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.

THE USE AND IMPACT OF RAPID HEALTH TECHNOLOGY ASSESSMENTS

2000 ◽  
Vol 16 (2) ◽  
pp. 651-656 ◽  
Author(s):  
David Hailey ◽  
Paula Corabian ◽  
Christa Harstall ◽  
Wendy Schneider
Keyword(s):  
Health Technology Assessment ◽  
Healthcare System ◽  
Technology Assessment ◽  
Rapid Assessment ◽  
Health Technology ◽  
Decision Makers ◽  
Assessment Program ◽  
Detailed Evaluation ◽  
The Impact

Objectives: To consider the impact of rapid health technology assessments undertaken as part of a program in a provincial healthcare system in response to urgent requests for advice.Methods: Review of the development and preparation of 20 rapid assessment reports, communication with decision makers within the healthcare system, and appraisal of data subsequent to preparation of the reports.Results: Fourteen of the assessments were judged to have had an influence on policy and other decisions, as judged by responses from those who had requested advice. Another four were considered to have provided guidance, while having less immediate influence on decisions, and two others had no apparent impact. Quality of the assessments was considered acceptable, on the basis of literature that subsequently became available and from comments received.Conclusions: These brief reports are considered to be a useful component of a health technology assessment program. However, they should be regarded as provisional appraisals and followed up with more detailed evaluation where possible.

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.

IMPACT OF HEALTH TECHNOLOGY ASSESSMENT REPORTS ON HOSPITAL DECISION MAKERS – 10-YEAR INSIGHT FROM A HOSPITAL UNIT IN SHERBROOKE, CANADA: IMPACT OF HEALTH TECHNOLOGY ASSESSMENT ON HOSPITAL DECISIONS

2018 ◽  
Vol 34 (4) ◽  
pp. 393-399 ◽  
Author(s):  
Thomas G. Poder ◽  
Christian A. Bellemare ◽  
Suzanne K. Bédard ◽  
Jean-François Fisette ◽  
Pierre Dagenais
Keyword(s):  
Decision Making ◽  
Health Technology Assessment ◽  
Technology Assessment ◽  
Contextual Factors ◽  
Health Technology ◽  
Decision Makers ◽  
Hospital Unit ◽  
Decision Making Processes ◽  
Process Factors ◽  
The Impact

Objectives:The overarching goal of this research was to (i) evaluate the impact of reports with recommendations provided by a hospital-based health technology assessment (HB-HTA) unit on the local hospital decision-making processes and implementation activities and (ii) identify the underlying factors of the nonimplementation of recommendations.Methods:All reports produced by the HB-HTA unit between December 2003 and March 2013 were retrieved, and hospital decision makers who requested these reports were solicited for enrolment. Participants were interviewed using a mixed design survey.Results:Twenty reports, associated with fifteen decision makers, fulfilled the study criteria. Nine decision makers accepted to participate, corresponding to thirteen reports and twenty-three recommendations. Of the twenty-three recommendations issued, 65 percent were implemented, 9 percent were accepted for implementation but not implemented, and 26 percent were declined. In terms of the utility of each report to guide decision makers, 92 percent of the reports were considered in the decision-making process; 85 percent had one or more recommendations adopted; and 77 percent had recommendations implemented. The most frequently mentioned reasons for nonimplementation were related to contextual factors (64 percent), production/diffusion process factors (14 percent), content/format factors (14 percent), or other factors (9 percent). Among the contextual factors, the complexity of the changes (i.e., administrative reasons), budget and resources constraints, failure to identify administrative responsibility to carry out the recommendation, and nonpriority status of the HTA recommendation, were provided.Conclusions:This study highlights that although HB-HTA reports are useful to hospital managers in their decision-making processes, certain barriers such as contextual factors need to be better addressed to improve HB-HTA efficiency and usefulness.

scholarly journals Development of a checklist to guide equity considerations in health technology assessment

2021 ◽  
Vol 37 ◽  
Author(s):  
Maria Benkhalti ◽  
Manuel Espinoza ◽  
Richard Cookson ◽  
Vivian Welch ◽  
Peter Tugwell ◽  
...  
Keyword(s):  
Knowledge Translation ◽  
Health Technology Assessment ◽  
Priority Setting ◽  
Technology Assessment ◽  
Literature Search ◽  
Health Inequities ◽  
Health Technology ◽  
Decision Makers ◽  
Added Value ◽  
Pilot Test

