Health Technology Assessment Network Research Articles

Medical Methods: What Makes them Necessary? Part I: Medical Methods, medical Necessity and its Main Criteria

"Medical necessity" (MedN) is a fuzzy term. Our project aims at concretising the concept between medical ethics, social law, and social medicine to support health care regulation, primarily within Germany's statutory health insurance system. In a previous publication we identified MedN as a tripartite predicate: A specific clinical condition requires a specific medical intervention to reach a specific medical goal. Our two-part text searches for and discusses criteria to classify medical methods as generally medically necessary (medn), provided a non-trivial clinical condition and a relevant, legitimate, and reachable goal actually exist. In this paper we present the first part of our results. Based on an extensive ethical, sociolegal and sociomedical body of literature, and starting with an non-controversial case vignette (thrombolysis in acute stroke), we generally followed a critical reconstructive approach. First we defined the term "medical method". In several interdisciplinary rounds, we then collected and discussed criteria from three sources: methods to develop clinical practice guidelines as compendia of indication rules, the National Model of Prioritisation in Swedish Health Care, and the HTA Core Model of the European Network for Health Technology Assessment as an instrument of political counselling. We identified general clinical efficacy and benefit as the 2 main "medical" criteria of MedN. As a third - epistemic - criterion, the corresponding bodies of evidence are always to be considered. Since clinical and prioritising guidelines grade their recommendations, the question arises whether MedN should be conceptualised as a dichotomous or finer graded predicate. In accord with German social law we advocate for the binary form. Further discussions focused on multifactorial MedN-configurations, the range of the term, and the variability of evidence requirements. No matter how the content of MedN is conceptualised, it seems impossible to include its criteria in an algorithm. So deliberative effort is indispensable at any stage of developing a programme to classify medical methods as medically necessary.

PNS101 YOU REAP WHAT YOU SOW; EUNETHTA COMING TO FRUITION

EUnetHTA was established in 2005 to create an effective and sustainable network for Health Technology Assessment (HTA) across Europe. JA2 (Joint Action 2) the first major assessment program, assessed four drugs between 2012 and 2015. JA3 was established in 2016 with the aim to increase the use, quality and efficiency of joint HTA work at the European level, including expedited timelines for development with final report to coincide with EPAR publication. This research aims to evaluate whether drugs evaluated under EUnetHTA JA3 have received better/faster outcomes by national European HTA bodies. Publicly available information on EUnetHTA JAs for individual drugs were identified along with the associated appraisal by NICE, SMC, IQWIG, TLV, HAS, AIFA, SMC, NCPE, ZIN, Medicinradet, AOTM and NOMA (to 16/01/2019). Statistical tests were carried out using a two-tailed t-test. Seven EUnetHTA JAs were identified, 4/7 were assessed during JA2, 3/7 were assessed during JA3. Overall 5/7 were for oncology indications and 2/7 were orphan drugs. Forty three corresponding national HTA appraisals were identified, 24% being positive recommendations with a mean delay of 289 days post-EC approval. EUnetHTA JA3 appraised products had a significantly higher recommendation rate by national HTAs (70%; 16/23) vs. those appraised under EUnetHTA JA2 (45%; 9/20). In addition, the mean delay from EC-approval to national HTA publication for EUnetHTA JA3 appraisals was significantly lower than that of EUnetHTA JA2 appraisals (218 days and 364 days respectively; p=0.006). To date, drugs appraised under JA3 have received significantly better national outcomes in a shorter time in comparison to those appraised under JA2. This likely reflects an improvement in the JA3 framework, including reducing the time to publication for JAs to prior to the start of national HTA processes. However, this may be confounded by differences in the types of drugs appraised under JA2 vs. JA3.

Health Technology Assessment of Carbon-ion Beam Radiotherapy: A Systematic Review of Clinical Effectiveness and Safety for 54 Oncological Indications in 12 Tumour Regions.

