The National Institute for Health and Care Excellence (NICE) has a formal policy stating patients, carers and citizens are involved throughout each Health Technology Assessment (HTA). One key way patient/carer organizations are involved is by nominating patient experts to participate in appraisal committee meetings.

A NICE 2014 report (1) on Patient Experts experiences identified a need to routinely survey Patient Experts. This has been ongoing since October 2015. This study highlights key findings, including new recommendations and whether previous concerns have been addressed.

We refined the 2012 survey to be routinely sent to all patient experts that attended a NICE technology appraisal committee meeting. Between October 2015 and December 2016 this online survey was sent to eighty-eight patient experts. After analysis the findings were compared to the previous report to identify whether concerns have been addressed and whether new recommendations should be considered.

There was a response rate of 47 percent (n = 41). Quantitative results and qualitative quotes demonstrate that patient experience varies widely. Key findings from the new data revealed that patient experts feel supported by the Public Involvement Programme, however would welcome more opportunities to speak. Notable improvements since 2012 include favourable opinions of support documents and the Chair more regularly introducing themselves to the patient expert before the meeting. Some experts still find the paperwork cumbersome and find the meetings very technical.

Progress has been made since 2012, but further improvements could facilitate even more effective patient involvement. We continue to routinely measure experiences to identify and address evolving issues. Some tensions remain between NICE's remit and processes, and patients expectations of these. The findings, although specific to NICE, hopefully can feed into other patient involvement developments in the wider HTA ecosystem.

Selecting candidates for graduate programs is considered to be a complex task, often subject to failures, especially regarding to the appraisal of non-cognitive (1,2) skills (for example, Motivation). Identifying suitable candidates is important for the overall success of the graduate programs, since dropouts and low productivity negatively affect the program classification by the Brazilian Governmental Agency.

This study aims to describe the use of Multicriteria Decision Analysis (3) in the selection of candidates for a master degree program in Health Technology Assessment (HTA).

The Multicriteria Decision Analysis (MCDA) technique was used to measure value in the selection of students applying for a masters degree program, in 2017, using Multi-Attribute Value Theory methods (MAVT) method. The examiners group consisting of full-time professors who selected the criteria, blinded ranked and assigned weight relative to each criterion, using swing weights technique, normalized to 100 percent. During the face to face interview with the students, each evaluator professor filled an individual spreadsheet based on pre-defined questions and curriculum analysis. The results were summarized with a mean. For criterion performance, a value from 0 until 3 was assigned if the candidate didn't meet the criterion, partially meet and fully meet. The performance scores were multiplied by the weight of each criterion, the results were summarized by simple additive model, and the candidates were ranked.

An interview was conducted with the examining group evaluating MCDA asking for difficulties, time consumed and if the result was considered fair. Seven criteria were listed: “Comprehension of HTA”, “Motivation”, “Ability to disseminate information”, “Availability to attend the course”, “Scientific production”, “Potential to work in HTA area” and “Scientific writing skills”.

The highest weight (24 percent) was attributed to the “Potential to work in HTA area” and “Scientific writing skills” (20 percent). The evaluating group was unanimous in considering the process easy, fast and fair.

The MCDA technique was applied successfully in student selection. Further prospective studies are needed.

In recent years, the Ghana health system has been faced with the challenge of financial sustainability. New ways of making decisions in a cost-effective manner that ensure efficient use of available resources is being explored. Consequently, Ghana has been pursuing the formal introduction of Health Technology Assessment (HTA) for decision making in the health system.

However, the limited use and impact of HTA on health systems has been associated with reasons including, and not restricted to, the knowledge and perception of decision makers towards it (1-3). Therefore as Ghana gears towards using HTA formally, it is important to assess the knowledge and attitude of potential users and producers of HTA. This will provide useful information for the setting up of an HTA agency.

A qualitative research approach using in-depth interviews was utilized. Twenty-three decision makers both at the national and district levels, and four researchers were interviewed. Thematic analysis was conducted using NVivo software.

