Fostering innovation for societal gain has been a core attribute of technology assessment (TA) since its inception. Although many observers were concerned that TA would be a means by which government would impede the development and use of technology, this was not the intent of policy makers or the agencies that conducted the original TAs.

Objectives: This study aims to describe how a negative reimbursement decision—based on the health technology assessment (HTA) report of a nondrug intervention—affects healthcare providers in Germany.

Methods: Knee arthroscopy was chosen as an example, because as of April 2016 this procedure is no longer reimbursed for osteoarthritis, but is still covered for other indications, including meniscal lesions. The exclusion followed an HTA report prepared by the Institute for Quality and Efficiency in Health Care (IQWiG). Here, we examine how the decision to revoke reimbursement for arthroscopy was perceived by the surgical community. Information was collected from official hospital statistics, the internet, and informal interviews with orthopedic surgeons.

Results: In 2015, a total of 37,920 arthroscopic procedures were performed for knee osteoarthritis in Germany. Several surgical societies were unhappy with the negative decision, which was issued as a directive in November 2015, and they challenged the decision-making process as well as the underlying scientific evidence. In March 2016, fifteen societies issued joint recommendations on how to differentiate osteoarthritis from other knee diseases and how to document other diseases in a way that inspections by representatives of health insurance funds would not detect any deficiencies. In informal interviews, orthopedic surgeons indicated that miscoding of the principal diagnosis (meniscal tear rather than knee osteoarthritis) is to be expected, especially in the hospital sector.

Conclusions: HTA can have a significant impact on the provision of health services, but various loopholes allow physicians to undermine policy decisions. Therefore, it is important to involve all stakeholders in HTA and to convince them of the benefits of evidence-based medicine.

Objectives: Clinical research data are often collected on paper and later inputted onto an electronic database. This method is time consuming and potentially introduces errors. Therefore, to make primary data collection more efficient and less error prone we aimed to develop a touch-screen application for data collection in a psoriatic arthritis research clinic and compared it with the pre-existing paper-based system.

Methods: We developed a Web application using Java and optimized it for the iPad®. It highlights missing fields for physicians in real time, and only permits submission of data collection form after corrections are made. For its evaluation, seven physicians participated, and before each patient visit they were randomly assigned paper or iPad® data entry. Number of errors, length of visit, and time between clinic visit and completion of data entry were measured.

Results: A total of 106 patients seen in the clinic who agreed to participate were randomly assigned to be evaluated by clinic physicians using the iPad® (fifty-three patients) or a paper protocol (fifty-three patients). On average, 3.34 omissions were found per paper form, of which 2.24 would have been detected on the iPad®. The iPad® increased the mean patient encounter time from 37.2 minutes to 46.5 minutes, but eliminated delay between a clinic visit and its data entry.

Conclusions: Entering data using the iPad® application makes the patient encounter slightly longer, but reduces “missing fields.” It also eliminates the delay between clinic visit and data entry thus improving the efficiency of clinical data capture in a research setting.

The Belgian healthcare system has a Bismarck-type compulsory health insurance, covering almost the entire population, combined with private provision of care. Providers are public health services, independent pharmacists, independent ambulatory care professionals, and hospitals and geriatric care facilities. Healthcare responsibilities are shared between the national Ministries of Public Health and Social Affairs, and the Dutch-, French-, and German-speaking Community Ministries of Health. The national ministries are responsible for sickness and disability insurance, financing, determination of accreditation criteria for hospitals and heavy medical care units, and construction of new hospitals. The six sickness and disability insurance funds are responsible for reimbursing health service benefits and paying disability benefits. The system's strength is that care is highly accessible and responsive to patients. However, the healthcare system's size remained relatively uncontrolled until recently, there is an excess supply of certain types of care, and there is a large number of small hospitals. The national government created a legal framework to modernize the insurance system to control budgetary deficits. Measures for reducing healthcare expenditures include regulating healthcare supply, healthcare evaluation, medical practice organization, and hospital budgets. The need to control healthcare facilities and quality of care in hospitals led to formal procedures for opening hospitals, acquiring expensive medical equipment, and developing highly specialized services. Reforms in payment and regulation are being considered. Health technology assessment (HTA) has played little part in the reforms so far. Belgium has no formal national program for HTA. The future of HTA in Belgium depends on a changing perception by providers and policy makers that health care needs a stronger scientific base.

