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A Systematic Review of the Value Assessment Frameworks Used within Health Technology Assessment of Omics Technologies and Their Actual Adoption from HTA Agencies.

ABSTRACT: BACKGROUND:Omics technologies, enabling the measurements of genes (genomics), mRNA (transcriptomics), proteins (proteomics) and metabolites (metabolomics), are valuable tools for personalized decision-making. We aimed to identify the existing value assessment frameworks used by health technology assessment (HTA) doers for the evaluation of omics technologies through a systematic review. METHODS:PubMed, Scopus, Embase and Web of Science databases were searched to retrieve potential eligible articles published until 31 May 2020 in English. Additionally, through a desk research in HTA agencies' repositories, we retrieved the published reports on the practical use of these frameworks. RESULTS:Twenty-three articles were included in the systematic review. Twenty-two frameworks, which addressed genetic and/or genomic technologies, were described. Most of them derived from the ACCE framework and evaluated the domains of analytical validity, clinical validity and clinical utility. We retrieved forty-five reports, which mainly addressed the commercial transcriptomic prognostics and next generation sequencing, and evaluated clinical effectiveness, economic aspects, and description and technical characteristics. CONCLUSIONS:A value assessment framework for the HTA evaluation of omics technologies is not standardized and accepted, yet. Our work reports that the most evaluated domains are analytical validity, clinical validity and clinical utility and economic aspects.

SUBMITTER: Hoxhaj I

PROVIDER: S-EPMC7663163 | biostudies-literature | 2020 Oct

REPOSITORIES: biostudies-literature

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A Systematic Review of the Value Assessment Frameworks Used within Health Technology Assessment of Omics Technologies and Their Actual Adoption from HTA Agencies.

Hoxhaj Ilda I Govaerts Laurenz L Simoens Steven S Van Dyck Walter W Huys Isabelle I Gutiérrez-Ibarluzea Iñaki I Boccia Stefania S

International journal of environmental research and public health 20201030 21

<h4>Background</h4>Omics technologies, enabling the measurements of genes (genomics), mRNA (transcriptomics), proteins (proteomics) and metabolites (metabolomics), are valuable tools for personalized decision-making. We aimed to identify the existing value assessment frameworks used by health technology assessment (HTA) doers for the evaluation of omics technologies through a systematic review.<h4>Methods</h4>PubMed, Scopus, Embase and Web of Science databases were searched to retrieve potential ...[more]

PMID: 33143182

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Project description:BackgroundHealth technology assessment (HTA) agencies have an important role to play in managing the rising demands on health systems. However, creating and running such agencies potentially diverts resources from frontline services. A large number of studies address the question of 'what is the impact of HTA?'. Several points of heterogeneity in this literature include: purpose of the study, definition of HTA, definition of impact, and scope and rigour of evaluations. Our study seeks to address several limitations in this literature. This study aims to explore the mechanisms of impact of an HTA agency. In doing so, we consider HTA as an institution rather than a knowledge product to build an impact evaluation framework from an international, multi-stakeholder and multi-dimensional perspective.MethodsWe conducted 9 key informant interviews with experts from the international HTA community. We addressed several questions, informed by existing frameworks of impact within the literature, to understand their perspectives on the mechanisms of impact of an HTA agency. We analyse data using logic modelling and impact mapping, as tools to understand and visualise mechanisms of change.FindingsOur impact mapping highlights several distinct, but not necessarily mutually exclusive, mechanisms through which the overall impact of an HTA agency is achieved. These are: the effective conduct of HTA studies; effective use of HTA in agenda-setting and policy formulation processes; effective engagement and external communications; good institutional reputation and fit within the healthcare and policy-making system; effective use of HTA as a tool for the negotiation of health technology prices; and the effective implementation of policy change regarding health technologies. We also identify indicators of these effects.ConclusionsOur findings and resulting evaluation framework complement and add to existing literature by offering a new perspective on the mechanisms by which HTA agencies generate impact. This new perspective considers HTA as an institution rather than a knowledge product, is international, multi-dimensional, and includes multi-stakeholder views. We hope the analysis will be useful to countries interested in managing HTA performance.

