Increased intraocular pressure (IOP) in open angle glaucoma (OAG) may lead to optic nerve damage due to progressive obstruction of aqueous humor drainage. Among surgery options, trabecular micro-bypass stent (iStent®) was recently introduced. This Health Technology Assessment (HTA) aimed to assess the effectiveness and safety of iStent®, combined or not with cataract surgery, in patients with mild-to-moderate OAG.

A systematic review (SR) was performed from 2000 to August 2016. Studies reporting data at three months or more on IOP and hypotensive medication use following iStent® implant were eligible. Governmental databases on safety issues were reviewed. The project involved an interdisciplinary group of experts.

Two HTA reports, one SR, four randomized controlled trials (RCTs) and nine observational studies (OSs) were included. Compared to cataract surgery alone, implantation of iStent®combined with cataract surgery was associated with a decrease in IOP at 12 months in RCTs (-1.37 mmHg; 95 percent Confidence Interval, CI: - 2.76 to .03 mmHg, p = .055). Results from RCTs and OSs on the effect of iStent® combined or not with cataract surgery suggest also a 12-month positive effect on IOP (mean reduction: 1.5 to 9.5 mmHg) and on mean number of medications (reduction: .3 to 2.0) compared to baseline. Scattered results were found on the proportion of patients who no longer use glaucoma medications. Small sample size, short duration of follow-up, and potential conflicts of interest were among studies limitations. The most common adverse events reported were posterior capsular opacification, decrease in visual acuity, and stent obstruction or malposition.

Appraisal of the effectiveness and safety suggests that iStent® implantation combined to cataract surgery in mild-to-moderate OAG is an emerging practice. Uncertainties related to clinical benefits, safety and care organization need to be clarified before an introduction as a standard of medical practice.

Historically, patient access processes of new and innovative medical devices including in-vitro diagnostics are made in the sequence of regulatory approval, new Health Technology Assessment (nHTA) approval, reimbursement coverage and coding finally reaching the pricing approval stage in South Korea. Although the individual patient access process has its own distinct objective and perspective, there are still opportunities for the authorities or agencies in charge to streamline their processes by working together to promote earlier patient access of new and innovative medical devices to patients without impacting their own decision making.

This research examined and analyzed the current policies about: patient access processes with a holistic viewpoint, industry-wide survey about patient access practices; case studies of two innovative medical devices for patient access in South Korea and also proposed new or alternative programs which can contribute to patient access harmonization efforts with a holistic approach.

Historically, health authorities play defensive strategies by delaying the adoption of new and innovative medical devices and implementing certain periods (that is, 2 to 5 years) for a patient's out-of-pocket payment scheme. It is well illustrated with the statistic that only twenty-nine percent of new and innovative medical technologies which have successfully gone through the nHTA process were determined for reimbursement coverage in the past 7 years.

The survey by the medical device industry to determine the patient access lead-time of innovative medical devices with a holistic perspective indicated significantly delayed patient access even considerabley exceeding the legally required decision-making lead time. The in-depth case studies with two innovative devices indicated the disadvantageous patient access processes to the innovator in terms of both final approval timing and the price level.

The concurrent review process for reimbursement coverage decision making for medical procedures, medical devices and reimbursement coverage payment guidelines committed within the Health Insurance Review and Assessment Service shall be created. New programs to deal with uncertainty in reimbursement coverage decision making shall be considered such as coverage with evidence development, performance-based risk-sharing arrangement, multi-criteria decision analysis and economic evaluation.

The National Committee for Health Technology Incorporation (CONITEC) (1) was created in 2011, when the participation of civil society in the Health Technology Assessment (HTA) process was formalized in Brazil. According to legislation, patient and public involvement (PPI) in HTA occurs through: public consultations (PC); representation of SUS (Brazilian Public Health System) users in the plenary of CONITEC and by public hearings in relevant cases. Due the incipient culture of social participation in Brazil, strategies involving better communication, direct participation and popular education were developed to broaden and qualify this participation.

• • Case study about PPI strategies developed in 5 years of CONITEC

• • Analysis of documents and official records from the Brazilian Ministry of Health.

