The evolution of ICER's review process for new medical interventions and a critical review of economic evaluations (2018-2019): how stakeholders can collaborate with ICER to improve the quality of evidence in ICER's reports.

BACKGROUND: Since its inception in 2006, the Institute for Clinical and Economic Review (ICER) has rapidly gained influence on drug pricing and reimbursement decisions despite historical resistance to the use of cost-effectiveness thresholds in the US health care system. Although patient groups, physicians, and pharmaceutical manufacturers voiced their concerns about the potential negative effects of increased use of ICER's assessments on patient access to innovative medications, there is little guidance and consensus on how the stakeholders should collaborate with ICER to ensure that its reviews reflect the best clinical and economic evidence. OBJECTIVES: To (1) summarize the evolution of ICER's evaluation procedure, scope, and topics; (2) evaluate the effectiveness of stakeholder engagement approaches; and (3) inform stakeholders of their potential role in collaborating with ICER in estimating the cost-effectiveness of new interventions. METHODS: Publicly available ICER evaluations from 2008 to 2019 were systematically reviewed. Changes in evaluation procedures, scope, and topics were summarized. For evaluations that occurred in 2018 (n = 12) and 2019 (n = 8), key characteristics were extracted from 172 letters documenting interactions between ICER and all stakeholders who provided comments to draft reports. Stakeholder suggestions were analyzed in terms of their effectiveness indicated by ICER's reconsideration of its original cost-effectiveness analysis approach. RESULTS: The number of ICER evaluations increased consistently from 2 to 12 per year between 2008 and 2018 but declined to 8 in 2019. Stakeholder opportunity to engage with ICER increased from 1 to 3 per evaluation between 2008 and 2015. ICER initially focused on reviewing general treatment strategies but shifted its focus to specific pharmaceuticals and medical devices in 2014. In 2018 and 2019, 30% of 172 stakeholder letters resulted in a revision in the base-case analysis (49 comments in 2018, 23 in 2019); nearly half of comments in these letters included specific alternative data or a published article to rationalize recommendations. Other common types of suggestions that resulted in ICER's base-case analysis revisions included comments relating to inconsistent methods used to derive model inputs across different treatments (12/49 in 2018, 5/23 in 2019); clinical justifications (12/49 in 2018, 0/23 in 2019); and justifications based on patient perspectives (1/49 in 2018, 5/23 in 2019). These revisions rarely affected ICER's conclusions on the cost-effectiveness of evaluated interventions. Among the 20 assessments that involved 172 stakeholder engagements in 2018 and 2019, only 2% (n = 3) of the engagements (all from 2018) were associated with a change in the cost-effectiveness conclusion. CONCLUSIONS: Between 2018 and 2019, stakeholders leveraged ICER evaluations as opportunities to promote dialogue for better understanding of the value of technologies. Actionable, evidence-based recommendations were accepted more often than other recommendations. DISCLOSURES: No outside funding supported this study. The authors have no conflicts of interest to disclose. Findings from this study were presented as a poster at Virtual ISPOR, May 17-20, 2021.

Content of Health Economics Analysis Plans (HEAPs) for Trial-Based Economic Evaluations: Expert Delphi Consensus Survey.

OBJECTIVES: Health economics analysis plans (HEAPs) currently lack consistency, with uncertainty surrounding appropriate content. We aimed to develop a list of essential items that should be included in HEAPs for economic evaluations conducted alongside randomized trials. METHODS: A list of potential items for inclusion was developed by examining existing HEAPs. An electronic Delphi survey was conducted among professional health economists. Respondents were asked to rate potential items from 1 (least important) to 9 (most important), suggest additional items, and comment on proposed items (round 1). A second survey (round 2) was emailed to participants, including the participant's own scores from round 1 along with summary results from the whole panel; participants were asked to rerate each item. Consensus criteria for inclusion in the final list were predefined as >70% of participants rating an item 7-9 and <15% rating it 1-3 after round 2. A final item selection meeting was held to scrutinize the results and adjudicate on items lacking consensus. RESULTS: 62 participants completed round 1 of the survey. The initial list included 72 potential items; all 72 were carried forward to round 2, and no new items were added. 48 round 1 respondents (77.4%) completed round 2 and reached consensus on 53 items. At the final meeting, the expert panel (n = 9) agreed that 58 items should be included in the essential list, moved 9 items to an optional list, and dropped 5 items. CONCLUSIONS: Via expert consensus opinion, this study identified 58 items that are considered essential in a HEAP.

