Health Technology Assessment Network Research Articles

2.G. Workshop: The development of HTA collaboration in Europe: where we are and where we are going

Abstract Health decision-making should be always well-informed. This draws the attention on the need to make the best use of available evidence in respect to different clinical and non-clinical issues to make a value-based allocation of resources. Health Technology Assessment (HTA) is a method for supporting evidence-informed health policymaking as it is defined as a multidisciplinary process that uses explicit methods to determine the value of a health technology at different points in its lifecycle. The role of HTA is of utmost importance at European Union level considering that citizens have the right to access healthcare in any EU country with reimbursement by their home country. Therefore, Member States (MS) cooperation in the evaluation of health technologies is envisaged to ensure safe, high-quality, and efficient healthcare. Several efforts have been put in place at EU level to make this collaboration possible. The cross-border healthcare directive 2011/24/EU have led to the establishment of a voluntary network of MS to facilitate their cooperation and the exchange of scientific information. This network has been supported by another network, namely the European Health Technology Assessment Network (EUnetHTA) that was launched in 2006 with the aim to increase the contribution of HTA to decision-making in EU MS, strengthen the link between HTA and health policymaking, and reduce the overlap and duplication of HTA efforts by promoting a more effective use of resources. EUnetHTA has created a long-lasting Joint Action that has developed principles, methodological guidelines, as well as functional online tools for the sharing production of HTA. In the meantime, starting from 2018, a proposal for an EU regulation on HTA has been discussed within the European Commission first and the European Council and Parliament later. The discussion led to the approval of the Regulation (EU) 2021/2282 on health technology assessment (HTAR) that entered into force on 11 January 2022 and will apply from 12 January 2025 onwards. The HTAR calls for mandatory participation in and use of joint clinical assessments at MS level opening a new era for HTA at EU level. In order to make public health professionals ready for the challenge, this skill-building seminar will provide the audience with basic knowledge in respect to the objective, the application, the methods, and the history of HTA at European level. After two formal presentations on these issues, a case study will lead the following interactive discussion with the audience. Key messages • Health decisions should be informed by the determination of the value of health technologies through shared methods, such as Health Technology Assessment. • Collaboration on Health Technology Assessment at European level has had a long-lasting story and is now looking out into a new challenging era that will be the EU regulation being implemented.

Implementation of Health Technology Assessment and Management Course in Undergraduate Program in Biomedical Engineering ITB.

The Undergraduate Program in Biomedical Engineering ITB, Indonesia, introduce the Health Technology Assessment and Management as an elective course in 2021. This course is implemented to support the World Health Assembly that urges the member states to establish national strategies in health technology assessment and management, particularly medical devices. Furthermore, it is designed to give biomedical engineering students a broader insight into their career opportunities. Therefore, this course is delivered by the practitioner and guided by the main lecturer. The course syllabus is developed from the WHO Medical Devices Technical Series and European Network for Health Technology Assessment. It tries to implement HTA Core Model for Rapid Relative Effectiveness Assessments. A questionnaire is used to measure the students' perception of the course implementation. Moreover, it is used to obtain the students' comments and feedback. The course that is delivered by the practitioner not only gives the course content but also the context. After attending the course, students have a broader insight into the career opportunities as biomedical engineers in Indonesia.

Strengthening the Interface of Evidence-Based Decision Making Across European Regulators and Health Technology Assessment Bodies

ObjectivesAccess to medicines in Europe depends on a benefit-risk decision taken by regulators and a relative effectiveness assessment performed by health technology assessment bodies (HTABs) to inform, as one element, a reimbursement decision. Although various similarities in evidence needs exist, understanding of their needs is currently suboptimal and therefore the evidence generated does not always meet their needs. Subsequently, delays in decision making can be expected, negatively affecting access. To overcome this, this study reviewed the evidentiary needs of European regulators and HTABs at European level and analyzed how their collaboration can further facilitate optimal evidence generation plans, evidence use, and evidence presentation. MethodsThrough systematic literature review, expert interviews, and pairwise comparison of assessment reports by the European Medicines Agency and European network for health technology assessment, respective clinical evidence requirements and impact of product-specific collaboration between European Medicines Agency and HTABs were established. ResultsClinical evidence needs are quite similar but differences exist in comparator choice, preferred efficacy endpoints, and target population. Results of the impact of collaboration to date were mixed: preapproval joint advice procedures were successful and highly valued by all stakeholders; information exchange at the time of regulatory decision is coming together, yet the European Public Assessment Report can be further optimized; and collaboration on postlicensing evidence generation requirements shows potential but needs solidifying. ConclusionsThese findings demonstrate the potential to further improve the evidence utilization across stakeholders to avoid duplication and streamline decision making, to ultimately improve access to medicines for European patients.

