Objectives: Ipilimumab is the first licensed immune checkpoint inhibitor for treatment of melanoma. The promising results of the registration clinical study need confirmation in real practice and its clinical success comes together with a relevant budget impact due to the high price of this drug. The aim of this work is to describe a new model of economical sustainability of ipilimumab developed in an Italian reference center for melanoma treatment.

Methods: This retrospective, observational, and monocentric study was carried out at the Veneto Institute of Oncology. Ipilimumab was administered to fifty-seven patients with advanced melanoma. Overall survival, progression free survival, and toxicity were evaluated. A local management procedure was evaluated together with the cost-saving strategies implemented by the Italian Medicines Agency (AIFA).

Results: We demonstrated that the use of ipilimumab for metastatic melanoma in real practice had an efficacy and toxicity similar to that reported in the literature. In this scenario, our management model (centralization of compounding + drug-day) permitted savings up to the 11.1 percent of the gross cost for the drug (calculated assuming that no cost saving procedures were applied) while the policy of cost containment designed by AIFA produced an additional 6.2 percent of savings.

Conclusions: In real practice conditions, the centralized administration of ipilimumab allows to replicate the results of clinical studies and in the meantime to contain the cost associated with this drug. The local strategy of management can be readily applied to most of the high cost drugs compounded in the hospital pharmacy. Impact of findings on practice: (i) We describe a new model of economic sustainability (drug-day, centralization of compounding, payback systems) of an expensive and innovative drug, ipilimumab, for treatment of melanoma within an Italian cancer center. (ii) This pivotal study demonstrated that a cost containment strategy is feasible and it needs the cooperation of all healthcare providers (oncologists, pharmacists, nurses, and technicians) to guarantee the full efficiency of the process.

Objectives: Hospital-based health technology assessment (HTA) has become increasingly important in Brazil due to its strategic importance to promote adoption, incorporation, dissemination, and disinvestment of technologies. A strategy to foster hospital-based HTA was implemented in 2009 by creating hospital-based HTA nuclei (NATS) at university hospitals and other strategic hospitals.

Methods: Between 2011 and 2012, we interviewed board members in twenty-three NATS located in all geographic regions of Brazil to assess their general characteristics, scientific output, and challenges.

Results: Of the total, 65 percent of the NATS belonged to teaching institutions, with 44 percent associated with federal universities. The bulk of their output was in the form of mini-HTA reports. Centers in the Southeast and South of Brazil had the highest production compared with other regions. Lack of expertise and low levels of advanced training were identified as limiting factors in the majority of centers.

Conclusions: The experience of the initial twenty-three NATS could be considered positive and has led to the creation of new ones around Brazil. Regional disparities in workload, production, and technical training should be targeted by new policies toward hospital-based HTA in Brazil. The limits and possibilities for intensifying the strategy relate to continuous investment in priority studies, which simultaneously, allow professionals who work in hospitals to receive continued education and produce relevant HTA work in a timely manner.

Objectives: The objective of this study was to analyze and present the current state of the implementation of health technology assessment (HTA) in Slovenia, identify its advantages and challenges, as well as potential improvements and developments.

Methods: The HTA structure and processes were analyzed and comprehensively described according to relevant literature, official documents, and experiences of the author.

Results: The important steps in the development and implementation of an HTA system are presented through eight key elements: capacity building; HTA funding; HTA legislation and organizational structure; the scope of HTA implementation; decision criteria; quality, timelines, and transparency of HTA implementation; use of local data; and international collaboration. Based on the current situation, possible further developments are presented.

Conclusions: Currently, there is no systematic HTA in Slovenia; however, some basic use of HTA principles can be found in the decision making. The biggest deficiency in the HTA field is the lack of knowledge and systematic implementation. Legislation and guidelines for study appraisals are needed at decision-making levels. HTA principles across health technologies need to be unified along with a central HTA coordination office being set up to lead and establish priorities for HTA work.

Objectives: This study describes the views of various stakeholders on the importance of different criteria for priority setting of HIV/AIDS interventions in Indonesia.

Methods: Based on a general list of criteria and a focus group discussion with stakeholders (n = 6), a list was developed of thirty-two criteria that play a role in priority setting in HIV/AIDS control in West-Java province. Criteria were categorized according to the World Health Organization's health system goals and building block frameworks. People living with HIV/AIDS (n = 49), healthcare workers (HCW) (n = 41), the general population (n = 43), and policy makers (n = 22) rated the importance of thirty-two criteria on a 5-point Likert-scale. Thereafter, respondents ranked the highest rated criteria to express more detailed preferences.

