Solid organ and hematopoietic cell transplantation are some of the more expensive procedures universally paid by the public Brazilian Unified Healthcare System (SUS). Transplanted patients depend on maintenance immunosuppression to prevent death or graft loss. A bottom-up heuristic process proposed new immunosuppression drugs for incorporation into the SUS.

Systematic evidence synthesis and Brazilian transplantation registries base-cases, Kaplan-Myer survival and economic assessments were presented in specialized national congresses with open public Delphi sessions to build professional Clinical and Therapeutic Protocols (PCDT) by consensus. Five consensus transplantation PCDTs with a SUS perspective budget impact and sensitivity analysis were submitted to the Health Ministry SUS Technology Incorporation National Commission (CONITEC) plenary for a decision. PCDTs were publicized in CONITEC Internet and Diário Oficial da União, an, official periodic publication, as well as undergoing widespread dissemination through mailings for Public Consultation. Public contributions were added to PCDTs to support Health Ministry policy making.

The São Paulo State Health Secretariat coordinated the synthesis and economic assessments made by 115 experienced transplantation specialists and health technology evaluators over ten years. Heart, lung, liver, pancreas and hematopoietic cells transplantation PCDTs (with tacrolimus, sirolimus and everolimus alternative immunosuppression) can significantly prevent 27.8 percent, 28.1 percent, 7.2 percent, 11.1 percent and 4.3 percent graft loss or graft versus host disease and death, respectively, for refractory transplantees rescue during the first year post-transplantation, saving healthcare resources. Ten-year follow-up data demonstrated partial benefits were sustained. Analysis demonstrated +USD689,655.17, +USD501,567.40, -USD377,802.51, +USD221.289,42 and +USD50.734,08 budget impact, respectively, resulting in an overall USD1,085,443.55 for 2,146 transplantees. The 5 PCDTs were favorably voted by CONITEC plenary members, 155 public contributions were added by patients and stakeholders, and the Brazilian Health Ministry decided to adopt the SUS reimbursement listing.

Democratic participation gave PCDTs real-world basis adjustments, SUS innovation and improved compliance.

Payment by result agreements have been quite widely used in Italy to provide access for high costs oncologic drugs and minimize uncertainties of real life benefits (1). The aim of this analysis was to overview the Roche experience in terms of Payment by Result (Pbr) in oncology and investigate the relation between timing for the evaluation of treatment failures and observed Time to Off Treatment (TTOT) from Phase III clinical trials (2).

A retrospective analysis of the Roche payment by results schemes in place in Italy was conducted. For each drug included in the analysis it was collected: (i) the negotiated timing to assess the treatment failure for payment by result, (ii) the median time to off treatment curve observed in clinical trials for the experimental drug, (iii) the median time to off treatment observed in clinical trials for the control arm. The mean ratios between timing to assess the treatment failure for payment by result and the time to off treatment observed for the experimental drug or the median time to off treatment observed in the control arm were calculated to identify potential correlations. High level of correlation was expected if ratio was close to 1 (±.2).

Roche products or different indications of the same product were identified as candidates for the analysis from 2008 to 2016. The timing for the evaluation of treatment failures for Pbr varies between 2 and 9 months, depending on the type of tumor and line of therapy. The mean Time to Payment By Result (TTPbr) / Control arm Time To Off Treatment (cTTOT) ratio was 1.16 (±.37) while the mean Time to Payment By Result (TTPbr) / Experimental arm Time To Off Treatment (eTTOT) ratio was .71 (±.13). Data analysis according to different time periods shows that the mean TTPbr/cTTOT and TTPbr/eTTOT for drugs negotiated from 2008 to 2015 were respectively 1.07 and 1.39 whereas for drugs negotiated in 2016 were respectively and .63 and 1.

Good level of correlation between TTPbr and cTTOT was found. This finding is in line with the methodology used by Italian Medicines Agency so far, leveraging the cTTOT as the most appropriate proxy to assess any incremental effect of a new drug compared to the previous Standard of Care. The analysis over time of TTPbr shows that in the first years of payment by result negotiation TTPbr is more correlated to the cTTOT whereas in the last years is moving closer to the experimental one.

