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This study has shown that reimbursement of orphan drugs in Belgium is possibly influenced by a combination of official and non-official factors. The identification of these factors is a crucial step in the development of a transparent and consistent framework which will guide future decision-making for reimbursement of orphan drugs. Acknowledgement. The authors would like to thank the interviewees for their valuable time and input and the NIHDI for the provided access to the reimbursement dossiers.]