Results: Stakeholders valued the following criteria as most important for the priority setting of HIV/AIDS interventions: an intervention's impact on the HIV/AIDS epidemic, reduction of stigma, quality of care, effectiveness on individual level, and feasibility in terms of current capacity of the health system (i.e., HCW, product, information, and service requirements), financial sustainability, and acceptance by donors. Overall, stakeholders’ preferences for the importance of criteria are similar.

Conclusions: Our study design outlines an approach for other settings to identify which criteria are important for priority setting of health interventions. For Indonesia, these study results may be used in priority setting processes for HIV/AIDS control and may contribute to more transparent and systematic allocation of resources.

Objectives: The practical significance of health technology assessment (HTA) in policy decisions or clinical practice has been challenged. Possibly, problem definitions underlying HTA do not concur sufficiently with the problem definitions held by policy makers or clinicians. We performed an in-depth case study on mebeverine, a drug prescribed to patients with irritable bowel syndrome, to explore this hypothesis.

Methods: The theoretical framework was provided by the theory of argumentative policy analysis. We analyzed documents and held semistructured interviews to collect data. We reconstructed interpretative frames to analyze actors' argumentation.

Results: The funding and usage problems relating to mebeverine were ill-structured. Actors disagreed on the information needed and the norms at stake. As a result, the problem definition shifted, and the resulting problem definitions failed to correspond with the problems perceived by the target populations.

Conclusions: To ensure that future studies on healthcare problems are useful, it is imperative that policy makers take the problem definitions of potential users into account.

As COVID-19 ravages the world, many countries are faced with the grim reality of not having enough critical-care resources to go around. Knowing what could be in store, the Thai Ministry of Public Health called for the creation of an explicit protocol to determine how these resources are to be rationed in the situation of demand exceeding supply. This paper shares the experience of developing triage criteria and a mechanism for prioritizing intensive care unit resources in a middle-income country with the potential to be applied to other low- and middle-income countries (LMICs) faced with a similar (if not more of a) challenge when responding to the global pandemic. To the best of our knowledge, this locally developed guideline would be among the first of its kind from an LMIC setting. In summary, the experience from the Thai protocol development highlights three important lessons. First, stakeholder consultation and public engagement are crucial steps to ensure the protocol reflects the priorities of society and to maintain public trust in the health system. Second, all bodies and actions proposed in the protocol must not conflict with existing laws to ensure smooth implementation and adherence by professionals. Last, all components of the protocol must be compatible with the local context including medical culture, physician–patient relationship, and religious and societal norms.

Objectives: The aim of this study was to describe the history and present situation with health technology assessment (HTA) in Israel.

Methods: The method used in this study was a historical analysis based mainly on the knowledge of the authors, but supplemented by the published literature.

Results: HTA originated in Israel as a centralized function conducted under the auspice of research, developing into an active multidisciplinary center. Throughout the expansion of the field, HTA was performed in affiliation with several local and international bodies, while providing direct and indirect support at the national level. Today, mainly as a result of vigorous dissemination of the principles, methodology and tools for HTA by the Israeli Center for Technology Assessment in Health Care (ICTAHC), this discipline is increasingly a decentralized activity conducted by a great variety of institutions. Israeli health policy decisions are increasingly based on the results of HTA.

Conclusions: ICTAHC's role and functioning has expanded since its beginnings. HTA has become an important part of health care in Israel.

Objectives: The aim of this study was to examine location of systematic reviews of test accuracy in five specialist review databases: York CRD's DARE and HTA databases, Medion (University of Maastricht), C-EBLM (International Federation of Clinical Chemistry), and the ARIF in-house database (University of Birmingham).

Methods: Searches were limited to the period 1996–2006. Test accuracy reviews were located using in-house diagnostic search filters and with help from database producers where databases were not confined to test accuracy reviews. References were coded according to disease area, review purpose, and test application. Ease of use, volume, overlap, and content of databases was noted.

Results: A large degree of overlap existed between databases. Medion contained the largest number (n = 672) and the largest number of unique (n = 328) test accuracy references. A combination of three databases identified only 76% of test reviews. All databases were rated as easy to search but varied with respect to timeliness and compatibility with reference management software. Most reviews evaluated test accuracy (85%) but the HTA database had a larger proportion of cost-effectiveness and screening reviews and C-EBLM more reviews addressing early test development. Most reviews were conducted in secondary care settings.

Conclusions: Specialist review databases offer an essential addition to general bibliographic databases where application of diagnostic method filters can compromise search sensitivity. Important differences exist between databases in terms of ease of use and content. Our findings raise the question whether the current balance of research setting, in particular the predominance of research on tests used in secondary care, matches the needs of decision makers.

