scholarly journals Health Technology Assessment of the Medical Devices: A Case Study from the Czech Republic

2021 ◽  
Vol 14 (2) ◽  
pp. 253-272
Author(s):  
Jana Rozmarinová ◽  
Barbora Říhová
Keyword(s):  
Czech Republic ◽  
Health Technology Assessment ◽  
Medical Devices ◽  
Technology Assessment ◽  
Health Technology ◽  
Decision Makers ◽  
Systematic Evaluation ◽  
The Czech Republic ◽  
Slowing Down

Abstract Health technology assessment (HTA) has become the systematic evaluation of health technology’s properties and effects that inform decision-makers. The implementation and expansion of HTA can contribute to slowing down burgeoning healthcare costs. In the Czech Republic, elements of HTA are quite standardly used in pharmacoeconomics, but questions arise on the use of HTA of medical devices. The theoretical framework developed is followed by a case study of the Czech Republic to assess whether the use of HTA of medical devices in the Czech Republic is implemented. This study uses publicly available resources, mainly public health acts and public notices related to HTA. We examined the institutionalisation of HTA for medical devices (HTA applied only at a selected area of medical devices) in the Czech Republic and compared Czech’s HTA principles of medical devices to the HTA Core Model. It was found that the HTA process used for medical devices is very limited in the Czech Republic. Our data show that HTA was officially established, but in reality, the medical devices have not been assessed following HTA principles.

scholarly journals Who’s afraid of institutionalizing health technology assessment (HTA)?: Interests and policy positions on HTA in the Czech Republic

2017 ◽  
Vol 13 (2) ◽  
pp. 137-161 ◽  
Author(s):  
Olga Löblová
Keyword(s):  
Health Policy ◽  
Czech Republic ◽  
Health Technology Assessment ◽  
Technology Assessment ◽  
Institutional Design ◽  
Health Technology ◽  
The Czech Republic ◽  
Policy Positions ◽  
Vested Interests ◽  
Elite Interviews

AbstractThis article identifies the interests and policy positions of key health policy stakeholders regarding the creation of a health technology assessment (HTA) agency in the Czech Republic, and what considerations influenced them. Vested interests have been suggested as a factor mitigating the diffusion of HTA bodies internationally. The Czech Republic recently considered and discarded establishing an HTA agency, making it a good case for studying actors’ policy positions throughout the policy debates. Findings are based on in-depth, semi-structured expert and elite interviews with 34 key Czech health policy actors, supported by document analysis and extensive triangulation. Findings show that the HTA epistemic community of ‘aspiring agents’ was the only actor strongly in favor of an HTA body. Payers and the medical device and diagnostics industry were against it; patients and clinicians had no clear preferences. Original decision-makers were in favor but a new minister of health opted for a simpler policy alternative to solve his need for expertise. Existing institutions, policy alternatives and the institutional design of a future HTA body influence domestic actors’ preferences for or against an HTA agency. Domestic and international proponents of HTA should give serious thought to their concerns when advocating for HTA bodies.

scholarly journals Evaluating the Benefits of New Drugs in Health Technology Assessment Using Multiple Criteria Decision Analysis: A Case Study on Metastatic Prostate Cancer With the Dental and Pharmaceuticals Benefits Agency (TLV) in Sweden

2018 ◽  
Vol 3 (2) ◽  
pp. 238146831879621 ◽  
Author(s):  
Aris Angelis
Keyword(s):  
Prostate Cancer ◽  
Decision Analysis ◽  
Health Technology Assessment ◽  
Technology Assessment ◽  
Health Technology ◽  
Value Theory ◽  
Multiple Criteria ◽  
Decision Makers ◽  
Multiple Criteria Decision Analysis

Background. Multiple criteria decision analysis (MCDA) has been identified as a prospective methodology for assisting decision makers in evaluating the benefits of new medicines in health technology assessment (HTA); however, limited empirical evidence exists from real-world applications. Objective. To test in practice a recently developed MCDA methodological framework for HTA, the Advance Value Framework, in a proof-of-concept case study with decision makers. Methods. A multi-attribute value theory methodology was adopted applying the MACBETH questioning protocol through a facilitated decision-analysis modelling approach as part of a decision conference with four experts. Settings. The remit of the Swedish Dental and Pharmaceutical Benefits Agency (Tandvårds- och läkemedelsförmånsverket [TLV]) was adopted but in addition supplementary value dimensions were considered. Patients. Metastatic castrate-resistant prostate cancer patients were considered having received prior chemotherapy. Interventions. Abiraterone, cabazitaxel, and enzalutamide were evaluated as third-line treatments. Measurements. Participants’ value preferences were elicited involving criteria selection, options scoring, criteria weighting, and their aggregation. Results. Eight criteria attributes were finally included in the model relating to therapeutic impact, safety profile, socioeconomic impact, and innovation level with relative importance weights 44.5%, 33.3%, 14.8%, and 7.4% per cluster, respectively. Enzalutamide scored the highest overall weighted preference value score, followed by abiraterone and cabazitaxel. Dividing treatments’ overall weighted preference value scores by their costs derived “costs per unit of value” for ranking the treatments based on value-for-money grounds. Limitations. Study limitations included lack of comparative clinical effects across treatments and the small sample of participants. Conclusion. The Advance Value Framework has the prospects of facilitating the evaluation process in HTA and health care decision making; additional research is recommended to address technical challenges and optimize the use of MCDA for policy making.

