Since the creation of the National Committee for Health Technology Incorporation in the Brazilian Health System (CONITEC), a new phase started in the public Brazilian Health System (SUS): a continuous updating of the system based on Health Technology Assessment (HTA). CONITEC was created by federal law in 2012 and is responsible for advising the Ministry of Health regarding the incorporation or disinvestment of health technologies. The whole process involves a strong interaction with society, including the composition of the committee, which has the participation of the National Health Council. The objective of this study was to describe the results of CONITEC in five years of operation.

This is a retrospective descriptive study, based on information from the database (period 2012–2016) and CONITEC's website.

Since 2012, CONITEC assessed 541 technologies, including drugs (360), health products (71) and procedures (110); 303 assessment requests came from SUS agencies and institutions and the other 238 requests from pharmaceutical companies, medical societies, patient associations and the judiciary bodies. In this period, there were 190 public consultations, during which more than 24,000 feedback from society were received. The average time for evaluation was 146 days. The committee recommended the incorporation of 186 technologies into SUS, the disinvestment of 43 and was unfavorable to the incorporation of 88, generating a budgetary impact of approximately BRL2.5 billion (USD764 million).

From 2012–2016, CONITEC tripled the average annual incorporation of new technologies compared to the period 2006–2011. In this process, it was necessary to assess efficacy, safety and cost-effectiveness of technologies, generating positive results for the expansion of access, health gains for patients and sustainability for the system. It should be considered that the use of evidence for decision making strengthens transparency in public management and the development of active processes of information, communication and social participation.

In Turkey, there is a scarcity of knowledge about the predictors of health outcomes at a national level, and it is well known that there is a gap between rural and urban parts of developing countries in terms of the level of health outcomes. This study aims to find out predictor factors of the public health outcomes at a province level in Turkey.

Life expectancy at birth and mortality are used as public health outcome indicators. Logistic regression and Random Forest classification generated by using 50, 100, and 150 trees were used to compare prediction performance of health outcomes. The results of different prediction methods were recorded changing the “k” parameter from 3 to 20 in k-fold cross validation. The Area Under the ROC Curve (AUC) was used as a measure of prediction accuracy. Prediction performance differences were tested using Kruskall-Wallis analysis and visualized on a heatmap. Finally, predictor variables of public health outcomes were shown on a decision tree.

Study results revealed that Logistic regression outperformed Random Forest classification. The difference between all prediction methods to predict public health outcome indicators was statistically significant (p<.000). The heatmap shows that AUC values to predict mortality have superior performance when compared with life expectancy at birth. Decision tree graphs present that the most important predictor variables were total number of beds for mortality and percentage of higher education graduates for life expectancy at birth.

The results of this study represent a preliminary attempt to determine public health outcome indicators. It is hoped that the results of this study serve as a basis to understand the determinants of health care outcomes at province level with focus on a developing country. This study illustrates that there is a need to spend extra effort for future studies to analyze public health outcomes to improve social welfare functions in health systems.

The early benefit assessment of drugs in Germany and their preceded market authorization pursue different objectives, resulting in divergent decision-making strategies. This is reflected inter alia by the diverse inclusion of confirmatory endpoints within the assessments of oncological drugs. The pharmaceutical manufacturers are facing the challenge of meeting the requirements for both evaluation processes by the available evidence and avoiding hereby negative early benefit assessments. This is mainly due to the concept of mutually relevant clinical trials.

Identification and gathering of the endpoints is based on a specifically developed guide. The extracted data from the documents of completed assessments up to July 2015 are used to estimate both separately and together the impact of explorative in relation to confirmatory endpoints on the drug approval and early benefit assessment, by contrasting the European Medicines Agency's risk-benefit-ratio and the benefit-harm-balancing of the national Health Technology Assessment (HTA) jurisdiction.

Twenty-one of fourty-one studies’ oncological assessments could be included in the endpoint analysis. From a procedural point of view both the drug approval and the early benefit assessment seem to be not confirmatory since they include explorative endpoints as well. Yet, drug approval is in terms of quality of endpoints more confirmatory than early benefit assessment since it contains a higher proportion of primary endpoints. The latter implies only in 67 percent of the assessments a primary endpoint to be relevant for the benefit-harm-balancing. Moreover, explorative mortality endpoints reached the highest agreement and explorative endpoints capturing health-related quality of life no agreement, referring to the mutual relevance of endpoints for the risk-benefit-ratio and the benefit-harm-balancing.

