20.500.12556/RUL-171413 Characteristics and availability of medicine early access programs and donations in Slovenia Background. Early access programs (EAPs) and medicine donation programs (MDPs) enable patients to have access to new medicines prior to regulatory approval or national reimbursement, respectively. The objective of this study was to evaluate the characteristics and timeliness of EAPs and MDPs in Slovenia. Methods. Originator medicines approved by the EMA through a centralized procedure from 2010 to 2019 were included in the study. Data on the EAPs and MDPs were obtained from the Agency for Medicinal Products and Medical Devices of Slovenia. Results. The EMA approved 458 new indications for 324 medicines during the study period. In Slovenia, a total of 58 medicine indications (12.7%) became available before national reimbursement, including 35 (7.6%) by EAPs and 26 (5.7%) by MDPs (3 through both programs). Among these, 35 (60.3%) medicine indications were associated with oncology. EAPs facilitated access to medicines a median of 21.0 months before reimbursement (24.7 months for oncology medicines). Initiating EAPs at the time of the marketing authorization application could potentially improve the time of early access by an additional 5.5 months (5.2 months for oncology). MDPs enabled access to medicines 9.5 months prior to reimbursement (9.4 months for oncology), with potential further improvement by 7.9 months with the initiation of access at the time of marketing authorization (5.7 months for oncology). Conclusion. Our findings highlight Slovenia’s successful implementation of EAPs and MDPs, with oncology emerging as the predominant focal area. The potential exists for improvements in the scope, timeliness, and transparency of information on EAPs and MDPs accessible to patients in Slovenia. early access programs compassionate use programs antineoplastic and immunomodulating agents oncology access time programi zgodnjega dostopa programi sočutne uporabe antineoplastična in imunomodulatorna zdravila čas dostopa onkologija imunomodulatorji true false true Angleški jezik Slovenski jezik Članek v reviji 2025-08-26 08:25:06 2025-08-26 08:25:09 2025-09-01 03:43:30 0000-00-00 00:00:00 2025 0 0 8 str. iss. 7, oyaf092 Vol. 30 Jul. 2025 0000-00-00 Zaloznikova Objavljeno NiDoloceno 0000-00-00 0000-00-00 0000-00-00 615.375:616-006 1549-490X 10.1093/oncolo/oyaf092 244806659 oyaf092.pdf oyaf092.pdf 1 A5D1BE0AA385C582AE63CCE55F5E5B1E a3975fab499c2a785d7c8c1702481c54cc6423e47ca37860fd3e90cabcaea408 c542a8c1-8245-11f0-9328-0050569b8976 https://repozitorij.uni-lj.si/Dokument.php?lang=slv&id=214727 https://academic.oup.com/oncolo/article/30/7/oyaf092/8210407 1 4af40b97-8245-11f0-9328-0050569b8976 https://repozitorij.uni-lj.si/Dokument.php?lang=slv&id=214726 Fakulteta za farmacijo 0 0 0