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OBJECTIVES: To evaluate outcomes and cost-effectiveness of targeted therapy sequencing for metastatic and recurrent cervical cancer. METHOD: Models were simulated based on phase II and III trials on bevacizumab (bev) from GOG-240, cemiplimab (cemi) from GOG 3016, pembrolizumab (pembro) from KEYNOTE-826, and tisotumab vedotin (tiso) from GOG 3023. Costs were based on IBM Micromedex RED BOOK™ and company listed costs. RESULTS: For [chemo + bev → chemo], total cost was $125,918.04, with median overall survival (mOS) of 21.8 months, and cost-effectiveness ratio (CER) of $119,835.79. For [chemo + bev → cemi], total cost was $187,562.99 with mOS of 28.5 months and CER of $162,039.16. For [chemo + bev + pembro → chemo], total cost was $319,963.78 with mOS 32.9 months and CER of $249,930.10. For [chemo + bev + pembro → tiso], total cost was $455,204.45, with mOS 36.5 months and CER of $320,072.99. CONCLUSION: The combination of immunotherapies and biologics have significantly increased overall survival, but with associated higher costs, primarily related to drug costs.

Multi-cancer gene panels for hereditary cancer syndromes (hereditary cancer panels, HCPs) are widely available, and some laboratories have programs that limit patients' out-of-pocket (OOP) cost share. However, little is known about practices by cancer genetic counselors for discussing and ordering an HCP and how insurance reimbursement and patient out-of-pocket share impact these practices. We conducted a survey of cancer genetic counselors based in the United States through the National Society of Genetic Counselors to assess the impact of reimbursement and patient OOP share on ordering of an HCP and hereditary cancer genetic counseling. Data analyses were conducted using chi-square and t tests. We received 135 responses (16% response rate). We found that the vast majority of respondents (94%, 127/135) ordered an HCP for patients rather than single-gene tests to assess hereditary cancer predisposition. Two-thirds of respondents reported that their institution had no protocol related to discussing HCPs with patients. Most respondents (84%, 114/135) indicated clinical indications and patients' requests as important in selecting and ordering HCPs, while 42%, 57/135, considered reimbursement and patient OOP share factors important. We found statistically significant differences in reporting of insurance as a frequently used payment method for HCPs and in-person genetic counseling (84% versus 59%, respectively, p

Older patients and those who require interpreters are least likely to use telehealth for gynecologic oncology care, showing disparities which continued after statewide vaccinations.

PurposeTo assess the impact of Lean primary care redesigns on the amount of time that physicians spent working each day.MethodsThis observational study was based on 92 million time-stamped Epic® EHR access logs captured among 317 primary care physicians in a large ambulatory care delivery system. Seventeen clinic facilities housing 46 primary care departments were included for study. We conducted interrupted time series analysis to monitor changes in physician work patterns over 6 years. Key measures included total daily work time; time spent on "desktop medicine" outside the exam room; time spent with patients during office visits; time still working after clinic, i.e., after seeing the last patient each day; and remote work time.ResultsThe amount of time that physicians spent on desktop EHR activities throughout the day, including after clinic hours, decreased by 10.9% (95% CI: -22.2, -2.03) and 8.3% (95% CI: -13.8, -2.12), respectively, during the first year of Lean implementation. Total daily work hours among physicians, which included both desktop activity and time in office visits, decreased by 20% (95% CI: -29.2, -9.60) by the third year of Lean implementation.ConclusionsThese findings suggest that Lean redesign may be associated with time savings for primary care physicians. However, since this was an observational analysis, further study is warranted (e.g., randomized trial) -to determine the impact of Lean interventions on physician work experiences.

BackgroundAlthough lung cancer incidence rates according to smoking status, sex, and detailed race/ethnicity have not been available, it is estimated that more than half of Asian American, Native Hawaiian, and Pacific Islander (AANHPI) females with lung cancer have never smoked.MethodsWe calculated age-adjusted incidence rates for lung cancer according to smoking status and detailed race/ethnicity among females, focusing on AANHPI ethnic groups, and assessed relative incidence across racial/ethnic groups. We used a large-scale dataset that integrates data from electronic health records from 2 large health-care systems-Sutter Health in Northern California and Kaiser Permanente Hawai'i-linked to state cancer registries for incident lung cancer diagnoses between 2000 and 2013. The study population included 1 222 694 females (n = 244 147 AANHPI), 3297 of which were diagnosed with lung cancer (n = 535 AANHPI).ResultsIncidence of lung cancer among never-smoking AANHPI as an aggregate group was 17.1 per 100 000 (95% confidence interval [CI] = 14.9 to 19.4) but varied widely across ethnic groups. Never-smoking Chinese American females had the highest rate (22.8 per 100 000, 95% CI = 17.3 to 29.1). Except for Japanese American females, incidence among every never-smoking AANHPI female ethnic group was higher than that of never-smoking non-Hispanic White females, from 66% greater among Native Hawaiian females (incidence rate ratio = 1.66, 95% CI = 1.03 to 2.56) to more than 100% greater among Chinese American females (incidence rate ratio = 2.26, 95% CI = 1.67 to 3.02).ConclusionsOur study revealed high rates of lung cancer among most never-smoking AANHPI female ethnic groups. Our approach illustrates the use of innovative data integration to dispel the myth that AANHPI females are at overall reduced risk of lung cancer and demonstrates the need to disaggregate this highly diverse population.

