long-acting repeatable (LAR) is approved for the management of symptoms due to carcinoid syndrome and may delay tumor progression among patients with neuroendocrine tumors (NETs). It is unknown whether dosage of octreotide LAR has an impact on survival. The current analysis evaluates the impact of initial octreotide LAR dosage on survival of elderly patients with NETs. Methods: Distant stage NET patients diagnosed between 1/1999 and 12/2009 who had received octreotide LAR treatment within 12 months of diagnosis were identified from the SEER-Medicare database. Those under age 65, enrolled in HMOs, or without continuous enrollment in Medicare Parts A and B were excluded. We compared the five-year survival of NET patients based on dose per 28 days averaged over the initial 3 months: Group A, 30 mg. Kaplan-Meier estimations and Cox proportional hazard modeling were used to examine the association between octreotide LAR dose and survival. Results: Among 214 distant stage patients (mean and median age at 74 years old) with octreotide LAR treatment, 73 (34%) received 30 mg. Median survival for patients who received low, medium and high dosage levels were 20.8 (95% CI: 13.2 – 31.5), 32.6 (95% CI: 20.5 – 51.1), and 36.3 (95% CI: 24.8 – N/A) months respectively. The log rank test had a p-value of 0.006. Multivariate analyses showed that higher octreotide LAR dosage levels were associated with significant survival improvement for distant stage patients. Compared to patients with the low dosage level, patients with medium dosage (HR=0.52, P=0.002) and patients with high dosage (HR=0.48, P=0.004) had better five-year survival. The difference in survival between Groups B and C was not statistically significant. Conclusions: This population-based study suggests potential survival benefits for octreotide LAR 30 mg dosage level among elderly distant stage NET patients.

Low-molecular-weight heparin (LMWH) has shown to be as effective as unfractionated heparin (UFH) in the treatment of deep venous thrombosis (DVT). Although the acquisition cost of LMWH is significantly greater than that of UFH, we hypothesized that once-daily dalteparin, a LMWH, could reduce treatment costs of cancer patients with DVT by eliminating anticoagulation monitoring and shortening hospitalization.We developed a cost-minimization model by using outcomes and resource utilization data from two retrospective matched cohorts of cancer patients who, between 1994 and 1999, were hospitalized at our comprehensive cancer center for treatment of DVT with either LMWH ( n=21) or UFH ( n=168). We assumed all LMWHs and UFH to be equally effective. The total costs for the dalteparin strategy and the UFH strategy were calculated in year 2003 U.S. dollars, from the provider's perspective, by multiplying the number of resources used for inpatient treatment of DVT by their unit costs.The mean total cost for inpatient care was $3,383 US dollars (95% CI= $2,683- $4,083) for dalteparin and $4,952 US dollars (95% CI=$4,718-$5,185) for UFH. Substantial savings resulted from shorter hospitalization among the dalteparin-treated patients (mean 3.19 versus 5.22 days). Sensitivity analysis did not change the conclusion that dalteparin is less expensive than UFH.Savings realized from less anticoagulant monitoring and shorter hospitalization offset the higher acquisition cost of dalteparin. The dalteparin strategy is less expensive than the UFH strategy for the inpatient treatment of DVT among cancer patients.

4112 Background: OCT-L is approved in the US for the management of secretory syndromes among patients with NETs. Two placebo-controlled studies have recently demonstrated that somatostatin analogue...

51 Background: Robotic-assisted radical prostatectomy (RARP) remains controversial due to exaggerated marketing claims, higher costs, hidden risks, and few clinically significant benefits, including an absence of improved cancer control compared to open radical prostatectomy (ORP). The purpose of our study is to compare surgical margin status by surgical approach. Methods: We identified 13,434 men with a histologically confirmed, non-metastatic prostate cancer treated with RARP versus ORP during 2004 and 2009 from Surveillance, Epidemiology, and End Results (SEER)–Medicare linked data. Propensity-based analyses were performed to minimize treatment selection biases. Generalized linear regression models were computed for comparison of radical prostatectomy surgical margin status by surgical approach. Results: During the study period, 5,556 and 7,878 men underwent RARP and ORP, respectively. In the propensity-adjusted cohort, the incidence of positive surgical margins was significantly lower among men undergoing RARP versus ORP (13.7% vs. 18.4%, odds ratio [OR]: 0.68, 95% confidence interval [CI]: 0.63–0.73, p

457 Background: The tx paradigm for mRCC has rapidly morphed from cytokine-based and cytotoxic tx to targeted therapy (TT). Five oral (O) and two intravenous (IV) TTs are approved for mRCC. No consensus exists on the sequence of TT use. This study aimed to examine the evolution of 1st through 3rd line tx patterns since 2004 and their associated costs. Methods: LifeLink Health Plan Claims Database (October 1, 2003-March 31, 2011), a commercial claims database, was used to create a cohort of age ≥ 18 yo, mRCC pts with at least 12 months of continuous enrollment. We examined tx patterns and sequences by year. When evaluating cost, we limited analysis to pts st line tx, 8 for 2nd, 8 for 3rd; most common 1st/2nd/3rd line tx was sunitinib (44%)/temsirolimus (24%)/everolimus=sunitinib (26%); most common sequence was VEGF->mTOR for the 1st switch and VEGF->VEGF->VEGF for 2nd switch. From 2004 to 2011, 1st line cytotoxic tx decreased from 47% to 6%, IFN-α from 47% to 3%, bevacizumab from 33% to 9%. Over time, more pts were able to go from 1st to 2nd line tx (p=0.01) and 2nd to 3rd line tx (p=0.025). Median time to switch (TTS) from 1st to 2nd line was 175 days (SD 103) with a longer TTS if started on O vs. IV tx (188 vs. 143 days) (pst line tx was O or IV, mean total 1st-yr tx cost/pt was $130,962 (IV) vs. $121,676 (O) (P=0.18) and total 1st-yr Rx cost was $36,636 (IV) vs. $54,596 (O) (p 1 switch. Conclusions: The results support a drastic shift in the tx of mRCC with wide heterogeneity in tx patterns, reflecting a lack of clear guidelines. Over the years, more pts are able to receive more lines of tx, TTS was longer with initial O tx, but 1st-yr Rx costs were lower with initial IV tx.