Principles of pharmacoeconomic analysis: the case of pharmacist-led interventions

In the past years, several factors such as evidence-based healthcare culture, quality-linked incentives, and patient-centered actions, associated with an important increase of financial constraints and pressures on healthcare budgets, resulted in a growing interest by policy-makers in enlarging pharmacists' roles in care. Numerous studies have demonstrated positive therapeutic outcomes associated with pharmaceutical services in a wide array of diseases. Yet, the evidence of the economic impact of the pharmacist in decreasing total health expenditures, unnecessary care, and societal costs relies on well-performed, reliable, and transparent economic evaluations, which are scarce. Pharmacoeconomics is a branch of health economics that usually focuses on balancing the costs and benefits of an intervention towards the use of limited resources, aiming at maximizing value to patients, healthcare payers and society through data driven decision making. These decisions can be guide by a health technology assessment (HTA) process that inform governmental players about medical, social, and economic implications of development, diffusion, and use of health technologies - including clinical pharmacy interventions. This paper aims to provide an overview of the important concepts in costing in healthcare, including studies classification according to the type of analysis method (e.g. budget-impact analysis, cost-minimization analysis, cost-effectiveness analysis, cost-utility analysis), types of costs (e.g. direct, indirect and intangible costs) and outcomes (e.g. events prevented, quality adjusted life year - QALY, disability adjusted life year - DALY). Other key components of an economic evaluation such as the models' perspective, time horizon, modelling approaches (e.g. decision trees or simulation models as the Markov model) and sensitivity analysis are also briefly covered. Finally, we discuss the methodological issues for the identification, measurement and valuation of costs and benefits of pharmacy services, and suggest some recommendations for future studies, including the use of Value of Assessment Frameworks

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Effects of a multifaceted intervention to promote the use of intravenous iron sucrose complex instead of ferric carboxymaltose in patients admitted for more than 24 h.

PURPOSE: Although more practical for use, the impact of ferric carboxymaltose (FCM) on the hospital budget is considerable, and intravenous iron sucrose complex (ISC) represents a cost-saving alternative for the management of iron deficiency anemia in patients during hospitalization. The Drug Committee decided to reserve FCM for day hospitalizations and contraindications to ISC, especially allergy. ISC was available for prescription for all other situations. METHODS: The impact of a multifaceted intervention promoting a switch from FCM to ISC was evaluated using an interrupted time series model with segmented regression analysis. The standardized rate of the dispensing of FCM, ISC, and oral iron by the hospital pharmacy, as well as the rate of the dispensing of packed red blood cells and the number of biological iron status measurements, was analyzed before and after the intervention. RESULTS: There was an immediate decrease in FCM consumption following the intervention, with a reduction of 88% (RR: 0.12 [CI95% 0.10 to 0.15]). Conversely, there was a large increase in ISC use (RR: 5.1 [CI95% 4.4 to 5.9]). We did not observe a prescription shift to packed red blood cells or oral iron after the intervention. The time series analysis showed the frequency of iron status testing to remain stable before and after. The direct savings for intravenous iron for 8 months were 187,417.54 €. CONCLUSION: Our intervention to lower the impact of intravenous iron therapy on the hospital budget was effective.

An International Review of Health Technology Assessment Approaches to Prescription Drugs and Their Ethical Principles.

In many countries, health technology assessment (HTA) organizations determine the economic value of new drugs and make recommendations regarding appropriate pricing and coverage in national health systems. In the US, recent policy proposals aimed at reducing drug costs would link drug prices to six countries: Australia, Canada, France, Germany, Japan, and the UK. We reviewed these countries' methods of HTA and guidance on price and coverage recommendations, analyzing methods and guidance documents for differences in (1) the methodologies HTA organizations use to conduct their evaluations and (2) considerations they use when making recommendations. We found important differences in the methods, interpretations of HTA findings, and condition-specific carve-outs that HTA organizations use to conduct evaluations and make recommendations. These variations have ethical implications because they influence the recommendations of HTA organizations, which affect access to the drug through national insurance and price negotiations with manufacturers. The differences in HTA approaches result from the distinct political, social, and cultural contexts of each organization and its value judgments. New cost-containment policies in the US should consider the ethical implications of the HTA reviews that they are considering relying on to negotiate drug prices and what values should be included in US pricing policy.

