Multicenter Adoption and Outcomes of Nodal Observation for Patients with Melanoma and Sentinel Lymph Node Metastases.

BACKGROUND: Following publication of the MSLT-II trial showing no survival benefit of completion lymphadenectomy (CLND) in patients with melanoma sentinel lymph node (SLN) metastases, it is expected that practice patterns have changed. The purpose of this study is to understand real-world practices and outcomes after publication of this landmark trial. PATIENTS AND METHODS: Patients with truncal/extremity melanoma SLN metastases diagnosed between 2013 and 2019 at four academic cancer centers were included in this retrospective cohort study. Descriptive statistics, Cox proportional hazards model, and multivariable regression were used to characterize the cohort and identify predictors of CLND, harboring non-SLN (NSLN) metastases, and survival. RESULTS: Results of 1176 patients undergoing SLN biopsy, 183 had SLN metastases. The number of patients who underwent CLND before versus after trial publication was 75.7.% versus 20.5% (HR 0.16, 95% CI 0.09-0.28). Of those undergoing nodal observation (NO), 92% had a first nodal-basin ultrasound, while 63% of patients had a fourth. In exploratory multivariable analyses, age ≥ 50 years was associated with lower rate of CLND (HR 0.58, 95% CI 0.36-0.92) and larger SLN deposit (> 1.0 mm) with increased rate of CLND (HR 1.87, 95% CI 1.17-3.00) in the complete cohort. Extracapsular extension was associated with increased risk of NSLN metastases (HR 12.43, 95% CI 2.48-62.31). Adjusted survival analysis demonstrated no difference in recurrence or mortality between patients treated with CLND versus NO at median 2.2-year follow-up. CONCLUSION: Nodal observation was rapidly adopted into practice in patients with melanoma SLN metastases at four centers in Canada. Younger age and higher nodal burden were associated with increased use of CLND after trial publication. Ultrasound (US) surveillance decreased with time from SLNB. In our study, CLND was not associated with a decreased risk of recurrence or mortality.

Treatment patterns and burden of complications associated with sickle cell disease: A US retrospective claims analysis.

Complications associated with sickle cell disease (SCD) that are highly impactful for patients but until recently have been less understood include priapism, nephropathy, and neurologic injury. We conducted a retrospective study using US administrative claims data from July 01, 2013 through March 31, 2020 to analyze incidence of these complications, SCD treatment patterns, and healthcare resource utilization (HCRU) and costs among 2524 pediatric and adult patients with SCD (mean [SD] age 43.4 [22.4] years). The most common treatments during follow-up were short-acting opioids (54.0% of patients), red blood cell transfusion (15.9%), and hydroxyurea (11.0%). SCD complications occurred frequently; in the overall population, the highest follow-up incidences per 1000 person-years were for acute kidney injury (53.1), chronic kidney disease (40.6), and stroke (39.0). Complications occurred across all age groups but increased in frequency with age; notably, acute kidney injury was 69.7 times more frequent among ages 65+ than ages 0-15 (p < 0.001). Follow-up per-patient-per-month HCRU also increased with age; however, all-cause healthcare costs were similarly high for all age groups and were driven primarily by inpatient stays. Patients with SCD across the age spectrum have a high burden of complications with the use of current treatments, suggesting unmet needs for treatment management.

Propensity to Succeed: Prioritizing Individuals Most Likely to Benefit from Care Coordination.

The objective was to develop a propensity to succeed (PTS) process for prioritizing outreach to individuals with Medicare Supplement (ie, Medigap) plans who qualified for a high-risk case management (HRCM) program. Demographic, socioeconomic, health status, and local health care supply data from previous HRCM program participants and nonparticipants were obtained from Medigap membership and health care claims data and public data sources. Three logistic regression models were estimated to find members with higher probabilities of engaging in the HRCM program, receiving high quality of care once engaged, and incurring enough monetary savings related to program participation to more than offset program costs. The logistic regression model intercepts and coefficients yielded the information required to build predictive models that were then applied to generate predicted probabilities of program engagement, high quality of care, and cost savings a priori for different members who later qualified for the HRCM program. Predicted probabilities from the engagement and cost models were then standardized and combined to obtain an overall PTS score, which was sorted from highest to lowest and used to prioritize outreach efforts to those newly eligible for the HRCM program. The validity of the predictive models also was estimated. The PTS models for engagement and financial savings were statistically valid. The combined PTS score based on those 2 components helped prioritize outreach to individuals who qualified for the HRCM program. Using PTS models may help increase program engagement and financial success of care coordination programs.

