An Exploratory Analysis of the Cost-Effectiveness of a Multi-cancer Early Detection Blood Test Compared with Standard of Care Screening in Ontario, Canada.

BACKGROUND: Determining whether multi-cancer early detection (MCED) tests are cost effective is important in deciding whether they should be included in the clinical path of cancer care, especially for cancers where screening tools do not exist. RESEARCH OBJECTIVE: The main objective of this study is to determine the cost effectiveness of including a MCED screening regimen together with existing provincial screening protocols for selected cancers that are prevalent in Ontario, Canada, among average risk persons aged 50-75 years. The selected cancers include breast, colorectal, lung, esophageal, liver, pancreatic, stomach, and ovarian. METHODS: Cost effectiveness was estimated from a provincial Ministry of Health perspective. A state-transition Markov model representing the decision path of both the proposed and existing screening strategies along the natural history of the selected types of cancers was implemented. The incremental cost-effectiveness ratio (ICER) was calculated using data from available literature and the guidelines published by the Canadian Agency for Drugs and Technologies in Health (CADTH) for conducting a cost-effectiveness analysis, which included a discount rate of 1.5% applied to all costs and outcomes. Costs were also converted to 2022 Canadian dollars. To test the robustness of the model, both univariate and probabilistic sensitivity analyses were conducted. RESULTS: MCED screening resulted in more diagnosed cases of each type of cancer, even at an earlier stage of disease. This was also associated with fewer related deaths compared with standard of care. Notwithstanding, the analysis revealed that the MCED intervention was not cost effective [ICER: CAD$143,369 per quality-adjusted life year (QALY)], given a willingness to pay (WTP) threshold of $100,000 per QALY. The probabilistic sensitivity analyses revealed that the MCED intervention strategy was preferred to standard of care no more than 2% of the time at this WTP for both males and females. The model was most sensitive to the cost of MCED screening, and the levels of specificity of the MCED and colorectal cancer screening tests. CONCLUSION: The main contribution of the study is to present and execute a methodological approach that can be adopted to test the cost effectiveness of an MCED tool in the Canadian setting. The model is also sufficiently generic that it could be adapted to other jurisdictions, and with consideration for increasing the WTP threshold beyond the common $100,000 per QALY limit, given the life-threatening nature of cancer, to ensure that MCED interventions are cost-effective.

Vertical integration of oncologists and cancer outcomes and costs in metastatic castration-resistant prostate cancer.

BACKGROUND: The share of oncology practices owned by hospitals (ie, vertically integrated) nearly doubled from 2007 to 2017. We examined how integration between hospitals and oncologists affected care quality, outcomes, and spending among metastatic castration-resistant prostate cancer (mCRPC) patients. METHODS: Using Surveillance, Epidemiology, and End Results-Medicare linked data and the Medicare Data on Provider Practice and Specialty, we identified Medicare beneficiaries who initiated systemic therapy for mCRPC between 2008 and 2017 (n = 9172). Primary outcomes included 1) bone-modifying agents (BMA) use, 2) time on systemic therapy, 3) survival, and 4) Medicare spending for the first 3 months following therapy initiation. We used a differences-in-differences approach to estimate the impact of vertical integration on outcomes, adjusting for patient and provider characteristics. RESULTS: The proportion of patients treated by integrated oncologists increased from 28% to 55% from 2008 to 2017. Vertical integration was associated with an 11.7 percentage point (95% confidence interval [CI] = 4.2 to 19.1) increased likelihood of BMA use. There were no satistically significant changes in time on systemic therapy, survival, or total per-patient Medicare spending. Further decomposition showed an increase in outpatient payment ($5190, 95% CI = $1451 to $8930) and decrease in professional service payment (-$4757, 95% CI = -$7644 to -$1870) but no statistically significant changes for other service types (eg, inpatient and prescription drugs). CONCLUSIONS: Vertical integration was associated with statistically significant increased BMA use but not with other cancer outcomes among mCRPC patients. For oncologists who switched service billing from physician offices to outpatient departments, there was no statistically significant change in overall Medicare spending in the first 3 months of therapy initiation. Future studies should extend the investigation to other cancer types and patient outcomes.

Health Economics Research in Cancer Screening: Research Opportunities, Challenges, and Future Directions.