Closing the cycle of innovation in healthcare in Europe.

Pragmatic or practice-oriented comparative effectiveness trials may be conducted to fill the evidence gaps that are revealed after the private sector has performed the trials needed for bringing their product to the market. A tool of increasing importance to identify such evidence gaps is resulting from health technology assessments (HTA) whereby the data derived from clinical research are examined in a systematic manner with reference to effect, safety, as well as additional parameters. Practice-oriented trials are informative for healthcare decision makers, practice-changing and may even be cost-saving for the healthcare payers. There are however only a limited number of funding sources for such trials. Public and private healthcare payers should stimulate the conduct of practice-oriented trials in their effort to maximize patient benefit within the limitation of the available resources. Pragmatic randomized trials can be performed at low cost when based on existing coded electronic health records and as well health registries. Public health decision makers are increasingly taking advantage of results from health technology assessments to support priority setting. In accordance with this it would appear reasonable that decision makers should get more involved in priority setting and funding also in the field of clinical research in order to provide further evidence needed for assessments, reassessments, and subsequent qualified decisions and resource allocations in health care. A closer dialogue and collaboration between the clinical research and HTA communities would facilitate a more efficient utilization of such opportunities.

Cost-effectiveness analyses using real-world data: an overview of the literature.

Objectives: Real-world evidence (RWE) may provide good estimates of absolute event probabilities and costs in patients in actual clinical practice, but their use in decision-analytic models poses many challenges. A literature review based on a systematic search was conducted to summarize the limitations of using RWE in decision-analytic modeling reported in the literature, but also to identify existing recommendations about real-world modeling. Methods: A literature search was performed on Medline and Embase databases, as well as relevant websites. No restrictions in language or geographical scope were imposed. Results: A total of 14 references were included. RWE is recognized as a valuable source of data for market access and reimbursement, and as a complement to clinical trial evidence for treatment pathways, resource use, long-term natural history, and effectiveness. The main limitations identified in the literature were: confounding bias, missing data, lack of accurate data related to drug exposure and outcomes, errors during the record-keeping process, protection of private data, and insufficient numbers of patients. Although most submission guidelines recognized the potential biases associated with RWE, guidance on the appropriate methods to deal with these biases, and approaches to review different relevant evidence to inform model development, were scarce. Several initiatives have attempted to provide guidance on the use of RWE in decision-modeling. Conclusions: RWE is likely to be particularly valuable for informing healthcare policy-makers when formulating appropriate treatment pathways, encouraging the optimal allocation of scarce resources, and improving aggregate patient outcomes. However, little guidance is available on the relative merits of using efficacy and/or effectiveness evidence in Health Technology Appraisal submissions. Further research is needed to better understand these methods and their potential applications in a broader range of scenarios and simulation studies, and their impact on economic modeling.

HTA and decision-making processes in Central, Eastern and South Eastern Europe: Results from a survey.

OBJECTIVE: To gain knowledge and insights on health technology assessment (HTA) and decision-making processes in Central, Eastern and South Eastern Europe (CESEE) countries. METHODS: A cross-sectional study was performed. Based on the literature, a questionnaire was developed in a multi-stage process. The questionnaire was arranged according to 5 broad domains: (i) introduction/country settings; (ii) use of HTA in the country; (iii) decision-making process; (iv) implementation of decisions; and (v) HTA and decision-making: future challenges. Potential survey respondents were identified through literature review-with a total of 118 contacts from the 24 CESEE countries. From March to July 2014, the survey was administered via e-mail. RESULTS: A total of 22 questionnaires were received generating an 18.6% response rate, including 4 responses indicating that their institutions had no involvement in HTA. Most of the CESEE countries have entities under government mandates with advisory functions and different responsibilities for decision-making, but mainly in charge of the reimbursement and pricing of medicines. Other areas where discrepancies across countries were found include criteria for selecting technologies to be assessed, stakeholder involvement, evidence requirements, use of economic evaluation, and timeliness of HTA. CONCLUSIONS: A number of CESEE countries have created formal decision-making processes for which HTA is used. However, there is a high level of heterogeneity related to the degree of development of HTA structures, and the methods and processes followed. Further studies focusing on the countries from which information is scarcer and on the HTA of health technologies other than medicines are warranted. CLASSIFICATION: Reviews/comparative analyses.

