Key Issues of Economic Evaluations for Health Technology Assessment in China: A Nationwide Expert Survey.

OBJECTIVES: Health technology assessment (HTA) is increasingly crucial in medicine price negotiations in China, yet previous appraisals revealed national discrepancies on key economic evaluation issues: willingness-to-pay threshold, pricing models for multi-indication medicines, and comparator selection principles. This study aimed to collect expert opinions on these issues for future HTA evaluations. METHODS: A nationwide anonymous web-based survey encompassing experts across academia, HTA, consultancy/contract research organization/industry, service provider, and payer. In 2023, a generic invitation containing a web link to the questionnaire was disseminated via WeChat using convenience and snowball sampling. Agreement rates for questionnaire views were analyzed using descriptive statistics. The relationship between participants' responses and demographics was examined using appropriate logistic models. RESULTS: A total of 303 responses were received from experts in 34 cities. Key expert views include a suggested base willingness-to-pay threshold ranging from 0.5 to 1.5 times gross domestic product (52.1% agreement); elevated thresholds for childhood diseases, rare diseases, end-of-life diseases, and first-in-class medicines (>78.0% agreement); a single pricing model for multi-indication medicines (60.4% agreement); consideration of multiple medicines as comparators (79.9% agreement); and avoiding the use of centrally procured medicines as comparators for medicines with a time to market of less than 3 years (71.0% agreement). Participants who are service provider had lower odds of selecting higher thresholds (odds ratio 0.26; P < .01) than responders from consultancy/contract research organization/industry. CONCLUSIONS: Expert views indicate the need for substantial changes in China's current HTA methods, highlighting the need for increased investment in HTA processes and expertise cultivation.

Changing inequity in health service utilization and financial burden among patients with hypertension in China: evidence from China Health and Retirement Longitudinal Study (CHARLS), 2011-2018.

BACKGROUND: China initiated a health system reform in 2009 to achieve Universal Health Coverage (UHC) by 2020. While the effectiveness of health-system reforms has been studied, equity in health-service utilization and financial burden remains underexplored. This study evaluated whether the health system reform has improved the equity in utilization and financial burden of health services among patients with hypertension in China. METHODS: We obtained data from four waves of the China Health and Retirement Longitudinal Study (CHARLS) conducted between 2011 and 2018. The main outcome variables were outpatient and inpatient service utilization rates and catastrophic health expenditure (CHE) for patients with hypertension. The Standardized Concentration Index (CI) was used to measure the changing equity in health service utilization and affordability. RESULTS: Outpatient service utilization was relatively equal among patients with varying socioeconomic statuses (SESs) (CI: 0.041 in 2011 and 0.064 in 2018). Inpatient service utilization inequity improved from CI 0.144 in 2011 to CI 0.066 in 2018. CHE incidence increased from 15.6% in 2011 to 24.2% in 2018. CI for CHE declined from -0.069 in 2011 to -0.012 in 2015 but increased to -0.063 in 2018. CONCLUSIONS: Health insurance expansion and poverty alleviation policies promoted equity in inpatient service utilization for hypertensive patients. However, the financial burden for the poor requires further attention through reimbursement policy adjustments for outpatient services in primary care settings.

Potential Clinical and Economic Impact of Switching Branded Medications to Generics.

Switching branded to generic medications has become a common cost-containment measure. Although this is an important objective for health care systems worldwide, the impact of this practice on patient outcomes needs to be carefully considered. We reviewed the literature summarizing the potential clinical and economic consequences of switching from branded to generic medications on patient outcomes. A literature search of peer-reviewed articles published 2003-2013 using key words of "generic switching" or "substitution" was conducted using PubMed, OvidSP, and ScienceDirect. Of 30 articles identified and reviewed, most were related to the diseases of the central nervous system, especially epilepsy. Based on our review, potential impacts of switching fell into 3 broad categories: patient attitudes and adherence, clinical and safety outcomes, and cost and resource utilization. Although in many cases generics may represent an appropriate alternative to branded products, this may not always be the case. Specifically, several studies suggested that switching may negatively impact medication adherence, whereas other studies found that generic switching was associated with poorer clinical outcomes and more adverse events. In some instances, switching accomplished cost savings but did so at increased total cost of care because of increased physician visits or hospitalizations. Although in many cases generics may represent an appropriate alternative, mandatory generic switching may lead to unintended consequences, especially in certain therapeutic areas. Although further study is warranted, based on our review, it may be medically justifiable for physicians and patients to retain the right to request the branded product in certain cases.

