Objectives: The impact of health technology assessment (HTA) in the judicialization of the right of health has not been deeply studied in Latin American countries. The purpose of this study is to review the process of judicialization of the access to high cost drugs in Uruguay and assess the impact HTAs have had on this process.

Methods: The methodology used for this study included a comprehensive literature search in electronic databases, local journals, internal documents developed in the Ministry of Health, as well as conducting interviews with key informants.

Results: Judicialization of the access of high cost drugs has been increasing since 2010. The strategy of the Ministry of Health of Uruguay to decrease this problem included the organization of roundtables with judges and other stakeholders on the basis of HTA, the training of defense lawyers in the use and interpretation of HTA, and the participation of a professional who develops HTA in the preparation of the defense arguments. A year after the implementation of this strategy, 25 percent of writs of protection were won by the Ministry of Health.

Conclusions: Even though the strategy implemented was effective in reducing the loss of litigations, it was not effective in reducing the growing number of writs of protection. It is essential to address this problem in a broad debate and to promote understanding between the parties.

A breast cancer screening program mainly aims at reducing mortality. However, it also has an effect, often not assessed, on the utilization of health care resources that is relevant to health care policy making. Using a simulation model, this paper forecasts the impact of introducing a breast cancer screening program on the utilization of resources for the primary therapy of breast cancer. The most important consequences from a health care point of view will be an increased use of breast-conserving therapy and an increased need for postoperative radiotherapy; there will also be a higher number of women diagnosed with noninvasive breast cancer. The results of this study could provide support for health care decision making by showing the consequences of policy decisions on the introduction of screening programs for health care utilization.

Objectives: The aim of this study was to assess the costs and effects of using specialized breast technologists in prereading mammograms to reduce the increasing workload of radiologists in daily clinical practice. Mammography is the most widely used imaging modality for early detection and diagnosis of breast cancer.

Methods: A total of 1389 mammograms of consecutive patients were evaluated by two technologists trained in mammogram interpretation. The costs and effects of four different experimental strategies of prereading mammograms by technologists were analyzed by decision analytic modeling and compared with the conventional strategy of standard evaluation by the radiologist on duty.

Results: Overall, the employment of technologists in this patient population resulted in a potential time saving up to 73 percent (1019/1389) for the radiologist. No additional false-negative imaging results were found as compared to the conventional strategy. The total diagnostic costs in the conventional strategy were determined at €150,602. The experimental strategies resulted in cost savings up to 17.2 percent (range, €122,494–€139,781).

Conclusions: The employment of technologists in prereading mammograms in a clinical patient population could be effective to reduce the workload of radiologists without jeopardizing the detection of malignancies. Furthermore, diagnostic costs can be reduced considerably.

Background: Throughout the world, decision makers face the need to plan on the basis of uncertainty. Prospective updates on future trends of medical technology usage are tools to improve national health status. In Israel, this challenge is met by several steps taken to promote insight into the realm of emerging technologies. Israel's unique horizon strategy refers to three time spans: the immediate to short-term (for the coming year) updating the National List of Health Services (NLHS) and quarterly scanning; the medium-term (3 years to a decade) revitalizing hospital devices and infrastructure; and long-term planning (over a decade), such as the “Health Israel 2020 Project”.

Methods: A description of the Israeli setup of different time spans and tiers.

Results: The matrix of players, loci, interests, population groups, and incentives creates a complex situation and the Ministry of Health has to regulate the different suppliers and tiers of insurance (obligatory, supplementary, and private), balancing need, equity, and cost containment in preparing for future health care. However, preparedness is not a sterile laboratory and is pervaded by numerous dilemmas and the search for adequate evidence for new less mature technologies is an on-going challenge.

Conclusion: Bridging the forecasting chasm for the future requires analyzing needs, reinforcing evidence and seeing “around the corner” when synergizing between all the “actors” in the national arena. Expert consultation and international cooperation with similar horizon organizations can assist in paving the way for more successful planning efforts for future medical technology implementation.

Objectives: The aim of this study was to assist in the development of a health technology assessment (HTA) program for the Ministry of Health (MOH) of the Republic of Kazakhstan

Methods: Mentoring of an initial HTA program in Kazakhstan was provided by the Canadian Society for International Health (CSIH) by means of a partnership with the Kazakhstan MOH. HTA materials, courses, and one-on-one support for the preparation of a series of initial HTA reports by MOH HTA staff were provided by a seven-member CSIH team over a 2.5-year project.

Results: Guidance documents on HTA and institutional strengthening were prepared in response to an extensive set of deliverables developed by the MOH and the World Bank. Introductory and train-the-trainer workshops in HTA and economic evaluation were provided for MOH staff members, experts from Kazakhstan research institutes and physicians. Five short HTA reports were successfully developed by staff in the Ministry's HTA Unit with assistance from the CSIH team. Challenges that may be relevant to other emerging HTA programs included lack of familiarity with some essential underlying concepts, organization culture, and limited time for MOH staff to do HTA work.

