Dengue virus is a serious global health problem with an estimated 3.97 billion people at risk for infection worldwide. In December 2015, the first vaccine (CYD-TDV) for dengue prevention was approved in Brazil, developed by Sanofi Pasteur (1). However, given that the vaccine will potentially be paid via the public health system, information is needed regarding consumers willingness to pay for the dengue vaccine in the country, as well as discussions related to the possible inclusion of this vaccine into the public health system at prices suggested by the manufacturer. This was the objective of this research.

We conducted a cross-sectional study with residents of Greater Belo Horizonte, Minas Gerais, about their willingness to pay for the CYD-TDV vaccine. Respondents had to be over 18 years and not currently have the disease although they may have had dengue in the past (2,3).

Five-hundred and seven individuals were interviewed, who were mostly female (62.4 percent), had completed high school (62.2 percent), were working (74.4 percent), had private health insurance (64.5 percent) and did not have dengue (67.4 percent). The maximum median value of consumers willingness to pay for the CYD-TDV vaccine, assuming vaccine efficacy against virologically-confirmed symptomatic dengue illness of approximately 60 percent, is USD33.61 (BRL120.00) for the complete 3-course schedule and USD11.20 (BRL40.00) per dose. At the price currently being assessed by the Brazil's regulatory chamber of pharmaceutical products market (CMED) for Dengvaxia® for three doses, only 17 percent of the population expressed a willingness to pay for the vaccine at this price.

Brazil is currently one of the largest markets for dengue vaccine in the world and the price established is a key issue. The manufacturer should asses the possibility of lowering its price in Brazil to reach a larger audience among the Brazilian population, especially as other public health activities to control the disease will continue.

Existing evidence on clinical and economic effectiveness of one long-acting injectable antipsychotic (LAI) versus another in successful management of schizophrenia is scarce. The study was conducted to compare all-cause inpatient healthcare utilization and associated costs among Medicaid patients with schizophrenia who initiated LAIs.

This retrospective cohort analysis used the Truven Health Analytics MarketScan® Medicaid claims database. Schizophrenia patients >18 years with at least one claim for one of the following LAI were identified between 1 January 2013 and 30 June 2014 (identification period): aripiprazole, fluphenazine, haloperidol, paliperidone palmitate, and risperidone. The first day of initiating an LAI was considered the index date. Patients were followed for 1 year from index date. Logistic and general linear regression models were used to estimate risk of inpatient hospitalization and associated costs during follow up.

Of the identified Medicaid patients with schizophrenia, 1,672 (36.7 percent) initiated an LAI: 44.0 percent received paliperidone, 26.4 percent haloperidol, 13.8 percent risperidone, 9.2 percent aripiprazole, and 6.6 percent fluphenazine. With the aripiprazole cohort as the reference group, the odds of having any inpatient hospitalizations were significantly higher in haloperidol [Odds Ratio, OR (95 percent Confidence Interval, CI): 1.51 (1.05 - 2.16)] and risperidone [OR (95 percent CI): 1.58 (1.07 - 2.33)] cohorts. Fluphenazine and paliperidone palmitate cohorts also had higher risk of having any inpatient hospitalizations compared with aripiprazole, but the differences were not statistically significant (p>.05). Among LAI initiators with any inpatient hospitalizations, the adjusted mean inpatient costs were lowest in the aripiprazole cohort (USD25,616), followed by haloperidol (USD30,811), paliperidone (USD30,833), risperidone (USD31,584), and fluphenazine (USD37,338), although differences were not statistically significant.

Our study findings highlight the value of aripiprazole in reducing inpatient hospitalizations and associated costs among patients with schizophrenia. However, our study is limited as our results are reflective of a multi-state Medicaid population. Future studies are warranted to confirm the results in non-Medicaid patient populations.