Pharmacological Prophylaxis for Venous Thromboembolism Among Hospitalized Patients With Acute Medical Illness: An Electronic Medical Records Study.

Patients hospitalized with acute medical illness have an elevated risk of venous thromboembolism (VTE). American College of Chest Physicians guidelines list various chronic illnesses, sepsis, advanced age, history of VTE, and immobility as risk factors and recommend prophylactic anticoagulation using fondaparinux, low-molecular weight heparin, or low-dose unfractionated heparin. The objectives of this study were to examine pharmacological prophylaxis against VTE among hospitalized medically ill patients and to assess demographic and clinical correlates related to VTE prophylaxis. A retrospective (1999-2010) electronic medical records study included patients aged 40 years and older hospitalized for at least 3 days, with significant medical illness or with a VTE hospitalization 30-365 days before admission. Each patient's first qualifying hospitalization was analyzed. Exclusions were if VTE treatment was started within 1 day of admission, or if warfarin (and not heparin or enoxaparin) was used. Prophylaxis was defined if the first inpatient dose of subcutaneous heparin or enoxaparin was at prophylaxis levels (lower than treatment levels). Multivariable logistic regression was used to examine factors associated with VTE prophylaxis. Among 12,980 patients, 22.1% received prophylaxis (11.8% with enoxaparin, 10.3% with heparin). VTE prophylaxis was positively associated with year of hospitalization, subcutaneous heparin in the month before admission, aspirin, self-pay status, age, and sepsis. VTE prophylaxis was negatively associated with smoking, alcohol, warfarin in the past 30 days, and primary diagnoses of stroke, infectious disease, or inflammatory bowel disease. Pharmacological VTE prophylaxis has increased significantly over the past 12 years but is still largely underused in patients hospitalized with acute medical illness. Multiple demographic, behavioral, and clinical factors are associated with inpatient VTE prophylaxis.

Pharmacologic Prophylaxis for Venous Thromboembolism Among Patients With Total Joint Replacement: An Electronic Medical Records Study.

Patients who have total hip (THR) or knee (TKR) replacement have an elevated risk of venous thromboembolism (VTE). The American College of Chest Physicians guidelines recommend prophylactic anticoagulation. The aim of the study was to examine pharmacologic prophylaxis against VTE among patients with THR or TKR and to assess demographic and clinical correlates related to VTE prophylaxis. Using 15 years of data (1995-2009) from an electronic medical record system for an inner-city public hospital in the United States, we examined pharmacologic prophylaxis against VTE and associated factors in patients after THR (n = 242) and TKR (n = 317). Before the early 2000s, aspirin was the most common prophylaxis agent (THR, 61% and TKR, 65%), and 26% of patients with THR and 19% of patients with TKR did not receive prophylaxis. Enoxaparin use has increased since 2000, and warfarin is now the most common prophylaxis agent (THR, 70% and TKR, 61%). After controlling for time period, factors associated with prophylaxis pattern included obesity, hip fracture, and the surgeon's number of years in practice. VTE prophylaxis medications in patients with total joint replacement have changed over 15 years, in trends generally consistent with the evolution of guidelines. Obesity, history of hip fracture, and physician's experience are associated with the prescription of VTE prophylaxis medications.

Estimating the future burden of cardiovascular disease and the value of lipid and blood pressure control therapies in China.