Cancer screening has long been considered a worthy public health investment. Health economics offers the theoretical foundation and research methodology to understand the demand- and supply-side factors associated with screening and evaluate screening-related policies and interventions. This article provides an overview of health economic theories and methods related to cancer screening and discusses opportunities for future research. We review 2 academic disciplines most relevant to health economics research in cancer screening: applied microeconomics and decision science. We consider 3 emerging topics: cancer screening policies in national as well as local contexts, "choosing wisely" screening practices, and targeted screening efforts for vulnerable subpopulations. We also discuss the strengths and weaknesses of available data sources and opportunities for methodological research and training. Recommendations to strengthen research infrastructure include developing novel data linkage strategies, increasing access to electronic health records, establishing curriculum and training programs, promoting multidisciplinary collaborations, and enhancing research funding opportunities.

A History of Health Economics and Healthcare Delivery Research at the National Cancer Institute.

With increased attention to the financing and structure of healthcare, dramatic increases in the cost of diagnosing and treating cancer, and corresponding disparities in access, the study of healthcare economics and delivery has become increasingly important. The Healthcare Delivery Research Program (HDRP) in the Division of Cancer Control and Population Sciences at the National Cancer Institute (NCI) was formed in 2015 to provide a hub for cancer-related healthcare delivery and economics research. However, the roots of this program trace back much farther, at least to the formation of the NCI Division of Cancer Prevention and Control in 1983. The creation of a division focused on understanding and explaining trends in cancer morbidity and mortality was instrumental in setting the direction of cancer-related healthcare delivery and health economics research over the subsequent decades. In this commentary, we provide a brief history of health economics and healthcare delivery research at NCI, describing the organizational structure and highlighting key initiatives developed by the division, and also briefly discuss future directions. HDRP and its predecessors have supported the growth and evolution of these fields through the funding of grants and contracts; the development of data, tools, and other research resources; and thought leadership including stimulation of research on previously understudied topics. As the availability of new data, methods, and computing capacity to evaluate cancer-related healthcare delivery and economics expand, HDRP aims to continue to support this growth and evolution.

Cancer Health Economics Research: The Future Is Now.

The goals of the "Future of Cancer Health Economics Research" virtual conference were to identify challenges, gaps, and unmet needs for conducting cancer health economics research; and develop suggestions and ideas to address these challenges and to support the development of this field. The conference involved multiple presentations and panels featuring several key themes, including data limitations and fragmentation; improving research methods; role and impacts of structural and policy factors; and the transdisciplinary nature of this field. The conference also highlighted emerging areas such as communicating results with nonresearchers; balancing data accessibility and data security; emphasizing the needs of trainees; and including health equity as a focus in cancer health economics research. From this conference, it is clear that cancer health economics research can have substantial impacts on how cancer care is delivered and how related health-care policies are developed and implemented. To support further growth and development, this field should continue to welcome individuals from multiple disciplines and enhance opportunities for training in economics and in analytic methods and perspectives from across the social and clinical sciences. Researchers should continue to engage with diverse stakeholders throughout the cancer community, building collaborations and focusing on the goal of improving health and well-being.

Evaluating the impact of multicancer early detection testing on health and economic outcomes: Toward a decision modeling strategy.

Emerging data provide initial support for the concept that a single, minimally invasive liquid biopsy test, performed in conjunction with confirmatory radiologic or other diagnostic testing, when indicated, could be deployed on a broad scale to screen individuals for multiple types of cancer. Ideally, such a test could do this in a way that yields a clinically important percentage of true-positive indications of cancer while minimizing false-positive signals. Modern decision modeling approaches can and should be deployed to investigate the health and economic consequences of such multicancer early detection (MCED) testing within defined at-risk populations. In this paper, through small-scale analyses involving 3 hypothetical MCED-detectible cancers, the authors illustrate the potential for MCED testing to be cost-effective, along with the pivotal role of test-induced stage shift on results. The time is ripe for additional, prospective investigations of the clinical value of MCED testing, the benefits versus the risks for screened populations, and the overall projected impact on health outcomes and costs over time.

A framework for cancer health economics research.

LAY SUMMARY: Cancer has substantial economic impacts for patients, their families and/or caregivers, employers, and the health care system. However, there is only limited understanding of how economic issues can affect access to cancer care services and the receipt of high-quality cancer care. Health economics research in cancer is particularly timely due to the large and increasing number of patients with cancer and cancer survivors, but there are many factors that may create barriers to performing cancer health economics research. This commentary has identified important topics and questions in cancer health economics research and will assist in the development of this critical field.

