Cost-utility of implantable tibial neuromodulation (Revi) versus conservative therapy for urgency urinary incontinence in adults: a US payer perspective.

内容摘要

Implantable tibial nerve neuromodulation (ITNM) represents a minimally invasive intervention for urgency urinary incontinence (UUI). This study evaluated the 3-year cost-utility of ITNM with an external wearable battery (Revi System) versus conservative treatments (behavioral ± pharmacotherapy) from a US payer perspective. A cohort state-transition (Markov) model with annual cycles compared ITNM to conservative treatment modalities (behavioral ± pharmacotherapy). ITNM clinical parameters were derived from the OASIS pivotal trial (N = 150); parameter uncertainty was propagated via 20,000 Monte Carlo simulations. Health states captured responder and non-responder status with permitted transitions, rescue interventions (onabotulinumtoxinA, sacral neuromodulation, percutaneous tibial nerve stimulation), and downstream event modules (falls, urinary tract infection, incontinence-associated dermatitis, depression, cognitive decline/dementia, and nursing-home entry). Costs and quality-adjusted life-years (QALYs) were discounted at 3% annually and expressed in 2025 US dollars. Parameter uncertainty was assessed using probabilistic sensitivity analysis (PSA; 20,000 simulations) and tornado analysis. ITNM was both more effective and less costly than behavioral ± pharmacotherapy. Mean 3-year costs were $39,308 versus $43,737 (ΔCost = -$4,428), with mean QALYs of 2.188 and 1.940, respectively (ΔQALY = +0.249). The incremental cost-effectiveness ratio was -$17,818/QALY (dominant). Incremental net monetary benefit at $40,000/QALY was $14,369, with 100% probability of cost-effectiveness across thresholds from $20,000-$150,000/QALY. Key value drivers were responder utility and fall-related parameters. The analysis adopts a US payer perspective with direct medical costs only. Some event risks were applied from population-level sources and may not fully capture patient-level heterogeneity. The 3-year base-case horizon may miss longer-term durability effects, though extended-horizon scenarios support consistent findings. Over 3 years, ITNM with an external wearable battery improves quality-adjusted survival and lowers overall payer costs compared with conservative therapies for UUI, supporting its inclusion as a value-consistent minimally invasive therapy. Urgency urinary incontinence (UUI) is a condition in which people experience sudden, uncontrollable urges to urinate that result in leakage. It affects millions of adults and can lead to falls, skin problems, depression, and nursing home placement. Current treatments include bladder training, pelvic floor exercises, and medications, but most people stop their medications within the first year due to side-effects or limited improvement.Implantable tibial neuromodulation (ITNM) is a newer, minimally invasive option. A small device implanted near the ankle delivers gentle electrical signals, powered by an external wearable battery, to calm the nerves controlling bladder function. A large clinical trial found that about 78% of people treated with ITNM experienced meaningful symptom improvement.Researchers built a computer model to compare the costs and health outcomes of ITNM against conservative treatments over 3 years from the perspective of US health insurers. The model tracked direct treatment costs and costs of related health events such as falls, urinary tract infections, and long-term care.Results showed that ITNM both saved money and improved quality-of-life. Over 3 years, ITNM saved an average of $4,428 per person while providing roughly three additional months of quality-adjusted life. Although ITNM costs more in the first year due to the implant procedure, those costs are offset by fewer complications in the following years. These findings held across a wide range of assumptions, suggesting that ITNM offers good value for people with UUI who have not responded to standard treatments.