European Network for Health Technology Assessment's Response to COVID-19: Rapid Collaborative Reviews on Diagnostic Tests and Rolling and Rapid Collaborative Reviews on Therapeutics.

In spring 2020, The European network for Health Technology Assessment (EUnetHTA) decided to join forces to produce best evidence to inform health policy in the COVID-19 pandemic. The objective of this paper is to describe the process and output of the coordinated and collaborative activities of EUnetHTA. Relevant published and internal documents were retrieved for a descriptive analysis of EUnetHTA processes, methods, and outputs related to EUnetHTA's response to the pandemic. Process: In April 2020, a COVID-19 task force was set up and a survey collected pressing health policy questions across Europe. Two coordinating agencies for diagnostic tests and therapeutics were assigned. A process for prioritization and selection was set up for therapeutics, as well as explicit starting and stopping rules. Methodology: To increase a timely response, it was agreed that the rapid collaborative reviews (rapid CRs) would not require the consultation of manufacturers and the involvement of external experts, but would not differ in the methods and conduct of the systematic search, review, and synthesis of all available evidence, nor in the requirement for reviewing by EUnetHTA partners. Final reports: The joint effort resulted in the production of two rapid CRs on diagnostic tests, nineteen collaborative rolling reviews on therapeutics, three of which later moved to rapid CRs. During COVID-19 pandemic, the EUnetHTA partners proved capable of prompt collaboration, which allowed speeding up the production and release of high-quality EUnetHTA outputs, while the relationships with the other European institutions facilitated their quick dissemination.

Early Dialogues for Pharmaceutical Products in European Network for Health Technology Assessment Joint Action 3: What Was Done and Where to Go in the Future.

The aim of this article is to describe the process, results, and experiences of European Network for Health Technology Assessment (EUnetHTA) Joint Action 3's (JA3) Early Dialogue (ED) activities and to highlight opportunities for improving the processes. A descriptive analysis of the steps of the EUnetHTA ED process and evaluation of the data from the EDs conducted by EU health technology assessment (HTA) bodies, published guidelines, and documents, as well as internal statistics. In JA3, an Early Dialogues Working Party (EDWP) was established, responsible for developing and improving processes and providing advice to pharmaceutical companies, supported by the ED Secretariat. From June 2017 to May 2021, 113 requests for pharmaceutical EDs were received and 38 conducted. The process was continuously optimized, and different approaches for involving patients were tested. Finally, a centralized procedure was chosen with the key documents produced by two responsible agencies and reviewed by the EDWP. Patient involvement was primarily done by interviewing a national patient representative to obtain general feedback on the disease and the planned study design. During JA3, EDs were established as an efficient, successful product. Pharmaceutical companies benefited not only from the positions of the individual agencies for the national HTA, but also from the recommendations that were common to all HTA authorities. In addition, regarding the European HTA Regulation, it will be important to conduct Joint Scientific Consultations with a view toward future Joint Clinical Assessments and to further develop processes aligned with the high demand for consultation.

EUnetHTA relative effectiveness assessments: efforts to increase usability, transparency and inclusiveness.

The objective of the European Network for Health Technology Assessment (EUnetHTA) Joint Action 3 (JA3) was to develop a sustainable European model for future collaboration on HTA, by reducing duplication in HTA production and increasing patient access to health technologies. Compared to the previous JA2, several procedural changes were made aiming to increase usability, transparency, and inclusiveness of relative effectiveness assessments (REAs). This article presents and highlights these changes, explains their rationale as well as their influence on HTA production. Feedback from REA teams and project managers was collected. At the end of JA3, all lessons learned were mapped, resulting in a set of recommendations for a future REA production process. In JA3, forty-three EUnetHTA REAs have been produced. Efforts to increase the usability of the REAs were made by focussing on the needs of REA producers and users (HTA agencies) and by increasing stakeholder involvement. Huge steps were taken with regard to transparency, which was achieved through publication of guidances, templates, and up-to-date information on the EUnetHTA website. In an attempt to improve inclusiveness, (stakeholder) interaction and involvement as well as feedback procedures were enhanced and streamlined. The fine-tuned project management brought all aspects together and facilitated a consistent and reliable workflow. Despite that HTA agencies have different national requirements, the procedural changes made in JA3 proved to counteract some of these challenges. Nevertheless, it is of utmost importance that further perceived methodological differences are being resolved to ensure a strong base for future European collaboration on REA production.