An evaluation of the Well at Dell health management program: health risk change and financial return on investment.

PURPOSE: To investigate the effectiveness of the Well at Dell comprehensive health management program in delivering health care and productivity cost savings relative to program investment (i.e., return on investment). DESIGN: A quasi-experimental design was used to quantify the financial impact of the program and nonexperimental pre-post design to evaluate change in health risks. SETTING: Ongoing worksite health management program implemented across multiple U.S. locations. SUBJECTS: Subjects were 24,651 employees with continuous medical enrollment in 2010-2011 who were eligible for 2011 health management programming. INTERVENTION: Incentive-driven, outcomes-based multicomponent corporate health management program including health risk appraisal (HRA)/wellness, lifestyle management, and disease management coaching programs. MEASURES: Medical, pharmacy, and short-term disability pre/post expenditure trends adjusted for demographics, health status, and baseline costs. Self-reported health risks from repeat HRA completers. Analysis: Propensity score-weighted and multivariate regression-adjusted comparison of baseline to post trends in health care expenditures and productivity costs for program participants and nonparticipants (i.e., difference in difference) relative to programmatic investment. RESULTS: The Well at Dell program achieved an overall return on investment of 2.48 in 2011. Most of the savings were realized from the HRA/wellness component of the program. Cost savings were supported with high participation and significant health risk improvement. CONCLUSION: An incentive-driven, well-managed comprehensive corporate health management program can continue to achieve significant health improvement while promoting health care and productivity cost savings in an employee population.

The impact of a value-based insurance design plus health coaching on medication adherence and medical spending.

The objective of this study was to evaluate medication adherence, medical services utilization, and combined medical and pharmacy expenditures associated with diabetes and hypertension value-based insurance design (VBID) plus health/disease coaching programs implemented by a large employer. A pre/post participant versus nonparticipant study design was used to measure medication possession ratios (MPRs), inpatient admissions, emergency room utilization, and combined medical and pharmacy expenditures for employees/spouses with diabetes (n = 1090; average 23 months follow-up) and hypertension (n = 3254; average 13 months follow-up) participating in a VBID plus health/disease coaching relative to eligible nonparticipants. Outcome measures were propensity score weighted and regression adjusted to estimate the independent impact of the programs. MPRs for diabetes and hypertension were significantly increased 3 to 4 percentage points for VBID participants, while MPRs for respective nonparticipants decreased by about 10 percentage points. Employer-paid pharmacy expenditures increased significantly for both participants with diabetes and hypertension while out-of-pocket patient co-payments decreased significantly. Medical expenditures for diabetes VBID participants decreased but not significantly. Hypertension participants experienced medical expenditure increases. Medical services utilization of inpatient admissions and emergency room visits underwent minimal change. Thus employer-sponsored diabetes and hypertension VBID plus health/disease coaching programs can be expected to lower patient co-payments and significantly increase medication adherence. Meanwhile, medical spending outcomes indicated that increased diabetes and hypertension pharmacy expenditures were partially offset by medical savings (for diabetes) but not sufficiently to be cost neutral.

Personalized preventive care reduces healthcare expenditures among Medicare Advantage beneficiaries.