Due to the unique physical dose distribution of carbon-ion radiotherapy (CIRT), CIRT can be regarded as a novel tumour irradiation technique - potentially advantageous for various tumour types. Yet it is unclear in how far, superiority or inferiority can be claimed when comparing CIRT to standard irradiation. This study aimed to assess the scientific evidence regarding the effectiveness and safety of CIRT. A systematic literature review was performed using the European Network for Health Technology Assessment (EUnetHTA) Core Model® for rapid relative effectiveness assessment. The literature search for clinical outcome studies on CIRT was performed using four databases [Cochrane (Central), Centre for Research and Dissemination (CRD), Embase and OVID MEDLINE]. The Cochrane Risk of Bias Tool (for randomised controlled trials) and the Institute of Health Economics (IHE-18) Checklist (for observational studies) were used to assess the risk of bias of the included studies. The evidence synthesis was restricted to 54 oncological indications in 12 broad tumour regions and studies with a low or moderate risk of bias, published between 2005 and 2017. Twenty-seven studies were eligible for the qualitative synthesis of the evidence regarding the effectiveness and safety of CIRT: One randomised controlled trial that primarily focused on the feasibility of CIRT, three case-control studies, three before- and after- studies with a focus on quality of life, and 20 further studies of case series. Overall, insufficient scientific evidence was found for superiority or inferiority of CIRT when compared to standard irradiation for 13/54 oncologicaI indications in 7/12 tumour regions (skull base tumours, brain cancer, cancer in the ear-nose-throat region, bone and soft-tissue tumours, lung cancer, prostate cancer, gastrointestinal tumours). No scientific evidence was found for the remaining 41/54 oncological indications. CIRT is undoubtedly, theoretically, a promising cancer treatment. To date, however, it lacks randomised controlled trials assessing the long-term effectiveness and harms associated with the use of CIRT. CIRT must be considered as an experimental treatment due to the lack of high-quality clinical research.

European Collaboration in Health Technology Assessment (HTA): goals, methods and outcomes with specific focus on medical devices.

SummaryThe European Network for Health Technology Assessment (EUnetHTA) was founded to support efficient production and use of health technology assessments (HTAs) across Europe by reducing redundancies through collaboration. To facilitate collaboration, a range of practical tools, methods and process definitions were developed. The article describes when and how these tools and methods are used along the HTA process with specific focus on “other technologies”, that is medical devices and non-pharmaceutical procedures. EUnetHTA was able to deliver tangible achievements complying with its goals. The practical tools and the developed methods formed a basis for close collaboration among over 70 agencies at a European level. The activities of EUnetHTA laid a strong foundation for sustainable cooperation. In the long run, jointly produced assessments could realise economies of scale with improved quality, consistency and transparency for the health systems in Europe.

Evaluation of Ethical Analyses in Seven Reports from the European Network for Health Technology Assessment.

Ethics has been considered among the core domains of health technology assessment (HTA), but there are still disputes regarding ethical analysis. This study aimed to examine full final reports of the European Network for Health Technology Assessment (EUnetHTA) in terms of their compliance with the ethical methodology and ethical perspective of the HTA Core Model®. The study examines seven full final HTA reports of EUnetHTA written based on the methodology proposed in the HTA Core Model®. The reports were analyzed using the following parameters: competency of the person/group who conducted ethical analysis, assessment elements, and the methodology of ethical analysis. The results show that, although the HTA Core Model® helped to standardize the final reports of the assessment, there are still concerns regarding the competency of the ethical analysis team, the perspectives on the purpose of ethical analysis, data sources and viewpoints of various stakeholders, use of ethical analysis methodology, and the evaluation of the ethical appropriateness of the entire HTA process. The HTA Core Model® helped to standardize the final reports on the HTA; however, not all issues with the content and outcomes were solved. The lack of expertise in ethics and insufficiency of the teams regarding ethical analysis are other existing problems. This study also demonstrated that stakeholder viewpoints in general and patient perspectives, in particular, have been overlooked in the HTA process.

The Spanish Network of Agencies for Health Technology Assessment and Services of the National Health System (RedETS).

