COVID-19 Vaccines: Moderna And Pfizer-BioNTech Use Varied By Urban, Rural Counties.

We investigated county-level variation in mRNA COVID-19 vaccine use among Medicare beneficiaries throughout the United States. There was greater use of Pfizer-BioNTech vaccines than Moderna vaccines in urban areas for first and booster doses.

Disparities in clinical trial enrollment at a Canadian comprehensive cancer center: A 15-year retrospective study.

INTRODUCTION: Disparities in clinical trials (CTs) enrollment perpetuate inequities in treatment access and outcomes, but there is a paucity of Canadian data. The objective of this study was to examine disparities in cancer CT enrollment at a large Canadian comprehensive cancer center. METHODS: Retrospective study of CT enrollment among new patient consultations from 2006 to 2019, with follow-up to 2021 (N = 154,880), with the primary outcome of enrollment as a binary variable. Factors associated with CT enrollment were evaluated using multivariable Bayesian hierarchical logistic regression with random effects for most responsible physician (MRP) and geography, adjusted for patient characteristics (sex, age, language, geography, and primary care provider [PCP]), area-level marginalization (residential instability, material deprivation, dependency, and ethnic concentration), disease (cancer site and stage), and MRP (department, sex, language, and training). A sensitivity analysis of the cumulative incidence of enrollment was conducted to account for differences in disease type and follow-up length. RESULTS: CT enrollment was 11.2% overall, with a 15-year cumulative incidence of 18%. Lower odds of enrollment were observed in patients who were female (adjusted odds ratio [AOR], 0.82; 95% confidence interval [CI], 0.78-0.86), ≥65 years (AOR vs. <40, 0.61; 95% CI, 0.56-0.66), non-English speakers (0.72; 95% CI, 0.67-0.77), living ≥250 km away (AOR vs. <15 km, 0.71; 95% CI, 0.62-0.80), and without a PCP. Disease characteristics accounted for the largest proportion of observed variation (20.8%), with significantly greater odds of enrollment in patients with genitourinary cancers and late-stage disease. CONCLUSION: Significant sociodemographic disparities were observed, suggesting the need for targeted strategies to increase diversity in access to cancer CTs in Canada.

Antidepressant Dispensing to US Adolescents and Young Adults: 2016-2022.

BACKGROUND: Mental health worsened in adolescents and young adults after the coronavirus disease 2019 (COVID-19) outbreak in March 2020, but whether antidepressant dispensing to this population changed is unknown. METHODS: We identified antidepressant prescriptions dispensed to US individuals aged 12 to 25 years from 2016 to 2022 using the IQVIA Longitudinal Prescription Database, an all-payer national database. The outcome was the monthly antidepressant dispensing rate, defined as the monthly number of individuals with ≥1 dispensed antidepressant prescription per 100 000 people. We fitted linear segmented regression models assessing for level or slope changes during March 2020 and conducted subgroup analyses by sex and age group. RESULTS: Between January 2016 and December 2022, the monthly antidepressant dispensing rate increased 66.3%, from 2575.9 to 4284.8. Before March 2020, this rate increased by 17.0 per month (95% confidence interval: 15.2 to 18.8). The COVID-19 outbreak was not associated with a level change but was associated with a slope increase of 10.8 per month (95% confidence interval: 4.9 to 16.7). The monthly antidepressant dispensing rate increased 63.5% faster from March 2020 onwards compared with beforehand. In subgroup analyses, this rate increased 129.6% and 56.5% faster from March 2020 onwards compared with beforehand among females aged 12 to 17 years and 18 to 25 years, respectively. In contrast, the outbreak was associated with a level decrease among males aged 12 to 17 years and was not associated with a level or slope change among males aged 18 to 25 years. CONCLUSIONS: Antidepressant dispensing to adolescents and young adults was rising before the COVID-19 outbreak and rose 63.5% faster afterward. This change was driven by increased antidepressant dispensing to females and occurred despite decreased dispensing to male adolescents.

Medicare price negotiation and pharmaceutical innovation following the Inflation Reduction Act.

