Characterising Uncertainty in the Assessment of Medical Devices and Determining Future Research Needs

Rothery, Claire; Claxton, Karl; Palmer, Stephen; Epstein, David; Tarricone, Rosanna; Sculpher, Mark

doi:10.1002/hec.3467

Cited by 65 publications

(82 citation statements)

References 19 publications

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“…Finally, in their paper, Rothery et al (2017) develop a general framework for considering the uncertainties in the economic evaluation of devices and linking the gathering of additional information with policies on approval for reimbursement.…”

Section: Developing Methods For Hta Of Medical Devicesmentioning

confidence: 99%

“…Additionally, in their paper, Rothery et al (2017) point out the issues relating to uncertainty and the value of research specific to devices: learning curve effects, incremental device innovation, investment and irrecoverable costs, and dynamic pricing. They show the circumstances under which requiring additional research after product launch, accompanied by conditional approval for reimbursement, may be an appropriate policy choice.…”

Section: Improving the Process For Hta Of Medical Devicesmentioning

confidence: 99%

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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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Section: Developing Methods For Hta Of Medical Devicesmentioning

confidence: 99%

Section: Improving the Process For Hta Of Medical Devicesmentioning

confidence: 99%

Key Recommendations from the MedtecHTA Project

2017

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“…[21,22], incomplete data generated for the outcomes of medical devices [23,24] or partial understanding of disease progression [25] put decision makers in a situation in which they must make decisions based on incomplete information. In limited knowledge environments, the lack of in-depth exploration of structural uncertainty may prevent both manufacturers and HTA agencies from optimally assessing the magnitude of prediction errors related to health economic outputs and consequently the confidence associated with economic evaluation (e.g.…”

Section: Taking Into Account Uncertainty In the Economic Evaluation Omentioning

confidence: 99%

Towards a New Framework for Addressing Structural Uncertainty in Health Technology Assessment Guidelines

Ghabri¹,

Cleemput

Josselin

2017

PharmacoEconomics

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International audienceProviding scientific advice and recommendations for public decision making entails identifying, selecting and weighing evidence derived from multiple sources of information through a systematic approach, while taking into account ethical, cultural and societal factors. Integrated in the evaluation process are exchanges between regulatory agencies, private firms, scientific experts and government representatives. In the case of drugs and medical devices, health technology assessment (HTA) agencies are increasingly commissioned to evaluate innovations in order to provide government with recommendations and advice on reimbursement and/or pricing. To undertake this task, HTA agencies [1–6] in Europe and elsewhere have developed methodological guidelines on the economic evaluation of health technologies [7]. One component of these guidelines deals with ways for both manufacturers (pharmaceutical and medical device firms) and HTA agencies evaluators (modelers, economists and public health experts) to address uncertainty. Several types of uncertainty have indeed been identified in HTA: methodological, parameter and structural uncertainty. Most guidelines describe quite well how to deal with the first two categories, although there is still room for improvement. However, recommendations about how to tackle structural uncertainty remain largely elusive. HTA agencies and decision makers may thus be exposed to oversimplifying assessments and recommendations by putting aside complex forms of uncertainty such as struc-tural ‘deep’ uncertainty [8]. The editorial is not intended to promote new approaches to exploring structural uncertainty, rather to emphasizeconcerns related to the topic, such as definition and analysis. Our aim is therefore to highlight the need to renew the analytical framework guidance for HTA

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“…The advantages and disadvantages of these initiatives, known collectively as 'performance-based risk-sharing agreements' have been reviewed by Garrison et al [13] and Drummond [14]. Rothery et al [15] discuss a number of the methodological issues in the design of these programs and how the nature of the evidence collected and the nature of the requirement imposed on manufacturers may change as the evidence base on the device becomes more mature.…”

Section: Strengthening the Arrangements For Post-market Researchmentioning

confidence: 99%