A sociological approach to medical technology assessment is outlined in this paper, first in general and then with specific reference to controversies surrounding the use of prostate-specific antigen (PSA) testing to population screening for prostate cancer.

Objectives: The costs of comprehensive cardiac rehabilitation are established and compared to the corresponding costs of usual care. The effect on health-related quality of life is analyzed.

Methods: An unprecedented and very detailed cost assessment was carried out, as no guidelines existed for the situation at hand. Due to challenging circumstances, the cost assessment turned out to be ex-post and top-down.

Results: Cost per treatment sequence is estimated to be approximately €976, whereas the incremental cost (compared with usual care) is approximately €682. The cost estimate is uncertain and may be as high as €1.877.

Conclusions: Comprehensive cardiac rehabilitation is more costly than usual care, and the higher costs are not outweighed by a quality of life gain. Comprehensive cardiac rehabilitation is, therefore, not cost-effective.

Objectives: The aim of this study was to assess incidence, time frame, and outcome of “Coverage with Evidence Development” (CED) decisions in the Swiss Basic Health Insurance scheme.

Methods: Analysis of all controversial medical technologies submitted to review by the Swiss Federal Office of Public Health (FOPH) from 1996 to 2012 with focus on decisions with constraints. Description of types of technology, type of initial decision, duration of evaluation period, final decision, and search for potential factors associated with changes over time.

Results: Forty-five (37.5 percent) of 120 controversial health technologies were classified as “yes, in evaluation, reimbursed” for a certain period of time and thirty-five (29.2 percent) as “no, in evaluation, not reimbursed” by the Federal Department of Home Affairs from 1996 to 2012. The rate of CED decisions ranged between zero and nine per year and was influenced by type of technology and calendar year. Forty-four of forty-five decisions were subject to further restrictions, to a “center or a specialist” (76 percent), “indications” (49 percent), “registry” (31 percent), or “other” (49 percent). The time to a final decision ranged from 1.5 to 11 years (median, 6 years). No factors associated with initial decision and final outcome could be identified.

Conclusions: CED as a reality in Switzerland might have enabled patients to obtain access to promising technologies early in their life cycle. CED might have acted as a trigger to a successful implementation of a comprehensive national registry. The lack of qualitative data stresses the urgent need for evaluation of the HTA decisions and their impact on patient outcome and costs.

This article gives a patient organization's perspective on health technology assessments (HTAs) and the role that such organizations can, and should, play in them.

Objectives: Patient Web portals (PWPs) have been gaining traction as a means to collect patient-reported outcomes and maintain quality patient care between office visits. PWPs have the potential to impact patient–provider relationships by rendering additional channels for communication outside of clinic visits and could help in the management of common chronic medical conditions. Studies documenting their effect in primary care settings are limited. This perspective aims to summarize the benefits and drawbacks of using PWPs in the management of chronic conditions, such as diabetes mellitus, hypertension, and asthma, focusing on communication, disease management, compliance, potential barriers, and the impact on patient–provider dynamic. After a review of these topics, we present potential future directions.

Methods: We conducted an exploratory PubMed search of the literature published from inception through December 2015, and focused our subsequent searches specifically to assess benefits and drawbacks of using PWPs in the management of diabetes mellitus, hypertension, and asthma.

Results: Our search revealed several potential benefits of PWP implementation in the management of chronic conditions with regards to patient–provider relationships, such as improved communication, disease management, and compliance. We also noted drawbacks such as potentially unreliable reporting, barriers to use, and increased workload.

Conclusions: PWPs offer opportunities for patients to report symptoms and outcomes in a timely manner and allow for secure online communication with providers. Despite the drawbacks noted, the overall benefits from successful PWP implementation could improve patient–provider relationships and help in the management of chronic conditions, such as diabetes mellitus, hypertension, and asthma.

The aim of Working Group 1 has been to assess health promotion and disease prevention activities in terms of benefits, risks, and economic, social, and ethical implications as a complement to community health indicators.

Objectives: Recent introduction of a quadrivalent human papillomavirus (HPV) vaccine for girls in New Zealand is expected to decrease the incidence of HPV infection as well as resultant cytological abnormalities and cervical cancer. This may affect the cost-effectiveness of the national cervical screening program by reducing the incidence of lesions detected. This study investigates the cost-effectiveness of the current cervical screening policy with and without the HPV vaccine and compares these results with the cost-effectiveness of a range of other screening strategies.