BACKGROUND: Lifestyle and dietary changes reflect an ongoing epidemiological transition in China, with cardiovascular disease (CVD) playing an ever-increasing role in China's disease burden. This study assessed the burden of CVD and the potential value of lipid and blood pressure control strategies in China. METHODS: We estimated the likely burden of CVD between 2016 and 2030 and how expanded use of lipid lowering and blood pressure control medication would impact that burden in the next 15 years. Accounting for the costs of drug use, we assessed the net social value of a policy that expands the utilization of lipid and blood pressure lowering therapies in China. RESULTS: Rises in prevalence of CVD risk and population aging would likely increase the incidence of acute myocardial infarctions (AMIs) by 75 million and strokes by 118 million, while the number of CVD deaths would rise by 39 million in total between 2016 and 2030. Universal treatment of hypertension and dyslipidemia patients with lipid and blood pressure lowering therapies could avert between 10 and 20 million AMIs, between 8 and 30 million strokes, and between 3 and 10 million CVD deaths during the 2016-2030 period, producing a positive social value net of health care costs as high as $932 billion. CONCLUSIONS: In light of its aging population and epidemiological transition, China faces near-certain increases in CVD morbidity and mortality. Preventative measures such as effective lipid and blood pressure management may reduce CVD burden substantially and provide large social value. While the Chinese government is implementing more systematic approaches to health care delivery, prevention of CVD should be high on the agenda.

Cost-effectiveness of apixaban vs. current standard of care for stroke prevention in patients with atrial fibrillation.

AIMS: Warfarin, a vitamin K antagonist (VKA), has been the standard of care for stroke prevention in patients with atrial fibrillation (AF). Aspirin is recommended for low-risk patients and those unsuitable for warfarin. Apixaban is an oral anticoagulant that has demonstrated better efficacy than warfarin and aspirin in the ARISTOTLE and AVERROES studies, respectively, and causes less bleeding than warfarin. We evaluated the potential cost-effectiveness of apixaban against warfarin and aspirin from the perspective of the UK payer perspective. RESULTS AND METHODS: A lifetime Markov model was developed to evaluate the pharmacoeconomic impact of apixaban compared with warfarin and aspirin in VKA suitable and VKA unsuitable patients, respectively. Clinical events considered in the model include ischaemic stroke, haemorrhagic stroke, intracranial haemorrhage, other major bleed, clinically relevant non-major bleed, myocardial infarction, cardiovascular hospitalization and treatment discontinuations; data from the ARISTOTLE and AVERROES trials and published mortality rates and event-related utility rates were used in the model. Apixaban was projected to increase life expectancy and quality-adjusted life years (QALYs) compared with warfarin and aspirin. These gains were expected to be achieved at a drug acquisition-related cost increase over lifetime. The estimated incremental cost-effectiveness ratio was £11 909 and £7196 per QALY gained with apixaban compared with warfarin and aspirin, respectively. Sensitivity analyses indicated that results were robust to a wide range of inputs. CONCLUSIONS: Based on randomized trial data, apixaban is a cost-effective alternative to warfarin and aspirin, in VKA suitable and VKA unsuitable patients with AF, respectively.

Recent advancement in integrating artificial intelligence and information technology with real-world data for clinical decision-making in China: A scoping review.

OBJECTIVE: Striking innovations and advancements have been achieved with the use of artificial intelligence and healthcare information technology being integrated into clinical real-world data. The current scoping review aimed to provide an overview of the current status of artificial intelligence-/information technology-based clinical decision support tools in China. METHODS: PubMed/MEDLINE, Embase, China National Knowledge Internet, and Wanfang data were searched for both English and Chinese literature. The gray literature search was conducted for commercially available tools. Original studies that focused on clinical decision support tools driven by artificial intelligence or information technology in China and were published between 2010 and February 2022 were included. Information extracted from each article was further synthesized by themes based on three types of clinical decision-making. RESULTS: A total of 37 peer-reviewed publications and 13 commercially available tools were included in the final analysis. Among them, 32.0% were developed for disease diagnosis, 54.0% for risk prediction and classification, and 14.0% for disease management. Chronic diseases were the most popular therapeutic areas of exploration, with particular emphasis on cardiovascular and cerebrovascular diseases. Single-center electronic medical records were the mainstream data sources leveraged to inform clinical decision-making, with internal validation being predominately used for model evaluation. CONCLUSIONS: To effectively promote the extensive use of real-world data and drive a paradigm shift in clinical decision-making in China, multidisciplinary collaboration of key stakeholders is urgently needed.

