The value of real world data (RWD) and real world evidence (RWE) to medical technology companies is no longer theoretical; companies are finding data gathered under real-life conditions to be instrumental in meeting safety, effectiveness, and performance commitments, establishing the value of a brand, securing reimbursement, and generating publications. Perhaps there’s no better way to prove the point, or to introduce you to the possibilities, than to describe a few real-life cases IQVIA recently supported.
Quantifying the economic burden of different treatment modalities
One company wanted to demonstrate to payers that the cost of its device for treating non-union fractures with electrical stimulation was favorable as compared to non-union surgery. IQVIA was able to calculate the costs of the treatments using data from a health plan database that integrates medical and pharmacy benefit claims from roughly 80 million people. Costs were tallied for office visits, medications, physical therapy, radiology, lab tests, surgical services, hospitalization, and ER visits over a 12-month period for over 2,000 patients in directly matched cohorts.
The study1 demonstrated convincingly that patients treated with the company’s device incurred significantly fewer costs, whether measured in total healthcare costs, medical outpatient, or inpatient costs.
Communicating the value of a medical device to payers
Another company needed an economic model2 to demonstrate the value of a device used to aid in the assessment of lymphedema following breast cancer. IQVIA built a decision model to calculate the one-year budget impact of using standard methods versus the customer’s device. Data on over 600 patients were used to create the model, which showed that the customer’s device resulted in significant savings for payers. It also decreased the severity of disease and reduced the incidence of downstream sequalae.
Demonstrating the value of capital equipment to hospitals
IQVIA’s customer was interested in quantifying the value to hospitals of adopting its product: an inventory tracking system for bone tissue and synthetic bone graft products. Supply costs account for more than one-third of the average operating budget within U.S. hospitals.
IQVIA designed a prospective survey study conducted at 90 U.S. facilities to understand the time and motion associated with storage operations. This study3 revealed that tracking tasks required less time after the system was implemented, and a quarter of sites no longer required any manual inventory processes. Adopting the technology was associated with a 30 percent decrease in the cost of inventory management.
Demonstrating cost efficiencies to maximize value
A company was interested in evaluating the intra-operative lens delivery time and total surgical case time and cost efficiency of using a new preloaded intraocular delivery system compared to a manually-loaded intraocular system.
IQVIA designed a time-and-motion non-interventional prospective study4 involving ophthalmologists and nurses. In over 160 surgeries, the study showed that the preloaded device was not associated with a decreased delivery time, but the surgical case time was statistically lower, primarily driven by a faster device preparation time.
These cases are but a few, illustrating what a powerful tool RWE can be for medical technology companies in their research, market development, and reimbursement planning.
Here’s why all this matters
It’s all about context, and as this blog, and Parts 1 and 2 demonstrated, the time to embrace RWD and RWE in the MedTech space is now. Here’s why.
- The use of RWE is increasing as the global regulatory landscape and clinical methodologists increasingly adopt RWE to support decision-making, strategic insights, and improved care.
- RWE data sources can be used to support MedTech’s clinical evidence requirements.
- RWE data can support the evidence requirements of diverse stakeholders, including physicians, patients, payers, purchasers, regulators, and researchers.
- RWE can be used in a variety of ways in MedTech including research initiatives, market development, and reimbursement planning.
To learn more about how the regulatory landscape is changing, what sources of RWD are available, and how several companies have leveraged RWE to their advantage, watch the on-demand webinar.
1 Mehta S, Long K, DeKoven M, Smith E, Steen G. Low-intensity pulsed ultrasound (LIPUS) can decrease the economic burden of fracture non-union. J Med Econ. 2015 Feb;18(7):542-549.
2 Bilir SP, DeKoven MP, Munakata J. Economic Benefits of BIS-Aided Assessment of Post-BC Lymphedema in the United States. Am J Manag Care. 2012;18(5):234-241.
3 Bilir SP, Munakata J, Ferrufino C, Borgman B, DeKoven M. Radiofrequency (RFID) Technology: Value in the Orthopaedic Operating Room. Value in Health 2016 May 1; 19(3): PA260. Presented at ISPOR 2016.
4 Goldberg D, Coyle K, Jones M, Lane S, Kim T, Martinez A, Kramer D, Keith M. US Multicenter Study of Time, Operational and Cost Efficiencies Associated with a New Preloaded IOL Delivery System. Ophthalmology 2016. Presented at American Academy of Ophthalmology 2016
