What aspects of the health technology assessment process recommended by international health technology assessment agencies received the most attention in Poland in 2008?

Author(s):  
Katarzyna Kolasa ◽  
Malgorzata Dziomdziora ◽  
Liberty Fajutrao

Objectives: The primary objective of this study was to determine the extent to which international standards on transparency and quality are met by the health technology assessment (HTA) process in Poland. A secondary objective is to describe the outcomes of the HTA process and their associated factors.Methods: All published online HTA appraisal and meeting proceedings on pharmaceutical products in 2008 were reviewed using a score card developed from international checklists recommended by INAHTA and ECHTA.Results: The sixty-nine reports reviewed showed that five of nine transparency standards and six of eight quality standards were usually met by the HTA reports. Areas for improvement for transparency include inputs from external stakeholders, availability of English summaries, conclusions, implications of results, and suggested program of action. Areas of improvement for quality include appropriateness of target population and comparator/s, sufficiency of evidence on efficacy and safety, methodological rigor, economic model assumptions, and adaptation to the Polish setting. A consideration of the ethical and social consequences to the healthcare system must also be strengthened.Conclusions: The study demonstrates that the incorporation and implementation of the HTA appraisal process in Poland has been successful. HTA appraisal reports in Poland have considered most of the international standards of transparency and quality. Recommendations for both HTA users and doers are forwarded for the improvement of the HTA process in the Polish setting.

2021 ◽  
pp. 0272989X2199455
Author(s):  
Oriana Ciani ◽  
Bogdan Grigore ◽  
Hedwig Blommestein ◽  
Saskia de Groot ◽  
Meilin Möllenkamp ◽  
...  

Background Surrogate endpoints (i.e., intermediate endpoints intended to predict for patient-centered outcomes) are increasingly common. However, little is known about how surrogate evidence is handled in the context of health technology assessment (HTA). Objectives 1) To map methodologies for the validation of surrogate endpoints and 2) to determine their impact on acceptability of surrogates and coverage decisions made by HTA agencies. Methods We sought HTA reports where evaluation relied on a surrogate from 8 HTA agencies. We extracted data on the methods applied for surrogate validation. We assessed the level of agreement between agencies and fitted mixed-effects logistic regression models to test the impact of validation approaches on the agency’s acceptability of the surrogate endpoint and their coverage recommendation. Results Of the 124 included reports, 61 (49%) discussed the level of evidence to support the relationship between the surrogate and the patient-centered endpoint, 27 (22%) reported a correlation coefficient/association measure, and 40 (32%) quantified the expected effect on the patient-centered outcome. Overall, the surrogate endpoint was deemed acceptable in 49 (40%) reports ( k-coefficient 0.10, P = 0.004). Any consideration of the level of evidence was associated with accepting the surrogate endpoint as valid (odds ratio [OR], 4.60; 95% confidence interval [CI], 1.60–13.18, P = 0.005). However, we did not find strong evidence of an association between accepting the surrogate endpoint and agency coverage recommendation (OR, 0.71; 95% CI, 0.23–2.20; P = 0.55). Conclusions Handling of surrogate endpoint evidence in reports varied greatly across HTA agencies, with inconsistent consideration of the level of evidence and statistical validation. Our findings call for careful reconsideration of the issue of surrogacy and the need for harmonization of practices across international HTA agencies.


Author(s):  
Marian Sorin Paveliu ◽  
Elena Olariu ◽  
Raluca Caplescu ◽  
Yemi Oluboyede ◽  
Ileana-Gabriela Niculescu-Aron ◽  
...  

Objective: To provide health-related quality of life (HRQoL) data to support health technology assessment (HTA) and reimbursement decisions in Romania, by developing a country-specific value set for the EQ-5D-3L questionnaire. Methods: We used the cTTO method to elicit health state values using a computer-assisted personal interviewing approach. Interviews were standardized following the most recent version of the EQ-VT protocol developed by the EuroQoL Foundation. Thirty EQ-5D-3L health states were randomly assigned to respondents in blocks of three. Econometric modeling was used to estimate values for all 243 states described by the EQ-5D-3L. Results: Data from 1556 non-institutionalized adults aged 18 years and older, selected from a national representative sample, were used to build the value set. All tested models were logically consistent; the final model chosen to generate the value set was an interval regression model. The predicted EQ-5D-3L values ranged from 0.969 to 0.399, and the relative importance of EQ-5D-3L dimensions was in the following order: mobility, pain/discomfort, self-care, anxiety/depression, and usual activities. Conclusions: These results can support reimbursement decisions and allow regional cross-country comparisons between health technologies. This study lays a stepping stone in the development of a health technology assessment process more driven by locally relevant data in Romania.


2014 ◽  
Vol 30 (2) ◽  
pp. 147-152 ◽  
Author(s):  
Sergei Muratov ◽  
David Hailey ◽  
Vicki Foerster ◽  
Bruce Brady ◽  
Don Juzwishin ◽  
...  

