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After a negative advice, companies may enter into negotiations for managed entry agreements (in which for example, the pharmaceutical company refunds a predefined percentage of the price for every unit sold) as defined by the Royal Decree of December 21 th2001 [14]. Dupont and Van Wilder performed a qualitative analysis of Belgian reimbursement dossiers of all orphan drugs with a specific focus on the evidence related to the five reimbursement criteria (therapeutic value, price, proposed reimbursement tariff, the importance of the drug in clinical practice, and the budgetary impact of the drug) [15].

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