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).

The “Judicialization of health” is a judicial option, provided by the Brazilian constitution, which aims to guarantee the access of the population to healthcare products or services to which they were denied or that were otherwise unavailable on the Unified Health System (SUS) (1). This highlights deficiencies in public policies (2). Considering the progressive impact of the judicialization on the budget and the lack of real-world evidence on the subject, the objective was to describe the judicialization profile of physiotherapeutic devices in the city of Rio de Janeiro and to estimate the spending on them within the system.

The profile was traced based on the analysis of the processes (n = 243) submitted to the Technical Advice Unit of the Rio de Janeiro Justice Court between May 2013 and September 2015, which litigated the provision of physiotherapeutic devices. Direct cost information was obtained from both public and private sources. The analysis was carried out using the SUS perspective.

About 63 percent of the patients were over 60 years old. The majority of the requests were due to chronic respiratory diseases, the most common being obstructive sleep apnea-syndrome (31 percent), chronic obstructive pulmonary disease (14 percent) and pulmonary fibrosis (11 percent). The most judicialized devices were continuous positive airway pressure (21 percent), oxygen concentrator (17 percent) and portable oxygen cylinder (13 percent). None of these devices are currently covered by SUS. The expenses related to the purchase of the devices pleaded was approximately USD812,500 over 29 months.

The total spend on these devices were considered very high when compared to Rio de Janeiro's health budgetary capacity. This scenario could be worse if this type of demand were not planned, and needed to be accomplished quickly with urgent purchases. The results obtained shows that judicialization phenomenon has a meaningful impact on the economic viability of the Brazilian healthcare system.

The use of applications (app) on mobile phones to health care is a trend. Its applications range from the use as energy calculators, monitoring clinical parameters, as well association with medical devices, personal health records or used to request appointments (1). Thus, it is intended to evaluate the regulatory instruments available in Brazil as to their sufficiency to analyze this new technology.

Assessment of regulatory instruments for mobile app registration by the Brazillian Health Regulatory Agency (Anvisa) (2). The main variables in the form of Class I and II are: Submission type, Postal Code, Electronic Site, Product code, Classification Rule, Class, Indication of Use / Purpose, Principle of Operation, Platform, Target Audience, Type of Environment, Compatibility, Safety Characteristics, Technical Standards used, Product Origin.

Since 2010, the registration of software in Anvisa has been observed. The evaluation of Class I and II software is performed through the registration analysis to be completed by the requesting company. Class III (high risk) software is registered as a medical device embedded software (2).

Anvisa's analysis of the software still depends directly on the application for registration of the companies. In this way most of the analyzed software are for use by health professionals and health services.

There are Brazilian regulations for health products with software registration forecast, however its use as a health service still lacks studies mainly with the trends of new information and communication technologies (3).

The regulation of mobile applications becomes difficult because applications are freely downloaded in virtual stores, their domains are usually in foreign territory and their use is given directly by the user.

We are experiencing a fundamental change in the way our target groups interact with information online, moving from passive consumption to more active creation of content, for example social video and social networks. This means a great potential in reaching more people in a cost-effective way which in the end will result in greater impact.

The Swedish Agency for Health Technology Assessment and Assessment of Social Services (SBU), have developed an easy way to produce and disseminate our results through social video and social networks.

SBU has a special social media editorial committee for communication via social media, which includes participants from different departments. The editorial committee discusses on a weekly basis the issues to be raised on the agency's Twitter and LinkedIn accounts.

SBU works actively with social video as a message channel. During the past year several videos have been published with various themes (1 - 3). All of the members of the social media committee have attendend a short training course in order to be able to produce and publish social videos. For shorter production, we make ourselves with iPhones and editing with iMovie or Adobe Premiere Pro. For more extensive videos we produce together with a production agency.

The number of followers on Twitter have increased from 500 in December 2015, to 1,400 in December 2016. Our followers are for example professors, doctors, nurses, physiotherapists, journalists, politicians, and opinion makers from patient organizations.

In our latest recruitment processes we have been experiencing significant number of qualified candidates, who found the link to our website through social media networks like Facebook and LinkedIn.

Social media should be at the heart of digital transformation as it crosses boundaries: you will have a broader impact and it has a great potential in reaching your target groups in a cost-effective way.