The missing information transparency of the assessment reports compared to the information offered within the early benefit assessment makes an assignment of endpoints with respect to the mutually relevant clinical trial sometimes troublesome. To warrant, in the long run, a broader confirmatory basis for decisions in health care supported by HTA, a closer inter-institutional cooperation of approval authorities and German HTA jurisdictions seems favorable.

In the last decade an increasing number of high-priced, new cancer treatments received marketing authorization in Europe. What is actually known about the clinical benefit of those therapies at the time of approval needs to be elucidated in order to inform decisions about the use and reimbursement of these novel treatment options. Thus, the aim of the current analysis was to systematically investigate oncological therapies approved between January 2009 and April 2016. We extracted, as well as quantified the level of knowledge of the clinical benefit at the time of marketing authorization.

To assess the benefit of new interventions as well as expanded indications, we extracted the median gain of the two study endpoints: progression-free survival (PFS) and overall survival (OS). Information is based on approval documents provided by the European Medicines Agency (EMA) and assessments from the Austrian Horizon Scanning programme (HSO). We included all cancer therapies approved in Europe between 1 January 2009 and 15 April 2016.

Cancer drugs for 134 new indications approved since 2009 were identified. In the case of thirty-seven indications (27 percent), no data was available for PFS or for OS. A positive difference in median overall survival was reached by seventy-six licensed indications (55.5 percent); twenty-two (16 percent) of them showed a difference of more than three months. Regarding the study endpoint progression-free survival, an improvement was shown in ninety indications (65.2 percent).

Scarce knowledge regarding the clinical benefit of anti-cancer therapies is available at the time of approval. In addition, the survival benefit of the approved indications is less than three months in the majority of approved therapies.

Under the Orphan Regulation, the European Medicines Agency (EMA) intended to incentivize the research and development of new treatments for rare and life-threatening conditions. Marketing authorisation of orphan medicinal products (OMPs) by the EMA is only the first step, as medicines are made available to patients when reimbursement or Health Technology Assessment (HTA) decisions are implemented by national health systems. We analyzed the availability and access to OMPs in the United Kingdom (UK), France, Germany, Italy and Spain. We compared the availability, which is the possibility to prescribe a given OMP, to the access, which refers to the full or partial reimbursement by the public health service.

We collected data on launches, HTA decisions, any centralized commissioning and/or reimbursement decision for all the OMPs authorised since 2000 in the UK countries (England, Scotland and Wales), France, Germany, Italy and Spain.

Since the Orphan Regulation inception, the EMA granted marketing authorization to 143 OMPs. These OMPs are most widely accessible in Germany and France. Reimbursement in Germany is immediate after authorization. France and Italy present a delay of 19 months from authorization to reimbursement, which is shorter than in other countries. In England, less than 50 percent of centrally authorised OMPs are routinely funded by the National Health Service (NHS), including one-third of these recommended by the National Institute for Health and Care Excellence (NICE), and those reimbursed via commissioning policies and the Cancer Drugs Fund.

The assessment of degree of access to OMPs across Europe is limited by differences in the national HTA and reimbursement systems and the heterogeneous information made publicly available on their decisions. Nonetheless, our study suggests that the primary purpose to grant equal availability to OMPs to the patients in the Eropean Union via the implementation of the orphan regulation was partially achieved with important variations of access observed across the countries included in our study.

Multiple-sclerosis (MS) is a highly disabling chronic disorder affecting young adults with long term economic consequences on society that escalate as MS disability increases (1,2). In the long-term, progression of MS results in increased level of disability and most patients will eventually experience some degree of functional impairment of the nervous system that impacts on mobility as well as sensory and coordination issues, bladder and sexual functioning, and mood and cognitionon (2). This is usually accompanied by a deterioration of their quality of life. Patient relevant outcome measures (PROMS) are largely used to measure individual disability, and quality of life in MS (2). International evidence from the International Multiple Sclerosis Study (IMPrESS) (2) was used to quantify the relationship between healthcare resources utilisation and disability, quality of life in individuals with MS.