The Inflation Reduction Act (IRA) requires Medicare to negotiate lower prices for some medicines with high Medicare spending. Using historical data from public and proprietary sources to apply the IRA's negotiation criteria retrospectively, we identify all drugs that met the eligibility criteria from 2012 to 2021 to classify drugs that would have had a negotiated price in effect in 2022 and to calculate associated decreases in industry revenues. Our results suggest that the IRA's reduction in overall industry revenue will be modest, will not affect most top-selling drugs and will not likely result in large-scale defunding of research and development. Changes in the net present value of drug-development projects will be concentrated in medicines where Medicare is a notable purchaser and where the ratio between expected revenue and development costs was only marginally positive before the IRA. Policymakers considering narrowing or expanding the scope of Medicare negotiation should carefully consider the tradeoffs across medicines with diverse characteristics.

Assessing the Impact of the 340B Drug Pricing Program: A Scoping Review of the Empirical, Peer-Reviewed Literature.

Policy Points The 340B Drug Pricing Program accounts for roughly 1 out of every 100 dollars spent in the $4.3 trillion US health care industry. Decisions affecting the program will have wide-ranging consequences throughout the US safety net. Our scoping review provides a roadmap of the questions being asked about the 340B program and an initial synthesis of the answers. The highest-quality evidence indicates that nonprofit, disproportionate share hospitals may be using the 340B program in margin-motivated ways, with inconsistent evidence for increased safety net engagement; however, this finding is not consistent across other hospital types and public health clinics, which face different incentive structures and reporting requirements. CONTEXT: Despite remarkable growth and relevance of the 340B Drug Pricing Program to current health care practice and policy debate, academic literature examining 340B has lagged. The objectives of this scoping review were to summarize i) common research questions published about 340B, ii) what is empirically known about 340B and its implications, and iii) remaining knowledge gaps, all organized in a way that is informative to practitioners, researchers, and decision makers. METHODS: We conducted a scoping review of the peer-reviewed, empirical 340B literature (database inception to March 2023). We categorized studies by suitability of their design for internal validity, type of covered entity studied, and motivation-by-scope category. FINDINGS: The final yield included 44 peer-reviewed, empirical studies published between 2003 and 2023. We identified 15 frequently asked research questions in the literature, across 6 categories of inquiry-motivation (margin or mission) and scope (external, covered entity, and care delivery interface). Literature with greatest internal validity leaned toward evidence of margin-motivated behavior at the external environment and covered entity levels, with inconsistent findings supporting mission-motivated behavior at these levels; this was particularly the case among participating disproportionate share hospitals (DSHs). However, included case studies were unanimous in demonstrating positive effects of the 340B program for carrying out a provider's safety net mission. CONCLUSIONS: In our scoping review of the 340B program, the highest-quality evidence indicates nonprofit, DSHs may be using the 340B program in margin-motivated ways, with inconsistent evidence for increased safety net engagement; however, this finding is not consistent across other hospital types and public health clinics, which face different incentive structures and reporting requirements. Future studies should examine heterogeneity by covered entity types (i.e., hospitals vs. public health clinics), characteristics, and time period of 340B enrollment. Our findings provide additional context to current health policy discussion regarding the 340B program.

Job lock among survivors of childhood cancer and their spouses post Affordable Care Act implementation: A Childhood Cancer Survivor Study brief report.

It is unknown how common job lock (i.e., staying at job to maintain health insurance) remains among childhood cancer survivors after Affordable Care Act (ACA) implementation in 2010. We examined prevalence of and factors associated with job lock using a cross-sectional survey from the Childhood Cancer Survivor Study (3503 survivors; 942 siblings). Survivor, spousal, and any survivor/spouse job lock were more frequently reported by survivors than siblings. Survivor job lock/any job lock was associated with older age, low income, severe chronic conditions, and debt/inability to pay debt. Job lock remains more common among survivors than siblings after ACA implementation.

Financial hardship among siblings of long-term survivors of childhood cancer: A Childhood Cancer Survivor Study report.

BACKGROUND: Siblings of children with cancer may experience adverse household economic consequences, but their financial outcomes in adulthood are unknown. METHODS: A total of 880 siblings (aged 18-64 years) of adult-aged childhood cancer survivors were surveyed to estimate the prevalence of financial hardship by three established domains (behavioral, material, and psychological). For individual financial hardship items matching the contemporaneous National Health Interview Survey or Behavioral Risk Factor Surveillance System, siblings were compared with the general population by calculating adjusted prevalence odds ratios (ORs) to sample-weighted responses. Multivariable logistic regression models examined associations between sibling characteristics and each hardship domain and between sibling hardship and survivors' cancer/treatment characteristics. RESULTS: Behavioral, material, and psychological hardship was reported by 24%, 35%, and 28%, respectively. Compared with national survey respondents, siblings were more likely to report worries about medical bills (OR, 1.14; 95% confidence interval [CI], 1.06-1.22), difficulty affording nutritious foods (OR, 1.79; 95% CI, 1.54-2.07), and forgoing needed medical care (OR, 1.38; 95% CI, 1.10-1.73), prescription medications (OR, 2.52; 95% CI, 1.99-3.20), and dental care (OR, 1.34; 95% CI, 1.15-1.57) because of cost. Sibling characteristics associated with reporting financial hardship in one or more domains included female sex, older age, chronic health conditions, lower income, not having health insurance, high out-of-pocket medical expenditures, and nonmedical/nonhome debt. No survivor cancer/treatment characteristics were associated with sibling financial hardship. CONCLUSIONS: Adult siblings of childhood cancer survivors were more likely to experience financial hardship compared with the general population. Childhood cancer may adversely affect entire households, with potentially lasting implications.

