Abstract:
High value diagnostics are important for the development of the personalized medicine (PM) approach and the improvement of healthcare efficiency. In order for the potential of PM to be fully realized, there is an increasing need for the availability of high value diagnostics in hospital and clinical settings. However many of the diagnostic technologies available to us have not made it into the European market thereby denying patient and clinician access. The problem exists in the complex and difficult market access (MA) process for diagnostic companies looking to penetrate these markets. This research therefore aims to look at the MA process from the diagnostic industry’s perspective, more specifically the challenges and success factors during this process. This research is comprised of an exploratory approach with the aim of exploring the perception of the challenges and success factors associated with the MA process in Germany and Sweden. Semi-structured interviews were conducted with key informants and senior management of diagnostic companies to gain valuable insights from the industry. The overall findings showed that the main challenges of MA were related to reimbursement and clinical acceptance. Interviews highlighted the lack of transparent reimbursement pathways, value under-appreciation within the current reimbursement system and clinical acceptance as the major challenges of MA in both Germany and Sweden. The findings also showed that different perceptions of value was an overarching challenge which was observed throughout the whole process. In order to address these challenges, the findings showed that companies need to understand who the key stakeholders are and ensure effective communication to them. Furthermore companies need to address organizational change towards market access culture and understand the importance of successful health technology assessments.