Objectives: In economic evaluations of healthcare technologies, situations arise where data are not randomized and numbers are small. For this reason, obtaining reliable cost estimates of such interventions may be difficult. This study explores two approaches in obtaining cost estimates for pregnant women screened for a fetal cardiac anomaly.

Methods: Two methods to reduce selection bias in health care: regression analyses and propensity scoring methods were applied to the total mean costs of pregnancy for women who received specialist cardiac advice by means of two referral modes: telemedicine and direct referral.

Results: The observed total mean costs of pregnancy were higher for the telemedicine group than the direct referral group (4,918 versus 4,311 GBP). The regression model found that referral mode was not a significant predictor of costs and the cost difference between the two groups was reduced from 607 to 94 GBP. After applying the various propensity score methods, the groups were balanced in terms of sizes and compositions; and again the cost differences between the two groups were smaller ranging from -62 (matching “by hand”) to 333 GBP (kernel matching).

Conclusions: Regression analyses and propensity scoring methods applied to the dataset may have increased the homogeneity and reduced the variance in the adjusted costs; that is, these methods have allowed the observed selection bias to be reduced. I believe that propensity scoring methods worked better for this dataset, because after matching the two groups were similar in terms of background characteristics and the adjusted cost differences were smaller.

Objectives: Conducting economic evaluation in the context of clinical studies is common but has been the subject of extensive discussion due to its limitations. Various standard approaches and guidelines how such studies should be conducted have been proposed, but there is very limited information available about how common these studies are, what type of data that is collected, and how the quality of the protocols compares to the suggested standards. This study examines the prevalence and study design of health economic evaluations conducted alongside clinical trials in Sweden between 1995 and 2005.

Methods: A systematic assessment of clinical trial protocols that had arrived as applications to the Medical Products Agency between 1995 and 2005 was performed. Only protocols arriving during the first half of odd years within the time period were included.

Results: A total number of 680 protocols from 1995 to 2005 were examined, and among them, 14.4 percent included a health economic part. With the exception of year 2001, a trend toward an increased prevalence of economic evaluations next to clinical trials can be seen.

Conclusions: This study shows that economic evaluations alongside clinical trials are becoming more common, although most trials still lack a health economic part of the protocol. The information about the economic evaluation provided in the protocols is in many cases scarce, possibly due to the fact that there currently are no generally accepted and applied guidelines for economic evaluations in clinical trial protocols. Introducing requirements for detailed study plans also for the economic evaluation should improve the quality of economic evaluations alongside clinical trials.

Objectives: A comprehensive health technology assessment (HTA) enables a patient-centered assessment of the effectiveness, economic, ethical, socio-cultural, and legal issues of health technologies that takes context and implementation into account. A question is whether these various pieces of evidence need to be integrated, and if so, how that might be achieved. The objective of our study is to discuss the meaning of integration in the context of HTA and suggest how it may be achieved in a more structured way.

Methods: An analysis of the concept of integration in the context of HTA and a review of approaches that were adopted in the INTEGRATE-HTA project that may support integration.

Results: Current approaches to integration in HTA are mainly methods of commensuration, which are not optimally geared to support public deliberation. In contrast, articulating evaluative frameworks could be an important means of integration which allows for exploring how facts and values can be brought to bear on each other.

Conclusions: Integration is not something that only needs to be addressed at the end, but rather throughout an HTA, right from the start. Integration can be conceived as a matter of accounting for the relevance of empirical evidence in view of a commitment to a set of potentially conflicting values. Various elements of the INTEGRATE-HTA project, such as scoping and the development of logic models, can help to achieve integration in HTA.