Earlier activities on health technology assessment (HTA) started in Spain around 1984, with the creation of a National Advisory Board on HTA, and the development of national and regional HTA organizations in the early 1990s. In 2012, the Spanish Health Ministry established the Spanish Network for Health Technology Assessment of the National Health System (RedETS); funded at national level and including all public HTA organizations at national and regional levels. RedETSis focused on the assessment of nondrug health technologies to inform the revision (approval and funding or disinvestment) of the Benefit Portfolio of the Spanish NHS. In parallel with European Network for Health Technology Assessment (EUnetHTA), RedETS has been setting-up and sharing common procedures and methodological guidelines to ensure effective cooperation and mutual recognition of the scientific and technical production in HTA. The output of RedETS is fifty to sixty annual reports, including the production of full HTA reports, Clinical Practice Guidelines, methodological guidance reports, relative effectiveness assessments, tools to support shared decision making between patients and healthcare professionals, and monitoring studies. The HTA assessments requested by the Regional Health Authorities are the biggest component of the annual RedETS working plan. These assessment needs are identified according to a yearly process and prioritized by a Commission composed of representatives from all Spanish regions with the aid of the PRITEC tool. The objectives of this study are to report and update the normative and organizational state of HTA in Spain; describing noteworthy advances witnessed over the past 10 years, as well as discussing existing challenges.

PP113 A Framework To Enhance Eurasian Economic Union Cooperation On Health Technology Assessment: Lessons From The European Network for Health Technology Assessment

IntroductionThe Eurasian Economic Union (EAEU), which currently includes Armenia, Belarus, Kazakhstan, Kyrgyzstan, and Russia, was established in 2015. Pursuing economic integration, and modeled in part after the structure of European Union, the EAEU launched a common medicines market in 2017. There have been various developments regarding cooperation in health technology assessment (HTA) across the EAEU countries, exemplified by a conference held in Kazakhstan in 2017. Here we discuss some considerations for developing cooperation in HTA throughout EAEU based on the experiences of implementing the European Network for Health Technology Assessment (EUnetHTA).MethodsLegal and review documents regarding the implementation of EUnetHTA were obtained from the European Commission website and research databases to inform this narrative review.ResultsAchieving recognition of the role of HTA at an inter-governmental level, akin to the actions of the European Commission prior to establishing EUnetHTA, appears pivotal at the current stage of HTA development among EAEU members. Similar to the EUnetHTA project stage of 2006-2008, the existing HTA structures and national standards will need to be accurately and systematically assessed by a working-group appointed specifically for that purpose. Besides the importance of accepting a unifying framework similar to the EUnetHTA core model, implementation features that are specific to the context of EAEU countries could include the development of common adaptation toolkits and glossaries. Capacity building efforts may also prove crucial to ensure the sustainability of HTA-related cooperation.ConclusionsOptimization of resources by streamlining HTA processes, whether in research, policy, or results dissemination, and avoiding duplication of effort by HTA agencies, is relevant in the context of limited healthcare resources in developing countries. This overview is an attempt at facilitating discussion to inform policy and research efforts to streamline HTA processes.

PP193 How Does HTA Address Social Expectations Now? An International Survey.

IntroductionAfter surveying its members on ethical issues (2003), the International Network of Agencies for Health Technology Assessment (INAHTA) mandated its Ethics Working Group (2005) to reflect on the role of health technology assessment (HTA) organizations in meeting social expectations. Some aspects of these have since been clarified by two studies addressing either the official position of INAHTA's members or the publication authors. An international survey was carried out on the perception of HTA professionals’ expectations when producing HTA reports: how to fulfil HTA's social role, which value judgments should be made explicit and what should be the status of ethical analysis.MethodsA twenty-two question, web-based, anonymous survey was devised from our recent systematic review on the integration of ethics into HTA and carried from April to July 2018. The information on 328 HTA agencies/contact persons from seventy-five countries was collected from the website of INAHTA, Health Technology Assessment International (HTAi), the European Network for Health Technology Assessment (EUnetHTA), EuroScan International Network, the HTA Network of the Americas (RedETSA) and the HTA Network of Asia (HTAsiaLink), a 2015 World Health Organization survey, HTAi members, and our local HTA network (Québec, Canada).ResultsEighty-nine participants completed and submitted a finalized survey for a 27 percent participation rate representing thirty-three countries. Regarding how the HTA reports should fulfil their social role, our results showed that over 84 percent of the respondents agreed upon the necessity to address it to decision makers, patients and citizens. At a lower and more variable level, the same result was found about the necessity to make value judgements explicit in different sections of the report, including ethical analysis. This contrasts with the variability of responses obtained on the status of ethical analysis although an agreement on the expertise required was observed. Variability in the usefulness of patient, public or stakeholder participation was observed.ConclusionsAt the dawn of this decade, this study reveals high expectations on context-dependent decisions in HTA: the necessity to integrate the ‘explicitation’ of value judgements and systematic ethical analysis to fulfil HTA's social role.