Marcos GRADE de la evidencia a la decisión (EtD): un enfoque sistemático y transparente para tomar decisiones sanitarias bien informadas. 2: Guías de práctica clínica / GRADE Evidence to Decision (EtD) frameworks: a systematic and transparent approach to making well informed healthcare choices. 2: Clinical practice guidelines

Los médicos no disponen del tiempo ni de los recursos para considerar la evidencia subyacente en las innumerables decisiones que tienen que tomar diariamente. En consecuencia, dependen de las recomendaciones de las guías de práctica clínica. Los paneles de las guías deben considerar todos los criterios relevantes que influyen en una decisión o recomendación de manera estructurada, explícita y transparente, y proporcionar a los médicos recomendaciones factibles. En este artículo describiremos los marcos de la evidencia a la decisión (EtD) para las recomendaciones de práctica clínica. La estructura general de un marco EtD para recomendaciones clínicas es similar a la de los marcos EtD para otras recomendaciones y decisiones, e incluye la formulación de la pregunta, la evaluación de los distintos criterios y las conclusiones. Las recomendaciones clínicas requieren que los criterios se consideren de forma diferente, dependiendo de si se adopta una perspectiva individual o poblacional. Por ejemplo, desde la perspectiva individual, los gastos personales son un aspecto importante a considerar, mientras que desde la perspectiva poblacional son más importantes el uso de recursos (no solo los gastos personales) y el coste-efectividad. Son también importantes desde la perspectiva poblacional la equidad, la aceptabilidad y la factibilidad, mientras que la importancia de estos criterios suele ser limitada en el caso de la perspectiva individual. Los subgrupos específicos para los cuales pueden necesitarse recomendaciones deben estar claramente identificados y considerados con relación a cada criterio, porque los juicios pueden variar entre subgrupos. El siguiente artículo es una traducción del artículo original publicado en British Medical Journal. Los marcos EtD se utilizan actualmente en el Programa de Guías de Práctica Clínica en el Sistema Nacional de Salud, coordinado por GuíaSalud (AU)

Clinicians do not have the time or resources to consider the underlying evidence for the myriad decisions they must make each day and, as a consequence, rely on recommendations from clinical practice guidelines. Guideline panels should consider all the relevant factors (criteria) that influence a decision or recommendation in a structured, explicit, and transparent way and provide clinicians with clear and actionable recommendations. In this article, we will describe the Evidence to Decision (EtD) frameworks for clinical practice recommendations. The general structure of the EtD framework for clinical recommendations is similar to EtD frameworks for other types of recommendations and decisions, and includes formulation of the question, an assessment of the different criteria, and conclusions. Clinical recommendations require considering criteria differently, depending on whether an individual patient or a population perspective is taken. For example, from an individual patient's perspective, out-of-pocket costs are an important consideration, whereas, from a population perspective, resource use (not only out-of-pocket costs) and cost effectiveness are important. From a population perspective, equity, acceptability, and feasibility are also important considerations, whereas the importance of these criteria is often limited from an individual patient perspective. Specific subgroups for which different recommendations may be required should be clearly identified and considered in relation to each criterion because judgments might vary across subgroups. This article is a translation of the original article published in the British Medical Journal. The EtD frameworks are currently used in the Clinical Practice Guideline Programme of the Spanish National Health System, co-ordinated by GuíaSalud (AU)

Integrating Scenario Planning and Cost-Benefit Methods.

