Scientific generalization of approaches to the development of the Health Technology Assessment system in international practice

Abstract

In the process of developing the national system of the HTA, it is very important to take into account the positive international experience in substantiating a promising model, a rational management structure, distribution of functions and powers, and establishing effective interaction with the public and international partner organizations. The purpose of the study is to analyze current approaches to the organization of HTA in different countries and to identify priority areas for the development of the national HTA system and its institutional structure, taking into account international experience. The study used the following methods: systematic search in the literature and on the websites of bodies and institutions that conduct HTA, system analysis, content analysis, structural and functional analysis, systematization and generalization. The article focuses on the peculiarities of the activities of 53 organizations that provide HTA in 27 European countries. HTA systems differ in the way they are created and structured depending on their place in the healthcare system and their role in the decision-making process on pricing and reimbursement. The organizational structure of the HTA system is being built mainly at the national level, except for countries with decentralized healthcare systems, due to the peculiarities of the state system and the structure of the system itself. There is a tendency to unite the efforts of the EU Member States to create a common medical space and increase access to and affordability of medicines and vaccines, and the HTA Regulation has been implemented to simplify the HTA procedure, unify the methodology and optimize costs. Institutions that conduct HTA at the national level are mostly independent of the competent authorities which they cooperate with (74%), although their activities are usually accountable to these authorities. In our view, arm's length bodies are more common in more developed HTA systems and ensure an appropriate level of transparency and impartiality. As a rule, most independent bodies perform an advisory function (54%) and publish their reports and results of the HTA in the public domain, while integrated bodies keep their results confidential. At the same time, most of the results of the HTA don’t have required legal validity (80%). It was found that all the countries analyzed have well-developed processes for the evaluation of medicines, but often lack them for other HTs. The existence of more than one HTA agency at the national level often indicates that these agencies have different mandates and evaluate different HTs. Some different concerned parties (such as public trade and patient’s organizations) are actively implicated to HTA management as commission of HTA members (94%) and/or with help of outdoor consultations (76%).