scholarly journals Evaluating Quality of Decision-Making Processes in Medicines' Development, Regulatory Review, and Health Technology Assessment: A Systematic Review of the Literature

2017 ◽  
Vol 8 ◽  
Author(s):  
Magdalena Bujar ◽  
Neil McAuslane ◽  
Stuart R. Walker ◽  
Sam Salek
Keyword(s):  
Systematic Review ◽  
Decision Making ◽  
Health Technology Assessment ◽  
Technology Assessment ◽  
Health Technology ◽  
Review Of The Literature ◽  
Regulatory Review ◽  
Decision Making Processes

scholarly journals Introducing health technology assessment in Tanzania

2019 ◽  
Vol 36 (2) ◽  
pp. 80-86 ◽  
Author(s):  
Gavin Surgey ◽  
Kalipso Chalkidou ◽  
William Reuben ◽  
Fatima Suleman ◽  
Jacqui Miot ◽  
...  
Keyword(s):  
Decision Making ◽  
Health Technology Assessment ◽  
Low Income ◽  
Priority Setting ◽  
Technology Assessment ◽  
Health Technology ◽  
Sub Saharan Africa ◽  
Essential Medicines ◽  
Revision Process ◽  
Decision Making Processes

AbstractObjectivesHealth technology assessment (HTA) is a cost-effective resource allocation tool in healthcare decision-making processes; however, its use is limited in low-income settings where countries fall short on both absorptive and technical capacity. This paper describes the journey of the introduction of HTA into decision-making processes through a case study revising the National Essential Medicines List (NEMLIT) in Tanzania. It draws lessons on establishing and strengthening transparent priority-setting processes, particularly in sub-Saharan Africa.MethodsThe concept of HTA was introduced in Tanzania through revision of the NEMLIT by identifying a process for using HTA criteria and evidence-informed decision making. Training was given on using economic evidence for decision making, which was then put into practice for medicine selection for the NEMLIT. During the revision process, capacity-building workshops were held with reinforcing messages on HTA.ResultsBetween the period 2014 and 2018, HTA was introduced in Tanzania with a formal HTA committee being established and inaugurated followed by the successful completion and adoption of HTA into the NEMLIT revision process by the end of 2017. Consequently, the country is in the process of institutionalizing HTA for decision making and priority setting.ConclusionWhile the introduction of HTA process is country-specific, key lessons emerge that can provide an example to stakeholders in other low- and middle-income countries (LMICs) wishing to introduce priority-setting processes into health decision making.

scholarly journals Resource allocation and health technology assessment in Australia: Views from the local level

2009 ◽  
Vol 25 (02) ◽  
pp. 134-140 ◽  
Author(s):  
Gisselle Gallego ◽  
Kees van Gool ◽  
Dianne Kelleher
Keyword(s):  
Decision Making ◽  
Health Service ◽  
Health Technology Assessment ◽  
Technology Assessment ◽  
Online Survey ◽  
Local Level ◽  
Healthcare Providers ◽  
Health Technology ◽  
Health Technologies ◽  
Decision Making Processes

Objectives:Several studies have shown that a key determinant of successful health technology assessment (HTA) uptake is a clear, fair, and consistent decision-making process for the approval and introduction of health technologies. The aim of this study was to gauge healthcare providers' and managers' perceptions of local level decision making and determine whether these processes offer a conducive environment for HTA. An Area Health Service (AHS) aimed to use the results of this study to help design a new process of technology assessment and decision making.Methods:An online survey was sent to all health service managers and healthcare providers working in one AHS in Sydney, Australia. Questions related to perceptions of current health technology decisions in participants' own institution/facility and opinions on key criteria for successful decision-making processes.Results:Less than a third of participants agreed with the statements that local decision-making processes were appropriate, easy to understand, evidence-based, fair, or consistently applied. Decisions were reportedly largely influenced by total cost considerations as well as by the central state health departments and the Area executive.Conclusions:Although there are renewed initiatives in HTA in Australia, there is a risk that such investments will not be productive unless policy makers also examine the decision-making contexts within which HTA can successfully be implemented. The results of this survey show that this is especially true at the local level and that any HTA initiative should be accompanied by efforts to improve decision-making processes.