Methods: A Markov state-transition model was built based on the natural history of HPV and cervical carcinogenesis. The model followed a hypothetical cohort of girls from 12 years to 85 years of age or death, through screening and treatment pathways. The model compared a “no vaccine and current screening” strategy with a selection of screening strategies with different age ranges and frequency intervals.

Results: The most cost-effective cervical screening strategy in the presence of the HPV vaccine would be screening women aged 30–60 every 5 years. Moving to this screening strategy from the base case of no vaccine and the current New Zealand strategy of screening women aged 20–69 every 3 years is predicted to have an incremental cost per quality-adjusted life-year gained of NZ$9,841 (€4,428).

Conclusions: Reducing screening intensity from 3 to 5 years as well as narrowing the screening age range for the vaccinated cohort once they reach mid-twenties is recommended. The importance of achieving a high vaccine uptake in New Zealand remains high.

Objective: This study describes the process of production, findings for a policy brief on Increasing Access to Skilled Birth Attendance, and subsequent use of the report by policy makers and others from the health sector in Uganda.

Methods: The methods used to prepare the policy brief use the SUPPORT Tools for evidence-informed health policy making. The problem that this evidence brief addresses was identified through an explicit priority setting process involving policy makers and other stakeholders, further clarification with key informant interviews of relevant policy makers, and review of relevant documents. A working group of national stakeholder representatives and external reviewers commented on and contributed to successive drafts of the report. Research describing the problem, policy options, and implementation considerations was identified by reviewing government documents, routinely collected data, electronic literature searches, contact with key informants, and reviewing the reference lists of relevant documents that were retrieved.

Results: The proportion of pregnant women delivering from public and private non-profit facilities was low at 34 percent in 2008/09. The three policy options discussed in the report could be adopted independently or complementary to the other to increase access to skilled care. The Ministry of Health in deliberating to provide intrapartum care at first level health facilities from the second level of care, requested for research evidence to support these decisions. Maternal waiting shelters and working with the private-for-profit sector to facilitate deliveries in health facilities are promising complementary interventions that have been piloted in both the public and private health sector. A combination of strategies is needed to effectively implement the proposed options as discussed further in this article.

Conclusions: The policy brief report was used as a background document for two stakeholder dialogue meetings involving members of parliament, policy makers, health managers, researchers, civil society, professional organizations, and the media.

The 1970s and early 1980s was the period in which high technology medicine became dominant. It had begun in the late 1950s with the introduction of effective artificial respiratory technology. This gave physicians, patients, and families the hope that the threats to fundamental life processes such as breathing could be countered by technology, and the dilemma of both meeting its costs and the ethical challenges of how to remove it when its use no longer produced benefits.

Background: Despite a clear call for greater input from health technology assessment (HTA) in the areas of clinical practice and policy making, there are currently very few formal training programs. The objectives of our Consortium were to (i) develop a master's level program in HTA, (ii) test its content with a group of Canadian and European students, and (iii) evaluate the Program's strengths and weaknesses.

Objectives: This study presents the results of our evaluation of the first edition of the Master's Program (2001–2003).

Methods: The evaluation relied on (i) a self-administered student questionnaire for each course (n = 142), (ii) interviews with students (n = 10), and (iii) interviews with internship supervisors (n = 5).

Results: A vast majority of students were satisfied with the course content and particularly appreciated the exercises and materials presented in an intensive format. However, they needed more systematic feedback from faculty members and recommended increasing the methodology content. The six key characteristics of the program are (i) flexible format adapted to the needs of skilled professionals, (ii) continuous interaction between HTA users and producers, (iii) international academic and professional collaboration, (iv) partnership with HTA agencies, (v) global approach to evidence-based methods and practices, and (vi) multidisciplinary approach.

Conclusions: Despite the numerous organizational barriers inherent to creating an international program and several areas for improvement in the Program itself, the Ulysses Project was successful in attaining its objectives. Because there is a growing need for human resources with special training in HTA, further efforts need to be devoted to strengthening the international research capacity in HTA.

The author argues that a “narrowing down” in the scope of HTA that occurred at the end of the 1970s was paralleled by developments in bioethics at the same time. Both disciplines responded to changes in the institutional and political field in which they operated. Over the past 20 years, decision making in the health field has changed again. To remain relevant, HTA must evolve further. Building in mechanisms for consultation with stakeholders will be an important element in this adjustment.

Objectives: We studied the cost-effectiveness of tenofovir and entecavir in e antigen positive (CHBe+) and negative (CHBe-) chronic hepatitis B.

