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.

Recently, a number of mobile apps to record symptoms and medication by patients themselves have been developed. These apps are expected to improve the patients' symptoms through self-management, and to enable a smooth decision making through effective communication between doctors and patients. “Itami Renrakucho” (Pain Diary, Welby Inc.) is one of these apps that records body pain, medication, physical conditions, and activity in life. We examined the relationship between pain and medication/activity based on its data.

Data between 25 December 2015 and 9 December 2016 were used. Medication and degree of pain (0-10, low < high) were recorded at morning, daytime, evening, and bedtime. Of ninteen activities, up to three were recorded about whether they could or could not do them. We compared the degree of pain among different frequency/timing of medication, or activities that they could or could not do.

Data included 708 individuals. Among 561 individuals who answered about pain, the mean (Standard Deviation, SD) degree was 5.0 (2.3). The mean degree in individuals taking 0, 1, 2, 3, and 4 times medication a day were 4.6, 5.0, 5.4, 5.5, and 6.2, respectively. Regarding medication timing and degree of pain in two consecutive time points (t0, t1), regression towards the mean occurred for individuals without medication in both time points. The degree changed more for individuals taking medicine only at t0, but not for those taking at both time points. Weaker pain was reported when they could do hanging laundry and rising early than when they could not, but they could do shopping, strolling and light exercise even having stronger pain.

We showed a tendency of relationship between pain and medication/activity based on the data from the app. More data and connecting to claims will help us to show characteristics of patients and diseases, select a treatment, and evaluate a medicine.

Health Technology Assessment (HTA) aims at providing decision makers with relevant data, matching different perspectives, with an evidence-based approach. The most common framework used is the European Network for Health Technology Assessment (EUnetHTA) Core Model (1): HTA may be further supported by a Multi-Criteria Decision Analysis (MCDA) (2,3), leading to a final quantitative synthesis, facilitating the appraisal phase.

This project presents a multi-dimensional comparison of the technologies available for the treatment of diabetic macular edema (Ranibizumab, Aflibercept, Dexamethasone implant and off-label Bevacizumab), comparing three Italian Regions: Lombardy, Liguria and Veneto.

The nine EUnetHTA dimensions were first prioritized by seventeen multidisciplinary evaluators. Thereafter a further nine professionals attributed a 3-level rating score (from “1” not performant, to “3” most performant) to each dimension and sub-dimension, after carefully assessing the three HTA reports. In conclusion, the investigation of statistically significant differences between the attributed scores of the evaluators was conducted, using a multi-variate analysis.

No statistically significant differences were reported in the prioritization of each dimension, except for the equity (more important in Liguria and in Lombardy) and the economic financial dimensions (more relevant in Veneto and in Lombardy).

Notwithstanding the evaluators’ different professional titles, job roles, center size, and various Regional contexts, they attributed similar scores to the HTA dimensions during the appraisal phase (even though conducted in different years, in 2015 and 2016). This finding demonstrates the robustness of both the evaluations and the final MCDA results: i) no statistically inter-regional significant differences emerged regarding Ranibizumab and Aflibercept (p-value >.05); ii) no statistically significant inter-regional differences emerged regarding Dexamethasone, except for the assessments in the clinical dimensions (p-value = .026), since in Lombardy Region the evaluation was carried out earlier in the technology's life-cycle.

Dexamethasone was consistently attributed a higher total score, considering the final normalised weight derived from the MCDA approach (p-value =.001).

Patients who experience Transient Ischaemic Attack (TIA) should be assessed and treated in a specialist clinic to reduce risk of further TIA or stroke. But referrals are often delayed. We aimed to identify published studies describing pathways for emergency assessment and referral of patients with suspected TIA at first medical contact: primary care; ambulance services; and emergency department.

We conducted a scoping literature review. We searched four databases (PubMed, CINAHL, Web of Science, Scopus). We screened studies for eligibility. We extracted and analysed data to describe setting, assessment and referral processes reported in primary research on referral of suspected TIA patients directly to specialist outpatient services.

