Evaluation of Renal Function Estimation Formulas Specific to Dynamic Renal Function for Drug Dosing in Critically Ill Patients.

OBJECTIVES: The study compared estimated creatinine clearance (eCrCl) between the Cockcroft-Gault (CG) equation and the Jelliffe, Chiou, and Brater equations designed for estimation in dynamic renal function and resulting antimicrobial dosing concordance of five antimicrobials (cefepime, meropenem, piperacillin/tazobactam, vancomycin, and fluconazole) commonly used in the intensive care unit (ICU). METHODS: Electronic medical records were used to identify the target patient population. Analysis of variance tests with repeated measures were performed to compare eCrCl. Bowker's tests of symmetry were applied to compare the dosing regimen discordance between CG and candidate equations. RESULTS: From January 1, 2008 through December 31, 2012, we identified 387 patients with acute kidney injury (AKI), among whom 62% (n = 240) were older adults (65 years and older) and 46% (n = 178) were obese (body mass index ≥30). In the declining phase of renal function, eCrCl means were different between the CG and Brater equations (32.0 vs 26.1 mL/min, P < 0.001). The dosing regimen discordance rates (CG vs candidate equations) in declining renal function varied from 19.3% to 25% and were statistically significant for cefepime and meropenem (P < 0.001) based on Food and Drug Administration recommendations for dose adjustment. In the improving phase, eCrCl means were different (P < 0.001) between CG (43.0 mL/min) and candidate formulas (Brater 47.9, Chiou 31.7, and Jelliffe 55.3 mL/min). The dosing regimen discordance rates (CG vs candidate equations) in the improving phase varied from 8.3% to 39% and were statistically significant for all 5 antimicrobials (P < 0.001). CONCLUSIONS: Differences in eCrCl between CG and candidate formulas were observed in surgical ICU patients with acute kidney injury. Discordant dosing recommendations may affect antimicrobial regimens in ICU patients with dynamic renal function.

Racial differences in receipt of adjuvant hormonal therapy among Medicaid enrollees in South Carolina diagnosed with breast cancer.

Several factors contribute to the pervasive Black-White disparity in breast cancer mortality in the U.S., such as tumor biology, access to care, and treatments received including adjuvant hormonal therapy (AHT), which significantly improves survival for hormone receptor-positive breast cancers (HR+). We analyzed South Carolina Central Cancer Registry-Medicaid linked data to determine if, in an equal access health care system, racial differences in the receipt of AHT exist. We evaluated 494 study-eligible, Black (n = 255) and White women (n = 269) who were under 65 years old and diagnosed with stages I-III, HR+ breast cancers between 2004 and 2007. Bivariate and multivariate analyses were conducted to assess receipt of ≥1 AHT prescriptions at any point in time following (ever-use) or within 12 months of (early-use) breast cancer diagnosis. Seventy-two percent of the participants were ever-users (70 % Black, 74 % White) and 68 % were early-users (65 % Black, 71 % White) of AHT. Neither ever-use (adjusted OR (AOR) = 0.75, 95 % CI 0.48-1.17) nor early-use (AOR = 0.70, 95 % CI 0.46-1.06) of AHT differed by race. However, receipt of other breast cancer-specific treatments was independently associated with ever-use and early-use of AHT [ever-use: receipt of surgery (AOR = 2.15, 95 % CI 1.35-3.44); chemotherapy (AOR = 1.97, 95 % CI 1.22-3.20); radiation (AOR = 2.33, 95 % CI 1.50-3.63); early-use: receipt of surgery (AOR = 2.03, 95 % CI 1.30-3.17); chemotherapy (AOR = 1.90, 95 % CI 1.20-3.03); radiation (AOR = 1.73, 95 % CI 1.14-2.63)]. No racial variations in use of AHT among women with HR+ breast cancers insured by Medicaid in South Carolina were identified, but overall rates of AHT use by these women is low. Strategies to improve overall use of AHT should include targeting breast cancer patients who do not receive adjuvant chemotherapy and/or radiation.

The role of cerebrovascular disease and the association between diabetes mellitus and dementia among aged medicare beneficiaries.

