Cost-of-illness studies in heart failure: a systematic review 2004-2016.

BACKGROUND: Heart failure is a major and growing medical and economic problem worldwide as 1-2% of the healthcare budget are spent for heart failure. The prevalence of heart failure has increased over the past decades and it is expected that there will be further raise due to the higher proportion of elderly in the western societies. In this context cost-of-illness studies can significantly contribute to a better understanding of the drivers and problems which lead to the increasing costs in heart failure. The aim of this study was to perform a systematic review of published cost-of-illness studies related to heart failure to highlight the increasing cost impact of heart failure. METHODS: A systematic review was conducted from 2004 to 2016 to identify cost-of-illness studies related to heart failure, searching PubMed (Medline), Cochrane, Science Direct (Embase), Scopus and CRD York Database. RESULTS: Of the total of 16 studies identified, 11 studies reported prevalence-based estimates, 2 studies focused on incidence-based data and 3 articles presented both types of cost data. A large variation concerning cost components and estimates can be noted. Only three studies estimated indirect costs. Most of the included studies have shown that the costs for hospital admission are the most expensive cost element. Estimates for annual prevalence-based costs for heart failure patients range from $868 for South Korea to $25,532 for Germany. The lifetime costs for heart failure patients have been estimated to $126.819 per patient. CONCLUSIONS: Our review highlights the considerable and growing economic burden of heart failure on the health care systems. The cost-of-illness studies included in this review show large variations in methodology used and the cost results vary consequently. High quality data from cost-of-illness studies with a robust methodology applied can inform policy makers about the major cost drivers of heart failure and can be used as the basis of further economic evaluations.

Health Economic Impact of a Pulmonary Artery Pressure Sensor for Heart Failure Telemonitoring: A Dynamic Simulation.

AIMS: Recently, a permanently implantable wireless system, designed to monitor and manage pulmonary artery (PA) pressures remotely, demonstrated significant reductions in heart failure (HF) hospitalizations in high-risk symptomatic patients, regardless of ejection fraction. The objectives of this study were to simulate the estimated clinical and economic impact in Germany of generalized use of this PA pressure monitoring system considering reductions of HF hospitalizations and the improvement in Quality of Life. MATERIALS AND METHODS: Based on the Prospective Health Technology Assessment approach, we simulated the potential of the widespread application of PA pressure monitoring on the German healthcare system for the period 2009-2021. RESULTS: This healthcare economic simulation formulated input assumptions based on results from the CHAMPION Trial, a multicenter, prospective, randomized controlled U.S. trial that demonstrated a 37% reduction of hospitalizations in persistently symptomatic previous HF patients. Based on these results, an estimated 114,800 hospitalizations would expected to be avoided. This effect would potentially save an estimated €522 million, an equivalent of $575 million, during the entire simulation period. CONCLUSION: This healthcare economic modeling of the PA pressure monitoring system's impact demonstrates substantial clinical and economic benefits in the German healthcare system.

The main cost drivers in dementia: a systematic review.

OBJECTIVES: Because of the increasing prevalence of dementia worldwide, combined with limited healthcare expenditures, a better understanding of the main cost drivers of dementia in different care settings is needed. METHODS: A systematic review of cost-of-illness (COI) studies in dementia was conducted from 2003 to 2012, searching the following databases: PubMed (Medline), Cochrane Library, ScienceDirect (Embase) and National Health Service Economic Evaluations Database. Costs (per patient) by care setting were analyzed for total, direct, indirect and informal costs and related to the following: (1) cost perspective and (2) disease severity. RESULTS: In total, 27 studies from 14 different healthcare systems were evaluated. In the included studies, total annual costs for dementia of up to $70,911 per patient (mixed setting) were estimated (average estimate of total costs = $30,554). The shares of cost categories in the total costs for dementia indicate significant differences for different care settings. Overall main cost drivers of dementia are informal costs due to home based long term care and nursing home expenditures rather than direct medical costs (inpatient and outpatient services, medication). CONCLUSIONS: The results of this review highlight the significant economic burden of dementia for patients, families and healthcare systems and thus are important for future health policy planning. The significant variation of cost estimates for different care settings underlines the need to understand and address the financial burden of dementia from both perspectives. For health policy planning in dementia, future COI studies should follow a quality standard protocol with clearly defined cost components and separate estimates by care setting and disease severity.