In their article “Assessment of MAST in European Patient-Centered Telemedicine Pilots” published in this journal (1), Anne Granstrøm Ekeland and Astrid Grøttland describe the results from a questionnaire study of how MAST (Model for Assessment of Telemedicine) (2) was used and perceived by the project managers in twenty-one studies of telemedicine in the European project RENEWING HEALTH.

As strong advocates and adopters of early cost-effectiveness modeling for test evaluation, we were excited to see the recent article “The Early Bird Catches the Worm: Early Cost-Effectiveness Analysis of New Medical Tests,” in which Buisman and colleagues present a succinct and generalizable framework for conducting this type of analysis. The authors have done an excellent job in identifying and summarizing the key components of this methodology, as well as highlighting fundamental differences between early analyses versus the traditional late-stage approach. As the number of medical tests coming to market continues to grow, there is an ever growing need to develop rigorous methodology in this area, and we commend the authors for this timely work.

A new definition of health technology assessment (HTA), developed by an International Joint Task Group claims to be a “milestone,” “an historic achievement,” and “a cornerstone reference”—claims that we think to be unjustified. We too favor clear definitions, especially when confusion abounds. However, the Task Group seems to have developed a definition without the help of usual conventions regarding definitions and, in our view, through an ill-described process. A definition ought to differentiate the entity defined from other entities. This one fails to do so. It states traits that are true of HTA (e.g., that is interdisciplinary) but HTA is not alone in this. There are other concerns: examples of HTA’s use are embodied in the definition, precluding other uses; the adjectives used, although generally true of HTA, are not differentiating features; and attributing to HTA specific purposes, thereby excluding other purposes. We have sympathy for these purposes but cannot consider them HTA’s only purposes or even, its main purpose. A newcomer to HTA, on reading this definition, will have no idea of HTA’s true potential. These numerous failings, we feel, send all the wrong signals, and could ultimately weaken, rather than strengthen perceptions of HTA’s legitimacy and objectivity. The production of a good definition remains, therefore, a work in progress.

Luxembourg's public health insurance is a compulsory insurance for all employees, self-employed professionals, farmers, and pensioners. It is financed through contributions of the insured people, as well as by state taxes. Providers of health care are mainly private nonprofit institutions and self-employed professionals. All healthcare procedures are defined in fee schedules determined by a common decision of the Ministers of Social Security and Health according to proposals of a board of experts. The relative value of a service is also determined by the corresponding fee schedule. Hospitals are financed by individual budgets negotiated between each hospital and the health insurance. These hospital budgets do not cover services provided in hospitals by medical specialists, who are reimbursed on a fee-for-service basis. A law on hospital planning and organization allows the government to restrict the installation in hospitals of very expensive equipment or of equipment for which there is only a limited need in Luxembourg hospitals. Until recently there has been limited interest in or use of health technology assessment (HTA). However, large hospital investments have provoked some interest in the last few years. The Ministry of Health has asked for some HTA studies when a concrete decision had to be taken. Luxembourg decision makers have become more aware that HTA may help them to become more informed about the short- and long-term consequences of the application of health technology.

In the article entitled “Rapid reviews versus full systematic reviews: An inventory of current methods and practice in health technology assessment,” by Watt et al. in volume 24 number 2 (Spring 2008) of International Journal of Technology Assessment in Health Care, the affiliation of Stephen Blamey is incorrectly listed as Department of Health & Ageing. Dr. Blamey is the current Chair of the Medical Services Advisory Committee (MSAC). MSAC is an independent scientific committee comprising individuals with expertise in clinical medicine, health economics, and consumer matters. The Department of Health & Ageing administers funding and operations for MSAC. However, members of MSAC act independently of the Department. As Chair of MSAC, Dr. Blamey can be contacted through the Department. Dr. Blamey is not affiliated with the Department of Health and Ageing and his contribution to the above-mentioned article does not reflect its policy. Dr. Blamey wishes to apologize for this misunderstanding.