OBJECTIVE: The aim of this study is to assess whether diabetes mellitus is associated with overall dementia and its subtypes (Alzheimer's disease and vascular dementia) among the elderly and to identify the role of cerebrovascular disease in the association between diabetes and dementia. METHODS: In a retrospective cross-sectional study, 5160 community-dwelling and institutionalized Medicare beneficiaries aged 65 years or over without health maintenance organization enrollment from the Medicare Current Beneficiary Survey in 2010 were included. The International Classification of Diseases-9 codes were used to identify the outcome and independent variables from the Medicare claims. The key predictor was diabetes mellitus and the outcomes were overall dementia and its subtypes. Logistic regression was employed to assess the association between dementia and diabetes after adjusting for age, gender, race, education, income, smoking status, and Charlson Comorbidity Index. RESULTS: After adjusting for potential confounders, diabetes mellitus was significantly associated with overall dementia (odds ratio [OR] = 1.42; 95% confidence interval [CI], 1.14-1.77), vascular dementia (OR = 1.29; 95% CI, 1.02-1.64), and Alzheimer's disease (OR = 1.51, 95% CI, 1.10-2.09). The OR decreased to 1.26 (95% CI, 1.01-1.58) for overall dementia, controlling for cerebrovascular disease. The associations between diabetes mellitus and vascular dementia (OR = 1.13, 95% CI, 0.89-1.44) and Alzheimer's disease (OR = 1.39, 95% CI, 1.00-1.92) were no longer statistically significant once cerebrovascular disease was controlled. CONCLUSIONS: The association between diabetes mellitus and dementia is only partially mediated through cerebrovascular disease, suggesting that diabetes mellitus is associated independently with overall dementia among the elderly, but not with vascular dementia and Alzheimer's disease.

Differences in proxy-reported and patient-reported outcomes: assessing health and functional status among medicare beneficiaries.

BACKGROUND: Proxy responses are very common when surveys are conducted among the elderly or disabled population. Outcomes reported by proxy may be systematically different from those obtained from patients directly. The objective of the study is to examine the presence, direction, and magnitude of possible differences between proxy-reported and patient-reported outcomes in health and functional status measures among Medicare beneficiaries. METHODS: This study is a pooled cross-sectional study of a nationally representative sample of community-dwelling Medicare beneficiaries from 2006 to 2011. Survey respondents can respond to the Medicare Current Beneficiary Survey either by themselves or via proxies. Health and functional status was assessed across five domains: physical, affective, cognitive, social, and sensory status. Propensity score matching was used to get matched pairs of patient-reports and proxy-reports. RESULTS: After applying the propensity score matching, the study identified 7,780 person-years of patient-reports paired with 7,780 person-years of proxy-reports. Except for the sensory limitation, differences between proxy-reported and patient-reported outcomes were present in physical, affective, cognitive, and social limitations. Compared to patient-reports, a question regarding survey respondents' difficulties in managing money was associated with the largest proxy response bias (relative risk, RR = 3.83). With few exceptions, the presence, direction, and magnitude of differences between proxy-reported and patient-reported outcomes did not vary much in the subgroup analysis. CONCLUSIONS: When there is a difference between proxy-reported and patient-reported outcomes, proxies tended to report more health and functional limitations among the elderly and disabled population. The extent of proxy response bias depended on the domain being tested and the nature of the question being asked. Researchers should accept proxy reports for sensory status and objective, observable, or easy questions. For physical, affective, cognitive, or social status and private, unobservable, or complex questions, proxy-reported outcomes should be used with caution when patient-reported outcomes are not available.

Regulatory and clinical considerations for biosimilar oncology drugs.

Biological oncology products are integral to cancer treatment, but their high costs pose challenges to patients, families, providers, and insurers. The introduction of biosimilar agents-molecules that are similar in structure, function, activity, immunogenicity, and safety to the original biological drugs-provide opportunities both to improve health-care access and outcomes, and to reduce costs. Several international regulatory pathways have been developed to expedite entry of biosimilars into global marketplaces. The first wave of oncology biosimilar use was in Europe and India in 2007. Oncology biosimilars are now widely marketed in several countries in Europe, and in Australia, Japan, China, Russia, India, and South Korea. Their use is emerging worldwide, with the notable exception of the USA, where several regulatory and cost barriers to biosimilar approval exist. In this Review, we discuss oncology biosimilars and summarise their regulatory frameworks, clinical experiences, and safety concerns.

Musculoskeletal safety outcomes of patients receiving daptomycin with HMG-CoA reductase inhibitors.