OP157 Carbon Ion Radiotherapy: A Systematic Review

IntroductionDue to the promising physical dose distribution of carbon ion radiation therapy (CIRT), CIRT can be regarded as a novel tumor irradiation technique and is sometimes considered as a breakthrough therapy for various tumor types. However, it is unclear whether superiority or inferiority can be claimed when compared to standard irradiation. This study aimed to assess the scientific evidence regarding the effectiveness and safety of CIRT.MethodsA systematic literature review was conducted using the European Network for Health Technology Assessment (EUnetHTA) Core Model® for rapid relative effectiveness assessment. The literature search for clinical outcome studies on CIRT was performed in four databases [Cochrane (Central), Centre for Research and Dissemination (CRD), Embase and OVID MEDLINE]. The risk of bias was assessed using the Cochrane Risk of Bias Tool (for randomized controlled trials) and the Institute of Health Economics (IHE) Checklist (for observational studies). The evidence synthesis was restricted to 12 tumor regions (and 54 indications) and studies with a low or moderate risk of bias, published between 2005 and 2017.ResultsIn total 27 studies were eligible for the qualitative synthesis of the evidence regarding the effectiveness and safety of CIRT; one randomized controlled trial that primarily focused on the feasibility of CIRT, three case-control studies, three before-after studies focusing on quality of life, and 20 further case series studies. Overall, insufficient scientific evidence was found for 13 (out of 54) indications in seven tumor regions and no scientific evidence was found for 41 (out of 54) indications.ConclusionsTheoretically, CIRT is undoubtedly a promising cancer treatment. To date, however, 54 oncologic indications in 12 tumor regions under investigation lack randomized controlled trials assessing the long-term effectiveness and harms associated with its use. CIRT must be considered as an experimental treatment due to the lack of high-quality clinical research.

PP08 Evaluation Of The Brazilian Health Technology Assessment Network

IntroductionThe Brazilian Network for Health Technology Assessment (REBRATS) is a network of collaborating centers and teaching and research institutions, focused on the generation and synthesis of scientific evidence in the field of health technology assessment. Currently, the network is composed of 119 member institutions and mobilizes approximately 1,094 researchers and 4,998 relations. The objective of this study was to evaluate the member institutions of REBRATS.MethodsThe evaluation process was developed in seven stages, including the identification of the objectives of the Network; identification of evaluation criteria; selection of performance indicators for each criterion; identification of the measures appropriate to each indicator; data collection and analysis; classification of the institutions and production of the final report.ResultsThe evaluation of the member institutions of REBRATS mapped the capacity of these institutions to produce health technology assessment activities. The evaluation also provided information on the advances and challenges of health technology assessment in the country. In the long term, the initiative will contribute to the strengthening of the evaluation of health technology in Brazil, since the weaknesses of these institutions in the development of activities were mapped.ConclusionsThe production of this study will contribute to the dissemination of the evaluation methodology at the national and international level. This study is one of the few initiatives that exist in the world on the evaluation of networks and will contribute to the strengthening of the evaluation of health technology in Brazil.

