Characteristics and availability of medicine early access programs and donations in Slovenia

Knez, Lea (author), Jazbar, Janja (author), Kos, Mitja (author)

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.

• Language: English
• Keywords: early access programs, compassionate use programs, antineoplastic and immunomodulating agents, oncology, access time
• Work type: Article
• Typology: 1.01 - Original Scientific Article
• Organization: FFA - Faculty of Pharmacy
• Publication status: Published
• Publication version: Version of Record
• Year: 2025
• Number of pages: 8 str.
• Numbering: Vol. 30, iss. 7, oyaf092
• PID: 20.500.12556/RUL-171413
• UDC: 615.375:616-006
• ISSN on article: 1549-490X
• DOI: 10.1093/oncolo/oyaf092
• COBISS.SI-ID: 244806659
• Publication date in RUL: 26.08.2025

Record is a part of a journal

• Title: The oncologist
• Shortened title: Oncologist
• Publisher: AlphaMed Press
• ISSN: 1549-490X
• COBISS.SI-ID: 521539609

Licences

• License: CC BY 4.0, Creative Commons Attribution 4.0 International
• Link: http://creativecommons.org/licenses/by/4.0/
• Description: This is the standard Creative Commons license that gives others maximum freedom to do what they want with the work as long as they credit the author.

Secondary language

• Language: Slovenian
• Keywords: programi zgodnjega dostopa, programi sočutne uporabe, antineoplastična in imunomodulatorna zdravila, čas dostopa, onkologija, imunomodulatorji

Projects

• Funder: ARIS - Slovenian Research and Innovation Agency
• Project number: P1-0189
• Name: Farmacevtska tehnologija: od dostavnih sistemov učinkovin do terapijskih izidov zdravil pri otrocih in starostnikih

• Funder: ARIS - Slovenian Research and Innovation Agency
• Project number: P3-0360
• Name: Celostna obravnava alergijskih bolezni in astme v Sloveniji: od epidemiologije do genetike