Unit:
Κατεύθυνση Ανάπτυξη Νέων Φαρμάκων: Έρευνα, Κυκλοφορία και ΠρόσβασηLibrary of the School of Health Sciences
Supervisors info:
Γεωργία Κουρλαμπά, Επίκουρη Καθηγήτρια, Τμήμα Νοσηλευτικής, Πανεπιστήμιο Πελοποννήσου
Κωνσταντίνος Ν. Συρίγος, Καθηγητής, Ιατρική Σχολή, ΕΚΠΑ
Κυριάκος Σουλιώτης, Καθηγητής, Σχολή Κοινωνικών και Πολιτικών Επιστημών, Πανεπιστήμιο Πελοποννήσου
Original Title:
Έγκριση και αποζημίωση των εξετάσεων βιοδεικτών στην ογκολογία στην εποχή της ιατρικής ακριβείας
Translated title:
Approval and reimbursement of biomarkers testing in oncology in the era of precision medicine
Summary:
Biomarkers are considered to be of major importance for the clinical application of precision medicine in the modern era. The purpose of this thesis is to collect and present data on access, regulatory framework, assessment and reimbursement of biomarker testing in the field of oncology on international and national level. A review of the relevant literature was conducted and data were collected from scientific articles by other researchers, which were retrieved from the online search engines Google Scholar, Pubmed by using keywords. In addition, important information was gathered from websites of competent authorities (indicatively EMA, FDA, HAS, NHS, EOF, EOPYY). Following the collection of the above mentioned data, inequalities have been identified among European countries in terms of patient access to biomarker testing and variations in the quality of the tests performed. In Europe, based on the Regulation (EU) 2017/746, the regulatory framework is under revision process and has become stricter for companion diagnostics (CDx). Variations were also observed between countries in the current procedures, methodologies and criteria considered for conducting the assessment and inclusion of biomarker tests in their reimbursement schemes. In Greece, the first oncology biomarker tests started to be reimbursed since 2014 for approved cancer indications, however, since then a small number of new tests has been added to the list of reimbursed biomarkers. At the same time, cases of reimbursement of personalized treatments by the National Organization for the Provision of Health Services (EOPYY) were found, without simultaneous reimbursement of their respective biomarker tests. Immediate action by the competent authorities to address the existing obstacles, as well as the adoption of national strategies with cancer as a priority by health policy makers, are considered necessary to ensure timely and equitable access to precision medicines and biomarker tests for all patients and to achieve a holistic approach to the treatment of cancer.
Main subject category:
Health Sciences
Keywords:
Precision medicine, Biomarkers, Regulatory framework, Cancer, Companion diagnostics, Reimbursement
File:
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Τελικό Διπλωματική Εργασία για βιοδείκτες Τομαρά Δήμητρα.pdf
1 MB
File access is restricted only to the intranet of UoA.