We identified eight studies in nine papers from five countries: 1/9 randomized trial; 6/9 before-and-after designs; 2/9 descriptive account. Five pathways were used by family doctors and three by Emergency Department (ED) physicians. None were used by paramedics. Clinicians identified TIA patients using a checklist incorporating the ABCD2 tool to describe risk of further stroke, online decision support tool or clinical judgement. They referred to a specialist clinic, either directly or via a telephone helpline. Anti-platelet medication was often given, usually aspirin unless contraindicated. Some patients underwent neurological and blood tests before referral and discharge. Five studies reported reduced incident of stroke at 90 days, from 6–10 percent predicted rate to 1.2-2.1 percent actual rate. Between 44 percent and 83 percent of suspected TIA cases in these studies were directly referred to stroke clinics through the pathways.

Research literature has focused on assessment and referral by family doctors and ED physicians to reduce hospitalization of TIA patients. No pathways for paramedic use were reported. Since many suspected TIA patients present to ambulance services, effective pre-hospital assessment and referral pathways are needed. We will use review results to develop a paramedic referral pathway to test in a feasibility trial.

In Brazil, the pharmaceutical sector has requested an individual incorporation in the Brazilian public health system (SUS) for each new drug for multiple sclerosis that receives sanitary authorization for marketing. Horizon Scanning within Brazilian Ministry of Health has played a key role in the recommendations made by the National Committee for Health Technology Incorporation (CONITEC). Horizon Scanning seeks to predict which technologies have potential to impact health care in SUS, before their formal request. This study aims to present the impact of horizon scanning in two assessments made by CONITEC on drugs to treat Multiple Sclerosis.

Grey literature was searched to find new and emerging drugs for multiple sclerosis treatment. Regulatory agencies were also searched: European Medicines Agency (EMA), Food and Drug Administration (FDA) and Brazilian Regulation and Health Surveillance Agency (Anvisa). A pre-defined standardized form was used. Information extracted about each drug was identified as: drugs name, mechanism of action, indication, administration route, finished phases of clinical trial and registration in other countries.

In 2014, horizon scanning identified seven drugs while CONITEC was assessing Fingolimod for multiple sclerosis. In this case, the drug's administration route was a differential, as only three new drugs identified were also orally administrated. Thus, Fingolimod received a positive recommendation for incorporation. In 2016, horizon scanning identified fourteen drugs while Teriflunomide was under assessment. At this moment, the orally administrated Fingolimod was already available and it was identified other eight new drugs with the same route. Therefore, the initial recommendation was against its incorporation.

Horizon scanning has proved to be of major importance for assisting recommendation-making process of the committee. In the two cases presented, horizon scanning information could predict which technologies were being developed and could be registered in Brazil. These new technologies had influenced the recommendations made by CONITEC's members. As a result, a horizon scanning section in all CONITEC's reports became mandatory.

Pediatric parenteral nutrition is mainly used in neonatal intensive care units (NICU) and requires close collaboration with the hospital pharmacy, especially for manufacturing time, application, preparation and delivery (1). In this context, a Health Technology Assessment (HTA) to evaluate an automatic system compared with a manual system was carried out.

The Decision-oriented HTA (DoHTA) method (2), coordinated by Bambino Gesù Children's Hospital (BGCH) HTA Unit, was applied to carefully assess the technology. It was developed starting from the European Network for HTA (EUnetHTA) Core Model® and integrated with the Analytic Hierarchy Process (AHP). Its purpose is to identify all the relevant assessment aspects of automatic system integrating the evidence from the scientific literature with experts’ judgments and the specific context analysis for BGCH: an evaluation scheme inherent safety, clinical effectiveness, technical and organizational aspects (represented by a decision tree at three levels: dimensions of evaluation, I and II level indicators) was subsequently created. A weight was finally associated to each identified element and the alternatives’ ranking was defined.

The study results show a “performance value” associated with the automatic system greater than about thirty-two percentage points compared to the manual system.

At the current state of the scientific evidence and the results of analysis carried out by the working group, it is believed that the choice should be made to introduce the automatic system is available in BGCH.