BackgroundA relatively high proportion of Asian American, Native Hawaiian, and Pacific Islander (AANHPI) females with lung cancer have never smoked. We used an integrative data approach to assemble a large-scale cohort to study lung cancer risk among AANHPIs by smoking status with attention to representation of specific AANHPI ethnic groups.MethodsWe leveraged electronic health records (EHRs) from two healthcare systems-Sutter Health in northern California and Kaiser Permanente Hawai'i-that have high representation of AANHPI populations. We linked EHR data on lung cancer risk factors (i.e., smoking, lung diseases, infections, reproductive factors, and body size) to data on incident lung cancer diagnoses from statewide population-based cancer registries of California and Hawai'i for the period between 2000 and 2013. Geocoded address data were linked to data on neighborhood contextual factors and regional air pollutants.ResultsThe dataset comprises over 2.2 million adult females and males of any race/ethnicity. Over 250,000 are AANHPI females (19.6% of the female study population). Smoking status is available for over 95% of individuals. The dataset includes 7,274 lung cancer cases, including 613 cases among AANHPI females. Prevalence of never-smoking status varied greatly among AANHPI females with incident lung cancer, from 85.7% among Asian Indian to 14.4% among Native Hawaiian females.ConclusionWe have developed a large, multilevel dataset particularly well-suited to conduct prospective studies of lung cancer risk among AANHPI females who never smoked.ImpactThe integrative data approach is an effective way to conduct cancer research assessing multilevel factors on cancer outcomes among small populations.

ObjectiveTo examine the effect of Lean primary care redesigns on patient satisfaction with care and timeliness of care received.Data/settingWe used patient surveys and time-stamped electronic health record (EHR) data in a large ambulatory care system.DesignLean-based changes to clinical spaces and care team workflows were implemented in one pilot site and then scaled to all primary care departments across the system. Redesigns included standardizing equipment and patient education materials in examination rooms, streamlining call management functions, co-locating physician and medical assistant dyads in a shared workspace, and creating new care team workflows. We used a non-randomized stepped-wedge study design and segmented regression with interrupted time series analysis to examine Lean impacts on patient outcomes.Data collectionWe analyzed patient satisfaction ratings and wait times as documented by the EHR. These longitudinal data were collected for 317 physician-led teams in 46 primary care departments from January 2011 to December 2016.Principal findingsAfter implementation of Lean redesigns, patients reported a 44.8 percent increase in satisfaction with the adequacy of time spent with care providers during office visits (P

BackgroundMany primary care practices have adopted Lean techniques to reduce the amount of time spent completing routine tasks. Few studies have evaluated both immediate and sustained impacts of Lean to improve this aspect of primary care work efficiency.ObjectiveTo examine 3-year impacts of Lean implementation on the amount of time taken for physicians to complete common clinical tasks.DesignNon-randomized stepped wedge with segmented regression and interrupted time series analysis (January 2011-December 2016).ParticipantsA total of 317 physician-led teams in 46 primary care departments in a large ambulatory care delivery system.InterventionLean redesign was initiated in one pilot site followed by system-wide spread across all primary care departments. Redesigns included standardization of exam room equipment and supplies, streamlining of call management processes, care team co-location, and team management of the electronic inbox.MeasuresTime-stamped EHR tracking of physicians' completion time for 4 common tasks: (1) office visit documentation and closure of patient charts; (2) telephone call resolution; (3) prescription refill renewal; and (4) response to electronic patient messages.ResultsAfter Lean implementation, we found decreases in the amount of time to complete: office visit documentation (- 29.2% [95% CI: - 44.2, - 10.1]), telephone resolution (- 22.2% [95% CI: - 38.1, - 2.27]), and renewal of prescription refills (- 2.96% per month [95% CI: - 4.21, - 1.78]). These decreases were sustained over several years. Response time to electronic patient messages did not change significantly.ConclusionsLean redesigns led to improvements in timely completion of 3 out of 4 common clinical tasks. Our findings support the use of Lean techniques to engage teams in routine aspects of patient care. More research is warranted to understand the mechanisms by which Lean promotes quality improvement and effectiveness of care team workflows.

