Real-world data: a comprehensive literature review on the barriers, challenges, and opportunities associated with their inclusion in the health technology assessment process.

Objective: This review aimed to assess the current use and acceptance of real-world data (RWD) and real-world evidence (RWE) in health technology assessment (HTA) process. It additionally aimed to discern stakeholders' viewpoints concerning RWD and RWE in HTA and illuminate the obstacles, difficulties, prospects, and consequences associated with the incorporation of RWD and RWE into the realm of HTA. Methods: A comprehensive PRISMA-based systematic review was performed in July 2022 in PubMed/Medline, Scopus, IDEAS-RePEc, International HTA database, and Centre for Reviews and Dissemination with ad hoc supplementary search in Google Scholar and international organization websites. The review included pre-determined inclusion criteria while the selection of eligible studies, the data extraction process and quality assessment were carried out using standardized and transparent methods. Results: Twenty-nine (n = 29) studies were included in the review out of 2,115 studies identified by the search strategy. In various global contexts, disparities in RWD utilization were evident, with randomized controlled trials (RCTs) serving as the primary evidence source. RWD and RWE played pivotal roles, surpassing relative effectiveness assessments (REAs) and significantly influencing decision-making and cost-effectiveness analyses. Identified challenges impeding RWD integration into HTA encompassed limited local data access, complexities in non-randomized trial design, data quality, privacy, and fragmentation. Addressing these is imperative for optimal RWD utilization. Incorporating RWD/RWE in HTA yields multifaceted advantages, enhancing understanding of treatment efficacy, resource utilization, and cost analysis, particularly via patient registries. RWE complements assessments of advanced therapy medicinal products (ATMPs) and rare diseases. Local data utilization strengthens HTA, bridging gaps when RCT data is lacking. RWD aids medical device decision-making, cancer drug reassessment, and indirect treatment comparisons. Challenges include data availability, stakeholder acceptance, expertise, and privacy. However, standardization, training, collaboration, and guidance can surmount these barriers, fostering enhanced RWD utilization in HTA. Conclusion: This study highlights the intricate global landscape of RWD and RWE acceptance in HTA. Recognizing regional nuances, addressing methodological challenges, and promoting collaboration are pivotal, among others, for leveraging RWD and RWE effectively in healthcare decision-making.

Cost-effectiveness Analysis and Impact on Length of Hospital Stay of the Introduction of Remdesivir as a Treatment Option for Hospitalized Patients With COVID-19 Requiring Supplemental Oxygen in Greece Versus Standard of Care.

PURPOSE: The COVID-19 pandemic is a global threat with a devastating impact on health, economy, and society in general. The objective of this study was to assess the clinical and economic value of remdesivir by developing a cost-effectiveness analysis model for hospitalized adults with COVID-19 requiring supplemental oxygen in Greece. METHODS: A cost-effectiveness model was developed that included a decision tree model and a Markov cohort model. Clinical effectiveness data for remdesivir were derived from a network meta-analysis. Health care resource use, current clinical practice, and cost data were derived from published literature. Both clinical and cost-effectiveness outcomes were assessed from a Greek health care payer perspective. FINDINGS: Treatment with remdesivir led to 1.45 more life-years and 1.11 quality-adjusted life-years gained compared with standard of care alone. In addition, treatment with remdesivir resulted in fewer days in the hospital per patient (0.87, 1.49, and 1.37 fewer days in the general ward, intensive care unit, and intensive care unit with mechanical invasive ventilation, respectively) than patients treated only with standard of care, as well as with lower hospital bed occupancy rates and fewer deaths. Treatment with remdesivir was also related to cost savings for the Greek health care system, making remdesivir a dominant intervention. IMPLICATIONS: This study provides good evidence for policymakers on the economic value of remdesivir as a treatment strategy for hospitalized patients moderately and severely infected by the virus who require supplemental oxygen. The results support the use of remdesivir as a first-line antiviral treatment option for hospitalized patients in the Greek national COVID-19 treatment algorithm. However, the model does not incorporate estimates on possible additional hospitalizations or rehabilitations, long-term adverse effects of COVID-19, adverse events of remdesivir, or indirect costs of the disease. Therefore, further research is needed to fully evaluate the cost-effectiveness and clinical implications of the use of remdesivir in treating patients with COVID-19 in Greece.

