COST-UTILITY OF EARLY TAVI WITH THE SAPIEN 3 ULTRA RESILIA VALVE VERSUS CLINICAL SURVEILLANCE IN ASYMPTOMATIC SEVERE AORTIC STENOSIS: A FRENCH HTA
Author(s)
Pascal Candolfi, PhD1, Christophe Roussel, MSc2, Romain Primel, MSc3, Jérémy CARETTE, PharmD4, Loïc BIRON, PharmD5.
1Public Affairs BP THV & Strategic Initiatives Sr. Director, Edwards Lifesciences Sàrl, Nyon, Switzerland, 2Edwards Lifesciences, Guyancourt, France, 3Cencora, PARIS, France, 4Cencora, Paris, France, 5public health expertise, Paris, France.
1Public Affairs BP THV & Strategic Initiatives Sr. Director, Edwards Lifesciences Sàrl, Nyon, Switzerland, 2Edwards Lifesciences, Guyancourt, France, 3Cencora, PARIS, France, 4Cencora, Paris, France, 5public health expertise, Paris, France.
OBJECTIVES: To assess the efficiency (cost-utility) of early transcatheter aortic valve implantation (TAVI) with the SAPIEN 3 Ultra RESILIA (S3UR) valve versus clinical surveillance (CS) in adults with asymptomatic severe aortic stenosis (AS) without unfavourable clinical or prognostic features, from a French healthcare system perspective, to support a Health Authority (HAS) reimbursement submission.
METHODS: A 3-state Markov model (alive and well, stroke, death; monthly cycles) simulated costs (2025 euros) and outcomes over a lifetime horizon (24 years). Clinical inputs (stroke, heart-failure hospitalisation, conversion to valve replacement, mortality) were derived from the EARLY-TAVR randomised trial (n=901; median follow-up 3.8 years). Valve reintervention reflected RESILIA tissue durability using external long-term data. Costs and QALYs were discounted at 2.5%. Deterministic (DSA), probabilistic (PSA; 1,000 iterations) and 21 scenario analyses were conducted.
RESULTS: Early TAVI with S3UR dominated CS: +0.09 QALY (7.57 vs 7.49) and a saving of 3,646 euros (-8.0%; 41,733 vs 45,379) per patient. No life-year difference was observed (10.45 each), so no cost per life-year was estimable. Savings were driven by fewer strokes (-4,728 euros), reinterventions (-1,574 euros) and pacemaker implants (-847 euros), offsetting higher device acquisition cost (+3,631 euros). In PSA, S3UR was dominant in 85.8% of simulations and had a 90.3% probability of an ICER below 10,000 euros/QALY. DSA confirmed dominance across all parameters. 20 of 21 scenarios remained dominant; the shortest horizon (10 years) yielded 5,965 euros/QALY. An exploratory analysis attributed 2,813 euros per patient in reintervention savings to RESILIA tissue alone.
CONCLUSIONS: From a French healthcare system perspective, early TAVI with the S3UR valve was dominant, being more effective and cost-saving versus clinical surveillance in asymptomatic severe AS, with conclusions robust across sensitivity and scenario analyses.
METHODS: A 3-state Markov model (alive and well, stroke, death; monthly cycles) simulated costs (2025 euros) and outcomes over a lifetime horizon (24 years). Clinical inputs (stroke, heart-failure hospitalisation, conversion to valve replacement, mortality) were derived from the EARLY-TAVR randomised trial (n=901; median follow-up 3.8 years). Valve reintervention reflected RESILIA tissue durability using external long-term data. Costs and QALYs were discounted at 2.5%. Deterministic (DSA), probabilistic (PSA; 1,000 iterations) and 21 scenario analyses were conducted.
RESULTS: Early TAVI with S3UR dominated CS: +0.09 QALY (7.57 vs 7.49) and a saving of 3,646 euros (-8.0%; 41,733 vs 45,379) per patient. No life-year difference was observed (10.45 each), so no cost per life-year was estimable. Savings were driven by fewer strokes (-4,728 euros), reinterventions (-1,574 euros) and pacemaker implants (-847 euros), offsetting higher device acquisition cost (+3,631 euros). In PSA, S3UR was dominant in 85.8% of simulations and had a 90.3% probability of an ICER below 10,000 euros/QALY. DSA confirmed dominance across all parameters. 20 of 21 scenarios remained dominant; the shortest horizon (10 years) yielded 5,965 euros/QALY. An exploratory analysis attributed 2,813 euros per patient in reintervention savings to RESILIA tissue alone.
CONCLUSIONS: From a French healthcare system perspective, early TAVI with the S3UR valve was dominant, being more effective and cost-saving versus clinical surveillance in asymptomatic severe AS, with conclusions robust across sensitivity and scenario analyses.
Conference/Value in Health Info
2026-11, ISPOR Europe 2026, Vienna, Austria
Value in Health, Volume 29, Issue 12S
Code
EE11
Topic
Clinical Outcomes, Economic Evaluation, Study Approaches
Disease
Cardiovascular Disorders (including MI, Stroke, Circulatory), No Additional Disease & Conditions/Specialized Treatment Areas