Only seven respondents had knowledge about HTA. Respondents perceived HTA differently, and the word ‘technology’, was often misconstrued as a device for communication such as mobile phone. Two main barriers to the use of HTA emerged; lack of resources (human, data, and finance) and politico-cultural issues. To address these barriers respondents recommended that stakeholders be involved in decisions concerning the guidelines for its conduct, composition of the appraisal team, and the focus of HTA. Generating of human, data and financial resources were also indicated.

There is paucity of knowledge about HTA in Ghana. For Ghana to successfully introduce HTA for health decision making and realize its expected benefits, there will be a need to address the perceived barriers in a comprehensive manner. Also, to mitigate data and human resource barrier, Ghana will have to examine the available local data and human resource to build on.

The French National Authority for Health (HAS) has participated in the work of the European Network for Health Technology Assessment (EUnetHTA) since its creation in 2006. HAS has been an active partner in most EUnetHTA activities, and the lead partner of specific work packages.

This report presents a summary of the main contribution of HAS to the two latest EUnetHTA projects (Joint Action (JA) 1 and Joint Action 2 (JA2)), their impact on national production, and Health Technology Assessment (HTA) doers feedback as to the opportunities and challenges of participating to the network and using its outputs.

In JA 1 and JA 2 projects, HAS has: coordinated activities related to Early Dialogues and Additional Evidence Generation; coordinated the development of nine JA1 methodological guidelines for rapid relative effectiveness assessment (REA) of pharmaceuticals; participated in the production of two JA2 methodological guidelines; participated in the production of one JA1 and seven JA2 rapid REA reports, and two JA2 full HTAs.

The national uptake of EUnetHTA outputs included entire adoptation of one REA report and adaptation of another. EUnetHTA templates and methodological guidelines have been taken into account when updating or developing national ones. Thanks to the network, HAS HTA doers could exchange on ongoing assessments with European colleagues, have enhanced their methodological know-how and enlarged their professional network.

As for the challenges encountered, it turned out that the re-use of EUnetHTA reports for a technology of interest to HAS was not always possible, mainly due to discordances in deadlines or assessment questions between EUnetHTA and national productions.

HAS has actively participated in different EUnetHTA projects since the network's creation. This collaboration has enabled HAS HTA doers, among others, to optimize national assessments and enhance their methodological know-how.

Guidelines compliance, with a priori non-invasive and earlier tests and interventions, depends on access. This study investigates the Brazilian Unified Health System (SUS) outpatient access to nuclear medicine procedures through SUS data comparison with those from the National Commission of Nuclear Energy (CNEN: Comissão Nacional de Energia Nuclear).

Data provided by the SUS outpatient database (SIA-DATASUS) regarding procedures performed from 2013 to 2016 was compared with data from institutions (Nuclear Medicine Services and Cyclotron Facilities) and radioprotection supervisors with numbers certified by CNEN.

CNEN has authorized 420 nuclear medicine institutions (.20 per million inhabitants) and certified 294 radioprotection supervisors (.14 per million inhabitants), and 1.4 services per supervisor. There are 457 graduated professionals qualified for radioactive sources preparation, use and handling for diagnostic and therapeutic radiopharmaceuticals (.9 professionals / installation). During the last four years, 08 new nuclear medicine facilities were authorized by CNEN. The number of nuclear medicine procedures performed slightly increased in the South, but remained constant in other regions. Annual SUS reimbursements increased by 21.2 percent on average for the 03 PET/CT (Positron emission tomography–computed tomography) adopted procedures: regional analysis showed the Central-West as the highest growth area (70.8 percent), compared to the South (53.4 percent), North-East region (30.8 percent), and the South-East (5 percent). Currently, thirteen Cyclotron Facilities operate in Brazil: South-East (six), South (three), North-East (three) and Central-West (one). Some nuclear medicine procedures largely outnumber the average increase: for example, reticuloendothelial system scintigraphy (513.9 percent), gastric transit scintigraphy (112.8 percent), and thyroid screening with suppression/stimulation test (100.6 percent). However, myocardial scintigraphy (stress and rest) and bone scintigraphy with or without blood flow still correspond to 82 percent of total nuclear medicine in vivo procedures.

Regional disparity is quantitatively depicted in Brazil and reflects access to SUS nuclear medicine procedures. This denotes a potential for improvements related to nuclear medicine areas, for example developments concerning new PET/CT coverage, new radiopharmaceuticals research, and national and international training.

