Coverage announced for eCoin system for urinary incontinence

Anthem Blue Cross and Blue Shield has published a medical policy for coverage of implantable tibial nerve stimulation (TNS) procedures, which includes the eCoin System procedure for the treatment of patients with urgency urinary incontinence (UUI) secondary to overactive bladder (OAB), according to a news release from Valencia Technologies, the developer of the device.¹

The eCoin device was approved by the FDA in March 2022 based on data from a pivotal open-label, single-arm trial of patients with OAB-related UUI.

The coverage policy for all TNS procedures went into effect on December 28, 2023. eCoin coverage can be utilized when medical necessity criteria are met.

The eCoin System is a coin-sized leadless tibial neurostimulator that is implanted subcutaneously during a minimally invasive, outpatient procedure to stimulate the tibial nerve twice weekly. The procedure can be reported using Current Procedural Terminology code 0816T, which went into effect on January 1, 2024.

"This Anthem coverage is the result of ongoing constructive dialogue between Valencia Technologies and Anthem. The coverage decision by Anthem highlights the strength of the published clinical data supporting the safety and efficacy of the eCoin system implantable TNS technology, as well as the patient outcomes demonstrated both in previous clinical trial and since the eCoin device became commercially available in 2022. We couldn't be more pleased that our efforts resulted in early coverage adoption from an influential health plan like Anthem Blue Cross and Blue Shield,” said Ann Decker, VP of reimbursement for Valencia Technologies, in the news release.¹ 

Decker continued, "There is nothing more satisfying than to know a growing number of patients seeking a permanent solution for treating their chronic and refractory symptoms of UUI will now have a clear path to the eCoin implantable TNS technology."

The eCoin device was granted FDA approval of a premarket approval application in March 2022 based on results from a pivotal open-label, single-arm trial (NCT03556891) of patients with OAB-related UUI. eCoin was a third- or fourth-line OAB therapy for these patients, who went through a washout period for any OAB medications. Device implantation was performed under local anesthesia and the mean time from initial incision to the final suture was 19.8 minutes.

Overall, the study met its primary end point by achieving a 50% or greater improvement in UUI in 68% of patients at 48 weeks following activation of the device.²

At 28 and 52 weeks, the rate of device-related adverse events (AEs) was 15%. AEs related to the device or procedure were generally considered to be mild to moderate. At 52 weeks post-implantation, 19% of patients had AEs related to either the procedure or device. The specific incidence of device-related events at 52 weeks of treatment was 16%. There was 1 serious AE, consisting of an infection related to the study procedure. According to the investigators, this resulted in an explant, which investigators were able to resolve without sequelae.

At 1 year after the procedure, 81% of patients reported that they felt "better" to "very much better." Additionally, 89% of patients indicated that they would recommend treatment with eCoin to their family or friends.

References

1. Anthem Blue Cross and Blue Shield announces coverage for the eCoin system for urinary incontinence. News release. Valencia Technologies Corporation. Published online and accessed January 9, 2024. https://www.prnewswire.com/news-releases/anthem-blue-cross-and-blue-shield-announces-coverage-for-the-ecoin-system-for-urinary-incontinence-302029238.html

2. Rogers A, Bragg S, Ferrante K, Thenuwara C, Peterson DKL. Pivotal study of leadless tibial nerve stimulation with eCoin for urgency urinary incontinence: An open-label, single arm trial. J Urol. 2021;206(2):399-408. doi:10.1097/JU.0000000000001733