Coal mining is associated with lung cancer risk in Xuanwei, China.

BACKGROUND: Xuanwei, China, experiences some of the highest rates of lung cancer in China. While lung cancer risk has been linked to the household use of bituminous coal, no study has comprehensively evaluated the risk of lung cancer associated with the mining of this coal in Xuanwei. In Xuanwei, coal is typically extracted from underground mines, without ventilation, and transported to the surface using carts powered by manpower or electricity. METHODS: We evaluated the risk of lung cancer and working as a coal miner, in the absence of diesel exhaust exposure, in a population-based case-control study of 260 male lung cancer cases and 260 age-matched male controls with information on occupational histories. Odds ratios (ORs) and 95% confidence intervals (CIs) for working as a coal miner and years of working as a coal miner were calculated by conditional logistic regression, adjusting for potential confounders, such as smoking and household coal use. RESULTS: We observed an increased risk of lung cancer among coal miners (OR = 2.7; 95%CI = 1.3-5.6) compared to noncoal miners. Further, a dose-response relationship was observed for the risk of lung cancer and the number of years working as a coal miner (P(trend) = 0.02), with those working as miners for more than 10 years experiencing an almost fourfold increased risk (OR = 3.8; 95%CI = 1.4-10.3) compared to noncoal miners. CONCLUSIONS: These findings suggest that coal mining in Xuanwei may be a risk factor for lung cancer.

Medication adherence: a call for action.

Poor adherence to efficacious cardiovascular-related medications has led to considerable morbidity, mortality, and avoidable health care costs. This article provides results of a recent think-tank meeting in which various stakeholder groups representing key experts from consumers, community health providers, the academic community, decision-making government officials (Food and Drug Administration, National Institutes of Health, etc), and industry scientists met to evaluate the current status of medication adherence and provide recommendations for improving outcomes. Below, we review the magnitude of the problem of medication adherence, prevalence, impact, and cost. We then summarize proven effective approaches and conclude with a discussion of recommendations to address this growing and significant public health issue of medication nonadherence.

A large observational study of cardiovascular outcomes associated with atorvastatin or simvastatin therapy in hypertensive patients without prior cardiovascular disease.

The objective of this study was to examine whether differences in effectiveness exist between statins in hypertensive patients seen in clinical practice. We assessed cardiovascular (CV) outcomes in hypertensive patients without cardiovascular disease who began therapy with atorvastatin (10 or 20 mg/d) or simvastatin (20 or 40 mg/d) between January 1, 2003, and September 30, 2005, using claims data from 92 US managed care plans in the PharMetrics database. A total of 98,471 hypertensive patients were identified, comprising 74,685 atorvastatin users (mean dose 13.6 mg/d) and 23,786 simvastatin users (mean dose 28.6 mg/d), and followed a median 1.5 years for the occurrence of a first CV event. The crude CV event rates were 2.81 and 3.92 per 100 person-years for atorvastatin and simvastatin, respectively [unadjusted hazard ratio (HR): 0.73; 95% confidence interval (CI): 0.68-0.78, P < 0.001]. After adjusting for clinical and demographic confounders, use of atorvastatin was associated with fewer CV events compared with simvastatin (HR: 0.91; 95% CI: 0.84-0.98, P = 0.009). However, the lipid-lowering efficacy of the 2 statins could not be assessed as patient lipid data were unavailable. In conclusion, hypertensive patients without cardiovascular disease who initiated atorvastatin (10 or 20 mg/d) had a significantly lower risk of subsequent CV events compared with those who initiated simvastatin at doses of similar potency (20 or 40 mg/d). As with all observational studies, the study is subject to certain limitations, and the findings should be regarded as hypothesis generating.