Conclusions: The project helped to define the need for HTA and mentored MOH staff in taking the first steps to establish a program to support health policy decision making in Kazakhstan. This experience offers practical lessons for other emerging HTA programs, although these should be tailored to the specific context.

Abstract Professional journals are of great importance in the transfer of information about technology, providing most physicians and medical students with the majority of their new information. Professional journals have mission statements and goals and many editorial categories to help achieve their goals. In addition, news media, books, television, and computerized journals are important methods for changing physician knowledge. Physician behavior is changed by many factors of which poor patient outcome is probably the key. Quality of information and activities is best assured by clear definition, goals, proper peer review, and good management. Appropriate use of technology is best approached by separating wants from needs.

Objectives: The current and past situation of health technology assessment (HTA) in Catalonia is presented in this study.

Methods: The approach used here is a historical review of facts and landmarks.

Results: Spain has undergone radical change in many aspects, but the changes in healthcare provision have been major indeed. Catalonia has had the ability to benefit from these changes and has been able to build upon professionals' experience and expertise to development a consistent HTA network and continuous evaluation paradigm. The early involvement of the Catalan Agency for Health Technology Assessment (CAHTA) in several relevant HTA international initiatives and the relationship of CAHTA and Research with other HTA agencies in Spain is also stressed.

Conclusions: HTA is currently of common use in Catalonia for decision making at different levels. Now emphasis has to be put on the coming challenges that the HTA community will have to face in the coming years: uncontrolled demand, capacity scarcity, a rapidly evolving knowledge frontier, and insufficient input from the economic sphere into evaluations.

The U.S. Congressional Office of Technology Assessment (OTA) established a health program in 1975. During the next few years, OTA's health program published a series of reports dealing with different aspects of health technology assessment (HTA) in some depth. The key report in this series concerned the efficacy and safety of health technology, which in many ways played a ground-breaking role. It pointed out the pervasive lack of accessible information on efficacy and safety, despite more-than-adequate methods of assessment. It also pointed to many problems that resulted from this lack, and the limited use of such information in clinical practice and policy making. It promoted synthesis of existing literature as a practical method of assessment. Other key reports developed other aspects of HTA, including cost-effectiveness. These reports are generally considered to have shaped the field of HTA at least into the 1990s. OTA also pioneered the use of HTA in determining what preventive services to cover in public healthcare programs.

The process of technology assessment is evolving. The process of policy development for technology is the least understood in the cycle of technology assessment. The process of policy development, which should involve extensive consultation and a broad-based research and evaluation program, is often fraught with difficulties and can cause further analysis or the assessment process to come grinding to a halt. This article reviews some social, political, and ethical issues and the role of civil society in influencing the technology assessment process for new reproductive technologies in Canada. It is written from the perspective of one of the Deputy Directors of Research and Evaluation for the Royal Commission on New Reproductive Technologies and highlights the strengths and difficulties of technology assessment when civil society and technology assessment come face to face. A brief update by a policy analyst in Health Canada on the current situation of legislation on new reproductive technologies has been provided and is included at the end of this article.

This article describes issues that are clinically significant when assessing quality of life of patients whose organ disease can be treated only through transplantation or reliance upon an artificial organ. Emphasis is placed on stresses that affect the family as well as the immediate patient, because, over time, these are inextricably interwoven. The transplant recipient who experiences a “good” medical outcome may perceive that he has little to live for if his family is severely disrupted or broken apart by the strain of the illness. The family of a patient who dies after unremitting complications while being sustained by an artificial organ may experience both relief at the lifting of an unmanageable burden, and continuing guilt that they were unable to provide unconditional love and support to a dying family member.

Economic evaluation of quality assurance programs is often called for but rarely reported. A study was designed to estimate the cost-utility of audit of thrombolysis in four U.K. district general hospitals, using the quality-adjusted life year. Although the results obtained were imprecise, the model used could be applied in future evaluations.

Objectives: Health Technology Assessment (HTA) is a relatively new concept in Latin America (LA). The objectives of this exploratory study were to identify HTA programs in LA, review HTA documents produced by those programs, and assess the extent to which HTA aims are being achieved.

Methods: An electronic search through two databases was performed to identify HTA programs in LA. A content analysis was performed on HTA documents (n = 236) produced by six programs between January 2000 and March 2007. Results were analyzed by comparing document content with the main goals of HTA.