Cost of the COVID-19 pandemic versus the cost-effectiveness of mitigation strategies in EU/UK/OECD: a systematic review.

OBJECTIVES: The economic burden of COVID-19 pandemic is substantial, with both direct and indirect costs playing a significant role. DESIGN: A systematic literature review was conducted to estimate the cost of the COVID-19 pandemic and the cost-effectiveness of pharmaceutical or non-pharmaceutical interventions. All cost data were adjusted to the 2021 Euro, and interventions compared with null. DATA SOURCES: Ovid MEDLINE and EMBASE were searched from January 2020 through 22 April 2021. ELIGIBILITY CRITERIA: Studies regarding COVID-19 outbreak or public health preparedness measures or interventions with outcome measures related to the direct and indirect costs for disease and preparedness and/or response in countries of the European Union (EU), the European Economic Area (EEA), the UK and the Organisation for Economic Co-operation and Development (OECD) of all relevant epidemiological designs which estimate cost within the selected time frame were considered eligible. DATA EXTRACTION AND SYNTHESIS: Studies were searched, screened and coded independently by two reviewers with high measure of inter-rater agreement. Data were extracted to a predefined data extraction sheet. The risk of bias was assessed using the Consensus on Health Economic Criteria checklist. RESULTS: We included data from 41 economic studies. Ten studies evaluated the cost of the COVID-19 pandemic, while 31 assessed the cost-benefit of public health surveillance, preparedness and response measures. Overall, the economic burden of the COVID-19 pandemic was found to be substantial. Community screening, bed provision policies, investing in personal-protective-equipment and vaccination strategies were cost-effective. Physical distancing measures were associated with health benefits; however, their cost-effectiveness was dependent on the duration, compliance and the phase of the epidemic in which it was implemented. CONCLUSIONS: COVID-19 pandemic is associated with substantial short-term and long-term economic costs to healthcare systems, payers and societies, while interventions including testing and screening policies, vaccination and physical distancing policies were identified as those presenting cost-effective options to deal with the pandemic, dependent on population vaccination and the Re at the stage of the pandemic.

Cost-Benefit Analysis of Single versus Repeated Use of Single-Use Devices in Cataract Surgery.

PURPOSE: To estimate the net cost effect associated with the real-world practice of repeated use of designated single-use medical devices (SUDs) versus their proper single use in cataract surgery in Greece. DESIGN: A cost-benefit analysis model was constructed in the form of a decision tree. METHODS: A digital expert panel was assembled in order to estimate the probabilities of intraoperative and postoperative complications associated with single and repeated use of SUDs. Unit costs for the management of each complication were obtained from the official Greek bulletins. A Monte Carlo-type sensitivity analysis was performed to assess the robustness of the results. RESULTS: Based on the probabilities of complications attained from the expert panel, repeated use of SUDs is associated with a higher chance of complications compared to single use, which results in higher cost of complication management. Under the healthcare sector perspective, the total expected cost per cataract surgery is 1,403.98€ (1,244.20€ the initial cost of cataract surgery plus 159.78€ the cost of adverse events) in the case of single use, while for repeated use the total cost is 1,486.29€ (1,146.86€ + 339.43€, respectively) and, thus, repeated use of SUDs in cataract surgery results in 82.31€ higher expected cost per patient compared to their single use. Moreover, the societal perspective analysis indicated even higher additional costs in the case of SUD reuse (108.24€). CONCLUSION: Repeated use of SUDs in cataract surgery is not appropriate, it jeopardizes patient safety and carries a legal liability for the reuser. The present study, which is the first to attach a monetary value to the common yet questionable practice of SUD reuse, shows that it is not cost beneficial. Therefore, it is expected that the results will have implications in policy formulations to improve the delivery of cataract healthcare.

Cost-effectiveness of emergency preparedness measures in response to infectious respiratory disease outbreaks: a systematic review and econometric analysis.

