In the first article in our series on the value of real world evidence (RWE) and real world data (RWD) to medical device companies, we reported on regulators’ growing acceptance of external evidence for their decision-making. While the regulatory landscape is changing globally, not all regions of the world afford equal access to the kind of data most useful to medical device manufacturers’ market access and health economics and outcomes research (HEOR) teams.
MedTech companies operating in the U.S. are fortunate in that RWD is readily available from a variety of sources (Figure 1). Whether it’s at the global, regional/national, or local level, data can be obtained to determine, demonstrate, and communicate the value of a medical device to various stakeholders.
Figure 1: RWD Sources in the U.S.
The Applications of a Closed Database of Adjudicated Claims
One readily available data asset for quantifying a medical device’s value proposition is IQVIA PharMetrics® Plus for MedTech, a closed database of adjudicated medical and pharmacy claims in the U.S. This includes cost information (payer allowed and paid amounts), patient demographic characteristics, as well as diagnosis and hospitalization details. The data asset, which maintains a history dating back to 2010, provides a view of the entire patient journey, which is a mile wide and an inch deep, with the following applications across the product lifecycle.
- Early pre-market measure healthcare resource utilization, identify treatment patterns, and, support forecasting
- Late pre-market cost of treatment, burden of disease, identification of value drivers, and competitor assessments
- Post market assess outcomes associated with device use, measure the time-to-device use, and highlight device safety
Deeper Insights from Linking Datasets
To obtain deeper, device-specific insights, PharMetrics Plus for MedTech can be deterministically linked with other data sources such as
- Clinical laboratory databases
- All-payer open source claims data
- Retail and mail order prescription data
- Hospital charge data master (CDM)
- Consumer data/registries
- Client-specific/previously collected data
- Oncology Electronic Medical Records (EMR)
- Ambulatory EMR (AEMR)
Via linkage, analysis that was previously restricted to being a mile wide and an inch deep can take a view that is a mile deep and an inch wide at certain points along the patient journey.
There are countless possibilities for using RWE to support your evidence needs. The next blog in this series reviews a range of real-life use cases and successes so you can more clearly see how MedTech may be able to benefit from RWD and RWE, too.