VP62 The EUnetHTA Companion Guide: A New Repository To Support European HTA

IntroductionGood quality management (QM) and the sound application of EUnetHTA's (European network for Health Technology Assessment) well-established methodology and tools are fundamental prerequisites for reliable and trustworthy joint work. To provide ultimate support and guidance to the assessment teams of EUnetHTA – and further, to ensure a sustainable mode of work for the post-2020 period – a comprehensive web-based so called “EUnetHTA Companion Guide” is established in Joint Action 3.MethodsThe Companion Guide was created using the open source Wiki software “DokuWiki”. We divided the content into five main parts: 1. EUnetHTA's QM concept, 2. QM for rapid Relative Effectiveness Assessment (REA) Pharma, 3. QM for rapid REA Other Technologies (OT) 4. Scientific Guidance & Tools and 5. QMS-related training material. The assessment processes for rapid REA Pharma and OT have been subdivided into single process steps for which the Companion Guide provides standard operating procedures (SOPs), checklists, templates, guidelines and tools. The content of the Companion Guide is continuously subjected to evaluation by means of a structured survey with regard to the achievement of its purpose of ensuring to ensure high-quality HTA reports.ResultsIn May 2018, the Companion Guide was launched and is now available to all EUnetHTA partners. It provides central access to all components of the newly established QMquality management system for EUnetHTA. The user has access to training modules that provide information on how to use the Companion Guide. Moreover, the training material enables EUnetHTA partners to build up necessary capabilities for QMquality management, and application of methodologies and tools in the context of EUnetHTA.ConclusionsThe purpose of the Companion Guide is to ensure the production of high-quality HTA reports by providing ultimate support and guidance to the EUnetHTA assessment teams during their joint work. The continuous evaluation will reveal necessary revisions and the need for further developments and guidance.

PP58 The Alliance Between Health Technology Assessment And Public Health In National Screening Policies

IntroductionDecision making regarding national population-based prenatal and newborn screening policies is recognized to be highly challenging. This paper aims to describe the formalized collaboration that has been established between the Spanish National Public Health Screening Advisory Committee (PHSAC) and the Spanish Network of Health Technology Assessment (HTA) agencies to support the development of evidence- and consensus-based recommendations to support this process.MethodsIn-depth description and analysis of the strategic and methodological processes that have been implemented within the Spanish National Health System prenatal and newborn screening frameworks, with special emphasis on the role, actions, and responsibilities of HTA agencies.ResultsThe role of HTA agencies is threefold: (i) support the PHSAC by providing evidence on safety, effectiveness and cost/effectiveness of the screening tests/strategies, as well as contextualized information regarding costs, organizational, social, legal and ethical issues; (ii) collaborate with the PHSAC in the development of formal evidence- and consensus-based recommendations for defining population screening programs, when required; (iii) analyze real-world data that is generated by piloted programs. This paper will provide real-life examples of how these processes were implemented in practice, with a special focus on the development of the non-invasive prenatal testing (NIPT) policy. Recommendations for NIPT were developed by a multidisciplinary group based on the European network for Health Technology Assessment (EUnetHTA) rapid assessment report and the predictive models that were built using national statistics and other contextualized data.ConclusionsThe current work represents an innovative approach for prenatal and newborn screening policymaking, which are commonly difficult to evaluate due to the low quality of evidence and the confounding public health issues. The paper raises awareness regarding the importance of joint collaborations in areas where evidence is commonly insufficient for decision making.

OP112 Project Management for EUnetHTA Non-Pharmaceutical Technologies

IntroductionThe European Network for Health Technology Assessment (EUnetHTA) facilitates and produces Health Technology Assessments (HTA) across Europe. Project Management (PM) provides the coordination and strategic overview of assessment production and enables the flow of scientific knowledge and assessment publications through collaboration and standardized processes, procedures and documentation.MethodsEUnetHTA established a central PM function at the Ludwig Boltzmann Institute for HTA (LBI-HTA) for central coordination and assessment production of non-pharmaceutical technologies. LBI-HTA subsequently pursued capability and capacity through a decentralized hub-and-spoke-PM model with six activity centers (AC) providing decentralized coordination and PM of assessments. LBI-HTA provided central oversight and supervision with training days, e-meetings and ad hoc e-mail and telephone support as required. This was complemented by standardized operating procedures (SOPs) in the online Companion Guide (CG). A qualitative data collection via electronic questionnaires collected feedback from AC-PM, LBI-HTA-PM and assessment authors. Specific questions with free-text responses assessed current experiences, challenges, recommendations, communication and task distributions of the centralized and decentralized PM processes from these different perspectives.ResultsThe feedback concluded that PM is a separate, well-defined and important role for assessment coordination and production. The AC-PM received adequate training from the central PM and authors experienced no difference between projects managed centrally or decentrally. The CG and SOPs are important for guiding standard practice and allowing AC-PM to operate independently. Challenges were around extended timelines due to complex topics, external stakeholder involvement, insufficient team communication and not yet published SOPs resulting in additional central support.ConclusionsDecentralized coordination of assessments, knowledge management and governance achieve scale, capacity and capability through a designated pool of agencies with established roles and growing experience in sustainable collaboration of HTA production. Valuable insight into the PM model's operational efficiency, avoidance of duplication and resource savings potentially provides a sustainable post 2020 European network policy and efficiency model for high quality HTA assessment production.