Daptomycin, a cyclic lipopeptide antibiotic, and 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase inhibitors (statins) are commonly administered in the inpatient setting and are associated with creatine phosphokinase (CPK) elevations, myalgias, and muscle weakness. Safety data for coadministration of daptomycin with statins are limited. To determine the safety of coadministration of daptomycin with statin therapy, a multicenter, retrospective, observational study was performed at 13 institutions in the Southeastern United States. Forty-nine adult patients receiving statins concurrently with daptomycin were compared with 171 patients receiving daptomycin without statin therapy. Detailed information, including treatment indication and duration, infecting pathogen, baseline and subsequent CPK levels, and presence of myalgias or muscle complaints, was collected. Myalgias were noted in 3/49 (6.1%) patients receiving combination therapy compared with 5/171 (2.9%) of patients receiving daptomycin alone (P = 0.38). CPK elevations of >1,000 U/liter occurred in 5/49 (10.2%) patients receiving combination therapy compared to 9/171 (5.3%) patients receiving daptomycin alone (P = 0.32). Two of five patients experiencing CPK elevations of >1,000 U/liter in the combination group had symptoms of myopathy. Three patients (6.1%) discontinued therapy due to CPK elevations with concurrent myalgias in the combination group versus 6 patients (3.5%) in the daptomycin-alone group (P = 0.42). CPK levels and myalgias reversed upon discontinuation of daptomycin therapy. Overall musculoskeletal toxicity was numerically higher in the combination group but this result was not statistically significant. Further prospective study is warranted in a larger population.

Effects of Alzheimer's disease and related dementias on dental care usage and economic burden in older adults: a cross-sectional study.

AIM: Distinct subtypes of Alzheimer's disease (AD) and related dementias (RD) might have different effects on dental care usage and economic burden. To determine the effects of AD and RD on specific types of dental care usage (preventive and treatment visits) and dental care costs from different payers (total and out-of-pocket costs). METHODS: A cross-sectional study was conducted using the Medicare Current Beneficiary Survey in 2016. This study identified 4268 community dwelling older adults with and without Alzheimer's disease and related dementias (ADRD) from a nationally representative sample of Medicare beneficiaries. Dental care usage and costs are based on self-reported data. Preventive dental events included preventive and diagnosis events. Treatment dental events included restorative, oral surgery and other events. RESULTS: This study identified 4268 (weighted N=30 423 885) older adults, including 94.48% without ADRD, 1.90% with AD and 3.63% with RD. Compared with older adults without ADRD, those with AD had similar dental care usage, but those with RD were 38% less likely to have treatment visit (OR: 0.62; 95% CI: 0.41 to 0.94) and had a 40% reduced number of total treatment visits (incidence rate ratio: 0.60; 95% CI: 0.37 to 0.98). RD was not associated with dental care costs, but AD was associated with higher total costs (ß: 1.08; 95% CI: 0.14 to 2.01) and higher out-of-pocket costs (ß: 1.25; 95% CI: 0.17 to 2.32). CONCLUSIONS: Patients with ADRD were more likely to have adverse dental care outcomes. Specifically, RD was associated with lower treatment dental care usage and AD was associated with higher total and out-of-pocket dental care costs. Effective patient-centred strategies should be used to improve dental care outcomes in patients with distinct subtypes of ADRD.

Age and geographic disparities in acute ischaemic stroke prehospital delays in China: a cross-sectional study using national stroke registry data.

Background: Stroke has been the leading cause of death in China for decades. The extremely low intravenous thrombolysis rate is largely due to the prehospital delays that make patients ineligible for the time-sensitive therapy. Limited studies evaluated prehospital delays across China. We investigated prehospital delays in the stroke population across China and the associated age, rurality, and geographic disparities. Methods: A cross-sectional study design was employed using the Bigdata Observatory platform for Stroke of China in 2020, the nationwide, prospective, multicentre registry of patients with acute ischaemic stroke (AIS). Mixed-effect regression models were used to account for the clustered data. Findings: The sample contained 78,389 AIS patients. The median onset-to-door (OTD) time was 24 h, with only 11.79% (95% confidence interval [CI]: 11.56-12.02%) patients arriving at hospitals within 3 h. About 12.43% (95% CI: 12.11-12.74%) of patients 65 years or older arrived at hospitals within 3 h, which was significantly higher than the young and middle-aged patients (11.03%; 95% CI: 10.71-11.36%). After controlling for potential confounders, young and middle-aged patients were less likely to present to hospitals within 3 h (adjusted odds ratio: 0.95; 95% CI: 0.90-0.99) compared to patients 65 years or older. The 3-h hospital arrival rate was the highest in Beijing (18.40%, 95% CI: 16.01-20.79%), which was almost 5 times higher than that in Gansu (3.45%, 95% CI: 2.69-4.20%). The arrival rate in urban areas was almost 2 times higher than that in rural areas (13.35% versus. 7.66%). Interpretation: We found that the low rates of timely arrival at hospitals after a stroke is more salient in the younger population, rural settings, or those residing in less developed geographic regions. This study calls for more tailored interventions focusing on younger people, rural areas, and less developed geographic regions. Funding: The National Natural Science Foundation of China; CIHR, Grant/Award Number: 81973157, PI: JZ. Natural Science Foundation of Shanghai; CIHR, Grant/Award Number: 17dz2308400, PI: JZ. Funding from the University of Pennsylvania; Grant/Award Number: CREF-030, PI: RL.