Chronic Pain (CP) is the uncontrolled pain that affects patients for a long time. CP can be caused by many conditions, sometimes still poorly understood, and its levels can vary from moderate to intense. The management of resistant CP requires a stepwise approach and spinal cord stimulation (SCS) could be considered an extreme strategy. With the aim of ensuring the economic sustainability, the Veneto Region usually establishes rigorous access criteria to high-cost medical devices through its Regional Technical Committee on Medical Devices (CTRDM) and a Health Technology Assessment (HTA) procedure.

The Regional Health Technology Assessment Unit (CRUF) conducted through Pubmed a literature review of randomized controlled trials, systematic reviews, meta-analysis on SCS published from March 2006 to February 2016. International and national clinical guidelines were included in the analysis as well. The regional multidisciplinary Working Group on CP, which involved local clinicians, pharmacists, clinical engineer and health economist, discussed the collected evidence by consensus. Final recommendations on the appropriate use were submitted to the CTRDM for final approval.

The regional guidance describes the type of pain that can be treated with spinal neurostimulators and the criteria which determine the success of the test procedure. A comparative analysis of spinal neurostimulators available on the market and related patients eligibility criteria have been also included. Moreover, the guidelines stated a list of compulsory requirements in order to become a regional center authorized in performing spinal neurostimulation procedure. Finally, the document describes some indicators for appropriateness monitoring. The CTRDM approved the final version in October 2016.

The regional guidance on SCS aims at ensuring the appropriate use of neurostimulators in patients affected by resistant CP. The strict monitoring of agreed indicators is essential for appropriateness and consequently the sustainability of medical devices expenditure throughout the Regional Health Service.

To outline the methodological issues associated with the assessment of newborn screening for severe combined immunodeficiency, which was conducted to address the policy question of whether this test should be added to an existing newborn screening panel.

We conducted a systematic review of published primary studies and critically appraised the methodological quality of selected studies (1).

Fifteen studies were included; six focused on screening test performance, and seven on treatment effectiveness, and two on the effectiveness of a newborn screening program. The methodological issues identified included: (i) Overall poor methodological quality ratings of included studies using the QUADAS-2 (Quality Assessment of Diagnostic Accuracy Studies-2). This tool was originally developed for assessing diagnostic accuracy studies where subjects usually receive both index test and reference standard so a 2×2 table can be constructed; however it is almost impossible to apply this cross-sectional approach to studies of a screening test for a rare disease like severe combined immunodeficiency. (ii) Case control design using healthy controls could inflate estimates of test accuracy compared to studies using a cohort of consecutive patients, possibly due to spectrum effects and limited-challenge bias. This type of study is useful in the early phase of test development, but estimates of test accuracy based on this type of study should be interpreted with caution. (iii) Some screening programs reported no false negatives, indicating a sensitivity of 100 percent. However, lack of a systematic search for “missed cases” created uncertainty in arriving at a true value for the sensitivity. (iv) Variations in inclusion of pre-term infants, races/ethnicities, and screening protocols made it difficult to compare screening test performance across different studies.

Although severe combined immunodeficiency screening was the first addition to the US Recommended Uniform Screening Panel following an evidence-based review process, caution needs to be exercised when interpreting research findings due to important methodological issues.

Nudging is the application of behavioural sciences aimed at influencing behaviour in a non-prescriptive way. It is a tool of public health decision makers to produce health gain. Just like decisions in the field of Health Technology Assessment (HTA), nudging decisions are inevitably value laden. The current European Network for HTA (EUnetHTA) approach to evaluate ethical aspects encompasses mainly utilitarian and principlistic approaches. The aim of this project is to incorporate the virtue ethics approach in public health decision-making processes based on the example of nudging.

The narrative analysis of nudging is based on a systematic literature search conducted from 28 October to 13 November 2015 in the following databases: Medline via Ovid, Embase, and TRIP Database. A total of sixty-two articles were listed as relevant as a result of searches and, in addition, twenty-five more articles were found through hand searching.

Regardless of the potential issues related to nudging (manipulation or coercion), nudging is considered cost-effective and inevitable because of the malleability of human psychology for example, alcoholic drinks served in smaller glasses nudge people to drink less alcohol.

No policy intervention, nudging or HTA, is value neutral and hence it requires an ethical evaluation. It takes traits of character, virtues, to discern which principle to apply in what circumstances and phronesis, practical wisdom, is the key virtue of a decision maker. Phronesis is not a moral judgement deduced from principles, but it is context specific, bottom-up, action orientated, and framed through dialogues. It focuses on the agent, the decision maker, who, via the use public scrutiny, should be held accountable for phronetic decisions made.