Multivariable logistic regression was performed in order to identify patient-related variables reporting disability (Barthel) and utility (EQ-5D) that predict use of healthcare services (visits to GP, specialists, nurses, hospitalisation and treatment) and work limitation within the participants of the IMPrESS.

Reponses were collected from 1,152 individuals across 21 countries of which 74.3 percent (856) were useful for analysis. Preliminary findings indicated that for the pooled data sets both EQ-5D and Barthel scores were predictors of healthcare resource use, across different categories (p<.05), except for nurse visits (Barthel only; p<.09). Overall the association between PROM data and use of healthcare resources appeared to be stronger with EQ-5D compared to Barthel. EQ-5D appeared to also predict the impact of MS on loss of productivity (in terms of work limitation; p<.05).

PROMs can be used to predict the economic consequences of MS on healthcare providers and society, but more research is needed to confirm the robustness of the evidence and its validity across individual healthcare system settings.

Ultrasound (US) detects synovitis more accurately than clinical examination (CE) in people with rheumatoid arthritis (RA). This review aimed to investigate the use of US, compared to CE alone, in treatment strategies for RA, and to estimate its potential to be cost-effective in making treatment decisions.

A systematic review was conducted of studies: investigating RA treatment response or strategies that compared US with CE-assessed synovitis; and of tapering RA treatment (1). A model was constructed to investigate the potential cost-effectiveness of US in (i) selecting patients suitable for treatment tapering; and (ii) avoiding treatment escalation (2).

Seven prospective cohort studies suggested US-detected synovitis was significantly associated with a treatment response or tapering failure, whereas in most cases clinical examination alone was not. Two randomized controlled trials (RCTs) identified suggested that US added to the Disease Activity Index (DAS)-based treatment strategies but did not significantly improve primary outcomes, but was associated with improved rate of DAS remission. The evidence showed that some patients (proportions varied widely) who had achieved low disease activity could have treatment tapered, with no, or little, short-term harm to the patient.

The model estimated that an average reduction of 2.5 percent in the costs of biological disease-modifying anti-rheumatic drug (bDMARDs) was sufficient to cover the costs of performing US every three months. This value increased to 4 percent and 13 percent for the costs of conventional disease-modifying anti-rheumatic drug (cDMARDs) depending on the assumed regimen.

Use of US to monitor synovitis could potentially be a cost-effective approach, given that low proportions of patients for whom clinicians consider amending treatment, would need to taper treatment, or remain on therapy without escalation. US could provide clinicians with more confidence in reducing the drug burden. However, there is considerable uncertainty in this conclusion due to lack of robust data relating to key parameters.

Sudden cardiac arrest (SCA) is the most common cause of death in patients with coronary artery disease. Mostly, ventricular tachycardia (VT) and ventricular fibrillation (VF) are the underlying aetiology of SCA, which is claimed to be successfully treated by a novel therapy, a wearable cardioverter defibrillator (WCD, LifeVest®).

The assessment, performed within the European Network for HTA (EUnetHTA), aimed to provide valid data on clinical effectiveness and safety of the WCD. Furthermore, the project intended to elicit patients views on aspects regarding their cardiac disease and the WCD therapy as well as to identify neglected outcomes.

A synthesis of evidence on the basis of a systematic literature search in Medline via Ovid, Embase, the Cochrane Library, and the Centre for Reviews and Dissemination (CRD) databases was performed. The search was complemented by citation tracking and handsearch.

A face-to-face semi-structured focus group interview was performed with five cardiac disease patients in the scoping phase.

Since no prospective controlled trials were found, no assessment of effectiveness could be performed. With regard to safety, five prospective studies were included, but the quality of the body of evidence was very low. Adverse events (AEs) reported were skin rash/itching (6 percent), false alarms (14 percent), palpitations/lightheadedness/fainting (9 percent) and discontinuation due to comfort/lifestyle issues (16-22 percent). Serious adverse events (SAEs) were inappropriate shocks (0-2 percent) and unsuccessful shocks (0-.7 percent). Frequency of SAEs leading to death was 0-.3 percent.

Patients of the focus group reported that experiencing a sense of security was crucial to them. The WCD therapy was not considered an option for weeks or months, due to expected restrictions in living a ‘normal’ and secure life.