Since its creation, the innovations of CONITEC regarding PPI were: creation of specific PC form to reproduce or represent the perspectives of patients and caregivers; summarized versions of technical reports written in a simplified language to improve users involvement; surveys prior to elaborating clinical guidelines, a bi-weekly educational program transmitted by streaming, and the recent launch of an HTA Users Guide and a mobile app.

After the implementation of these strategies (which started in 2014), there was an increase of annual contributions, from 2,584 in 2014 to 13,619 in 2015. Most participants were patients, family members or caregivers. Surveys concerning clinical guidelines received about 3,000 contributions. There were thirty-seven published society reports until December 2016. The publication of the HTA Users Guide and other related actions increased the number of accesses to the CONITEC website and its subsection for social participation. The educational program had more than 800 online accesses in five months.

These actions allowed expanding and qualifying PPI beyond what is legally defined, and it is possible to predict an increasingly favorable scenario regarding the patient and public participation in HTA in Brazil.

The Spanish Network of Agencies for Health Technology Assessment (REDETS) is a group of eight agencies, units and services, depending on National and Regional Governments that coordinate their work within a common methodological framework, guided by the principles of mutual recognition and cooperation. In this work, guided by the necessity of implementing a Quality Management System, we present the process to achieve this objective.

As an initial step, a review was carried out based on a structured search strategy in the main electronic databases Medline and EMBASE, and a manual search in websites of national and international agencies (March 2016) in order to collate previous knowledge and experiences. Through the information included in this review, a proposal to create a quality, self-evaluating tool is necessary.

In total, 800 references were found and finally 6 studies were included in the review (1-3). All had a similar structure. Some lists of good practices, classified in dimensions related to different quality aspects in Health Technology Assessment (HTA) organizations, were found. Also some information about questions for evaluating quality standards was indicated. Taking all this information, a proposal of sixty-six standard titles was put forward. These standards were then grouped into twelve quality criteria structured in four dimensions: I Responsibility, II Clients and Stakeholders, III Production Process and IV Resources.

Based on the systematic review, we developed a proposal for a self-evaluating tool and this is the baseline for a common Quality Management System for the Spanish Network of HTA Agencies. The quality management process will require the development of a handbook by each member of REDETS that will be based on agreed quality standards.

Quality of Life (QoL) is considered to be an important outcome which is widely used in Health Technology Assessment (HTA). In economic evaluations QoL is represented by quality-adjusted life years (QALYs) - adding utility scores to the years of life lived in a determined health status (1). The EuroQol - 5 dimensions (EQ-5D) is a QoL questionnaire that generates utility scores and provides a simple and generic measure of health (2). Electronic QoL instruments have been reported equivalent to paper-based methods, however no studies have assessed agreement between EQ-5D application methods in Brazil (3). Thus, our study aimed to evaluate the measurement equivalence between the original (paper) and adapted (tablet) versions of the EQ-5D-3L Brazilian questionnaire.

A cross-sectional study was conducted on 509 adult individuals selected at random in economically different regions of two major Brazilian cities. EQ-5D-3L and Visual Analogue Scale, paper and tablet versions, were applied. Subjects were randomized to two groups; one group assigned for test-retest assessment using only electronic media (tablet-tablet), and a crossover group - half of which answered the tablet version before the paper questionnaire (tablet-paper), and the other half which answered the tablet version after the paper questionnaire (paper-tablet). There was a washout period of a minimum of 24 hours and maximum of 7 days between applications. The Intraclass Correlation Coefficient (ICC) and kappa coefficient were used to determine the agreement between methods. The level of significance was set at .05 for all analyses.

Females predominated in all groups, and the mean age ranged from 41 to 44 years. In the crossover group the obtained ICC values were: .76 (CI .58–.89) for EQ-5D scores and .77 (CI .68–.84) for Visual Analogue Scale (VAS) scores in the tablet-paper subjects; .83 (CI .75–.89) for EQ-5D scores and .75 (CI .67–.85) for VAS scores in the paper-tablet subjects. In the test-retest group, the ICC values were .85 (CI .73–.91) for EQ-5D scores, .79 (CI .66–.87) for VAS scores. Kappa values were higher than .69 in test-retest group. Internal consistency was similar between methods.

Paper and tablet versions of the EQ-5D were equivalent. Test-retest and crossover agreement was high and the acceptability of the methods was similar.