Balancing costs and benefits at different stages of medical innovation: a systematic review of Multi-criteria decision analysis (MCDA).

BACKGROUND: The diffusion of health technologies from translational research to reimbursement depends on several factors included the results of health economic analysis. Recent research identified several flaws in health economic concepts. Additionally, the heterogeneous viewpoints of participating stakeholders are rarely systematically addressed in current decision-making. Multi-criteria Decision Analysis (MCDA) provides an opportunity to tackle these issues. The objective of this study was to review applications of MCDA methods in decisions addressing the trade-off between costs and benefits. METHODS: Using basic steps of the PRISMA guidelines, a systematic review of the healthcare literature was performed to identify original research articles from January 1990 to April 2014. Medline, PubMed, Springer Link and specific journals were searched. Using predefined categories, bibliographic records were systematically extracted regarding the type of policy applications, MCDA methodology, criteria used and their definitions. RESULTS: 22 studies were included in the analysis. 15 studies (68 %) used direct MCDA approaches and seven studies (32 %) used preference elicitation approaches. Four studies (19 %) focused on technologies in the early innovation process. The majority (18 studies - 81 %) examined reimbursement decisions. Decision criteria used in studies were obtained from the literature research and context-specific studies, expert opinions, and group discussions. The number of criteria ranged between three up to 15. The most frequently used criteria were health outcomes (73 %), disease impact (59 %), and implementation of the intervention (40 %). Economic criteria included cost-effectiveness criteria (14 studies, 64 %), and total costs/budget impact of an intervention (eight studies, 36 %). The process of including economic aspects is very different among studies. Some studies directly compare costs with other criteria while some include economic consideration in a second step. CONCLUSIONS: In early innovation processes, MCDA can provide information about stakeholder preferences as well as evidence needs in further development. However, only a minority of these studies include economic features due to the limited evidence. The most important economic criterion cost-effectiveness should not be included from a technical perspective as it is already a composite of costs and benefit. There is a significant lack of consensus in methodology employed by the various studies which highlights the need for guidance on application of MCDA at specific phases of an innovation.

Exploring the perspectives and preferences for HTA across German healthcare stakeholders using a multi-criteria assessment of a pulmonary heart sensor as a case study.

BACKGROUND: Health technology assessment and healthcare decision-making are based on multiple criteria and evidence, and heterogeneous opinions of participating stakeholders. Multi-criteria decision analysis (MCDA) offers a potential framework to systematize this process and take different perspectives into account. The objectives of this study were to explore perspectives and preferences across German stakeholders when appraising healthcare interventions, using multi-criteria assessment of a heart pulmonary sensor as a case study. METHODS: An online survey of 100 German healthcare stakeholders was conducted using a comprehensive MCDA framework (EVIDEM V2.2). Participants were asked to provide i) relative weights for each criterion of the framework; ii) performance scores for a health pulmonary sensor, based on available data synthesized for each criterion; and iii) qualitative feedback on the consideration of contextual criteria. Normalized weights and scores were combined using a linear model to calculate a value estimate across different stakeholders. Differences across types of stakeholders were explored. RESULTS: The survey was completed by 54 participants. The most important criteria were efficacy, patient reported outcomes, disease severity, safety, and quality of evidence (relative weight >0.075 each). Compared to all participants, policymakers gave more weight to budget impact and quality of evidence. The quantitative appraisal of a pulmonary heart sensor revealed differences in scoring performance of this intervention at the criteria level between stakeholder groups. The highest value estimate of the sensor reached 0.68 (on a scale of 0 to 1, 1 representing maximum value) for industry representatives and the lowest value of 0.40 was reported for policymakers, compared to 0.48 for all participants. Participants indicated that most qualitative criteria should be considered and their impact on the quantitative appraisal was captured transparently. CONCLUSIONS: The study identified important variations in perspectives across German stakeholders when appraising a healthcare intervention and revealed that MCDA can demonstrate the value of a specified technology for all participating stakeholders. Better understanding of these differences at the criteria level, in particular between policymakers and industry representatives, is important to focus innovation aligned with patient health and healthcare system values and constraints.