Nudging is a cost-effective tool that can improve the populations health in a non-prescriptive way. Transparent reporting open to public scrutiny is necessary for the sake of evaluating whether the decisions made were phronetic for it takes traits of character, virtues, to decide between competing moral principles.

Hyperhidrosis is characterized by uncontrollable excessive sweating, which occurs at rest, regardless of temperature. Symptoms can significantly affect quality of life. There is substantial variation in the secondary care treatment of hyperhidrosis and uncertainty regarding optimal patient management. The objective of the Health Technology Assessment (HTA) was to review the evidence and establish the expected value of undertaking additional research into effective interventions for the management of primary hyperhidrosis in secondary care. Capturing the perspectives of patients and clinicians treating hyperhidrosis was an important part of the research.

The assessment included a systematic review and economic model, including value of information analysis. Patients, dermatologists, a vascular surgeon and a specialist nurse (who set up the UK Hyperhidrosis Support Group) provided advice at various stages, including at an end-of-project workshop, to help interpret results and prioritize research recommendations.

Patient and clinician advisors were unsurprised by the finding that there is evidence of a large effect of botulinum toxin injections on axillary hyperhidrosis symptoms in the short to medium term; there was consensus amongst patients and clinicians that botulinum toxin injections were very effective. The advisors agreed that a trial of botulinum toxin injections (plus anesthetic) versus iontophoresis for palmar hyperhidrosis would be useful. Patients and clinicians were happy with the sequence of treatments identified as being cost effective for axillary hyperhidrosis: iontophoresis, botulinum toxin injections, anticholinergic medication, curettage, endoscopic thoracic sympathectomy. All patients agreed that the Hyperhidrosis Quality of Life index (HidroQoL©) tool was superior to other commonly used tools for assessing quality of life in hyperhidrosis.

Patients and clinicians considered the key findings of the systematic review and economic analyses to be appropriate. Advisors advocated a trial of botulinum toxin injections (plus anaesthetic) versus iontophoresis for palmar hyperhidrosis. Patients preferred the HydroQoL® tool over other commonly used quality of life tools in hyperhidrosis research.

An appropriate governance of the installed equipment base, by defining replacements strategies and programming introductions of innovative Biomedical Technologies (BT), has direct effects on the efficiency and effectiveness of health systems. An effective health technology management is of paramount importance for providing safe, high quality and innovative care with the constraint of health-care budgets, safeguarding equity, access and choice principles. Data from the regional BT information flow show that, compared to the gold standard (1), the North Region of Italy has about 15 percent less of large medical equipment younger than 5 years and about 15 percent more of equipment older than 10 years.

In order to draw a unified path of BT procurement processes, in 2013 and 2014 regional regulations (2,3) were enacted. Each Public Hospital and Local Health Authorities (ASRs) defined a plan (PLTB) containing, regardless of the form of procurement and type of funding, all BT requests for a value greater than EUR40,000 distinguished in replacement/new acquisition/upgrade, innovative acquisition and donations. Requests of BT have to obtain the authorization by the Regional Healthcare Authority Commission (GTB), in compliance with defined criteria, including financial and sustainability aspects, after the evaluation of the Regional Clinical Engineering Commission (GIC) supported by IRES, Health Technology Assessment and Management research group.

Over the years 2014 and 2015, the ASRs submitted 491 BT requests, of which 87 percent were replacement/new acquisition/upgrade, 9 percent innovative acquisition and 4 percent donations. Altogether 26 percent of these instances were urgent and 2 percent were unique BT on the market. Sixteen percent of requests for replacement/new acquisition/upgrade of BT related to large medical equipment with mean age of 13.3 years, 2 percent regarded innovative BT with average age of 8.4 years and 48 percent widespread technologies with mean age of 15.6 years.

The limitations in investments deriving from being a Region in “Recovery Plan”, have originated an absence of BT programming, as shown in PLTB by the prevalence of requests for the replacement management of obsolete equipment with inadequate performance, high machine downtimes and elevated maintenance costs.