Abstract Objectives Health technology assessment (HTA) can impact health inequities by informing healthcare priority-setting decisions. This paper presents a novel checklist to guide HTA practitioners looking to include equity considerations in their work: the equity checklist for HTA (ECHTA). The list is pragmatically organized according to the generic HTA phases and can be consulted at each step. Methods A first set of items was based on the framework for equity in HTA developed by Culyer and Bombard. After rewording and reorganizing according to five HTA phases, they were complemented by elements emerging from a literature search. Consultations with method experts, decision makers, and stakeholders further refined the items. Further feedback was sought during a presentation of the tool at an international HTA conference. Lastly, the checklist was piloted through all five stages of an HTA. Results ECHTA proposes elements to be considered at each one of the five HTA phases: Scoping, Evaluation, Recommendations and Conclusions, Knowledge Translation and Implementation, and Reassessment. More than a simple checklist, the tool provides details and examples that guide the evaluators through an analysis in each phase. A pilot test is also presented, which demonstrates the ECHTA's usability and added value. Conclusions ECHTA provides guidance for HTA evaluators wishing to ensure that their conclusions do not contribute to inequalities in health. Several points to build upon the current checklist will be addressed by a working group of experts, and further feedback is welcome from evaluators who have used the tool.

scholarly journals Health technology assessment for the acute and preventive treatment of migraine: A position statement of the International Headache Society

Cephalalgia ◽  
2021 ◽  
pp. 033310242198924
Author(s):  
Hans Christoph Diener ◽  
Messoud Ashina ◽  
Isabelle Durand-Zaleski ◽  
Tobias Kurth ◽  
Michel Lantéri-Minet ◽  
...  
Keyword(s):  
Health Technology Assessment ◽  
Technology Assessment ◽  
International Headache Society ◽  
Preventive Treatment ◽  
Health Technology ◽  
Position Statement ◽  
Decision Makers ◽  
Synthetic Approach ◽  
Multiple Data ◽  
Real World Evidence

The Clinical Trials Subcommittee of the International Headache Society presents the first Health Technology Assessment for the Acute Treatment of Migraine Attacks and Prevention of Migraine. Health technology assessments are systematic evaluations of the properties, effects, and consequences of healthcare technologies; this position statement is designed to inform decision makers about access to and reimbursement for medications and devices for the acute and preventive treatment of migraine. This position statement extends beyond the already available guidelines on randomized controlled trials for migraine to incorporate real-world evidence and a synthetic approach for considering multiple data sources and modelling methods when assessing the value of migraine treatments.

scholarly journals COST, CONTEXT, AND DECISIONS IN HEALTH ECONOMICS AND HEALTH TECHNOLOGY ASSESSMENT

2018 ◽  
Vol 34 (5) ◽  
pp. 434-441 ◽  
Author(s):  
Anthony J. Culyer
Keyword(s):  
Health Economics ◽  
Health Technology Assessment ◽  
Decision Maker ◽  
Technology Assessment ◽  
Health Technology ◽  
Decision Makers ◽  
Negative Consequences ◽  
Middle Income ◽  
Middle Income Countries ◽  
Context Dependent

Objectives:This study is an attempt to demystify and clarify the idea of cost in health economics and health technology assessment (HTA).Methods:Its method draws on standard concepts in economics. Cost is a more elusive concept than is commonly thought and can be particularly elusive in multidisciplinary territory like HTA.Results:The article explains that cost is more completely defined as opportunity cost, why cost is necessarily associated with a decision, and that it will always vary according to the context of that decision: whether choice is about inputs or outputs, what the alternatives are, the timing of the consequences of the decision, the nature of the commitment to which a decision maker is committed, who the decision maker is, and the constraints and discretion limiting or liberating the decision maker. Distinctions between short and long runs and between fixed and variable inputs are matters of choice, not technology, and are similarly context-dependent. Harms or negative consequences are, in general, not costs. Whether so-called “clinically unrelated” future costs and benefits should be counted in current decisions again depends on context.Conclusions:The costs of entire health programs are context-dependent, relating to planned rates of activity, volumes, and timings. The implications for the methods of HTA are different in the contexts of low- and middle-income countries compared with high-income countries, and further differ contextually according to the budget constraints (fixed or variable) facing decision makers.