Trend and effects of high-deductible health insurance plans in the health care system: financial access problems in management of cognitive impairment.

BACKGROUND: High-deductible health plans (HDHPs) are characterized by higher deductibles and lower monthly premiums compared with a typical health plan. HDHPs may reduce, or delay, needed care, which will ultimately lead to poorer access to care for chronically affected participants. OBJECTIVES: To (1) investigate the HDHP enrollment trend and (2) determine the effects of HDHPs on financial access problems for individuals with self-reported cognitive impairment. METHODS: Data between 2010 and 2018 were obtained from the National Health Interview Survey (NHIS). Individuals with cognitive impairment were identified if they were limited by memory difficulties. Problems regarding financial access to health care were assessed based on 6 survey questions from the Centers for Disease Control and Prevention. Multivariable logistic regressions were implemented to evaluate the effects of HDHPs. RESULTS: This study identified 1,148 individuals with cognitive impairment, representing 3.9 million individuals in the United States from 2010 to 2018. A nearly 2-fold increase in HDHP enrollment with cognitive impairment was observed from 2010 (20.9%) to 2018 (41.9%). This increase is similar to that reported for noncognitively impaired individuals. After controlling for possible confounding variables, cognitively impaired individuals with HDPHs were more likely to have overall financial access difficulties compared with those without HDHPs (OR = 1.17, 95% CI = 0.88-1.56, P = 0.271), but this likelihood was not statistically significant. CONCLUSIONS: HDHPs are intended to support effective care options and reduce health care costs. However, our research found that among individuals with cognitive impairment, those with HDHPs experienced some financial access problems, such as affording medical care, follow-up care, and specialists, than those without HDHPs, indicating that HDHPs might have unintended consequences for health care usage. DISCLOSURES: No outside funding supported this study. The authors have no conflicts of interest or financial interests to disclose.

Evidence of Chinese Herbal Medicine Use From an Economic Perspective: A Systematic Review of Pharmacoeconomics Studies Over Two Decades.

Objectives: Pharmacoeconomics evaluation (PE) is increasingly used in the healthcare decision-making process in China. Little is known about PE conducted in Chinese Herbal Medicines (CHMs). We aimed to systematically review trends, characteristics, and quality of PE of CHMS. Methods: We systematically searched both Chinese (CNKI, WanFang, and VIP) and English (Pubmed) databases. Studies were included if they were PE studies comparing both costs and outcomes between two or more interventions published in Chinese or English. Assessment of the quality of studies was conducted using the Quality of Health Economic Analyses (QHES) instrument. T-test and Chi-square tests were used to compare the studies before and after the first edition of China Guidelines for PE published in 2011, and between studies published in Chinese and English. Results: A total of 201 articles were included. There was an increasing trend of PE studies on CHMs during the study period. The top three studied diseases were central nervous system (CNS), mental, and behavioral disorders; cardiovascular diseases; and blood, immune and endocrine diseases. The average QHES score for the included studies was 63.37. Cost-effectiveness analysis (CEA) accounted for the majority (76.6%) of the included studies. Only a quarter of the articles (27.4%) were funded, and there were significantly more studies funded after the publication of China guidelines for PE. About 96.5% of studies did not specify evaluation perspectives and 89.6% of studies had a sample size of less than 300. Around half of the studies (55%) used incremental analysis, but only a few of them considered using a threshold. Half of the studies lacked sensitivity analysis. There was no significant improvement in the quality of studies published after the publication of China Guidelines for PE, and English articles had significantly higher quality than Chinese articles. Conclusion: This study identified several problems in PE studies on CHMs, including having small sample sizes, lacking necessary research elements, and using single evaluation methods. The quality of PE studies on CHMs was not sufficient. Researchers need to understand the standardized way to conduct PE studies and improve the quality and level of PE studies on CHMs.