By their nature, the most vexing social problems reflect collisions between social and economic interests of parties with highly divergent views and perspectives on the cause and character of what is at issue and the consequences that flow from it. Conflicts around biotechnology applications are good examples of these problems. When considering the potential consequences of proposed biotechnology applications, an enormous range of perspectives arise reflecting the breadth of different and often competing interests with a stake in life's future. This essay starts from an assumption that the traditional tool of cost-benefit analysis is not adequate for adjudicating competing claims around the introduction of new biotechnology applications. It tends to require implicit simplifying assumptions that reduce or mask true underlying levels of complexity and uncertainty, and the results it produces deliver a definitive and singular answer, as opposed to a multiplicity of outcomes. In this essay, I describe some of the key elements of formal scenario planning to show how CBA could be redeployed as a supporting tool within the broader decision support methodology of formal scenario planning.

An Evaluation of Clinical Economics and Cases of Cost-effectiveness.

In order to maintain and develop a universal health insurance system, it is crucial to utilize limited medical resources effectively. In this context, considerations are underway to introduce health technology assessments (HTAs), such as cost-effectiveness analyses (CEAs), into the medical treatment fee system. CEAs, which is the general term for these methods, are classified into four categories, such as cost-effectiveness analyses based on performance indicators, and in the comparison of health technologies, the incremental cost-effectiveness ratio (ICER) is also applied. When I comprehensively consider several Japanese studies based on these concepts, I find that, in the results of the analysis of the economic performance of healthcare systems, Japan shows the most promising trend in the world. In addition, there is research indicating the superior cost-effectiveness of Rituximab against refractory nephrotic syndrome, and it is expected that health economics will be actively applied to the valuation of technical innovations such as drug discovery.

Association Between Medicare's Mandatory Hospital Value-Based Purchasing Program and Cost Inefficiency.

BACKGROUND: The Patient Protection and Affordable Care Act instituted pay-for-performance programs, including Hospital Value-Based Purchasing (HVBP), designed to encourage hospital quality and efficiency. OBJECTIVE AND METHOD: While these programs have been evaluated with respect to their implications for care quality and financial viability, this is the first study to assess the relationship between hospitals' cost inefficiency and their participation in the programs. We estimate a translog specification of a stochastic cost frontier with controls for participation in the HVBP program and clinical and outcome quality for California hospitals for 2012-2015. RESULTS: The program-participation indicators' parameters imply that participants were more cost inefficient than their peers. Further, the estimated coefficients for summary process of care quality indexes for three health conditions (acute myocardial infarction, pneumonia, and heart failure) suggest that higher quality scores are associated with increased operating costs. CONCLUSION: The estimated coefficients for the outcome quality variables suggest that future determination of HVBP payment adjustments, which will depend solely on mortality rates as measures of clinical care quality, may not only be aligned with increasing healthcare quality but also reducing healthcare costs.

Advancing the role of the pharmacy technician: A systematic review.

OBJECTIVES: To summarize the findings of a literature search on advancing the role of pharmacy technicians, including the types of training identified and the potential costs and benefits to both the technician and the pharmacy. DATA SOURCES: A literature search of Scopus, Embase, and Medline was conducted on January 11, 2017. STUDY SELECTION: Original research, research reports, case studies, or association reports were included for review. Articles were considered to be relevant based on identification of an advanced pharmacy technician role or addressing additional training/education for technician functions. DATA EXTRACTION: A standard data extraction form was used to collect study authors, article title, year published, journal title, study design, brief description of methods, primary outcome measures, advanced technician roles identified, additional education or training addressed, and additional costs and benefits identified in each article. RESULTS: A total of 33 articles were included for full review and data extraction. Study design varied, with 17 (52%) quantitative, 1 (3%) qualitative, 5 (15%) mixed-method, and 10 (30%) case study designs. Seventeen (52%) of the studies included were published after 2006. The mechanism of training was primarily through supervised on-the-job training, allowing technicians to assume administrative-based positions that facilitated a pharmacist-led clinical service, with either the pharmacist or the pharmacy receiving the greatest benefits. CONCLUSION: Although the literature supports technicians performing advanced roles in the pharmacy, resulting in either improved patient outcomes or opportunities for pharmacists to engage in additional clinical services, the benefits to the technician were primarily indirect, such as an increase in job satisfaction or a more desirable work schedule. If a technician is to take on additional roles that require completion of a formalized training or educational program, benefits that are more tangible may help to inspire technicians to pursue these roles.