No statement can be made about the device effectiveness – further research is needed. More data and more adequate reporting of AEs and SAEs are needed in order to establish the device safety. In particular, more data is needed for risk stratification of high risk patients in order to further narrow down the wide range of indications for the WCD use.

Between December 2013 and April 2016, an unprecedented epidemic of Ebola Virus Disease (EVD) took place. This epidemic urged countries all over the world to be prepared for the possibility of having an EVD patient (1). Besides morbidity and mortality of the disease, containment efforts also have economic consequences for society. In this study, costs of preparedness for and response to EVD made by the Dutch health system were estimated.

We used an activity-based costing method in which cost of personnel time targeted at preparedness, and response activities was based on a time recording system and interviews with key professionals of the organizations involved. In addition, patient days of hospitalizations, laboratory tests, personal protective equipment (PPE), as well as costs for additional cleaning and disinfection were acquired via the organizations. All costs are expressed at the 2015-euro price level.

The estimated total costs of EVD preparedness and response in the Netherlands were averaged at EUR14.1 million, ranging from EUR7.6 to EUR24.9 million. There were thirteen possible cases clinically evaluated and one confirmed case, admitted through an international evacuation request, corresponding to approximately EUR1 million per case (2). Preparedness activities of personnel, especially of all ambulance care services and hospitals that could possibly receive a case, and expenditures on PPE, were the main cost drivers.

The estimated total cost of EVD preparedness and response in the Netherlands was substantial. Costs made by healthcare organizations were higher than among public health organizations (3). Designating one ambulance care service and fewer hospitals for the assessment of possible patients with viral hemorrhagic fever or other highly infectious disease of high consequence might improve efficiency and reduce future costs. The experiences and collaboration of healthcare organizations that managed patients with possible EVD can serve as a valuable resource for future outbreaks of other highly infectious diseases.

Health Technology Assessment (HTA) in the hospital framework involves evaluating safety and cost-effective benefits alongside additional perspectives. We must take into account: professional skills, patient mix, infrastructure costs, the competitive arena and promoting innovation as part of the hospital strategy. Within budgetary constraints, hospitals need to focus on clinical excellence, prioritizing selected technologies in key fields.

A survey was conducted among thirty-five mid-level managers; department directors and head nurses from eight medical centers. The data was collected from a structured questionnaire scoping five fields: clinical efficiency, risk, benefit, contribution of relevant “players” for decision making and impact of adoption.

Personal characteristics of the responders correlated with certain trends: managers with longer seniority ranked life-saving higher than younger managers, as did men in comparison to women. Participants from the peripheral regions ranked improvement in quality of life higher than respondents from the center of the country. The importance of functional improvement of the patient was graded higher by nurses, compared to the physicians.

In operative aspects, improving staff communication was considered significantly higher among experienced managers, women, staff members in the central region hospitals and among nurses in comparison to physicians. Women ranked improvement of medical standards and guidelines higher, irrespective of their professional sector. At initial stages of the technology lifespan, scientific evidence on effectiveness was found to have a stronger influence on adoption decisions than national guidelines.

Budgetary repercussions of adopting a new technology were ranked significantly higher in the central region. Experienced managers attributed greater impact to economic issues than younger managers.

Social dimensions, such as providing care for a large population, reaching the target population, improvement of service and patient preferences were graded significantly higher by women.

The survey highlights the insights of managers for decision making on adopting technologies in hospitals. These decisions need to integrate clinical advantages, competitive markets and national strategies with personal and professional parameters assists in bridging the gaps between local hospital activities and governance.

Innovative therapies with high cost are increasing in every therapeutic area, making it increasingly difficult the role of the pharmacist in trying to rationalize the economic resources to satisfy the needs of the entire population. The analysis of therapeutic appropriateness has a key role in the management of chronic inflammatory diseases where the biological drugs are used by patients for a long period of time. With increasing competition among companies and the advent of the first biosimilar drugs, the costs are declining and the duty of the Pharmacist is the supervision of treatments so that there is a good cost / effectiveness in an attempt to free resources and safeguard the survival of the Health Service National.

In the year 2015 up to September 2016, all patients were monitored in the departments of Rheumatology, Gastroenterology and Dermatology based on the type of disease, drugs, route of administration and dosages. We evaluated the previous non-biological treatments of first line, therapeutic switch between any drugs with different mechanisms of action, the analysis on the state of the disease, any therapeutic dosages not reported in Summary of Product Characteristics and the reasons that lead the doctors to deviate from guidelines.