Impact of National Volume-Based Procurement on the Procurement Volumes and Spending for Antiviral Medications of Hepatitis B Virus.

Introduction: Although persistent inhibition of HBV replication by antiviral therapy has shown to slow disease progression, cost-related access barriers to these essential medicines are becoming salient. The national volume-based procurement (NVBP) was piloted in China and led to substantial reduction in the list price of prescription drugs. To examine the impact of NVBP on selected antiviral medication costs per defined daily dose (DDD), procurement volumes, and spending. Methods: We employed an interrupted time series design to examine changes in cost per defined daily dose (DDD), procurement volumes, and spending for NVBP bid-winning antiviral medications (tenofovir disoproxil fumarate and entecavir) in 11 pilot cities from 2017 to 2020. Procurement transaction data were obtained from 9,454 hospitals in the Chinese Hospital Pharmaceutical Audit (CHPA) database. In the secondary analysis, the control group comprised two non-NVBP drugs (adefovir and lamivudine) procured in 11 cities not exposed to the NVBP. Results: Cost per DDD of the two hepatitis B virus (HBV) antiviral medications reduced by CNY1.598 (p = 0.002) immediately following the implementation of NVBP, dropping from an average cost of CNY16.483 per DDD at baseline to CNY6.420 at the end of the observation period. NVBP implementation resulted in a substantial reduction in daily costs of antivirals and an increase in monthly procurement volumes by 6.674 million DDDs (p = 0.017), while monthly spending was reduced by CNY138.26 million (p = 0.002). In the secondary ITS analysis with a control group, the average cost per DDD of the NVBP bid-winning antivirals declined by CNY4.537 (p < 0.001), monthly procurement volumes increased by 7.209 million DDDs (p = 0.002), and monthly spending dropped by CNY138.83 million (p < 0.001). Conclusion: Volume-based procurement piloted in China may be effective for reducing price and total expenditures and improving drug utilization, which is especially important for HBV patients who need constant access to antiviral therapies.

Analysis of Time to the Hospital and Ambulance Use Following a Stroke Community Education Intervention in China.

Importance: Prehospital delay (time from symptom onset of stroke to the door of a hospital) in patients with stroke is long in China. With the goal of improving public awareness and knowledge of stroke recognition, Stroke 1-2-0 was developed in China as an education program to prompt rapid response to the onset of stroke based on clinical practice in China, and examination of its outcomes is needed. Objective: To investigate the association of the Stroke 1-2-0 educational campaign with prehospital delay for patients with ischemic stroke. Design, Setting, and Participants: In a population-based cross-sectional study, all patients with ischemic stroke events were admitted to the Minhang Hospital, which is the only tertiary care hospital with a stroke center that provides acute stroke care in Xinzhuang county, Shanghai, China. The study period was from January 1, 2016, to December 31, 2019, and data analysis was performed from January 1 to July 31, 2021. Exposures: A multifaceted Stroke 1-2-0 educational campaign comprising slides, videos, brochures, and posters distributed in the community. Main Outcomes and Measures: Proportion of patients with hospital arrival within 3 hours and use of an ambulance to seek medical care, as well as the odds of seeking medical attention within 3 hours after the stroke before vs after initiation of the multifaceted educational campaign. Results: A total of 2857 patients (1774 men [62.1%]; mean [SD] age, 69.83 [12.66] years) with stroke were identified, including 503 in the precampaign period and 2354 in the postcampaign period. Following the multifaceted campaign, the median (IQR) prehospital delay time decreased from 18.72 (7.44-27.84) hours to 6.00 (2.00-16.35) hours (P < .001). After the implementation of the Stroke 1-2-0 campaign, the proportion of patients with hospital arrival time within 3 hours increased from 5.8% to 33.4% (P < .001) and use of an ambulance increased from 3.2% to 30.6% (P < .001). In an interrupted time series analysis, the initiation of the Stroke 1-2-0 campaign was associated with significantly increased odds of arriving at the hospital within 3 hours (odds ratio, 8.01; 95% CI, 7.17-8.95; P < .001) and use of an ambulance (odds ratio, 9.41; 95% CI, 8.24-10.74; P < .001). Conclusions and Relevance: The persistent multifaceted campaign using the Stroke 1-2-0 program was associated with reduced prehospital delay and improved timely arrival rate and ambulance arrival rate for patients with stroke. These findings suggest that Stroke 1-2-0 can be adopted in other regions of China to possibly improve health outcomes and reduce clinical burdens for all patients with stroke.

