Incentivizing research into the effectiveness of medical devices

Drummond, Michael; Tarricone, Rosanna; Torbica, Aleksandra

doi:10.1007/s10198-016-0820-3

Cited by 11 publications

(8 citation statements)

References 12 publications

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“…Unlike drugs, MDs often undergo several product modifications over time, which may have an impact on health gain, costs and patient experience (50). In late technology adopter CEE countries, often modified versions of MDs are introduced and have to be evaluated by HTA.…”

Section: Issue 3: Hta Process Challenge 31: Frequent Product Modificmentioning

confidence: 99%

Quo Vadis HTA for Medical Devices in Central and Eastern Europe? Recommendations to Address Methodological Challenges

Daubner-Bendes¹,

Kovács

Niewada

et al. 2021

Front. Public Health

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Objectives: Methodological challenges in the evaluation of medical devices (MDs) may be different for early and late technology adopter countries, as well as the potential health technology assessment (HTA) solutions to tackle them. This study aims to provide guidance to Central and Eastern European (CEE) countries on how to address key challenges of HTA for MDs with special focus on the transferability of scientific evidence.Methods: As part of the COMED Horizon 2020 project, a comprehensive list of issues related to MD HTA were identified based on a targeted literature review. Health technology assessment issues which pose a greater challenge or require different solutions in late technology adopter countries were selected. Draught recommendations to address these issues were developed and discussed in a focus group. The recommendations were then validated with a wider group of experts, including HTA and reimbursement decision makers from CEE countries in May and June 2020.Results: A consolidated list of 11 recommendations were developed in 3 major areas: (1) clinical value assessment, focusing on the use of joint EU work, relying on real-world evidence, use of coverage with evidence development schemes, transferring evidence from foreign countries and addressing the challenges of learning curve and centre effect; (2) economic value assessment, covering cost calculation of complex medical devices and transferability of economic evaluations of MDs; (3) HTA processes, related to the frequent product modifications and various indications of MDs.Conclusions: Central and Eastern European countries with limited resources for conducting HTA, can benefit from HTA methods and evidence generated in early technology adopter countries. Considering the appropriate reuse of international HTA materials, late technology adopter countries can still implement HTA, even for MDs, which have a more limited evidence base compared with pharmaceuticals.

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Section: Issue 3: Hta Process Challenge 31: Frequent Product Modificmentioning

confidence: 99%

Quo Vadis HTA for Medical Devices in Central and Eastern Europe? Recommendations to Address Methodological Challenges

Daubner-Bendes¹,

Kovács

Niewada

et al. 2021

Front. Public Health

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“…those very similar to a device or devices already on the market) needs particular consideration. Drummond et al [81] suggest that, if a registry has been set up in order to gather more evidence on the original device of that type, similar new devices could be added to the registry. This approach would have the dual benefits of (a) sharing the burden and cost of evidence generation among all the manufacturers, rather than it being borne by the first to market and (b) enabling us to assess whether the devices are truly equivalent clinically.…”

Section: Q2: How Could the Evidence Generation Ecosystem Be Adapted To Optimize Patient Access Considering The Risks For Patients Healthcmentioning

confidence: 99%

Lifecycle evidence requirements for high-risk implantable medical devices: a European perspective

Tarricone

Ciani

Torbica

et al. 2020

Expert Review of Medical Devices

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Introduction:The new European Union (EU) Regulations on medical devices and on in vitro diagnostics provide manufacturers and Notified Bodies with new tools to improve pre-market and post-market clinical evidence generation especially for high-risk products but fail to indicate what type of clinical evidence is appropriate at each stage of the whole lifecycle of medical devices. In this paper we address: i) the appropriate level and timing of clinical evidence throughout the lifecycle of high-risk implantable medical devices; and ii) how the clinical evidence generation ecosystem could be adapted to optimize patient access. Areas covered: The European regulatory and health technology assessment (HTA) contexts are reviewed, in relation to the lifecycle of high-risk medical devices and clinical evidence generation recommended by international network or endorsed by regulatory and HTA agencies in different jurisdictions. Expert opinion: Four stages are relevant for clinical evidence generation: i) pre-clinical, pre-market; ii) clinical, pre-market; iii) diffusion, post-market; and iv) obsolescence & replacement, post-market. Each stage has its own evaluation needs and specific studies are recommended to generate the appropriate evidence. Effective lifecycle planning requires anticipation of what evidence will be needed at each stage.

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“…It was mentioned above that the paucity of clinical data, particularly prior to market entry of MDs, can limit the possibilities for economic evaluation and health technology assessment (HTA). Drummond et al (2016) discussed several options for resolving this problem. First, the requirements for conducting clinical studies in the pre-marketing phase could be strengthened by, for example, insisting on randomized controlled trials for all high-risk devices and some medium risk devices (eg orthopaedic implants).…”

Section: Improving the Clinical Evidence Base For Mdsmentioning

confidence: 99%

“…Rothery et al (2017) also discuss the incentives for further research and how the value and cost of such research might be shared between the manufacturer and the health care sector. Drummond et al (2016) argue that incentives to manufacturers to conduct research need particular attention, give the lack of data exclusively mentioned earlier. In a situation where a PBRSA has been established for the first device to market, this might provide an opportunity for different manufacturers to share the costs of the research, as opposed to most of the costs being borne by the first to market.…”

Section: Managing the Diffusion Of Mdsmentioning

confidence: 99%

Economic Evaluation of Medical Devices

Drummond¹,

Tarricone²,

Torbica³

2018

Oxford Research Encyclopedia of Economics and Finance

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There are a number of challenges in the economic evaluation of medical devices (MDs). They are typically less regulated than pharmaceuticals, and the clinical evidence requirements for market authorization are generally lower. There are also specific characteristics of MDs, such as the device–user interaction (learning curve), the incremental nature of innovation, the dynamic nature of pricing, and the broader organizational impact. Therefore, a number of initiatives need to be taken in order to facilitate the economic evaluation of MDs. First, the regulatory processes for MDs need to be strengthened and more closely aligned to the needs of economic evaluation. Second, the methods of economic evaluation need to be enhanced by improving the analysis of the available clinical data, establishing high-quality clinical registries, and better recognizing MDs’ specific characteristics. Third, the market entry and diffusion of MDs need to be better managed by understanding the key influences on MD diffusion and linking diffusion with cost-effectiveness evidence through the use of performance-based risk-sharing arrangements.

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Incentivizing research into the effectiveness of medical devices

Cited by 11 publications

References 12 publications

Quo Vadis HTA for Medical Devices in Central and Eastern Europe? Recommendations to Address Methodological Challenges

Quo Vadis HTA for Medical Devices in Central and Eastern Europe? Recommendations to Address Methodological Challenges

Lifecycle evidence requirements for high-risk implantable medical devices: a European perspective

Economic Evaluation of Medical Devices

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