Health Technology Assessment-Informed Decision Making by the Federal Joint Committee/Institute for Quality and Efficiency in Health Care in Germany and the National Institute for Health and Care Excellence in England: The Role of Budget Impact.

OBJECTIVES: This study aimed to test (official) evaluation criteria including the potential role of budget impact (BI) on health technology assessment (HTA) outcomes published by the Federal Joint Committee (Gemeinsamer Bundesausschuss [GBA]) and the Institute for Quality and Efficiency in Health Care (Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen [IQWiG]) in Germany as well as the National Institute for Health and Care Excellence (NICE) in England. METHODS: Data were extracted from all publicly available GBA decisions and IQWiG assessments as well as NICE single technology appraisals between January 2011 and June 2018, and information with regard to evaluation criteria used by these agencies was collected. Data were analyzed using logistic regression to estimate the effect of the BI on the HTA outcomes while controlling for criteria used by GBA/IQWiG and NICE. RESULTS: NICE recommendations are largely driven by the incremental cost-effectiveness ratio and, if applicable, by end-of-life criteria (P < .01). While IQWiG assessments are significantly affected by the availability of randomized controlled trials and patient-relevant endpoints (P < .01), GBA appraisals primarily focus on endpoints (P < .01). The BI correlated with NICE single technology appraisals (inverted-U relationship, P < .1) and IQWiG recommendations (increasing linear relationship, P < .05), but not with GBA decisions (P > .1). Nevertheless, given that IQWiG assessments seem to be more rigorous than GBA appraisals regarding the consideration of evidence-based evaluation criteria, decisions by GBA might be negatively associated with the BI. CONCLUSIONS: Results reveal that GBA/IQWiG and NICE follow their official evaluation criteria consistently. After controlling for all significant variables, the BI seems to have an (independent) effect on HTA outcomes as well.

[How robust are studies of currently permanently included digital health applications (DiGA)? Methodological quality of studies demonstrating positive health care effects of DiGA]. / Wie belastbar sind Studien der aktuell dauerhaft aufgenommenen digitalen Gesundheitsanwendungen (DiGA)? Methodische Qualität der Studien zum Nachweis positiver Versorgungseffekte von DiGA.

INTRODUCTION: Since September 2020 digital health applications (DiGA) can be prescribed by physicians and psychotherapists and are reimbursed within the German Statutory Health Insurance (SHI) system for the first time worldwide. For full reimbursement, the manufacturers have to provide evidence based on scientific studies that the DiGA can provide 'positive health care effects'. This study aims to analyze and evaluate the methodological quality of efficacy studies of DiGA in the categories 'Nervensystem' and 'Psyche' of the DiGA register that are permanently accepted. METHODS: The methodological quality was assessed using the revised Cochrane risk-of-bias tool for randomized trials (RoB 2). The risk of bias was assessed for the primary endpoint of each study according to an intention-to-treat analysis. RESULTS: Six DiGA were assessed for their methodological quality. Randomized controlled trials were conducted for all 6 DiGA that showed a high risk of bias, which was, in particular, due to a lack of blinding of the studies. In addition, drop-outs were significantly higher in the intervention group than in the control group in most studies. For most of the DiGA no published study protocol was available in advance so an analysis of a potential selective choice of the evaluation methodology was not possible. DISCUSSION: For reasons of transparency, verifiability, and comprehensibility of the study results, registration in a study registry and, more importantly, the publication of study protocols should be mandatory before the start of the studies. In addition, studies should be blinded by comparing the DiGA with a 'sham application' to reduce the high risk of bias. Differences in the drop-out rates of the investigated studies could indicate a lack of efficacy of the treatment in the intervention group, (technical) problems in the application of the DiGA, or a lack of motivation of the participants. CONCLUSION: The interim results 18 months after the introduction of DiGA in the German SHI system show that the studies on the evidence of the benefits of DiGA have a high potential for bias in certain areas. However, it should be positively emphasized that the manufacturers submitted randomized controlled trials to prove the medical benefit of the DiGAs investigated.

The Dementia Assessment of Service Needs (DEMAND): Development and Validation of a Standardized Needs Assessment Instrument.