More specifically, from the point of view of safety, automatic system is safer for both patient and operators; about clinical effectiveness, the system improves the nutritional intake, allows a reduction of post-infusional adverse events and the use of antibiotic therapy; concerning economic aspects, the analysis of available data shows a substantial equivalence between the alternatives considered; the technical-functional aspects show an improvement according to almost all indicators; organizational aspects show a slight improvement in the working and in process management and finally the legal aspects indicate a slight advantage for the automatic system.

In 2013 the Essencial Project launched in Catalonia promotes the identification of low-value practices (LVP) by healthcare professionals and elaborates recommendations to avoid them. This project aims to reduce unnecessary care of health care services which harm outweighs the benefits, resulting in physical, psychological to the patients and wasteful healthcare services. The main objectives are to describe the implementation process at the primary care level and to evaluate the impact of recommendations on general practitioners (GPs) practice.

The implementation process consists in:

(i) Nomination of clinical leaders to promote the project among their primary care teams (PCT) and to lead the implementation activities by identification of barriers and enablers for change in clinical practice towards avoiding LVP.

(ii) Selection of recommendations to be implemented and definition of corresponding activities to be carried out by each PCT according to the specific characteristics of their organizations.

(iii) Development of related indicators and comparison between baseline status

One hundred and sixteen PCT (covering 30 percent of the Catalan population) participated in the pilot experience of implementation. Twenty-one recommendations were selected such as: bisphosphonates in post-menopausal women with low risk of fracture, PSA screening and statins for primary prevention of cardiovascular disease, among others. At 12 month follow-up, use of bisphosphonates were reduced by 21 percent (p = .0005), PSA was reduced by 14 percent (p = .0009). The use of other treatments such as antidepressants, benzodiazepines for some specific clinical conditions decreases with no statistically significant changes.

This is the first experience in Catalonia and Spain of implementation of the recommendations to avoid LVP with early involvement of target professionals. Follow-up results provide information about the early impact of recommendations at primary care level. Our challenge is to implement the recommendations at hospital level.

Severe aortic stenosis with symptoms or left ventricular dysfunction has commonly a poor prognosis. Aortic valve replacement is usually performed for these patients aiming at improving their functional class and survival rate. Transcatheter aortic valve implantation (TAVI) is often presented as an option in patients with high surgical risk for conventional surgical valve replacement.(1) Nonetheless, in this group of patients, the literature has yielded conflicting evidence suggesting that benefits of TAVI for patients of high or intermediate surgical risk is not consistent.(2,3)

This retrospective study aimed to evaluate the mortality rate from a cohort of patients after the correction of aortic valve dysfunction with TAVI. It consisted of a convenience sample of patients at high risk for open surgery for the correction of aortic valve dysfunction treated with TAVI from 2013 to 2016. All included patients were being provided healthcare assistance by a private nonprofit health maintenance organization (HMO) operating in Belo Horizonte, Brazil. Since TAVI is not currently covered by the Brazilian supplementary healthcare system, reimbursements were enforced by lawsuits. Data was extracted from an administrative database, using the software Oracle Business Intelligence®. Continuous variables were expressed as mean and standard deviation. The Kaplan-Meier method was used to adjust the 1-year survival curve using the software STATA 13.1 (Stata Corp, College Station, TX, USA). This historical cohort resulted in no interventions, neither during the course of the instituted treatment nor after the observed outcome. Privacy of subjects and the confidentiality of their personal information were handled in accordance to the ethical principles of the Declaration of Helsinki.

Overall, seventeen patients with a mean age of 80.5 years (68-91) underwent TAVI; 59 percent were women. Peri-operative mortality rate was 23.5 percent (n = 4) and accumulated overall one-year mortality was 35.3 percent (n = 6). Mean length of hospital stay was 26.9 ± 16.6 days. Prolonged hospital stay (≥ 7 days) occurred in 14/17 cases (82.3 percent), with a maximum of 51 days.

In similarity to our findings, other authors described a high early and late mortality rate in patients undergoing TAVI. The strategy to use TAVI as an alternative in patients at high risk for open surgery is still under debate and should be carefully discussed taking into consideration the local team expertise as well as local healthcare available recourses.

