Shingles Vaccination in Medicare Part D After Inflation Reduction Act Elimination of Cost Sharing.

This cross-sectional study uses data from retail pharmacies to examine shingles vaccine uptake among Medicare Part D beneficiaries following an IRA policy to eliminate cost sharing.

Association of Intensive Lifestyle Intervention for Type 2 Diabetes With Labor Market Outcomes.

Importance: An intensive lifestyle intervention (ILI) has been shown to improve diabetes management and physical function. These benefits could lead to better labor market outcomes, but this has not been previously studied. Objective: To estimate the association of an ILI for weight loss in type 2 diabetes with employment, earnings, and disability benefit receipt during and after the intervention. Design, Setting, and Participants: This cohort study included participants with type 2 diabetes and overweight or obesity and compared an ILI with a control condition of diabetes support and education. Data for the original trial were accrued from August 22, 2001, to September 14, 2012. Trial data were linked with Social Security Administration records to investigate whether, relative to the control group, the ILI was associated with improvements in labor market outcomes during and after the intervention period. Difference-in-differences models estimating relative changes in employment, earnings, and disability benefit receipt between the ILI and control groups were used, accounting for prerandomization differences in outcomes for linked participants. Outcome data were analyzed from July 13, 2020, to May 17, 2023. Exposure: The ILI consisted of sessions with lifestyle counselors, dieticians, exercise specialists, and behavioral therapists on a weekly basis in the first 6 months, decreasing to a monthly basis by the fourth year, designed to achieve and maintain at least 7% weight loss. The control group received group-based diabetes education sessions 3 times annually during the first 4 years, with 1 annual session thereafter. Main Outcomes and Measures: Employment and receipt of federal disability benefits (Supplemental Security Income and Social Security Disability Insurance), earnings, and disability benefit payments from 1994 through 2018. Results: A total of 3091 trial participants were linked with Social Security Administration data (60.1% of 5145 participants initially randomized and 97.0% of 3188 of participants consenting to linkage). Among the 3091 with fully linked data, 1836 (59.4%) were women, and mean (SD) age was 58.4 (6.5) years. Baseline clinical and demographic characteristics were similar between linked participants in the ILI and control groups. Employment increased by 2.9 (95% CI, 0.3-5.5) percentage points for the ILI group relative to controls (P = .03) with no significant relative change in disability benefit receipt (-0.9 [95% CI, -2.1 to 0.3] percentage points; P = .13). Conclusions and Relevance: The findings of this cohort study suggest that an ILI to prevent the progression and complications of type 2 diabetes was associated with higher levels of employment. Labor market productivity should be considered when evaluating interventions to manage chronic diseases.

The Forgotten Middle: Worsening Health And Economic Trends Extend To Americans With Modest Resources Nearing Retirement.

In an aging US society, anticipating the challenges that future seniors will face is essential. This study analyzed the health and economic well-being of five cohorts of Americans in their mid-fifties between 1994 and 2018 using the Future Elderly Model, a dynamic microsimulation based on the Health and Retirement Study. We projected mortality, quality-adjusted life years, health expenditures, and income and benefits. We classified individuals by economic status and focused on the lower middle and upper middle of the economic distribution. Outcome disparities between people in these two groups widened substantially between the 1994 and 2018 cohorts. Quality-adjusted life expectancy increased (5 percent) for the upper-middle economic status group but stagnated for their lower-middle peers. We found that the combined value of the current stock (financial and housing wealth) and the present value of the expected flow of resources (income, health expenditures, and quality-adjusted life-years) after age sixty grew 13 percent for the upper-middle group between cohorts, whereas people in the lower-middle group in 2018 were left scarcely better off (3 percent growth) than their peers two decades earlier. The relatively neglected "forgotten middle" group of near-retirees in the lower-middle group may require stronger supports than are currently available to them.

Insulin Fills by Medicare Enrollees and Out-of-Pocket Caps Under the Inflation Reduction Act.

This study uses data from IQVIA's National Prescription Audit to assess the association of the Inflation Reduction Act's cap on cost sharing with insulin fills by Medicare beneficiaries.