BACKGROUND: Dementia is one of the main triggers for care dependency among older adults who are predominantly cared for at home by relatives. To provide support in the care situation, health systems need valid information about the central needs of the affected people. OBJECTIVE: The present study aimed to develop a research instrument to assess the most important needs of people with dementia and their family caregivers. METHODS: The development of the 'Dementia Assessment of Service Needs (DEMAND)' took place within the project 'Digital Dementia Registry Bavaria (digiDEM Bayern)'. A focus group and an online survey with dementia experts were conducted to identify the most relevant support services and to develop the design of the instrument. The questionnaire was deployed in the digiDEM baseline data collection. Participants were asked to evaluate the comprehensibility of the questionnaire. Readability was assessed using the Flesch reading ease score. RESULTS: Seventeen experts participated in the focus group and 59 people in the online survey. The final questionnaire included 13 support services. One hundred eighty-three participants (50 people with dementia and 133 family caregivers) completed the questionnaire at baseline. The mean comprehensibility score was 3.6 (SD = 2.3). The Flesch reading ease score result was 76. CONCLUSION: A research instrument could be developed, enabling people with dementia and family caregivers to directly express their individual needs for specific support services. Results show that the DEMAND is easy to understand and short in execution. Therefore, supply gaps can be identified and transformed into a specific health care plan.

Exploring physicians and patients' perspectives for current interventions on thyroid nodules using a MCDA method.

BACKGROUND: The detection of thyroid cancer has rapidly increased over last few decades without an increase in disease specific mortality. Several studies claim that the diagnose of thyroid nodules through routine ultrasound imaging is often the trigger for cascade effects leading to unnecessary follow-up over many years or to invasive treatment. The objective of this study was to explore physicians' and patients' insights and preferences regarding the current interventions on thyroid nodules. METHODS: An online survey was developed using a comprehensive multi-criteria decision analysis (MCDA) framework, the EVIdence based Decision-Making (EVIDEM). The EVIDEM core model used in this study encompassed 13 quantitative criteria and four qualitative criteria. Participants were asked to provide weights referring to what matters most important in general for each criterion, performance scores for appraising the interventions on thyroid nodules and their consideration of impact of contextual criteria. Normalized weights and standardized scores were combined to calculate a value contribution across all participants, additionally differences across physicians and patients' group were explored. RESULTS: 48 patients and 31 physicians were included in the analysis. The value estimate of the interventions on thyroid nodules reached 0.549 for patients' group and 0.5 was reported by the physicians' group, compared to 0.543 for all participants. The highest value contributor was 'Comparative effectiveness' (0.073 ± 0.020). For the physicians' group, 'Comparative safety' (0.050 ± 0.023) was given with higher value. And for the patients' group, 'Type of preventive benefits' (0.059 ± 0.022) contributed more positively to the value estimation. 51% participants considered 'Population priorities and access' having a negative impact on the interventions of nodules.66% participants thought that the 'system capacity' had a negative impact. CONCLUSION: Our study shows participants' preferences on each criterion, i.e., physician indicated keeping the interventions safe and effective more important, patients indicated quality of life after receiving interventions more important. Through comparison among participants, differences have been highlighted, which can make better communication between physicians and patients. This study provides a supportive decision-making for healthcare providers when they explored the interventions on thyroid nodules.

[Predictors of Caregiver Burden in Dementia: Results of the Bavarian Dementia Survey (BayDem)]. / Einflussfaktoren auf die Pflegebelastung der Angehörigen von Menschen mit Demenz: der Bayerische Demenz Survey (BayDem).

BACKGROUND: Dementia is an age-specific disease with increasing care needs over the course of the disease. Care is predominantly conducted by caregivers. Caregiver burden is a core criterion for the evaluation of the care situation. The aims of this examination are to identify predictors of caregiver burden and to analyze the course of the caregiver burden over a 12 months period. METHODS: The Bavarian Dementia Survey (BayDem) is a supra-regional, longitudinal study carried out at 3 different sites in Bavaria, Germany. Participants were people with dementia (pwd) as defined by ICD-10 and their informal caregivers. Data was collected by standardized face-to-face interviews in cooperation with local actors. For statistical analysis, a multiple regression as well as a mixed ANOVA (Analysis of Variance) and repeated measures ANOVAs were used. RESULTS: In this analysis, 295 pwd and 276 caregivers were studied. Key factors influencing caregiver burden were gender of the pwd, behavioral and psychological symptoms and a decline of everyday functioning of the pwd as well as gender of the informal caregivers, their relation to the pwd and if they live at the same household as the pwd. Analysis showed a significant main effect of time over the course of the caregiver burden. CONCLUSION: A permanent high caregiver burden can cause health problems for the caregivers. However, caregivers can be supported according to the specific factors of the caregiver burden. One approach in order to support caregivers could be a combination of pharmacological and non-pharmacological interventions for the treatment of disease-specific symptoms and an empowerment as well as the provision of support services for the caregivers. Furthermore, tailored services for specific target groups can be meaningful.