A systematic review of health technology assessment tools in sub-Saharan Africa: methodological issues and implications.

BACKGROUND: Health technology assessment (HTA) is mostly used in the context of high- and middle-income countries. Many "resource-poor" settings, which have the greatest need for critical assessment of health technology, have a limited basis for making evidence-based choices. This can lead to inappropriate use of technologies, a problem that could be addressed by HTA that enables the efficient use of resources, which is especially crucial in such settings. There is a lack of clarity about which HTA tools should be used in these settings. This research aims to provide an overview of proposed HTA tools for "resource-poor" settings with a specific focus on sub-Saharan Africa (SSA). METHODOLOGY: A systematic review was conducted using basic steps from the PRISMA guidelines. Studies that described HTA tools applicable for "resource-limited" settings were identified and critically appraised. Only papers published between 2003 and 2013 were included. The identified tools were assessed according to a checklist with methodological criteria. RESULTS: Six appropriate tools that are applicable in the SSA setting and cover methodological robustness and ease of use were included in the review. Several tools fulfil these criteria, such as the KNOW ESSENTIALS tool, Mini-HTA tool, and Multi-Criteria Decision Analysis but their application in the SSA context remains limited. The WHO CHOICE method is a standardized decision making tool for choosing interventions but is limited to their cost-effectiveness. Most evaluation of health technology in SSA focuses on priority setting. There is a lack of HTA tools that can be used for the systematic assessment of technology in the SSA context. CONCLUSIONS: An appropriate HTA tool for "resource-constrained" settings, and especially SSA, should address all important criteria of decision making. By combining the two most promising tools, KNOW ESSENTIALS and Multi-Criteria Decision Analysis, appropriate analysis of evidence with a robust and flexible methodology could be applied for the SSA setting.

Clinical assessment of amyloid imaging in Alzheimer's disease: a systematic review of the literature.

BACKGROUND/AIMS: Healthcare systems face an increased prevalence of Alzheimer's disease and increasing costs. The use of molecular biomarkers and imaging could offer an effective solution for these issues. The objective of this study was to assess amyloid imaging regarding clinical utility and impact. METHODS: A literature search was performed in several databases, searching articles between 2008 and January 2013 following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. The results are reported according to the clinical correlates of amyloid imaging. RESULTS: Thirty-three studies were included in the final analysis. Five studies evaluated amyloid imaging for diagnosis. Nine studies assessed the prognostic value. Twenty-two studies provided correlations to cognitive measures. Amyloid imaging provides a high reliability in diagnosis and prognosis, but cognitive measures only showed weak correlations. CONCLUSION: The evidence clearly indicated that amyloid imaging has not arrived yet in clinical practice. However, it can provide substantial benefits in special aspects of diagnostic accuracy and for a diagnosis up to 10 years before clinical diagnosis. This can be a base for early preventive treatment strategies such as anti-amyloid therapy. In this context, amyloid imaging is crucial to understand the early pathologic process in Alzheimer's disease.

Artificial intelligence for imaging-based COVID-19 detection: Systematic review comparing added value of AI versus human readers.