OP162 Stakeholder Involvement In EUnetHTA Relative Effectiveness Assessments

IntroductionAppropriate involvement of stakeholders is one of the founding principles of the European Cooperation on Health Technology Assessment. The European Network for Health Technology Assessment (EUnetHTA) produces Rapid Relative Effectiveness Assessments (REAs) to assess pharmaceutical (PT) or other technologies (OT). Stakeholders essentially participate in the scoping, the draft assessment phase, or both.MethodsAll REAs published since 2013 were reviewed. Stakeholder participation in scoping (project plan) and draft assessment was evaluated. We aggregated categories of stakeholders in four groups (Health Care Providers and Academia, Patients and Consumers, Manufacturers, and Regulators and Payers). Means of collaboration (meetings, comments to project plan and draft assessment, questionnaires, focus groups) are also analyzed. Data is continuously updated with new REAs.ResultsMore than 20 REAs have been published at the moment, with a higher number of OT. Health Care Providers and Academia acted as experts in both phases, participating in all REA of OT, and less of PT. Manufacturers participated in all REA in the scoping phase. Regulators and Payers, less involved, participated mainly in the scoping phase. The main methods are providing comments in a standardized form and meetings. Patients' contribution, similar in OT and PT, has increased over the years. Questionnaires or interviews were the main method of involvement, followed by participation in meetings and focus groups. Visibility and transparency have also improved, with a clearer reporting of the stakeholder contribution in the last assessments.ConclusionsThe stakeholder involvement in EUnetHTA REAs is steadily growing, with the different nature of stakeholders’ categories reflected in their contribution to the assessments. EUnetHTA is standardizing stakeholder involvement procedures taking into account the particularities of each group when generating guidance for stakeholder involvement.

OP168 The EUnetHTA Quality Management System: Development And Evaluation

IntroductionOne objective of the European Network for Health Technology Assessment (EUnetHTA) Joint Action 3 (JA3) is to set up a quality management system (QMS) for joint work that serves as a standalone infrastructure for a sustainable European HTA-collaboration. Structures of the QMS (quality policy, processes and procedures, and organizational structures) combined with the measures of QM (quality planning, assurance, control and improvement) both ensure achieving the objective of producing high-quality HTAs.MethodsBased on a thorough concept with involvement of a spectrum of EUnetHTA partners, re-evaluation, internal workshops and national expertise, the existing inventory consisting of procedures, templates, methodological guidelines and tools is being refined, complemented and revised. Procedures are gradually being transferred into Standard Operating Procedures (SOPs), seamlessly and chronologically covering all assessment phases. Supplemented by quality-control-checklists and templates these SOPs are linked to relevant guidelines and tools. The so-established QMS is subject to continuous improvement by recurrently applying the Plan-Do-Check-Act (PDCA)-cycle. Members of the assessment teams are surveyed after the publication of each EUnetHTA-report (check-phase). Processed results lead to modification, maintenance and improvement of the inventory (act-phase).ResultsThe majority of content has already been developed or revised and was already made available to the assessment teams to put to practical test. The survey results are systematically collected, processed and compiled. Derived from these results, a comprehensive report and a thorough list of improvement measures have been developed and will serve as a basis for further adaptions.ConclusionsThe establishment of structures of QMS and measures of QM both are supposed to assure high-quality HTA-reports for EUnetHTA and a possible permanent European collaboration on HTA after JA3 as proposed by the EU-commission's regulation proposal 2018/0018 (COD). The installed systematic data collection, processing and compilation mechanisms are a solid basis for the identification of future needs for developments.