OBJECTIVES: To investigate the impact on healthcare expenditure and utilization trends of a personalized preventive care program designed to deliver individualized care focused on disease preventionamong Medicare Advantage beneficiaries. STUDY DESIGN: MD-Value in Prevention (MDVIP) consists of a network of affiliated primary care physicians who utilize a model of healthcare delivery based on an augmented physician-patient relationship and focused on personalized preventive healthcare. The cost-effectiveness of the program was estimated using medical and pharmacy claims data relative to nonmembers. METHODS: Multivariate modeling was used to control for demographic, socioeconomic, supply of healthcare services, and health status differences between members and nonmembers. Healthcare expenditure and utilization trends for members and nonmembers were tracked from the pre-period prior to member enrollment for a period of 2 years post enrollment. RESULTS: MDVIP members experienced significantly reduced utilization rates for emergency department visits and inpatient admissions. Reduced medical utilization resulted in program savings of $86.68 per member per month (PMPM) in year 1 and $47.03 PMPM in year 2 compared with nonmembers. CONCLUSIONS: A primary care model based on an augmented physician-patient relationship and focused on personalized preventive medicine can reduce Medicare Advantage healthcare spending.

A value-based insurance design program at a large company boosted medication adherence for employees with chronic illnesses.

This paper contributes to a small but growing body of evidence regarding the efficacy of value-based insurance design. In a retrospective, observational study of employees of a large global pharmaceutical firm, we evaluated how reduced patient cost sharing for prescription drugs for asthma, hypertension, and diabetes affected the use of these drugs and related medical services. We estimate that prescription medication use rose 5 percent per enrollee across the entire enrolled population. Increased use was most evident for patients taking cardiovascular medication. By the third year, adherence to cardiovascular medications was 9.4 percent higher, and patients realized cost savings over time. Overall, the program was mostly cost-neutral to the company, and there was no aggregate change in spending. However, we raise the prospect that this program may have saved the company money by reducing other medical costs.

Cost-sharing effects on adherence and persistence for second-generation antipsychotics in commercially insured patients.

PURPOSE: To assess the relationship between patient cost-sharing (e.g., copayments or coinsurance) and adherence and persistence to second-generation (atypical) antipsychotic (SGA) medications. DESIGN AND METHODOLOGY: A retrospective, observational study of adults aged 18-64 years with schizophrenia or bipolar disorder (n = 7,910) who initiated SGA medications with employer-sponsored insurance in the 2003-2006 MarketScan Commercial Claims and Encounters Database. Adherence was defined as percent of days covered in each calendar quarter. Persistence was defined as days from initiation of SGA to the first 90-day gap in medication on-hand. Generalized Estimating Equations were used to determine the effects of cost-sharing on adherence to SGA medications based on patient-quarter data. A Cox proportional hazards model with patient cost-sharing as a time-varying covariate estimated the effects on persistence with SGA medication. PRINCIPAL FINDINGS: Higher cost-sharing was associated with a lower likelihood of adherence. When compared to plans with cost-sharing below $10, adherence rates were approximately 27% lower for patients in plans with SGA cost-sharing of $50 and above and about 10% lower for patients in plans with cost-sharing between $30 and $50. In both cases, the reduction in adherence was significant. Higher cost-sharing was also associated with a shorter time to discontinuation (HR: 1.028; 95% CI [1.006-1.051]). CONCLUSION: High SGA cost-sharing appears to be a financial barrier to SGA medication compliance, especially when cost-sharing levels exceeded $30. Our findings have implications for health plans, employers, and policymakers who have, or are, contemplating establishing cost-sharing tiers for SCA medications for commercially insured patients with serious mental illnesses.

Cost sharing, adherence, and health outcomes in patients with diabetes.