PURPOSE: A growing number of studies have examined whether Artificial Intelligence (AI) systems can support imaging-based diagnosis of COVID-19-caused pneumonia, including both gains in diagnostic performance and speed. However, what is currently missing is a combined appreciation of studies comparing human readers and AI. METHODS: We followed PRISMA-DTA guidelines for our systematic review, searching EMBASE, PUBMED and Scopus databases. To gain insights into the potential value of AI methods, we focused on studies comparing the performance of human readers versus AI models or versus AI-supported human readings. RESULTS: Our search identified 1270 studies, of which 12 fulfilled specific selection criteria. Concerning diagnostic performance, in testing datasets reported sensitivity was 42-100% (human readers, n = 9 studies), 60-95% (AI systems, n = 10) and 81-98% (AI-supported readers, n = 3), whilst reported specificity was 26-100% (human readers, n = 8), 61-96% (AI systems, n = 10) and 78-99% (AI-supported readings, n = 2). One study highlighted the potential of AI-supported readings for the assessment of lung lesion burden changes, whilst two studies indicated potential time savings for detection with AI. CONCLUSIONS: Our review indicates that AI systems or AI-supported human readings show less performance variability (interquartile range) in general, and may support the differentiation of COVID-19 pneumonia from other forms of pneumonia when used in high-prevalence and symptomatic populations. However, inconsistencies related to study design, reporting of data, areas of risk of bias, as well as limitations of statistical analyses complicate clear conclusions. We therefore support efforts for developing critical elements of study design when assessing the value of AI for diagnostic imaging.

Assessing the safety and efficacy of TAVR compared to SAVR in low-to-intermediate surgical risk patients with aortic valve stenosis: An overview of reviews.

BACKGROUND: Transcatheter aortic valve replacement (TAVR) was initially introduced to treat patients with aortic valve stenosis (AS) at high-risk for surgical aortic valve replacement (SAVR). Today, there is ample evidence supporting TAVR in high-risk groups. However, in recent years TAVR has been extended to low-to intermediate risk groups and relevant clinical evidence is still emerging, leaving some uncertainties. METHODS: To obtain information on TAVR versus SAVR in low-to intermediate risk groups, we conducted an overview of systematic reviews following PRISMA guidelines and based on a systematic search of EMBASE, MEDLINE, Cochrane and CRD databases. We focused on systematic reviews assessing mortality and VARC 2 as clinical outcomes. RESULTS: The majority of the 11 systematic reviews included in our study reported no differences in mortality between TAVR and SAVR at short and long-term follow-up times. Two reviews that included the most recent RCTs on low-risk patients reported a decreased mortality risk with TAVR at one-year follow-up. Regarding the secondary endpoints of stroke and MI, the majority of studies presented similar results for TAVR and SAVR. Acute Kidney Injury, Bleeding Complications, Atrial Fibrillation were less frequent with TAVR, with lower risk of Permanent Pacemaker Implantation and Aortic Regurgitation with SAVR. CONCLUSIONS: Our overview indicated that TAVR is a promising intervention for low-to-intermediate surgical risk patients; however additional evidence from longer term follow-up is needed to confirm these findings. This overview highlights inconsistencies about reporting and presentation of data, most notably limited clarity on effects of risk of bias on trial results.

Quality criteria for medical device registries: best practice approaches for improving patient safety - a systematic review of international experiences.

INTRODUCTION: As the benefit of medical device registries (MDRs) depends on their content and quality, it is important to ensure that MDRs have a robust and adequate structure to fulfill their objectives. However, no requirements are specified for the design and content of MDRs. The aim of this work is to analyze different MDRs in the field of implants and to give best practice recommendations for quality criteria regarding their design and development. Areas covered: A systematic literature search performed in databases (Medline, Cochrane Library, Scopus, Embase, CRD York), selected journals and websites identified 66 articles describing either a general MDR structure or the development process of specific registries. Extracted information about MDRs served as the basis for recommendations: MDRs should deliver a minimal data set and report information about the geographical area, data collection, numbers of patients enrolled, registry staff, and security and confidentiality of data. Expert commentary: Well-structured registries are a cornerstone of the regulatory process of medical devices and a major tool for decision makers. A future goal is to establish agreed minimal data sets for different devices - overcoming national borders. By establishing clear guidelines, the outcomes as well as registry comparability can be fundamentally improved.

Accessing the medical devices market in Egypt and Saudi Arabia: a systematic review of policies and regulations.