Rheumatoid arthritis (RA) is an inflammatory, autoimmune disease of unknown etiology that usually results in joint lesions and physical incapacitation. RA treatment includes disease-modifying antirheumatic drugs (DMARD), synthetic (sDMARD) and/or biologics (bDMARD). In this study we carried out a cost-utility analysis comparing Adalimumab (ADA) versus Etanercept (ETA), with or without synthetic DMARDs (± sDMARD).

Effectiveness measures used were the Clinical Disease Activity Index (CDAI) and Quality-Adjusted Life Years (QALY) obtained from an open prospective cohort study with Brazilian RA patients. Costs were obtained from a historical cohort composed of every patient who was prescribed medicines to treat RA in the State of Minas Gerais, Brazil. A public sector perspective was adopted. The Markov model included six-month cycles, time horizon of 5 years and 5 percent discount rates. Sensitivity analyses were performed by varying costs and outcome values.

There was no significant difference in effectiveness between the two bDMARDs. Treatment with ETA (± sDMARD) was more expensive after 5 years of follow-up: incremental cost of USD28,210.87. Overall, treatment with ADA (± sDMARD) was more cost-effective: incremental cost-effectiveness ratio for ETA (± sDMARD) was USD79,148.34/ QALY. Sensitivity analysis showed that this was sensitive to changes in the cost of ETA (± sDMARD).

Currently two Anti-tumour Necrosis Factor Alpha (anti-TNF alpha) medicines – ADA and ETA are available within the Brazilian public health system in addition to infliximab. Treatment with ADA (±sDMARD) was more cost-effective with an incremental cost effectiveness ratio for ETA (±sDMARD) at USD79,148.34 per QALY. Sensitivity analysis showed that outcomes are sensitive to changes in the cost of ETA (± sDMARD) treatment. Overall, both therapeutic alternatives are valuable from the public sector perspective especially when the Clinical Protocol and Therapeutic Guidelines are properly applied in patients no longer responding to treatment. Alternatives are needed as some patients will respond differently to different anti-TNF alpha medicines.

This study estimated, from the societal perspective, the costs and benefits of the intensive inpatient rehabilitation treatments (IIRT) on patients after stroke using the interim results of a large ongoing registry in Korea, the Korean Stroke Cohort for Functioning and Rehabilitation (KOSCO) (1).

Among others, the benefits were measured by two major cost savings: (i) decrease in government disability subsidy and (ii) caregiver savings. One of the KOSCO study results showed the functional status of the post-stroke patients, measured by the Korean Modified Barthel Index (K-MBI), improved significantly and the disability grades, which the government is using to classify the subsidy amount, reduced as well. Caregiver cost savings were calculated by K-MBI improvements, the average daily compensation of caregivers (USD58.33) and the average period of caregiving. To measure the cost of IIRT on post-stroke patients, the average costs reported by a National Evidence-based Healthcare Collaboration Agency (NECA) Health Technology Assessment report was used (2).

The disability grade improvements showed savings of government subsidy by USD58.65 to USD478.39 depending on the patient income from the registry. The average caregiving cost decrease was USD6,042 annually. The average cost of IIRT on post-stroke patients was USD926.34 for the first year.

This study estimated the cost-benefit of IIRT on post-stroke patients using the KOSCO study interim data. The intensive rehabilitation treatment improves patients functional status significantly enough to save two major cost items, the disability grades which also resulted in a decrease in government subsidy amounts and the caregiver costs which the patient family has to pay in Korea. The results warrant the use of IIRT for the post-stroke patients in Korea from the societal perspective.

The evaluation of orphan drugs raises both positive and normative issues. Due to the rarity of the disease, higher drug costs and greater uncertainty on effectiveness often result in incremental cost-effectiveness ratios (ICER) far beyond the usually accepted thresholds for reimbursement. However, decision makers may need to consider other criteria to assess the social value of orphan drugs such as equity, the rule of rescue, and the perceived need in the community. Hereditary Angioedema (HAE) is a rare congenital deficiency resulting in recurrent attacks of angioedema in affected patients. These episodes cause extreme pain and distress, and may even be fatal when air pathways are involved. In Italy, icantibant or C1-Esterase-Inhibitors (C1-INH) are the indicated treatments for acute attacks. Although more expensive, icantibant may reduce time to symptom-relief and the need for further treatments. Nonetheless, evidence on its social value is missing. The present study aims at evaluating the cost-effectiveness of icantibant and providing new insights on other potentially relevant criteria for decision making on HAE treatments.