Tunisia recently implemented a Health Technology Assessment (HTA) agency (INASanté) to inform decisions around health technologies and to improve clinical practice by means of the elaboration of Clinical Practice Guidelines (CPG). However many decisions on new and emerging technologies, their implementation and coverage in the health care system are still taken at the hospital level without any structured process that informs the decisions. The aim of this project was to improve the methods and flow-chart of decision-making processes on innovation uptake in the Tunisia Healthcare System.

By means of the toolkit of EuroScan for the implementation of an early awareness and alert system (EAAS), and its checklist, it was discussed specifically within INASanté the characteristics of the Tunisia Healthcare System and its specificities regarding decisions on drugs and medical devices. The analysis included the process of innovation uptake at the hospital level and its specific flow-chart. In depth interviews and a devoted workshop were performed with personal in INASanté: two physicians (one involved in CPG elaboration and the second in accreditation), three pharmacists (HTA), one nutritionist (HTA), two librarians and other stakeholders, including the Directorate of Hospitals.

The uptake of innovations in Tunisia does not follow a structured process. In fact, there is no central purchase of medical devices in Tunisia and most medical devices are purchased by hospitals within a tender process in accordance with the Tunisian public procurement law. The main pitfalls are: lack of awareness around innovations that could impact the system, non-structured process of information sharing among the different decision-makers that promotes inequity in access to technologies and services, and lack of explicit criteria that determine decisions around health technologies.

Tunisia requires a structured and informed process on decisions around innovation uptake in the healthcare system. The principles that should govern this system are: anticipation of the impact of new health technologies, establishing priorities and criteria for decision making in all places of decision. The decisions should be recorded and publicly shared to avoid inequities in the access to technologies.

Japan plans to introduce Health Technology Assessment (HTA) in 2018 after a two-year trial period. Japan currently requires HTA for certain innovative products which may have a large budget impact. Through this trial implementation, the government can examine the criteria of applicable products, the necessary infrastructure to conduct and evaluate HTA, the quality of data content, and localization to meet the current Japanese reimbursement and pricing scheme. However, the pharmaceutical industry in Japan is still puzzled by this introduction. The aim of this study is to visualize the issues and implementation challenges of HTA in Japan through a survey of the pharmaceutical industry.

A semi-structured nineteen-item questionnaire was designed and the survey was conducted through face-to face or phone interviews. Answers were summarized after the interview and confirmed with the respondents via e-mail. The survey focused on pharmaceutical companies which develop new innovative products.

The differences between Japanese and non-Japanese pharmaceutical companies were observed in terms of HTA staff expertise and experience, the source of HTA data, and relationships with external vendors. Many respondents stated that a sufficient number of HTA professionals in Japan is critical to implement HTA, and raised a concern that the same public experts who are involved in HTA preparation may also review HTA submissions. Although companies are generally pessimistic about HTA for pharmaceutical pricing, they also have some positive views that HTA may be used as an indicator to enable stakeholders to understand product value. Many are unsure about the link between HTA and pharmaceutical prices.

If HTA is implemented for an extended number of products, a shortage of experts may cause delays of HTA review and appraisal processes. Consequently, product launch and patient access will be delayed. Practical timing of HTA review and appraisal after product launch could affect the results of re-pricing.

Emerging health technologies (EHT) are important to meet the challenges faced by healthcare systems but a major pressure on health systems as well (1). The International Information Network on New and Emerging Health Technologies (EUROSCAN) is a collaborative network to manage the introduction of EHT and share information on the results of early identification and assessment of EHT (2). This article analyzed the early assessment reports of EHT during 2000–2016 published in the EUROSCAN database (3), in order to reflect the 21st century development trend of the EHT.

The EHT report data was downloaded by researchers from the official website of the EUROSCAN and arranged using Excel 2007. A descriptive analysis on the number and growth rate of EHT, distribution of technology type and specialties, developmental trend of the integrated technologies were conducted with SAS 9.3.