In a budget constrained environment characterized by an increasing number of high-cost medicines, manufacturers need to demonstrate that their drugs can provide value-for-money. In this complex environment Managed Entry Agreements (MEAs) have been developed with the aim of sharing the risk between the National Health Service (NHS) and manufacturers (1). The objective of this analysis was to identify a correlation between Anatomical Therapeutic Chemical Classification (ATC) and different type of agreements assigned taking into consideration the distribution of Italian Medicines Agency registries by ATC and by kind of agreement negotiated (financial or performance based) (2).

This analysis takes into account all drugs under monitoring AIFA registries in place in Italy from 2006. For each registry included in the analysis it was collected the status of the registry (active, closed or incoming), the disease area that the registry covers and the monitored drugs with or without an associated Managed Entry Agreements. Considering the high weight of oncology drugs, a sub-analysis was done to investigate registries distribution for each specific form of cancer.

The majority of drugs monitored are under a registry with no associated risk sharing agreement according to AIFA (60 percent). For what concerned monitored drugs with an associated agreement, performance-based agreement is the most diffused type of MEA. In terms of therapeutic area involved in the monitoring registries activity, oncology was the most common area. Financial based agreements characterize principally medicines used for Leukemia and Hepatitis C, whereas drugs administrated for Melanoma, Breast and Ovarian Cancer and Ophthalmology diseases follow performance based agreements.

MEAs represent a way to guarantee a sustainable access for innovative medicines. It is proven that oncology products are most likely to have a MEA since they represent some of the most expensive drugs launched in recent years. From this study appear a correlation between the therapeutic disease area of the monitored drugs and MEA assigned by AIFA which is influenced also by other factors like budget impact, risk-benefit ratio and the presence of appropriate endpoints to evaluate the treatment response.

One of the barriers of integrating ethics in Health Technology Assessment (HTA) relates to the social role of HTA (1). The aim of this study is to provide a better understanding of the way by which law circumscribes the social role of HTA. Our hypothesis: HTA's social role is embedded within a mixed governance based on hard law and soft law.

Three HTA agencies were conveniently selected for our study: Haute Autorité de santé (HAS) (France), National Institute for Health and Care Excellence (NICE) (United Kingdom) and Institut national d'excellence en santé et en services sociaux (INESSS) (Québec, Canada). Our analysis of the legal, administrative and procedural documents relating to the existence and assessment processes of these three agencies is guided by the following criteria:

1. 1. The normative strength of the documents (categories of hard law or soft law) (2)

2. 2. The definition of the agencies’ social role (1)

3. 3. The integration of ethics in the agencies’ mandate.

Hard law contributes to establish a general mandate and some legal legitimacy for these agencies. Soft law, grounded in the HTA producers' practices, plays a major role in the legal governance of HTA. Our results demonstrate that these agencies existing practices seem to circumscribe their social role further than their constitutive laws. In this context, social actors become responsible to define, structure and operationalize the implementation of HTA.

In addition, the legal framework (hard law) through which HTA unfolds does not clearly support its structural and social role. Despite existing legal frameworks, the normative legitimacy of HTA is not entirely established, as it depends on soft law. Taken altogether, this maintains a persisting conceptual vagueness in HTA governance.

The social role of HTA should be defined either through modifying existing legislations (hard law) or through harmonization of the agencies internal policies and regulations (soft law). Such legal initiatives would help clarify the aims of HTA evaluations: assessments (scientific) or appraisal (value-laden), and therefore give a clearer indication on how best to integrate ethics in HTA.

Our Hospital-based Health Technology Assessment unit (HB-HTA) was founded in 2011 following the nomination of Louis-H. Lafontaine hospital as the Montreal University Mental Health Institute (IUSMM). From the beginning, the HB-HTA has been supporting and advising the Chief Executive Officer of IUSMM in the decision-making process concerning the implementation of new technologies and practices in mental health. Since 2015, the HB-HTA is part of the East of Montreal Regional Integrated Health and Social Services Centre (CIUSSS de l'Est-de-l’Île de Montréal), continuing to support decisions in mental health. Currently, the HB-HTA unit is nested in the Quality, Performance and Ethics department.

Formed by a coordinator, a scientific advisor and a manager, the HB-HTA team plans, organizes and sets up the evaluation activities. The unit benefits from the support of a Steering Committee which consists of representatives of clinical, administrative and research directions, as well as of health users and families. This committee determine the strategic orientation of the HB-HTA unit, prioritize the projects, approves the evaluation products and gives indications on the knowledge transfer process.

