Analysis of Patient Access to Personalized Oncology Medicines in Turkiye

OBJECTIVES: Personalized medicine is an evolving field in which physicians use diagnostic tests to determine which medical treatments will work the best for each patient or use medical interventions to alter molecular mechanisms that impact health. In this study, it was aimed to examine the access, license and reimbursement status of personalized oncology medicines approved in Turkiye.

METHODS: In the study the list of personalized oncology medicines was obtained from official websites of FDA and EMA. A search was conducted using the drug substance and trade names on the Abroad Medicines List, Annex-4A List of Reimbursed Medicines, Annex-4C Abroad Medicine Price List, Licensed Products List published by the Turkish Medicines and Medical Devices Agency, Social Security Institution and ECONALiX Medicine Databank to determine the access of patients to these medicines in Turkiye. The descriptive analyzes for the study were conducted through the Microsoft Office Excel program.

RESULTS: As a result of the analysis, it was determined that there are 116 drug substances in the lists published by the FDA or EMA as personalized oncology medicines. Patient access is available for 63 of 116 drug substances in Turkiye. While 43 of the 63 drug substances have marketing authorization approval (MAA) in Turkiye, 20 of them do not have any MAA but they can be imported as named patient sales (NPS). 30 of the 43 medicines with MAA are under reimbursement coverage (Annex-4A). Only 6 of the 20 NPS medicines are under reimbursement coverage (Annex-4C). As a summary, 36 of 116 personalized oncology medicines have reimbursement in Turkiye either with MAA or NPS.

CONCLUSIONS: Increasing access to personalized oncology medicines in Turkiye for better disease prevention, more accurate diagnoses, safer medicine prescriptions, fewer diseases and more effective treatments is a crucial need for policy makers to address.