PP32 Joint Early Dialogs Between Medical Device Regulation and Health Technology Assessment

IntroductionIn Europe, the new Medical Device Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR) that entered into force 2017 will have to be applied until 2020 and 2022, respectively. Under the old regulation, there was a large gap between evidence requirements for market approval and market access for high risk (class IIb and III) medical devices (MD). The MDR/IVDR will require appropriate clinical investigations for these MD classes. Despite the different purpose of market approval and surveillance and reimbursement decisions, there are possible synergies with regard to evidence generation, for example, design of pivotal trials and post-launch evidence generation with observational data. In the MDR, early scientific advice can be provided by expert panels of the European Commission if requested by MD developers. For medicinal products, the European network for Health Technology Assessment (EUnetHTA) has established joint early dialogs (JED) of HTA agencies with the European Medicines Agency and manufacturers. A similar approach might be possible with the Medical Device Coordination Group (MDCG). The objective was to explore possible synergies for JED with the MDCG and EUnetHTA.MethodsIn 2018, EUnetHTA established a task force for HTA and MDR/IVDR. A workshop, which will explore possible synergies and activities on JED as well as the viewpoints of stakeholders will be held in May 2019. Participants will be Directorate-Generals GROW (Internal Market, Industry, Entrepreneurship and SME) and SANTE (Health and Food Safety), EUnetHTA members assessing MD, representatives of national competent authorities, Team Notified Bodies, MedTech Europe, patient representatives and academia.ResultsA report on the presentations, the results of the discussion, and next steps in a possible collaboration will be presented.ConclusionsJoint early scientific advice to manufacturers on the European level for evidence generation by HTA agencies and the MDCG has the potential to streamline evidence generation in the life cycle of high risk MD.

PP179 Health Technology Assessment Of Pediatric Intensive Care Ventilators

IntroductionA health technology assessment (HTA) process to evaluate the best intensive care ventilator manufacturers has been carried out in different pediatric intensive care units (ICUs) of Bambino Gesù Children's Hospital (OPBG). The purpose of this study is to determine: (i) the most relevant features of a ventilator to be considered between different manufacturers, and (ii) the methodology to conduct the assessment to support the decision-making process about the choice to adopt the suitable technology for OPBG.MethodsThe decision-oriented HTA method (Do-HTA), developed by the HTA unit of OPBG, was applied to conduct the assessment. Do-HTA involves the integration of the European Network for HTA (EUnetHTA) CoreModel and the Analytic Hierarchy Process with the support of an informatics tool. It provides the definition and numerical evaluation of assessment parameters to evaluate the performance of technologies. A literature review involving ICU professionals was used to define and weight the assessment elements on clinical, technical, organizational, economic, and safety domains. In particular, a subgroup of these domains has been included in a checklist for the comparative evaluation of different ventilator models, each of which was tested in three independent runs performed in three different ICUs.ResultsResults show that safety and clinical effectiveness had highest the impact within the evaluation, followed by organizational, technical and economic aspects. A percentage value per each ventilator has been assigned, representing the global performances regarding the assessment elements.ConclusionsThis study presents and discusses the benefits and drawbacks of innovative features of ventilators, all characteristics to be taken into account during the evaluation process and a methodology to conduct it. The project identified the best performing ventilator model through a collective decision, giving a reliable recommendation to the Hospital Decision Makers.

