Unit:
Κατεύθυνση Ανάπτυξη Νέων Φαρμάκων: Έρευνα, Κυκλοφορία και ΠρόσβασηLibrary of the School of Health Sciences
Supervisors info:
Κωνσταντίνος Ν. Συρίγος, Καθηγητής, Ιατρική Σχολή, ΕΚΠΑ
Αριστοτέλης Θ. Μπάμιας, Καθηγητής, Ιατρική Σχολή, ΕΚΠΑ
Γεωργία Χ. Κουρλαμπά, Ακαδημαϊκός υπότροφος, Ιατρική Σχολή, ΕΚΠΑ
Original Title:
Ο ρόλος της επιδημιολογίας στην αξιολόγηση και αποζημίωση νέων φαρμάκων
Translated title:
The role of epidemiology in health technology assessment and reimbursement of new medicines
Summary:
Health Technology Assessment (HTA) is a multidisciplinary process that uses well defined methods to specify the value of health technologies. Its main purpose is to provide health policy makers with evidenced information so that they can develop safe, effective, patient-centered and cost-effective policies for health systems.
It studies medical, social, ethical and economic implications of the development and use of new technologies which may be medicinal products, medical equipment, methods of diagnosis, prevention and treatment. This dissertation focuses on the evaluation of new, innovative drugs. In the context of HTA, the main criteria for evaluating new drugs are clinical benefit, comparison with available reimbursable treatments, degree of reliability of clinical trial data, cost-effectiveness ratio, and budget impact.
Epidemiology is one of the criteria evaluated for reimbursement, but epidemiology directly or indirectly participates in other stages / criteria of evaluation until the final decision for reimbursement or not and the determination of the final price of new drugs.
The purpose of this dissertation is to present the role that epidemiology plays in every step of the process of evaluation, pricing and reimbursement of new drugs according to international and national experience and practice. In particular, to present how the epidemiological data of a disease can contribute to the final decision on the reimbursement of new drugs as well as to the determination of the final reimbursed price.
We carried out literature review regarding criteria, data sources, reimbursement procedures for technology evaluation by several international and european organizations, in order to identify the role of epidemiology.
In conclusion, epidemiology is used internationally at various stages of the process of evaluation and reimbursement of new drugs, starting from the prioritization of the products under evaluation to the determination of the final confidential price of the products under evaluation. Epidemiology has been found to play a dominant role in identifying and supporting unmet medical need considering that it is a key component of the disease burden as expressed through rates of mortality, morbidity and not only. In addition, it participates in the evaluation of the results of the cost-effectiveness analysis and the budget impact analysis. It also plays a particularly important role in shaping managed entry agreements for innovative medicines.
Main subject category:
Health Sciences
Keywords:
Epidemiology, Assessment of new medicines, Reimbursement of new medicines, Unmet medical need
File:
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Final_Διπλωματική εργασία_Ο ρόλος της επιδημιολογίας στην αξιολόγηση και αποζημίωση νεών φαρμάκων copy.pdf
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