Project description:ObjectiveWe aim to develop a comprehensive checklist for evaluating Health Technology Assessment (HTA) studies commissioned in India. The primary objective of this work is to capture all vital aspects of an HTA study in terms of conduct, reporting and quality.MethodologyThe development of a quality appraisal checklist included 3 steps. First, a targeted review of the literature was done to gather information on existing HTA checklists. After reviewing these checklists, an initial draft of the HTA quality appraisal checklist (HTA-QAC) for India was prepared with discussion amongst the authors. Second, the draft checklist was reviewed by the members of the Technical Appraisal Committee (TAC) and their feedback was incorporated. Subsequently, the revised checklist was presented at a virtual meeting of the TAC. Finally, a pilot phase was undertaken to apply HTA-QAC for the approved HTA study reports. Three rounds of virtual discussions were held with the researchers who were involved in the conduct of these HTA studies to resolve any discordance in opinion or develop solutions for the problems in the use of the HTA-QAC followed by a further revision of the checklist.ResultsThe HTA-QAC is divided into two parts: a self-reporting section to be completed by the author, and the other to be completed by the reviewer. The reviewer checklist has two sections: one to review the report and the other to review the model. The author section is in a self-reporting format, which includes details of basic study information, the rationale for the study, policy relevance, study description, study methods, reporting of model parameters, and results. The reviewer section of the checklist focuses on the quality aspect of the conducted study. The domains included in the report review include details on study methodology, results, discussion, and conclusion. The second part of the reviewer section of HTA-QAC constitutes a review of the model in terms of model assumptions, functionality, model inputs, calculations, uncertainty analysis, model output, and model validation.ConclusionWe recommend a standardised process of quality appraisal to ensure the high quality of HTA evidence for policy use in the Indian context. The proposed HTA-QAC will help authors to ensure standardised reporting, as well as allow reviewers to assess the quality of analysis.

Project description:Aim: Regulatory and health technology assessment (HTA) agencies have increasingly published frameworks, guidelines, and recommendations for the use of real-world evidence (RWE) in healthcare decision-making. Variations in the scope and content of these documents, with updates running in parallel, may create challenges for their implementation especially during the market authorization and reimbursement phases of a medicine's life cycle. This environmental scan aimed to comprehensively identify and summarize the guidance documents for RWE developed by most well-established regulatory and reimbursement agencies, as well as other organizations focused on healthcare decision-making, and present their similarities and differences. Methods: RWE guidance documents, including white papers from regulatory and HTA agencies, were reviewed in March 2024. Data on scope and recommendations from each body were extracted by two reviewers and similarities and differences were summarized across four topics: study planning, choosing fit-for-purpose data, study conduct, and reporting. Post-authorization or non-pharmacological guidance was excluded. Results: Forty-six documents were identified across multiple agencies; US FDA produced the most RWE-related guidance. All agencies addressed specific and often similar methodological issues related to study design, data fitness-for-purpose, reliability, and reproducibility, although inconsistency in terminologies on these topics was noted. Two HTA bodies (National Institute for Health and Care Excellence [NICE] and Canada's Drug Agency) each centralized all related RWE guidance under a unified framework. RWE quality tools and checklists were not consistently named and some differences in preferences were noted. European Medicines Agency, NICE, Haute Autorité de Santé, and the Institute for Quality and Efficiency in Health Care included specific recommendations on the use of analytical approaches to address RWE complexities and increase trust in its findings. Conclusion: Similarities in agencies' expectations on RWE studies design, quality elements, and reporting will facilitate evidence generation strategy and activities for manufacturers facing multiple, including global, regulatory and reimbursement submissions and re-submissions. A strong preference by decision-making bodies for local real-world data generation may hinder opportunities for data sharing and outputs from international federated data networks. Closer collaboration between decision-making agencies towards a harmonized RWE roadmap, which can be centrally preserved in a living mode, will provide manufacturers and researchers clarity on minimum acceptance requirements and expectations, especially as novel methodologies for RWE generation are rapidly emerging.

Project description:BackgroundHealth technology assessment (HTA) is increasingly performed at the local or hospital level where the costs, impacts, and benefits of health technologies can be directly assessed. Although local/hospital-based HTA has been implemented for more than two decades in some jurisdictions, little is known about its effects and impact on hospital budget, clinical practices, and patient outcomes. We conducted a mixed-methods systematic review that aimed to synthesize current evidence regarding the effects and impact of local/hospital-based HTA.MethodsWe identified articles through PubMed and Embase and by citation tracking of included studies. We selected qualitative, quantitative, or mixed-methods studies with empirical data about the effects or impact of local/hospital-based HTA on decision-making, budget, or perceptions of stakeholders. We extracted the following information from included studies: country, methodological approach, and use of conceptual framework; local/hospital HTA approach and activities described; reported effects and impacts of local/hospital-based HTA; factors facilitating/hampering the use of hospital-based HTA recommendations; and perceptions of stakeholders concerning local/hospital HTA. Due to the great heterogeneity among studies, we conducted a narrative synthesis of their results.ResultsA total of 18 studies met the inclusion criteria. We reported the results according to the four approaches for performing HTA proposed by the Hospital Based HTA Interest Sub-Group: ambassador model, mini-HTA, internal committee, and HTA unit. Results showed that each of these approaches for performing HTA corresponds to specific needs and structures and has its strengths and limitations. Overall, studies showed positive impacts related to local/hospital-based HTA on hospital decisions and budgets, as well as positive perceptions from managers and clinicians.ConclusionsLocal/hospital-based HTA could influence decision-making on several aspects. It is difficult to evaluate the real impacts of local HTA at the different levels of health care given the relatively small number of evaluations with quantitative data and the lack of clear comparators. Further research is necessary to explore the conditions under which local/hospital-based HTA results and recommendations can impact hospital policies, clinical decisions, and quality of care and optimize the use of scarce resources.