Deprescribing Antipsychotics Based on Real-World Evidence to Inform Clinical Practice: Safety Considerations in Managing Older Adults with Dementia.

Background: Antipsychotics are commonly used in dementia patients but have potential risks that often outweigh clinical benefits. Limited studies have assessed the healthcare utilization and medical costs associated with antipsychotic use, especially those focused on cumulative days of use. Objectives: To examine clinical and economic burdens associated with different cumulative days of antipsychotic use in older adults with dementia in the United States. Methods: This study used Medicare Current Beneficiary Survey (2015-2017). Older (≥65 years) Medicare beneficiaries with dementia, without concurrent schizophrenia, bipolar disorder, Huntingon's disease, or Tourette's syndrome were included. Antipsychotic use was measured using Medicare Part D prescription events. Healthcare utilization was measured as inpatient services, outpatient services, and emergency room (ER) visits. Total medical costs were classified as Medicare and out-of-pocket costs. The logistic regression, negative binomial regression, and generalized linear model with a log link and gamma distribution were used to examine factors, healthcare utilization, and medical costs. Survey sampling weights were applied to generate national estimates. Results: Among older adults with dementia, 13.18% used antipsychotics. Factors associated with antipsychotic use were being Hispanic (OR: 2.90; 95% CI: 1.45, 5.78), widowed (OR: 3.52; 95% CI: 1.46, 8.48), and single (OR: 3.25; 95% CI: 1.53, 6.87). Compared to non-users, antipsychotic use was associated with higher inpatient visits (IRR: 2.11; 95% CI 1.53, 2.90), ER visits (IRR: 1.61; 95% CI: 1.21, 2.13), total costs (ß: 0.53; 95% CI: 0.36, 0.71), Medicare costs (ß: 0.49; 95% CI 0.26, 0.72), and out-of-pocket costs (ß: 0.66; 95% CI: 0.35, 0.97). With the increase in cumulative days of antipsychotic use, the magnitude of clinical and economic burdens was decreased. Conclusion: The significant clinical and economic burdens associated with antipsychotic use, especially with short-term use, provide real-world evidence to inform clinical practice on deprescribing antipsychotics among community-dwelling geriatric dementia patients.

Gender Disparities in Anti-dementia Medication Use among Older Adults: Health Equity Considerations and Management of Alzheimer's Disease and Related Dementias.

Objective: The prevalence of Alzheimer's disease and related dementias (ADRD) in women is higher than men. However, the knowledge of gender disparity in ADRD treatment is limited. Therefore, this study aimed to determine the gender disparities in the receipt of anti-dementia medications among Medicare beneficiaries with ADRD in the U.S. Methods: We used data from the Medicare Current Beneficiary Survey 2016. Anti-dementia medications included cholinesterase inhibitors (ChEIs; including rivastigmine, donepezil, and galantamine) and N-methyl-D-aspartate (NMDA) receptor antagonists (including memantine). Descriptive analysis and multivariate logistic regression models were implemented to determine the possible gender disparities in the receipt of anti-dementia medications. Subgroup analyses were conducted to identify gender disparities among beneficiaries with Alzheimer's disease (AD) and those with only AD-related dementias. Results: Descriptive analyses showed there were statistically significant differences in age, marital status, and Charlson comorbidities index (CCI) between Medicare beneficiaries who received and who did not receive anti-dementia medications. After controlling for covariates, we found that female Medicare beneficiaries with ADRD were 1.7 times more likely to receive anti-dementia medications compared to their male counterparts (odds ratio [OR]: 1.71; 95% confidence interval [CI]: 1.19-2.45). Specifically, among Medicare beneficiaries with AD, females were 1.2 times more likely to receive anti-dementia medications (Odds Radio: 1.20; 95% confidence interval: 0.58-2.47), and among the Medicare beneficiaries with only AD-related dementias, females were 1.9 times more likely to receive anti-dementia medications (OR: 1.90; 95% CI: 1.23-2.95). Conclusion: Healthcare providers should be aware of gender disparities in receiving anti-dementia medications among patients with ADRD, and the need to plan programs of care to support both women and men. Future approaches to finding barriers of prescribing, receiving and, adhering to anti-dementia medications by gender should include differences in longevity, biology, cognition, social roles, and environment.