ObjectivesTo examine the temporal trajectory of insurance coverage for next-generation tumor sequencing (sequencing) by private US payers, describe the characteristics of coverage adopters and nonadopters, and explore adoption trends relative to the Centers for Medicare and Medicaid Services' National Coverage Determination (CMS NCD) for sequencing.MethodsWe identified payers with positive coverage (adopters) or negative coverage (nonadopters) of sequencing on or before April 1, 2019, and abstracted their characteristics including size, membership in the BlueCross BlueShield Association, and whether they used a third-party policy. Using descriptive statistics, payer characteristics were compared between adopters and nonadopters and between pre-NCD and post-NCD adopters. An adoption timeline was constructed.ResultsSixty-nine payers had a sequencing policy. Positive coverage started November 30, 2015, with 1 payer and increased to 33 (48%) as of April 1, 2019. Adopters were less likely to be BlueCross BlueShield members (P < .05) and more likely to use a third-party policy (P < .001). Fifty-eight percent of adopters were small payers. Among adopters, 52% initiated coverage pre-NCD over a 25-month period and 48% post-NCD over 17 months.ConclusionsWe found an increase, but continued variability, in coverage over 3.5 years. Temporal analyses revealed important trends: the possible contribution of the CMS NCD to a faster pace of coverage adoption, the interdependence in coverage timing among BlueCross BlueShield members, the impact of using a third-party policy on coverage timing, and the importance of small payers in early adoption. Our study is a step toward systematic temporal research of coverage for precision medicine, which will inform policy and affordability assessments.

BackgroundThere is tremendous potential to leverage the value gained from integrating electronic health records (EHR) and population-based cancer registry data for research. Registries provide diagnosis details, tumor characteristics, and treatment summaries, while EHRs contain rich clinical detail. A carefully conducted cancer registry linkage may also be used to improve the internal and external validity of inferences made from EHR-based studies.MethodsWe linked the EHRs of a large, multispecialty, mixed-payer health care system with the statewide cancer registry and assessed the validity of our linked population. For internal validity, we identify patients that might be "missed" in a linkage, threatening the internal validity of an EHR study population. For generalizability, we compared linked cases with all other cancer patients in the 22-county EHR catchment region.ResultsFrom an EHR population of 4.5 million, we identified 306,554 patients with cancer, 26% of the catchment region patients with cancer; 22.7% of linked patients were diagnosed with cancer after they migrated away from our health care system highlighting an advantage of system-wide linkage. We observed demographic differences between EHR patients and non-EHR patients in the surrounding region and demonstrated use of selection probabilities with model-based standardization to improve generalizability.ConclusionsOur experiences set the foundation to encourage and inform researchers interested in working with EHRs for cancer research as well as provide context for leveraging linkages to assess and improve validity and generalizability.ImpactResearchers conducting linkages may benefit from considering one or more of these approaches to establish and evaluate the validity of their EHR-based populations.See all articles in this CEBP Focus section, "Modernizing Population Science."

Background Recent therapeutic advances have improved survival among lung cancer (LC) patients, who are now at high risk of second primary lung cancer (SPLC). Hispanics comprise the largest minority in the United States, who have shown a lower LC incidence and mortality than other races, and yet their SPLC risk is poorly understood. We quantified the SPLC incidence patterns among Hispanics vs other races. Methods We used data from the Multiethnic Cohort, a population-based cohort of 5 races (African American, Japanese American, Hispanic, Native Hawaiian, and White), recruited between 1993 and 1996 and followed through 2017. We identified patients diagnosed with initial primary lung cancer (IPLC) and SPLC via linkage to Surveillance, Epidemiology, and End Results registries. We estimated the 10-year cumulative incidence of IPLC (in the entire cohort) and SPLC (among IPLC patients). A standardized incidence ratio (SIR) was calculated as the ratio of SPLC-to-IPLC incidence by race and ethnicity. Results Among 202 692 participants, 6788 (3.3%) developed IPLC over 3 871  417 person-years. The 10-year cumulative IPLC incidence was lower among Hispanics (0.80%, 0.72 to 0.88) vs Whites (1.67%, 1.56 to 1.78) or Blacks (2.44%, 2.28 to 2.60). However, the 10-year SPLC incidence following IPLC was higher among Hispanics (3.11%, 1.62 to 4.61) vs Whites (2.80%, 1.94 to 3.66) or Blacks (2.29%, 1.48 to 3.10), resulting in a significantly higher SIR for Hispanics (SIR = 8.27, 5.05 to 12.78) vs Whites (SIR = 5.60, 4.11 to 7.45) or Blacks (SIR = 3.48, 2.42 to 4.84; P  < .001). Conclusion Hispanics have a higher SPLC incidence following IPLC than other races, which may be potentially due to better survival after IPLC and extended duration for SPLC development. Continuing surveillance is warranted to reduce racial disparities among LC survivors. [ABSTRACT FROM AUTHOR]