Private Health Insurance Incentives in Australia: In Search of Cost-Effective Adjustments.

BACKGROUND: The appropriate structure, scope and cost of government incentives in the private health insurance (PHI) market is a matter of ongoing debate. OBJECTIVE: In order to inform policy decisions we designed a two-stage study to (1) model the uptake of PHI covering hospital treatment in Australia, and (2) identify the costs of various policy scenarios to the government. METHODS: Using a microsimulation with a cost-benefit component, we modelled the insurance decisions made by individuals who collectively represented the Australian insurance population in the financial year 2014-15. RESULTS: We found that the mean willingness to pay (WTP) for PHI ranged from A$446 to A$1237 per year depending on age and income. Our policy scenarios showed a considerable range of impacts on the government budget (from A$4 billion savings to A$6 billion expense) and PHI uptake (from 3.4 million fewer to 2.5 million more individuals insured), with cost-effectiveness ranging from -A$305 to A$22,624 per additional person insured, relative to the status quo. CONCLUSIONS: Based on the scenario results we recommend policy adjustments that either increase the PHI uptake at a small per-person cost to the public budget or substantially reduce government subsidisation of PHI at a relatively small loss in terms of persons insured.

A systematic review of economic evaluations of interventions to tackle tuberculosis in homeless people / Evaluación económica de intervenciones para abordar la tuberculosis en las personas sin hogar: revisión sistemática / Revisão sistemática de análises econômicas de intervenções para combater a tuberculose em pessoas sem-teto

ABSTRACT Objective To analyze economic evaluations of interventions related to tuberculosis (TB) diagnostics/screening, treatment, and prevention in homeless people. Methods A systematic review was conducted. The eligibility criteria were original studies reporting economic evaluation results. The search was not restricted by language or year. A critical appraisal approach was used. Results A total of 142 studies were identified, including five research articles (three full economic evaluations and two partial) that were selected for the final review. Most of the studies were conducted in the United States, adopted a public health perspective, and analyzed active TB. Interventions related to diagnostics/screening (the use of interferon-gamma release assay (IGRA) and mobile screening units), treatment (incentives for continuing treatment, and housing programs), and prevention (with the Bacillus Calmette-Guérin (BCG) vaccine) were identified. Conclusions No high-quality data were found on cost-effectiveness of interventions on TB diagnostics/screening, treatment, or prevention in homeless people. However, active searching for cases via mobile screening, and financial incentives, could help increase treatment adherence, and the use of IGRA helps boost detection. TB in homeless people is neglected worldwide, especially in developing countries, where this disease tends to afflict more people made vulnerable by their precarious living conditions. Public funding mechanisms should be created to develop cross-sectoral actions targeting homeless people, as the complex dynamics of this group tend to hamper prevention and diagnosis of TB and the completion of TB treatment.

RESUMEN Objetivo Analizar la evaluación económica de intervenciones relacionadas con el diagnóstico y tamizaje, el tratamiento y la prevención de la tuberculosis en las personas sin hogar. Métodos Se realizó una revisión sistemática en la cual se usó como criterio de selección estudios originales en los que se presentaran los resultados de una evaluación económica. No se restringió la búsqueda por idioma ni por año. Se usó el enfoque de la evaluación crítica. Resultados Se encontraron en total 142 estudios, entre los cuales había cinco artículos de investigación (tres evaluaciones económicas completas y dos parciales) que se seleccionaron para la revisión final. En la mayoría de los estudios, realizados en los Estados Unidos, se adoptó una perspectiva de salud pública y se analizó la tuberculosis activa. Se encontraron intervenciones relacionadas con el diagnóstico y tamizaje (el uso de la prueba de liberación de interferón gamma —IGRA, por su sigla en inglés— y los equipos móviles de tamizaje), el tratamiento (incentivos para continuar el tratamiento y programas de viviendas) y la prevención (el uso de la vacuna BCG). Conclusiones No se encontraron datos de calidad alta sobre la costo-efectividad de las intervenciones relacionadas con el diagnóstico o tamizaje, el tratamiento o la prevención de la tuberculosis en personas sin hogar. Sin embargo, la búsqueda activa de casos mediante el uso de equipos móviles para el tamizaje, así como los incentivos financieros, podrían ayudar a aumentar la adhesión al tratamiento; además, el uso de la prueba IGRA ayuda a lograr una mayor detección. La tuberculosis en las personas sin hogar se subestima en todo el mundo, especialmente en los países en desarrollo donde esta enfermedad tiende a afectar a más personas que pasan a ser vulnerables por la precariedad de sus condiciones de vida. Deben crearse mecanismos de financiamiento con fondos públicos para llevar adelante medidas intersectoriales dirigidas a las personas sin hogar, puesto que la compleja dinámica de este grupo tiende a obstaculizar tanto la prevención y el diagnóstico de la tuberculosis como la finalización del tratamiento antituberculoso.