Opportunities to improve reporting of rapid response in health technology assessment

2021 ◽  
Vol 38 (1) ◽  
Author(s):  
Matheus O. de Almeida ◽  
Thais Montezuma ◽  
Haliton A. de Oliveira Júnior ◽  
Cleusa Pinheiro Ferri
Keyword(s):  
Health Technology Assessment ◽  
Technology Assessment ◽  
Epidemiologic Study ◽  
Health Technology ◽  
Risk Of Bias ◽  
Quality Of Reporting ◽  
Quality Of Evidence ◽  
Health Technologies ◽  
Study Selection

Abstract Introduction Mini health technology assessment (HTA) reports have been used to support policy makers and health systems by providing a timely summary of scientific evidence. The objective of this meta-epidemiologic study was to evaluate the quality of reporting of mini-HTA reports published in Brazil. Methods An electronic search for all mini-HTA reports published between 2014 and March 2019 was conducted in the SISREBRATS and CONITEC databases. The study selection and data extraction were performed by two independent assessors. The following data were extracted: bibliographic data; research question; characteristics of the population, health technologies and outcomes assessed; eligibility criteria; information about searches and study selection; risk of bias assessment; quality of evidence assessment; synthesis of results; and recommendation about the technology evaluated. A descriptive analysis was used to summarize the information retrieved from all the included mini-HTA reports. Results We included 103 mini-HTA reports, the great majority of which (92.3 percent) focused on the coverage of the technologies in the healthcare system, with more than 60 percent being about drugs. Only five mini-HTA reports (4.8 percent) gave reasons for the choice of outcomes, and fifteen (14.5 percent) discriminated between primary and secondary outcomes. All mini-HTAs reported the databases searched and 99 percent of them reported using Medline. Sixty percent of the mini-HTA reported assessing the risk of bias, and 52 percent reported assessing the quality of evidence. Conclusion The quality of reporting of the mini-HTA reports performed in Brazil is insufficient and needs to be improved to guarantee transparency and replicability.

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.

OP135 Confirmatory Versus Explorative Endpoints In Drug Approval Versus Health Technology Assessment

2017 ◽  
Vol 33 (S1) ◽  
pp. 63-64
Author(s):  
Ines Niehaus ◽  
Charalabos-Markos Dintsios
Keyword(s):  
Health Technology Assessment ◽  
Technology Assessment ◽  
Drug Approval ◽  
Health Technology ◽  
Benefit Assessment ◽  
Benefit Ratio ◽  
Early Benefit Assessment ◽  
The Impact ◽  
Early Benefit

INTRODUCTION:The early benefit assessment of drugs in Germany and their preceded market authorization pursue different objectives, resulting in divergent decision-making strategies. This is reflected inter alia by the diverse inclusion of confirmatory endpoints within the assessments of oncological drugs. The pharmaceutical manufacturers are facing the challenge of meeting the requirements for both evaluation processes by the available evidence and avoiding hereby negative early benefit assessments. This is mainly due to the concept of mutually relevant clinical trials.METHODS:Identification and gathering of the endpoints is based on a specifically developed guide. The extracted data from the documents of completed assessments up to July 2015 are used to estimate both separately and together the impact of explorative in relation to confirmatory endpoints on the drug approval and early benefit assessment, by contrasting the European Medicines Agency's risk-benefit-ratio and the benefit-harm-balancing of the national Health Technology Assessment (HTA) jurisdiction.RESULTS:Twenty-one of fourty-one studies’ oncological assessments could be included in the endpoint analysis. From a procedural point of view both the drug approval and the early benefit assessment seem to be not confirmatory since they include explorative endpoints as well. Yet, drug approval is in terms of quality of endpoints more confirmatory than early benefit assessment since it contains a higher proportion of primary endpoints. The latter implies only in 67 percent of the assessments a primary endpoint to be relevant for the benefit-harm-balancing. Moreover, explorative mortality endpoints reached the highest agreement and explorative endpoints capturing health-related quality of life no agreement, referring to the mutual relevance of endpoints for the risk-benefit-ratio and the benefit-harm-balancing.CONCLUSIONS:The missing information transparency of the assessment reports compared to the information offered within the early benefit assessment makes an assignment of endpoints with respect to the mutually relevant clinical trial sometimes troublesome. To warrant, in the long run, a broader confirmatory basis for decisions in health care supported by HTA, a closer inter-institutional cooperation of approval authorities and German HTA jurisdictions seems favorable.

Sign in / Sign up

Export Citation Format

Share Document