Changing Landscape of Orphan Drug Reimbursement – Evidence From EU-4 and England

Germany continuously provides the most robust patient access to ODs, wide access to ODs is maintained in France despite an increased percentage of ODs still in the price negotiation due to the Early Access programme. The largest improvement can be seen in Italy which corresponds to the legislative changes in the pricing negotiation process and their COVID-19 mitigating strategies. In England, the increased percentage of positive recommendations coincides with the increased median TTR, presumably due to the higher number of ODs in the reimbursement process. With issues identified in previous research prevailing, Spain remains the most challenging market.

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