Budget Impact Analysis of Vibegron for the Treatment of Overactive Bladder in the USA

• Published in: PharmacoEconomics 2022-10, Vol.40 (10), p.979-988
• Main Authors: Chen, Jing Voon, Gahn, James C., Nesheim, Jeffrey, Mudd, Paul N.
• Format: Article
• Language: English
• Subjects: Adrenergic Agonists - therapeutic use; Adrenergic beta agonists; Adrenergic receptors; Age; Aged; Analysis; Anticholinergics; Behavior modification; Bladder; Cholinergic Antagonists - therapeutic use; Clinical outcomes; Cost control; Dementia; Drug interactions; Drug therapy; Economic aspects; Health Administration; Health care expenditures; Health Economics; Humans; Market shares; Medical care, Cost of; Medicare; Medicine; Medicine & Public Health; Original; Original Research Article; Patients; Pharmacoeconomics and Health Outcomes; Public Health; Pyrimidinones; Pyrrolidines; Quality of Life Research; United States; Urinary Bladder, Overactive - drug therapy; Urinary incontinence
• ISSN: 1170-7690; 1179-2027; 1179-2027
• DOI: 10.1007/s40273-022-01163-5

Background Overactive bladder (OAB) is associated with considerable clinical and economic burden. Treatment of patients with OAB using anticholinergics is limited by tolerability issues and increased anticholinergic burden, which is associated with increased risk of dementia and falls/fractures. This analysis assessed the budget impact of introducing the β 3 -adrenergic agonist vibegron for the treatment of patients with OAB from US commercial payor and Medicare perspectives. Methods A budget impact model (BIM) with a 5-year time horizon was developed using a top-down, prevalence-based approach and projected market shares for 1-million-member US commercial and Medicare plans. The BIM included vibegron, mirabegron, and anticholinergics, incorporating changes in clinical outcomes (efficacy, drug–drug interactions, anticholinergic burden (ACB), OAB-related comorbidities, and adverse events (AEs)). Costs per member per month (PMPM) and per treated member per month (PTMPM) were determined. One-way sensitivity analyses quantified the impact of changes in key variables. Results The introduction of vibegron was associated with a modest increase in PMPM cost over 5 years of $0.12 (range for years 1‒5, $0.01‒$0.26) for commercial payors and $0.24 ($0.01‒$0.52) for Medicare (PTMPM cost: $2.70 ($0.17‒$4.85) and $3.15 ($0.19‒$5.82), respectively). Costs were partially offset by savings related to decreased third-line treatment use, yearly decreases in AE and comorbidity incidence, reduced drug–drug interactions, and reduced ACB associated with vibegron introduction. PMPM costs were most sensitive to vibegron market share assumptions, OAB prevalence, and vibegron persistence at 1 month for private payors and Medicare and additionally vibegron persistence at 12 months for Medicare. Conclusions Vibegron may address unmet needs in treating OAB and is a useful addition to health plans while minimizing risks of anticholinergic AEs, ACB, and drug–drug interactions, which may partially offset increased pharmacy costs. Plain Language Summary Adults with overactive bladder (OAB) experience frequent and sudden urges to urinate. OAB affects more than 100 million men and women in the USA. In 2020, the projected cost of OAB was $82.6 billion. One of the standard treatments for OAB includes a class of drugs called anticholinergics. Anticholinergic drugs can cause side effects such as dry mouth and constipation. Over time, taking a lot of anticholinergic drugs may lead to increased ri