COST-UTILITY ANALYSIS OF CLOSED LOOP STIMULATION PACEMAKERS VERSUS CONVENTIONAL RATE-ADAPTIVE PACING IN THE UNITED KINGDOM
Author(s)
Gemma Pelargonio, MD, PhD1, Oleg Borisenko, MD, PhD2, vasily lukyanov, MSc2, Andrei Maslov, MD2, Mikhail Kukushkin, MD, MPA3, Alessio Gargaro, MSc4, Stylianos Daskalinas, MSc5, Ennio Carmine Luigi Pisanò, MD6, Valeria Calvi, MD7, Giuseppe Arena, MD8, Emanuele Bertaglia, MD, PhD9, Giovanni Luca Botto, MD10.
1Fondazione Policlinico Gemelli IRCCS Università Cattolica del Sacro Cuore, Rome, Italy, 2MTRC HEOR Ltd., Leeds, United Kingdom, 3BIOTRONIK SE & Co. KG, Berlin, Germany, 4BIOTRONIK Italia S.p.A., Milan, Italy, 5University of Rome Tor Vergata, Rome, Italy, 6Di Summa-Perrino Hospital, Brindisi, Italy, 7G. Rodolico - San Marco University Hospital, Catania, Italy, 8Apuane New Hospital, Massa, Italy, 9Camposampiero Hospital, Padova, Italy, 10ASST Rhodense, Rho & Garbagnate Hospitals, Milan, Italy.
1Fondazione Policlinico Gemelli IRCCS Università Cattolica del Sacro Cuore, Rome, Italy, 2MTRC HEOR Ltd., Leeds, United Kingdom, 3BIOTRONIK SE & Co. KG, Berlin, Germany, 4BIOTRONIK Italia S.p.A., Milan, Italy, 5University of Rome Tor Vergata, Rome, Italy, 6Di Summa-Perrino Hospital, Brindisi, Italy, 7G. Rodolico - San Marco University Hospital, Catania, Italy, 8Apuane New Hospital, Massa, Italy, 9Camposampiero Hospital, Padova, Italy, 10ASST Rhodense, Rho & Garbagnate Hospitals, Milan, Italy.
OBJECTIVES: To determine the cost-utility of closed loop stimulation (CLS) dual-chamber pacemakers versus conventional rate-adaptive (DDDR) pacing in patients with sinus node dysfunctions (SND) from the healthcare payer perspective in the United Kingdom (UK).
METHODS: A decision-analytic Markov model was developed over a 10-year time horizon, including health states: SND, SND with atrial high-rate episodes (AHREs), stroke, post-stroke, transient ischemic attack (TIA), post-TIA, heart failure-related hospitalization (HFRH), post-HFRH, death. The premise of analysis is that patients with CLS pacemakers develop fewer episodes of AHREs (known risk factor) compared with patients with DDDR pacemakers, leading to a reduction in negative outcomes. Clinical, cost, and utility inputs were derived from a randomized controlled trial and published literature. Costs were presented in 2024‒25 British pounds, and a 3.5% discount rate for costs and benefits was applied. Deterministic and probabilistic sensitivity analyses were performed.
RESULTS: CLS was the dominant strategy, yielding incremental gains of 0.031 LYs and 0.029 QALYs per patient. Total costs per patient were lower for CLS (£11,087) than for DDDR (£11,460), yielding cost savings of £373. At a willingness-to-pay threshold of £35,000 per QALY, the incremental net monetary benefit (NMB) of CLS compared to DDDR was £1,386. One-way sensitivity analysis indicated that results were most sensitive to the relative risk of heart failure-related hospitalization associated with AHREs, the utility values assigned to the SND and AHRE health states, and the relative risk of AHRE in the CLS arm during years 1-3. Probabilistic sensitivity analysis demonstrated that the CLS strategy was leading to positive NMB in 95.5% of simulations.
CONCLUSIONS: This cost-utility analysis demonstrated that CLS pacemakers were a dominant cost-effective strategy compared with DDDR pacing in the UK.
METHODS: A decision-analytic Markov model was developed over a 10-year time horizon, including health states: SND, SND with atrial high-rate episodes (AHREs), stroke, post-stroke, transient ischemic attack (TIA), post-TIA, heart failure-related hospitalization (HFRH), post-HFRH, death. The premise of analysis is that patients with CLS pacemakers develop fewer episodes of AHREs (known risk factor) compared with patients with DDDR pacemakers, leading to a reduction in negative outcomes. Clinical, cost, and utility inputs were derived from a randomized controlled trial and published literature. Costs were presented in 2024‒25 British pounds, and a 3.5% discount rate for costs and benefits was applied. Deterministic and probabilistic sensitivity analyses were performed.
RESULTS: CLS was the dominant strategy, yielding incremental gains of 0.031 LYs and 0.029 QALYs per patient. Total costs per patient were lower for CLS (£11,087) than for DDDR (£11,460), yielding cost savings of £373. At a willingness-to-pay threshold of £35,000 per QALY, the incremental net monetary benefit (NMB) of CLS compared to DDDR was £1,386. One-way sensitivity analysis indicated that results were most sensitive to the relative risk of heart failure-related hospitalization associated with AHREs, the utility values assigned to the SND and AHRE health states, and the relative risk of AHRE in the CLS arm during years 1-3. Probabilistic sensitivity analysis demonstrated that the CLS strategy was leading to positive NMB in 95.5% of simulations.
CONCLUSIONS: This cost-utility analysis demonstrated that CLS pacemakers were a dominant cost-effective strategy compared with DDDR pacing in the UK.
Conference/Value in Health Info
2026-11, ISPOR Europe 2026, Vienna, Austria
Value in Health, Volume 29, Issue 12S
Code
MT38
Topic
Economic Evaluation, Medical Technologies
Disease
Cardiovascular Disorders (including MI, Stroke, Circulatory)