BUDGET IMPACT ANALYSIS OF EVOQUE TRANSCATHETER TRICUSPID VALVE REPLACEMENT FOR SEVERE SYMPTOMATIC TRICUSPID REGURGITATION FROM THE FRENCH HEALTHCARE PAYER PERSPECTIVE
Author(s)
Apolline Grangeon, PharmD1, Martin Connock, PhD2, Peter Auguste, PhD2, Jean-François Obadia, MD, PhD3, Maurice Enriquez-Sarano, MD, PhD4, Benjamin Essayagh, MD5, Xavier ARMOIRY, PhD, PharmD6.
1University Claude Bernard ISPB, Lyon, France, 2Health Services Management Centre School of Social Policy and Society, College of Social Sciences, University of Birmingham and Centre for Evidence and Implementation Science (CEIS), Birmingham, United Kingdom, 3Hopital Cardiovasculaire Louis Pradel, Chirurgie Cardio-Vasculaire et Transplantation Cardiaque, Hospices Civils de Lyon and Claude Bernard University, Lyon, France, 4Abbott Northwestern Hospital, Minneapolis, MN, USA, 5Department of Echocardiography, Cardio X Clinic, Cannes, France, 6Pharmacy Department and Laboratoire MATEIS, Hospices Civils de Lyon and Claude Bernard University, Lyon, France.
1University Claude Bernard ISPB, Lyon, France, 2Health Services Management Centre School of Social Policy and Society, College of Social Sciences, University of Birmingham and Centre for Evidence and Implementation Science (CEIS), Birmingham, United Kingdom, 3Hopital Cardiovasculaire Louis Pradel, Chirurgie Cardio-Vasculaire et Transplantation Cardiaque, Hospices Civils de Lyon and Claude Bernard University, Lyon, France, 4Abbott Northwestern Hospital, Minneapolis, MN, USA, 5Department of Echocardiography, Cardio X Clinic, Cannes, France, 6Pharmacy Department and Laboratoire MATEIS, Hospices Civils de Lyon and Claude Bernard University, Lyon, France.
OBJECTIVES: Severe symptomatic tricuspid regurgitation (TR) is associated with substantial morbidity, mortality, and healthcare resource utilization. Evoque™ is a transcatheter tricuspid valve replacement (TTVR) therapy developed for patients with severe TR who remain symptomatic despite optimal medical therapy (OMT). This study assessed the potential budget impact of introducing Evoque™ TTVR in France.
METHODS: A budget impact model was developed from the perspective of the French National Health Insurance (NHI) and was derived from a previously published Markov model evaluating Evoque™ in patients with severe symptomatic TR. Costs included device acquisition, procedure-related costs, follow-up care, heart failure hospitalizations, end-of-life care, and were valued using 2026 French national tariffs. The target population of 6000 patients was based on the HAS assessment Committee opinion of Evoque™. A three-year time horizon was considered. Scenario analyses considered variations on treatment price, market share and mortality assumptions.
RESULTS: Across the explored scenarios, the cumulative budget impact over three years associated with the introduction of Evoque™ ranged from €92 million to €247 million, increasing expenditures incurred by the French NHI for the management of severe tricuspid regurgitation by 112% to 299% compared with OMT alone. Device acquisition costs accounted for approximately 90% of total budget impact across all scenarios. Reductions in downstream healthcare costs represented less than 10% of device acquisition costs. Depending on assumptions regarding market shares between 9,900 and 14,700 patients would be treated with Evoque™ TTVR over the analysis period. The mean cost per-patient treated with Evoque™ was estimated at €45k (mainly driven by acquisition cost) versus €7k with OMT alone over 3 years.
CONCLUSIONS: The introduction of Evoque™ is expected to substantially increase expenditures incurred by the French NHI for the management of severe TR. Device acquisition costs remained the primary driver of budget impact across all explored scenarios.
METHODS: A budget impact model was developed from the perspective of the French National Health Insurance (NHI) and was derived from a previously published Markov model evaluating Evoque™ in patients with severe symptomatic TR. Costs included device acquisition, procedure-related costs, follow-up care, heart failure hospitalizations, end-of-life care, and were valued using 2026 French national tariffs. The target population of 6000 patients was based on the HAS assessment Committee opinion of Evoque™. A three-year time horizon was considered. Scenario analyses considered variations on treatment price, market share and mortality assumptions.
RESULTS: Across the explored scenarios, the cumulative budget impact over three years associated with the introduction of Evoque™ ranged from €92 million to €247 million, increasing expenditures incurred by the French NHI for the management of severe tricuspid regurgitation by 112% to 299% compared with OMT alone. Device acquisition costs accounted for approximately 90% of total budget impact across all scenarios. Reductions in downstream healthcare costs represented less than 10% of device acquisition costs. Depending on assumptions regarding market shares between 9,900 and 14,700 patients would be treated with Evoque™ TTVR over the analysis period. The mean cost per-patient treated with Evoque™ was estimated at €45k (mainly driven by acquisition cost) versus €7k with OMT alone over 3 years.
CONCLUSIONS: The introduction of Evoque™ is expected to substantially increase expenditures incurred by the French NHI for the management of severe TR. Device acquisition costs remained the primary driver of budget impact across all explored scenarios.
Conference/Value in Health Info
2026-11, ISPOR Europe 2026, Vienna, Austria
Value in Health, Volume 29, Issue 12S
Code
EE472
Topic
Economic Evaluation, Health Technology Assessment, Medical Technologies
Topic Subcategory
Budget Impact Analysis
Disease
Cardiovascular Disorders (including MI, Stroke, Circulatory)