Assessment of Medical and Public Assistance Expenditures and Employment Among US Adults With Cancer Diagnoses.

Importance: Prior research suggests significant social value associated with increased longevity due to preventing and treating cancer. Other social costs associated with cancer, such as unemployment, public medical spending, and public assistance, may also be sizable. Objective: To examine whether a cancer history is associated with receipt of disability insurance, income, employment, and medical spending. Design, Setting, and Participants: This cross-sectional study used data from the Medical Expenditure Panel Study (MEPS) (2010-2016) for a nationally representative sample of US adults aged 50 to 79 years. Data were analyzed from December 2021 to March 2023. Exposure: Cancer history. Main Outcomes and Measures: The main outcomes were employment, public assistance receipt, disability, and medical expenditures. Variables for race, ethnicity, and age were used as controls. A series of multivariate regression models were used to assess the immediate and 2-year association of a cancer history with disability, income, employment, and medical spending. Results: Of 39 439 unique MEPS respondents included in the study, 52% were female, and the mean (SD) age was 61.44 (8.32) years; 12% of respondents had a history of cancer. Individuals with a cancer history who were aged 50 to 64 years were 9.80 (95% CI, 7.35-12.25) percentage points more likely to have a work-limiting disability and were 9.08 (95% CI, 6.22-11.94) percentage points less likely to be employed compared with individuals in the same age group without a history of cancer. Nationally, cancer accounted for 505 768 fewer employed individuals in the population aged 50 to 64 years. A cancer history was also associated with an increase of $2722 (95% CI, $2131-$3313) in medical spending, $6460 (95% CI, $5254-$7667) in public medical spending, and $515 (95% CI, $337-$692) in other public assistance spending. Conclusions and Relevance: In this cross-sectional study, a history of cancer was associated with increased likelihood of disability, higher medical spending, and decreased likelihood of employment. These findings suggest there may be gains beyond increased longevity if cancer can be detected and treated earlier.

The Long-term Value of Bariatric Surgery Interventions for American Adults With Type 2 Diabetes Mellitus.

BACKGROUND: Bariatric surgery can cause type 2 diabetes (diabetes) remission for individuals with comorbid obesity, yet utilization is <1%. Surgery eligibility is currently limited to body mass index (BMI) ≥35 kg/m 2 , though the American Diabetes Association recommends expansion to BMI ≥30 kg/m 2 . OBJECTIVE: We estimate the individual-level net social value benefits of diabetes remission through bariatric surgery and compare the population-level effects of expanding eligibility alone versus improving utilization for currently eligible individuals. METHODS: Using microsimulation, we quantified the net social value (difference in lifetime health/economic benefits and costs) of bariatric surgery-related diabetes remission for Americans with obesity and diabetes. We compared projected lifetime surgical outcomes to conventional management at individual and population levels for current utilization (1%) and eligibility (BMI ≥35 kg/m 2 ) and expansions of both (>1%, and BMI ≥30 kg/m 2 ). RESULTS: The per capita net social value of bariatric surgery-related diabetes remission was $264,670 (95% confidence interval: $234,527-294,814) under current and $227,114 (95% confidence interval: $205,300-248,928) under expanded eligibility, an 11.1% and 9.16% improvement over conventional management. Quality-adjusted life expectancy represented the largest gains (current: $194,706; expanded: $169,002); followed by earnings ($51,395 and $46,466), and medical savings ($41,769 and $34,866) balanced against the surgery cost ($23,200). Doubling surgical utilization for currently eligible patients provides higher population gains ($34.9B) than only expanding eligibility at current utilization ($29.0B). CONCLUSIONS: Diabetes remission following bariatric surgery improves healthy life expectancy and provides net social benefit despite high procedural costs. Per capita benefits appear greater among currently eligible individuals. Therefore, policies that increase utilization may produce larger societal value than expanding eligibility criteria alone.

Association between use of ß2-adrenergic receptor agonists and incidence of Parkinson's disease: Retrospective cohort analysis.

