To provide leadership and a multi-stakeholder, collaborative platform for the Medical Device and Diagnostic community to address opportunities, issues and challenges impacting the policy, economic evaluation, and payment landscape for the device and diagnostic space.
- Develop and disseminate best practices in outcome research of medical technologies
- Promote scientific discussions on relevant topics for devices and diagnostics
- Prioritize, develop and promote research and education related to medical devices and diagnostics.
- Provide an international network of stakeholders to advance the validation, adoption and utilization of medical devices and diagnostics.
Medical devices and diagnostics account for roughly a quarter of hospital technology expenditures and are a rapidly growing technology field. There is a broad group of stakeholders affected by the medical device and diagnostics marketplace that is relevant to ISPOR, including scientists, economists, manufacturers, policy makers, clinicians, HTA organizations, payers, procurement, media, advocacy organizations and patients. Efforts to define market value of medical devices and diagnostics are confounded by several factors especially a scarcity of verifiable evidence in the early and mid-stages of product commercialization. Difficulty in performing timely and reliable assessments compounded with fragmented and diverse payment pathways, can limit market access and reimbursement. It is critical to advance this dialogue with multiple stakeholders to ensure appropriate provider and patient access, while ensuring healthcare system value for money.
Manuscripts & Reports
- Onwudiwe, NC, Charter, R, Gingles, B, et al. Generating Appropriate and Reliable Evidence for Value Assessment of Medical Devices: An ISPOR Medical Devices and Diagnostics Special Interest Group Report. Journal of Medical Devices (ASME Digital Collection)
- Onwudiwe, N. C, Baker, A. M, Belinson, S, Gingles, B. Assessing the Value of Medical Devices—Choosing the Best Path Forward: Where Do We Go From Here? Value & Outcomes Spotlight 2017; 3(3):15-17
- Garfield S, Polisena J, Spinner DS, et al. Health Technology Assessment for Molecular Diagnostics: Practices, Challenges, and Recommendations from the Medical Devices and Diagnostics Special Interest Group. Value in Health. 2016;19(5):577-587
- Virtual ISPOR Europe 2021: Linking HTA and Procurement: Forum Discussion on Assessing the Value of Medical Device - ISPOR SIG MD&D Key Project Presentation
- Virtual ISPOR 2021: Can Performance-based Risk Sharing Arrangements (PBRSAs) for Medtech Address Procurement and Market Access Challenges? Scanning the Current Horizon and a View to the Future.
- Virtual ISPOR Europe 2020: COVID-19 and Hospital Procurement - The Role of Value Assessment for Medical Devices & Diagnostics in Pandemic Public Health Situations
- ISPOR Europe 2019: ISPOR Medical Devices and Diagnostics and Personalized/Precision Medicine Special Interest Groups: Value Demonstration and HTA of Next Generation Diagnostic Testing Approaches: Current State and Future Needs For Driving Precision Medicine Expansion
Arthi Chandran, MS, BS, DrPH, MPH
Ulises Garay, MSc, BEc
Richard Charter, MSc
Belinda Mohr, PhD
Bjoern Schwander, RN, BSc, MA
Stakeholder Perspectives on Assessing the Value of Medical Devices
Michael Cangelosi, MPH, MA
Akriti Chahar, PhD
Simon Eggington, MSc, BSc
Assessing the value of medical devices is a key element in making adoption and coverage decisions for medical devices. Several value assessment frameworks (VAFs) have been published with the goal of providing measures which to evaluate medical interventions (Anderson 2014, Schnipper 2016) with some acknowledging the challenges in applying value frameworks to medical devices (ICER 2017). Medical devices have unique characteristics, such as frequent device iterations and user learning curves, which make it difficult to generalize outcomes, and therefore value, to the broader patient population (Drummond 2009). In some cases, such as with high-risk implantables, the value of the device can change over time as users gain experience and outcomes improve, which creates a challenge for value frameworks that aim to assess device value at a point in time. Additionally, a large number of device types exist, each potentially requiring different criteria to assess value, and stakeholders may view the value of any medical technology differently based on their specific needs. The aim of this project is to identify what specific criteria procurement-related stakeholders use to assess the value of medical devices when making purchasing decisions. This will help inform evidence generation strategies for medical device companies and researchers with the goal of generating evidence either through controlled trials and/or taking advantage of real-world data that is more relevant to the stakeholder making the decision. This work aims to fill the knowledge gap by identifying what information is needed for value-based procurement purposes and provide considerations for sponsors and HTA agencies regarding how that information is disseminated.
Health Technology Assessment of Next Generation Diagnostic Testing Approaches
Joint project with the Precision Medicine and Advanced Therapies Special Interest Group
- Daryl S. Spinner, PhD, MBA – Vice President, Market Access and Reimbursement, Variantyx, Inc
- Susan M. Snyder, PhD, MBA – Associate Professor, Health Policy & Behavioral Sciences, Georgia State University School of Public Health
- Bettina Zimmermann, BS, Access Global Lead, Roche, Basel, Switzerland
In the past 2-3 years there has been an explosion in the availability and utilization of next generation testing (NGT) that includes multiple genes/genomic biomarkers. A recent report indicates that between March 2017 and 2018 more than 800 new multigene panels entered a market with more than 8,500 already existing panels in the US alone. While the compiled evidence for most NGTs is sparse to non-existent, the total amount of data being generated through routine use, and thus potentially available for evaluating their real-world clinical utility in HTA decision-making is substantial. Despite these recommendations and the increasingly prevalent use of such tests, few HTAs have been conducted and even fewer are reimbursed by payers. The challenges of defining and assessing the value of NGS testing approaches including data gaps, clinical practice issues, reimbursement/ funding considerations, and potential solutions will be addressed.
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