U.S. payer budget impact of the Leva Pelvic Health System to improve pelvic floor muscle training as first-line treatment of female urinary incontinence compare to real-world clinical practice.

Aim: Urinary incontinence (UI) is a common condition for adult women impacting over 60% of women with 9.8% experiencing daily symptoms and 32.4% experiencing monthly symptoms. It is associated with significant negative impacts on patients' quality of life, well-being, and social functioning, resulting in substantial healthcare costs to payers. The goal of this study was to analyze 24-month budget impact of treatment of urinary incontinence (UI) in adult women enrolled in a 1-million-member US commercial health plan by comparing clinical practice that includes the use of the Leva Pelvic Health System (CP with Leva) to current clinical practice without Leva (CCP).

Methods: A budget-impact model compared 24-month costs associated with first-line pelvic floor muscle training (PFMT) in women seeking UI treatment in two cohorts: 85% receiving first-line CCP treatment/15% receiving the CP with Leva, compared to all patients treated with CCP. Medical spending per treated patient and per-member-per-month were calculated by summing 24-month UI treatment costs comparing CCP to CP with Leva. The treatment pathway was developed based on published guidelines and literature to obtain estimates of success and complications. Commercial payer costs were estimated by applying a 1.50× multiplier to published Medicare costs based on Congressional Budget Office data for Hospital and Physician Services.

Results: In a 1-million-beneficiary US commercial health plan with 334,191 adult women, 31,438 (9.4%) adult women were treated for UI over a 24-month period. Total estimated 24-month cost per treated patient was $11,267 in the CCP and $10,447 in the CP with Leva groups, respectively. Estimated total health plan 24-month savings was $25,782,112, or $1.07 per-member-per-month.

Limitations: The model may not capture all events in the care pathway for female UI patients seeking medical treatment, as there are significant variations in practice patterns; the rate of Leva adoption as a first-line therapy is based on estimates. The costs and savings calculated in this model may not be generalizable to every commercial health plan, given that actual costs routinely rely on specifically negotiated reimbursement rates.

Conclusions: The model demonstrates that access to first-line Leva therapy can reduce two-year UI treatment costs compared to CCP.