OBJECTIVES

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TAVI is an extensively studied minimally invasive treatment for severe Aortic Stenosis (AS). Numerous HTAs have been performed on TAVI since the mid-2000’s with varying level of focus and rigor. The objective of this study is to investigate the evolution and trends in published International HTA’s on TAVI.

METHODS

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A systematic search (Sept 2019) of HTA organisation websites (62 sites) was augmented by a search of PubMed and the CRD York HTA database using targeted search terms for TAVI. The main characteristics of published HTAs was extracted.

RESULTS

: Since 2008, twenty published HTA’s on TAVI use in AS from 14 geographies including one core HTA regional report (EUnetHTA) were retrieved for review. The purpose and objectives, methods utilised, evidence included and final conclusions and recommendations of the HTAs varied between countries and over time. Several HTAs were acknowledged to be rapid assessments, although the definition and application of this method was inconsistent. While differences existed, in most countries, early HTAs focussed on severe/inoperable AS patients, then more recently, moderate/low risk populations were evaluated, which follows closely the generation of the RCT evidence for TAVI. However, there were differences in how this evidence was synthesised and the use or type of economic evaluation utilised. Despite this, the cost-effectiveness of TAVI in most healthcare settings improved over time as clinical evidence accumulated. Use of real-world data was permitted by some HTA bodies in order to justify actual resource use, local patient demographics and other areas of uncertainty. Interestingly, the acceptability and quality of this type of evidence was often disputed.

CONCLUSIONS

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International HTA reports for TAVI use in AS differ substantially, driven largely by the unique objectives of each health system. The impact of these differences on patient access and ultimately health outcomes needs to be examined.