Determining initial and follow-up costs of cardiovascular events in a US managed care population.

BACKGROUND: Cardiovascular (CV) events are prevalent and expensive worldwide both in terms of direct medical costs at the time of the event and follow-up healthcare after the event. This study aims to determine initial and follow-up costs for cardiovascular (CV) events in US managed care enrollees and to compare to healthcare costs for matched patients without CV events. METHODS: A 5.5-year retrospective matched cohort analysis of claims records for adult enrollees in ~90 US health plans. Patients hospitalized for first CV event were identified from a database containing a representative sample of the commercially-insured US population. The CV-event group (n = 29,688) was matched to a control group with similar demographics but no claims for CV-related events. Endpoints were total direct medical costs for inpatient and outpatient services and pharmacy (paid insurance amount). RESULTS: Overall, mean initial inpatient costs were US dollars ($) 16,981 per case (standard deviation [SD] = $20,474), ranging from $6,699 for a transient ischemic attack (mean length of stay [LOS] = 3.7 days) to $56,024 for a coronary artery bypass graft (CABG) (mean LOS = 9.2 days). Overall mean health-care cost during 1-year follow-up was $16,582 (SD = $34,425), an excess of $13,792 over the mean cost of matched controls. This difference in average costs between CV-event and matched-control subjects was $20,862 and $26,014 after two and three years of follow-up. Mean overall inpatient costs for second events were similar to those for first events ($17,705/case; SD = $22,703). The multivariable regression model adjusting for demographic and clinical characteristics indicated that the presence of a CV event was positively associated with total follow-up costs (P < 0.0001). CONCLUSIONS: Initial hospitalization and follow-up costs vary widely by type of CV event. The 1-year follow-up costs for CV events were almost as high as the initial hospitalization costs, but much higher for 2- and 3-year follow-up.

Switching from atorvastatin to simvastatin in patients at high cardiovascular risk: effects on low-density lipoprotein cholesterol.

Since generic simvastatin became available in the United States in 2006, approximately one million patients have switched from atorvastatin to simvastatin. We examined the association between switching from atorvastatin to simvastatin and changes in low-density lipoprotein cholesterol (LDL-C) levels in clinical practice. We compared atorvastatin-treated patients at high cardiovascular risk who switched to simvastatin between June 2006 and July 2007 with randomly selected matched patients who remained on atorvastatin and evaluated changes in LDL-C and percentage of patients reaching LDL-C less than 100 mg/dL. Of patients who switched from atorvastatin to simvastatin, the majority were excluded as a result of lack of LDL-C measurements, leaving 383 patients in the analysis. Among these, 122 (31.9%) switched to a simvastatin dose that was less than therapeutically equivalent to their prior atorvastatin dose. Compared with control subjects, switched patients were less likely to reach an LDL-C less than 100 mg/dL (68.4% versus 74.0%; odds ratio, 0.76; 95% confidence interval, 0.59-0.99; P = 0.041) and had higher measured LDL-C (91.4 versus 87.2 mg/dL; P = 0.009). Switched patients who were not prescribed a higher milligram dose of simvastatin were significantly less likely to reach an LDL-C less than 100 mg/dL (62.3% versus 74.0%; odds ratio, 0.55; 95% confidence interval, 0.36-0.84; P = 0.006) and had higher LDL-C (95.1 versus 87.2 mg/dL; P = 0.002) than control subjects. A large proportion of patients who switch from atorvastatin to simvastatin are prescribed doses that are not therapeutically equivalent, and these patients were significantly less likely to meet LDL-C treatment goals compared with patients who remained on atorvastatin.

Incremental cardiovascular costs and resource use associated with diabetes: an assessment of 29,863 patients in the US managed-care setting.

