| Summary: | Background: Increasing costs and quantities of orphan drugs within the European market has led to much debate in Sweden on how they should be handled within the existing reimbursement system. Previously, there has been little research looking at local and regional handling of and implications of these issues when it comes to decision-making, financing, and access. This study aims to provide insight into these issues through perspectives and experiences obtained in interviews with representatives working for County Councils in Northern Sweden. Methods: A case study comprised of semi-structured interviews following a qualitative methodology with an inductive approach was used for this study. Five informants from three different work groups engaged with the orphan drug introduction process in Northern Sweden were interviewed. A thematic analysis was performed on the data where common themes were identified through several rounds of coding to allow cross-sectional analysis between data obtained from informants. Results: The thematic analysis identified five major themes surrounding the introduction process for orphan drugs; centralization of processes, methods & standardization, ethical considerations, economics & price setting, and challenges & difficulties. Informants provided insights, opinions, and a deeper understanding of these themes within the introduction process for orphan drugs. Conclusion: This study confirms many of the complexities in establishing a clear and fair process for introducing orphan drugs. In line with existing literature, informants highlighted how centralization and the pooling of resources and expertise is vital in ensuring equal quality and access to care for patients suffering from rare diseases. There is broad agreement how orphan drug legislation and processes should develop, but substantial hurdles concerning the specifics as well as issues with external actors on pricing of orphan drugs. Addressing these issues could potentially have important benefits, not only for ...
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