PurposeThere is uncertainty about when personalized medicine tests provide economic value. We assessed evidence on the economic value of personalized medicine tests and gaps in the evidence base.MethodsWe created a unique evidence base by linking data on published cost-utility analyses from the Tufts Cost-Effectiveness Analysis Registry with data measuring test characteristics and reflecting where value analyses may be most needed: (i) tests currently available or in advanced development, (ii) tests for drugs with Food and Drug Administration labels with genetic information, (iii) tests with demonstrated or likely clinical utility, (iv) tests for conditions with high mortality, and (v) tests for conditions with high expenditures.ResultsWe identified 59 cost-utility analyses studies that examined personalized medicine tests (1998-2011). A majority (72%) of the cost/quality-adjusted life year ratios indicate that testing provides better health although at higher cost, with almost half of the ratios falling below $50,000 per quality-adjusted life year gained. One-fifth of the results indicate that tests may save money.ConclusionMany personalized medicine tests have been found to be relatively cost-effective, although fewer have been found to be cost saving, and many available or emerging medicine tests have not been evaluated. More evidence on value will be needed to inform decision making and assessment of genomic priorities.

AimsTrastuzumab, one of the best known examples of personalized medicine, requires regular cardiac monitoring because it can cause heart failure. We aimed to assess the utilization of cardiac monitoring in women with nonmetastatic breast cancer receiving trastuzumab-based chemotherapy in routine clinical practice.Patients & methodsThe medical records of women continuously enrolled in a large national health insurance plan who were diagnosed with nonmetastatic breast cancer and treated with trastuzumab from 2006 to 2008 were reviewed (n = 109). The primary outcome variables were the use and type of cardiac monitoring testing before and during trastuzumab therapy. An exploratory multivariable logistic regression analysis was performed to identify predictors for receiving cardiac monitoring both at baseline and during trastuzumab treatment.ResultsMonitoring both before and during therapy was less common (62%), although 74% had cardiac monitoring before therapy and 80% had at least one test during therapy. Radionuclide ventriculogram was utilized more often than echocardiography (48 vs 42%). Only the use of anthracycline (odds ratio: 2.39; 95% CI: 1.01-5.71) was significantly associated with use of a cardiac monitoring both at baseline and during trastuzumab treatment.ConclusionThe use of cardiac monitoring testing was variable and opportunities to improve quality and reduce cost are evident. These results have clinical implications for other personalized medicine interventions requiring regular laboratory monitoring.

The objective of this paper is to provide an overview of economic evaluation of personalized medicine, focusing particularly on the use of cost-effectiveness analysis and other methods of valuation. We draw on insights from the literature and our work at the University of California, San Francisco Center for Translational and Policy Research on Personalized Medicine (TRANSPERS). We begin with a discussion of why personalized medicine is of interest and challenges to adoption, whether personalized medicine is different enough to require different evaluation approaches, and what is known about the economics of personalized medicine. We then discuss insights from TRANSPERS research and six areas for future research: Develop and Apply Multiple Methods of Assessing Value Identify Key Factors in Determining the Value of Personalized Medicine Use Real World Perspectives in Economic Analyses Consider Patient Heterogeneity and Diverse Populations in Economic Analyses Prepare for Upcoming Challenges of Assessing Value of Emerging Technologies Incorporate Behavioral Economics into Value Assessments.

Although modest improvements in colorectal cancer (CRC) screening utilization have occurred, rates remain low among Latinos. It is unclear whether acculturation plays a role in the utilization of CRC screening.This study aimed to examine the relationships between acculturation and CRC screening among older Mexican, Puerto-Rican and Cuban adults.Cross-sectional observational study.Latinos 50 years and older, never diagnosed with CRC, and who were surveyed in the 2000, 2003 and 2005 National Health Interview Survey (NHIS).We measured acculturation with US nativity and language of interview, and examined three different CRC screening outcomes: fecal occult blood test (FOBT) in the past year, up-to-date endoscopy and any up-to-date CRC screening. Logistic regression models were adjusted for predisposing, enabling and health-care need factors consistent with the behavioral model of health-care utilization.In adjusted analyses, US nativity was positively associated with up-to-date endoscopy among Mexicans (OR: 1.5; 95% CI: 1.1, 2.2), but negatively associated with FOBT in the past year among Puerto Ricans (OR: 0.3; 95% CI: 0.2, 0.7). In contrast to this latter finding among Puerto Ricans, English language interview was positively associated with FOBT in the past year (OR: 2.5; 95% CI: 1.1, 5.4).Results underscore the importance of stratification by national origin in studies of acculturation and cancer screening and of targeting less acculturated adults to promote CRC screening. Clinicians, however, should consider the complexity of acculturation and treat US nativity and language preference as independent dimensions among their Latino patients.