RESUMO Objetivo Examinar as análises econômicas de intervenções relacionadas à prevenção, detecção precoce/diagnóstico e tratamento da tuberculose (TB) em pessoas sem-teto. Métodos Foi realizada uma revisão sistemática. Os critérios para inclusão foram estudo original contendo resultados de análise econômica. A busca não foi restrita por idioma ou ano. Foi usada uma abordagem de análise crítica. Resultados Foram identificados ao todo 142 estudos, dentre eles cinco artigos de pesquisa (três análises econômicas completas e duas parciais) que foram selecionados para a revisão final. A maioria dos estudos foi realizada nos Estados Unidos, partindo de uma perspectiva de saúde pública e com análise de TB ativa. Foram identificadas intervenções relacionadas à detecção precoce/diagnóstico (ensaio de liberação de interferon-gama [IGRA] e unidades móveis para prevenção), tratamento (incentivos para o tratamento continuado e programas de moradia) e prevenção (vacinação com o bacilo de Calmette-Guérin [BCG]). Conclusões Não foram encontrados dados de alta qualidade sobre o custo-efetividade das intervenções de detecção precoce/diagnóstico, tratamento ou prevenção de TB em pessoas sem-teto. Porém, a busca ativa de casos por meio da triagem em unidades móveis e incentivos financeiros poderiam ajudar a melhorar a adesão ao tratamento e o uso do IGRA intensifica a detecção de infecção. A TB em pessoas sem-teto é uma doença negligenciada em todo o mundo, principalmente nos países em desenvolvimento onde ela costuma afligir um número maior de pessoas por sua vulnerabilidade devido às condições de vida precárias. Mecanismos públicos de financiamento devem ser criados para desenvolver ações intersetoriais voltadas aos sem-teto, porque a dinâmica complexa deste grupo dificulta a prevenção, o diagnóstico e a conclusão do tratamento de TB.

Education-earnings linkage for assessing societal benefits of interventions for children and youth in Sweden / Vínculo educación-ingresos para evaluar los beneficios sociales de las intervenciones para niños y jóvenes en Suecia

Some long-term societal benefits of early psychosocial interventions supporting children and youth at various developmental risks can be estimated with school results as a mediatory. In this paper we develop causal education-earnings links for educational achievement thresholds at the end of the nine-year compulsory school (CS) and the three-year upper secondary school (USS) in Sweden. Gross earnings are calculated with age profiles estimated on micro-level register data for the whole population. We also estimate the indirect costs of education (forgone earnings) with this data and find that they can be ignored. For the base case, we calculate the expected net present value of meeting minimum requirements for transition from CS to a national USS-program to euros112,000 (SEK 1.1 million) and for graduation from such a program to euros163,000 (SEK 1.6 million)

Pueden calcularse algunos de los beneficios sociales a largo plazo de las intervenciones psicosociales precoces que respaldan a los niños y jóvenes con ciertos riesgos evolutivos utilizando los resultados escolares como hilo mediador. En este documento desarrollamos vínculos causales educación-ingresos para los umbrales del logro educativo al finalizar la escuela obligatoria (EO) de nueve años de duración y la escuela secundaria superior (ESS) en Suecia. Se calculan los ingresos brutos con los perfiles de edad estimados en un registro de datos a micronivel para la totalidad de la población. También calculamos los costes educativos indirectos (ingresos no percibidos) con estos datos, y encontramos que pueden ser ignorados. Para el caso básico, calculamos el valor actual neto previsto del logro de los requisitos mínimos para la transición de la EO al programa nacional de ESS de 112,000euros (1.1 millones de coronas suecas) y para la graduación en dicho programa de 163,000euros (1.6 millones de coronas suecas)

Strengthening expertise for health technology assessment and priority-setting in Africa.