To answer the decision questions, our HB-HTA unit employs two types of products: evaluation reports and informative notes. Based on an exhaustive literature search and consultations with stakeholders, the evaluation reports offer recommendations to support the decision-making process. The informative notes are rapid responses based on a partial literature search. The nature of this type of analysis does not allow the formulation of recommendations, however, a conclusion of the consulted literature is offered.

Based on the work of our HB-HTA unit, some important decisions were made by the IUSMM. As an example, the systematic screening of psychiatric patients for drug and alcohol was not favored by our institution; rather than this, priority was given to staff training, in order to better identify and treat psychiatric patients with substance abuse comorbidity.

Anxiety and depression are major drivers of health-related quality of life, adherence to therapy, and motivation to self-manage chronic conditions. A number of studies have shown rates of anxiety and depression to be higher among individuals with hemophilia compared to that of the general population (1). As the primary point of care for persons with hemophilia, hematologists are well-placed to assess the mental health state of their patients (2). The aim of this study is to explore physician- and patient-reported rates of anxiety and depression among a cohort with severe hemophilia.

Data were drawn from the Cost of Haemophilia across Europe – a Socioeconomic Survey (CHESS), a cost-of-illness study in severe hemophilia A and B across five European countries (France, Germany, Italy, Spain, and the UK) (3). Physicians provided clinical and sociodemographic information for 1,285 adult patients, 551 of whom completed corresponding questionnaires, including EuroQol EQ-5D-3L. We compared the self-reported EQ-5D with physician reports of anxiety and depression.

Across the five countries, physicians recorded a diagnosis of anxiety disorder in 189 patients (15 percent; range 4 percent-28 percent) and depression in 178 patients (14 percent; range 10 percent-28 percent). Seventy-three patients (6 percent) recorded comorbid anxiety and depression. Forty-six percent of patients with anxiety and 58 percent of patients with depression were receiving some form of treatment for their condition.

Within the EQ-5D measure, 42 percent of individuals recorded problems with anxiety or depression, with 6 percent of patients reporting “extreme” anxiety or depression. Twenty-two percent of individuals with a self-reported problem were not recorded with a corresponding diagnosis by their hematologist; 39 percent of patients reporting “extreme” anxiety or depression were absent of any physician-reported diagnosis.

Anxiety and depression are notable conditions within the hemophilia community, particularly so among those with severe condition. The mental health of individuals with hemophilia is an important aspect in ensuring therapy adherence and overall wellbeing and should be considered as part of a multidisciplinary approach to management of the condition.

The increasing complexity of decision-making in clinical practice and the financial pressure requires clinicians to develop some background about the economic consequences of their decisions and to become more and more managers of pre-defined budgets. The present work aims at describing a simple technology solution that could support prescription decisions and illustrates the results of a preliminary assessment of the tool in a sample of professionals. The solution has been developed to allow informed decision-making in the prescription of oral anti-diabetic drugs (OADs) in type II diabetes mellitus (T2DM) patients by supporting prescriptive appropriateness.

The tool developed is compatible with many kinds of hardware architectures and the most diffused web browsers. The system allows real-time reproduction of economic evaluation of the different therapeutic options for the management of T2DM patients. Assessment of “ease to use” and “usefulness” of the tool was performed in a convenience sample of clinicians and pharmacists through a specific questionnaire.

The tool was developed to compare dipeptidyl-peptidase inhibitors (DPP4i) with sulfonylureas, as second line therapy, for T2DM patients. The tool has a user-friendly Graphical User Interface allowing users to quickly and easily select the therapeutic options to compare, choosing geographical context, perspective of analysis, and changing some model parameters. Feedbacks obtained from thirty-three different professionals were generally positive for the “ease to understand information offered”, “ease of introduction of the tool to support usual working activity”, “usefulness within the usual working activity”.

The study showed that the introduction of the tool as a support for clinicians in optimizing their practice could satisfy unmet needs of professionals by supporting informed prescriptive appropriateness in the choice of OADs as it allows to consider diabetes drug related costs in a comprehensive way. The routinely use of the tool developed could become a solution helping clinicians in the management of several diseases.

