Jiří Klimeš, Tomáš Mlčoch, Bálint Pásztor, Karolína Baloghová, Šárka Veselá, Lenka Bulejová, Jan Tužil, Eva Ornstová, Kateřina Chadimová, Barbora Decker, Jana Bartáková, Tomáš Doležal

Health economic assessment is an integral part of the methodology and a comprehensive Health Technology Assessment (HTA) system. This concept, which is successfully applied to a wide range of medical technologies in many countries, is broader than the health and economic assessment itself, and by definition includes a societal perspective covering social, ethical, organizational and legal aspects.

These updated guidelines (from May, 2020): https://farmakoekonomika.cz/812-2/ reflect not only developments in the field of health economic assessment methodology in general, but also reflect local requirements and issues that all stakeholders are confronted with within the HTA system. Above all, it is a closer specification of the correct clinical data synthesis and its interpretation, as well as an emphasis on a comprehensive view of the disease as a condition with a much broader impact than just the patient himself. The practical use of local real-world evidence/ data is described in more detail. Lastly, there is the attention on the discount rate, especially with regards to exceptional cases / interventions such as modern therapy, etc. As of the date of issue of this directive, pharmacoeconomic methods are used in the Czech Republic in the reimbursement process of medicinal products and foodstuffs for special medical purposes (since 2008) and since 2019 also in the areas of selected medical devices. The principles are anchored in the Act on Public Health Insurance (48/1997 Coll.), in its implementing regulations and in the relevant methodologies of the State Institute for Drug Control.

These updated guidelines define the basic standard of health and economic evaluation. The authors evaluating a technology or technologies may, of course, deviate from the guidelines in specific analyzes. However, if the creation of a health and economic assessment will proceed in a different way, the author should justify the choice of a different procedure used.  These guidelines should be understood and interpreted in the context of the legislation of the Czech Republic, as well as the recommendations of international institutions that are respected by the Czech Pharmacoeconomic Society, such as ISPOR, EUNETHTA or HTAi.