A cost-effectiveness model of icantibant versus C1-INH (Berinert) was developed. Using a two-part bayesian model, costs were estimated from real-world data of an unpublished national registry. Efficacy data were synthesized from both the registry and an indirect comparison of existing trials, whereas utilities were derived from the literature.

In our Italian registry, respectively 98 percent and 60 percent of patients self-administered icatibant or Berinert at home in absence of medical personnel. On average, per treatment costs were 60 percent higher and attack duration 25 percent shorter with icantibant compared to Berinert. The resulting ICER greatly exceeded the considered threshold of EUR30,000.

On cost-effectiveness grounds icantibant did not demonstrate good value for money compared to Berinert. However, further considerations are needed on whether standard health-related quality of life measures are able to truly reflect societal preferences for HAE treatments.The use of real-world data for the economic evaluation of orphan drugs can support decision making when evidence from clinical studies is too sparse.

The Patient Reported Outcomes Burdens and Experiences (PROBE) questionnaire was developed with direct patient involvement in questionnaire design, conduct and analysis using patient-centered outcomes to assess health status in patients with hemophilia (PWH). Phase 1 confirmed robustness of the methodology and feasibility. Phase 2a investigated individual test-retest reliability. Phase 2b will explore population level reproducibility.

PWH and non-PWH individuals who attended a hemophilia-related workshop were asked to complete the PROBE questionnaire 3 times (paper-based survey on 2 consecutive days and then a web-based version). Test-retest reliability was analyzed using the percentage agreement and Kappa statistic. Kappa coefficient interpretation .81-1.00 almost perfect, .61- .80 substantial; .41- .60 moderate; .21 -.40 fair; .00 -.20, slight; and < .00 poor agreement.

Sixty-three participants from twenty-one countries were enrolled with a median age of 50 (range 14–76) years. Of these, thirty (47.6 percent) were PWH or carriers, thirty-three (52.5 percent) were participants with no known bleeding disorders. On general health domain, Kappa coefficients ranged from .69 to .92, indicating substantial to almost perfect agreement, for all items. Reliability of the web-based questionnaire showed moderate to substantial agreement for all except one item. For the hemophilia-related domain, Kappa coefficients ranged from .5-1.0. Of these, five of eleven items were in perfect agreement (Kappa = 1.0). Reliability of web-based questionnaire items were in substantial to almost perfect agreement. For overall health related quality of life, the EuroQol five dimensions questionnaire (EQ-5D) had Kappa coefficients of .62 to .92. Intraclass correlation coefficient of visual analog scale (VAS) was .90 (95 percent Confidence Interval, CI; .83-.94). Test-retest reliability was comparable between hemophilia patients and participants with no known bleed.

Phase 2a demonstrated individual test-retest reliability and suggests PROBE is a reliable tool to assess Patient Reported Outcomes in PWH. The Web-based questionnaire has an acceptable agreement with the standard paper-based version in all domains. PROBE Phase 2b, to demonstrate reproducibility at the population level, is on-going. To date, 1,039 participants have been recruited from 10 countries.

Patient evidence is submitted to the National Institute for Health and Care Excellence (NICE) by patient organizations and individual patient experts. Previously NICE developed a new patient organization evidence submissions template, based on the international HTAi patient submission template for medicines (1). The NICE template was reviewed by surveying committee members and also patient organizations who had used the submission template. The findings were presented at HTAi 2016.

The limitation of that review was the low response rate from patient organizations. The key recommendation was to extend the survey to include a larger number of patient organizations. These local findings are an opportunity to contribute to the global Health Technology Assessment (HTA) ecosystem.

