Mandavia, Rishi; (2022) The PATH study: Preparing for the Adoption of innovative hearing THerapies. Doctoral thesis (Ph.D), UCL (University College London).

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Abstract

BACKGROUND: Innovative drug, gene and cell therapies are being developed to address the unmet clinical need of people with hearing loss. With approval for clinical use on the horizon in the next 5 years, it is essential to start preparing for the implementation of these therapies in hearing healthcare services. AIM: To provide stakeholders who develop, will use and pay for innovative hearing therapies, with a detailed understanding of the elements that influence their adoption and implementation and with practical strategies to facilitate their uptake in the UK healthcare system. METHOD: 1) To inform product development and decisions on value for money, I constructed an early health economic model with input data from literature searches and 26 interviews. 2) To characterise and understand the elements that influence the adoption and implementation of innovative hearing therapies in the UK healthcare system, I conducted 37 semi-structured interviews drawing upon insights from the early health economic model. 3) To add to this understanding, I performed a hermeneutic review of elements that influence the adoption and implementation of innovative therapies in general. 4) To integrate the findings from my thesis, I constructed a framework that maps the elements that influence innovative hearing therapy adoption and implementation, and that summarises practical strategies to facilitate uptake. RESULTS: I found that alliances between clinicians, scientists, patients, biotechnology and hearing technology companies can facilitate adoption of innovative hearing therapies, benefitting from pooled resources, diffusion networks and established market access. Timely clinician education can break down engrained clinical practices and gain clinician buy-in. Early engagement with patients can help ensure these therapies meet patient needs and generate patient and public interest, which can influence clinician uptake and policy decisions. Precision diagnostics are critical to the development and uptake of innovative hearing therapies; co-development strategies and novel regulatory pathways can accelerate their development. Accelerator organisations can help navigate healthcare systems, assist with manufacturing and distribution strategies, support clinical trialing, help develop business cases, and lobby decision makers. Additional insights revealed that novel payment strategies and robust business cases can help make procurement affordable and avoid delays in adoption. Real world data can increase confidence to take-up innovative hearing therapies, support payment strategies, early access programs and help fulfil regulatory requirements. CONCLUSION: My research has resulted in a framework that can accelerate the uptake of innovative hearing therapies across healthcare systems. Stakeholders can use my framework to gain detailed information on the processes that need to take place for adoption and implementation of these therapies as well as strategies to facilitate these processes.

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