The treatments of 684 patients were analyzed: 409 in Rheumatology, 212 in Gastroenterology and 63 in Dermatology. The most frequently used drugs are those that have major use in clinical practice: Adalimumab, Etanercept and Infliximab (three anti-TNF alpha drugs). The first two, having a subcutaneous administration compared to intravenous administration, allow greater patient compliance and are therefore preferred to Infliximab. In Rheumatology the use of newer drugs with different mechanisms of action by inhibition of TNF alpha is not negligible and this is an indication of poor accuracy in the application of the guidelines.

Biologicals are well tolerated and improve the quality of life of people with highly disabling diseases. The therapeutic appropriateness and adherence to guidelines are the only way to try to contain costs. The hope is that, in this new year 2017, new biosimilar drugs are approved that would make, at least for the naïve subjects, more sustainable management of these diseases.

Health Technology Assessment (HTA) has various areas of application, one of which is quality improvement activities in clinical settings. Using patients' satisfaction as indicator of quality of care can inform the ‘needs assessment’ of a clinical deparment.

The principal aim of this study is to quantify patients’ satisfaction with the anesthesia services received perioperatively at our hospital, including physical discomfort and anesthesia care. To this end, we asked the following question: “In adult patients who undergo day surgery at our hospital, what is the level of satisfaction with the anesthesia services received perioperatively?" A second aim is to discuss how quality assessment and HTA can intertwine.

This is a quality assessment study, using a patient self-administered survey method.

We included all patients who had a day-surgery at our hospital and we excluded those who cannot understand English or French, who present cognitive barriers, and those who were admitted the same day.

Patients were recruited postoperatively in phase II of recovery, using a nonprobability convenience sampling method. We used a validated questionnaire which addresses the two dimensions of anesthesia care related our research question: (i) physical discomfort and (ii) satisfaction with anesthesia care. We added to this questionnaire, a supplemental question to measure satisfaction with preoperative anesthetic care. Parallel to this, we also gathered the data routinely collected by the recovery nurses during a 24 hour postoperative patient follow-up.

We collected data from November 2015 to February 2016. A total of 156 questionnaires was completed. Two respondents (1.3 percent) said they were ‘unsatisfied’ or ‘very unsatisfied’ with the anesthesia care they received in general and thirty-six (23 percent) said they were ‘satisfied’. The most frequently reported physical discomfort symptoms were: thirst (78 percent), pain (72 percent), drowsiness (68 percent), cold (58 percent), and sore throat (54 percent).

Our study suggests that, while reporting patients' level of satisfaction regarding various aspects of the anesthesia care they received, such quality assessment study can identify gaps in the use of existing methods and technologies and help in acquisition prioritizing.

The Korea National Health Insurance (K-NHI) has covered medical devices with low cost-effectiveness evidence by what is known as the Selective Benefit (SB) since December of 2013 as a type of conditional coverage. Most medical devices in the SB category are new technology and have higher levels of clinical effectiveness and/or functions than those in the benefit category, but they are characterized as being expensive. We compare the K-NHI medical device coverage system to those in Japan and Taiwan so as to be more informed about how to cover and set prices for new medical devices.

We searched for materials related to medical device coverage or the reimbursement systems of three countries (Korea, Japan, and Taiwan). National health insurance laws, policy reports, and the websites of the Ministries of Health of the respective countries, for instance, were also reviewed.

The NHI systems of Korea, Japan, and Taiwan have several similarities with regard to their medical device benefit lists. They reimburse listed medical devices separately although they cover them basically by including procedures or a diagnosis-related group (DRG) fee. The K-NHI reimburses for medical devices with low cost-effectiveness using the actual market medical price, similar to other medical devices in the benefit category. However, there are no detailed rules regarding how to set prices for these devices. Every listed medical device is covered at the notified price in Japan, but the prices of new medical devices with improved functions can add 1 -100 percent of the price to the notified price. The prices of devices related to new medical procedures are determined by cost-accounting methods. The NHI service in Taiwan compensates for medical devices which are alternates but clinically improved types through a balance billing method.