Advanced or metastatic renal cell-carcinoma (RCC) is associated with poor health outcomes; in particular in those whose disease progressed after first line treatment. A literature review was conducted to elucidate evidence on health-related utility associated with advanced and metastatic RCC.

A systematic literature search from 2006 onwards (date of search: July 2016) was conducted for studies evaluating health-related quality of life (QoL) and utility outcomes. Searches included Medline, Embase, National Health Service (NHS) Economic Evaluation Database and HTA Database and were supplemented by free internet search for key European Health Technology Assessment reports. Publications were limited to 2006 onwards as previous research (1) revealed no prior relevant evidence.

The search yielded 4,178 records. The selection process revealed seventy-eight relevant publications. Generic EuroQol (EQ)-5D scale was most commonly used. Health-state utilities were assessed for specific treatments and at different time points. Mean reported value for patients after failure of one prior systemic therapy ranged from .79 - .62. For patients without progression (on and off-treatment) reported utility values were in range from .80 – .63. Utility in stable patients with adverse events ranged from .71 - .47. For patients with progressive diseases, utility was reported from .71 - .36. Utility for interventions due to skeletal-related events in patients with bone metastasis was reported to range between .46 and .15.

Identified evidence confirms advanced or metastatic RCC leads to significant detriment to patients health-related utility. Further research efforts are warranted to assess health-state utility beyond clinical trial assessment.

Existing findings on effectiveness of long-acting injectable antipsychotics (LAIs) versus oral antipsychotics in preventing hospitalizations are inconclusive. This study was conducted to compare hospitalization costs between Medicaid patients diagnosed with schizophrenia who initiated a LAI and those who changed from one oral antipsychotic to another.

This retrospective cohort analysis used the Truven Health Analytics MarketScan® Medicaid claims database to study patients ≥18 years with schizophrenia. The two cohorts were: “LAI”, defined as initiating LAI (no prior LAI therapy) between 1 January 2013 and 30 June 2014; and “oral”, defined as changing from one oral antipsychotic to another during the same period. The first day of LAI or the new oral antipsychotic was the index date. A linear regression model was conducted to estimate hospitalization costs.

The final sample included 2,861 (36.7 percent) LAI and 4,926 (63.3 percent) oral users. Compared to oral users, LAI patients were younger (mean (Standard Deviation, SD): 39.9 (13.2) versus 42.7 (13.1); p<.001) and had a lower mean Charlson Comorbidity Index score (mean (SD): 1.1 (1.9) versus 1.7 (2.3); p<.001). Of the 877 LAI initiators and 1,688 oral users who were hospitalized during the 1-year post-index follow-up period, the unadjusted mean hospitalization costs for LAI and oral users were USD32,626 and USD36,048, respectively. After adjusting for patient demographic and clinical characteristics, baseline medication use, and baseline ED or hospitalizations, the adjusted average hospitalization costs were USD1,170 lower in LAI initiators than oral users. None of the unadjusted or adjusted differences were statistically significant.

This real-world study suggests that among hospitalized patients, hospitalization costs are lower in LAI initiators than in oral antipsychotic users, although the difference is not statistically significant. Our study is limited as our results are reflective of a multi-state Medicaid population. Future studies are warranted to confirm the results in non-Medicaid patient populations.

Through technological innovations based information and communication technologies (ICT), advantageous telediagnostic systems can be developed to improve the health care of remote populations (1). In the context of universal coverage and the efficient use of available resources, there is a favorable opportunity to develop telemedicine towards an integrated ecosystem to improve health care in remote locations without access to specialists. This study, performed by the Telemedicine Unit (MoH) in collaboration with the Biomedical Engineering Dept (IICS-UNA) and the Basque Country University (UPV/EHU) evaluated a telediagnostic system implemented in 2014 in public health. The results of a cost utility analysis for this telediagnosis project in remote, regional and district hospitals in Paraguay are presented.

This is a prospective study, where the results of using telediagnosis implemented in remote hospitals over three years 2014–16 were evaulated. For these purposes, a utility analysis was carried out by comparing the cost of performing telediagnosis versus performing it “face to face” in a diagnosis center in the capital city.