Health technology early assessment reports (3,151) have been published in the past 17 years, of which drugs had the highest proportion (54.3 percent). Most of new and emerging health technologies were adopted in oncology and radiotherapy (32.2 percent). The average growth rate every 4 years of EHT from 2001 to 2016 was 34.6 percent, the fastest-growing period was between 2005 and 2008 (63.8 percent). Rehabilitation & disability was the fastest-growing EHT specialty (184.4 percent) and the integrated technologies was the fastest-growing EHT type (64.6 percent).

With the objective needs of effective technologies to deal with cancer and chronic disease, as well as the revolution of science, EHT were in the process of vigorous development, especially oncology & radiotherapy technologies. The integrated technologies and the ones applied in multidisciplinary areas have become a new spotlight. Early identification and timely assessment of new and emerging health technologies has aroused wide public concern. It is suggested to establish an Early Awareness and Alert Systerm in China.

Russian system of medicines provision is one of the biggest in the world. It covers 85 regions, around 17.1 million square kilometers and 146.5 million people; therefore the organizing of a stable and effective system is a challenge for decision makers. In this paper we make an effort to clarify main principles and aspects.

To systemize all the information concerning Russian medicines provision system, we review legislation, literature and made interview of experts.

By 2015 more than 3,230 International Non-proprietary Names and 26,239 Trade names were registered in the Russian Federation. The pharmaceutical market consists of the commercial drug sector, drug reimbursement and hospital sector: 8 percent, 22 percent and 70 percent in monetary values and 1 percent, 19 percent and 80 percent in volume terms, respectively. Medicines provision through compulsory health insurance is divided into in-patient health services (first health and sanitary treatment, special health treatment and palliative treatment) and emergency services. Three drug lists form the reimbursement system: “list of vital and essential medicines”, “7 disease areas” and “Medicines provision population”. The “List of vital and essential medicines” is a basis for all other drug lists and fixes the maximum sale price for drugs. The “7 disease areas” detach high-priced drugs that are used in treatment of particular diseases and optimize the financing of treatment of people with high-cost diseases. The “Medicines provision for population” states the list of drugs that are reimbursed by the federal budget. Federal and regional budgets divides medicines into fully and partly reimbursed medicines.

At the present time, the Russian system of medicines provision is rather complicated. Nevertheless, the system still develops: in 2016 Russian Ministry of Health began the development of the concept of medicines insurance system.

Consistently high-quality health care is expected throughout Europe while concurrently, financial resources of member states are decreasing. National Health Technology Assessment (HTA) institutes are informing evidence-based reimbursement decisions in the national context, leading to redundancies in HTA production and tying up limited resources. Since 2006, the European Union project, the European Network for HTA (EUnetHTA) is aiming at enhancing the efficient use of HTA resources and facilitating transnational collaboration. Our aim is to present previous experience in joint assessment of medical devices. Furthermore, possible benefits of European collaboration for stakeholders will be discussed.

Processes and challenges of the completed EUnetHTA Joint Action (JA) 2 are summarized and discussed. Benefits, aims and opportunities of the ongoing EUnetHTA JA 3 are described.

Six rapid assessments of medical devices, focusing on the assessment of effectiveness and safety, were published during EUnetHTA JA 2. Challenges in European medical device assessment encompass the choice of topics, the time point of assessments and the lack of European standards for systematic patient involvement. Characteristics of medical devices, like learning curves, call for monitoring them throughout their lifecycle.

The benefit of European collaboration for stakeholders is manifold: uncertainty with regard to actual added value of a technology is minimized through Early Dialogues; harmonized and transparent assessment processes increase the quality of reports; work division among HTA organizations allows a resource-efficient assessment of a bigger amount of technologies; patient involvement ensures consideration of patient relevant endpoints.

The importance of cross-border collaboration in HTA is shown in the continuation of the EUnetHTA project, which aims to sustainably strengthen international collaboration even after expiration of EU-funding.

European collaboration in medical device assessment can ensure cross-border health care and efficient cooperation of national health systems. The focus should be set on a wide implementation of jointly established methods and quality standards. The European collaboration can lead to a concrete benefit for various stakeholders.