VP83 How To Identify Technologies Eligible For Health Technology Assessment: A Bottom-Up Approach

2017 ◽  
Vol 33 (S1) ◽  
pp. 187-187
Author(s):  
Susanna Maltoni ◽  
Maria Domenica Camerlingo ◽  
Antonella Negro ◽  
Luigi Palestini ◽  
Giovanni Ragazzi ◽  
...  
Keyword(s):  
Health Technology Assessment ◽  
Medical Devices ◽  
Technology Assessment ◽  
Local Level ◽  
Health Technology ◽  
Decision Makers ◽  
Bottom Up ◽  
Health Technologies ◽  
Emilia Romagna Region ◽  
User Friendly

INTRODUCTION:Governance of health technologies in Emilia-Romagna region, Italy, includes a local and a regional level. Medical devices (MDs) are requested by clinicians to hospital committees that may carry out an evaluation at local level or ask for a regional evaluation using Health Technology Assessment (HTA) methodology. Until the past year, committees weren't provided with a clear pathway to identify technologies for regional HTA evaluation. The aim of this study was to describe a bottom-up, shared approach to produce a tool with elements to be considered when judging if a technology is eligible for regional HTA or not.METHODS:To identify elements, we adopted a qualitative approach and the methodology of focus group (1,2) which consisted in starting from health professionals experience to build a shared knowledge. Two panels of stakeholders were convened, the first one comprising regional decision-makers deciding whether to reimburse and introduce a MD in Regional Health System; the second panel comprised regional clinicians that use, test and ask for MDs. Panels were asked to capture possible elements of MDs that should be considered for identifying the most promising and interesting ones for a regional HTA.RESULTS:The two panels (seventeen regional clinicians and twenty-two decision makers, respectively) had two operative meetings and worked in parallel. At the end of the second meeting, a draft of the tool with elements identified by both groups was built. Panels were asked to test the draft on few medical devices and identify possible tool's criticalities limiting transferability. Tool resulted user-friendly and complete, requiring no changes. The final version, approved by two panels convened together during the last meeting, reports thirty-two distinct items referred to five domains (that is, potential: innovativeness, clinical, economic, and organizational impact, environmental factors). Each item must be valued on a Likert scale. The tool will be applied on every MD requested by regional clinicians and before implementation it will be tested during a 6-month pilot phase beginning March 2017.CONCLUSIONS:The process was plain and feedback from stakeholders has been positive. The tool is expected to increase transparency and homogeneity in identifying technologies eligible for regional HTA.

Health Technology Assessment: Current Issues Impacting on the Regulatory and Legal Framework

2021 ◽  
pp. 158-176
Keyword(s):  
Health Technology Assessment ◽  
Medical Devices ◽  
Technology Assessment ◽  
Digital Health ◽  
Health Technology ◽  
Legal Framework ◽  
Systematic Evaluation ◽  
Health Technologies ◽  
Based Medicine ◽  
Significant Milestone

6This chapter reviews how new or innovative pharmaceuticals, medical devices, diagnostics, and digital health technologies are appraised for their clinical and cost effectiveness by the National Institute for Health and Care Excellence. It gives context on the processes and considerations in following the regulation of medical devices and medicines. It also refers to the Health Technology Assessment (HTA) as a branch of policy that aims at examining and rationally optimising the value of measures to improve healthcare and prevent ill health. The chapter defines the HTA as a systematic evaluation of the properties and effects of a health technology. It recounts the beginnings of health technology that go back to the dawn of evidence-based medicine, in which the randomised comparative experiments of naval surgeon James Lind on scurvy in the eighteenth century were a significant milestone.

Health technology assessment in Poland, the Czech Republic, Hungary, Romania and Bulgaria

2014 ◽  
Vol 15 (S1) ◽  
pp. 13-25 ◽  
Author(s):  
László Gulácsi ◽  
Alexandru M. Rotar ◽  
Maciej Niewada ◽  
Olga Löblová ◽  
Fanni Rencz ◽  
...  
Keyword(s):  
Czech Republic ◽  
Health Technology Assessment ◽  
Technology Assessment ◽  
Health Technology ◽  
The Czech Republic

scholarly journals HEALTH TECHNOLOGY ASSESSMENT IN EVALUATION OF PHARMACEUTICALS IN THE CZECH REPUBLIC

2017 ◽  
Vol 33 (3) ◽  
pp. 339-344 ◽  
Author(s):  
Lenka Vostalová ◽  
Jana Mazelová ◽  
Jiří Samek ◽  
Milan Vocelka
Keyword(s):  
Czech Republic ◽  
Health Technology Assessment ◽  
Technology Assessment ◽  
New Technologies ◽  
Health Technology ◽  
Medicinal Products ◽  
State Institute ◽  
The Czech Republic ◽  
Administrative Proceedings ◽  
The Impact

Objectives: In the Czech Republic, the health technology assessment (HTA) approaches have been implemented in evaluation of medicinal products since 2008.The aim of this study was to provide an overview of the implementation of HTA and different levels thereof in the evaluation process conducted by the State Institute for Drug Control (SUKL) and to describe the impact of HTA on the entrance of new medicinal entities into out-patient healthcare system including highly innovative and orphan drugs.Methods: Materials supporting this overview were collected using the records in the database of administrative proceedings of SUKL, in-house standard operating procedures, and the legislation in force. Based on these sources as well as the hands-on knowledge of the current practice, a brief description of the general rules of administrative proceedings involving HTA of varying complexity was elaborated. Characteristic features of the individual types of proceedings, basic differences in the complexity of HTA employed, and its most important challenges were summarized.Results: In Czech Republic, HTA in the formal administrative proceedings ensures a transparent process of introduction of new medicinal products into clinical practice and leaves space for restriction of reimbursement conditions to minimize budget impact.Conclusions: As a robust as well as pragmatic HTA methodology has been implemented by SUKL, relevant stakeholders (marketing authorization holders, Health Care Funds, clinical expert groups) are now able to influence reimbursement of new technologies.

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.

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