BACKGROUND: Patients with type 2 diabetes are at increased risk of cardiovascular events, and there is an associated economic burden attached to this risk. We conducted a retrospective claims database analysis to evaluate incremental cardiovascular costs in diabetic versus non-diabetic patients hospitalized for a cardiovascular event. METHODS: Patients hospitalized for a cardiovascular event between January 1, 2001 and June 30, 2005 were identified from a large US managed-care population. Diabetic patients were identified by evidence of type 2 diabetes in the 12 months prior to the index hospitalization. Direct medical costs and resource use - including inpatient expenditures (for the index and first recurrent hospitalizations), as well as outpatient, laboratory, and pharmacy expenditures (during the 3-year follow-up period) - were determined for patients with or without diabetes. RESULTS: Of the 29,863 patients identified with a cardiovascular hospitalization, 5,501 patients (18.4%) had a history of diabetes in the pre-index period (mean age, 57.8 years; 42.1% female). The overall mean follow-up period was 22.8 months. The incidence of subsequent cardiovascular events in the first year of follow-up was significantly higher for patients with diabetes compared with non-diabetic patients for all types of cardiovascular events except angina. Compared with non-diabetic patients, patients with diabetes had similar mean direct medical costs per patient for the index cardiovascular hospitalization ($17,435 versus $16,917; P = 0.09), and the first recurrent cardiovascular hospitalization ($18,488 versus $17,481; P = 0.2), yet higher mean total direct medical costs per patient for cardiovascular events during follow-up years (Year 1: $8,805 versus $6,982; Year 2: $13,860 versus $10,056; Year 3: $16,149 versus $12,163; all P < or = 0.0002). The cost difference between diabetic and non-diabetic patients remained significant after adjusting for age, gender and other potential confounders in multivariate regression analysis. The mean (SD) total period of inpatient cardiovascular hospitalization after 3 years of follow-up was 3.3 (12.4) days for patients with diabetes compared with 1.8 (5.8) days for non-diabetic patients (P < 0.0001). CONCLUSION: Diabetic patients hospitalized for a cardiovascular event incur higher costs for cardiovascular care than their non-diabetic counterparts. This analysis of the incremental cardiovascular cost and resource use provides the basis for greater accuracy and precision when modeling the economic value of initiatives aimed at reducing cardiovascular morbidity in patients with diabetes mellitus.

Variation in lung cancer risk by smoky coal subtype in Xuanwei, China.

Lung cancer rates in Xuanwei County have been among the highest in China for both males and females and have been causally associated with exposure to indoor smoky (bituminous) coal emissions that contain very high levels of polycyclic aromatic hydrocarbons. There are numerous coal mines across the County. Although lung cancer risk is strongly associated with the use of smoky coal as a whole, variation in risk by smoky coal subtype has not been characterized as yet. We conducted a population-based case-control study of 498 lung cancer cases and 498 controls, individually matched to case subjects on age (+/-2 years) and sex to examine risk by coal subtype. Odds ratios (ORs) and 95% confidence intervals (CIs) for coal subtype were calculated by conditional logistic regression, adjusting for potential confounders. Overall, smoky coal use was positively and statistically significantly associated with lung cancer risk, when compared with the use of smokeless coal or wood (OR = 7.7, 95% CI = 4.5-13.3). Furthermore, there was a marked heterogeneity in risk estimates for specific subtypes of smoky coal (test for heterogeneity: p = 5.17 x 10(-10)). Estimates were highest for coal of the Laibin (OR = 24.8, 95% CI = 12.4-49.6) and Longtan (OR = 11.6, 95% CI = 5.0-27.2) coal types and lower for coal from other subtypes. These findings strongly suggest that in Xuanwei and elsewhere, the carcinogenic potential of coal combustion products can exhibit substantial local variation by specific coal source.

Dietary factors, food contamination and lung cancer risk in Xuanwei, China.