Objectives: The aim of this study was to assist in the development of a health technology assessment (HTA) program for the Ministry of Health (MOH) of the Republic of KazakhstanMethods: Mentoring of an initial HTA program in Kazakhstan was provided by the Canadian Society for International Health (CSIH) by means of a partnership with the Kazakhstan MOH. HTA materials, courses, and one-on-one support for the preparation of a series of initial HTA reports by MOH HTA staff were provided by a seven-member CSIH team over a 2.5-year project.Results: Guidance documents on HTA and institutional strengthening were prepared in response to an extensive set of deliverables developed by the MOH and the World Bank. Introductory and train-the-trainer workshops in HTA and economic evaluation were provided for MOH staff members, experts from Kazakhstan research institutes and physicians. Five short HTA reports were successfully developed by staff in the Ministry's HTA Unit with assistance from the CSIH team. Challenges that may be relevant to other emerging HTA programs included lack of familiarity with some essential underlying concepts, organization culture, and limited time for MOH staff to do HTA work.Conclusions: The project helped to define the need for HTA and mentored MOH staff in taking the first steps to establish a program to support health policy decision making in Kazakhstan. This experience offers practical lessons for other emerging HTA programs, although these should be tailored to the specific context.


Vestnik ◽  
2021 ◽  
pp. 315-323
Author(s):  
Л.К. Кошербаева ◽  
З.Р. Сагындыкова ◽  
Т.Б. Егеубаев

В условиях ограниченных бюджетов для современного здравоохранения рациональное потребление ресурсов является очень актуальной проблемой. Оценка технологий здравоохранения (ДСТБ) - комплексная оценка относительно доказанной клинической и клинико-экономической (фармаколого-экономической) эффективности и безопасности технологий здравоохранения, а также экономических, социальных и этических последствий их применения. Цель оценки технологий здравоохранения-одобрение заявленных технологий здравоохранения и включение заявленных технологий здравоохранения в перечень компенсации и информирование политиков в области здравоохранения. Следует ли применять здоровье сберегающую технологию, как ее применять и какую пользу от нее получают пациенты. Обучение экспертным знаниям о выживаемости, диагностике и лечении болезней и болезней, в том числе о методе оказания помощи (для анализа затрат и выгод), бремени болезней, выявлении пробелов в уходе, выявлении и удовлетворении потребностей. Предоставление отзывов о лечении (или отсутствии лечения и поддержки) социальных последствий заболевания способствует подходу пациентов, процессу принятия решений по мере необходимости. In the context of limited budgets for modern healthcare, rational resource consumption is a very urgent problem. Health Technology Assessment (OST) - a comprehensive assessment of the relatively proven clinical and clinical- economic (pharmacological-economic) effectiveness and safety of health technologies, as well as the economic, social and ethical consequences of their use. The purpose of the health technology assessment is to approve the claimed health technologies and include the claimed health technologies in the compensation list and inform health policy makers. It shows whether healthcare technology should be used or not, how it should be used, and how patients can benefit from it. Providing expert knowledge on the pain and burden of living, diagnosis and treatment, including the method of providing assistance (to analyze costs and benefits), the burden of diseases, identifying gaps in care, identifying and meeting needs. Giving feedback on the treatment (or lack of treatment and support) of the social consequences of the disease contributes to the decision-making process depending on the patient's attitude, needs.


2017 ◽  
Vol 33 (S1) ◽  
pp. 168-169
Author(s):  
Francesco Faggiano ◽  
Martina Andellini ◽  
Federico Nocchi ◽  
Carlo Capussotto ◽  
Francesca Sabusco ◽  
...  

INTRODUCTION:The purpose of the study was to evaluate different type and manufacturers of intensive care ventilators in order to support the healthcare decision-making process about the choice to adopt the best available technology for ventilation of pediatric patient in intensive care units at Bambino Gesù Children's Hospital.METHODS:The technology assessment process was developed by using a new methodology, the Decision-oriented Health Technology Assessment (HTA) (DoHTA), a new implementation of the European Network for Health Technology Assessment (EUnetHTA) CoreModel, integrating the Analytic Hierarchy Process (1). A literature review was carried out to gather evidence on safety and overall effectiveness of different kind of intensive care ventilators, with several ventilation modalities and strategies. The synthesis of scientific evidence, and results of the specific context analysis resulted in the definition of components of the decisional hierarchy structure, consisting in detailed characteristics of the technology's performances covering the aspects on feasibility, safety, efficacy, costs, and organizational and technical characteristics of the technology. A subgroup of these indicators has been included in a checklist form for the evaluation of different type and manufacturers of intensive care ventilators, each of which was tested in three independent runs performed in three different departments. In addition, an economic evaluation was also carried out.RESULTS:Preliminary DoHTA results showed that the domains with the highest impacts within the evaluation are safety and clinical effectiveness (34.8 percent and 25.7 percent, respectively) followed by organizational aspects, technical characteristics of technology and costs and economic evaluation. The final objective is to define the alternatives’ ranking through a comparison between alternative technologies’ performances.CONCLUSIONS:The technology assessment project allowed to identify strengths and limits of the most recent intensive care ventilator’ models in the specific contexts of use by involving all health professionals interested, and eventually identify the best option for the hospital.


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