The Role of Epidemiology in Health Technology Assessment and Reimbursement of New Medicines: A Review

Objectives. After a medicinal product has been licensed, national health technology assessments (HTAs) are performed to ensure patients have affordable access to new treatments. However, little is known about the role of epidemiology in this phase. Therefore, the aim of this review is to summarize the impact of epidemiology on the HTA process, up until the final determination of the new drug reimbursement prices.
Material and Methods. A literature review was conducted to identify the criteria, data sources, and reimbursement procedures used by various international and European HTA bodies.
Results. Epidemiology is a vital component of both economic and clinical assessments of innovative drugs. It plays a crucial role in several stages of the HTA process, including: a) determining which health technologies will be assessed, b) providing information on the disease burden and unmet medical needs, and c) uncovering the economic worth of the product and projecting the financial effects of launching it in the market. d) ascertaining the conclusive confidential reimbursement amount by means of negotiation. The HTA process utilizes epidemiological data, obtained primarily from national representative databases containing real-world data, which is often hard to access, particularly in certain countries.
Conclusion. Epidemiology serves as the foundation for the economic and clinical evaluation of cutting-edge medicines during the HTA phase. To guarantee the dependability of the evaluation, epidemiological information sourced from national representative databases should be employed.