October Warsaw1 Financing of expensive pharmacotherapy (e.g.: orphan drugs) National Health Insurance Fund Administration (OEP) Pharmaceutical Department Tamás Kovacs Deputy Head of Pharmaceutical Department

October Warsaw2 Definition Regulation 141/2000 of the European Parliament and of the Council Different definitions of Orphan Disease U.S. ( )1 : 1,300 E.U. (1999)1 : (5/10.000) Japan (1993)1 : (<50.000) Australia (1997)1 : (<2.000)

October Warsaw3 Financing of expensive Drugs and Orphan Drugs In Hungary there is no special financing for expensive drugs. The financing form can be: Co-payment –Public procurement by NHIFA (100%) –Through pharmacies (100%, minimal co-payment 1,2€) –Through hospitals (100%, hospital fee 1,2€ /day) –Patient name finance (individual)(?)

October Warsaw4 Financing of expensive Drugs and Orphan Drugs In Hungary there is no special financing for expensive drugs. The financing form can be: Control –Public procurement by NHIFA (MD’s, process) –Through pharmacies (limited no. of MD’s,Settlement System) –Through hospitals (Patient name finance) –Patient name finance (individual) (Application)

October Warsaw5 Financed Orphan drugs Available for individual reimbursement Aldurazyme Exjade Lysodren Myozyme Orfadin Revatio Somavert Tracleer Financed Fabrzyme Replagal Glivec Savene

October Warsaw6 Not financed Orphan drugs Applied for reimbursement Refused Revatio Tracleer Decision in progress Exjade Nexavar Sprycel Sutent Xagrid Did not applied for reimbursement Busilvex, Carbaglu, Evoltra, Litak, Naglazyme, Onsenal, Pedea, Photobarr, Prialt, Thelin, Trisenox, Ventavis, Wilzin, Xyrem, Zavesca

October Warsaw7 Thank you for your attention!