OBJECTIVES: Respiratory infectious disease outbreaks pose a threat for loss of life, economic instability and social disruption. We conducted a systematic review of published econometric analyses to assess the direct and indirect costs of infectious respiratory disease outbreaks that occurred between 2003 and 2019. SETTING: Respiratory infectious disease outbreaks or public health preparedness measures or interventions responding to respiratory outbreaks in OECD countries (excluding South Korea and Japan) so as to assess studies relevant to the European context. The cost-effectiveness of interventions was assessed through a dominance ranking matrix approach. All cost data were adjusted to the 2017 Euro, with interventions compared with the null. We included data from 17 econometric studies. PRIMARY AND SECONDARY OUTCOME MEASURES: Direct and indirect costs for disease and preparedness and/or response or cost-benefit and cost-utility were measured. RESULTS: Overall, the economic burden of infectious respiratory disease outbreaks was found to be significant to healthcare systems and society. Indirect costs were greater than direct costs mainly due to losses of productivity. With regard to non-pharmaceutical strategies, prehospitalisation screening and the use of protective masks were identified as both an effective strategy and cost-saving. Community contact reduction was effective but had ambiguous results for cost saving. School closure was an effective measure, but not cost-saving in the long term. Targeted antiviral prophylaxis was the most cost-saving and effective pharmaceutical intervention. CONCLUSIONS: Our cost analysis results provide evidence to policymakers on the cost-effectiveness of pharmaceutical and non-pharmaceutical intervention strategies which may be applied to mitigate or respond to infectious respiratory disease outbreaks.

Qualitative comparative analysis of health economic evaluation guidelines for health technology assessment in European countries.

OBJECTIVE: To classify, analyze, and compare published guidelines for economic evaluation within health technology assessment (HTA) in European countries and highlight differences and similarities. METHODS: We performed a literature review to identify published guidance for the conduct and assessment of economic evaluation studies that are undertaken within the context of HTA processes in European countries. Organizations and working groups were identified via the ISPOR, INAHTA, and EUnetHTA databases. Following the identification of official documents, we performed a qualitative content analysis to highlight discrepancies or common practices under the following categories: comparator, perspective on costs/benefits, time horizon, economic evaluation method, instrument used for utility measurement, outcome measure, source for efficacy, modeling, sensitivity analysis, discounting, and incremental cost-effectiveness ratio. RESULTS: A total of nineteen guidance documents were identified (in English) providing data for the analysis in nineteen countries. The comparative content analysis identified common practices in most countries regarding the approaches to the choice of comparator, source of data, the preferred economic evaluation method, the option for a lifetime analytical horizon, discounting, and the choice of key outcome measure-for which, most countries recommend the use of the EQ-5D instrument. Differences were mainly found in the choice of perspective, dealing with uncertainty and sensitivity analysis, the use of end points, and the required use of modeling. CONCLUSIONS: The use of economic evaluation constitutes one of the key pillars of the HTA process in Europe. Although a methodological convergence has occurred during the last few years, notable differences still remain.

Unusual posteromedial tubercle fracture extending to the talar dome.

The present case is unique in that the fracture of the posteromedial talar tubercule involved the tibiotalar rather than the subtalar joint as described in existing reports, which underlines the need for acute management by the Orthopaedic Surgeon.

Medium-Term Results after Surgical Treatment of High-Energy Tibial Plateau Fractures.

The aim of the article is to present the medium-term results of surgical treatment of Schatzker's IV, V, and VI tibial plateau fractures, in a retrospective study of 22 patients at a level-1 trauma center. Twenty-two of 34 patients with Schatzker's IV-VI fractures completed follow-up at a mean of 56 months (range: 7-103 months). Patients' mean age was 47.6 years (range: 18-76 years). Open reduction and internal fixation were performed in 16 patients, while external fixators were used in the remaining six patents. Patients were assessed radiologically for the presence of arthritis using the Kellgren-Lawrence scale. Functional outcomes were measured using the Lysholm's knee score, knee injury, and osteoarthritis outcome score (KOOS). Quality of life was also assessed postoperatively using the EuroQol-5D (EQ-5D) form and EQ-VAS (visual analogue scale) score. There were no postoperative infections and no fracture went on to nonunion. Absence of arthritic change was noted in only 6.3% of cases. The average KOOS score was 80 and the average Lysholm's score was 84.91. Regarding the postoperative quality of life, mobility was impaired in 45.5%, self-care in 27.3%, and usual activities in 36.3% of patients. Pain or discomfort was reported in 77.2% and anxiety or depression in 40.9% of cases. The mean VAS score was 77.8. Eighty percent of patients had returned to their previous activities at the time of last follow-up. Although complex tibial plateau fractures are associated with a high rate of complications and can have a severe impact on the injured knee, most patients had quite satisfactory results during their medium-term clinical evaluation, in our study. It is a Level IV case series study.