Building a model of health technology assessment cooperation: lessons learned from EUnetHTA joint action 3.

The European Network for Health Technology Assessment (EUnetHTA) was established in 2006. During its final project phase (joint action 3 [JA3]), it undertook an activity to define the scientific and technical principles of a model of health technology assessment (HTA) cooperation in Europe. This policy article presents the key learnings from JA3 partners about developing a model of HTA cooperation. There were two phases to the activity: (i) A descriptive phase to describe the elements of HTA cooperation that were already in place in EUnetHTA JA3 and to identify which elements could be improved or were missing. (ii) An analytic phase synthesizing the data collected to identify learnings from the JA3 and to define the scientific and technical principles for a future model of HTA cooperation. Learnings for developing HTA cooperation were identified in regard to the framework used to support the cooperation, the HTA activities undertaken, the involvement of internal and external actors, managing decision making and the required human resources and support services needed to undertake HTA activities and to coordinate collaboration. These learnings coming from the experiences of the EUnetHTA JA3 are useful to inform discussions on a European Union regulation for HTA cooperation as well as subsequent work to set up the structures that will be defined in the regulation. The findings also have broader applicability and are relevant to individuals, groups, and organizations setting up HTA programs or establishing their own international collaborations.

Transferability of a EUnetHTA relative effectiveness assessment to low- and middle-income countries setting.

In 2020, European Network for Health Technology Assessment (EUnetHTA) published a relative effectiveness analysis (REA) of Pretomanid in combination with Bedaquiline and Linezolid for the treatment of extensively drug-resistant (XDR) or treatment-intolerant or nonresponsive multidrug-resistant (MDR) tuberculosis (TB) (REA PTJA14). This REA may have a significant value for low- and middle-income countries (LMICs) outside Europe, particularly those with a high burden of drug-resistant TB. This commentary focuses on whether the REA PTJA14 can be transferred and to what extent a REA can be translated to LMICs context outside Europe. We found that the assessments on the clinical effectiveness and risks of bias reported in REA PTJA14 are useful for LMICs outside Europe. The highly standardized management of TB will support the applicability of the REA to LMICs outside of Europe. Transferring this REA can reduce workload and efficiently use limited resources to conduct health technology assessment (HTA). However, the transfer should consider several critical issues, including variations in health system delivery and clinical practice and setting-specific constraints. In the TB context, the differences in the current standard treatment for XDR or nonresponsive MDR TB, resources availability for drug-resistant TB management, and how healthcare is delivered in the countries can complicate the applicability of the REA PTJA14. Given that LMICs have limitations in doing HTA, it is now critical to develop standard guidelines for transferring REA or other HTA results from high-income countries or other LMICs to maximize the benefits of the REA for LMICs outside Europe.

European collaboration on health technology assessment: looking backward and forward

The establishment of health technology assessment (HTA) has been an important topic in Europe for many years. There have been a series of activities starting with first projects in 1994 leading to joint actions from the European Network of HTA (EUnetHTA) ending in 2021. This long interval of engagement with HTA structures, methodology, and processes by all member states led to a reliable basis for European collaboration in HTA. This article shows milestones and developments from EUR-ASSESS in 1994 through the progress of EUnetHTA and the accompanying EU-HTA-Network up to the recent elaboration of the EU-HTA-Regulation. With the EU-HTA-Regulation HTA collaboration is taken out of the trial phase of more than 15 years. Through the previous EU HTA collaboration, the appreciation and understanding of the differences and complexities behind the HTA processes in the EU healthcare systems have improved. It is now necessary to make the final steps toward a sustainable European Network for HTA.

