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Introduction: This paper summarizes the results from a forum of healthcare experts, academia representatives, and public agency officials from emerging and established market countries on Value-Based Healthcare (VBHC) and Health Technology Assessment (HTA). Presentations from experts provided insights into current developments and challenges, followed by interactive roundtable discussions. Emerging markets have unique healthcare systems, patient populations, resource constraints and needs. Areas covered: Each roundtable explored specific topics including the role of HTA and Real-world evidence (RWE) in healthcare decision-making, challenges in biosimilar value assessment and incorporating non-price criteria reflecting context-related specifications of emerging markets such as the multifaceted nature of value in healthcare decision-making, emphasizing stakeholder perspectives and system complexities. Expert opinion: RWE emerged as important in understanding biosimilar value recognition and decision-making processes, with insights into its applications and challenges. Recommendations were provided for utilizing Multi-Criteria Decision Analysis (MCDA) in pharmaceutical procurement, particularly for off-patent medicines, underscoring the importance of comprehensive evaluation frameworks and adherence to value-based principles. Overall findings suggest avenues for collaboration between industry, academia, and public agencies to address implementation barriers and promote equitable, efficient, and high-quality healthcare systems in emerging markets through public–private partnerships, joint capacity building and training initiatives, and knowledge transfers. [ABSTRACT FROM AUTHOR]

As incidences of osteoporotic hip fractures (OHFs) have increased, identifying OHFs has become important to establishing the medical guidelines for their management. This study was conducted to develop an operational definition to identify patients with OHFs using two diagnosis codes and eight procedure codes from health insurance claims data and to assess the operational definition's validity through a chart review. The study extracted data on OHFs from 522 patients who underwent hip surgeries based on diagnosis codes. Orthopedic surgeons then reviewed these patients' medical records and radiographs to identify those with true OHFs. The validities of nine different algorithms of operational definitions, developed using a combination of three levels of diagnosis codes and eight procedure codes, were assessed using various statistics. The developed operational definition showed an accuracy above 0.97 and an area under the receiver operating characteristic curve above 0.97, indicating excellent discriminative power. This study demonstrated that the operational definition that combines diagnosis and procedure codes shows a high validity in detecting OHFs and can be used as a valid tool to detect OHFs from big health claims data. [ABSTRACT FROM AUTHOR]

Electronic prescribing (E-RX) is a component of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA). The objective of this study was to identify factors related to physicians' [...]

Introduction: The proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor is a new treatment option for patients with hypercholesterolemia. The objective of this study was to systematically review the cost-effectiveness of lipid-lowering agents.Areas Covered: Based on Pubmed, Embase, and Cochrane Database of Systematic Reviews, we identified 29 relevant articles. Studies found statins were cost-effective compared with placebo or no treatment in general. Atorvastatin was reported to be cost-effective against simvastatin. In most cases, rosuvastatin was more cost-effective than atorvastatin or simvastatin. Additionally, ezetimibe was considered to be cost-effective compared with no treatment for statin intolerant patients. For patients not meeting treatment goals with their statins, switching to ezetimibe plus simvastatin was consistently reported cost-effective. The cost-effectiveness of ezetimibe plus a hybrid of a statin varied by the source of clinical data and cost of ezetimibe. Finally, the cost-effectiveness of PCSK9 inhibitor plus a statin against statin monotherapy was uncertain. The PCSK9 inhibitor plus a stain was cost-ineffective compared with ezetimibe plus a statin.Expert Commentary: Drug costs and treatment efficacy were the key drivers of the cost-effectiveness results in prior analyses. Future evaluations are warranted to reflect the decreasing drug prices and the long-term treatment effects of PCSK9 inhibitors. [ABSTRACT FROM AUTHOR]