The NHI systems in Japan and Taiwan set prices with regard to reimbursements for new medical devices separately, specifically for devices which are advanced clinically or functionally but expensive. The K-NHI must consider establishing a pricing or reimbursement system for new medical devices through the discussion with stakeholders for reasonable reimbursements and decreasing the financial burden on the K-NHI.

Conventional gastric balloons for weight loss require endoscopy for placement and removal. The ELIPSETM is a new gastric balloon designed for weight loss that is swallowed and does not require endoscopy or anesthesia. The device is designed to remain in the stomach and be expelled after a predetermined time of 4 months. The objective of this work is to assess the efficacy and safety of the ELIPSETM procedureless gastric balloon for weight loss.

The ELIPSETM procedureless gastric balloon was identified by the early Awareness and Alert System, “SINTESIS-new technologies,” of The Instituto De Salud Carlos III (AETS-ISCIII). An early assessment of the technology was conducted. The searched databases were: MEDLINE (PubMed), Centre for Reviews and Dissemination, and the Cochrane Library. Clinical studies using the device published in any language until 10 January 2017 were reviewed.

A prospective, non-randomized, open label study supported by industry was retrieved. Thirty-four patients were enrolled. Six patients treated with an experimental device were excluded. Twenty-eight patients successfully swallowed the device. No endoscopy or anesthesia was required. All devices were excreted safely. Of the twenty-five patients finally studied, the mean percent total body weight loss was 10 percent (95 percent Confidence Interval, CI 7.3–12.7) and the mean waist circumference was reduced by 8.4cm (95 percent CI 5.7-11.8) at 4 months. Improvements were also seen in metabolic parameters (HbA1c, Low density lipoprotein, triglycerides and blood pressure). All aspects of quality of life measured by the Impact of Weight on Quality of Life (IWQoL) questionnaire demonstrated significant improvements. About safety, there were no serious adverse events or serious adverse device effects, however 64 percent of patients had vomiting, 54 percent experienced nausea, 25 percent had abdominal pain and 2 patients were excluded because of symptoms.

The ELIPSETM gastric balloon for weight loss seems to be an effective therapy with an acceptable safety profile. However it would be necessary to continue further studies to confirm these results, including comparative studies with current treatments.

Drug abuse is a social and public health problem because of its negative consequences of emotional and physical development in individuals. There are few studies evaluating substance abuse by individuals with sickle cell disease (SCD). These patients have severe and recurrent pain crises (1), frequently needing opioids to control it (2). The compromised quality of life can predispose this population to the occurrence of non-psychotic disorders such as depression, making them vulnerable to substance abuse (3).

We evaluated the consumption of alcohol and drugs in a cohort followed at the Sickle Cell Disease Reference Center (CRAF), at Hospital de Clínicas de Porto Alegre, estimating the percentage of patients in treatment of SCD who abuse alcohol and drugs, mainly opioids. A cross-sectional study was of a convenience sample of 139 patients with SCD treated at CRAF. The pattern of substance use was evaluated using the Brazilian version of Alcohol, Smoking and Substance Involvement Screening Test (ASSIST). The exposure to opioids was measured by their use and prescription in the 24 months before the interview. The Self-Reporting Questionnaire (SRQ-20) was used to estimate the occurrence of non-psychotic disorders in this population. Descriptive analyses were performed using absolute and relative frequencies. The association between the variables was verified using the chi-square test or Fisher's exact test.

The prevalence of abusive use was 1.5 percent for alcohol and 3.0 percent for tobacco, with no abusive use of any other substance including opioids was identified. Of note was the pattern for substance use that was not influenced by exposure to substances or the presence of non-psychotic disorders.

Our data shows that use of opioid analgesics for the management of SCD painful crises is safe and does not induce substance abuse. Regular follow-up of these patients is recommended. The results of this study might be useful in other countries.

Mr. Shinjiro Koizumi and some younger members of Japan's National Diet suggested a new policy, “Health Gold License” which would introduce financial incentives to encourage population health management, with people receiving medical checkups receiving a reduction in coinsurance from the current 30 percent to 20 percent. In this research, to evaluate the policy, we adjusted confounding factors of those insured who receive medical checkups (Medical-Checkup Group) and those who do not (Non-Medical-Checkup Group) using claims data, and estimated the effect of medical checkups on medical costs.