INTRODUCTION: Previous observational studies assessing ß2-agonist/-antagonist use on PD risk have yielded conflicting results. We evaluated the relationship between ß2-agonist use and the incidence of Parkinson's disease in patients with chronic lung disease. METHODS: We performed a retrospective cohort analysis on a 20% random sample abstracted from a traditional (fee-for-service) Medicare program in the United States. Inclusion criteria were individuals over 65 years old diagnosed with asthma, COPD, and/or bronchiectasis who were enrolled in a prescription drug (standalone Part D) plan over 2007-2010 and alive through 2014. The main outcome measure was a diagnosis of Parkinson's disease over the period 2011-2014, in relation to the number of 30-day-equivalent drug claims over 2007-2010. Logistic regression analysis was performed on a sample including 236,201 Medicare beneficiaries. RESULTS: The sample was 68% female, 80% white, and on average 77 years old as of 2010. Compared to non-users, ß2-agonist users were more likely to be younger (76.3y versus 78.0y), smokers (40.4% versus 31.1%) and asthmatic (62.4% versus 28.3%). The odds ratio for a ß2-agonist claim on PD development was 0.986 (95% CI 0.977-0.995) after adjusting for demographics, smoking history, respiratory exacerbations, comorbidities, and other drug use. Risk reductions were larger for males than females (0.974 versus 0.994, P = 0.032), and for individuals with COPD compared to those with asthma (0.968 versus 0.998, P = 0.049). Reverse causality was addressed with a Cox analysis that allowed ß2-agonist use to vary from medication initiation to disease onset. By the end of the follow-up period, ß2-agonist use was shown to be associated with a true protective effect against PD onset. DISCUSSION: ß2-agonist use is associated with decreased risk of PD incidence. Further investigation, possibly including clinical trials, is warranted to strengthen the evidence base supporting clinical decision-makers looking to repurpose pharmaceuticals to prevent neurodegenerative disease onset.

Formulary restrictions and stroke risk in patients with atrial fibrillation.

OBJECTIVES: To determine the use of formulary restrictions (prior authorization and step therapy) on the use of non-vitamin K antagonist oral anticoagulants (NOACs) and their effect on health outcomes. STUDY DESIGN: Longitudinal cohort study. We identified a sample of Medicare beneficiaries with an incident diagnosis of atrial fibrillation (AF) in 2011 to 2015 and followed them until the end of 2016 or death. We compared anticoagulant use and health outcomes associated with Medicare Part D plan coverage of NOACs. METHODS: The primary outcomes were composite rates of death, stroke, transient ischemic attack, and systemic embolism. We used Cox proportional hazards models to estimate the association between formulary restrictions and adverse health outcomes. RESULTS: Beneficiaries enrolled in Part D plans that restricted access to NOACs had a lower probability of NOAC use (30.2% vs 32.2%), worse adherence conditional on NOAC use (32.1% vs 34.3% adherent), and longer delays in filling an initial prescription (46% vs 55% filled within 30 days of AF diagnosis). Beneficiaries in restricted plans had higher aggregate risk of mortality/stroke/transient ischemic attack (adjusted HR, 1.098; 95% CI, 1.079-1.118). CONCLUSIONS: Limiting access to NOACs may exacerbate current underuse of anticoagulants and increase the risk of stroke among patients with newly diagnosed AF. Pharmacy benefit managers and Part D plans need to continuously review the appropriateness of formulary policies to ensure patient access to effective medications.

The costs of developing treatments for Alzheimer's disease: A retrospective exploration.

INTRODUCTION: With the exception of the recent accelerated approval of aducanumab, in over 26 years of research and development (R&D) investment in Alzheimer's disease (AD), only five novel drugs-all for symptomatic treatment only-have reached FDA approval. Here, we estimate the costs of AD drug development during this period in the private sector. METHODS: To estimate private R&D funding, we collected information on AD clinical trials (n = 1099; phases 1-4) conducted between January 1, 1995 and June 21, 2021 from various databases. Costs were derived using previously published methodologies and adjusted for inflation. RESULTS: Since 1995, cumulative private expenditures on clinical stage AD R&D were estimated at $42.5 billion, with the greatest costs (57%; $24,065 million) incurred during phase 3; approximately 184,000 participants were registered or are currently enrolled in clinical trials. DISCUSSION: Measures to reduce expenditures while moving toward disease-modifying therapies that alleviate the rising burden of AD require continued investment from industry, government, and academia.