Methods: Using a multicenter survey including 544 patients we measured patient quality of life and attributable costs by clinical disease stage. Natural disease progression was studied in 278 patients in a single center. A Markov model was constructed to follow hypothetical cohorts of treated and untreated 40-year-old CHBe+ and CHBe- patients and 50-year-old patients with compensated cirrhosis.

Results: We did not find an improvement in quality of life when viral load was reduced under treatment. Transition rates to liver cirrhosis were found to be age-dependent. Assuming equal effectiveness, tenofovir dominates the entecavir strategy because of its lower price in Belgium. The incremental cost-effectiveness ratio (ICER) of tenofovir after 20 years is more favorable for treating Caucasian cirrhotic patients (mean ICER €29,000/quality-adjusted life-year [QALY]) compared with treating non-cirrhotic patients (mean ICER €110,000 and 131,000/QALY for CHB e+ and e-, respectively). Within the non-cirrhotic patients the ICER decreases with increasing cohort starting age from 30 to 50 years.

Conclusions: Results of long-term models for tenofovir or entecavir treatment of CHB need to be interpreted with caution as long-term trials with hard end points are lacking. Especially the effect on HCC remains highly uncertain. Based on cost-effectiveness considerations such antiviral treatment should be targeted at patients with cirrhosis or at risk of rapid progression to this disease stage.

Background: Timely provision of information on the cost-effectiveness of innovations in health care becomes more and more important, resulting in increasing pressure on researchers to provide proof of cost-effectiveness in a short time frame. However, most of these innovations require considerable time and effort to optimally implement leading to a biased “steady state” cost-effectiveness outcome. As decision makers in health care predominantly have a short-term focus, the discrepancy between short-term study outcomes and long-term cost-effectiveness may very well lead to misguided decisions about the adoption of innovations in health care.

Methods: Factors such as learning effects, capacity constraints, and delayed time to benefit are all related to a short-run timeframe and result in inefficiencies during the implementation of an innovation. These factors and the mechanisms by which they influence the cost-effectiveness outcome are explained for three different types of healthcare innovations.

Results: As standard cost-effectiveness analysis assumes costs and effects to behave constant and representative for an innovation's entire economic lifetime, resulting cost-effectiveness outcomes might give a biased, and often overly pessimistic, reflection of the actual cost-effectiveness of an innovation. This is further amplified by the fact that short-run inefficiencies are most prevalent and impactful during an innovation's earliest stage of operation.

Conclusions: This study advocates to carefully take into account the different factors contributing to lag-time bias in the design and analysis of cost-effectiveness studies, and to communicate potential biases due to short-run inefficiencies to all stakeholders involved in the decision making process.

Introduction: The translation of best evidence into practice has become an important purpose of policy making in health care. In Brazil, a country of continental dimensions with widespread regional and social inequalities, the dissemination and use of the best-evidence in policy making is a critical issue for the healthcare system.

Objectives: The main purpose of this study is to describe an evidence-based public health policy with special emphasis on guidelines creation for high-cost medicines. We also describe how that strategy was diffused to the judiciary system and to other parts of the healthcare system.

Results: We present an 11-year follow-up of a national project for creating and updating guidelines for high-cost medicines in Brazil. A total of 109 national guidelines were published (new or updated versions) for 66 selected diseases, the first such effort in Brazilian history. The project influenced the Brazilian legislature, which has recently established a Federal Law requiring national guidelines for any new technology listed for payment by the Brazilian public healthcare system.

Conclusion: We were able to involve many different stakeholders in a partnership between academia and policy makers, which made possible the widespread dissemination of the clinical practice guidelines. Problems and constraints were also encountered. This evolving public health strategy might be useful for other developing countries.

Since the origin of technology assessment (TA) in the 1960s, including TAs of certain medical interventions, and formal recognition and institutionalization of health technology assessment (HTA) in the 1970s, the field of HTA has evolved in programs large and small in the public and private sectors. It has diffused into an increasing number of nations in a range of policy-making and decision-support contexts. Since its inception, the development and diffusion of HTA have been strongly characterized by international collaboration involving sharing of expertise and practical experience, and joint efforts to advance the state of the art. Also during that time, there have been periodic collaborations to identify or develop standard frameworks, good practices, guiding principles, checklists, and other normative, “how-to” documentation for the field. Recognizing the diversity and ongoing evolution of HTA, these efforts have generally sought to balance the appeal of standardization with that of flexibility to accommodate the ranges of HTA program remits and contexts.