During the study 182,406 remote diagnoses were performed in the fifty-four remote hospitals using the telediagnosis tool. Of the total, 37.3 percent (68,085) corresponded to tomography (CT), 62.0 percent (113,059) to electrocardiography (ECG), 0.68 percent (1,243) to electroencephalography (EEG) and 0.01 percent (19) to ultrasound studies. The average cost of a tele-tomography, tele-ECG and tele-ultrasound was USD2.6, and USD8.6 for tele-EEG, respectively. The cost reduction through the telediagnosis was 26.4 times for tomography, 4.5 times for ECG, 8.0 times for EEG and 8.3 times for ultrasound. The cost utility analysis performed demonstrates an economic benefit of USD12.9 million to the citizens of the fifty-four communities included in this project.

Despite the potential benefit of the telediagnosis (2) to facilitate the universal coverage, and optimize the use of scarce human and health financial resources shown in this study, other important aspects such as acceptance of the technology, patient satisfaction and a widespread use-assessment should be analyzed (3) before a large diffusion.

The Changi General Hospital (CGH) carries out viscosupplementation for patients with knee osteoarthritis through intra-articular hyaluronic acid injections, using Synvisc or Synvisc-One (containing hylan G-F 20). Some patients on Synvisc are susceptible to flare or pseudoseptic reaction on repeated therapy. It was proposed to procure Synolis V-A intra-articular injection as an alternative for these patients.

A rapid health technology assessment was carried out on the following PICO elements: Population - Patients with knee osteoarthritis, Intervention - Synolis V-A, Comparator - Synvisc, Outcomes - Risk of flare reaction/pseudoseptic arthritis.

Based on a preliminary scan of the literature, a simple search was conducted for all publications on Synolis V-A, and for reviews on the risk of flare/pseudoseptic reaction with Synvisc.

No publications reporting on flare/pseudoseptic reactions with Synolis V-A were found. There are limited case series of patients treated with Synolis V-A, with most evidence coming from a prospective post-marketing surveillance case series, which showed reduced pain and functional impairment at 6 months. Adverse reactions were rare. CGH's own small trial of Synolis V-A did not show any flare reactions.

In contrast, flare/pseudoseptic reactions with Synvisc are an established phenomenon. A systematic review of randomized controlled trials documented one flare reaction among 381 patients (0.26 percent) in Synvisc compared to none in patients receiving other hyaluronan products. Small case series of patients on Synvisc showed incidences of flare reaction of 21 percent (in repeat treatment) to 27 percent. CGH's own experience is that flare occurs in 4.7 percent of patients on Synvisc.

It is reasonable for the hospital to stock an alternative for patients who show repeated flare reactions to Synvisc. The limited evidence base is not a barrier to using Synolis V-A as an alternative, given the local experience.

Gaucher disease (GD) is a genetic autosomic disorder for which treatment has been funded by the Brazilian government since the 1990s. In our state most patients are treated with enzyme replacement therapy (ERT) and followed by our Reference Center under the recommendation of the Ministry of Health Brazilian guidelines. There is a lack in the literature about adherence of patients to treatment. The objective was to describe adherence to the treatment in a cohort of all GD patients in the southern state of Brazil.

This was a cohort study of all GD patients treated with velaglucerase α, taliglucerase α and imiglucerase from January 2010 to January 2015. Adherence was measured as recommended by the Brazilian guidelines as to perform more than 50 percent of the anticipated infusions per year.

Our study included thirty-seven patients of both genders. Doses of ERT varied from 15 to 45IU/kg for type 1 patients and from 30 to 60 IU/kg for type 3 patients. A mean of 83 percent of anticipated infusions were performed and from all patients only one did not adhere to the treatment during the 5 years of our study. The majority of the patients performed at least 50 percent of all anticipated infusions.

We noted a very high rate of adherence to treatment with a very few adverse effects. Our data might be showing that the very high rate of adherence in these chronic disease patients may be attributed to the value of treatment by patients and their family, and also due to the existence of a multidisciplinary team at the reference center. These data might be useful for public health policy making in other countries.

In Italy, the cohorts of women who were offered Human papillomavirus (HPV) vaccination in 2007/08 will reach the age for cervical cancer (CC) screening from 2017. According to the National Prevention Plan 2014–18, HPV-based screening must be implemented for women ≥30 years old, following the Italian Health Technology Assessment (HTA) report recommendations (1). The simultaneous shift from cytology-based screening to HPV test-based screening gives the opportunity for unprecedented reorganisation of CC prevention.

