Case Study
Case Study
Supporting payer adoption with real-world evidence: Nalu Medical demonstrates value with OM1 data
Client Challenges
Chronic peripheral nerve pain is debilitating, costly, and often unresponsive to conventional therapies. While Nalu Medical’s Peripheral Nerve Stimulation (PNS) System has shown strong clinical promise as a minimally invasive, drug-free approach to pain management, payer reimbursement of PNS therapies is limited by a lack of clear evidence demonstrating its economic value.
To differentiate their microimplantable pulse generator (micro-IPG) technology from the standard of care and expand patient access, Nalu needed rigorous, independent real-world evidence that not only confirmed clinical benefit but also quantified reductions in healthcare utilization and the overall cost of care.
OM1 Solution
Nalu partnered with OM1 to design and conduct a real-world study leveraging the OM1 Real-World Data Cloud, which includes longitudinal, multi-source, multi-specialty data from linked EMR, medical, and pharmacy claims covering over 370 million patient lives going back to 2013. De-identified data from the Nalu Medical registry was tokenized and linked with OM1 data, bridging gaps to generate a comprehensive view of the patient journey before and after the IPG device placement.
The study evaluated chronic pain patients implanted with the Nalu PNS System between 2019 and 2023, comparing healthcare utilization and costs 12 months before versus 12 months after implant. Outcomes of interest were aligned to payer priorities, including outpatient costs, additional service use, opioid reliance, and overall medical spend.
“Partnering with OM1 enabled us to generate real-world evidence that payers can trust —evidence that has already helped expand coverage for millions of patients. OM1 has been a strong partner in helping us translate clinical success into broader adoption and access.”
- Thomas A. West President & Chief Executive Officer, Nalu Medical
Key Finding 1
50%
Reduction in total medical costs post-implant
Key Finding 2
61%
Overall reduction in outpatient costs
Key Finding 3
$13,776
Average savings per patient in the first year
Key Finding 4
38%
Reduction in costs from additional services (imaging/procedures)
Key Finding 5
31%
Decrease in opioid use
Impact
By addressing the lack of U.S. evidence on healthcare costs and resource utilization for PNS in chronic pain, this study delivered compelling real-world proof points that directly influenced payer decision-making and patient access.
Expanded Coverage: Findings helped drive major policy updates, including Aetna’s reclassification of Nalu’s micro-IPG as “medically necessary,” expanding access to 20M+ members nationwide, followed by CareFirst BCBS coverage for 3.5M+ lives.
Direct ROI: Nalu identified 140 patients who were previously denied access to the micro-IPG system by Aetna, with nearly half now estimated to gain access to treatment in the near future.
For Patients & Payers: Expanded coverage provides broader access to a safe, effective, drug-free therapy, improving patients’ lives by reducing chronic pain and reliance on opioids. At the same time, the therapy delivers substantial cost savings and reduced resource utilization for healthcare systems and payers.
“OM1’s robust, longitudinal real-world data and analytic expertise allowed us to rigorously demonstrate both the clinical and economic value of the Nalu PNS System, producing credible evidence that payers can rely on to inform coverage decisions.”
- Patrick Martin, VP, Clinical Affairs, Nalu Medical
View the Peer-Reviewed Journal Publication:
Kalia, H., Thapa, B., Staats, P., Martin, P., Stetter, K., Feldman, B., & Marci, C. (2025). Real-world healthcare utilization and costs of peripheral nerve stimulation with a micro-IPG system. Pain Management, 1–10. https://doi.org/10.1080/17581869.2025.2449810 . Dec, 2024.