Results: The number of HTA documents increased incrementally during the study period. The documents produced were mostly short HTA documents (82 percent) that assessed technologies such as drugs (31 percent), diagnostic and/or screening technologies (18 percent), or medical procedures (18 percent). Two-thirds (66 percent) of all HTA documents addressed issues related to clinical effectiveness and economic evaluations. Ethical, social, and/or legal issues were rarely addressed (<1 percent). The two groups most often targeted for dissemination of HTA information were third-party payers (55 percent) or government policy makers (41 percent).

Conclusions: This study showed that while HTA programs in LA have attempted to address the main goals of HTA, they have done so through the production of short documents that focus on practical high-technology areas of importance to two specific target groups. Clinical and economic considerations still take precedence over ethical, social, and/or legal issues. Thus, an integrated conceptual framework in LA is wanting.

For certain single-gene disorders, DNA probes allow individuals to make more informed decisions about family size and the outcomes of pregnancies. They may also have important psychological effects. We present a method of assessing their impact on the outcomes of pregnancy. We conclude that the traditional approach, which focuses solely on the potential of prenatal diagnostic services to reduce affected births, is limited. It neglects the potential of such services to promote an increase in unaffected births by reducing the number of unnecessary terminations.

It has been suggested that health economists need to improve their methods in order to meet the challenges of evaluating genomic/genetic tests. In this article, we set out twelve challenges identified from a rapid review of the literature and suggest solutions to the challenges identified. Two challenges were common to all economic evaluations: choice of perspective and time-horizon. Five challenges were relevant for all diagnostic technologies: complexity of analysis; range of costs; under-developed evidence base; behavioral aspects; and choice of outcome metrics. The final five challenges were pertinent for genomic tests and only these may require methodological development: heterogeneity of tests and platforms, increasing stratification, capturing personal utility; incidental findings; and spillover effects. Current methods of economic evaluation are generally able to cope with genomic/genetic tests, although a renewed focus on specific decision-makers’ needs and a willingness to move away from cost-utility analysis may be required. Certain analysts may be constrained by reference cases developed primarily for the assessment of pharmaceuticals. The combined impact of multiple challenges may require analysts to be particularly careful in setting the scope of their analysis in order to ensure that feasibility is balanced with usefulness to the decision maker. A key issue is the under-developed evidence-base and it may be necessary to rethink translation processes to ensure sufficient, relevant evidence is available to support economic evaluation and adoption of genomic/genetic tests.

Objective: To assess the influence of physician specialty and the way in which patient data are presented in the treatment recommended for patients with coronary artery disease.

Methods: In a prospective study, 3,628 patients with significant coronary artery disease who had been referred to 1 of 10 heart centers in the Netherlands as possible candidates for either percutaneous transluminal coronary angioplasty (PTCA) or coronary artery bypass graft surgery (CABG) were recruited. Within each center, the recommended treatment is determined by a team consisting of cardiologists only, cardiovascular surgeons only, or cardiologists and cardiovascular surgeons (i.e., composite teams). The main outcome measures are the proportions of patients for whom PTCA, CABG, or noninvasive (medical) therapy was recommended.

Results: Composite teams made 71% of recommendations, surgeon-only teams, 12%, and cardiologist-only teams, 17%. Cardiologist-only teams primarily recommended patients to PTCA, surgeon-only teams to CABG, while combined teams made more evenly distributed recommendations (p < .001). Although the patients discussed by the three types of teams were clinically different, the recommendation patterns remained significant after adjusting for these differences (p < .001). For patients with recent myocardial infarction, direct presentation of the case to the team by the referring cardiologist reduced the likelihood that CABG would be recommended.

Conclusions: The treatment recommended to patients with coronary artery disease is affected by the composition of the team providing the recommendation. These findings have important implications for clinical decision making for patients with cardiovascular disease.

Formularies are used by payers to optimize access and ensure the appropriate use of medications. Lack of follow-up and re-evaluation can lead to outdated formularies that are not reflective of current evidence. Formulary modernization, an approach to re-align formularies with current evidence has proven successful. The Ontario Drug Policy Research Network (ODPRN) launched a framework for conducting comprehensive drug-class reviews. This commentary describes the individual components of this framework and lessons learned through completion of 12 reviews between 2013 and 2016. We present the ODPRN drug-class review of treatments for chronic hepatitis B as a case example to illustrate the components and impact. The incorporation of foundational health technology assessment components such as economic evaluations and knowledge synthesis with contextualizing evidence such as patient and clinician perspectives (through qualitative studies), real-world evidence (through data analytics), and cross-jurisdictional comparisons (through environmental scans and data analytics), successfully developed jurisdictionally specific policy recommendations grounded in up-to-date evidence. The ODPRN framework for conducting comprehensive drug-class reviews is a robust and feasible approach to conduct formulary modernization. This framework allows for actionable and specific policies which are likely to be considered by decision makers. Adoption of similar frameworks in other jurisdictions may improve uptake of evidence-informed policy recommendations.