The National Screening Monitoring Centre and the Italian Group for Cervical Screening, following a commitment by the Italian the Ministry of Health (MoH), identified the consensus conference as the most suitable method for addressing this topic. The objective was defining the best screening methods in girls vaccinated against HPV and the knowledge needs for defining evidence-based screening strategies. During the consensus celebration (24 November 2015) a jury made recommendations about questions and proposals formulated by a panel of experts representative of Italian scientific societies involved in CC prevention and based on systematic reviews (2).

The jury considered changing the screening protocols for girls vaccinated in their 12th year as appropriate. Tailored screening protocols based on vaccination status could be replaced by “one size fits all” protocols only when a herd immunity effect has been reached. Vaccinated women should start screening at age 30, instead of 25, with the HPV test. Furthermore, there is a strong rationale for applying longer intervals for re-screening HPV negative women than the currently recommended 5 years, but research is needed to determine the optimal screening time points. For non-vaccinated women and for women vaccinated in their 15th year or later, the current protocol should be kept.

As further action, in 2016 the Ministry of Health funded a Health Technology Assessment program of the new screening protocol proposed by the consensus conference and a cohort study for determining a safe interval in vaccinated women.

Anemia is a major problem, frequently resulting from iron deficiency (1). Guidelines recommend the administration of intravenous (IV) iron, leaving blood transfusions for critical patients due to the potential impact in length of stay (LOS) and mortality (2,3). We aimed to characterize IV iron sucrose utilization and health resource utilization in anemic patients.

This is a retrospective ongoing cohort study. Patient records from a general Portuguese Hospital with an administration of iron sucrose in 2014–2015 were reviewed. Adult anemic patients with at least one hemoglobin (Hb) evaluation before and after the administration of IV iron were included. Endpoints assessed were: Hb level (baseline, 4 and 8 weeks after), anemia correction rate at weeks 4 and 8, blood transfusions, length of stay (LOS), rate of readmissions (<30 days) and inpatient mortality. Statistical analysis included non-parametric and chi-square tests to assess differences between groups and a logistic regression model, using a 5 percent significance level.

Data was collected for 401 patients (63.1 percent female; mean age Standard Deviation, SD: 62.6 (21.7) years) and 431 IV iron sucrose administration episodes. Mean cumulative iron dose was 679.5 mg. Baseline Hb level was 84.5 g/l and increased to 94.3 g/l (week 4) and to 103.0 g/l (week 8). Blood transfusions were performed in 53.8 percent of the episodes. Overall 157 (36.4 percent) episodes had a >20 g/l increase in Hb level. Blood transfusions were associated with a higher proportion of Hb level increase >20 g/l (44.0 percent versus 27.9 percent, p<.001). The overall mean LOS was 15.3 days, although episodes with transfusions had a significantly longer duration (17.5 days versus 12.7 days; p<.001). Overall readmission rate was 25.8 percent, with a higher proportion in episodes with blood transfusions (29.3 percent versus 21.6 percent). A total of 36 patients (9.0 percent) died at the hospital before discharge. Transfusions performed during or after IV iron administration increased 3.1 times the risk of in-hospital death (95 percent Confidence Interval, CI: 1.3-7.0; p = .008), after adjusting for age and sex.

We observed a high rate of blood transfusions in this cohort treated with intravenous iron sucrose for anemia. Transfusions were associated with substantial burden of resource consumption and in-hospital mortality.

The State Program for Health Development of the Republic of Kazakhstan (RK) “Densaulyk” for 2016–2019 initiated the modernization of primary health care with the introduction of family practice in order to ensure the availability, completeness and quality of health services on the basis of an integrated healthcare system focused on the needs of the population. The aim of this study was to determine the effectiveness of the cochlear implantation (CI) programs.

A literature search was conducted for all clinical trials, randomized controlled trials, and reviews in the PubMed, Cochrane, and Center for Reviews and Dissemination databases. Two reviewers independently evaluated all publications for selection. The analysis included the cost-effectiveness and benefit from the CI program.

