Abstract
It is well accepted that medical devices (MDs) and procedures have several unique characteristics compared with pharmaceuticals, such as learning curve (LC), incremental innovation (II), dynamic pricing (DP), and organizational impact (OI). The objective of this study was to determine the extent to which these MD characteristics are routinely assessed by health technology assessment (HTA) agencies and incorporated in their guidelines and reports. Three approaches were taken. First, a review of the most recent HTA methods guidelines from 14 selected HTA agencies and 5 HTA networks was undertaken. Next, HTA reports from these agencies were reviewed for inclusion of MD-specific characteristics for 16 selected MDs. Finally, a narrative literature review on this topic was conducted. A total of 13 of the included HTA organizations, and some HTA networks (2/5), have published either general or MD-specific method guidelines, whilst several addressed MD-specific characteristics. NICE included all four MD characteristics in their guidelines, but this did not equate to their inclusion in published HTA evaluations. European Network HTA (EUnetHTA) described the inclusion of LC (within patient safety) and OI within their guidance. The results highlight a lack of consistency. For the narrative review, 10/149 articles identified were reviewed. Most provided recommendations on challenges faced by HTAs, proposed steps to address uncertainties around MD characteristics and reported a lack of methodological guidance for evaluating MDs. A lack of inclusion of MD characteristics in HTA is a complex interplay of several important factors. For these characteristics to become a formal part of HTA of MDs in the future, clear guidance and frameworks are required to enable manufacturers to develop appropriate evidence, and HTA practitioners to assess their impact more broadly.
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Acknowledgements
We thank the following for their assistance with identifying and interpreting country-level HTA reports: Jonas Villinger and Illona Vogt-Humberg (Germany and Austria); Lydie Vancauwenberghe (Belgium), Astrid Holm and Mette Lundsby Jensen (Nordic countries); and Fernanda Laranjeira (Brazil).
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This study was funded by Medtronic.
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All the authors: Rituparna Basu (R.B.), Simon Eggington (S.E.), Natalie Hallas (N.H.), and Liesl Strachan (L.S.), are employees of Medtronic. Among them, all have Medtronic stocks except N.H.
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All the authors meet the four criteria mentioned under ICMJE guideline and were involved in writing and reviewing the paper. In addition, R.B. and S.E. were responsible for the initial conception of the work. L.S. and N.H. contributed substantially toward the content of the work given their expertise in health technology assessment. All authors reviewed and approved the final submitted version.
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Basu, R., Eggington, S., Hallas, N. et al. Are Medical Device Characteristics Included in HTA Methods Guidelines and Reports? A Brief Review. Appl Health Econ Health Policy (2024). https://doi.org/10.1007/s40258-024-00896-y
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DOI: https://doi.org/10.1007/s40258-024-00896-y