scholarly journals From idealistic rookies to a regional leader: The history of health technology assessment in Poland

2009 ◽  
Vol 25 (S1) ◽  
pp. 156-162 ◽  
Author(s):  
Rafał Niżankowski ◽  
Norbert Wilk
Keyword(s):  
Primary Care ◽  
Health Care ◽  
Decision Making ◽  
Health Technology Assessment ◽  
Technology Assessment ◽  
Health Technology ◽  
The Public ◽  
History Of ◽  
Decision Making Processes ◽  
Public Payer

In 1989, Poland started to slowly release itself not only from the burden of a half-century of communist indoctrination and soviet exploitation, but also from the consequences of the Semashko model of healthcare organization: low doctors' salaries, primary care based on multispecialty groups, overdeveloped hospital infrastructure, and limited access to sophisticated interventions overcome by patients' unofficial payments.A few years after the 1998 workshop on health technology assessment (HTA) in Budapest, the first HTA reports were elaborated in the National Center for Quality Assessment in Health Care, which could mark the beginning of HTA in Poland. Several individuals and organizations have been involved in developing HTA, both from noncommercial and commercial standpoints.A goal to establish a national HTA agency appeared among the priorities of the Polish Ministry of Health in 2004 and was realized a year later. The Agency for HTA in Poland published guidelines on HTA and established a sound and transparent two-step (assessment-appraisal) process for preparing recommendations on public financing of both drugs and nondrug technologies. The recommendations of the Agency's Consultative Council were warmly welcomed by the public payer. However, the recent major restructuring of the Agency and new drug reimbursement decisions aroused doubts as to keeping transparency of the decision-making processes.

scholarly journals International guidelines for self-report and proxy completion of paediatric health-related quality of life measures: a protocol for a systematic review

BMJ Open ◽  
2021 ◽  
Vol 11 (12) ◽  
pp. e052049
Author(s):  
Christine Mpundu-Kaambwa ◽  
Gang Chen ◽  
Kim Dalziel ◽  
Nancy Devlin ◽  
Julie Ratcliffe
Keyword(s):  
Quality Of Life ◽  
Systematic Review ◽  
Health Technology Assessment ◽  
Technology Assessment ◽  
Health Technology ◽  
Health Related Quality ◽  
Related Quality ◽  
Health Related ◽  
Guidelines And Recommendations

IntroductionMeasures of health-related quality of life (HRQoL), accompanied by the values (or utilities) required to estimate quality-adjusted life-years, are crucial for determining health benefits within economic evaluation and health technology assessment. Several generic and condition-specific measures or instruments of HRQoL, accompanied by values, currently exist for application with child populations. However, there is a lack of a structured summary of guidelines and recommendations for applying these measures in practice. This protocol describes a systematic review of guidelines and recommendations for child and proxy completion of child-specific measures of HRQoL. The aims of the review are to (1) identify and summarise published guidelines and recommendations for existing child-specific measures of HRQoL, (2) determine whether the identified guidelines and recommendations differ by instrument and child characteristics, (3) identify current gaps in these guidelines and recommendations and (4) identify best practices for child self and proxy assessment in paediatric HRQoL measurement for economic evaluation and health technology assessment.Methods and analysisThe review will identify, collate and synthesise published guidelines and recommendations for existing child-specific utility measures of HRQoL. Electronic databases to be searched include the Cochrane Library, Medline, Scopus, Web of Science, EconLit, PsycINFO, CINAHL, Embase and Informit. The search will be extended to websites of (1) international organisations for health technology assessment, (2) regulation, health economics and HRQoL outcomes research and (3) instrument developers. Three reviewers will independently screen titles and abstracts against the inclusion criteria. A narrative synthesis will describe the key features of the guidelines identified.Ethics and disseminationEthical approval is not required as the proposed systematic review will not use primary data. A paper of the systematic review will be submitted to a peer-reviewed journal for publication.PROSPERO registration numberCRD42020207160.