Spending On Targeted Therapies Reduced Mortality In Patients With Advanced-Stage Breast Cancer.

Costly targeted therapies are playing an increasingly important role in treating cancer. To characterize trends in spending on targeted therapies for breast cancer and to estimate the association of these therapies with cancer mortality, we analyzed cancer diagnoses in the Surveillance, Epidemiology, and End Results Program-Medicare linked database. We categorized total cancer spending into spending on targeted therapies, spending on nontargeted therapies, and spending on other cancer care. Diagnosis-year spending on targeted therapies increased from $1,024 per patient in 2000 to $18,809 per patient in 2015 for patients with advanced-stage cancer and from $82 to $3,289 for patients with early-stage cancer. For patients with advanced-stage cancer, a $1,000 increase in spending on targeted therapies in the diagnosis year was associated with a 0.55-percentage-point decrease in adjusted three-year cancer mortality, whereas for patients with early-stage cancer, there was no association. The other two types of spending (on nontargeted therapies and other cancer care) were not associated with mortality among patients with either advanced- or early-stage cancer. Our results indicate that among various types of cancer treatments, only targeted therapies generated meaningful survival gains for patients with advanced-stage breast cancer.

Modelling the value of innovative treatments for Alzheimer's disease in the United States.

Alzheimer's disease (AD) is the predominant cause of dementia and a leading cause of death globally. With no cure or treatment to slow disease progression, AD-related healthcare costs are substantial and increase as the severity of the disease progresses. Given the complexity of this disease, including initial pathophysiological damage occurring decades before clinical manifestation, finding new impactful treatments for AD relies on highly innovative research and development. However, such sizable and sustained investments bring into question whether conventional value assessment models are fit for this purpose. In this article, we examine the importance and challenges of assimilating the perspectives of varied stakeholders, including patients, caregivers, health systems, payers, and society at large, into a comprehensive value assessment model that may be well suited for a breakthrough treatment for AD.

The future of the elderly population health status: Filling a knowledge gap.

The aging process in OECD countries calls for a better understanding of the future disease prevalence, life expectancy (LE) and patterns of inequalities in health outcomes. In this paper we present the results obtained from several dynamic microsimulation models of the Future Elderly Model family for 12 OECD countries, with the aim of reproducing for the first time comparable long-term projections in individual health status across OECD countries. We provide projections of LE and prevalence of major chronic conditions and disabilities, overall, by gender and by education. We find that the prevalence of main chronic conditions in Europe is catching-up with the United States and significant heterogeneity in the evolution of gender and educational gradients. Our findings represent a contribution to support policymakers in designing and implementing effective interventions in the healthcare sector.

The economics of alternative payment models for pharmaceuticals.

Pharmaceuticals are priced uniformly by convention, but vary in their degree of effectiveness for different disease indications. As more high-cost therapies have launched, the demand for alternative payment models (APMs) has been increasing in many advanced markets, despite their well-documented limitations and challenges to implementation. Among policy justifications for such contracts is the maximization of value given scarce resources. We show that while uniform pricing rules can handle variable effectiveness in efficient markets, market inefficiencies of other kinds create a role for different value-based pricing structures. We first present a stylized theoretical model of efficient interaction among drug manufacturers, payers, and beneficiaries. In this stylized setting, uniform pricing works well, even when treatment effects are variable. We then use this framework to define market failures that result in obstacles to uniform pricing. The market failures we identify include: (1) uncertainty of patient distribution, (2) asymmetric beliefs, (3) agency imperfection by payer, (4) agency imperfection by provider, and (5) patient behavior and treatment adherence. We then apply our insights to real-world examples of alternative payment models, and highlight challenges related to contract implementation.