Optimal Surveillance Frequency After CRS/HIPEC for Appendiceal and Colorectal Neoplasms: A Multi-institutional Analysis of the US HIPEC Collaborative.

BACKGROUND: No guidelines exist for surveillance following cytoreductive surgery with hyperthermic intraperitoneal chemotherapy (CRS/HIPEC) for appendiceal and colorectal cancer. The primary objective was to define the optimal surveillance frequency after CRS/HIPEC. METHODS: The U.S. HIPEC Collaborative database (2000-2017) was reviewed for patients who underwent a CCR0/1 CRS/HIPEC for appendiceal or colorectal cancer. Radiologic surveillance frequency was divided into two categories: low-frequency surveillance (LFS) at q6-12mos or high-frequency surveillance (HFS) at q2-4mos. Primary outcome was overall survival (OS). RESULTS: Among 975 patients, the median age was 55 year, 41% were male: 31% had non-invasive appendiceal (n = 301), 45% invasive appendiceal (n = 435), and 24% colorectal cancer (CRC; n = 239). With a median follow-up time of 25 mos, the median time to recurrence was 12 mos. Despite less surveillance, LFS patients had no decrease in median OS (non-invasive appendiceal: 106 vs. 65 mos, p < 0.01; invasive appendiceal: 120 vs. 73 mos, p = 0.02; colorectal cancer [CRC]: 35 vs. 30 mos, p = 0.8). LFS patients had lower median PCI scores compared with HFS (non-invasive appendiceal: 10 vs. 19; invasive appendiceal: 10 vs. 14; CRC: 8 vs. 11; all p < 0.01). However, on multivariable analysis, accounting for PCI score, LFS was still not associated with decreased OS for any histologic type (non-invasive appendiceal: hazard ratio [HR]: 0.28, p = 0.1; invasive appendiceal: HR: 0.73, p = 0.42; CRC: HR: 1.14, p = 0.59). When estimating annual incident cases of CRS/HIPEC at 375 for non-invasive appendiceal, 375 invasive appendiceal and 4410 colorectal, LFS compared with HFS for the initial two post-operative years would potentially save $13-19 M/year to the U.S. healthcare system. CONCLUSIONS: Low-frequency surveillance after CRS/HIPEC for appendiceal or colorectal cancer is not associated with decreased survival, and when considering decreased costs, may optimize resource utilization.

Lung Surveillance Strategy for High-Grade Soft Tissue Sarcomas: Chest X-Ray or CT Scan?

BACKGROUND: Given the propensity for lung metastases, National Comprehensive Cancer Network guidelines recommend lung surveillance with either chest x-ray (CXR) or CT in high-grade soft tissue sarcoma. Considering survival, diagnostic sensitivity, and cost, the optimal modality is unknown. METHODS: The US Sarcoma Collaborative database (2000 to 2016) was reviewed for patients who underwent resection of a primary high-grade soft tissue sarcoma. Primary end point was overall survival (OS). Cost analysis was performed. RESULTS: Among 909 patients, 83% had truncal/extremity and 17% had retroperitoneal tumors. Recurrence occurred in 48%, of which 54% were lung metastases. Lung surveillance was performed with CT in 80% and CXR in 20%. Both groups were clinically similar, although CT patients had more retroperitoneal tumors and recurrences. Regardless of modality, 85% to 90% of lung metastases were detected within the first 2 years with a similar re-intervention rate. When considering age, tumor size, location, margin status, and receipt of radiation, lung metastasis was independently associated with worse OS (hazard ratio 4.26; p < 0.01) and imaging modality was not (hazard ratio 1.01; p = 0.97). Chest x-ray patients did not have an inferior 5-year OS rate compared with CT (71% vs 60%; p < 0.01). When analyzing patients in whom no lung metastases were detected, both cohorts had a similar 5-year OS rate (73% vs 74%; p = 0.42), suggesting CXR was not missing clinically relevant lung nodules. When adhering to a guideline-specified protocol for 2018 projected 4,406 cases, surveillance with CXR for 5 years results in savings of $5 million to $8 million/year to the US healthcare system. CONCLUSIONS: In this large multicenter study, lung surveillance with CXR did not result in worse overall survival compared with CT. With considerable savings, a CXR-based protocol can optimize resource use for lung surveillance in high-grade soft tissue sarcoma; prospective trials are needed.