Administrative data (for example, hospital discharge databases, HDDs) can be used as a real world source of clinical and economic evidence for assessing new medical devices (MDs), provided that their use can be identified in the data. In absence of updated classification systems for procedures and diagnoses, which allow to identify the use of new technologies in the data, traceability can still be achieved thanks to authorities coding guidelines (that is, indication on how to combine the existing codes for procedures and/or diagnoses when new technologies are used).

In 2009 Italy adopted version 2007 of the International Classification System of Diseases (ICD-9-CM) and version 24 of Diagnosis Related Groups (DRGs), which are still in use. The aim of this work was to investigate the capacity of the classification system currently used in Italy, which is at high risk of obsolescence, to identify innovative MDs.

To achieve our goal, we performed a systematic search of all the national and regional coding guidelines published from 2009 (that is, the year of introduction of the new classification systems) to 2015. We extracted from each document the list of technologies for which the Ministry of Health and/or the Regional Authorities provided with coding indications.

Our results show that only a few recent technological innovations can be identified in the Italian HDDs. This reduces the possibility for decision makers to measure new technologies outcomes and costs in the real world clinical practice.

The traceability of new MDs' can support Heath Technology Assessment (HTA). Indeed, HTA programs should use real world evidence to re-assess MDs 2–3 years after their introduction in clinical practice. The use of routinely collected data, such as HDD, would allow to measure new technologies' “real” effectiveness in “real” world, on “real” patients in “real” hospitals to complement the evidence from Randomized Controlled Trials.

Adequate pain relief at the scene of injury and during transport to hospital is a major challenge in all acute traumas, especially for those with hip fractures, whose injuries are difficult to immobilize and long-term outcomes may be adversely affected by administration of opiate analgesics. Fascia Iliaca Compartment Block (FICB) is a procedure routinely undertaken by clinicians in emergency departments for hip fracture patients, but use by paramedics at the scene of emergency calls, is not yet evaluated (1).

We undertook a randomized controlled feasibility trial using novel audited scratchcard randomization to allocate eligible patients to FICB or usual care. Paramedics are recruited and trained to assess patients for hip fracture and carry out FICB. We will follow up patients to assess accuracy of paramedic diagnosis, acceptability to patients and paramedics, compliance of paramedics and also measures of pain, side effects, time in hospital and quality of life in order to plan a full trial if appropriate. The primary outcome measure is health related quality of life, measured using Short Form (SF)-12 at 1 and 6 months. Interviews and focus groups will be used to understand acceptability of FICB to patients and paramedics. This study was funded by Health and Care Research Wales (1003).

We have developed:

• • paramedic pathway to assess patients for hip fracture and FICB

• • paramedic training package, delivered by Consultant Anaesthetist

• • randomization scratchcards.

To date we have recruited nineteen paramedics; ten are fully trained and recruiting patients, the remainder are being trained. Fifty-four patients have been randomized and thirty-five have consented to follow-up. Thirteen 1-month and five 6-month follow-up questionnaires have been received.

This study will enable us to recommend whether to undertake a definitive multi-centre randomized controlled trial of FICB by paramedics for hip fracture to determine if the procedure is effective for patients and worthwhile for the National Health Service.

The increase of litigation in Brazil on the right to health, and the Brazilian Public Health System (SUS) targets of litigation, are phenomena that generate discussions both in the judiciary, and among researchers and managers of health. The lawsuits are based on the integrality that includes the right to any health technology. Our aim was to gather information on the use of scientific evidence by judges and other law professionals to support their decisions in lawsuits involving health care in Brazil.

A narrative review by literature search using key terms of legalization in specific databases was conducted.

Twenty-five studies showed litigation matters relating to health care which were focused on legal claims about drugs. In general, law operators used the scientific evidences in a limited way when making decisions, by considering the medical report and medication label indications and disregarding therapeutic alternatives contemplated in the SUS list. The access to health technologies, by litigation, reveals that the gap between scientific knowledge and legal practice are similar to those found between science and decision-making in the formulation and implementation of health policies. The Health Technology Assessment studies have high potential for use by the judiciary as a reference source to support technical and scientific decisions in lawsuits on health care.

For the judiciary to ensure not only access to health technologies, but also the efficacy and safety of technologies to system users, their decisions must be substantiated by scientific evidence. The National Committee for Health Technology Incorporation (CONITEC) in SUS has established actions in conjunction with law operators and society, such as a communication using e-mail, aiding the decision for the injunction and elaboration of technical reports and a policy brief, with the intention that the decisions are taken with the greatest possible knowledge about technologies provided by SUS, and based on scientific evidence.