The introduction of new biologic treatments has radically changed the management of Immune-mediated inflammatory diseases (IMID). Due to the high costs of the treatments a strong control and monitoring of claims databases could help decision makers to understand the consequences of their decisions.

The objective of the study was to identify the cohort of biologics treatment-naïve patients in the years 2011–2013 in the Lazio region (6 millions of inhabitants), in order to investigate the parameters influencing the biologic treatment expense at the regional level.

Patients were enrolled based on administrative databases of the Lazio region. Treatment-naïve patients were defined as subjects who did not have a prescription in the two years before the index prescription. Switcher patients were defined as those who had an Anatomical Therapeutic Chemical classification (ATC) prescription different than the one at enrolment, within one year of the index date. Treatment adherence was estimated as the number of doses actually prescribed as compared to the number indicated in the Summary of Product Characteristics (SPC).

From a total number of 10,120 patients treated with biologic drugs between 2011–2013 in the Lazio region, 2,929 were estimated as treatment-naïve patients (42 percent male). The most frequently used drugs were etanercept (31 percent), adalimumab (30 percent) and infliximab (17 percent). Considering the disease treatment distribution, 28.6 percent of patients were treated for rheumatoid arthritis, 25.5 percent for psoriatic arthritis, 16.4 percent for psoriasis and the remaining patients for other diseases. Some patients switched biologic therapy (367), of which 22.6 percent were within the first 120 days. Total mean adherence was estimated in 87.7 percent: 21.5 percent of patients showed a low adherence (SPC< 60 percent) while 18.1 percent were estimated as dose increase patients (SPC>110 percent), 11.4 percent for rheumatic diseases, 32.3 percent for dermatological diseases and 26.9 percent for inflammatory bowel disease.

The study provides a map of the current treatment settinga with biologics in the Lazio region considering the disease, adherence and prescribed treatments. A considerable number of treatment-naïve patients were identified (2,929), 12.5 percent of whom switched ATC within 1 year. Total mean adherence was estimated in 87.7 percent, low adherence occurred in 21.5 percent of patients, while dose-increase was in 18.1 percent.

Multiple Sclerosis (MS) is an inflammatory neurological disease. The standard treatment is disease modifying drugs which may alleviate symptoms and slow the progress of disability, but not lead to remission. Autologous Hematopoetic Stem Cell Transplantation (AHSCT) is a new technology for treatment of MS in Norway. Disease remission in some patients treated with AHSCT has been postulated, in particular in patients in the early course of disease with high disease activity classified as having Relapsing-remitting multiple sclerosis (RRMS), but severe complications have also been reported.

We conducted a systematic literature search. No restrictions were set in terms of study design, although case series should include at least ten patients with a majority having RRMS. We performed a cost analysis from a healthcare perspective with a time frame of one year.

One randomized controlled trial (RCT) (n = 21, RRMS = 7), one registry study (n = 345), and seven case series (n = 442, RRMS = 277) without control groups were included. Estimated transplant-related mortality was 2 percent or lower. Serious adverse events, such as infections, were common during follow-up. Stabilization or improvement in neurological status was reported in 63 percent to 89 percent of the patients after three years, and the number of Gd+ and T2 lesion volume assessed by Magnetic Resonance Imaging was reduced. The quality of evidence assessed using the “Grading of Recommendation Assessment, Development, and Evaluation” tool was low for transplant-related mortality and very low for the other outcomes. HSCT costs were approximately between 480,000 and 605,000 Norwegian kroner per patient in the intervention year. A heterogeneous disease progression, significant risks associated with the method, lack of effective treatment options, and uncertainty about the benefit versus risk, implies that any decision to offer HSCT in the treatment of MS is ethically challenging.

The main limitation in this HTA is the absence of controlled studies, which introduces a high risk of bias. Studies without control groups, including mainly patients with RRMS, reported that disease activity could be delayed or stopped for a period of up to three years in several patients, whereas adverse events were common. Ethical considerations are associated with significant uncertainty of benefit versus harm. The low level of evidence implies the need for controlled trials.