Christine Kriza

The main cost drivers in dementia: a systematic review

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.

Cost of Illness in Colorectal Cancer: An International Review

ObjectivesGiven 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.MethodsA 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.ResultsAmong 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

Registries of implantable medical devices in Europe

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.ConclusionsThis 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?

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.

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

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.

A systematic review of Health Technology Assessment tools in sub-Saharan Africa: methodological issues and implications

BackgroundHealth 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.MethodsAn 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.ResultsThe 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.ConclusionsThe 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.

Recalls of Cardiac Implants in the Last Decade: What Lessons Can We Learn?

BackgroundHealth 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).MethodologyA 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.ResultsSix 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.ConclusionsAn 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.

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

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.

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

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

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

575 million, during the entire simulation period. CONCLUSION This healthcare economic modeling of the PA pressure monitoring systems impact demonstrates substantial clinical and economic benefits in the German healthcare system.