Project description:BackgroundThe number of Health Technology Assessment (HTA) agencies increases. One component of HTAs are economic aspects. To incorporate economic aspects commonly economic evaluations are performed. A convergence of recommendations for methods of health economic evaluations between international HTA agencies would facilitate the adaption of results to different settings and avoid unnecessary expense. A first step in this direction is a detailed analysis of existing similarities and differences in recommendations to identify potential for harmonization. The objective is to provide an overview and comparison of the methodological recommendations of international HTA agencies for economic evaluations.MethodsThe webpages of 127 international HTA agencies were searched for guidelines containing recommendations on methods for the preparation of economic evaluations. Additionally, the HTA agencies were requested information on methods for economic evaluations. Recommendations of the included guidelines were extracted in standardized tables according to 13 methodological aspects. All process steps were performed independently by two reviewers.ResultsFinally 25 publications of 14 HTA agencies were included in the analysis. Methods for economic evaluations vary widely. The greatest accordance could be found for the type of analysis and comparator. Cost-utility-analyses or cost-effectiveness-analyses are recommended. The comparator should continuously be usual care. Again the greatest differences were shown in the recommendations on the measurement/sources of effects, discounting and in the analysis of sensitivity. The main difference regarding effects is the focus either on efficacy or effectiveness. Recommended discounting rates range from 1.5%-5% for effects and 3%-5% for costs whereby it is mostly recommended to use the same rate for costs and effects. With respect to the analysis of sensitivity the main difference is that oftentimes the probabilistic or deterministic approach is recommended exclusively. Methods for modeling are only described vaguely and mainly with the rational that the "appropriate model" depends on the decision problem. Considering all other aspects a comparison is challenging as recommendations vary regarding detailedness and addressed issues.ConclusionThere is a considerable unexplainable variance in recommendations. Further effort is needed to harmonize methods for preparing economic evaluations.

Project description:ObjectivesThe aim of this study was to review and compare current health technology assessment (HTA) activities for medical devices across non-European Union HTA agencies.MethodsHTA activities for medical devices were evaluated from three perspectives: organizational structure, processes, and methods. Agencies were primarily selected upon membership of existing HTA networks. The data collection was performed in two stages: stage 1-agency Web-site assessment using a standardized questionnaire, followed by review and validation of the collected data by a representative of the agency; and stage 2-semi-structured telephone interviews with key informants of a sub-sample of agencies.ResultsIn total, thirty-six HTA agencies across twenty non-EU countries assessing medical devices were included. Twenty-seven of thirty-six (75 percent) agencies were judged at stage 1 to have adopted HTA-specific approaches for medical devices (MD-specific agencies) that were largely organizational or procedural. There appeared to be few differences in the organization, process and methods between MD-specific and non-MD-specific agencies. Although the majority (69 percent) of both categories of agency had specific methods guidance or policy for evidence submission, only one MD-specific agency had developed methodological guidelines specific to medical devices. In stage 2, many MD-specific agencies cited insufficient resources (budget, skilled employees), lack of coordination (between regulator and reimbursement bodies), and the inability to generalize findings from evidence synthesis to be key challenges in the HTA of medical devices.ConclusionsThe lack of evidence for differentiation in scientific methods for HTA of devices raises the question of whether HTA needs to develop new methods for medical devices but rather adapt existing methodological approaches. In contrast, organizational and/or procedural adaptation of existing HTA agency frameworks to accommodate medical devices appear relatively commonplace.

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A Systematic Review of the Value Assessment Frameworks Used within Health Technology Assessment of Omics Technologies and Their Actual Adoption from HTA Agencies.

Publications

A Systematic Review of the Value Assessment Frameworks Used within Health Technology Assessment of Omics Technologies and Their Actual Adoption from HTA Agencies.

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