Objective: This study aimed to estimate treatment costs attributable to overweight and obesity in patients with diabetes who were less than 65 years of age in the United States.Methods: This study used data from the Medical Expenditure Panel Survey from 2001 to 2013. Patients with diabetes were identified by using the International Classification of Diseases, Ninth Revision, Clinical Modification code (250), clinical classification codes (049 and 050), or self-reported physician diagnoses. Total treatment costs attributable to overweight and obesity were calculated as the differences in the adjusted costs compared with individuals with diabetes and normal weight. Adjusted costs were estimated by using generalized linear models or unconditional quantile regression models.Results: The mean annual treatment costs attributable to obesity were $1,852 higher than those attributable to normal weight, while costs attributable to overweight were $133 higher. The unconditional quantile regression results indicated that the impact of obesity on total treatment costs gradually became more significant as treatment costs approached the upper quantile.Conclusions: Among patients with diabetes who were less than 65 years of age, patients with diabetes and obesity have significantly higher treatment costs than patients with diabetes and normal weight. The economic burden of diabetes to society will continue to increase unless more proactive preventive measures are taken to effectively treat patients with overweight or obesity. [ABSTRACT FROM AUTHOR]

Background: To examine whether medication related information processing defined as reading of over-the-counter drug labels, understanding prescription instructions, and information seeking-and medication adherence account for the association between health literacy and quality of life, and whether these associations may be moderated by age and gender.Methods: A sample of 305 adults in South Korea was recruited through a proportional quota sampling to take part in a cross-sectional survey on health literacy, medication-related information processing, medication adherence, and quality of life. Descriptive statistics and structural equation modeling (SEM) were performed.Results: Two mediation pathways linking health literacy with quality of life were found. First, health literacy was positively associated with reading drug labels, which was subsequently linked to medication adherence and quality of life. Second, health literacy was positively associated with accurate understanding of prescription instructions, which was associated with quality of life. Age moderation was found, as the mediation by reading drug labels was significant only among young adults whereas the mediation by understanding of medication instruction was only among older adults.Conclusion: Reading drug labels and understanding prescription instructions explained the pathways by which health literacy affects medication adherence and quality of life. The results suggest that training skills for processing medication information can be effective to enhance the health of those with limited health literacy. [ABSTRACT FROM AUTHOR]

Introduction: Cetuximab is a novel biological agent with superior therapeutic efficacy for colorectal cancer treatment. This study aimed to systematically review the existing evidence related to the cost-effectiveness of cetuximab. Areas covered: Using Medline and Cochrane Database of Systematic Reviews, a total of 12 articles were identified. Previous studies have shown mixed results on the cost-effectiveness of first-line cetuximab combined with FOLFIRI (5-Fluorouracil, leucovorin, irinotecan). However, cetuximab-irinotecan therapy as third-line treatment has consistently been found to be cost-ineffective compared to best supportive care or no third-line therapy. The Kristen-rat-Sarcoma-viral-oncogene (KRAS) testing strategy prior to cetuximab use has been reported as cost-effective compared with the cetuximab-containing strategy without KRAS testing. Expert commentary: The results should be interpreted with consideration of the specific healthcare settings in which cetuximab use was evaluated. Future studies are expected to examine the economic value of cetuximab compared with other newly approved biologic products. [ABSTRACT FROM AUTHOR]

Histone deacetylase ( HDAC) inhibition is a potentially attractive approach to cancer therapy. A number of HDAC inhibitors are in clinical development stages for the treatment of cancer as well as immune and inflammatory disorders. Although there are several approved HDAC inhibitors by the US FDA, they show a broad inhibitory spectrum against HDAC subfamily. Herein, we synthesized a series of novel hydroxamate analogs, and evaluated them with lymphoma cancer cell. Conclusively, we identified an HDAC3 selective inhibitor which shows good anticancer activity for the lymphoma model, as well as a good drug metabolism and pharmacokinetics ( DMPK) profile. [ABSTRACT FROM AUTHOR]

