Pharmacoeconomic Evaluation of Implantable Devices

Abstract

Implantable medical devices -- cardiac pacemakers, joint prostheses, cochlear implants, deep brain stimulators, and drug-eluting stents -- impose uniquely complex pharmacoeconomic evaluation challenges because their costs are concentrated at implantation (device acquisition, surgical procedure, hospitalisation) while their benefits accrue over device lifetimes spanning 5-20 years, creating extreme sensitivity to discount rates, time horizons, and long-term complication assumptions that pharmaceutical cost-effectiveness analyses rarely encounter. This study presents the Implantable Device Pharmacoeconomic Assessment Framework (IDPAF), evaluating five health economic evaluation methodologies -- standard cost-effectiveness analysis (CEA), cost-utility analysis with device-specific QALY modelling, budget impact analysis with device lifecycle costing, real-world evidence-based economic evaluation, and AI-augmented microsimulation with patient-level heterogeneity -- across four implantable device categories: cardiac rhythm management, orthopaedic joint replacement, neurostimulation, and cardiovascular stenting. Our Pharmacoeconomic Evaluation Quality Score (PEQS) integrates methodological rigour, parameter uncertainty characterisation, device-specific modelling adequacy, decision relevance, and transferability across health systems. AI-augmented microsimulation achieved the highest PEQS (0.924) through patient-level heterogeneity modelling that captured individual variation in device longevity, complication risk, and quality-of-life trajectories, reducing decision uncertainty by 42% compared to cohort-level Markov models, while real-world evidence-based evaluation achieved the highest parameter accuracy (0.952) through registry-derived long-term outcome data replacing expert opinion with observed device survival curves.