Simulating the Fiscal Impact of Anti-Obesity Medications as an Obesity Reduction Strategy.

While substantial public health investment in anti-smoking initiatives has had demonstrated benefits on health and fiscal outcomes, similar investment in reducing obesity has not been undertaken, despite the substantial burden obesity places on society. Anti-obesity medications (AOMs) are poorly prescribed despite evidence that weight loss is not sustained using other strategies alone.We used a simulation model to estimate the potential impact of 100% uptake of AOMs on Medicare and Medicaid spending, disability payments, and taxes collected relative to status quo with negligible AOM use. Relative to status quo, AOM use simulation would result in Medicare and Medicaid savings of $231.5 billion and $188.8 billion respectively over 75 years. Government tax revenues would increase by $452.8 billion. Overall, the net benefit would be $746.6 billion. Anti-smoking efforts have had substantial benefits for society. A similar investment in obesity reduction, including broad use of AOMs, should be considered.

Improved survival for individuals with common chronic conditions in the Medicare population.

It is well established that the United States lags behind peer nations in life expectancy, but it is less established that there is heterogeneity in life expectancy trends. We compared mortality trends from 2004 to 2014 for the United States with 17 high-income countries for persons under and over 65. The United States ranked last in survival gains for the young but ranked near the middle for persons over 65, the group with universal access to public insurance. To explore the over-65 mortality trend, we estimated Cox proportional hazards models for individuals soon after entering Medicare. These were estimated separately by race and sex, controlling for 26 chronic conditions and condition-specific time trends. The separate regressions enabled survival comparisons for the 2004 and 2014 cohorts by race and sex, conditional on baseline health. We predicted 5-year survival for all combinations of diabetes, hyperlipidemia, hypertension, and ischemic heart disease (IHD). All 16 combinations of these conditions showed survival gains, with diabetes as a key driver. Notably, survival improved and racial disparities narrowed for individuals with diabetes, hypertension, and IHD. White females, black females, white males, and black males gained 3.61, 3.90, 3.57, and 5.89 percentage points in 5-year survival, respectively.

Associations of Intensive Lifestyle Intervention in Type 2 Diabetes With Health Care Use, Spending, and Disability: An Ancillary Study of the Look AHEAD Study.

Importance: Intensive lifestyle interventions focused on diet and exercise can reduce weight and improve diabetes management. However, the long-term effects on health care use and spending are unclear, especially for public payers. Objective: To estimate the association of effective intensive lifestyle intervention for weight loss with long-term health care use and Medicare spending. Design, Setting, and Participants: This ancillary study used data from the Look AHEAD randomized clinical trial, which randomized participants with type 2 diabetes to an intensive lifestyle intervention or control group (ie, diabetes support and education), provided ongoing intervention from 2001 to 2012, and demonstrated improved diabetes management and reduced health care costs during the intervention. This study compared Medicare data between study arms from 2012 to 2015 to determine whether the intervention was associated with persistent reductions in health care spending. Exposure: Starting in 2001, Look AHEAD's intervention group participated in sessions with lifestyle counselors, dieticians, exercise specialists, and behavioral therapists with the goal of reducing weight 7% in the first year. Sessions occurred weekly in the first 6 months of the intervention and decreased over the intervention period. The controls participated in periodic group education sessions that occurred 3 times per year in the first year and decreased to 1 time per year later in the trial. Main Outcomes and Measures: Outcomes included total Medicare spending, Part D prescription drug costs, Part A and Part B Medicare spending, hospital admissions, emergency department visits, and disability-related Medicare eligibility. Results: This study matched Medicare administrative records for 2796 Look AHEAD study participants (54% of 5145 participants initially randomized and 86% of 3246 participants consenting to linkages). Linked intervention and control participants were of a similar age (mean [SD] age, 59.6 [5.4] years vs 59.6 [5.5] years at randomization) and sex (818 [58.1%] women vs 822 [59.3%] women). There was no statistically significant difference in total Medicare spending between groups (difference, -$133 [95% CI, -$1946 to $1681]; P = .89). In the intervention group, compared with the control group, there was statistically significantly higher Part B spending (difference, $513 [95% CI, $70 to $955]; P = .02) but lower prescription drug costs (difference, -$803 [95% CI, -$1522 to -$83]; P = .03). Conclusions and Relevance: This ancillary study of a randomized clinical trial found that reductions in health care use and spending associated with an intensive lifestyle intervention for type 2 diabetes diminished as participants aged. Intensive lifestyle interventions may need to be sustained to reduce long-term health care spending. Trial Registration: ClinicalTrials.gov Identifier: NCT03952728.