A Novel Validated Recurrence Risk Score to Guide a Pragmatic Surveillance Strategy After Resection of Pancreatic Neuroendocrine Tumors: An International Study of 1006 Patients.

OBJECTIVE: Despite heterogeneous biology, similar surveillance schemas are utilized after resection of all pancreatic neuroendocrine tumors (PanNETs). Given concerns regarding excess radiation exposure and financial burden, our aim was to develop a prognostic score for disease recurrence to guide individually tailored surveillance strategies. METHODS: All patients with primary nonfunctioning, nonmetastatic well/moderately differentiated PanNETs who underwent curative-intent resection at 9-institutions from 2000 to 2016 were included (n = 1006). A Recurrence Risk Score (RRS) was developed from a randomly selected derivation cohort comprised of 67% of patients and verified on the validation-cohort comprised of the remaining 33%. RESULTS: On multivariable analysis, patients within the derivation cohort (n = 681) with symptomatic tumors (jaundice, pain, bleeding), tumors >2 cm, Ki67 >3%, and lymph node (LN) (+) disease had increased recurrence. Each factor was assigned a score based on their weighted odds ratio that formed a RRS of 0 to 10: symptomatic = 1, tumor >2 cm = 2, Ki67 3% to 20% = 1, Ki67 >20% = 6, LN (+) = 1. Patients were grouped into low- (RRS = 0-2; n = 247), intermediate-(RRS = 3-5; n = 204), or high (RRS = 6-10; n = 9)-risk groups. At 24 months, 33% of high RRS recurred, whereas only 2% of low and 14% of intermediate RRS recurred. This persisted in the validation cohort (n = 325). CONCLUSIONS: This international, novel, internally validated RRS accurately stratifies recurrence-free survival for patients with resected PanNETs. Given their unique recurrence patterns, surveillance intervals of 12, 6, and 3 months are proposed for low, intermediate, and high RRS patients, respectively, to minimize radiation exposure and optimize cost/resource utilization.

Racial and socioeconomic disparities in adherence to preventive health services for ovarian cancer survivors.

PURPOSE: To examine ovarian cancer survivors' adherence to evidence-based guidelines for preventive health care. METHODS: A case-control, retrospective study of Medicare fee-for-service beneficiaries diagnosed with stage I, II, or III epithelial ovarian cancer from 2001 to 2010 using the Surveillance, Epidemiology, and End Results-Medicare database. Survivors were matched 1:1 to non-cancer controls from the 5% Medicare Beneficiary file on age, race, state of residence, and follow-up time. Receipt of flu vaccination, mammography, and bone density tests were examined in accordance with national guidelines. Adherence was assessed starting 1 year after cancer diagnosis, across 2 years of claims. Interaction with the health care system, including outpatient and cancer surveillance visits, was tested as a potential mechanism for receipt of services. RESULTS: 2437 survivors met the eligibility criteria (mean age, 75; 90% white). Ovarian cancer survivors were more likely to be adherent to flu vaccination (5 percentage points (pp); < 0.001) and mammography guidelines (10 pp.; < 0.001) compared to non-cancer controls, but no differences were found for bone density test guidelines (- 1 pp.; NS). Black women were less likely to be adherent to flu vaccination and bone density tests compared with white women. Women dually eligible for Medicare and Medicaid were less likely to be adherent compared to those without such support. Adherence was not influenced by measures of outpatient visits. CONCLUSION: Ovarian cancer survivors are receiving preventive services with the same or better adherence than their matched counterparts. Minority and dual-eligible survivors received preventive services at a lower rate than white survivors and those with higher income. The number of outpatient visits was not associated with increased preventive health visits. IMPLICATIONS FOR CANCER SURVIVORS: Ovarian cancer survivors are receiving adequate follow-up care to be adherent to preventive health measures. Efforts to improve care coordination post-treatment may help reduce minority and low SES disparities.

Clinical risks and healthcare utilization of hematopoietic cell transplantation for sickle cell disease in the USA using merged databases.

