scholarly journals Analysis of Transparency Amongst International Health Technology Assessment Organizations

2013 ◽  
Vol 16 (7) ◽  
pp. A481-A482
Author(s):  
F. Jebrail ◽  
M. Duong ◽  
D. Shum
Keyword(s):  
Health Technology Assessment ◽  
Technology Assessment ◽  
International Health ◽  
Health Technology

scholarly journals Validity of Surrogate Endpoints and Their Impact on Coverage Recommendations: A Retrospective Analysis across International Health Technology Assessment Agencies

2021 ◽  
pp. 0272989X2199455
Author(s):  
Oriana Ciani ◽  
Bogdan Grigore ◽  
Hedwig Blommestein ◽  
Saskia de Groot ◽  
Meilin Möllenkamp ◽  
...  
Keyword(s):  
Health Technology Assessment ◽  
Technology Assessment ◽  
International Health ◽  
Surrogate Endpoint ◽  
Health Technology ◽  
Surrogate Endpoints ◽  
Patient Centered ◽  
Statistical Validation ◽  
Level Of Evidence ◽  
The Impact

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.

scholarly journals MENTORING A HEALTH TECHNOLOGY ASSESSMENT INITIATIVE IN KAZAKHSTAN

2014 ◽  
Vol 30 (2) ◽  
pp. 147-152 ◽  
Author(s):  
Sergei Muratov ◽  
David Hailey ◽  
Vicki Foerster ◽  
Bruce Brady ◽  
Don Juzwishin ◽  
...  
Keyword(s):  
Health Technology Assessment ◽  
Technology Assessment ◽  
International Health ◽  
Policy Decision ◽  
Health Technology ◽  
Organization Culture ◽  
Train The Trainer ◽  
Staff Members ◽  
Health Policy Decision ◽  
The Republic

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.

scholarly journals Health technology assessment in Brazil: what do healthcare system players think about it?

2011 ◽  
Vol 129 (4) ◽  
pp. 198-205 ◽  
Author(s):  
Marcos Bosi Ferraz ◽  
Patricia Coelho de Soárez ◽  
Paola Zucchi
Keyword(s):  
Health Economics ◽  
Health Technology Assessment ◽  
Healthcare System ◽  
Technology Assessment ◽  
International Health ◽  
Health Technology ◽  
Cross Sectional Study ◽  
Cross Sectional ◽  
Public And Private ◽  
The Government

CONTEXT AND OBJECTIVES: The health technology assessment (HTA) process has been developed locally. The aim of this study was to describe, analyze and compare the opinions of participants in international health economics symposia about the HTA process used in Brazil. DESIGN AND SETTING: Observational cross-sectional study at the 2006 and 2008 International Health Economics Symposia, in São Paulo. METHODS: A structured questionnaire was applied. For the statistical analysis, the percentage distribution for each category was calculated, and variables were compared using tests for two-sample proportion hypotheses. RESULTS: Totals of 153 and 74 participants answered the 2006 and 2008 surveys, respectively. The response rate was better for the 2006 survey (67.1%) than for the 2008 survey (31.8%). Most interviewees were between the ages of 30 and 49 years and were managers in the healthcare system. Most of them considered that the current HTA process was incomplete and unable to meet the needs of the healthcare system. They mentioned the government, academia and experts as the three main groups of people who should be involved in the process, and selected efficiency/effectiveness, safety and disease relevance as the three main criteria to be considered in the HTA process. There is a trend towards developing decentralized regionalized HTA processes, with separate assessment and decision-making for the public and private systems. CONCLUSIONS: The HTA concept is well known. Healthcare system players feel that the process has methodological limitations. Additional surveys are needed to track the HTA process and its application in Brazil.