Objectives: Previously in Finland, each municipality selected which methods to use in screening for fetal abnormalities. This resulted in practice variation and inequity. The national health technology assessment (HTA) office Finohta compared the methods and time frames available when screening for chromosomal and structural abnormalities. The assessment identified a need to discuss several value-laden questions before policy decisions could be taken.

Methods: The National Screening Committee (NSC) at the Ministry of Health and Social Affairs (MOH) formulated a statement based on the HTA report to inform policy makers. This article describes the steps in the policy process.

Results: The national screening committee organized an open forum to discuss the ethically relevant aspects of fetal screening, and a lengthy public discussion highlighted the viewpoints of various stakeholders. Based on the assessment, public discussion, and several committee meetings that heard further experts, the NSC formulated a conclusion based on equity of access. This also offered options for families unwilling to terminate a pregnancy due to fetal abnormality. The MOH sent the conclusion to a comment round, and the proposal was accepted with minor adjustments. The Ministry decided to unify the regulation of all public screening programs by one statute. The policy process lasted three years, and the methods to screen for fetal abnormalities will be unified after a further 3 years.

Conclusions: The assessment of screening programs for fetal abnormalities reached beyond its original mandate. The process of examining values behind screening resulted in a program that respects the differing objectives and ethical values of pregnant families, and to national legislation on screening programs.

Objectives: This study aims to assess the impact of articles with very high reprint orders (“high-reprint articles”) by measuring their citation in the subsequent literature as compared with a control group of articles.

Methods: The twenty-one articles (published in the Lancet in 1998) with reprint orders of over 10,000 were matched with a control set of twenty-one articles with smaller reprint orders. The Science Citation Index was used to obtain the number of citations for each of the forty-two articles.

Results: The twenty-one high-reprint articles were cited 2,548 times; the mean number of citations was 121 (range, 3 to 499 citations per article). Five of the twenty-one high-reprint articles had more than 200 citations, but seven (33%) were cited twenty-five times or fewer. The twenty-one control articles were cited 986 times; the mean number of citations was forty-seven (range, 1 to 165). Fifteen (71%) of the twenty-one control articles were cited twenty-five times or fewer. Thirteen of the high-reprint articles were reports of randomized trials with a mean of 163 citations. In the control articles, six were reports of randomized trials with a mean of eighty-eight citations.

Conclusions: Articles with a high-reprint order were cited more frequently than other articles. However, some high-reprint articles were cited infrequently. If the size of a reprint order is related to the importance of an article, those articles with very high reprint orders may, therefore, be perceived as more important. Further research is needed to explore other aspects of the relative importance and impact of high-reprint articles.

Objectives: The objectives of this study were to analyze the current structure of the Turkish pharmaceuticals market to explain the latest developments and to offer some insight into the likely policy issues that this sector will face.

Methods: Systematic searches of the relevant Turkish and English research literature were made, using electronic databases in addition to written reports.

Results: The pharmaceutical industry in Turkey currently has eighty-seven manufacturing firms, eleven raw material manufacturers and thirty-eight importing firms. These add up to a total of 136 firms, 35 of which are driven by foreign capital, with 8 of these foreign-run firms having their own plants in Turkey. The industry employs approximately 19,000 personnel. In terms of growth, the value of pharmaceutical products in Turkey recently has exceeded that in Europe. In addition, per capita drug consumption levels are quite low compared with the Organisation for Economic Co-operation and Development and European Union countries. Major international players in the medical equipment and pharmaceutical products sector have also been opening offices in Turkey to reap the benefits of this rapidly evolving market.

Conclusions: The pharmaceutical industry in Turkey is quite advanced and diverse, with high quality, generic pharmaceutical products being manufactured as well as poor quality copies that have not been appropriately tested in terms of bioequivalence and bioavailability. The country faces a low level of drug consumption due to economic and cultural constraints compared with Western countries. Governmental control and regulations are key issues because the majority of drug purchases (70–80 percent) throughout the country are currently reimbursable through public sector agencies such as the Pension Fund and the Social Insurance Organization.

Objectives: The headroom method was introduced for the very early evaluation of the potential value of new technologies. It allows for establishing a ceiling price for technologies to still be cost-effective by combining the maximum effect a technology might yield, the maximum willingness-to-pay (WTP) for this effect, and potential downstream expenses and savings. Although the headroom method is QALY-based, not all innovations are expected to result in QALY gain.