INTRODUCTION OF HEALTH TECHNOLOGY ASSESSMENT FOR MEDICINES IN SLOVAKIA

2017 ◽  
Vol 33 (3) ◽  
pp. 345-349 ◽  
Author(s):  
Tomas Tesar ◽  
Adam Hloska ◽  
Martin Wawruch ◽  
Lubica Lehocka ◽  
Miroslava Snopkova ◽  
...  
Keyword(s):  
Health Technology Assessment ◽  
Technology Assessment ◽  
Slovak Republic ◽  
Health Technology ◽  
Decision Makers ◽  
Therapeutic Class ◽  
Legislative Framework ◽  
Decision Making Processes ◽  
Legislative Activities

Objectives: The aim of our study was to describe approaches to health technology assessment (HTA) for medicines in the Slovak healthcare system and the related decision-making processes concerning reimbursement for medicines.Methods: Analysis of the Slovak legislative framework related to HTA and the reimbursement process for medicines was performed. Additionally, current practices of the Working Group for Pharmacoeconomics, Clinical Outcomes and Health Technology Assessment of the Slovak Ministry of Health were evaluated.Results: In Slovakia, there is always at least one treatment available in each determined therapeutic class with no co-payment. HTA is becoming an established method for the evaluation of cost-effectiveness of medicines in Slovak healthcare policy. The majority of decision makers within Slovakia support the idea of increased use of and the quality and efficiency of HTA methods. However, it is crucial to overcome several practical barriers to facilitate progress in the field of HTA in the Slovak Republic.Conclusions: It can be seen that participation within the European Network for Health Technology Assessment (EUnetHTA JA 2 and EUnetHTA JA 3 projects) has significantly improved the quality of the process of HTA in Slovakia. Further legislative activities in this field are required due to the approved strategy for European Union cooperation on HTA.

EUR-ASSESS Project Subgroup Report on Methodology:Methodological Guidance for the Conduct of Health Technology Assessment

1997 ◽  
Vol 13 (2) ◽  
pp. 186-219 ◽  
Author(s):  
Alessandro Liberati ◽  
Trevor A. Sheldon ◽  
H. David Banta
Keyword(s):  
Health Care ◽  
Decision Making ◽  
Health Policy ◽  
Health Technology Assessment ◽  
Technology Assessment ◽  
Health Technology ◽  
Policy Decisions ◽  
Health Technologies ◽  
Benefits And Costs

Health technology assessment (HTA) is primarily concerned with the consequences (benefits and costs) of health care and health policy decisions. Because decision making is complex and outcomes are often uncertain, it is helpful to attempt to assess the consequences. The quality of decisions can be improved by a process that provides a consistent framework for identifying and assessing health technologies.

OP318 Health Technology Assessment And Decision-Making Processes: The Purchase Of Magnetic Resonance Imaging Technology

2021 ◽  
Vol 37 (S1) ◽  
pp. 13-13
Author(s):  
Maria Maia
Keyword(s):  
Magnetic Resonance Imaging ◽  
Decision Making ◽  
Magnetic Resonance ◽  
Health Technology Assessment ◽  
Technology Assessment ◽  
Health Technology ◽  
Decision Makers ◽  
Decision Making Process ◽  
Resonance Imaging ◽  
Decision Making Processes

IntroductionMedical devices play an essential role in health care, but they are also a leading causes of increasing healthcare expenditures. The purchase of technologies and the determination of how and when they should be used are among the most important decisions made by decision-makers, at the institutional level.The present research focuses on the Portuguese health system and sheds light on the characterization of decision-making process by those involved in Magnetic Resonance Imaging (MRI) purchases.MethodsTo characterize the decision-making process, results from forty questionnaires and twenty-seven semi-structured interviews with key decision-makers were merged, using a mixed method approach. To assess competences for decision-making, a questionnaire was applied, and Exploratory and Confirmatory Factorial Analysis conducted.ResultsCost and suppliers’ characteristics are seen as the most important indicators to guide decisions. The decision is undertaken by a committee, in a bottom-up process, characterized by a bounded rationality, influenced by intuition and a consultant decision-maker. The reasoning and justification for selection of the committee members is unclear. The decision process is considered to be bureaucratic, time-consuming and long. Patients are negatively perceived as stakeholders in the process. Few studies were performed (mostly related to the workload of the Radiology Department) to support the decision and no national or international health technology assessment (HTA) study was used in the process, to guide decisions. Decision-makers have limited knowledge and training in areas of decision-making in the areas of health informatics, health economics and especially HTA. This may limit their ability to truly understand the future implications of their purchase decisions.ConclusionsTo foster HTA in decision-making processes, recommendations are made, in particular, to: (i) establish an HTA in-house unit, able to carry out studies considering the hospital context and aiming to inform managerial local decisions (ii) promote a team comprised of technology assessment multidisciplinary researchers but also professionals from the health institution able to carry out HTA studies (iii) foster common languages and values to increase uptake of HTA studies.