BACKGROUND: In rural Xuanwei County, China, the high incidence of lung cancer is attributable largely to burning smoky coal indoors for heating and cooking without adequate ventilation. Such burning generates very high levels of indoor air pollutants, including carcinogenic polycyclic aromatic hydrocarbons, which could contaminate foodstuffs in the home. Thus, residents could be exposed to carcinogenic coal emissions not only via inhalation but also via ingestion of these foodstuffs. METHODS: A population-based case-control study of 498 lung cancer patients and 498 controls was conducted from 1985 through 1990 in Xuanwei. The interviewer-administered study questionnaire queried the frequency of food items commonly consumed in this region. Overall and sex-specific multiple logistic regression models were constructed to estimate Odds ratios (OR) and 95% confidence intervals (CI) for consumption of these foods. RESULTS: Intake of rice, green vegetables, mushrooms and fresh meat was associated with an increased risk of lung cancer. In contrast, intake of corn, buckwheat, radishes, peppers, melons, pickled vegetables, and salt-preserved meats was associated with reduced risk. The detrimental effect of ingesting green vegetables (OR, 2.39; 95% CI, 1.28-4.48) is consistent with previous reports. CONCLUSIONS: These findings suggest that in Xuanwei, food contamination by environmental polycyclic aromatic hydrocarbons may be an important risk factor for lung cancer, and that differential contamination of foods by polycyclic aromatic hydrocarbons possibly explained the different associations with lung cancer risk.

An economic evaluation of atorvastatin for primary prevention of cardiovascular events in type 2 diabetes.

OBJECTIVE: The CARDS trial, a multicentre, randomized, controlled trial, found that atorvastatin 10 mg/day for patients with type 2 diabetes mellitus and normal low-density lipoprotein (LDL)-cholesterol significantly reduced cardiovascular (CV) events, including stroke. We estimated the cost effectiveness of atorvastatin as primary prevention against CV disease from the short-term and lifetime US payer perspectives. RESEARCH DESIGN AND METHODS: We constructed a decision analytic (Markov) model to evaluate long-term costs and outcomes for atorvastatin 10 mg/day versus no HMG-CoA reductase inhibitor (statin) therapy for patients with type 2 diabetes and no history of a CV event. CV event rates and survival were based on risk equations calibrated to CARDS and applied to a US type 2 diabetes population; the atorvastatin effect on CV events was based on hazard ratios from CARDS; direct medical care costs were based on US treatment patterns and published costs analyses of patients with diabetes. Costs were valued in $US, year 2005 values; costs and benefits were discounted at 3% per annum. RESULTS: Within the time horizon of the trial (5 years), the cost effectiveness of atorvastatin was $US137 276 per QALY. At 10 years, the incremental cost per QALY improved to $US3640 per QALY. At 25 years, overall costs were lower and QALYs higher in the atorvastatin arm. Costs of managing CV events were lower after 5 years for patients treated with atorvastatin. CONCLUSIONS: For patients with type 2 diabetes and one additional risk factor for CV disease, normal LDL-cholesterol and no history of a CV event, primary prevention with atorvastatin appears to be cost saving and improve outcomes over 25 years, although it is costly from a short-term US payer perspective. From both a medical and an economic viewpoint, primary prevention is desirable in this patient population.

A comparison of costs and hospital length of stay associated with intravenous/oral linezolid or intravenous vancomycin treatment of complicated skin and soft-tissue infections caused by suspected or confirmed methicillin-resistant Staphylococcus aureus in elderly US patients.