The estimated annual financial impact of gene therapy in the United States.

Gene therapy is a new class of medical treatment that alters part of a patient's genome through the replacement, deletion, or insertion of genetic material. While still in its infancy, gene therapy has demonstrated immense potential to treat and even cure previously intractable diseases. Nevertheless, existing gene therapy prices are high, raising concerns about its affordability for U.S. payers and its availability to patients. We assess the potential financial impact of novel gene therapies by developing and implementing an original simulation model which entails the following steps: identifying the 109 late-stage gene therapy clinical trials underway before January 2020, estimating the prevalence and incidence of their corresponding diseases, applying a model of the increase in quality-adjusted life years for each therapy, and simulating the launch prices and expected spending of all available gene therapies annually. The results of our simulation suggest that annual spending on gene therapies will be approximately $20.4 billion, under conservative assumptions. We decompose the estimated spending by treated age group as a proxy for insurance type, finding that approximately one-half of annual spending will on the use of gene therapies to treat non-Medicare-insured adults and children. We conduct multiple sensitivity analyses regarding our assumptions and model parameters. We conclude by considering the tradeoffs of different payment methods and policies that intend to ensure patient access to the expected benefits of gene therapy.

Trends in Buprenorphine Initiation and Retention in the United States, 2016-2022.

This study uses data from an all-payer database of prescriptions dispensed in US retail pharmacies to assess trends in buprenorphine initiation and retention during 2016-2022.

Out-of-Pocket Costs of Treatment Among Employer-Insured Women With Invasive Breast Cancer.

This cross-sectional study examines out-of-pocket costs for the treatment of invasive breast cancer in employer-insured women younger than 65 years.

Dispensing of Ivermectin From Veterans Administration Pharmacies During the COVID-19 Pandemic.

This cohort study compares changes in ivermectin dispensing during the COVID-19 pandemic between the Veterans Administration (VA) and retail pharmacy settings and examines the association of the VA national formulary restriction with ivermectin dispensing.

COVID-19 Vaccine-Related Beliefs and Behaviors Among Patients With and Survivors of Hematologic Malignancies.

PURPOSE: Patients with and survivors of hematologic malignancies are particularly vulnerable to COVID-19 disease and complications. This study examined patients' vaccination attitudes and behaviors and their correlates. METHODS: A two-wave survey was fielded in December 2020 and June 2021 among hematologic malignancy patients and survivors (N = 2,272). Demographic characteristics, intent to get vaccinated, vaccination status, attitudes toward vaccination, and level of trust in specific sources of information about COVID-19 vaccines were assessed. Descriptive statistics were calculated, and linear probability models were estimated to examine binary outcomes and their correlates. RESULTS: In December 2020, before COVID-19 vaccines were available, 73% stated they were likely or very likely to get vaccinated if an FDA-approved vaccine became available; however, in June 2021 over 90% reported being vaccinated. Being younger, unmarried, trusting local faith leaders, and not having a bachelor's degree or more were negatively associated with getting vaccinated. Among those hesitant in December 2020, those who expressed a distrust of vaccines in general were least likely to get vaccinated. Being vaccinated in June 2021 was positively associated with the degree to which respondents trust their oncologist, federal agencies, and pharmaceutical companies. Oncologists and primary care physicians were reported as the most trusted sources for information about vaccines. DISCUSSION: COVID-19 vaccine hesitancy remains a public policy concern even now, as additional boosters are recommended among vulnerable populations. Our findings suggest that patient trust in their treating physicians can play a critical role in promoting individual patient and public health goals.

