Factors Influencing the Introduction of Point-of-care Diagnostics: An Analysis of European Reimbursement Decisions

Abstract

Point-of-care (POC) diagnostics are an exciting class of in-vitro diagnostic test capable of providing rapid, accurate results in the vicinity of the patient, empowering clinicians to make informed decisions that streamline the treatment process. In the current healthcare situation where pressure to reduce spending is experienced, this efficient method of diagnostic testing offers the potential to provide economic benefit, while increasing quality of care. Despite the potential cost savings and patient benefit, POC diagnostic adoption levels into healthcare systems are lower than expected. An exploratory qualitative case study approach utilising a sequential design, provides insight into the factors that may influence POC diagnostic introduction to the European healthcare sector. This study is grounded in institutional theory to explore the trends seen in the adoption of POC diagnostics by the differing healthcare systems considered in this study. Phase I of this study presents an analysis of factors that influence POC diagnostic introduction in the literature. An in-depth analysis of political, economic, social, and technological (PEST) factors that influence the reimbursement of POC diagnostics informs phase II of this study by allowing the construction of a targeted survey tool. Phase II consists of primary data collection and analysis whereby experts in the vastly different POC diagnostics industries of England, Germany, and Spain provide valuable insight into how reimbursement decisions are made by healthcare authorities. A main finding of this study through the opinions of key stakeholders in the countries of interest highlight the impact of budgetary considerations and diagnostic costing to the healthcare groups involved as being paramount in overcoming the reimbursement issues experienced by POC diagnostics in the healthcare systems of Europe. Reimbursement of medical technologies emerged as one major factor holding back the adoption of these diagnostics which is of interest to players in the POC diagnostics industry and healthcare authorities in optimising their adoption.