Risk factors and costs associated with 30-day readmissions following alcohol-related hospitalizations in the United States from 2010 to 2015.

Patients with alcohol-related diagnoses at initial hospitalization are at high risk of 30-day readmission. Understanding risk factors for 30-day readmission among these patients may help to identify those who would benefit from efforts to reduce risk of readmission. The Nationwide Readmissions Database was used to estimate 30-day all-cause readmissions among United States patients with an alcohol-related index hospitalization and to evaluate risk factors and costs associated with these readmissions. Included patients were 18 years of age or older at initial hospitalization, had an alcohol-related primary diagnosis (based on ICD-9-CM codes), and were discharged between 2010 and 2015. They were followed for 30 days after initial hospitalization within the calendar year to identify all-cause readmissions. A logistic regression analysis assessed the association between risk factors and 30-day readmission. Average costs of initial admissions and readmissions were estimated. Among 113,931,723 adult index hospitalizations, 1,124,228 had alcohol-related diagnoses. Patients had a mean age of 49 years, 73% were male, and 45% had public insurance coverage. The annual rate of 30-day readmissions among patients with index alcohol-related hospitalizations increased from 119 readmissions per 1000 admissions in 2010 to 140 per 1000 in 2015, while the rate of readmissions among patients with all-cause hospitalizations declined from 103 to 98 per 1000. The regression analysis suggested that age, male sex, comorbid conditions, discharge against medical advice, admission to large and teaching hospitals, and Medicaid vs. non-Medicaid payment were all risk factors for 30-day readmission. Mean costs of initial alcohol-related hospitalizations were greater among those with a 30-day readmission than without a 30-day readmission, and the mean cost of 30-day readmission was even greater. Mitigating the upward trend in rates of readmission following alcohol-related initial hospitalizations may be addressed through better identification of high-risk patients who are admitted with an alcohol-related diagnosis and greater use of existing evidence-based psychosocial and pharmacotherapy treatment methods.

Lifetime Burden of Adult Congenital Heart Disease in the USA Using a Microsimulation Model.

Congenital heart defects (CHD) represent a growing burden of illness among adults. We estimated the lifetime health, education, labor, and social outcomes of adults with CHD in the USA using the Future Adult Model, a dynamic microsimulation model that has been used to study the lifetime impacts of a variety of chronic diseases. We simulated a cohort of adult heads of households > 25 years old derived from the Panel Survey of Income Dynamics who reported a childhood heart problem as a proxy for CHD and calculated life expectancy, disability-free and quality-adjusted life years, lifetime earnings, education attainment, employment, development of chronic disease, medical spending, and disability insurance claiming status. Total burden of disease was estimated by comparing to a healthy cohort with no childhood heart problem. Eighty-seven individuals reporting a childhood heart problem were identified from the PSID and were used to generate the synthetic cohort simulated in the model. Life expectancy, disability-free, quality-adjusted, and discounted quality-adjusted life years were an average 4.6, 6.7, 5.3, and 1.4 years lower than in healthy adults. Lung disease, cancer, and severe mental distress were more common compared to healthy individuals. The CHD cohort earned $237,800 less in lifetime earnings and incurred higher average total medical spend by $66,600 compared to healthy individuals. Compared to healthy adults, the total burden of CHD is over $500K per adult. Despite being among the healthiest adults with CHD, there are significant decrements in life expectancy, employment, and lifetime earnings, with concomitant increases in medical spend.