Clinical and non-clinical aspects of reimbursement policy for orphan drugs in selected European countries
European countries differ in terms of the impact of clinical issues and additional clinical aspects on the reimbursement policy for ODs. Reimbursement decisions were affected by OD-specific legislation, policies, and EMA authorization status. HTA dossiers and procedures significantly influenced reimbursement decisions, although some ODs were reimbursed regardless of the positive or negative recommendations. ATC codes were significantly correlated with reimbursement status and positive recommendation.
Authors
- Gisbert Selke (ORCID: https://orcid.org/0000-0002-9614-9875)
- Tanja Mueller
- S Jakubowski (ORCID: https://orcid.org/0000-0001-6419-9686)
- Rafał Nowak (ORCID: https://orcid.org/0000-0002-3380-1563)
- Outi Salminen (ORCID: https://orcid.org/0000-0003-0427-858X)
- Przemysław Holko (ORCID: https://orcid.org/0000-0002-6821-4078)
- Salvatore Crisafulli (ORCID: https://orcid.org/0000-0001-6625-1943)
- Marc Dooms
- Eleanor Grieve (ORCID: https://orcid.org/0000-0002-4115-2882)
- M. Warmuth
- Einar Magnússon
- Imma Danés (ORCID: https://orcid.org/0000-0002-8711-9666)
- Paweł Kawalec
- Lucas Cortial (ORCID: https://orcid.org/0009-0008-3447-9423)
- C. Georgi
- Fons Strijbosch
Institutions
- University of Verona (IT)
- Jagiellonian University (PL)
- University of Piraeus (GR)
- University of Strathclyde (GB)
- Aix-Marseille Université (FR)
- Administration of Occupational Safety and Health (IS)
- Vall d'Hebron Hospital Universitari (ES)
- Health Strat (Kenya) (KE)
- Institut de Neurosciences de la Timone (FR)
- Wissenschaftliches Institut der AOK (DE)
- Ministry of Social Affairs and Health (FI)
- University of Glasgow (GB)
Publication Details
- Journal
- Frontiers in Pharmacology
- Published
- 2024-11-19
- DOI
- https://doi.org/10.3389/fphar.2024.1498386
- Citations
- 5
- Primary Topic
- Pharmaceutical Economics and Policy
- Type
- article
- Field-Weighted Citation Impact
- 5.65
Funders
- Uniwersytet Jagielloński Collegium Medicum