[Symptom Burden, Health Services Utilization and Places and Causes of Death in People with Dementia at the End of Life: the Bavarian Dementia Survey (BayDem)]. / Symptombelastung, Inanspruchnahme des Gesundheitssystems und Todesumstände von Menschen mit Demenz in der letzten Lebensphase: der Bayerische Demenz Survey (BayDem).

BACKGROUND: Dementia is usually a life-limiting disease. However, evidence-based guidelines for palliative care for people with dementia (PwD) are currently lacking. One reason for this is the dearth of reliable empirical data on PwD at the end of life. The aim of this study is to describe the symptom burden, causes of death, places of death and the use of various health services for PwD at the end of life. METHODS: The Bavarian Dementia Survey (BayDem) was a multi-center, longitudinal study at 3 different sites in Bavaria, Germany (Dachau, Kronach, Erlangen). Participants were PwD defined by ICD-10 and their informal caregivers. Data were collected in standardized face-to-face interviews in cooperation with local actors. In order to obtain comparable groups, deceased and non-deceased PwD were matched using 1:1 propensity score matching. For the statistical analyses, McNemar tests as well as paired t-tests were used. RESULTS: In this analysis, 58 deceased and 58 non-deceased PwD were studied (n=116). In most cases, PwD died at home (36.2%), in hospital (25.9%) or in a nursing home (19.0%), but no one in palliative care. The most common causes of death were respiratory (13.8%) and cardiovascular complications (12.1%) as well as stroke (12.1%). PwD at the end of life showed more pronounced physical comorbidities than the other PwD (Charlson-Index: M=2.75 vs. M=1.80; p=0.030, Cohen's d=0.425) and were therefore admitted to hospital (46.6 vs. 12.1%, p<0.001, OR=6.250) or emergency departments (22.4 vs. 3.4%, p=0.007, OR=6.500) more frequently. Behavioral and psychological symptoms were very pronounced (NPI Score: M=31.67 vs. M=24.77, p=0.118, Cohen's d=0.303). Nevertheless, the utilization of outpatient health services was low. CONCLUSION: The results underline the need to develop evidence-based guidelines to provide palliative care specifically adapted to the needs of PwD at the end of life. In this context, the high incidence of behavioral and psychological symptoms should be taken into account, as should the high incidence of physical comorbidities. Considering the frequent hospital admissions, special attention should also be paid to the development of recommendations for the inpatient sector (acute hospital and palliative care unit).

Determining Value in Health Technology Assessment: Stay the Course or Tack Away?

The economic evaluation of new health technologies to assess whether the value of the expected health benefits warrants the proposed additional costs has become an essential step in making novel interventions available to patients. This assessment of value is problematic because there exists no natural means to measure it. One approach is to assume that society wishes to maximize aggregate health, measured in terms of quality-adjusted life-years (QALYs). Commonly, a single 'cost-effectiveness' threshold is used to gauge whether the intervention is sufficiently efficient in doing so. This approach has come under fire for failing to account for societal values that favor treating more severe illness and ensuring equal access to resources, regardless of pre-existing conditions or capacity to benefit. Alternatives involving expansion of the measure of benefit or adjusting the threshold have been proposed and some have advocated tacking away from the cost per QALY entirely to implement therapeutic area-specific efficiency frontiers, multicriteria decision analysis or other approaches that keep the dimensions of benefit distinct and value them separately. In this paper, each of these alternative courses is considered, based on the experiences of the authors, with a view to clarifying their implications.

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 evaluations of non-pharmacological interventions for persons with dementia and their informal caregivers: a systematic review.

BACKGROUND: This systematic review aims to review the literature on trial-based economic evaluations of non-pharmacological interventions directly targeted at persons with dementia as well as persons with mild cognitive impairment and their respective caregivers. METHODS: A systematic literature research was conducted for the timeframe from 2010 to 2016 in the following databases: Centre for Reviews and Dissemination, EconLit, Embase, Cochrane Library, PsycINFO and PubMed. Study quality was assessed according to the Drummond criteria. RESULTS: In total sixteen publications were identified. Health economic evaluations indicated the cost-effectiveness of physical exercise interventions and occupational therapy. There was also evidence to suggest that psychological and behavioral therapies are cost-effective. Health economic studies investigating psychosocial interventions mainly targeted towards informal caregivers showed inconsistent results. CONCLUSIONS: Due to the increasing prevalence of dementia non-pharmacological interventions and their health economic impact are of increasing importance for health care decision-makers and HTA agencies.