Objectives: Earlier treatment of publicly funded patients may achieve health gains that justify the additional costs of reducing waiting times. This study reports on the cost-effectiveness of implementing a private contracting model to meet alternative maximum waiting time targets for publicly funded patients undergoing total knee replacement surgery in Australia.

Methods: A linked decision tree and cohort Markov model was developed and populated and validated using secondary data sources to represent the pathways, costs, and quality adjusted life-years (QALYs) gained of non-urgent patients with alternative waiting times for total knee replacement surgery to a maximum age of 100 years.

Results: Assuming public waiting times are reduced through the purchase of private services, additional QALYs are gained at an incremental cost of less than $40,000. Value could be increased if lower private prices could be negotiated. Results are also sensitive to the rate of deterioration in function while waiting for surgery and the impact of functional status at the time of surgery on postsurgery outcomes.

Conclusions: More evidence on the value of expanded capacity or new models of care may inform new funding models to support such investments and reduced prices for new technologies, leading to more efficient and sustainable publicly funded healthcare systems.

This study aimed to evaluate manufacturers’ perceptions of the decision-making process for new drug reimbursement and to formulate implications in operating a health technology assessment system. In 2019, we conducted a questionnaire survey and a semistructured group interview for domestic (n = 6) and foreign manufacturers (n = 9) who had vast experience in introducing new medicines into the market through a health technology assessment. Representatives of manufacturers indicated that disease severity, budget impact, existence of alternative treatment, and health-related quality of life were relevant criteria when assessing reimbursement decisions. Compared with domestic manufacturers, foreign manufacturers were risk takers when making reimbursement decisions in terms of adopting a new drug and managing pharmaceutical expenditure. However, foreign manufacturers were risk-averse when evaluating new drugs with uncertainties based on real-world data such as clinical effectiveness. Based on manufacturers’ perceptions of the decision-making process for new drug reimbursement, there is room for improvement in health technology assessment systems. Explaining the underlying reasons behind their decisions, unbiased participation by various stakeholders and their embedded roles in the decision-making process need to be emphasized. However, the measures suggested in this study should be introduced with cautions. The process of health technology assessment might be a target for those who undermine the system in pursuit of their private interests.

Objectives: An example of technology assessment in dental care by evaluating the (cost-)effectiveness of types of three-surface inlays (gold, laboratory-fabricated ceramic, and chairside CAD/CAM ceramic) is provided.

Methods: MEDLINE, EMBASE, and the Cochrane Library were searched for studies published between 1966 and June 2003 that reported annual survival probabilities and annual observations. The longevity of different types of inlays was measured by the number of failure-free years. Annual survival rates from different studies were pooled by weighing the rates of each study by the inverse of the variance of the effect estimate. A cost-effectiveness analysis from the perspective of German private health insurers was performed using billing charges.

Results: Three, five, and two case series on laboratory-fabricated ceramic, chairside CAD/CAM ceramic, and gold inlays, respectively, were included. Over a 9-year observation period, the number of undiscounted failure-free years was 8.62 (95 percent confidence interval, 8.40–8.85), 8.65 (8.58–8.73), and 8.76 (8.72–8.80) for laboratory-fabricated ceramic, chairside CAD/CAM ceramic, and gold inlays, respectively. Laboratory-fabricated ceramic inlays were the most expensive.

Conclusions: While laboratory-fabricated ceramic, chairside CAD/CAM ceramic, and gold inlays had a strikingly similar failure-free survival rate, laboratory-fabricated ceramic inlays had the highest costs and, thus, were less cost-effective than chairside CAD/CAM ceramic and gold inlays.

For patients who have had the misfortune to develop terminal renal failure, three basic modes of treatment can be offered. One is renal transplantation, with a graft taken from either a living or a cadaveric donor. When successful, it offers the best quality of life and treatment for patients with end-stage kidney disease. However, the elderly and those with severe cardiovascular or systemic complications are not always suitable candidates for renal transplantation (1).