Several studies have explored how Health Technology Assessment (HTA) processes, HTA submission requirements, perception and handling of uncertainties vary across different jurisdictions (1-3). However, no study has elicited HTA stakeholders’ preferences/priorities on criteria that shape coverage decisions across countries. We aimed to identify the extent to which preferences on criteria, uncertainties and other factors that shape HTA recommendations differ across countries.

HTA stakeholders in Brazil, England, France, Italy, Netherlands, Spain and Sweden were invited via email to complete a web-survey. A number of clinical, economic and other criteria (that is, rarity/orphan status and stakeholder input, among others) considered in HTAs, along with additional factors related to clinical evidence uncertainties, unmet need and innovative nature of treatment were ranked in terms of their importance on a 7-point Likert-scale. Responses were anonymised and analyzed using descriptive statistics.

Responses were received from Brazil (n = 9), England (n = 7), France (n = 10), Italy (n = 6), Netherlands (n = 3), Spain (n = 3) and Sweden (n = 3). “Achievement of/Concerns around clinical benefit” was the only clinical criterion/uncertainty scoring equally important across countries (100 percent of respondents in each country). The requirement for/uncertainty around “Appropriate comparators” scored high in importance overall but was not consistent across countries, nor was the “Acceptability of surrogate rather than clinical endpoints”. Variation was seen in all economic criteria, apart from “Budget impact analysis” (equally important for more than 80 percent of respondents in each country). Greater differences were observed in the level of priority that innovation, disease severity and stakeholder input have towards HTA coverage decisions across countries.

Although agreement was seen in preferences mostly for some of the clinical criteria and/or evidentiary requirements ranked, there were notable differences on countries' priorities for economic evidence criteria/uncertainties and the extent to which unmet need, disease burden and innovation are considered important towards HTA decision-making, possibly explaining differences in HTA recommendations.

Health Technology Assessment (HTA) is applied to determine the value of innovative technologies. It usually relies on robust assessment of the clinical cost-effectiveness of the technology, while clinical and economic evidence required for this purpose are often not available for orphan drugs (OD) (1,2). The objective of the study is to undertake a systematic comparison between HTA agencies worldwide in order to identify similarities and differences in the methods and processes in HTA of OD.

A cross-sectional web-based survey was conducted between September 2013 and May 2015. The data were obtained from a semi-structured questionnaire. We received responces from 161 HTA organizations based in 39 countries.

HTA of OD is performed by agencies in South America (38.5 percent), followed by agencies in Australia (37.5 percent) and Europe (36.1 percent). The agencies in high income countries produce more assessments of OD (36.8 percent), which in 31.2 percent they determine as innovative technologies compared with 11.8 percent of the units based in low income countries and active in OD assessment (11.1 percent). We prove association (p< .05) between (i) the type of HTA and income per capita; the level at which the organization operates; its main activity; and the level of recommendation dissemination; (ii) the main target group and consumers of the final HTA product; the stage of evolution of the technology, on which it is likely to be assessed; and approaches to identify innovative technologies. The most active in the preparation of HTA reports are biomedical companies or other organizations in the private sector (50.0 percent) and organizations in the pharmaceutical and/or medical industry (66.7 percent). HTA bodies that assess OD develop (36.0 percent) and distribute recommendations (35.9 percent) nationally; their main activity is to produce guidelines for good clinical practice (46.9 percent). Agencies that perform OD assessment are active in evaluation of innovative (37.2 percent) and emerging (35.9 percent) technologies, which are able to be identified by developing early warning systems (32.0 percent).

Making coverage decisions based on HTA recommendations control the technologies introduction into the healthcare system, that is why it's very important that this tool is properly adjusted to the specific needs of OD assessment (3).

Governance of health technologies in Emilia-Romagna region, Italy, includes a local and a regional level. Medical devices (MDs) are requested by clinicians to hospital committees that may carry out an evaluation at local level or ask for a regional evaluation using Health Technology Assessment (HTA) methodology. Until the past year, committees weren't provided with a clear pathway to identify technologies for regional HTA evaluation. The aim of this study was to describe a bottom-up, shared approach to produce a tool with elements to be considered when judging if a technology is eligible for regional HTA or not.