VP37 Patient Involvement In EUnetHTA Assessments (Non-Pharma Technologies)

IntroductionPatients can provide valuable experience on living with diseases, health-related quality of life, various therapies and relevant outcomes. Their input and perspectives can be helpful in complementing health technology assessment (HTA) processes. The European Network for HTA (EUnetHTA), funded by the European Commission, aims to further advance and standardise patient involvement processes in order to add to the quality and applicability of HTAs and to allow capability building.MethodsDifferent methods for patient involvement in HTAs on non-pharmaceutical technologies were tested: Patient input templates (open questions sent to relevant patient organizations, or published on EUnetHTA website); scoping meeting with patients/patient representatives; one-on-one conversation and group conversation. Applied methods depended on the scope of the HTA and other factors like timelines of HTAs and burden of disease for patients.ResultsPatients were included in eight of sixteen HTAs on non-pharmaceutical technologies. Applied methods were: group conversation (n = 2), scoping meeting (n = 1), patient input templates (n = 4), one-on-one conversation (n = 2,) and other approach (i.e. written feedback on scope n= 2). In some HTAs more than one method was used. Main reasons for not including patients were inability to identify suitable patients or tight timelines. Patients' feedback on health-related quality of life and outcome measures proved most useful in the scoping phase.ConclusionsThe different approaches were useful for complementing HTA processes. Those need to be further tested and evaluated in order to formulate deeper understanding about the impact of patient involvement on HTA. Additionally, feedback from patients that were actively involved in the HTAs should be collected to further improve the involvement methods that should serve as basis for future recommendations post 2020.

PP178 Health Technology Assessment Of Laboratory Medicine

IntroductionRecent studies have investigated the re-organization and automation of laboratory medicine as a challenge for the hospital in terms of reduction of costs, turnaround time, workload, optimization of human and technological resources and improvement of safety. The purpose of this study was to conduct a health technology assessment (HTA) evaluation process about the possibility to re-organize and automate laboratory medicine at Bambino Gesù Children's Hospital.MethodsThe decision-oriented HTA (Do-HTA) method, involving the integration of the European Network for HTA (EUnetHTA) CoreModel and the Analytic Hierarchy Process, was applied to assess the best technology solution. Twenty-one professionals were involved to define tender specifications related to the adaptation works of the new dedicated rooms, and the automatic technologies and organizational solutions for the new laboratory department. Finally, two manufacturer companies were consulted.ResultsUsing Do-HTA, the study was focused on laboratory technologies while the infrastructure evaluation was conducted by the Engineering and Logistic Units of the hospital. Results showed that the total performance score of the first proposal was slightly higher (2.5 percent) than the second one, proving the comparable high qualitative level of both manufactures technologies. After an accurate analysis, evaluating all aspects (safety, clinical efficacy, cost, organization & technical criteria) and integrating the infrastructure evaluation, the decision has fallen upon the first company offer.ConclusionsThis HTA project provided an in-depth examination of two proposed technological and organizational solutions. Thanks to the Do-HTA method, which produced and developed data and all needed information, it was possible to guide and assist the decision makers on the choice between the two technical solutions.

OP81 Building Technical Capacity To Promote Patient Involvement In Health Technology Assessment

IntroductionIn December 2017, a patient involvement (PI) Interest Group was created in the Spanish Network of Agencies for Assessing National Health System Technologies and Performance (RedETS) Annual conference. It started as a voluntary group of health technology assessment (HTA) methodologists interested in PI. The objective of the Group is to promote and facilitate PI in HTA. With the support of the Spanish Ministry of Health and the RedETS Council the Interest Group grew to at least one member for each of the eight RedETS regional agencies and units. It currently has 22 members. The PI Interest Group works in periodic online meetings and an annual offline meeting to establish a space for experiences exchange and reach consensus on main issues regarding PI.MethodsRedETS published a strategy to facilitate effective and efficient PI in HTA processes in 2017. The long-term objective is to mainstream PI in all RedETS products. This strategy was built on a literature review and a qualitative study with semi-structured interviews. The interviews detected capacity building needs for technicians and methodologist in the network to be able to actively engage patients in HTA reports.ResultsSince the kick-off meeting the PI Interest Group has worked in a number of activities. The main lines of action since its creation were: (i) evaluation of PI process in RedETS HTA reports in 2017 and in current reports, (ii) discussion on main methodological and procedural aspects, and feasibility of different patient participation approaches, (iii) development of technical protocols and templates to facilitate PI, (iv) the creation/adaptation of educational materials for patients and (v) translation of the HTAi Glossary for patients to Spanish.ConclusionsPeer-to-peer learning processes can foster technical capacity of HTA methodologist in the Spanish HTA Network and may favor the implementation of the PI strategy.