Advances in allogeneic hematopoietic cell transplantation for sickle cell disease have improved outcomes, but there is limited analysis of healthcare utilization in this setting. We hypothesized that, compared to late transplantation, early transplantation (at age <10 years) improves outcomes and decreases healthcare utilization. We performed a retrospective study of children transplanted for sickle cell disease in the USA during 2000-2013 using two large databases. Univariate and Cox models were used to estimate associations of demographics, sickle cell disease severity, and transplant-related variables with mortality and chronic graft-versus-host disease, while Wilcoxon, Kruskal-Wallis, or linear trend tests were applied for the estimates of healthcare utilization. Among 161 patients with a 2-year overall survival rate of 90% (95% confidence interval [CI] 85-95%) mortality was significantly higher in those who underwent late transplantation versus early (hazard ratio (HR) 21, 95% CI 2.8-160.8, P=0.003) and unrelated compared to matched sibling donor transplantation (HR 5.9, 95% CI 1.7-20.2, P=0.005). Chronic graftversus host disease was significantly more frequent among those translanted late (HR 1.9, 95% CI 1.0-3.5, P=0.034) and those who received an unrelated graft (HR 2.5, 95% CI 1.2-5.4; P=0.017). Merged data for 176 patients showed that the median total adjusted transplant cost per patient was $467,747 (range: $344,029-$799,219). Healthcare utilization was lower among recipients of matched sibling donor grafts and those with low severity disease compared to those with other types of donor and disease severity types (P<0.001 and P=0.022, respectively); no association was demonstrated with late transplantation (P=0.775). Among patients with 2-year pre- and post-transplant data (n=41), early transplantation was associated with significant reductions in admissions (P<0.001), length of stay (P<0.001), and cost (P=0.008). Early transplant outcomes need to be studied prospectively in young children without severe disease and an available matched sibling to provide conclusive evidence for the superiority of this approach. Reduced post-transplant healthcare utilization inpatient care indicates that transplantation may provide a sustained decrease in healthcare costs over time.

Socioeconomic Factors Are Associated With Readmission After Lobectomy for Early Stage Lung Cancer.

BACKGROUND: Data regarding risk factors for readmissions after surgical resection for lung cancer are limited and largely focus on postoperative outcomes, including complications and hospital length of stay. The current study aims to identify preoperative risk factors for postoperative readmission in early stage lung cancer patients. METHODS: The National Cancer Data Base was queried for all early stage lung cancer patients with clinical stage T2N0M0 or less who underwent lobectomy in 2010 and 2011. Patients with unplanned readmission within 30 days of hospital discharge were identified. Univariate analysis was utilized to identify preoperative differences between readmitted and not readmitted cohorts; multivariable logistic regression was used to identify risk factors resulting in readmission. RESULTS: In all, 840 of 19,711 patients (4.3%) were readmitted postoperatively. Male patients were more likely to be readmitted than female patients (4.9% versus 3.8%, p < 0.001), as were patients who received surgery at a nonacademic rather than an academic facility (4.6% versus 3.6%; p = 0.001) and had underlying medical comorbidities (Charlson/Deyo score 1+ versus 0; 4.8% versus 3.7%; p < 0.001). Readmitted patients had a longer median hospital length of stay (6 days versus 5; p < 0.001) and were more likely to have undergone a minimally invasive approach (5.1% video-assisted thoracic surgery versus 3.9% open; p < 0.001). In addition to those variables, multivariable logistic regression analysis identified that median household income level, insurance status (government versus private), and geographic residence (metropolitan versus urban versus rural) had significant influence on readmission. CONCLUSIONS: The socioeconomic factors identified significantly influence hospital readmission and should be considered during preoperative and postoperative discharge planning for patients with early stage lung cancer.

Assessing Colorectal Cancer Screening Adherence of Medicare Fee-for-Service Beneficiaries Age 76 to 95 Years.

INTRODUCTION: There are concerns about potential overuse of colorectal cancer (CRC) screening services among average-risk individuals older than age 75 years. MATERIALS AND METHODS: Using a 5% random noncancer sample of Medicare beneficiaries who resided in the SEER areas, we examined rates of CRC screening adherence, defined by the Medicare coverage policy, among average-risk fee-for-service beneficiaries age 76 to 95 years from 2002 to 2010. The two outcomes are the status of overall CRC screening adherence, and the status of adherence to colonoscopy (v other modalities) conditional on patient adherence. RESULTS: Overall CRC screening adherence rates of Medicare beneficiaries age 76 to 95 years increased from 13.0% to 21.4% from 2002 to 2010. In 2002, 2.2% of beneficiaries were adherent to colonoscopy, and 10.7%, by other modalities; the corresponding rates were 19.5% and 1.9%, respectively, in 2010. Specifically, rates of adherence to colonoscopy were 1.1% for those age 86 to 90 years and almost nil for those age 91 to 95 years in 2002, but the rates became 13.5% and 8.2%, respectively, in 2010. Compared with white beneficiaries, black beneficiaries age 76 to 95 years had a 7-percentage-point lower adherence rate. However, overall adherence rates among blacks increased by 168.6% from 2002 to 2010, whereas rates among whites increased by 63.0%. Logistic regressions showed that blacks age 86 to 95 years were less likely than whites to be adherent (odds ratio, 0.56; 95% CI, 0.47 to 0.59) but were more likely to be adherent to colonoscopy (odds ratio, 2.34; 95% CI, 1.47 to 3.91). CONCLUSION: High proportions of average-risk Medicare fee-for-service beneficiaries screened by colonoscopy may represent opportunities for improving appropriateness and allocative efficiency of CRC screening by Medicare.

