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      Towards a European harmonization of health technology assessment recommendations executive paper of European regulatory conference focused on the EU commission proposal to harmonize HTA

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          Abstract

          Health Technology Assessment (HTA) is a multidisciplinary process which supports policy “decision-making”, including those related to drug reimbursement and price negotiation based on comprehensive clinical and non-clinical evaluations. The discrepancies in HTA recommendations among European countries are related to the differences in health care systems and willingness to invest in health care, differences in assessment methodologies and appraisal practices, and variations in economic constraints, and may produce disparities in terms of patient access to medicines. The political discussion about the adoption of the European Regulation on HTA lasted for years due to concerns about its feasibility and its implications for national health care systems In this paper we highlighted the importance to harmonize HTA process in Europe and some critical issues emerged during the discussion among experts in the field carried out at the European Regulatory Conference.

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          Key principles for the improved conduct of health technology assessments for resource allocation decisions.

          Health technology assessment (HTA) is a dynamic, rapidly evolving process, embracing different types of assessments that inform real-world decisions about the value (i.e., benefits, risks, and costs) of new and existing technologies. Historically, most HTA agencies have focused on producing high quality assessment reports that can be used by a range of decision makers. However, increasingly organizations are undertaking or commissioning HTAs to inform a particular resource allocation decision, such as listing a drug on a national or local formulary, defining the range of coverage under insurance plans, or issuing mandatory guidance on the use of health technologies in a particular healthcare system. A set of fifteen principles that can be used in assessing existing or establishing new HTA activities is proposed, providing examples from existing HTA programs. The principal focus is on those HTA activities that are linked to, or include, a particular resource allocation decision. In these HTAs, the consideration of both costs and benefits, in an economic evaluation, is critical. It is also important to consider the link between the HTA and the decision that will follow. The principles are organized into four sections: (i) "Structure" of HTA programs; (ii) "Methods" of HTA; (iii) "Processes for Conduct" of HTA; and (iv) "Use of HTAs in Decision Making."
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            Using health technology assessment to assess the value of new medicines: results of a systematic review and expert consultation across eight European countries

            Background Although health technology assessment (HTA) systems base their decision making process either on economic evaluations or comparative clinical benefit assessment, a central aim of recent approaches to value measurement, including value based assessment and pricing, points towards the incorporation of supplementary evidence and criteria that capture additional dimensions of value. Objective To study the practices, processes and policies of value-assessment for new medicines across eight European countries and the role of HTA beyond economic evaluation and clinical benefit assessment. Methods A systematic (peer review and grey) literature review was conducted using an analytical framework examining: (1) ‘Responsibilities and structure of HTA agencies’; (2) ‘Evidence and evaluation criteria considered in HTAs’; (3) ‘Methods and techniques applied in HTAs’; and (4) ‘Outcomes and implementation of HTAs’. Study countries were France, Germany, England, Sweden, Italy, Netherlands, Poland and Spain. Evidence from the literature was validated and updated through two rounds of feedback involving primary data collection from national experts. Results All countries assess similar types of evidence; however, the specific criteria/endpoints used, their level of provision and requirement, and the way they are incorporated (e.g. explicitly vs. implicitly) varies across countries, with their relative importance remaining generally unknown. Incorporation of additional ‘social value judgements’ (beyond clinical benefit assessment) and economic evaluation could help explain heterogeneity in coverage recommendations and decision-making. Conclusion More comprehensive and systematic assessment procedures characterised by increased transparency, in terms of selection of evaluation criteria, their importance and intensity of use, could lead to more rational evidence-based decision-making, possibly improving efficiency in resource allocation, while also raising public confidence and fairness. Electronic supplementary material The online version of this article (doi:10.1007/s10198-017-0871-0) contains supplementary material, which is available to authorized users.
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              Variation in Health Technology Assessment and Reimbursement Processes in Europe

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                Author and article information

                Journal
                Frontiers in Drug Safety and Regulation
                Front. Drug Saf. Regul.
                Frontiers Media SA
                2674-0869
                August 15 2022
                August 15 2022
                : 2
                Article
                10.3389/fdsfr.2022.970661
                ee132a85-605d-4bd3-9ce1-d24434d9fb1d
                © 2022

                Free to read

                https://creativecommons.org/licenses/by/4.0/

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