PMID- 35881325 OWN - NLM STAT- MEDLINE DCOM- 20221003 LR - 20221101 IS - 1179-2027 (Electronic) IS - 1170-7690 (Print) IS - 1170-7690 (Linking) VI - 40 IP - 10 DP - 2022 Oct TI - Budget Impact Analysis of Vibegron for the Treatment of Overactive Bladder in the USA. PG - 979-988 LID - 10.1007/s40273-022-01163-5 [doi] AB - 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 beta(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. CI - (c) 2022. The Author(s). FAU - Chen, Jing Voon AU - Chen JV AD - Medical Decision Modeling, Indianapolis, IN, USA. FAU - Gahn, James C AU - Gahn JC AD - Medical Decision Modeling, Indianapolis, IN, USA. FAU - Nesheim, Jeffrey AU - Nesheim J AUID- ORCID: 0000-0003-0805-5615 AD - Urovant Sciences, 5281 California Ave, Suite 100, Irvine, CA, 92617, USA. Jeffrey.nesheim@urovant.com. FAU - Mudd, Paul N Jr AU - Mudd PN Jr AD - Urovant Sciences, 5281 California Ave, Suite 100, Irvine, CA, 92617, USA. LA - eng PT - Journal Article PT - Research Support, Non-U.S. Gov't DEP - 20220726 PL - New Zealand TA - Pharmacoeconomics JT - PharmacoEconomics JID - 9212404 RN - 0 (Adrenergic Agonists) RN - 0 (Cholinergic Antagonists) RN - 0 (N-(4-((5-(hydroxy(phenyl)methyl)pyrrolidin-2-yl)methyl)phenyl)-4-oxo-4,6,7,8-tetrahydropyrrolo(1,2-a)pyrimidine-6-carboxamide) RN - 0 (Pyrimidinones) RN - 0 (Pyrrolidines) MH - Adrenergic Agonists/therapeutic use MH - Aged MH - Cholinergic Antagonists/therapeutic use MH - Humans MH - Medicare MH - Pyrimidinones MH - Pyrrolidines MH - United States MH - *Urinary Bladder, Overactive/drug therapy PMC - PMC9522665 OAB - 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 risk of cognitive impairment or dementia. Vibegron is from a different class of drug for the treatment of OAB known as beta(3)-adrenergic receptor agonists. Adding a new drug to the market may have a financial impact on healthcare plans. This study assessed if adding vibegron for treating OAB is affordable in US commercial and Medicare plans. Adding vibegron to a health plan somewhat increased monthly costs over 5 years. For commercial insurance plans, monthly costs over 5 years increased $0.12 per person enrolled in the plan. For Medicare plans, monthly costs over 5 years increased $0.24 per person enrolled in the plan. However, adding vibegron to the market lowered overall costs not directly related to OAB by lowering healthcare costs related to taking a lot of anticholinergic drugs or costs of outpatient visits. Vibegron for treating OAB may be a helpful addition to health plans. Vibegron may reduce some healthcare costs for patients with OAB. OABL- eng COIS- Jing Voon Chen was an employee of Medical Decision Modeling at the time of analysis. James C. Gahn is an employee of Medical Decision Modeling. Jeffrey Nesheim is an employee of Urovant Sciences. Paul N. Mudd, Jr. was an employee of Urovant Sciences at the time the work was conducted. EDAT- 2022/07/27 06:00 MHDA- 2022/10/04 06:00 PMCR- 2022/07/26 CRDT- 2022/07/26 11:22 PHST- 2022/05/29 00:00 [accepted] PHST- 2022/07/27 06:00 [pubmed] PHST- 2022/10/04 06:00 [medline] PHST- 2022/07/26 11:22 [entrez] PHST- 2022/07/26 00:00 [pmc-release] AID - 10.1007/s40273-022-01163-5 [pii] AID - 1163 [pii] AID - 10.1007/s40273-022-01163-5 [doi] PST - ppublish SO - Pharmacoeconomics. 2022 Oct;40(10):979-988. doi: 10.1007/s40273-022-01163-5. Epub 2022 Jul 26.