We analyzed the effectiveness of the services for CI in the RK and other countries (1). In our analysis, we identified that there is no research on Quality-adjusted Life Years (QALYs) and Cost-Utility Analysis (CUA) in RK. We found that, in general, the cost of CI and pre-surgical procedures are comparable with other countries. The length of stay in Kazakhstan was much higher (an average of 8 days) compared with other countries (3 days). Also in RK, there were significantly lower prices per hospital day and cost of various consultations. Postoperative costs of other countries consisted of one-third to two-thirds of the total costs for preoperative and implantation stages (2, 3). There was a little information on the effectiveness of rehabilitation programs in RK.

Economic research like QALYs and CUA are new directions in the healthcare system in the RK. Lack of integration between primary care, rehabilitation and other services leads to difficulties in assessing the effectiveness of CI programs (for example, in our case, there was the restriction of assessment in only postoperative costs).

The Health Technology Assessment (HTA) researchers at the Institute of Health Economics, in collaboration with researchers from two HTA agencies in Australia and Spain, developed, piloted, and validated a 20-criteria quality appraisal checklist specific for case series studies (before-after single arm studies with no control group) (1,2). Since its publication in 2012, the use of the checklist has spread globally through the HTA community and to researchers in other areas. This presentation will briefly introduce the tool, summarize user experiences, outline potential challenges, and provide practical solutions for using or adapting the checklist to various HTA topics.

Feedback from fifteen researchers was collected informally by email and/or formally by questionnaire. The questions included focused on the relevance, clarity, and usefulness of the checklist and its instructions, as well as potential revisions and/or addition of other criteria.

While some of the checklist's criteria apply to all studies of a particular type, others are specific to the research question and/or the technology under investigation; discussion on the modification and/or adaptation of the checklist and its instructions is therefore required before commencing appraisal. Some criteria are difficult to score owing to study reporting limitations. Quality assessment can be challenging when multiple types of studies are included; however, currently there is no single universally validated tool available for diverse study designs. There are frequent demands for a cut-off point in order to separate high- from low-quality studies. However, no scale or numeric scoring was developed for the checklist, due to the well-recognized risks associated with such a scoring system.

The increased use of the checklist and general positive feedback indicates the need for such a tool. User feedback helped improve our understanding of the checklist's applicability with various topics, as well as the potential refinements needed to increase its utility and robustness.

During the information search revealed that there is no published analysis reflecting the actual status of pharmacoeconomic and clinical-economic research, but there are databases that allow you to do so. The platform for searching research data was scientific electronic library “eLIBRARY.RU”. This portal is Russia's largest internet library of scientific publications, with rich search capabilities and the timely receipt of necessary information.

A search was carried out during the period from 2005 to 2015 of research papers on Russian and foreign pharmacoeconomic and clinical-economic research was carried out as at 1 September 2016 on the words “pharmacoeconomic*”, “clinical and econom*” with the appropriate endings. The criteria for inclusion in this analysis were general accessibility and availability of full text scientific material on the portal.

Over the last ten years the number of publications increased by 4 times. The leading destinations included cardiovascular, pulmonary, oncological and endocrinological diseases. According to published reports pharmacoeconomic and clinical-economic studies carried out in fifty-two subjects of the Russian Federation on the basis of sixty-three Universities. In addition to researchers from the Russian Federation, has placed the representatives from eleven countries. Only one third of the published studies are generally cited. Among the methods of pharmacoeconomic analysis of the most popular in published studies is the analysis of “cost–effectiveness”, which is used in about 45 percent of the available studies.

As a result, 1,425 articles were identified and analyzed. With the aim of providing concrete data that clearly illustrate the situation with the Russian scientific, pharmacoeconomic and clinical-economic writings to date all studies were classified according to the following parameters: geographical, temporary, local and nosological. In the framework of the analysis highlighted the authors whose works are most RISC (Russian Science Citation Index) with leading positions in the number of publications.

A reference hospital, specialized in cardiology, has standardized clopidogrel, ticagrelor and recently the incorporation of prasugrel was approved with an estimate of fifteen patients with stent implantation monthly. Stent thrombosis is a rare but serious complication and it is recommended that patients be treated with antiplatelet therapy. Considering the existing therapeutic options and the low adherence to treatment, a cost study was requested to discuss a disinvestment proposal.