It takes on average 17 years to translate a promising laboratory development into better patient treatments or services. About 10 years of this innovation process lies within the National Institute for Health Research (NIHR) research pathway. Innovations developed through research have both national and global impact, so selecting the most promising studies to fund is crucial. Peer review of applications is part of the NIHR research funding process, but requires considerable resources. The NIHR is committed to improving efficiency and proportionality of this process. This study is part of a wider piece of work being undertaken by NIHR (1) to reduce the complexity of the funding pathway and thus make a real difference to patients lives.

This study elicited the views of various stakeholders concerning current and possible future methods for peer review of applications for research funding. Stakeholder groups included: members of boards with responsibility for making funding decisions; applicants (both successful and unsuccessful); peer reviewers and NIHR staff. Qualitative interviews were conducted with stakeholders selected from each group, and results were analyzed and integrated using a thematic template analytical method. The results were used to inform a larger online opinion survey which will be reported separately.

The views and insights of thirty stakeholders across the four groups about the peer review process of applications for funding will be presented. Findings generalizable to other funding programs outside the NIHR will be emphasized. The key themes which emerged included: strengths and weaknesses of applications, feedback, targeting and acknowledgement of peer reviewers.

The results of our study of peer review processes carried out by one national research funder has relevance for other funding organizations, both within our country and internationally.

Metastatic castration-resistant prostate cancer (mCRPC) is an incurable disease and represents a significant clinical, economic, and social burden. The therapeutic scenario of mCRPC has completely changed over the last years with the approval of several treatments (1). Radium-223 is a new target-alpha therapy showing a significant survival benefit in mCRPC patients (2,3). The study aimed to evaluate the introduction of radium-223 in Italy using Health Technology Assessment methodology.

To assess epidemiological, clinical, economic, organizational, social, and ethical aspects, a literature review was carried out. A cost-effectiveness and a budget impact analysis were performed from the National Health Service (NHS) perspective to compare radium-223 with other treatments and determine the budgetary impact of the utilization of radium-223 for the treatment of mCRPC.

In Italy, prostate cancer represents the most diagnosed cancer in men and the third in the whole population. When the disease becomes metastatic, approximately 80 percent of patients develop bone metastases, commonly associated to skeletal-related events (SREs) with a significant impact on survival, quality of life, and costs (1). Radium-223 is a novel alpha particle emitting therapeutic agent which targets new bone growth surrounding bone metastases. Different from other radiopharmaceuticals, radium-223 prolongs overall survival with a favorable safety profile (2,3). In order to optimize patient outcome, the management of radium-223 should be viewed in a multidisciplinary context. The administration is quite simple and requires only basal shielding. Currently it can be administered in hospital inpatient settings and in some regions the outpatient usage is allowed. Finally, radium-223 showed a favorable budget impact profile and cost-effectiveness when compared with best supportive care and new therapeutic agents (abiraterone, enzalutamide, cabazitaxel) (1).

The introduction of radium-223 allows provision of a new therapy, offering a valid alternative to patient with mCRPC without any increase of costs for the NHS.

In Bulgaria, the regulatory body sets for the first time legal requirements for Health Technology Assessment (HTA) in Law on Medicinal Products in Human Medicine (LMPHM) on 27 June 2015. The next essential step for HTA capacity building was the promulgation of Ordinance 9 / December 1, 2015 on the conditions and procedures for conducting health technology assessment by the Ministry of Health (1). In the beginning of 2016, the Main Price and Reimbursement Committee was set and launched a process for establishing the small working groups with the task of reviewing the first applicants reports of pharmaceuticals for inclusion in the Positive Drug List (PDL).

The objective of this study is to summarize the recommendations of the newly established HTA Committee in Bulgaria and to examine the characteristics of the technologies and the key considerations that led to those decisions. We systematically read all published by the Committee recommendations for 2016 and analyzed them under: type of recommendations (positive or negative for inclusion in PDL), population, specialization, type of service, type of justification and the impact on final conclusions.

For the first year of its work the HTA Committee was able to assess fifteen technologies (pharmaceuticals) and only one received a negative recommendation (6 percent) from the working group. All the rest (n = 14; 94 percent) were recommended for funding. The final recommendation from the Main Price and Reimbursement Committee is available for four (27 percent) technologies – all positive for inclusion in PDL. All recommendations were connected with adults and in oncology (n = 4; 27 percent); heart diseases (n = 4; 27 percent); Chronic Obstructive Pulmonary Disease, COPD (n = 2; 13 percent); diabetes (n = 2; 13 percent); psoriasis (n = 2; 13 percent); Hepatitis C (n = 1; 7 percent). The only negative recommendation was justified due to lack of robust evidence, safety issues and credibility of HTA analysis (2).