What Predicts an Advanced-Stage Diagnosis of Breast Cancer? Sorting Out the Influence of Method of Detection, Access to Care, and Biologic Factors.

BACKGROUND: Multiple studies have yielded important findings regarding the determinants of an advanced-stage diagnosis of breast cancer. We seek to advance this line of inquiry through a broadened conceptual framework and accompanying statistical modeling strategy that recognize the dual importance of access-to-care and biologic factors on stage. METHODS: The Centers for Disease Control and Prevention-sponsored Breast and Prostate Cancer Data Quality and Patterns of Care Study yielded a seven-state, cancer registry-derived population-based sample of 9,142 women diagnosed with a first primary in situ or invasive breast cancer in 2004. The likelihood of advanced-stage cancer (American Joint Committee on Cancer IIIB, IIIC, or IV) was investigated through multivariable regression modeling, with base-case analyses using the method of instrumental variables (IV) to detect and correct for possible selection bias. The robustness of base-case findings was examined through extensive sensitivity analyses. RESULTS: Advanced-stage disease was negatively associated with detection by mammography (P < 0.001) and with age < 50 (P < 0.001), and positively related to black race (P = 0.07), not being privately insured [Medicaid (P = 0.01), Medicare (P = 0.04), uninsured (P = 0.07)], being single (P = 0.06), body mass index > 40 (P = 0.001), a HER2 type tumor (P < 0.001), and tumor grade not well differentiated (P < 0.001). This IV model detected and adjusted for significant selection effects associated with method of detection (P = 0.02). Sensitivity analyses generally supported these base-case results. CONCLUSIONS: Through our comprehensive modeling strategy and sensitivity analyses, we provide new estimates of the magnitude and robustness of the determinants of advanced-stage breast cancer. IMPACT: Statistical approaches frequently used to address observational data biases in treatment-outcome studies can be applied similarly in analyses of the determinants of stage at diagnosis. Cancer Epidemiol Biomarkers Prev; 25(4); 613-23. ©2016 AACR.

Necitumumab in Metastatic Squamous Cell Lung Cancer: Establishing a Value-Based Cost.

IMPORTANCE: The SQUIRE trial demonstrated that adding necitumumab to chemotherapy for patients with metastatic squamous cell lung cancer (mSqCLC) increased median overall survival by 1.6 months (hazard ratio, 0.84). However, the costs and value associated with this intervention remains unclear. Value-based pricing links the price of a drug to the benefit that it provides and is a novel method to establish prices for new treatments. OBJECTIVE: To evaluate the range of drug costs for which adding necitumumab to chemotherapy could be considered cost-effective. DESIGN, SETTING, AND PARTICIPANTS: We developed a Markov model using data from multiple sources, including the SQUIRE trial, which compared standard chemotherapy with and without necitumumab as first-line treatment of mSqCLC, to evaluate the costs and patient life expectancies associated with each regimen. In the analysis, patients were modeled to receive gemcitabine and cisplatin for 6 cycles or gemcitabine, cisplatin, and necitumumab for 6 cycles followed by maintenance necitumumab. Our model's clinical inputs were the survival estimates and frequency of adverse events (AEs) described in the SQUIRE trial. Log-logistic models were fitted to the survival distributions in the SQUIRE trial. The cost inputs included drug costs, based on the Medicare average sale prices, and costs for drug administration and management of AEs, based on Medicare reimbursement rates (all in 2014 US dollars). MAIN OUTCOMES AND MEASURES: We evaluated incremental cost-effectiveness ratios (ICERs) for the use of necitumumab across a range of values for its cost. Model robustness was assessed by probabilistic sensitivity analyses, based on 10 000 Monte Carlo simulations, sampling values from the distributions of all model parameters. RESULTS: In the base case analysis, the addition of necitumumab to the treatment regimen produced an incremental survival benefit of 0.15 life-years and 0.11 quality-adjusted life-years (QALYs). The probabilistic sensitivity analyses established that when necitumumab cost less than $563 and less than $1309 per cycle, there was 90% confidence that the ICER for adding necitumumab would be less than $100 000 per QALY and less than $200 000 per QALY, respectively. CONCLUSIONS AND RELEVANCE: These findings provide a value-based range for the cost of necitumumab from $563 to $1309 per cycle. This study provides a framework for establishing value-based pricing for new oncology drugs entering the US marketplace.