Abstract Objective: To determine risk factors for both warfarin discontinuation and bleeding in patients with atrial fibrillation (AF). Methods: Data from the MarketScan database (January 2005-June 2008) were retrospectively analyzed for patients >=18 years old who used warfarin continuously (>=2 prescriptions for 6 months) subsequent to an AF diagnosis. Patients were followed until one of the following endpoints occurred: warfarin discontinuation or end of the 30 month study period (whichever happened first). Recent bleeding was defined as occurring within 90 days before discontinuation. Drug interactions related to bleeding were defined as occurring within 120 days prior to bleeding. Results: The study included 7971 eligible patients (mean age 67.8 years; 41.2% female). During follow-up, 51.7% of patients discontinued warfarin (P < .001). More patients with recent bleeding (61.8%) discontinued warfarin compared to patients without recent bleeding (51.3%). After adjustment, patients with recent bleeding were 35% more likely to discontinue warfarin compared to those without recent bleeding (relative risk = 1.35; CI: 1.16-1.58). Age >85 years and a history of >=1 hospitalizations/emergency room visits were associated with an increased likelihood of discontinuation (P < .001). Female gender, daily dosage >5 mg, concomitant use of gastroprotective agents, and CHADS2 scores >=1 were associated with a decreased likelihood of discontinuation (P < .05). Conclusions: Risk factors for warfarin discontinuation include older age, recent bleeding, and a high number of concomitant medications. Risk factors associated with bleeding events are older age, use of a warfarin-potentiating medication, previous bleeding, and higher CHADS2 scores. [ABSTRACT FROM AUTHOR]

Abstract: Objectives: This study examined the treatment patterns, direct healthcare costs and predictors of treatment costs associated with levodopa-induced dyskinesia (LID) in Parkinson''s disease (PD). Methods: This retrospective cohort study followed PD patients for 1‐year pre- and post-onset of LID, using a large US health insurance claims database from January 1, 2004 to December 31, 2008. Patients with LID were matched to patients without LID based on propensity scores to control for potential selection bias. Descriptive statistics and bootstrap techniques were employed to assess patient demographic and clinical characteristics and costs incurred. Factors influencing treatment costs were analyzed using a generalized linear model with log-link function and gamma distribution. Costs were adjusted to 2009 prices. Results: After patients developed LID, their total treatment costs were increased from $18,645 during the 12months preceding LID onset to $26,439 for the 12-month period subsequent to LID onset (incremental costs of $7795: P<0.001). PD-related costs increased from $3917 to $8110 (incremental costs of $4194: p<0.001) LID events, medical resource utilization, higher levodopa dosage, and use of alternative PD medications were associated with increases in total treatment costs. Few changes in medication treatment patterns were noted following the initial LID, with only slight increases in levodopa dosage and few additions of alternative agents. Conclusions: In the United States, PD patients with LID impose a significant economic burden when compared to patients without LID. Currently available, treatment strategies for dyskinesia should be used more frequently in PD management, and new treatment strategies should be considered as they may lower healthcare costs. [Copyright &y& Elsevier]

Purpose: Medication errors remain a threat to patient safety. Therefore, the purpose of this study was to determine the relationships among characteristics of the nursing practice environment, nurse staffing levels, nurses' error interception practices, and rates of nonintercepted medication errors in acute care hospitals. Design: This study, using a nonexperimental design, was conducted in a sample of 82 medical-surgical units recruited from 14 U.S. acute care hospitals. Registered nurses (RNs) on the 82 units were surveyed, producing a sample of 686 staff nurses. Methods: Data collected for the 8-month study period included the number of medication errors per 1,000 patient days and the number of RN hours per patient day. Nurse survey data included the Practice Environment Scale of the Nursing Work Index as a measure of environmental characteristics; a metric of nurses' interception practices was developed for the study. All survey measures were aggregated to the unit level prior to analysis with hierarchical linear modeling. Findings: A supportive practice environment was positively associated with error interception practices among nurses in the sample of medical-surgical units. Importantly, nurses' interception practices were inversely associated with medication error rates. Conclusions: A supportive practice environment enhances nurses' error interception practices. These interception practices play a role in reducing medication errors. Clinical Relevance: When supported by their practice environments, nurses employ practices that can assist in interrupting medication errors before they reach the patients. [ABSTRACT FROM AUTHOR]