BACKGROUND: Achieving sustainable universal health coverage depends partly on fair priority-setting processes that ensure countries spend scarce resources wisely. While general health economics capacity-strengthening initiatives exist in Africa, less attention has been paid to developing the capacity of individuals, institutions and networks to apply economic evaluation in support of health technology assessment and effective priority-setting. OBJECTIVE: On the basis of international  lessons, to identify how research organisations and partnerships could contribute to capacity strengthening for health technology assessment and priority-setting in Africa. METHODS: A rapid scan was conducted of international formal and grey literature and lessons extracted from the deliberations of two international and regional workshops relating to capacity-building for health technology assessment. 'Capacity' was defined in broad terms, including a conducive political environment, strong public institutional capacity to drive priority-setting, effective networking between experts, strong research organisations and skilled researchers. RESULTS: Effective priority-setting requires more than high quality economic research. Researchers have to engage with an array of stakeholders, network closely other research organisations, build partnerships with different levels of government and train the future generation of researchers and policy-makers. In low- and middle-income countries where there are seldom government units or agencies dedicated to health technology assessment, they also have to support the development of an effective priority-setting process that is sensitive to societal and government needs and priorities. CONCLUSIONS: Research organisations have an important role to play in contributing to the development of health technology assessment and priority-setting capacity. In Africa, where there are resource and capacity challenges, effective partnerships between local and international researchers, and with key government stakeholders, can leverage existing skills and knowledge to generate a critical mass of individuals and institutions. These would help to meet the priority-setting needs of African countries and contribute to sustainable universal health coverage.

Large funding inflows, limited local capacity and emerging disease control priorities: a situational assessment of tuberculosis control in Myanmar.

There are numerous challenges in planning and implementing effective disease control programmes in Myanmar, which is undergoing internal political and economic transformations whilst experiencing massive inflows of external funding. The objective of our study-involving key informant discussions, participant observations and linked literature reviews-was to analyse how tuberculosis (TB) control strategies in Myanmar are influenced by the broader political, economic, epidemiological and health systems context using the Systemic Rapid Assessment conceptual and analytical framework. Our findings indicate that the substantial influx of donor funding, in the order of one billion dollars over a 5-year period, may be too rapid for the country's infrastructure to effectively utilize. TB control strategies thus far have tended to favour medical or technological approaches rather than infrastructure development, and appear to be driven more by perceived urgency to 'do something' rather informed by evidence of cost-effectiveness and sustainable long-term impact. Progress has been made towards ambitious targets for scaling up treatment of drug-resistant TB, although there are concerns about ensuring quality of care. We also find substantial disparities in health and funding allocation between regions and ethnic groups, which are related to the political context and health system infrastructure. Our situational assessment of emerging TB control strategies in this transitioning health system indicates that large investments by international donors may be pushing Myanmar to scale up TB and drug-resistant TB services too quickly, without due consideration given to the health system (service delivery infrastructure, human resource capacity, quality of care, equity) and epidemiological (evidence of effectiveness of interventions, prevention of new cases) context.

Using Lean Process Improvement to Enhance Safety and Value in Orthopaedic Surgery: The Case of Spine Surgery.

Lean methodology was developed in the manufacturing industry to increase output and decrease costs. These labor organization methods have become the mainstay of major manufacturing companies worldwide. Lean methods involve continuous process improvement through the systematic elimination of waste, prevention of mistakes, and empowerment of workers to make changes. Because of the profit and productivity gains made in the manufacturing arena using lean methods, several healthcare organizations have adopted lean methodologies for patient care. Lean methods have now been implemented in many areas of health care. In orthopaedic surgery, lean methods have been applied to reduce complication rates and create a culture of continuous improvement. A step-by-step guide based on our experience can help surgeons use lean methods in practice. Surgeons and hospital centers well versed in lean methodology will be poised to reduce complications, improve patient outcomes, and optimize cost/benefit ratios for patient care.