INTRODUCTION: Despite the significant medical devices market size in Egypt and Saudi Arabia, information regarding policies and regulations for medical devices market access is highly deficient. AREAS COVERED: The aim of this paper is to provide a systematic review on market access policies and regulations in both countries, to allow safe and timely access to medical technology. The following databases were searched: PubMed, Science Direct, Scopus, and Al Manhal Arabic database. Additionally, the web portals of regulatory authorities of both countries were searched. There are 34 records included in the qualitative synthesis of this review. Expert commentary: Main findings include; adopted regulatory framework from reference countries, and interim main regulatory documents, In conclusion, the market access schemes are relatively structured. However, some recommendations are put forward to navigate towards a more comprehensive policy framework in both countries.

Recalls of cardiac implants in the last decade: what lessons can we learn?

BACKGROUND: Due to an ageing population and demographic changes worldwide, a higher prevalence of heart disease is forecasted, which causes an even higher demand for cardiac implants in future. The increasing high incidence of clinical adverse events attributed especially to high-risk medical devices has led an advocated change from many stakeholders. This holds especially true for devices like cardiac implants, with their high-risk nature and high complication rates associated with considerable mortality, due to their frequent use in older populations with frequent co-morbidities. To ensure patients' safety, the objective of this study is to analyze different cardiac implants recall reasons and different recall systems, based on an overview of the recalls of cardiac implant medical devices in the last decade. On the basis of the results from this structured analysis, this study provides recommendations on how to avoid such recalls from a manufacturer perspective, as well as how to timely react to an adverse event from a post-surveillance system perspective. METHODS AND FINDINGS: A systematic search of cardiac implant recalls information has been performed in the PubMed, ScienceDirect and Scopus databases, as well as data sources in regulatory authorities from 193 UN Member States. Data has been extracted for the years 2004-2014 with the following criteria applied: cardiac implant medical device recalls and reasons for recall, associated harm or risk to patients. From the data sources described above, eleven regulatory authorities and 103 recall reports have been included in this study. The largest cardiac implant categories include ICDs 40.8%, pacemakers 14.5% and stents 14.5%. Regarding the recall reasons, the majority of reports were related to device battery problems (33.0%) and incorrect therapy delivery (31.1%). From a total of 103 recall reports, five reported death and serious injuries. Our review highlights weaknesses in the current cardiac implant recall system, including data reporting and management issues and provides recommendations for the improvement of safety information and management. CONCLUSION: Due to the mortality associated with the nature of cardiac implants, the traceability and transparency of safety hazards information is crucial. By a structured analysis of recall reasons and their efficient management, important knowledge is gained to inform an effective safety-reporting system for monitoring the safety of cardiac implanted patients, ideally by building up cardiac implant registries worldwide in the future.

Screening for breast cancer with Breast-CT in a ProHTA simulation.

AIMS: The potential of dedicated Breast-CT is evaluated by simulating its impact onto the performance of the German breast cancer screening program. Attendance rates, cancer detection and economic implications are quantified. METHODS: Based on a prospective health technology assessment approach, we simulated screening in different scenarios. RESULTS: In the simulation, attendance rates increase from 54 to up to 72% due to reduced pain. Breast cancers will be detected earlier while nodal positives and distant recurrences decrease. Assuming no additional cost, cost savings of up to €55 million in one screening period are computed. CONCLUSION: The simulation indicates that earlier cancer detection, fewer unnecessary biopsies and less pain are potential benefits of Breast-CT resulting in cost savings and higher attendance.

Assessing new developments in the pre-market regulatory process of medical devices in the People's Republic of China.

The objective of this paper is to provide a systematic overview of the Chinese medical device registration processes, identify challenges and suggest how these can be addressed. In addition, the paper will outline the impact of new policies and regulations since the restructuring of the China FDA. A systematic review was performed for journal articles between the year of 2009 and 2013 in the following databases: PubMed, ScienceDirect and Zhongguozhiwang. The review has identified 184 papers which were potentially relevant. Seventeen articles were included in the review, which highlights the challenges and opportunities related to the medical device registration process. In order to understand the actual impact of the regulation environment and its policies including the lack of regulatory guidance regular assessment updates are crucial. The results of this paper are aimed at informing regulatory bodies, health policy decision makers, national and international Health Technology Assessment networks as well as medical devices manufacturers.