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

2011 ◽  
Vol 27 (1) ◽  
pp. 84-94 ◽  
Author(s):  
Katarzyna Kolasa ◽  
Malgorzata Dziomdziora ◽  
Liberty Fajutrao
Keyword(s):  
Health Technology Assessment ◽  
Technology Assessment ◽  
International Health ◽  
Target Population ◽  
Health Technology ◽  
Pharmaceutical Products ◽  
Primary Objective ◽  
Social Consequences ◽  
International Standards ◽  
Assessment Process

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.

scholarly journals Medicare Spending on Drugs and Biologics Not Recommended for Coverage by International Health Technology Assessment Agencies

2019 ◽  
Vol 34 (11) ◽  
pp. 2319-2321 ◽  
Author(s):  
Alexander C. Egilman ◽  
Joshua D. Wallach ◽  
Sanket S. Dhruva ◽  
Gregg S. Gonsalves ◽  
Joseph S. Ross
Keyword(s):  
Health Technology Assessment ◽  
Technology Assessment ◽  
International Health ◽  
Health Technology ◽  
Medicare Spending

scholarly journals Drugs for Rare Diseases: A Review of National and International Health Technology Assessment Agencies and Public Payers’ Decision-Making Processes

2021 ◽  
Vol 1 (5) ◽  
Author(s):  
Reimbursement Review Team
Keyword(s):  
Health Technology Assessment ◽  
Rare Diseases ◽  
Technology Assessment ◽  
Health Care Systems ◽  
International Health ◽  
Health Technology ◽  
Small Sample ◽  
Economic Evidence ◽  
Eligibility Criteria ◽  
Public Drug

Drugs for rare diseases can address significant unmet therapeutic needs for patients living with seriously debilitating and life-threatening conditions; however, the high costs of these drugs can pose challenges for public drug programs and health care systems. There are challenges with the application of standard health technology assessment methods for the assessment of drugs for rare diseases, including uncertainty with the clinical and economic evidence due to small sample sizes, poorly characterized natural history of disease, uncertain epidemiology, absence of comparative studies, heterogenous phenotypes, and lack of diagnostic accuracy. In addition, there are challenges applying commonly accepted economic benchmarks due to the very high cost of these drugs. To address these challenges, agencies and public payers have established separate or modified processes and programs to review and make reimbursement recommendations for drugs for rare diseases. There is a lack of consistency across agencies with respect to how drugs for rare diseases are defined and what aspects of the process are modified to address the challenges with these drugs; however, common features include greater acceptance of uncertainty with the clinical and economic evidence and a higher willingness-to-pay threshold. The majority of health technology assessment agencies have highlighted that drugs for ultra-rare diseases are particularly challenging and warrant special consideration. This includes the creation of completely separate review processes for drugs indicated for use in the treatment of ultra-rare conditions in the UK (both England and Scotland). The majority of processes for funding drugs for rare diseases by public drug programs included in this report manage the drugs through standard formulary processes involving the use of special authorization to ensure that patients meet the eligibility criteria for the drugs. Those that have specialized formularies have largely focused on providing access to ultra-rare conditions.

scholarly journals The history of health technology assessment in Norway

2009 ◽  
Vol 25 (S1) ◽  
pp. 148-155 ◽  
Author(s):  
Berit Mørland
Keyword(s):  
Health Technology Assessment ◽  
Technology Assessment ◽  
International Health ◽  
Cochrane Collaboration ◽  
Health Technology ◽  
Consensus Conferences ◽  
The People ◽  
History Of ◽  
Set Up ◽  
The Cochrane Collaboration

Objectives: The aim of this study was to describe the Norwegian contribution to the broad picture of our international health technology assessment (HTA) history.Methods: A general examination of some pre-HTA activities, as consensus conferences, closer reading of all background papers to the establishment of an HTA agency in Norway, the ongoing activities of this agency, its evaluation, and its merge into a broader knowledge center for the health services were performed. All information and statements are the authors’ own understandings, but also were reviewed by some of the people taken part in these processes.Results: The Norwegian HTA activity was set up rather late compared to, for instance, Sweden, and our involvement in Nordic early warning activities. This may be related to Norwegian scientists being more involved in the Cochrane Collaboration. However, when established, the HTA agency was regarded as highly successful in involving clinical experts and responding to questions arising from the macro- as well as micro-levels of decision makers. International collaboration was essential in building the capacity to serve all levels. After 6 years, the agency was merged with some related health service knowledge activities, into a new center.Conclusions: During the 10 years’ time, HTA has become a well-established activity in Norway.

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