Financial Hardship in Adult Survivors of Childhood Cancer in the Era After Implementation of the Affordable Care Act: A Report From the Childhood Cancer Survivor Study.

PURPOSE: To estimate the prevalence of financial hardship among adult survivors of childhood cancer compared with siblings and identify sociodemographic, cancer diagnosis, and treatment correlates of hardship among survivors in the era after implementation of the Affordable Care Act. METHODS: A total of 3,555 long-term (≥ 5 years) survivors of childhood cancer and 956 siblings who completed a survey administered in 2017-2019 were identified from the Childhood Cancer Survivor Study. Financial hardship was measured by 21 survey items derived from US national surveys that had been previously cognitively tested and fielded. Principal component analysis (PCA) identified domains of hardship. Multiple linear regression examined the association of standardized domain scores (ie, scores divided by standard deviation) with cancer and treatment history and sociodemographic characteristics among survivors. RESULTS: Survivors were more likely than siblings to report hardship in ≥ 1 item (63.4% v 53.7%, P < .001). They were more likely to report being sent to debt collection (29.9% v 22.3%), problems paying medical bills (20.7% v 12.8%), foregoing needed medical care (14.1% v 7.8%), and worry/stress about paying their rent/mortgage (33.6% v 23.2%) or having enough money to buy nutritious meals (26.8% v 15.5%); all P < .001. Survivors reported greater hardship than siblings in all three domains identified by principal component analysis: behavioral hardship (mean standardized domain score 0.51 v 0.35), material hardship/financial sacrifices (0.64 v 0.46), and psychological hardship (0.69 v 0.44), all P < .001. Sociodemographic (eg,

Out-of-pocket spending for health care after COVID-19 hospitalization.

OBJECTIVES: Many patients report financial stress following hospitalization for COVID-19. Although many COVID-19 survivors require extensive care after discharge, the degree to which this care contributes to financial stress is unclear. Using national data, we assessed out-of-pocket spending during the 180 days after discharge among patients hospitalized for COVID-19. STUDY DESIGN: Retrospective cohort analysis of Optum's deidentified Clinformatics Data Mart, a national database of medical and pharmacy claims. METHODS: Among privately insured and Medicare Advantage patients hospitalized for COVID-19 between March and June 2020, we calculated median out-of-pocket spending during the 180 days after discharge. For comparison, we repeated this calculation among patients hospitalized for pneumonia. RESULTS: Of 7932 patients with COVID-19 included in analyses, 2061 (26.0%) had private insurance. Among privately insured and Medicare Advantage patients, median (25th-75th percentile) out-of-pocket spending after discharge was $287 ($59-$842) and $271 ($63-$783), respectively. Out-of-pocket spending exceeded $2000 for 10.9% and 9.3% of these patients, respectively. Among privately insured and Medicare Advantage patients hospitalized for pneumonia, median (25th-75th percentile) out-of-pocket spending after discharge was $276 ($62-$836) and $570 ($181-$1466). Out-of-pocket spending exceeded $2000 for 12.1% and 17.2% of these patients, respectively. CONCLUSIONS: For most patients hospitalized for COVID-19, postdischarge care may not be a major source of financial stress. Although this is reassuring, our findings also suggest that a sizable minority of COVID-19 survivors have substantial out-of-pocket spending after discharge. These survivors could be particularly vulnerable to financial toxicity if they also receive bills for the hospitalization owing to the expiration of insurer cost-sharing waivers. Insurers should consider this possibility when deciding whether to reinstate cost-sharing waivers for COVID-19 hospitalizations.

From COVID Vaccines to HIV Prevention: Pharmaceutical Financing and Distribution for the Public's Health.

The complexity and inefficiency of the U.S. health care system complicates the distribution of life-saving medical technologies. When the public health is at stake, however, there are alternatives. The proposal for a national PrEP program published in this issue of the Journal applies some of the lessons of the national COVID vaccine campaign to HIV prevention. In doing so, it draws on other examples of public health approaches to the financing of medical technology, from vaccines for children to hepatitis C treatment.

Opportunities and Challenges of Generic Pre-Exposure Prophylaxis Drugs for HIV.

Antiretroviral pre-exposure prophylaxis (PrEP) is protective against HIV. Low utilization rates amongst HIV vulnerable populations are due in part to the high cost of PrEP. Generic PrEP offers the potential to improve health at significantly reduced costs. In this study, we examine early utilization patterns and prices for generic PrEP. We discuss the opportunities and challenges for generic PrEP to improve health among HIV vulnerable populations.