OBJECTIVES: To assess the relationship between cost sharing and adherence to antidiabetic medications in patients with type 2 diabetes and to examine the relationship between medication adherence and outcomes, including complication rates, medical service utilization, and workplace productivity measures. STUDY DESIGN: A retrospective, cross-sectional study analyzing the healthcare experience of patients with type 2 diabetes on oral antidiabetic medication (OAD) with or without insulin (n = 96,734) and patients on OAD only (n = 55,356) with employer-sponsored insurance in the 2003-2006 MarketScan Database. METHODS: Using a 2-stage residual inclusion model, the first stage estimated the effects of cost sharing on adherence to antidiabetic medications in an 18-month time frame (January 2003 through June 2004). Adherence was determined from the percentage of days covered. The second stage estimated the effects of adherence on complication rates (eg, retinopathy, neuropathy, peripheral vascular disease), medical service utilization rates, and measures of productivity (absence days and short-term disability days) in the subsequent 2 years (July 2004 through June 2006). RESULTS: A $10 increase in the patient cost-sharing index resulted in a 5.4% reduction in adherence to antidiabetic medications for patients on OAD only and a 6.2% reduction in adherence for patients on OAD with or without insulin. Adherence was associated with lower rates of complications (eg, amputation/ulcers, retinopathy) and also was associated with fewer emergency department visits and short-term disability days. CONCLUSIONS: Medical plans, employers, and policy makers should consider implementing interventions targeted to improve antidiabetic medication adherence, which may translate to better outcomes.

Long-term medical costs and resource utilization in systemic lupus erythematosus and lupus nephritis: a five-year analysis of a large medicaid population.

OBJECTIVE: To estimate the long-term direct medical costs and health care utilization for patients with systemic lupus erythematosus (SLE) and a subset of SLE patients with nephritis. METHODS: Patients with newly active SLE were found in the MarketScan Medicaid Database (1999-2005), which includes all inpatient, outpatient, emergency department, and pharmaceutical claims for more than 10 million Medicaid beneficiaries. The date a patient became newly active was defined as the earliest observed SLE diagnosis code, with a 6-month clean period prior to the diagnosis. This method identified 2,298 patients with a consecutive followup of 5 years. A reference group of patients without SLE was constructed using propensity score matching. Nephritis was assessed based on diagnosis and procedure codes involving the kidney. RESULTS: Mean annual medical costs for SLE patients totaled $16,089 at year 1, which is significantly greater (by $6,831) than that for reference patients. Costs decreased slightly at year 2 but then increased yearly at an average rate of 16% through year 5, to $23,860. SLE patients without nephritis (n = 1,809) had costs $967-3,756 higher than the reference patients. SLE patients with nephritis (n = 489) had costs $13,228-34,907 greater than the reference group. Inpatient visits for the nephritis subgroup were 0.6-1.0 per capita, which are approximately twice the rate for all SLE patients and 3 to 4 times higher than the reference group. CONCLUSION: SLE is a costly condition to treat. Medical expenses incurred by SLE patients increase steadily over time, particularly for patients with nephritis.

Characteristics of patients initiating raloxifene compared to those initiating bisphosphonates.

BACKGROUND: Both raloxifene and bisphosphonates are indicated for the prevention and treatment of postmenopausal osteoporosis, however these medications have different efficacy and safety profiles. It is plausible that physicians would prescribe these agents to optimize the benefit/risk profile for individual patients. The objective of this study was to compare demographic and clinical characteristics of patients initiating raloxifene with those of patients initiating bisphosphonates for the prevention and treatment of osteoporosis. METHODS: This study was conducted using a retrospective cohort design. Female beneficiaries (45 years and older) with at least one claim for raloxifene or a bisphosphonate in 2003 through 2005 and continuous enrollment in the previous 12 months and subsequent 6 months were identified using a collection of large national commercial, Medicare supplemental, and Medicaid administrative claims databases (MarketScan). Patients were divided into two cohorts, a combined commercial/Medicare cohort and a Medicaid cohort. Within each cohort, characteristics (demographic, clinical, and resource utilization) of patients initiating raloxifene were compared to those of patients initiating bisphosphonate therapy. Group comparisons were made using chi-square tests for proportions of categorical measures and Wilcoxon rank-sum tests for continuous variables. Logistic regression was used to simultaneously examine factors independently associated with initiation of raloxifene versus a bisphosphonate. RESULTS: Within both the commercial/Medicare and Medicaid cohorts, raloxifene patients were younger, had fewer comorbid conditions, and fewer pre-existing fractures than bisphosphonate patients. Raloxifene patients in both cohorts were less likely to have had a bone mineral density (BMD) screening in the previous year than were bisphosphonate patients, and were also more likely to have used estrogen or estrogen/progestin therapy in the previous 12 months. These differences remained statistically significant in the multivariate model. CONCLUSION: In this sample of patients enrolled in commercial, Medicare, and Medicaid plans, patients who initiated raloxifene treatment differed from those initiating bisphosphonates. Raloxifene patients were younger, had better overall health status and appeared to be less likely to have risk factors for new osteoporotic fractures than bisphosphonate patients. Differences in the clinical profiles of these agents may impact prescribing decisions. Investigators using observational data to make comparisons of treatment outcomes associated with these medications should take these important differences in patient characteristics into consideration.