Diagnosis of cognitive decline and dementia in rural areas - A scoping review.

OBJECTIVES: Due to the demographic change, the global prevalence of dementia will continually rise. Barriers to diagnosis and care are still high. But timely diagnosis is associated with valuable benefits and can promote timely and optimal management. Receiving an early diagnosis is especially in rural areas a problem due to the limited access to assessments. Therefore, the aim of our scoping review is to investigate different interventions targeted at rural living elderly to screen and diagnose cognitive decline and dementia. METHODS: A scoping review was conducted in line with the framework of Arksey and O'Malley. The following databases were systematically searched: PubMed, PsycINFO, Cochrane Library, and ScienceDirect. The interventions were categorized in four main categories (interventions for general practitioners/institutions; online/mobile offers; telehealth applications; telephone-based screenings). RESULTS: Thirty studies were included. The four categories show different scopes of application. Telehealth applications show that it is feasible and valid to diagnose dementia via videoconference. Assessments described in three other categories show that remotely used tools are appropriate to screen for mild cognitive impairment or cognitive decline, but are not valid to establish a dementia diagnosis. CONCLUSIONS: Telehealth applications can appropriately be used to diagnose dementia. However, most of the studies included only small sample sizes and did not test the applications explicitly in rural or remote populations. Therefore, studies taking these limitations into account are needed. On top, only two RCTs are included in this review indicating that more high quality studies in this field are needed.

Acceptance by laypersons and medical professionals of the personalized eHealth platform, eHealthMonitor.

INTRODUCTION AND BACKGROUND: Often, eHealth services are not accepted because of factors such as eHealth literacy or trust. Within this study, eHealthMonitor was evaluated in three European countries (Germany, Greece, and Poland) by medical professionals and laypersons with respect to numerous acceptance factors. METHODS: Questionnaires were created on the basis of factors from literature and with the help of scales which have already been validated. A qualitative survey was conducted in Germany, Poland, and Greece. RESULTS: The eHealth literacy of all participants was medium/high. Laypersons mostly agreed that they could easily become skillful with eHealthMonitor and that other people thought that they should use eHealthMonitor. Amongst medical professionals, a large number were afraid that eHealthMonitor could violate their privacy or the privacy of their patients. Overall, the participants thought that eHealthMonitor was a good concept and that they would use it. DISCUSSION AND CONCLUSION: The main hindrances to the use of eHealthMonitor were found in trust issues including data privacy. In the future, more research on the linkage of all measured factors is needed, for example, to address the question of whether highly educated people tend to mistrust eHealth information more than people with lower levels of education.

Determining the value of medical technologies to treat ultra-rare disorders: a consensus statement.

BACKGROUND: In most jurisdictions, policies have been adopted to encourage the development of treatments for rare or orphan diseases. While successful as assessed against their primary objective, these policies have prompted concerns among payers about the economic burden that might be caused by an annual cost per patient in some cases exceeding 100,000 Euro. At the same time, many drugs for rare disorders do not meet conventional standards for cost-effectiveness or 'value for money'. Owing to the fixed (volume-independent) cost of research and development, this issue is becoming increasingly serious with decreasing prevalence of a given disorder. METHODS: In order to critically appraise the problems posed by the systematic valuation of interventions for ultra-rare disorders (URDs), an international group of clinical and health economic experts was convened in conjunction with the Annual European ISPOR Congress in Berlin, Germany, in November 2012. Following this meeting and during subsequent deliberations, the group achieved a consensus on the specific challenges and potential ways forward. RESULTS: The group concluded that the complexities of research and development for new treatments for URDs may require conditional approval and reimbursement policies, such as managed entry schemes and coverage with evidence development agreements, but should not use as justification surrogate end point improvement only. As a prerequisite for value assessment, the demonstration of a minimum significant clinical benefit should be expected within a reasonable time frame. As to the health economic evaluation of interventions for URDs, the currently prevailing logic of cost-effectiveness (using benchmarks for the maximum allowable incremental cost per quality-adjusted life year gained) was considered deficient as it does not capture well-established social preferences regarding health care resource allocation. CONCLUSION: Modified approaches or alternative paradigms to establish the 'value for money' conferred by interventions for URDs should be developed with high priority.

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.

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.

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.

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.

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.

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.