International comparison of the definition and the practical application of health technology assessment

Draborg, Eva; Gyrd‐Hansen, Dorte; Poulsen, Peter Bo; Hørder, Mogens

doi:10.1017/s0266462305050117

Cited by 94 publications

(76 citation statements)

References 5 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…32 However, many organizations now report using systematic and transparent methods to develop clinical, public health and policy recommendations, including a growing number of organizations funded by government. [33][34][35] Progress in how WHO develops and disseminates recommendations for member states and in how it supports member states in their efforts to adapt and implement recommendations will require leadership. WHO's Cabinet recognised the need for using systematic and transparent methods to develop recommendations when it endorsed the guidelines for WHO guidelines in 2003.…”

Section: Discussionmentioning

confidence: 99%

Use of evidence in WHO recommendations

2007

View full text Add to dashboard Cite

Section: Discussionmentioning

confidence: 99%

Use of evidence in WHO recommendations

2007

View full text Add to dashboard Cite

“…However, definitions of HTA vary between authorities 1 . In the UK, the National Institute for Health and Clinical Excellence (NICE) includes three key elements in HTAs: the broad balance of clinical benefits and costs offered by the technology; the degree of clinical need among patients with the condition or disease; and the potential for long-term benefits to the NHS that arise from the innovation 2 .…”

Section: I a L D I S T R I B U T I O N U N A U T H O R I Z E D U S mentioning

confidence: 99%

Addressing the health technology assessment of biosimilar pharmaceuticals

Stewart

Aubrey

Belsey³

2010

Current Medical Research and Opinion

View full text Add to dashboard Cite

The growing number of biosimilars presents challenges to regulatory and health technology assessment (HTA) systems. This paper illustrates these challenges by focusing on biosimilars used in the oncological setting. In particular, discordances between data required by regulatory and HTA authorities potentially deprive patients of effective treatments and hinder optimal resource allocation. Regulatory and HTA authorities need to harmonize requirements to foster the development and widespread use of biosimilars, which potentially release considerable resources. The authors believe that ofteninappropriate methodology creates a very real chance that HTA authorities will reject some biosimilars. This would effectively extend patent protection and, in the absence of competitor pressure from biosimilars, result in prices remaining unnecessarily high. The authors propose that HTA organizations should accept pharmacokinetic and pharmacodynamic equivalence between the brand and the biosimilar as a proxy of biological comparability. HTA organizations should then adopt, in the absence of compelling reasons otherwise, cost-minimization analysis (CMA) as the basis of the cost-effectiveness deliberations. In the absence of adequate studies demonstrating equivalent efficacy, a prerequisite of CMA, HTA organizations should require threshold analysis. Once approved, biosimilar manufacturers and regulators should maintain rigorous pharmacovigilance to exclude immunoreactivity or other rare adverse events. Furthermore, cancer centres and trusts should regularly audit and publish the impact of biosimilars on clinical outcomes and resource use. When appropriate, regulatory and HTA authorities should demand revised cost-effectiveness analyses from biosimilar manufacturers. This approach would hone the accuracy of the cost-effectiveness analyses, protect patients and allow health services rapid access to low cost treatments.

show abstract

“…The methodologies adopted by HTA reports are varied and include primary research, systematic reviews, and economic evaluations (4).…”

mentioning

confidence: 99%

The adaptation of health technology assessment reports: Identification of the need for, and development of, a toolkit to aid the process

Turner

Chase

Milne

et al. 2009

Int J Technol Assess Health Care

View full text Add to dashboard Cite

Objectives: Europe has many health technology assessment (HTA) agencies, each producing their own HTA reports. Adapting HTA reports for different contexts could reduce the need for multiple reports on the same health technology with resultant saving of time and resources. This study aims to examine and understand the process of adaptation, and to develop a toolkit that would help the adaptation of reports produced by other countries. Methods: The methods used were a review of the literature; a survey of twenty-nine European HTA organizations, two rounds of a Delphi survey, a face-to-face meeting of twenty-one European network for Health Technology Assessment (EUnetHTA) representatives, iterative rounds of review, and two rounds of quality assurance testing (termed applicability testing). Results: Descriptions of previous examples of adaptation in the literature are sparse. Most respondents had previous experience in adapting reports, and all believed that adaptation was useful, and there was the ability to benefit from the use of a toolkit to aid in the process. EUnetHTA Partners developed and tested an adaptation toolkit. The toolkit is composed of a series of checklists and resources that identify or clarify the relevance, reliability, and transferability of data and information from existing reports. Conclusions: Consensus of opinion from twenty-nine European organizations/networks has indicated that the adaptation of HTA reports would be desirable and beneficial. A This study was undertaken within the framework of the European network for Health Technology Assessment (EUnetHTA) project, which was supported by a grant from the European Commission (Grant agreement 2005110 project 790621). This work, although coordinated from NCCHTA in England, was very much a collaborative effort between twenty-nine groups across Europe. Further details and all other acknowledgements can be found in: Kristensen et al. (15). The role of NCCHTA in the EUnetHTA project was jointly funded by the NIHR Health Technology Assessment Programme (project number 05/52/01). The sole responsibility for the content of this publication lies with the authors. The European Commission and the Department of Health in England are not responsible for any use that may be made of the information contained therein.

show abstract

International comparison of the definition and the practical application of health technology assessment

Cited by 94 publications

References 5 publications

Use of evidence in WHO recommendations

Use of evidence in WHO recommendations

Addressing the health technology assessment of biosimilar pharmaceuticals

The adaptation of health technology assessment reports: Identification of the need for, and development of, a toolkit to aid the process

Contact Info

Product

Resources

About