Methods: This study explores the feasibility and usefulness of the headroom method in the evaluation of technologies that are unlikely to result in QALY gain. This will be illustrated with the diagnostic trajectory of complex pediatric neurology (CPN).

Results: Our headroom analysis showed a large room for improvement in the current diagnostic trajectory of CPN in terms of diagnostic yield. Combining this with a maximum WTP value for an additional diagnosis and the potential downstream expenses and savings, resulted in a total headroom of €15,028. This indicates that a new technology in this particular diagnostic trajectory, might be cost-effective as long as its costs do not exceed €15,028.

Conclusions: The headroom method seems a useful tool in the very early evaluation of medical technologies, also in cases when immediate QALY gain is unlikely. It allows for allocating healthcare resources to those technologies that are most promising. It should be kept in mind, however, that the headroom assumes an optimistic scenario, and for that reason cannot guarantee future cost-effectiveness. It might be most useful for ruling out those technologies that are unlikely to be cost-effective.

The need to progress and innovate in health technology assessment (HTA) is a must in a continuously changing environment. The HTAi Policy Forum reflected on two specific areas for development where it was thought there was need for careful consideration and deliberation during the main annual meeting in February 2016. The study by Husereau et al. (1) in this journal presents the discussions resulting from this Forum. To further share the deliberations of the Forum and with a view to opening this debate to the wider HTA community, a panel session during the HTAi Annual Meeting in Tokyo was organized. Presentations at the panel included a summary of the HTAi Policy Forum discussions and perspectives from a patient, a representative of healthcare system provider, and a representative from an HTA organization and industry. This letter presents the issues raised in the panel session.

This economic assessment of the implementation of magnetic resonance imaging (MRI) in a French hospital examines data on the diagnostic resources used in neurology and neurosurgery before and after MRI was available. Given a similar patient population and case mix, there was no change in the resources used other than the addition of MRI. So far, MRI appears to be a complement to, and not a substitute for, other imaging techniques used in neuroradiology. The focus of this work is purely economic; its conclusions do not challenge the major scientific contributions of MRI.

Proliferation of acute health care technology creates problems and benefits for nurses and patients. In this paper the impact of technology on the nursing work role is reviewed through the international literature. The thrust of the nursing literature has, not surprisingly, matured over time as the use of technology has become well established in the acute care environment, and three themes can be identified. The implications for acute care nurse specialists, including their educational needs, are set in context of the Australian health care system, with particular reference to the cardiac care environments.

Coronary bypass surgery developed as another in a line of surgical procedures dating back more than 60 years. The medical profession at first assessed this procedure with time-honored anecdotal techniques. Gradually, for a variety of reasons, improved methods of comparisons worked their way into assessments of bypass surgery. Randomized controlled trials met resistance but have been very influential. Assessment of percutaneous transluminal coronary angioplasty has benefited from the knowledge generated during the last 25 years, but clinicians have been slower to apply the most advanced techniques.

In-vitro fertilization (IVF) is a relatively recent approach to overcoming human fertility problems. This study explored factors in the diffusion of IVF in England and in the Netherlands. Many factors were common to the two countries. Governments in both countries have been passive, apparently wishing to avoid entering a controversial field. Technology assessment has played little part in the diffusion process in these two countries.

A rapidly evolving technology, percutaneous transluminal coronary angioplasty, is increasingly favored over bypass surgery for treating some types of coronary stenosis because of its less traumatic invasion, better recovery response, and lower initial cost. However, substantially higher failure rates in initial procedures offset PTCA's savings to an unknown extent and cloud analysis of its overall impact. Lack of randomized clinical data precludes valid cost-effectiveness comparison of the technologies at this time. Criteria for establishing valid data and evaluations of currently available data are described in this paper.

We performed an economic evaluation of HIV testing among intravenous drug users (IVDUs) in Italy using the analytical framework of cost-effectiveness analysis. A semi-Markov model was developed to calculate costs and life expectancy of a cohort of IVDUs with and without an annual HIV testing program. We also investigated the incremental cost-effectiveness of a hypothetical early treatment to prolong the life expectancy of HIV-infected asymptomatic subjects by 1 year. The testing program is cost saving in the low prevalence scenario (0.05), and costs L 14,000,000 (US $8,400) and L 55,800,000 (US $33,500) per year of life saved in areas of medium (0.3) and high (0.6) prevalence, respectively. The incremental cost-effectiveness of the hypothetical early treatment may compare favorably with other health care interventions. The program may be considered a cost-effective procedure in low and medium prevalence areas. Where prevalence is high, more evidence about the magnitude of the behavior change is needed. In these areas, the availability of an effective early treatment may become the economic rationale for implementing such a program.