Perspective of the hospital; Population: patients with myocardial infarction and stent implantation; Intervention: prasugrel; Comparators: clopidogrel and ticagrelor; Outcomes of interest: stent thrombosis and major bleeding; and types of study: meta-analyses and randomized clinical trials. Literature review was performed in the Medline database, via Pubmed and performed meta-analysis. Cost estimates: data collection made in the institution's database.

Thirteen articles were selected; there are no differences in the outcomes for prasugrel and ticagrelor; discontinuation of treatment is the most important risk factor for stent thrombosis and major bleeding is an important predictor of nonadherence to treatment. Quantitative analysis: three clinical trials. All showed a superiority of prasugrel and ticagrelor over clopidogrel for outcome of stent thrombosis (Odds Ratio, OR .60 Confidence Interval, CI 95 percent [.40; .90]), which was committed by the heterogeneity of studies (I2 = 64 percent); and favorable outcome for clopidogrel compared to ticagrelor and prasugrel for the outcome of major bleeding (OR 1.28 CI 95 percent [1.10; 1.50]). Annual cost with treatment of the fifteen patients: clopidogrel = USD5,765.86; prasugrel = USD41,047.48; and ticagrelor = USD44,081.30.

The evidences found support the opening of a disinvestment process and suggest to the managers of the institution a reflection on: strategy to optimize adherence to treatment; and especially in the cost of opportunity with new technologies about 10 times more expensive.

The volume of lawsuits for drugs has increased in Brazil. The scientific evidence basis consideration by the Brazilian judiciary system is being debated. In the State of São Paulo, the drug with the highest number of lawsuits is insulin glargine. Between January and August 2016, the São Paulo State Department of Health lost 264 insulin glargine lawsuits requiring supply for adult patients (>18 years old). Insulin glargine has already been submitted and unfavorably assessed by the Health Ministry SUS Technology Incorporation National Commission (CONITEC), so is not available in the Brazilian public system.

Random analysis of 153 (58 percent) lawsuits were carried out on digital court records. Data collected from legal proceedings were: the type of diabetes (1, 2 or unspecified); age of the patient; origin of the order; specialty of the prescriber and the reason described for the request. Each record was structured with variables data within a matrix in Microsoft Excel© software. Analysis of frequencies, absolute and relative distribution of quantitative variables, as well as conceptual clusters in the qualitative textual analysis are presented.

The mean age of the 153 patients was 49±17 years. The majority of patients requested insulin glargine to achieve glycemic control (n = 116; 76 percent): because -“diabetes is uncontrolled and the analogous insulin is essential to get it” (n = 106; 69 percent); or -“patient claims to have obtained glycemic control with insulin glargine but there are none of the mandatory laboratory tests results in lawsuits” (n = 7; 5 percent); or -“ask replacement of insulin detemir with glargine for glycemic control” (n = 3; 2 percent). Only 87 (57 percent) lawsuits reported the patients diabetes type: type 1 (n = 42; 28% percent or 2 (n = 45; 29 percent). Most of this judicialization came from private outpatient clinics (n = 116; 76 percent) and 99 (65 percent) were prescribed by endocrinologists.

Judicial decisions are still insufficiently underpinned by scientific evidence (only the patients drug needs claim has been recorded to justify supply) and are incomplete regarding objective diagnostic variables. Also, the judges awareness of interdisciplinary measures to achieve diabetic patients glycemic control, besides complementary drugs, may improve the Brazilian judicialization burden.

Prudent health care aims to do the minimum needed to achieve the greatest patient benefit. This aim relies on the availability of evidence on the safety and efficacy of interventions to support decision making. The principles of prudent healthcare support co-production, whereby service users contribute to service provision. Collection of patient reported data is becoming more widespread, however use of this data to inform decision making is limited.

A national patient reported outcome measures (PROMs) program has been formed supported by the Welsh Government, Welsh Health Boards and the NHS Wales Informatics Service. An electronic platform has been developed to facilitate collection of PROMs and patient reported experience measures (PREMs) from patients treated in secondary care. We collected baseline PROMs where possible and invited patients to submit PROMs and PREMs post-treatment. Data collected included EuroQuol five dimensions questionnaire (EQ5D), co-morbidities, body mass index (BMI), smoking history and alcohol intake. Disease specific tools were used where available and responses linked to clinical data. Individual level data will be available during clinic consultations, and collated data analyzed on national and health board levels to assess clinical effectiveness. The platform is currently being piloted in several sites across Wales.