Lowering drug prices and enhancing pharmaceutical affordability: an analysis of the national volume-based procurement (NVBP) effect in China.

To cope with the increasing healthcare costs brought about by the universal health insurance programme, national volume-based procurement (NVBP) was implemented in China to reduce drug prices. However, the impact of NVBP remains unknown. We reported the effects of the NVBP pilot programme on medication affordability and discussed the challenges and recommendations for further reforms. A total of 25 molecules won the bidding in the NVBP pilot programme, and price cuts ranged from 25% to 96%. Medication affordability was measured as the number of days' wages needed to pay for a course of treatment, and the medication was identified as affordable if the cost of a treatment course was less than the average daily wage. After the NVBP, the proportion of affordable drugs increased from 33% to 67%, and the mean affordability improved from 8.2 days' wages to 2.8 days' wages. Specifically, for rural residents, the proportion of affordable drugs increased from 13% to 58%, and the mean affordability improved from 15.7 days' wages to 5.3 days' wages. For urban residents, the proportion of affordable drugs increased from 54% to 71%, and the mean affordability improved from 5.9 days' wages to 2.0 days' wages. Implementing the NVBP substantially improved medication affordability. In future reforms, a multifaceted approach addressing all issues in the health system is needed to enhance medicine access.

Age and Gender Disparities in Adverse Events Following COVID-19 Vaccination: Real-World Evidence Based on Big Data for Risk Management.

Background: Two coronavirus disease 2019 (COVID-19) vaccines have received emergency use authorizations in the U.S. However, the safety of these vaccines in the real-world remains unknown. Methods: We reviewed adverse events (AEs) following COVID-19 vaccination among adults in the Vaccine Adverse Event Reporting System (VAERS) from December 14, 2020, through January 22, 2021. We compared the top 10 AEs, serious AEs, along with office and emergency room (ER) visits by age (18-64 years, ≥65 years) and gender (female, male). Results: There were age and gender disparities among adults with AEs following COVID-19 vaccination. Compared to younger adults aged between 18 and 64 years, older adults were more likely to report serious AEs, death, permanent disability, and hospitalization. Males were more likely to report serious AEs, death, and hospitalization compared to females. Conclusions: COVID-19 vaccines are generally safe but possible age and gender disparities in reported AEs may exist.

Medical costs and associated racial/ethnic and sex disparities in erythropoiesis-stimulating agent use: anemia management under the Medicare reimbursement policy.

BACKGROUND: Before 2007, erythropoiesis-stimulating agents (ESAs) were the highest-expenditure drug in the Medicare system. In 2007, CMS issued a reimbursement policy change for ESAs used by cancer patients. However, empirical evidence is currently lacking to evaluate medical costs after the policy change, especially by sex and racial/ethnic groups. OBJECTIVE: To examine the impact of the Medicare reimbursement policy change and associated racial/ethnic and sex disparities on medical costs for cancer patients who were new users of ESAs. METHODS: This study was an exploratory retrospective treatment effectiveness study, which used SEER-Medicare linked data. A difference-in-difference design was used that incorporated a control group of patients with chronic kidney disease. A generalized linear model, with a log link and a gamma distribution, was used to examine medical costs. RESULTS: The Medicare reimbursement policy change was statistically significantly associated with an 11% (95% CI = 2%-20%) reduction in anemia-related costs, including a 10% (95% CI = 1%-19%) reduction in Medicare payment and an 18% (95% CI = 10%-26%) reduction in patient cost sharing. For total medical costs, the policy change was statistically significantly associated with a 12% (95% CI = 6%-18%) reduction, including an 11% (95% CI = 5%-18%) reduction in Medicare payment and a 14% (95% CI = 7%-20%) reduction in patient cost sharing. Medical costs were reduced in patients who were male and those who were White but remained the same for patients who were female and those who were Black, Hispanic, and other races or ethnicities. CONCLUSIONS: Anemia-related and total medical costs associated with ESAs used by cancer patients with chemotherapy-induced anemia were reduced after the Medicare reimbursement policy change. However, the policy change was only effective for patients who were male and those who were White. The policy change had no effect on patients who were female and those of racial/ethnic minorities. DISCLOSURES: This study was funded by the SPARC Research Grant. The funder had no role in any part of this study. This study used the linked SEER-Medicare database. The interpretation and reporting of the data are the sole responsibility of the authors. The authors have nothing to disclose.