Registries of implantable medical devices in Europe.

BACKGROUND: In early 2012, a number of serious events in the implant area raised public awareness and started a discussion on safety issues and monitoring medical devices in academics and politics. Apparently, there is a lack in the surveillance of medical devices. Therefore, the objective of this work is to detect and classify implant registries in Europe. METHODS AND FINDINGS: A systematic search of literature was carried out to identify the different types of registries. Furthermore, to characterize the implant registries by different criteria a medical device classification system was established. One hundred and one European registries were found. Most registries exist in the field of cardiac implants and arthroplasty (38 and 29) and their distribution showed variation within Europe. For a lot of implant categories, none or very few registries could be identified. Some countries run more registries than others. There are a lot of differences in aim and structure among the registries. CONCLUSION: There is only a limited number of reviews on registries and a centralized monitoring system in Europe is missing. Our results reveal a lack of transparency concerning number, aim, structure and quality of registries. This is crucial, as registries work as early warning systems for identifying and notifying patients at risk.

Cost of illness in colorectal cancer: an international review.

OBJECTIVES: Given the current-and increasing-pressure to limit expenditure on health care provision in many countries, a better understanding of the cost burden of colorectal cancer is needed. Cost-of-illness studies and reviews thereof can be a useful tool for analysing and critically evaluating the cost-related development of colorectal cancer, and they highlight important cost drivers. METHODS: A systematic review was conducted from 2002 to 2012 to identify cost-of-illness studies related to colorectal cancer, searching the Medline, PubMed, Science Direct, Cochrane Library and the York CRD databases. RESULTS: Among the 10 studies (from France, the US, Ireland and Taiwan) included in the review, 6 studies reported prevalence-based estimates and 4 studies focussed on incidence-based data. In the studies included in the review, long-term costs for colorectal cancer of up to $50,175 per patient (2008 values) were estimated. Most of the studies in the review showed that the initial and terminal phases of colorectal cancer care are the most expensive, with continuing treatment being the least costly phase. One study also highlighted that stage I CRC disease was the least costly and stage III the most costly of all 4 stages, due to the high cost impact of biological agents. CONCLUSIONS: This review has highlighted a trend for rising costs associated with CRC, which is linked to the increasing use of targeted biological therapies. COI studies in colorectal cancer can identify specific components and areas of care that are especially costly, thereby focussing attention on more cost-effective approaches, which is especially relevant to the increased use of biological agents in the field of personalised medicine. COI studies are an important tool for further health economic evaluations of personalised medicine.

An international review of the main cost-effectiveness drivers of virtual colonography versus conventional colonoscopy for colorectal cancer screening: is the tide changing due to adherence?

OBJECTIVES: The majority of recent cost-effectiveness reviews concluded that computerised tomographic colonography (CTC) is not a cost-effective colorectal cancer (CRC) screening strategy yet. The objective of this review is to examine cost-effectiveness of CTC versus optical colonoscopy (COL) for CRC screening and identify the main drivers influencing cost-effectiveness due to the emergence of new research. METHODS: A systematic review was conducted for cost-effectiveness studies comparing CTC and COL as a screening tool and providing outcomes in life-years saved, published between January 2006 and November 2012. RESULTS: Nine studies were included in the review. There was considerable heterogeneity in modelling complexity and methodology. Different model assumptions and inputs had large effects on resulting cost-effectiveness of CTC and COL. CTC was found to be dominant or cost-effective in three studies, assuming the most favourable scenario. COL was found to be not cost effective in one study. CONCLUSIONS: CTC has the potential to be a cost-effective CRC screening strategy when compared to COL. The most important assumptions that influenced the cost-effectiveness of CTC and COL were related to CTC threshold-based reporting of polyps, CTC cost, CTC sensitivity for large polyps, natural history of adenoma transition to cancer, AAA parameters and importantly, adherence. There is a strong need for a differential consideration of patient adherence and compliance to CTC and COL. Recent research shows that laxative-free CTC screening has the potential to become a good alternative screening method for CRC as it can improve patient uptake of screening.