ODs with a positive TPR conclusion, not subject to a conditional approval, and approved without requering a pass would be more likely to be reimbursed in Spain

• Published in: Orphanet journal of rare diseases Vol. 18; no. 1; pp. 4 - 11
• Main Authors: Poveda, José Luis, Gómez, Claudia, Gil, Alicia, Badia, Xavier
• Format: Journal Article
• Language: English
• Published: England BioMed Central Ltd 06.01.2023; BioMed Central; BMC
• Subjects: Drug Approval; Europe; Humans; Licensing, certification and accreditation; Management; Marketing; Orphan Drug Production; Orphan drugs; Prescription pricing; Prices and rates; Pricing; Regulatory Variables; Reimbursement; Spain; Europe; Spain; Orphan drugs; Reimbursement; Regulatory Variables; Pricing; Spain

The present study aims to assess clinical and regulatory variables that would influence pricing and reimbursement (P&R) decisions for Orphan Drugs (ODs) in Spain. ODs approved by the European Commission (EC) between 2006 and 2021 were classified according to their P&R status in Spain: approv...