Reported Challenges in Health Technology Assessment of Complex Health Technologies

ObjectivesWith complex health technologies entering the market, methods for health technology assessment (HTA) may require changes. This study aimed to identify challenges in HTA of complex health technologies. MethodsA survey was sent to European HTA organizations participating in European Network for HTA (EUnetHTA). The survey contained open questions and used predefined potentially complex health technologies and 7 case studies to identify types of complex health technologies and challenges faced during HTA. The survey was validated, tested for reliability by an expert panel, and pilot tested before dissemination. ResultsA total of 22 HTA organizations completed the survey (67%). Advanced therapeutic medicinal products (ATMPs) and histology-independent therapies were considered most challenging based on the predefined complex health technologies and case studies. For the case studies, more than half of the reported challenges were “methodological,” equal in relative effectiveness assessments as in cost-effectiveness assessments. Through the open questions, we found that most of these challenges actually rooted in data unavailability. Data were reported as “absent,” “insufficient,” “immature,” or “low quality” by 18 of 20 organizations (90%), in particular data on quality of life. Policy and organizational challenges and challenges because of societal or political pressure were reported by 8 (40%) and 4 organizations (20%), respectively. Modeling issues were reported least often (n = 2, 4%). ConclusionsMost challenges in HTA of complex health technologies root in data insufficiencies rather than in the complexity of health technologies itself. As the number of complex technologies grows, the urgency for new methods and policies to guide HTA decision making increases.

OP181 Adapting Evidence To Produce A Health Technology Assessment Of Mammography Screening: An Example From The West Bank

IntroductionHealth technology assessment (HTA) can play a key role in evidence-based decision-making. However, HTA requires resources that might be lacking in low-income settings. To test the feasibility of adapting existing evidence as part of the HTA process, this project evaluated the effectiveness and economic impact of breast cancer screening programs for women over 40 years in the West Bank, where mammography screening is provided for free in governmental clinics.MethodsWe conducted a search for systematic reviews, HTAs and guidelines in electronic databases. We included the most recent global systematic review and meta-analysis that fulfilled our inclusion criteria. The European Network for Health Technology Assessment (EUnetHTA) adaptation toolkit was used to guide adaptation and undertake a budget impact analysis of the economic impact of mammography screening. We build capacity by working as a team of HTA experts and first-time HTA researchers. The results were disseminated to raise awareness for HTA.ResultsThe European Commission Guidelines on Breast Cancer Screening were identified as most recent global systematic review with meta-analyses, out of 2,365 references. The adapted evidence may inform policies on screening in the West Bank. Our experience is that adaption requires extensive skills and resources, including finding, assessing, and adapting relevant evidence. The EUnetHTA toolkit is useful, but also adds to the workload. Furthermore, local stakeholder engagement is important in topic selection, to access information, and to contextualize global evidence to the local setting.ConclusionsThis study is currently ongoing, but preliminary findings show that producing an HTA by adapting existing evidence in resource-limited settings is feasible. There is a need for nuanced guidance on transferability of evidence from other settings. Future studies should investigate innovative methods to optimize the adaption process. Capacity building in adaptation is important to ensure the production of quality HTA products. Inclusion of local team members and stakeholders is important for future development of HTA in the region.

OP164 Extracorporeal Cytokine Adsorption Therapy: An Update Systematic Review Of Clinical Efficacy And Safety For Two Indications

IntroductionThe idea of using extracorporeal cytokine adsorption therapy (ECAT) is to remove cytokines from the blood in order to restore a balanced immune response. Yet, it is unclear as to whether the use of ECAT improves patient-relevant outcomes. Hence, the aim of this article is to synthesize the currently available evidence with regard to a potential clinical benefit of ECAT used in cardiac surgery or sepsis.MethodsWe conducted an updated systematic review summarizing the body of evidence with regard to a potential clinical benefit of ECAT. The study followed the PRISMA statement and the European Network for Health Technology Assessment (EUnetHTA) guidelines. The quality of the individual studies and the strength of the available evidence was assessed using the Cochrane risk of bias tool (v.1) and the GRADE approach respectively. Mortality, organ function, length of stay in the intensive care unit and length of hospitalization, as well as adverse events, were defined as critical outcomes.ResultsFor the preventive treatment of ECAT in patients undergoing cardiac surgery, we found very low-quality inconclusive evidence for mortality (5 randomized controlled trials (RCTs), n = 163), length of stay in the intensive care unit (5 RCTs, n = 163), and length of hospitalization (3 RCTs, n = 101). In addition, very low-quality inconclusive evidence was found for (serious) adverse events (4 RCTs, n = 148). For the therapeutic treatment of ECAT in patients with sepsis/ septic shock, we found very low-quality inconclusive evidence for mortality up to 60-day follow-up (2 RCTs, n = 117), organ function (2 RCTs, n = 117) and length of stay in the intensive care unit (1 study, n = 20). Similarly, very low-quality inconclusive evidence was found for (serious) adverse events (2 RCTs, n = 117). There are currently eighteen ongoing RCTs on the use of ECAT.ConclusionsThere is a lack of reliable data on the clinical benefit of using ECAT as an add-on treatment preventively in cardiac surgery and therapeutically in patients with sepsis or septic shock. While theoretical advantages are anticipated, the current available evidence is inconclusive and was not able to establish the efficacy and safety of ECAT in combination with standard care in the investigated indications. In light of the available RCTs, we strongly recommend the consideration of studies with patient-relevant endpoints and adequate statistical power, instead of investing further research funds on small studies that may not shed more light onto the potential clinical benefit of ECAT. The results of ongoing RCTs are awaited to guide the decision on whether further research funds should be invested in ECAT research or to conclude that the intervention may not show clinical benefits for patients.