OBJECTIVES: This study compared the costs and hospital length of stay (LOS) and duration of intravenous therapy associated with intravenous/oral linezolid or intravenous vancomycin treatment of complicated skin and soft-tissue infections (cSSTIs) caused by suspected or confirmed methicillin-resistant Staphylococcus aureus (MRSA) in elderly US patients. METHODS: Data were obtained from elderly (>or=65 years) US patients participating in a multinational randomized trial of hospitalized cSSTI patients treated with linezolid or vancomycin. Costs (hospital and total) from the provider perspective were estimated for intent-to-treat (ITT) patients (ie, all those receiving >or=1 dose) using national 2003 costs (ward, medication, intravenous administration). LOS for inpatient care, duration of intravenous linezolid and vancomycin therapy (ITT and MRSA groups), and cure rates were evaluated. RESULTS: Of 717 enrolled subjects, 163 (23%) were elderly (87 linezolid, 76 vancomycin), with no significant differences in demographic characteristics between the linezolid and vancomycin groups. Mean hospitalization and total costs were lower with linezolid compared with vancomycin (hospitalization: US $4510 vs US $6478, P<0.001; total: US $6009 vs US $7329, P=0.03). Linezolid was associated with a 3.5-day reduction in LOS and a 9.5-day reduction in the duration of intravenous therapy compared with vancomycin in the ITT group (both, P<0.001). Cure rates were comparable between linezolid and vancomycin in both the ITT group (88.7% vs 81.4%, respectively) and the MRSA group (80.0% vs 71.4%). In multivariate analyses of the ITT group, linezolid patients were 57% less likely than vancomycin patients to have a LOS >7 days (odds ratio = 0.43; 95% CI, 0.21-0.87). Chronic renal failure, malnutrition, and a diagnosis of infected ulcer predicted an LOS >7 days. CONCLUSIONS: In this analysis of data from elderly patients with cSSTI caused by suspected or confirmed MRSA, linezolid treatment was associated with reductions in the costs of care, LOS, and duration of intravenous treatment without affecting the clinical outcomes. Although the use of a subset of patients from a larger trial that did not focus on the elderly can be seen as a study limitation, the elderly represent an important population when evaluating health care resource use and costs.

The economic effect of oral linezolid versus intravenous vancomycin in the outpatient setting: the payer perspective.

Oral antibiotic therapy can reduce complications and costs compared with intravenous (IV) therapy. The object of this study was to determine the health economic and resource utilization effects of outpatient treatment with oral linezolid relative to IV vancomycin. Longitudinal claims data from 80 health care plans were used. Patients 18 years and older, who did not have osteomyelitis, with a pharmacy claim for linezolid or vancomycin between January 1, 2002 and March 31, 2004 were eligible. Clinical and resource utilization data were collected for 12 months before and 35 days after treatment. Patients treated with linezolid were matched with controls treated with vancomycin, based on propensity scoring. Direct medical costs paid by health plans were compared. A total of 1,048 matched pairs were identified. Demographic and clinical characteristics were comparable between groups. Patients with linezolid claims had lower resource utilization versus those with vancomycin claims during follow-up, including fewer mean physician office visits (4.1+/-5.7 vs. 8.4+/-13.8 visits; P< .001); lab/diagnostic claims (6.3+/-18.0 vs. 10.4 +/-15.2 claims; P< .001); pharmacy claims (7.3+/-8.1 vs. 13.6+/-17.4 claims; P< .001); emergency room visits (9.7% vs. 13.9%; P= .003) and hospitalization (15.3% vs. 19.1%; P= .024). Patients receiving vancomycin were more likely to be hospitalized or have an emergency room visit than patients receiving linezolid. Mean total adjusted cost was 4,707 dollars less for linezolid compared with vancomycin (8,401dollars vs. 13,108 dollars; P< .001). Similar trends were observed for patients matched based on complicated skin and soft tissue infection diagnosis. Outpatient treatment with oral linezolid was associated with significantly lower resource utilization and total medical costs compared with IV vancomycin.

Coming full circle in the measurement of medication adherence: opportunities and implications for health care.

There is little debate that medication nonadherence is a major public health issue and that measuring nonadherence is a crucial step toward improving it. Moreover, while measuring adherence is becoming both more feasible and more common in the era of electronic information, the reliability and usefulness of various measurements of adherence have not been well established. This paper outlines the most commonly used measures of adherence and discusses the advantages and disadvantages of each that depend on the purpose for which the measure will be used. International consensus statements on definitions and guidelines for selection and use of medication adherence measures were reviewed. The quality of recommended measures was evaluated in selected publications from 2009 to 2014. The most robust medication adherence measures are often ill suited for large-scale use. Less robust measures were found to be commonly misapplied and subsequently misinterpreted in population-level analyses. Adherence assessment and measurement were rarely integrated into standard patient care practice patterns. Successful scalable and impactful strategies to improve medication adherence will depend on understanding how to efficiently and effectively measure adherence.