We analyzed Japanese employee-based claims data provided by the Japan Medical Data Center Co. Ltd. for the 3 million insured from January 2005 to December 2015. Two regression models were developed. Under model A, explanatory variables were year, age, dummy variables for various hierarchical condition categories and for medical checkups. Under model B, explanatory variables were estimated medical costs per patient per month (PMPM) in 2012 and a dummy variable for medical checkups. We also simulated the financial impact if Japan introduced Health Gold License for all insured.

The coefficients of medical checkups in model A and in model B were -JPY4,816 PMPM and -JPY8,735 PMPM, respectively. The gap of medical costs between the Medical-Checkup Group and Non-Medical-Checkup Group was JPY4,588 PMPM, without any adjustment. If all of those insured received medical checkups, the breakeven coinsurance would be 27.2 percent.

The Medical-Checkup Group is less expensive than Non-Medical-Checkup Group by at least 30%, therefore, the break-even coinsurance for them would be 0 percent. However, because most of those insured have already gone to medical check-ups every year, if the coinsurance were reduced from 30 percent to 20 percent for all insured, the finance would be largely negative. The break-even as 27.2 percent, we believe, would not incentivize the Non-Medical-Checkup Group to receive medical checkups. Therefore, the coinsurance reduction proposed under Health Gold License is not fully justified financially.

Health Technology Assessment (HTA) reports may have a major impact on the health care provided in a country. Hence, one would assume that these reports have a high methodological quality and thus represent a potentially important source of information, for instance, for identifying primary studies for inclusion in the evidence syntheses (for example, systematic reviews, Cochrane reviews, HTA reports). The aim of the present analysis is to evaluate the methodological quality of HTA reports used as a literature source for HTA reports produced by the German Institute for Quality and Efficiency in Health Care (IQWiG).

Eligible IQWiG reports were assessments of drug or non-drug interventions considering HTA reports as the literature source for primary studies and published up to October 2016. An HTA report included in the IQWIG report was considered in the analysis if it was a complete report published in English or German and indexed in the Health Technology Assessment Database (Wiley) or MEDLINE. Only the most current HTA report in an IQWiG report was considered; if more than one current HTA report was available, the one for inclusion in the analysis was randomly selected. The methodological quality of the HTA reports identified was evaluated with the AMSTAR (“Assessment of Multiple Systematic Reviews”) tool (1), which comprises 11 items on methodological quality (meaning a maximum achievable score of 11).

A total of fifty eligible IQWiG reports using fourty-one eligible HTA reports as literature sources were identified. The mean AMSTAR score of these HTA reports was 5.3 (95 percent Confidence Interval, CI: 4.3, 6.2). None of the HTA reports achieved a score of 11, nineteen (46 percent) had a score between 6 and 10, and twenty-two had a score below 6.

HTA reports included in IQWiG reports only have an average methodological quality.

Due to their chronic nature and high prevalence, alcohol and cannabis addiction leads to a significant (disease) burden and high costs, both for those involved and for society. The latter includes effects on health care, quality of life, employment, criminality, education, social security, violence in the public and private domain, and traffic accidents. In the Netherlands, a considerable number of people with an alcohol or cannabis addiction currently do not receive addiction care. Cognitive Behavioral Therapy (CBT) is effective as a treatment for both alcohol and cannabis addiction and is widely used in specialized addiction care centers. This social cost-benefit analysis (SCBA) models costs and benefits of increasing the uptake of CBT for persons with an alcohol addiction and for adolescents with a cannabis addiction, taking into account a wide range of social costs and effects (1).

The method follows general Dutch guidance for performing SCBA. A literature search was conducted to evaluate efficacy of CBT for alcohol and cannabis dependence. In addition, the social costs of alcohol and cannabis addiction for society were mapped, and the costs of enhancing the uptake of CBT were explored. Costs and benefits of increased uptake of CBT for different social domains were modeled for a ten year period, and compared with current (unchanged) uptake during this period. Compliance problems (about 50 percent of clients do not finish CBT) and fall-back to addiction behavior (decrease of effects of CBT over time) were taken into account in model estimations.