OP277 Rapid Development Of An Evaluation Framework: Capturing The Impact Of COVID-19 Activities By A Health Technology Assessment Body

IntroductionHealth Technology Wales (HTW) is committed to evaluating the impact of our work. In March 2020, HTW directed efforts to support Welsh Government and health and social care providers in response to the COVID-19 pandemic. We adapted the HTW evaluation framework to specifically capture the impact of our additional COVID-19 work. Here we analyze data collected since the framework was implemented.MethodsBoth formal and informal feedback was analyzed. Formal feedback was obtained through the HTW Impact Questionnaire, which was developed to support more formalized data capture for all HTW workstreams and to facilitate feedback from all stakeholder groups. It was piloted with a targeted list of individuals and responses were received for COVID-19 work. Informal feedback included feedback received via email or through word of mouth.ResultsHTW COVID-19 products to date include Topic Exploration Reports, rapid evidence summaries and an Evidence Appraisal Report (EAR) on COVID-19 diagnostic tests (molecular and antibody tests). Stakeholders were positive about these outputs, describing them as valuable and informative. Reported impacts included informing policy and decision making, reducing duplication of efforts and helping to target development. The EAR received national and international focus, leading to HTW involvement in the European Network for Health Technology Assessment (EUnetHTA) COVID-19 reviews. Survey participants who gave feedback on COVID-19 activities included two members of Health Technology Assessment organizations, a health board representative and an industry representative; all agreed that HTW's COVID-19 work was useful, that the methods were reliable and robust and that HTW is responsive. All participants also felt that HTW's COVID-19 work had a positive impact in the wider health and social care context.ConclusionsHTW was able to respond rapidly to the COVID-19 pandemic and adapt current evaluation practices to capture the impact of COVID-19 work. We will continue to evaluate our COVID-19 activities. Future work will involve following up on the developing impact of our COVID-19 work and expanding our methods for data capture, for example conducting stakeholder interviews.

PP94 Pandemic Preparedness: EUnetHTA COVID-19 Rapid Response With “Rolling Collaborative Reviews (RCR)”

IntroductionPotential therapies and interventions for COVID-19 are emerging and developing rapidly. In a response to this public health emergency, the European Network for Health Technology Assessment (EUnetHTA) aims to support health policy in preparation for evidence-based purchasing. To monitor the emerging evidence, a new EUnetHTA product was created: Rolling Collaborative Reviews (RCRs).MethodsRCRs are living documents that are descriptive in nature, updated monthly, and centrally coordinated. They are based on the following three sources of information: (i) published randomized controlled trials (RCTs) presented as a summary of efficacy and safety data (synthesized for a network meta-analysis conducted by the Department of Epidemiology Lazio Regional Health Service, Italy); (ii) published prospective observational studies for safety results, provided by the Map of COVID-19 Evidence conducted by the Norwegian Institute of Public Health, Norway; and (iii) RCTs registered in clinical trial registries (ClinicalTrials.gov, EudraCT Register, and the ISRCTN registry). Additionally, detailed stopping and starting rules were defined.ResultsAs of November 2020, 14 RCRs were ongoing. From the initial list of RCRs, one was suspended due to lacking effectiveness and two moved on to rapid collaborative reviews due to European Medicines Agency approvals. Four RCRs are updated on a bimonthly basis due to a lack of high-quality evidence, and five new RCRs will be started because of promising clinical studies.ConclusionsRCRs can be a means of providing timely and continuous policy support, but they require a high level of coordinated effort.