A project group was convened consisting of NICE staff, a committee lay member and a patient organization representative. Together we reassessed the suitability of the previous feedback survey. This was then sent out to patient groups who had completed the submission template from July 2014 to November 2016. Additionally, public involvement staff telephoned selected patient organizations to increase the feedback response rate and gain greater understanding. The anonymized results were shared with patients involved in NICE who helped interpret the results from a patient organization's perspective.

Key findings are that patient organizations find:

• • the template clear

• • it was easiest to provide information about living with the condition

• • it was hardest to give information on equality issues and research evidence.

They would also like a submission guide, and to receive feedback on their submissions.

Although it was difficult to obtain feedback from the patient organizations on the submission template, the depth of information provided by them was fundamental to updating the template and producing a supporting guide.

This feedback on the local English needs can be used when evaluating the international submission template to form a greater part of the HTA ecosystem.

In Europe, the work done by the European Commission and the European Network for Health Technology Assessment (EUnetHTA) has consolidated the role of Health Technology Assessment (HTA), and promises to better harmonize its impact across European Union (EU) countries. However, more work is needed to improve patient involvement in assessing new health technology, and in developing research priorities.

The European Cancer Patient Coalition (ECPC) developed a model for engagement of patients in HTA based on the experience from:

• • ECPC's ‘Value of Innovation in Oncology’ White Paper, which includes input from ECPC's membership

• • ECPC's leading role in the Patient Preferences in Benefit-Risk Assessments during the Drug Life Cycle (PREFER) study, funded by the Innovative Medicines Initiative, to develop guidelines on how patient-preference studies should be performed throughout the development of new medical treatments.

The ECPC ‘Value of Innovation in Oncology’ White Paper was launched in 2017. The paper provides ECPC's policy position on key obstacles to equitable access to meaningful innovation. The paper recommends the establishment of an EU-wide HTA body to reduce delays and variations in access and to avoid duplication of effort by individual Member States. The paper also recommends that patients should be formally and routinely included in HTA policy and operations at EU and at national levels. These recommendations were also submitted to the European Commission's public consultation on strengthening EU cooperation on HTA.

Through its work in PREFER, ECPC is helping to improve how patient preferences are measured and valued to capture the impact of health technology on patients daily life. Patient preferences are concerned with measuring how patients value components such as treatment end points, route of administration, treatment duration, treatment frequency, frequency of side-effects, price, and quality of life.

Patient organization involvement in HTA is vital. Patient organizations offer unique insights, experiences, identify unmet needs, and can help to produce practical recommendations

The National Institute for Health and Care Excellence (NICE) medicines health technology assessments (HTAs) involve patients throughout (1): scoping the topic, evidence submission, attending committee as ‘patient experts’, consultation and appeal. A 2013 Health Select Committee report stated “It is important for the credibility of NICE and for the decisions that it makes that the patient voice is effectively and openly represented in all its work” (2). We thus wished to build on previous evaluation projects with more formal research into the views of patient organizations and individual patient experts on their involvement. We additionally sought to explore barriers to involvement.

The research was a collaboration between staff from three teams at NICE: public involvement, market research, and HTA committee support. A mix of interviews, focus groups and surveys was used to gather feedback – from patients and organizations who have engaged with NICE, but also those who had not, plus NICE committee chairs and staff. Facilitators and barriers to involvement were investigated, along with attitudes towards process and support. We used qualitative thematic analysis alongside quantitative methods.

Key findings were that patients and patient organizations mostly:

• • hold favourable opinions of NICE

• • have a good understanding of process and expectations

• • remain unsure of the impact of their inputs.

Improvements identified include clarifying communications, language and roles. Plus increasing transparency of decision making and patient impact.

The research findings and action plan, although specific to NICE, hopefully can inform others in the wider HTA ecosystem. Resources developed will be shared with Health Technology Assessment International (HTAi) networks, including updated correspondence templates and new videos explaining decision making in lay language. The research further adds to discussions around appropriate use of patient organizations scarce resources, and how best to feedback to participants and demonstrate impact of patient involvement.

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.