The information about the number of applications received from the Committee is not available and correct conclusions about the capability is not possible, but indirect circumstances, as the lack of well-trained HTA experts, certainly impede establishment of the small working groups and slow the assessment process (3). At this point it is clear that additional efforts are need to overcome the barriers and smooth adoption and implementation of HTA methods in Bulgaria.

The aim of this work is to evaluate the stability and robustness of the solution obtained at the end of the Health Technology Assessment (HTA) process by conducting a sensitivity analysis. Sensitivity analysis allows identification of the elements representing the source of uncertainty and to determine the impact of this variability on the stability of the assessment results, in order to provide more adequate and objective support to decision-making process.

A new method for health technologies evaluation, Decision-oriented HTA (1), which integrates the Analytic Hierarchy Process (AHP) (2) in the model Core Model® of the European Network for HTA (EUnetHTA) was taken into account. In this context, a mathematical model was implemented to conduct a sensitivity analysis on weights and on performance values of the technology alternatives evaluated. The objective is to evaluate the effects on AHP results induced by a change on initial values of each criterion of the decision-making model. Sensitivity analysis was carried out by calculating the minimum changes of the weights and performances needed to reverse the current ranking of alternatives technologies (3).

This approach was applied to some technology assessment studies such as video-laparoscopy, femtosecond laser, da Vinci robot, to test their efficacy and reliability. It is very important to perform a sensitivity analysis and assure the stability of the solution when the performance values associated to the technology alternatives are close because, in this case, a small change of performance values reversed the ranking of alternatives technologies.

Applying sensitivity analysis to such decision-making processes is essential to ensure the consistency of final decisions. This evidence has shown that this method allows for a more rapid interpretation of results, thus facilitating the choice of decision-makers about the decision to invest or not in new technology.

Drug product changes occur in hospitals for different reasons: improved efficacy or tolerance of a drug, reduced costs, new pharmaceutical innovations or drug shortage (1). The aim of this analysis is to develop a process model for drug product changes and to determine a hospital specific threshold when product change is reasonable, provided that the efficacy and safety of the new product is economically reasonable (2).

The individual process steps at the Klinikum rechts der Isar in Munich (MRI) were recorded to develop a process model. The required expenditure of time for the different process modules was documented and a process cost calculation undertaken.

Product changes can be divided into three groups: generic changes, identical active ingredient but different brand name, and complex drug changes with different active ingredients or changed drug formulation. The later change is associated with a higher demand for information, which is reflected in higher process costs. Relevant costs arise during the process of product purchase and on the ward. The cost per product change inclusive operating expenses at the MRI range (3) from EUR2,300 to EUR6,420 and depend on the frequency of prescription and the complexity of the product.

This Health Technology Assessment (HTA) shows that main costs for a drug product change arise due to additional staff costs on the ward. Reasonable thresholds can aid in decision making when considering cost effectiveness and potential risks of the medication or patient safety.

Drugs are a special commodity for treating diseases and protecting health. There are problems in China's drug research, production, distribution and use (1) thus the national drug policies, including government long-term frameworks and specific policies, play an important role (2). This study summarized and analyzed drug policies in China since the New Medical Reform, to determine patterns of policy change, and aiming to provide theoretical support for drug policy making for the world.

We downloaded all drug policies issued between April 2009 to December 2016 on State Council, National Development and Reform Commission, National Health and Family Planning Commission, China Food and Drug Administration websites. These documents were combined with academic articles to extract data, which was processed in Microsoft Excel 2013. We also use the Advocacy Coalition Framework to analyze dynamic factors for drug policy change in China.

There are 113 drug policies during last 8 years on 4 websites; 76 of them are released by a single ministry. Thirteen, ten, ten, fifteen, seven, fourteen, twenty-six and eighteen policies are issued each year, respectively. Fifteen are classified in long-term frameworks, while the other ninety-eight are specific policies. And fourteen of ninety-eight policies are focusing on basic drug systems, while six are on centralized purchases, nine on public hospitals reform, seven on drug safety, sixteen on prices, fourteen on distribution, twelve on administration, five on traditional medicine, and fifteen on specific drugs.