Initial baseline pilot data from hip replacement patients found that over 55 percent of responders were classed as overweight or obese, with over 80 percent carrying out less than the national guidelines for exercise.

The baseline scores for hip patients were; EQ-5D Index (Mean .29, median .29, range (-.59 -1)), EuroQol-visual analogue scales (EQ-VAS) (Mean 57.8, median 60, range (0:100)), and Oxford Hip Score (Mean 14.9, median 14, range (0:48)).

When compared to baseline scores collected by NHS England in 2015/16 (1), the average EQ5D Index and Oxford Hip Score collected in Wales was lower than that in England (p< .05).

The program will provide a large dataset from patients across all of Wales with data on numerous chronic and acute conditions. The data collected will facilitate service improvements and will inform decision making as part of the prudent healthcare agenda.

Patients presenting to emergency ambulance services with Transient Ischemic Attack (TIA) are usually conveyed to the Emergency Department (ED) with subsequent referral to specialist assessment at a TIA clinic within one week if at low risk of stroke. There is opportunity for paramedics to refer patients with TIA at low risk of recurrent stroke directly to a specialist TIA clinic, avoiding the transportation and care at the ED however evidence is lacking about current practice, safety and effectiveness of this intervention.

We aimed to describe current service developments across the United Kingdom (UK) for the pre-hospital emergency care of patients with TIA, to inform the development of an intervention for testing.

We surveyed all UK Ambulance Trusts (n = 13) by email, asking them to identify initiatives related to the management of TIA, and followed up services reporting an alternative TIA pathway by telephone to gather further details.

Twelve ambulance services responded to our survey. Eight reported that they had not developed or implemented TIA referral pathways. Three reported currently using a TIA referral pathway; one had discontinued their pathway due to service reconfiguration. All (4/4) pathways used the FAST test and ABCD2 tool to screen patients, in line with national guidelines, and classified patients as low risk if the ABCD2 score was ≤3. All indicated that eligible low-risk TIA patients should be referred by paramedics to specialist care, 2/4 by telephone, and 2/4 by fax.

Although protocol compliance was audited in an initial pilot in one service, no formal evaluation of effectiveness was reported.

Several UK ambulance services have introduced similar referral pathways for low risk TIA patients, avoiding transportation of patients to the ED. Existing initiatives can inform the development of an intervention for evaluation in a randomized trial.

The aim of the study was to estimate the benefits provided and pension costs of patients with central nervous system (CNS) diseases and specifically for multiple sclerosis (MS), between 2009 and 2015 by age in the Italian regions.

The database of approved claims was analyzed and the mean cost per benefit of the National Institute of Social Security (INPS) determined for four types of social security benefits: incapacity pensions (for workers without work ability), disability pensions and disability benefits (for workers with reduced work ability) and attendance allowance (for people without work ability with physical and/or mental disability). From this data we estimated the total benefit provided and the total costs for CNS and MS, considering the regional distribution and age of the applicants. A probabilistic model with a Monte Carlo simulation was developed in order to estimate the total benefits provided and costs.

The model estimated for CNS diseases a total of incapacity pensions paid (thirteen grants for each beneficiary for every single year) from 2009 to 2015 of about 1.7 million (13,000 beneficiaries on average annually with a mean annual increase of 1 percent) corresponding to EUR1.1 billion (EUR165 million each year with a mean annual increase of 2 percent); a total of disability pensions paid of about 9.8 million (180,000 annual beneficiaries with a mean annual decrease of -10 percent) for a cost of EUR5.3 billion (EUR763 million each year with a mean annual decrease of -9 percent) and a total of disability benefits provided of about 2.7 million (30,000 annual beneficiaries with a mean annual increase of 5 percent) corresponding to EUR1.8 billion (EUR255 million every year with a mean annual increase of 7 percent). For the attendance allowance the model estimated a total of 8,900 beneficiaries in 2015 for a total cost of EUR57 million. The results of the regional analysis showed that the central and part of the southern regions (in particular the Sardinia region) reported the highest rates of benefits provided related to the resident population.

The most important indirect costs in Italy from 2009 to 2015 were represented by disability pensions (64 percent of the total cost), followed by disability benefits (21 percent of total indirect cost).