Per client treated with CBT, the estimated benefits to society are EUR10,000-14,000 and EUR9,700-13,000, for alcohol and cannabis addiction, respectively. These benefits result from reduced morbidity and mortality, improved quality of life, higher productivity, fewer traffic accidents, and fewer criminal activities.

This SCBA shows that not only treated clients but also society will benefit from an increase in people treated with CBT in specialized addiction care centers.

Risk prediction scores have been devised to identify patients at increased risk for Venous Thromboembolism (VTE) in different patient populations and settings. Guideline recommendations for VTE risk assessment vary greatly. We performed a systematic review to synthesize evidence on clinical risk prediction scores for VTE in hospitalized medical and surgical patients.

We systematically searched Medline, EMBASE, Cochrane, National Institute of Health and Care Excellence (NICE), National Guidelines Clearinghouse (NGC), and Guidelines International Network (GIN) databases up to March 2016. We included studies validating risk prediction scores for adult hospitalized patients. We excluded studies for any of the following reasons: non-English publication, conducted in non-OECD (Organisation for Economic Co-operation and Development) countries, validation cohorts focused solely on critical care patients, or scores developed for specific surgical or medical sub-specialty populations. We plotted receiver operating characteristic (ROC) curves of included studies and performed summary ROC meta-analyses for scores in which >1 external validation studies were combinable. Risk of bias was assessed qualitatively. We assessed the strength of the evidence base using Grading of Recommendations Assessment, Development and Evaluation (GRADE).

We screened 110 primary studies and included 18 of those for analysis. There were seven studies of the Caprini score, three studies of the Padua score, two studies of the IMPROVE score; and one study each of the Arcelus, Geneva, Khorana, RAP, and Kucher scores . Strength of evidence was downgraded for study risk of bias because most studies disproportionately included patients at high risk of VTE. Our summary estimates of the performance of the three combinable scores at clinically-relevant thresholds are: Caprini score at a threshold of three in surgical patients – 96 percent sensitivity, 44 percent specificity; IMPROVE at a threshold of one in medical patients – 96 percent sensitivity, 20 percent specificity; and Padua at a threshold of 4–87 percent sensitivity and 58 percent specificity.

There is moderate strength evidence for use of the Caprini score to predict VTE in surgical patients and for the Padua and IMPROVE scores in medical patients. Lower thresholds may be warranted to achieve sufficient sensitivity to identify low risk populations who may not require routine VTE prophylaxis. Studies making direct comparisons of risk prediction scores in similar patient populations are lacking and are necessary to ascertain which score is most effective.

Clostridium difficile infection is the leading cause of nosocomial diarrhea in developed countries and may progress to pseudomembranous colitis, sepsis and death. The risk factors are antibiotics use, advanced age and prolonged hospitalization. The diagnosis of Clostridium difficile infection is based on clinical history in combination with laboratory tests, which detect the Clostridium difficile presence or toxins. Clostridium difficile remains in spore form contaminating the environment and requiring measures to prevent hospital transmission. Tests with more accurate results to identify true carriers of Clostridium difficile allow the clinician to determine a safer treatment. This study evaluated accuracy and cost-effectiveness of the real-time polymerase chain reaction compared with the enzyme-linked immunosorbent assay from the perspective of a Brazilian public cardiology hospital.

A study diagram was constructed by type of test, linking the data of prevalence in hospital, accuracy and direct costs of tests. The costs were based on a hypothetical population comparing two strategies to identify the incremental expenditure between technologies. The analysis included comparisons for each test versus no test, and with each other. The prices were converted to the American currency taking into account the date of purchase of each product and respective price.

For real-time polymerase chain reaction test versus no test, 214 patients would have tested to justify one empirical treatment suspension, at a cost of USD90,926.46. For enzyme-linked immunosorbent assay test, to prevent one unnecessary treatment, 375 patients would have to be tested at a cost of USD6,603.75. In the comparative analysis, only a single false-positive patient would have the treatment suspended after performing 375 real-time polymerase chain reaction tests at USD424.89 each one (USD159,333.75 in total). An incremental cost of USD152,730.00 may be necessary to benefit a single patient by discontinuing empirical treatment.

The Real-time polymerase chain reaction test has restrictions as a test of choice for the diagnosis of Clostridium difficile infection, in services with low disease prevalence. It undergoes a significant change in its positive predictive value and does not offer a great impact in the clinical diagnosis.