The hospital's design today must be prepared for changes resulting from the incorporation of new information and communication technologies (ICT) (1). These will affect non-finalistic (warehouse, archive), diagnostic support (laboratory and image) and finalistic activities (emergency, surgical center, clinics) (2). The Health Technology Assessment (HTA) is fundamental in the dimension of the impact of each technology on the structure of healthcare facilities (HCF). In this way, this work intends to evaluate the trends of impact of the new ICT on hospitals’ structure.

The main technologies under discussion in Management of HCF in Brazillian Health Regulatory Agency were raised. From this survey an impact matrix was built with hospital environmental design and the trends of adequacy of its space.

ICT that tend to decrease the physical space are: electronic health record for the archive, use of digital imaging for radiology, Radio-Frequency Identification (RFID) for the warehouse, point of care and automated laboratory equipment for clinical laboratories.

ICT that tend to increase physical space are: Telemedicine for the surgical center, Internet of Things - IoT for Intensive Care Units, beds for emergency and hospitalization.

The technologies that present an undefined tendency in relation to physical space are: automatic dispensers of drugs for nursing posts.

The use of database servers and the need for network points are still undefined due to the use of Wi-Fi technology and cloud storage. However, it's possible to increase use of electricity and the internet.

It is concluded that the new ICT will have an impact on the planning and building of the future HCF (3). The designs of today's buildings should consider this trend so that the future reality is adequate and the regulatory requirements about HCF should be able to consider it.

Knowledge transfer (KT) of Health Technolgy Assessment (HTA) results presents numerous challenges, one being the lack of time of busy decision makers. Our hospital-based HTA unit is now part of a large network comprising 100 installations. To bridge the gap between complex HTAs and even more limited time by executive officers and managers, we needed to develop a new approach to deliver effectively key HTA messages. We initiated a new strategy with a report on drug-eluting stent (DES). DES may have the potential to eradicate restenosis and the necessity to perform multiple revascularization procedures subsequent to percutaneous coronary intervention (PCI). However, the technology is expensive and some concerns about safety remain. The second generation of DES stents show promising results in terms of efficacy and safety.

We conducted a systematic review of meta-analyses comparing bare-metal stents (BMS) with second generation DES. Data extracted were used to perform a cost-benefit analysis for our organization. Main findings were illustrated in relation to the strategic plan of our institution.

As compared to BMS, the second generation of DES is very effective and potentially leads to huge savings. Safety is improved as regard to myocardial infarction, but not to mortality. For our institution, the use of second-generation DES has the potential to reduce waiting lists for a PCI. In an effort to improve clarity of the results and increase knowledge transfer among managers, we developed a new communication strategy involving the six axes considered as strategic by our Chief Executive Officer, namely: university mission, judicious use of resources, accessibility and quality of care and services, to build for and with the staff, and to act for and with the patient and his family. This led to a smart visual scheme directly showing the results in terms of what is important for our hospital. This initiative was very appreciated by managers.

Using our institutional strategic plan to communicate our results allowed a greater visibility of HTA activities and was greatly appreciated by managers. This will help in disseminating our results locally and in promoting the utility of HTA.

Coronary heart disease (CHD) is the most common cause of mortality globally. The burden of CHD is a challenge for Tunisia causing 27.14 percent of total mortality (1).

Statins are the leading molecules used to prevent CHD in Tunisia. The amount paid by the national insurance fund for statins in 2015 represents 9 percent of total drug expenditures (2).

INASanté has launched a Health Technology Assessment (HTA) study to compare the intensification of statin monotherapy versus a combination therapy for the CHD prevention in patients with moderate to high cardiovascular risk. The aim of this contextualized HTA report is to diminish prescription variability and not justified therapies.

Research was carried out in the following databases: CRD, NICE search evidence, Cochrane, Belgian Health Care Knowledge Centre (KCE), Canadian Agency for Drugs and Technologies in Health (CADTH), Adelaide Health Technology Assessment (AHTA), Institut National d'excellence En Santé et en Services Sociaux (INESS), Euroscan International Network, National Institute for Health Research (NIHR), Agency for Healthcare Research and Quality (AHRQ) and Haute Autorité de Santé (HAS) from 2006 to 2017. Title, abstract and full text screening were performed by two independent reviewers relying on prespecified eligibility criteria. Critical appraisal of literature was conducted using INAHTA and PRISMA checklists, FLC 2.0 and The European Network for HTA (EUnetHTA) adaptation toolkit. One review from AHRQ was retained.