Are Key Principles for improved health technology assessment supported and used by health technology assessment organizations?

2010 ◽  
Vol 26 (1) ◽  
pp. 71-78 ◽  
Author(s):  
◽  
Peter J. Neumann ◽  
Michael F. Drummond ◽  
Bengt Jönsson ◽  
Bryan R. Luce ◽  
...  
Keyword(s):  
Decision Making ◽  
Health Technology Assessment ◽  
Societal Perspective ◽  
Technology Assessment ◽  
Working Group ◽  
Good Practice ◽  
Health Technology ◽  
Wide Range ◽  
Decision Making Processes

Previously, our group—the International Working Group for HTA Advancement—proposed a set of fifteen Key Principles that could be applied to health technology assessment (HTA) programs in different jurisdictions and across a range of organizations and perspectives. In this commentary, we investigate the extent to which these principles are supported and used by fourteen selected HTA organizations worldwide. We find that some principles are broadly supported: examples include being explicit about HTA goals and scope; considering a wide range of evidence and outcomes; and being unbiased and transparent. Other principles receive less widespread support: examples are addressing issues of generalizability and transferability; being transparent on the link between HTA findings and decision-making processes; considering a full societal perspective; and monitoring the implementation of HTA findings. The analysis also suggests a lack of consensus in the field about some principles—for example, considering a societal perspective. Our study highlights differences in the uptake of key principles for HTA and indicates considerable room for improvement for HTA organizations to adopt principles identified to reflect good HTA practices. Most HTA organizations espouse certain general concepts of good practice—for example, assessments should be unbiased and transparent. However, principles that require more intensive follow-up—for example, monitoring the implementation of HTA findings—have received little support and execution.

OP114 The Public's Role In Understanding The Value Of Health Technologies

2018 ◽  
Vol 34 (S1) ◽  
pp. 43-44
Author(s):  
Tania Stafinski ◽  
Jackie Street ◽  
Devidas Menon
Keyword(s):  
Decision Making ◽  
Health Technology Assessment ◽  
Technology Assessment ◽  
Health Technology ◽  
Informed Decision ◽  
Informed Decision Making ◽  
The Public ◽  
Health Technologies ◽  
Decision Making Processes ◽  
Definition Of

Introduction:Increasingly, health technology assessment (HTA) organizations have instituted mechanisms for involving patients in assessment and review processes. The reasons are obvious—to understand the “patient experience” with a disease and to ensure that patient perspectives are considered during deliberations about the value of new treatments. More recently there have been efforts to engage the public in HTAs and HTA-informed decision-making processes. However, the goals of these efforts have not been well articulated. This may be attributable to the lack of a shared definition of “the public”. The objective of this study was to develop a common understanding of the term “the public” within the context of HTA.Methods:The following were conducted: a survey of HTA organizations; a systematic review; consultation with Health Technology Assessment international's Special Interest Group on Patient and Citizen Involvement; and a workshop comprising representatives from patient organizations, industry, and HTA bodies in Canada.Results:In many HTA processes, the terms “public” and “patients” are synonymous. Definitions found in scholarly articles vary and depend on the rationale for involving the public in a particular issue. Through consultations it became clear that, in the context of HTA, the definition depends on understanding what is missing from current deliberations around the value of new health technologies. There was consensus among workshop participants that: (i) “patients” and “the public” are not the same; (ii) the role of the public may be to ensure societal values are reflected in HTAs and HTA-informed decision-making processes (e.g. serving an audit function); and (iii) a legitimate definition of “the public” could be: “A non-aligned community member with no commercial or professional interest in the HTA process who is not a patient or member of a stakeholder group”.Conclusions:Consensus on the use of the terms “patient” and “public” will support rigorous, evidence-based public and patient engagement in HTA. The proposed definition indicates a way forward in this debate.

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