Abstract
INTRODUCTION: Chronic idiopathic constipation (CIC) is a common disorder that has a large unmet clinical need, affecting 8.0-12.0% of the US population and disproportionately affecting female individuals more than male individuals. Patients and physicians are equally dissatisfied with over-the-counter and prescription treatments. Physician dissatisfaction is at 78%. CIC has a significant negative impact on quality of life (QoL). The objective of this analysis was to compare the total cost and QoL of the Vibrant System vs. linaclotide, over 1-3 years of treatment. METHODS: Markov models were utilized to project 1-3-year US costs and health outcomes (quality adjusted life years, QALYs) comparing the Vibrant System to the current standard of care pharmacologic therapy (linaclotide). One model examined direct (D) costs plus QALYs. Direct (D) costs included list price of product and medical treatment costs due to adverse events. Costs (D) were as of 2024; derived from the medical literature. A second model examined D as well as indirect (I) costs (absenteeism, presenteeism) [D + I] and QALYs. Longitudinal 12-month persistence prescription data for linaclotide was obtained from IQVIA claims data. The Vibrant System persistence data was derived from post market collection. One-way sensitivity analyses were also performed. RESULTS: Years 1-3 direct costs were lower with Vibrant System with improved QALYs. Cumulative D + I data analysis for the Vibrant System at 12 months, and for years 2 and 3 show increased cost savings from $345 to $3866 with improved effectiveness. CONCLUSION: On the basis of lower costs and improved QALYs, the Vibrant System should be considered a first-line therapy for CIC and should be covered by insurers.