OP244 Tools And Experiences To Facilitate Effective Patient Participation In Health Technology Assessment

IntroductionIn 2017, a Patient Involvement Interest Group (PIIG) was created in the Spanish Network for Health Technology Assessment of the National Health System (RedETS) to facilitate and promote Patient Involvement (PI) in Health Technology Assessment (HTA). The PIIG proposed a decisional flowchart to guide researchers’ in decisions regarding PI methods in HTA. The flowchart proposed a combination of direct involvement and incorporation of patient-based evidence depending on the scope and the aims of the assessment.This work aims to present the flowchart and the results of the evaluation of the latest experiences in PI in HTA in RedETS (2018–2020), including direct-involvement and patient-based evidence.MethodsA survey was sent to the HTA researchers who implemented PI initiatives in RedETS assessments. The survey asked to describe their experiences, lessons learned, challenges and added value regarding the use of direct-involvement, systematic reviews (SR) and primary studies. A descriptive analysis was performed and the results were discussed in an online PIIG workshop.ResultsThirty-two assessments included direct PI, twenty-one SR synthesized qualitative and quantitative studies about patient experiences, values and preferences and eight included primary studies, mainly of qualitative design. Recruitment and the lack of methodological resources were the main barriers both for direct PI and primary studies. Relevance of the included studies was the main barrier for SR. Added value was found in all PI methods. Direct-involvement had an impact on the project plan and PICO definition, outcomes relevance, information about the health condition and treatments. SR contributed with relevant patient-based evidence, deeper assessment of patient experiences, values and preferences and implementation factors. Primary studies developed new or contextualized knowledge directly applicable to decision-making.ConclusionsThe PI flowchart has served to facilitate the incorporation of patient input in HTA reports. The different approaches implemented have allowed to provide relevant and well-grounded data in each report to inform decision-making in patient-centered healthcare provision, but it is necessary that specific training and resources are provided to enable adequate and timely implementation.

OP248 A Minimum Data-Set For Left Ventricular Assist Device On Destination Therapy: Cross-Border Collaboration Pilot On Real World Data

IntroductionThe European Health Technology Assessment Network (EUnetHTA) Work Package 5B1, is focused on testing the levels of cross-border collaboration on real world data for supporting reimbursement/pricing decision-making. Within this Work Package, we are conducting a pilot on Left Ventricular Assist Device on destination therapy in collaboration with the National Institute for Health and Care Excellence (NICE, UK), the Belgian Health Care Knowledge Centre (KCE, Belgium) and the Italian National Agency for Regional Health Services (AGENAS, Italy). This pilot aims to define the minimum data set for gathering and sharing high quality registry data on key uncertainties found at the time of the health technology assessment (HTA). Furthermore, the pilot will assess the feasibility of carrying out a common analysis or reusing this data for National or Joint Reassessments.MethodsEvidence gaps were based on the four national assessments. Collaborating partners were responsible for agreeing on the key outcomes and proposing the minimum dataset to be registered. European clinical experts and patients rated and prioritized the dataset using a two round Delphi technique (not relevant, important but not critical; critical). The dataset will confirm the basis for the Spanish LVAD registry, implemented at the national health service level to inform inclusion into the healthcare portfolio.ResultsThe key outcomes agreed upon by agencies relate to safety, effectiveness, satisfaction and acceptability of the patient and cost-effectiveness, budget impact and organizational impact. Expert cardiologists and cardiac surgeons representing the European and Spanish Society, among others, participated in the prioritization of basic data. The final dataset is expected by December 2020.ConclusionsThe variation in the quality and definition of outcome measures for measuring key evidence gaps reduces the utility of registries for HTA, making it difficult to compare, link, and aggregate data across countries. The EUnetHTA pilot is intended to offer a model for cross-border collaboration on real world data for supporting the decision-making process for pricing and reimbursement.

Extracorporeal Cytokine Adsorption Therapy As a Preventive Measure in Cardiac Surgery and As a Therapeutic Add-On Treatment in Sepsis: An Updated Systematic Review of Comparative Efficacy and Safety.

