“Assessing the value of medical devices is a key element in making adoption and coverage decisions, but there are challenges in applying value frameworks to them” said author Simon Eggington, MSc, Medtronic International Trading Sarl, Tolochenaz, Switzerland. “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. Additionally, many device types exist, each potentially requiring different assessment criteria, and stakeholders may view the value of any technology differently based on their specific needs. As a result, while there is a vast reservoir of information and guidance on HTA, there remains a knowledge gap as to whether nonpayer, non-HTA stakeholders, such as hospital procurement, use the available HTA reports, and conclusions in their assessment of medical devices.”
In an effort to fill this gap, members of the ISPOR Medical Devices and Diagnostics Special Interest Group, in collaboration with the Special Interest Group leadership team, conducted a systematic literature review to identify relevant studies and summarize the current evidence base for the criteria used for procurement of medical devices. The 11 studies that met the inclusion criteria came from diverse parts of the world: 2 studies each from the United States, the United Kingdom, and Canada; in addition to studies from Italy, Australia, South Africa; and 2 studies that were not specific to country or region. Some focused on national-level HTA, while others described the establishment of hospital HTA processes to inform decision making at a local level. The decision-making criteria used largely covered standard elements of HTA, including cost (100% of studies), safety (91%), efficacy (82%), cost-effectiveness (64%), and budget impact (36%).
Overall, however, there was sparse evidence regarding the use of HTA in device purchasing, making it problematic to draw firm conclusions about the impact of HTA on procurement, and what little evidence exists is incomplete regardless of the level or geography at which the HTA and procurement occurs.
The application of HTA (and its impact on treatment decisions) varies widely in different geographies, complicating the process of making generalizations. The use of “mini” or hospital-level HTA appears to be growing, suggesting a shift from “classic” HTA to local evaluations, which aims to directly inform procurement decisions. Nevertheless, most of the hospital-level HTA studies reviewed also drew on national-level HTA and published systematic reviews of evidence to inform their conclusions, indicating a continued need for national or regional assessments.
“Based on the political stature and assessment thoroughness of many HTA bodies, we anticipate that HTA has more impact than our findings suggest, possibly reflecting a lack of publication incentive among procurement bodies, concerns regarding making public the approach to decision making in competitive healthcare markets, competitive advantages in decision making with competitive healthcare markets, and/or owing to confidentiality concerns,” said Eggington. “Further research is needed to better understand the relationship between HTA and procurement, and to identify strategies to bring the 2 areas closer together and encourage broader and more systemic evidence-based decision making.”
ISPOR—The Professional Society for Health Economics and Outcomes Research (HEOR), is an international, multistakeholder, nonprofit dedicated to advancing HEOR excellence to improve decision making for health globally. The Society is the leading source for scientific conferences, peer-reviewed and MEDLINE®-indexed publications, good practices guidance, education, collaboration, and tools/resources in the field.
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ABOUT VALUE IN HEALTH
Value in Health (ISSN 1098-3015) is an international, indexed journal that publishes original research and health policy articles that advance the field of health economics and outcomes research to help healthcare leaders make evidence-based decisions. The journal’s 2022 impact factor score is 4.5 and its 5-year impact factor score is 6.2. Value in Health is ranked 8th of 87 journals in health policy and services, 21st of 105 journals in healthcare sciences and services, and 69th of 380 journals in economics. Value in Health is a monthly publication that circulates to more than 10,000 readers around the world.
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ABOUT THE ISPOR MEDICAL DEVICES AND DIAGNOSTICS SPECIAL INTEREST GROUP
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.