Examination of the Two-Year US Commercial Payer Budget Impact (BI) of the Leva Pelvic Health System, a Prescription Medical Device That Provides Supervised Pelvic Floor Muscle Training (PFMT) As First-Line Treatment for Female Urinary Incontinence...
Author(s)
Evelyn Hall, MD1, Ayachi Sharma, MS2, Thomas F. Goss, BS, PharmD2, Kristin J. Hung, MD3;
1Tufts University School of Medicine, Obstetrics and Gynecology, Urogynecology + Pelvic Reconstructive Surgery, Boston, MA, USA, 2BeaconOne Healthcare Partners, Newton, MA, USA, 3Massachusetts General Hospital / Harvard Medical School, Urogynecology and Reconstructive Pelvic Surgery, Boston, MA, USA
1Tufts University School of Medicine, Obstetrics and Gynecology, Urogynecology + Pelvic Reconstructive Surgery, Boston, MA, USA, 2BeaconOne Healthcare Partners, Newton, MA, USA, 3Massachusetts General Hospital / Harvard Medical School, Urogynecology and Reconstructive Pelvic Surgery, Boston, MA, USA
Presentation Documents
OBJECTIVES: To analyze the 24-month budget impact comparing clinical practice that includes the Leva Pelvic Health System, a prescription medical device that provides supervised PFMT at home (CP with Leva) to current clinical practice without Leva (CCP) for treatment of UI in adult women enrolled in a 1-million member US commercial health plan (CHP).
METHODS: A BI model was designed to compare 24-month costs associated with first-line PFMT in women seeking UI treatment in two cohorts: 85% receiving first-line CCP treatment/15% receiving CP with Leva, compared to all patients treated with CCP. Medical spending/treated patient and per-member-per-month (PMPM) were calculated after summing 24-month treatment costs comparing CCP to CP with Leva treatment. Guidelines-based treatments and estimates of treatment outcomes were extracted from published literature. A 1.50x multiplier was applied to published Medicare costs based on Congressional Budget Office data for Hospital and Physician Services. One-way sensitivity analysis examined the impact of uncertainty of key variables on results; parameters (base case estimate, (range)) included: Leva efficacy 61% (44% - 74%) Leva cost $2,160, ($1,860-$,2460), Leva adoption 15%, (10%-20%) and the percentage of patients seeking UI treatment 33%, (28%-38%).
RESULTS: A 1-million member CHP with 334,191 adult women beneficiaries is projected to have 31,438 (9.4%) adult women seeking UI treatment over a 24-month period. Total estimated 24-month cost/treated patient in the CCP and CP with Leva groups were $11,267 and $10,447, respectively. Estimated 24-month CHP savings was $25,782,112, or $1.07 PMPM. One-way sensitivity analyses indicate that the CP with Leva group provides robust 24-month savings over the range of parameters tested, and was most sensitive to the rate of Leva adoption, with estimated 24-month savings ranging from $12.11 million at 10% Leva adoption up to $39.45 million at 20% adoption.
CONCLUSIONS: Access to first-line Leva therapy can reduce two-year female UI treatment costs compared to CCP.
METHODS: A BI model was designed to compare 24-month costs associated with first-line PFMT in women seeking UI treatment in two cohorts: 85% receiving first-line CCP treatment/15% receiving CP with Leva, compared to all patients treated with CCP. Medical spending/treated patient and per-member-per-month (PMPM) were calculated after summing 24-month treatment costs comparing CCP to CP with Leva treatment. Guidelines-based treatments and estimates of treatment outcomes were extracted from published literature. A 1.50x multiplier was applied to published Medicare costs based on Congressional Budget Office data for Hospital and Physician Services. One-way sensitivity analysis examined the impact of uncertainty of key variables on results; parameters (base case estimate, (range)) included: Leva efficacy 61% (44% - 74%) Leva cost $2,160, ($1,860-$,2460), Leva adoption 15%, (10%-20%) and the percentage of patients seeking UI treatment 33%, (28%-38%).
RESULTS: A 1-million member CHP with 334,191 adult women beneficiaries is projected to have 31,438 (9.4%) adult women seeking UI treatment over a 24-month period. Total estimated 24-month cost/treated patient in the CCP and CP with Leva groups were $11,267 and $10,447, respectively. Estimated 24-month CHP savings was $25,782,112, or $1.07 PMPM. One-way sensitivity analyses indicate that the CP with Leva group provides robust 24-month savings over the range of parameters tested, and was most sensitive to the rate of Leva adoption, with estimated 24-month savings ranging from $12.11 million at 10% Leva adoption up to $39.45 million at 20% adoption.
CONCLUSIONS: Access to first-line Leva therapy can reduce two-year female UI treatment costs compared to CCP.
Conference/Value in Health Info
2025-05, ISPOR 2025, Montréal, Quebec, CA
Value in Health, Volume 28, Issue S1
Code
EE309
Topic
Economic Evaluation
Topic Subcategory
Budget Impact Analysis
Disease
No Additional Disease & Conditions/Specialized Treatment Areas, SDC: Urinary/Kidney Disorders