Evaluating whether there is a clinical benefit of using extracorporeal cytokine adsorption therapy in two indications. Systematic review. Search on four databases, Medline, Embase, The Cochrane Library, and the European Network for Health Technology Assessment planned and ongoing projects database. Patients with sepsis/septic shock; patients undergoing cardiac surgery. Cytokine adsorption. Randomized controlled trials and prospective studies with concurrent control were eligible for the evidence synthesis. The quality of the individual studies and the strength of the available evidence were assessed using the Cochrane risk of bias tool and the Grading of Recommendations, Assessment, Development, and Evaluation approach, respectively. For the preventive treatment of extracorporeal cytokine adsorption therapy in patients undergoing cardiac surgery, we found very low-quality inconclusive evidence for mortality (five randomized controlled trials, n = 163), length of stay in the ICU (five randomized controlled trials, n = 163), and length of hospitalization (three randomized controlled trials, n = 101). Very low-quality inconclusive evidence was found for (serious) adverse events (four randomized controlled trials, n = 148). For the therapeutic treatment of extracorporeal cytokine adsorption therapy in patients with sepsis/septic shock, we found very low-quality inconclusive evidence for mortality up to 60-day follow-up (two randomized controlled trials, n = 117), organ function (two randomized controlled trials, n = 117) and length of stay in the ICU (one randomized controlled trial, n = 20). Very low-quality inconclusive evidence was found for (serious) adverse events (two randomized controlled trials, n = 117). Given the available evidence, the efficacy and safety of extracorporeal cytokine adsorption therapy in combination with standard care in the investigated indications was not established. We strongly recommend considering well-powered studies with patient-relevant endpoints instead of investing further research funds on studies that may not shed light on the clinical benefit of extracorporeal cytokine adsorption therapy.

An Integrated Framework to Measure the Performance of Inter-Organizational Programme on Health Technology Assessment

Combining insights from collaborative governance, performance management, and health technology assessment (HTA) literature, this study develops an integrated framework to systematically measure and monitor the performance of HTA network programmes. This framework is validated throughout an action research carried out in the Italian HTA network programme for medical devices. We found that when building up collaborative performance management systems, some elements such as the participation in the design and the use of context specific performance assessment framework, facilitate their acceptance by managers and policy makers especially in high professionalized and sector-specific organizations because it reflects their distinctive language and culture. The hybrid framework may help health authorities and policymakers to understand the HTA network, monitor its performance, and ensure network sustainability over time.

Which Criteria are Considered and How are They Evaluated in Health Technology Assessments? A Review of Methodological Guidelines Used in Western and Asian Countries.

This study aimed to provide an exhaustive description of criteria and methodological recommendations for evaluating them in health technology assessment (HTA) in Western and Asian countries. We conducted a system literature review of HTA-related guidelines by searching the websites of HTA agencies and related data sources. The guidelines, reports, or recommendations introducing the HTA evaluation methods, processes, decision-making frameworks, and criteria for priority setting were eligible to be included. The review was limited to guidelines from countries belonging to the European Network for Health Technology Assessment (EUnetHTA) and HTAsiaLink organisations and other countries with well-established available guidelines. A total of 52 guidelines from 24 countries were identified, including 13 countries from the EUnetHTA organisation, 9 countries from the HTAsiaLink organisation and 2 other countries (Canada and the USA). A strong consensus was observed among the HTA agencies on the core set of criteria including efficacy or effectiveness, cost-effectiveness, safety, and budget impact. More similarities were observed than differences in methodological recommendations for clinical and economic evaluations among the agencies. Substantial convergence is seen in the criteria included in the HTA process, as well as the methods to evaluate and quantify them. Further efforts are needed to verify whether the criteria identified from the guidelines are incorporated in real HTA decisions, and how they are assessed and weighted in practice.

Patient involvement in relative effectiveness assessments in the European Network for Health Technology Assessment.

Patient involvement in the process of producing health technology assessments has become increasingly important. In the European Network for Health Technology Assessment (EUnetHTA), several approaches to patient involvement were explored. The outcome was a document on "Patient Input in Relative Effectiveness Assessments" that is available for access and was published in 2019.The aim of this article is to analyze the experience gained by EUnetHTA in patient involvement for EUnetHTA assessment production, describe and quantify the approaches used, and outline the challenges and avenues for the improvement of current processes.Patients were involved in twenty-three of thirty-six pharmaceutical and other technology EUnetHTA assessments from June 2016 until the end of November 2019. Approaches to patient involvement included using a patient input template, one-on-one conversations, group conversations, scoping meeting with patients, and other approaches.Although it is recognized that patient involvement is important to understand the needs of the target patient population, challenges remain with timely patient involvement. Additionally, further efforts are needed to guide assessment teams on how to implement and enhance the visibility of patient input in assessments.