The role of early health economics within implementation science: the case of innovative hearing treatments

Background Early health economic modelling (HEM) is increasingly used to inform the design, pricing and market access of health innovations before clinical efficacy is established. How this early economic evidence is generated, interpreted and acted upon by industry, regulators, clinicians and government bodies remains poorly understood. Implementation science offers structured pathways for planning adoption, but existing theories, models and frameworks treat cost and value as largely implicit or underspecified. Innovative hearing treatments (IHTs) for sensorineural hearing loss, including drug, cell and gene therapies currently entering the clinical domain, exemplify this gap. This paper aims to extend the Structured Pathway for Real-world ImplemeNTation (SPRINT) framework, a practice-oriented implementation science tool derived from Normalization Process Theory, by integrating early HEM as an explicit domain alongside its implementation science stages and strategies. Methods We adopted a framework-development design. Two previously published early HEM studies of IHTs, in age-related and idiopathic sudden-onset sensorineural hearing loss, served as worked examples through which to explore interactions between health economic methods and each SPRINT stage. Drawing on the authorship team's expertise in health economics, implementation science and clinical practice, we mapped the analyses conducted in these models onto the relevant SPRINT stages and strategies. Results The resulting extended framework, ECONO-SPRINT, adds a health economics domain to each of SPRINT's six stages, specifying where health economics and implementation science strategies can be generated and interpreted together and where each needs to stand alone. The worked examples show how headroom, scenario, sensitivity, threshold, value of information and budget impact analyses align with successive stages of the implementation pathway and expose a persistent gap between cost-effectiveness and affordability that neither discipline addresses alone. Conclusions ECONO-SPRINT is a theoretical development amenable to prospective instrument development and evaluation. Although generated through an IHT case study, we argue that the framework is transferable to other high-cost, potentially curative innovations facing the same tension between cost-effectiveness and affordability. Future work should apply and test it prospectively, generating health economic and implementation science evidence together as an innovation progresses through its lifecycle.