To identify elements, we adopted a qualitative approach and the methodology of focus group (1,2) which consisted in starting from health professionals experience to build a shared knowledge. Two panels of stakeholders were convened, the first one comprising regional decision-makers deciding whether to reimburse and introduce a MD in Regional Health System; the second panel comprised regional clinicians that use, test and ask for MDs. Panels were asked to capture possible elements of MDs that should be considered for identifying the most promising and interesting ones for a regional HTA.

The two panels (seventeen regional clinicians and twenty-two decision makers, respectively) had two operative meetings and worked in parallel. At the end of the second meeting, a draft of the tool with elements identified by both groups was built. Panels were asked to test the draft on few medical devices and identify possible tool's criticalities limiting transferability. Tool resulted user-friendly and complete, requiring no changes. The final version, approved by two panels convened together during the last meeting, reports thirty-two distinct items referred to five domains (that is, potential: innovativeness, clinical, economic, and organizational impact, environmental factors). Each item must be valued on a Likert scale. The tool will be applied on every MD requested by regional clinicians and before implementation it will be tested during a 6-month pilot phase beginning March 2017.

The process was plain and feedback from stakeholders has been positive. The tool is expected to increase transparency and homogeneity in identifying technologies eligible for regional HTA.

One of the initiatives promoted by the Department of Health of Catalonia to promote the policies of clinical safety and quality of care was the construction of a synthetic indicator to obtain a global ranking that assess the quality of care and recognizes the best acute hospitals in Catalonia.

For the selection of dimensions and individual indicators, focus groups with experts, focus groups with patient representatives and a wide consensus process with health professionals were carried out. Weights of dimensions and indicators have been obtained from this consensus with experts. We identified fourty-seven individual indicators grouped into four dimensions, fourty-nine hospitals grouped into five categories were included. Goal programming methodology was used to construct synthetic dimensional indicators and then aggregate to obtain the global ranking based on the global synthetic indicator.

The best situation regarding quality of care of general acute hospitals is achieved in hospitals with better indicators of both the clinical effectiveness and adequacy dimension and patient safety, specifically the synthetic indicator places the hospitals with lowest percentage of patients with postoperative complications or with lowest percentage of infections of organ-space surgical localization in elective colonic or rectal surgery in a better position. Both in the synthetic global indicator and in the synthetic dimensional indicators, position the county hospitals as the best in the ranking, followed by reference hospitals.

We have presented a new methodology to assess the quality of care of hospitals which offers several advantages over existing ones. It is designed to be practical and to facilitate obtaining synthetic indicators that can be easily interpreted, based on information provided by the reference value corresponding to each indicator and adjusted by the clinical criterion supported by the consensus of more than 300 experts in the field of the evaluation of hospital care quality.

The outcomes from clinical and other healthcare trials of most interest to patients and health systems are usually increases in the quality and length of life (overall survival (OS)). This poses a problem, because complete knowledge on the true increase in OS is not available until the last person in the trial dies. However, if OS is sufficiently correlated with a surrogate endpoint that is observable within the trial period or soon after the treatment has finished, this can be used to estimate OS, without much error. The most widely-used surrogate endpoint in oncology is progression-free survival (PFS). We aim at (i) analyzing the methods used to extrapolate from PFS to OS in the field of oncology; (ii) identifying whether a clear guidance exists in the literature about what is considered to be ‘best practice’ in extrapolation from PFS to OS; (iii) determining the key limitations, weaknesses and gaps in the current literature and method used to test PFS surrogacy.

We extend the literature review carried out previously (1), we interview experts from regulatory and reimbursement bodies, and we explore academic research into the methodology of surrogacy and the need for better reporting of surrogacy papers.

A number of factors affect the relationship between PFS and OS. Therefore, there is no unique correct answer for the question of whether PFS is an appropriate surrogate for OS in oncology. Many of these factors are related to the length and characteristics of post-progression survival (PPS).

Any consideration of evidence relating to PFS should consider both tumour type and other factors, particularly those related to PPS. Protocols of future follow-up of clinical trial patients should specify procedures for gathering information about the effect of post-progression management of the disease. This should allow stronger conclusions to be extracted from statistical analyses. Improved reporting standards will aid in achieving this goal. In addition, it is very likely that increasing the use of IPD will result in greater precision in estimating the benefits of worthwhile drugs.