After the basic drug system was built in 2009, the government started to focus on its distribution over the next 7 years. Policies on centralized purchases are mainly issued in 2010 and 2015, and creative modes have been coming up since 2015. The Government cares not only about production safety, but also safety in sales. Prices were decided by government at first but then follow the market forces. Work focus shifted from the above contents to drug distribution, price, management and traditional medicine after 2012. The peak of policy releases occurred when the great reform took place, such as 2009 when reform began, and in 2012 the Twelfth Five-year plan began. There was a decrease in 2013 due to national leadership change (3). Overall, dynamic factors for policy change mainly are social conditions, public issues and opinions, and feedback on former policy effects.

Treatment options for macular edema include intravitreal corticosteroids (1). Traditionally, an injectable suspension of triamcinolone acetonide (TA) had been employed off-label (2); in recent years, authorities have approved sustained-release drug delivery systems (DDSs) for corticosteroids (3). Considering the hypothesis that the use of these drugs is based on widely variable evidence in terms of methodological quality and robustness, the purpose of this analysis is to compare the quality of the evidence on efficacy and safety of three different formulations of intravitreal corticosteroids: the dexamethasone (DEX) implant, the fluocinolone acetonide (FA) implant, and the preservative-free injectable suspensions of TA, in the management of two retinal pathologies: diabetic macular edema (DME) and macular edema secondary to retinal vein occlusion (RVO).

A search of clinical trials on MEDLINE from 1 January 2000 to 16 December 2015 was performed. Studies were included in the analysis if they met the following criteria: (i) related to at least one of the preparations of interest in patients with DME or macular edema secondary to RVO; (ii) included a control group treated with placebo, observation, sham procedures or conventional treatments; and (iii) included visual acuity, retinal thickness and/or safety parameters as outcomes. Results were summarized in a narrative manner.

Twenty-five publications from nineteen RCTs were included. We observed increased attention of researchers towards TA compared to DEX and FA; however, studies for TA are less robust. Scientific publications related to DEX and FA implants are of higher quality, especially in terms of randomization and masking procedures.

Even though each of the three considered corticosteroid-containing medicines are approved for marketing and included in clinical guidelines for treatment of macular edema, a high degree of heterogeneity in terms of quality of evidence has been noticed among them. This observation underlines the need to review the requirements for drug approval and their inclusion in clinical recommendations, as well as the importance of post-markeing monitoring to generate new evidence.

In 2014, the Ministry of Health, Labor and Welfare (MHLW) in Japan began to assume a cost-effectiveness perspective. Some expensive pharmaceutical and medical devices have been regulated, which resulted in a drastic change of the healthcare system.

The Japanese National Insurance Claims Database (NDB) is an administrative database based on claims data from Medical Insurance Claims since 2008. The government enacted the Act on Assurance of Medical Care for Elderly People during health care reform in 2008. In 2006, the MHLW commenced discussions on a framework for the optimization of the healthcare expenses, which aimed to evaluate the structure of the increase in healthcare expenditure.

The NDB was developed as a tool for investigation and analysis by the MHLW in the context of the Healthcare reform. In addition, the NDB was used for the development of academic research in order to contribute to the implementation and evaluation of healthcare policy management.

A major strength of the NDB is its exhaustiveness or completeness of insurance claims. The NDB collects data from all insured people nationwide and covers all medical institutions in Japan.

We applied to the Expert Meeting on Provision of Medical Insurance Claims to examine the research plan, items extracted, and data management. Inpatient and Outpatient information was extracted on medical procedures and payment. Diagnoses for both inpatients and outpatients are coded according to the International Classification of Diseases Tenth Edition (ICD-10). The coding of treatments and surgeries follow Japan's local procedure and surgical coding, which was specifically developed for insurance claims.

We generated any personally traceable patient ID from the “hash ID” generated by patient name, sex, date of birth, and insurer number with the aim of protecting personal identifying information in the NDB. The disease of stroke was defined to analyze the database for cost-effectiveness analysis, and to connect disease information to. The prescription claims information described pharmaceutical names, prescription date, total dose, and number of days.

Our study showed the new standard way of analysis for cost-effectiveness analysis using the Japanese National Insurance Claims Database.