Medical Devices and Diagnostics

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.

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.