Transient Ischaemic Attack (TIA) is a neurologic event with symptom resolution within 24 hours. Early specialist assessment of TIA reduces risk of stroke and death. National United Kingdom (UK) guidelines recommend patients with TIA are seen in specialist clinics within 24 hours (high risk) or seven days (low risk).

We aimed to develop a complex intervention for patients with low risk TIA presenting to the emergency ambulance service. The intervention is being tested in the TIER feasibility trial, in line with Medical Research Council (MRC) guidance on staged development and evaluation of complex interventions.

We conducted three interrelated activities to produce the TIER intervention:

• • Survey of UK Ambulance Services (n = 13) to gather information about TIA pathways already in use

• • Scoping review of literature describing prehospital care of patients with TIA

• • Synthesis of data and definition of intervention by specialist panel of: paramedics; Emergency Department (ED) and stroke consultants; service users; ambulance service managers.

The panel used results to define the TIER intervention, to include:

1. 1. Protocol for paramedics to assess patients presenting with TIA and identify and refer low risk patients for prompt (< 7day) specialist review at TIA clinic

2. 2. Patient Group Directive and information pack to allow paramedic administration of aspirin to patients left at home with referral to TIA clinic

3. 3. Referral process via ambulance control room

4. 4. Training package for paramedics

5. 5. Agreement with TIA clinic service provider including rapid review of referred patients

We followed MRC guidance to develop a clinical intervention for assessment and referral of low risk TIA patients attended by emergency ambulance paramedic. We are testing feasibility of implementing and evaluating this intervention in the TIER feasibility trial which may lead to fully powered multicentre randomized controlled trial (RCT) if predefined progression criteria are met.

The use of health apps is rapidly increasing. They intend to promote health or to treat diseases; in some cases, substituting medical duties. No specific frameworks to assess mHealth solutions in a broad scope and in a comprehensive way have been identified. We aim to propose a framework for mHealth assessment.

The framework development was based on:

• • Literature review to identify existing assessment models including the evaluation of health effects

• • Exploratory analysis with experts and user group discussions

• • Definition of the assessment model, following the domains of health technology assessment.

Existing frameworks are mainly focused on certification criteria. Professionals and users agreed on the need to undertake mHealth assessments as to better inform user decisions. Assessments should be sensible to continuous changes of these technologies and be undertaken by independent organizations.

The proposed framework offers a step-by-step process by which any mHealth solution can be categorized and analyzed, according to: (i) Risk classification matrix: combining intervention type and patient type, (ii) Users: patients, professionals, informal caregivers individually or all of these together and (iii) Integration: stand-alone, fully integrated.

The model has four evaluation domains: technical maturity, risks, benefits and resources needed, including the commonly accepted evaluation perspectives: technical, contents, clinical/health, user perspective, organizational and socio-economic. Sub-domains are defined as: end-user, organization, healthcare system and community (society as a whole). Aspects to be assessed are selected according to the purpose of the evaluation (intended use / intended impact) and vary depending on the type of the mHealth solution: product or service.

The mHealth assessment process is needed and should be: (i) continuous/iterative, providing timely conclusions and recommendations for improvement, (ii) inclusive/collaborative, involving all stakeholders,and (iii) constantly adapting to standards. The proposed framework is intended to support informed decisions when developing, integrating, selecting, recommending, or adopting mHealth solutions.

With the possibility to analyze gene expression a plethora of new genomic tests are surging into the medical market. The assessment of these new technologies in Health Technology Assessment (HTA) reports is challenging and we need international consensus on uniform criteria to support HTA, but also to establish clear and standardized requirements for clinical studies.

The German Institute for Quality and Efficiency in Health Care (IQWiG) has been commissioned to assess the benefits and harms of biomarkers to predict which women would benefit from chemotherapy treatment after surgery of primary breast cancer. The final report was published in October, 2016 (1).