Cost-Effectiveness Analysis of Regorafenib for Metastatic Colorectal Cancer.

PURPOSE: Regorafenib is a standard-care option for treatment-refractory metastatic colorectal cancer that increases median overall survival by 6 weeks compared with placebo. Given this small incremental clinical benefit, we evaluated the cost-effectiveness of regorafenib in the third-line setting for patients with metastatic colorectal cancer from the US payer perspective. METHODS: We developed a Markov model to compare the cost and effectiveness of regorafenib with those of placebo in the third-line treatment of metastatic colorectal cancer. Health outcomes were measured in life-years and quality-adjusted life-years (QALYs). Drug costs were based on Medicare reimbursement rates in 2014. Model robustness was addressed in univariable and probabilistic sensitivity analyses. RESULTS: Regorafenib provided an additional 0.04 QALYs (0.13 life-years) at a cost of $40,000, resulting in an incremental cost-effectiveness ratio of $900,000 per QALY. The incremental cost-effectiveness ratio for regorafenib was > $550,000 per QALY in all of our univariable and probabilistic sensitivity analyses. CONCLUSION: Regorafenib provides minimal incremental benefit at high incremental cost per QALY in the third-line management of metastatic colorectal cancer. The cost-effectiveness of regorafenib could be improved by the use of value-based pricing.

Nonclinical Factors Associated with 30-Day Mortality after Lung Cancer Resection: An Analysis of 215,000 Patients Using the National Cancer Data Base.

BACKGROUND: Clinical variables associated with 30-day mortality after lung cancer surgery are well known. However, the effects of nonclinical factors, including insurance coverage, household income, education, type of treatment center, and area of residence, on short-term survival are less appreciated. We studied the National Cancer Data Base, a joint endeavor of the Commission on Cancer of the American College of Surgeons and the American Cancer Society, to identify disparities in 30-day mortality after lung cancer resection based on these nonclinical factors. STUDY DESIGN: We performed a retrospective cohort analysis of patients undergoing lung cancer resection from 2003 to 2011 using the National Cancer Data Base. Data were analyzed using a multivariable logistic regression model to identify risk factors for 30-day mortality. RESULTS: During our study period, 215,645 patients underwent lung cancer resection. We found that clinical variables, such as age, sex, comorbidity, cancer stage, preoperative radiation, extent of resection, positive surgical margins, and tumor size were associated with 30-day mortality after resection. Nonclinical factors, including living in lower-income neighborhoods with a lesser proportion of high school graduates, and receiving cancer care at a nonacademic medical center were also independently associated with increased 30-day postoperative mortality. CONCLUSIONS: This study represents the largest analysis of 30-day mortality for lung cancer resection to date from a generalizable national cohort. Our results demonstrate that, in addition to known clinical risk factors, several nonclinical factors are associated with increased 30-day mortality after lung cancer resection. These disparities require additional investigation to improve lung cancer patient outcomes.

Leveraging state cancer registries to measure and improve the quality of cancer care: a potential strategy for California and beyond.

Despite recent increased attention to healthcare performance and the burden of disease from cancer, measures of quality of cancer care are not readily available. In 2013, the California HealthCare Foundation convened an expert workgroup to explore the potential for leveraging data in the California Cancer Registry (CCR), one of the world's largest population-based cancer registries, for measuring and improving the quality of cancer care. The workgroup assessed current registry operations, the value to be gained by linking CCR data with health insurance claims or encounter data and clinical data contained in health system electronic health records, and potential barriers to these linkages. The workgroup concluded that: 1) The CCR mandate should be expanded to include use of its data for quality of cancer care measurement and public reporting; and 2) a system should be developed to support linkage of registry data with both claims data and provider electronic health record data.