Linking the Regulatory and Reimbursement Processes for Medical Devices: The Need for Integrated Assessments

Ciani, Oriana; Wilcher, Britni; Giessen, Anoukh van; Taylor, Rod S

doi:10.1002/hec.3479

Cited by 40 publications

(51 citation statements)

References 34 publications

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“…case series, case studies and manufacturers' reports) and provided indications on safety and efficacy only. This finding clearly illustrates some of the typical challenges of assessing MDs, such as the lack of evidence at the time of market approval and the relevance of collecting post‐marketing evidence, accompanied by an iterative process to assess the new evidence as it is generated (Drummond et al ., ; Tarricone et al ., ; Ciani et al ., ). Interestingly, although the lack of evidence leads to difficulties in conducting full HTAs, this does not seem to have delayed the uptake of TAVI in Europe, where the yearly implant rate grew by 815% in the first 5 years, that is before its use in any indication was formally recommended by HTA agencies.…”

Section: Discussionmentioning

confidence: 97%

“…In a further paper, included in this supplement (Ciani et al ., ), a sample of HTA reports were analysed in order to assess whether there were any key differences in the methods applied in the HTA of devices as compared with drugs. They found that there were several differences in the types of clinical studies forming the basis for the HTAs, how the health problem and use of the technology were considered, the description and technical characteristics of the technology and the consideration of the organisational aspects of the use of the technology.…”

Section: Introductionmentioning

confidence: 99%

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Improving the Methods for the Economic Evaluation of Medical Devices

et al. 2017

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Medical devices (MDs) have distinctive features, such as incremental innovation, dynamic pricing, the learning curve and organisational impact, that need to be considered when they are evaluated. This paper investigates how MDs have been assessed in practice, in order to identify methodological gaps that need to be addressed to improve the decision-making process for their adoption.We used the Consolidated Health Economic Evaluation Reporting Standards (CHEERS) checklist supplemented by some additional categories to assess the quality of reporting and consideration of the distinctive features of MDs. Two case studies were considered: transcatheter aortic valve implantation (TAVI) representing an emerging technology and implantable cardioverter defibrillators (ICDs) representing a mature technology. Economic evaluation studies published as journal articles or within Health Technology Assessment reports were identified through a systematic literature review. A total of 19 studies on TAVI and 41 studies on ICDs were analysed. Learning curve was considered in only 16% of studies on TAVI. Incremental innovation was more frequently mentioned in the studies of ICDs, but its impact was considered in only 34% of the cases. Dynamic pricing was the most recognised feature but was empirically tested in less than half of studies of TAVI and only 32% of studies on ICDs. Finally, organisational impact was considered in only one study of ICDs and in almost all studies on TAVI, but none of them estimated its impact.By their very nature, most of the distinctive features of MDs cannot be fully assessed at market entry. However, their potential impact could be modelled, based on the experience with previous MDs, in order to make a preliminary recommendation. Then, well-designed post-market studies could help in reducing uncertainties and make policymakers more confident to achieve conclusive recommendations.

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Section: Discussionmentioning

confidence: 97%

Section: Introductionmentioning

confidence: 99%

Improving the Methods for the Economic Evaluation of Medical Devices

et al. 2017

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“…In their paper in this supplement, Ciani et al (2017) argue that (i) more stringent requirements supported by appropriate methodological choices are needed to provide clinical trial data for high-risk devices; (ii) post-marketing surveillance based on device and user real world data should be encouraged; (iii) international harmonization of practices will benefit the manufacturers and (iv) progressive alignment of regulatory and HTA evaluation for parallel submissions will improve efficiency in the health systems and promote timely access to affordable effective technologies.…”

Section: Improving the Process For Hta Of Medical Devicesmentioning

confidence: 96%

Key Recommendations from the MedtecHTA Project

2017

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There are particular characteristics of Medical Devices, such as the device-user interaction, the incremental nature of innovation and the broader organizational impact that lead to additional challenges for health technology assessment (HTA). The project explored key aspects of the conduct and methods of HTA for MDs. Systematic reviews and original research studies were conducted to determine improvements in processes and methods that could enhance the potential for HTA and optimize the diffusion of MDs.Regulatory processes for MDs should be more closely aligned, the HTA evaluative framework should be harmonized and processes for conditional coverage and evidence development should be used. The methods for HTA should consider MDs as complex interventions, require the establishment of high quality registries, consider an iterative approach to the evaluation over time, recognize and allow for the particular characteristics of devices and use appropriate approaches for confounder adjustment in comparative effectiveness studies. To optimize the diffusion, a common classification should be developed across countries in order to facilitate international comparisons, factors driving diffusion should be explored in HTA reports and physiciansˈ personal goals and motivation should be better understood.The key recommendations of the MedtecHTA project should improve the conduct and use of HTA for MDs.

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“…In the second paper in this supplement, Ciani et al () focus on the second phase of their research, in which they analysed a sample of HTA reports in the field of cardiovascular disease in order to assess whether there are any key differences in how methods are applied. They found that there were several differences, in the types of clinical studies forming the basis for the HTAs, how the health problem and use of the technology were considered, the description and technical characteristics of the technology and the consideration of the organizational aspects of the use of the technology.…”

Section: Cross‐country Analysis Of Regulation and Hta Of Medical Devicesmentioning

confidence: 99%

Challenges in the Assessment of Medical Devices: The MedtecHTA Project

2017

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Assessing medical devices (MDs) raises challenges which require us to reflect on whether current methods are adequate. Major features of devices are: (i) device-operator interaction can generate learning curve effects; (ii) incremental nature of innovation needs to be addressed by careful identification of the alternatives for comparative and incremental costeffectiveness analysis; and (iii) broader organizational impact in terms of training and infrastructure, coupled with dynamic pricing, requires a more flexible approach to costing.The objective of the MedtecHTA project was to investigate improvements in HTA methods to allow for more comprehensive evaluation of MDs. It consisted of several work packages concerning (i) the available evidence on the currently adopted approaches for regulation and HTA of medical devices; (ii) the geographical variation in access to MDs; (iii) the development of methodological frameworks for conducting comparative effectiveness research and economic evaluation of MDs; and (iv) the organizational impact of MDs.This introductory paper summarizes the main results of the project and draws out the main overarching themes. This supplement represents a comprehensive report of all the main findings of the MedtecHTA project, and it is intended to be the main source for researchers and policy makers wanting information on the project.

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Linking the Regulatory and Reimbursement Processes for Medical Devices: The Need for Integrated Assessments

Cited by 40 publications

References 34 publications

Improving the Methods for the Economic Evaluation of Medical Devices

Improving the Methods for the Economic Evaluation of Medical Devices

Key Recommendations from the MedtecHTA Project

Challenges in the Assessment of Medical Devices: The MedtecHTA Project

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