Only eight studies complied with the inclusion criteria of the systematic review. No prognostic study fulfilled the inclusion criteria. Only two randomized controlled trials (RCTs) delivered information utilizable for benefit assessment. Based mainly on 5-year results from the MINDACT trial, the report concluded that there currently is not enough information to support a positive decision on biomarkers in this specific indication. Ongoing randomized controlled trials like TailorX, PlanB, RxPONDER, ADAPT or OPTIMA are expected to provide some additional evidence in the near future. After publication of the IQWiG report an extensive debate on several methodological characteristics of this report was fuelled. In addition, some other HTA agencies, such as the National Institute for Health and Care Excellence (NICE) made slightly different conclusions.

The presentation will give a résumé of the main arguments and focus on differences between the IQWiG report and other HTA reports. Questions, like the required study type, study characteristics (for example, attrition rate, follow up, outcomes), data quality, cut-offs or patient preferences in diagnostic information will be provided. The aim of the presentation and discussion is to get a step forward in defining key characteristics and elements of benefit assessment and primary studies for these new technologies. A consensus among HTA reviewers in these approaches seems to be essential in the near future.

No single assessment can evaluate the wide spectrum of health technologies pending access to healthcare systems. It is important to envision a complex systematic framework, in which different instruments are used for different purposes - all criteria should be used to ensure the transparency of the process, and should model good assessment and implementation practices (1,2).

A cross-sectional web-based survey was conducted from September 2013 to May 2015 which was designed to gain information about the present status of Health Technology Assessment (HTA) activities; to examine its institutional contexts and the kind of application of its principles, logic, assessment methods, tools and best practices.

A total number of 161 questionnaires from 39 countries on 6 continents were received representing a 41.7 percent response rate. Based on analysis of the results, a complex systematic framework for value assessment was designed. Five major features define the framework that can fully measure the common and support the evaluation of more complex health technologies: (i) implementation of higher-order evaluation approaches that support complex multi-criteria assessment, rather than emphasizing only the use of basic evaluation procedures; (ii) precise evaluation of critical criteria, that measure technologies directly as they will be used in actual practical settings; (iii) assessment approaches, based on international best HTA practices that are accurate, in terms of the content and context of the evaluated technology, as well as the expected performance; (iv) high-fidelity priority-setting elements that are evaluation sensitive; and (v) assessments that are sound, unbiased, and transparent – in order to be truly valid for a wide range of technologies, assessments should evaluate them accurately and do so reliably across technology content and context. They should be unbiased and accessible and used in ways that support superior outcomes and higher quality for healthcare systems.

The healthcare systems that decide to use this framework should evaluate the set of assessments they select and develop them against the standards required, and should use them in ways for which they have been appropriately validated and in contexts that ensure a transparent evaluation process (3).

Among economists, there is widespread agreement that the monetary valuation of health gains should reflect the preferences of those who will be affected by resource allocation decisions. In the context of Health Technology Assessments (HTAs), this view implies a need for reliable empirical estimates of the value of statistical life year (VSLY), which should provide a useful point of reference for cost benefit analyses.

We conducted a systematic review of the literature on the economic value of a statistical life (VSL). We searched in the EconBiz and EconLit databases for studies, which reported VSL estimates based on original research and were published between 1995 and 2015. We classified studies by methodology, that is, revealed preference (RP) or stated preference (SP; that is, CV, contingent valuation, or DCE (discrete choice experiment) approach, and by regional origin of data. We transformed VSL estimates into VSLY expressed in year 2014 Euros, using life expectancy tables for the populations studied, a real discount rate of 3 percent, national Consumer Price Indices for inflating, and purchasing power parities for currency conversion. In addition, we calculated ratios of VSLY to gross domestic product (GDP) per capita.

Our search yielded 120 studies appropriate for inclusion. From these, we extracted a total of 132 VSL estimates (RP, n = 60; SP, n = 72). The median VSLY was 6.4 times GDP/capita. Transformed into Euro (2014), the median VSLY was EUR165,000 (mean, EUR217,000). We found significant differences by regional source of data (North American, median EUR272,000; European, EUR158,000) and by method (RP, EUR241,000; SP: CV, EUR117,000; DCE, EUR187,000). VSLY estimates were sensitive to discount rate.

Our data indicate that VSLY estimates based on empirical data exceed benchmarks commonly used in the context of HTAs. However, inter-study variability, methodological limitations, and normative considerations, all suggest to exercise caution before translating this observation into actual policy.