Direct cost burden among insured US employees with migraine.

OBJECTIVE: To provide a current estimate of the national direct health-care cost burden of illness associated with migraine among a US insured population. BACKGROUND: Individuals with migraine use health-care resources more than those without migraine, incurring substantial costs to US employers. METHODS: The Thomson Medstat's Commercial Claims and Encounters 2004 database was utilized for this study. Only paid claims were analyzed. The migraine cohort had a primary migraine diagnosis and/or a migraine-specific abortive drug prescription during 2004. A matched control cohort with no evidence of migraine was generated using propensity score techniques. Demographic characteristics and overall comorbidities were similar between cohorts. A second-stage regression controlled for any remaining significant intergroup differences. The burden of illness of migraine was defined as the difference in average total health-care expenditures per person between cohorts. The national burden of illness was defined as the average expenditure for migraine of national population estimates of privately insured individuals, and was estimated by projecting the migraine prevalence rate and average expenditure using Medical Expenditure Panel Survey population estimates. RESULTS: Patients with migraine (n=215,209) had significantly higher average health-care expenditures compared with matched controls ($7007 vs $4436 per person per year; difference of $2571; P<.001). Migraine-associated national expenditure estimates: outpatient care, $5.21 billion; prescriptions, $4.61 billion; inpatient care, $0.73 billion; and emergency department care, $0.52 billion. CONCLUSIONS: The direct costs associated with patients with migraine were found to be $2571 per person per year higher than in matched nonmigraine controls. The projected national burden of migraine of $11.07 billion is substantially higher than previous estimates.

Indirect cost burden of migraine in the United States.

OBJECTIVE: The purpose of this study was to determine the indirect cost burden associated with migraine. METHODS: Data were obtained from Thomson-Medstat's Health and Productivity Management (HPM) database for the 2002 through 2003 calendar years. The migraine cohort was composed of patients who had a diagnosis of migraine or migraine-specific abortive prescription medication, or both. A control cohort of patients without migraine was matched to patients in the migraine cohort. The average annual indirect burden of illness (BOI) of migraine and a national indirect BOI were estimated. RESULTS: Annual indirect expenditures were significantly higher in the migraine group compared with the control group ($4453 vs $1619; P<0.001). The national annual indirect BOI, excluding presenteeism, was estimated to be $12 billion (mostly attributed to absenteeism). CONCLUSIONS: Migraine imparts a substantial indirect cost burden. Projected to a national level, this amounts to an annual cost to US employers of approximately $12 billion.

Long-term impact of Johnson & Johnson's Health & Wellness Program on health care utilization and expenditures.

The long-term impact of corporate health and wellness programs is largely unknown, because most evaluations focus on impact in just 1 or 2 years after program initiation. This project estimated the longer-term impact of the Johnson & Johnson Health & Wellness Program on medical care utilization and expenditures. Employees were followed for up to 5 years before and 4 years after Program implementation. Fixed-effects regression models were used to control for measurable and unmeasurable factors that may influence utilization and expenditures. Results indicated a large reduction in medical care expenditures (approximately $224.66 per employee per year) over the 4-year Program period. These benefits came from reduced inpatient use, fewer mental health visits, and fewer outpatient visits compared with the baseline period. Most benefits occurred in years 3 and 4 after Program initiation. We conclude that programs designed to better integrate occupational health, disability, wellness, and medical benefits may have substantial health and economic benefits in later years.