An adaptation process has been launched. Data on lipid lowering agents intake from key institutions have been gathered and a qualitative study has been started through interviews with thirty-three cardiologists and general practitioners from public, private sector and scientifc societies. Interviews have been analysed using NVivo. After results discussion with the working group, the report will be synthesized and validated.

According to the AHRQ report, all evidence for clinical outcomes were graded insufficient when comparing the therapies. Results on lowering low density lipoprotein (LDL-C) depend on the combination agent Ezetimibe has shown remarkable results (3).

The Tunisian context shows that there is no standardized method to assess the cardiovascular risk according to the preliminary results. The only combination therapy reported is with fibrates, mainly in case of associated hypertriglyceridemia. Ezetimibe has not yet obtained the marketing authorization.

There are significant differences between contexts and among practitioners prescriptions. This can be related to the lack of common guidelines and inequitable access to drugs and healthcare resources in general.

Within the Home Radiology service of the Piedmont Region - R@dhome (1) - it was decided to employ a mobile radiological service to allow minor radiological procedures to be conducted in rural areas. Cortemilia (average age of population 51.6 years, population over 65 years 33.6 percent) is situated in Piedmont (Langhe region) and it is about 40 kilometers, with bad roads, from the nearest hospital. For this reason it's important to optimize the potential offered by telemedicine. The purpose of R@dhome is to provide simple radiological services (ambulatory) to vulnerable patients in outpatient settings. The aim of this work was to implement an assessment, based on Health Impact Analysis (HIA) (2,3) criteria, of the health intervention provided by the R@dhome service.

From January 2016 to December 2016 the following were assessed:

• • number of patients examined in the local radiological ambulatory service

• • inhabitants opinions (using questionnaires)

• • General Practitioner, Pharmacist, Family nurse opinions (using semi-structured interviews)

• • stakeholder opinions (Mayor, local politicians, using semi-structured interviews)

• • number of cars and ambulances used for the transport of patients to the nearest hospital

• • number of patients who avoided transportation to the nearest hospital

• • pollutants PM10 (particle size 10) related to cars and ambulance traffic.

Forty percent of people interviewed were more than 60 years old, 76 percent needed x-rays (in 2015), 96.8 percent considered it useful to have a closer x-ray service, only 42 percent had a driver's licence but preferred not to drive; GP's said that 50 percent of local patients had trouble reaching the hospital and that 30 percent of local patients need informal or formal care. From Januay to December 2016 we examined (mainly chest and bone x-rays) in 598 patients using as an alternative to private cars and ambulances the radiological mobile station, and the pollutant emissions were shown to be reduced by 85 percent.

This study has provided a comprehensive HIA report which shows that the R@dhome intervention improves patient's QOL, reduces social costs, reduces the number of patients in the Hospital Radiology Department, reduces rate of hospitalization and pollution.

New immunotherapies have had great successes, but also incredibly debilitating side effects for patients. This discrepancy needs to be a focus of pharmaceutical companies because it will affect the way Health Technology Assessment (HTA) agencies review drugs. Two or three case studies of patient and caregiver experiences surrounding immuno-oncology clinical trials, both past and ongoing, will be used in order to gain a better understanding of how these trials have impacted individuals.

Conduct in-person or telephone interviews with patients and their caregivers to find out more about patient experiences and see how key takeaways can help pharmaceutical companies better prepare submissions for HTA agencies as they launch future immuno-oncology drugs.

Preliminary results indicated that a patient completed a course of treatment and is very happy with the results. She had metastatic melanoma on her scalp. When she was being prepared for surgery, two new tumors on her scalp were discovered. As a result, she was included in a melanoma clinical trial.

Another patient is still undergoing treatment and is responding, but is experiencing severe side effects that are impacting his life and that of his primary caregiver. He was hospitalized once for sepsis.

Patient experiences can wildly vary. It is an area that needs more careful study, using both formal metrics and individual stories. Giving more attention to quality of life creates an opportunity for stronger submissions to HTA agencies and better assessments by those agencies.