Impact of Medicare prescription drug (Part D) coverage expansion on utilisation and financial burden of benzodiazepines among older adults: an interrupted time series analysis.

OBJECTIVE: Benzodiazepines were excluded from Medicare Part D coverage since its introduction in 2006. Part D expanded coverage for benzodiazepines in 2013. The objective was to examine the impact of Medicare Part D coverage expansion on the utilisation and financial burden of benzodiazepines in older adults. DESIGN: Interrupted time series with a control group. SETTING: Nationally representative sample. PARTICIPANTS: 53 150 468 users of benzodiazepines and 21 749 749 users of non-benzodiazepines (an alternative therapy) from the Medicare Current Beneficiary Survey between the pre-expansion (2006-2012) and post-expansion (2013-2017) periods. INTERVENTION: Medicare Part D coverage expansion on benzodiazepines. PRIMARY AND SECONDARY OUTCOME MEASURES: Annual rate of benzodiazepines and non-benzodiazepines, average number of benzodiazepines and non-benzodiazepines and average cost of benzodiazepines and non-benzodiazepines. RESULTS: After Medicare Part D coverage expansion, the level of the annual rate of benzodiazepines increased by 8.20% (95% CI: 6.07% to 10.32%) and the trend decreased by 1.03% each year (95% CI: -1.77% to -0.29%). The trend of the annual rate of non-benzodiazepines decreased by 0.72% each year (95% CI: -1.11% to -0.33%). For the average number of benzodiazepines, the level increased by 0.67 (95% CI: 0.52 to 0.82) and the trend decreased by 0.10 each year (95% CI: -0.15 to -0.05). For the average number of non-benzodiazepines, the level decreased by 0.11 (95% CI: -0.21 to -0.01) and the trend decreased by 0.04 each year (95% CI: -0.08 to -0.01). No significant level and trend changes were identified for the average cost of benzodiazepines and non-benzodiazepines. CONCLUSIONS: After Medicare Part D coverage expansion, there was a sudden increase in the utilisation of benzodiazepines and a decreasing trend in the long-term. The increase in the utilisation of benzodiazepines did not add a financial burden to older adults. As an alternative therapy, the utilisation of non-benzodiazepines decreased following the coverage expansion.

Corrigendum: Big Data and Real-World Data Based Cost-Effectiveness Studies and Decision-Making Models: A Systematic Review and Analysis.

[This corrects the article DOI: 10.3389/fphar.2021.700012.].

Impact of Cost-Related Medication Nonadherence on Economic Burdens, Productivity Loss, and Functional Abilities: Management of Cancer Survivors in Medicare.

Background: Cancer survivors are vulnerable to have medication nonadherence. We aimed to estimate the impact of cost-related medication nonadherence on economic burdens, productivity loss, and functional abilities among cancer survivors. Methods: A cross-sectional study was conducted using data from the National Health Interview Survey (NHIS), 2011-2018. Cost-related medication nonadherence was identified based on NHIS prompts. An ordinal logistic regression model was used to determine the impact of cost-related medication nonadherence on survivors' economic burden. Two negative binomial regression models were implemented to estimate the impact on productivity loss. In addition, four logistic regression models were used to determine the impact on functional abilities. The weighted analysis was used to generate national estimates. Results: Among 35, 773, 286 cancer survivors, 15, 002, 192 (41.9%) respondents reported that they experienced cost-related medication nonadherence. Compared to cancer survivors without cost-related medication nonadherence, those with nonadherence were significantly associated with an increased economic burden (OR: 1.89, 95% CI: 1.70-2.11). Also, cancer survivors with cost-related medication nonadherence were significantly more likely to have an increased bed disability day (IRR: 1.46, 95% CI: 1.21-1.76). In terms of the limitations, cancer survivors with nonadherence were significantly more likely to have both activity limitation (OR: 1.42, 95% CI: 1.25-1.60) and functional limitation (OR: 2.12, 95% CI: 1.81-2.49). Conclusion: Cost-related medication nonadherence increased economic burdens, productivity loss, and limitations in functional abilities among cancer survivors. Strategies are needed to help cancer survivors with cost-related medication nonadherence to be adherent to prescriptions.