Health Technology Assessment Challenges for Orphan Medicinal Products in Low- and Middle-Income Countries in Europe”

摘要

The purpose of this research is to provide a short overview of the differences in access to and health technology assessment of OMPs in selected low- and middle-income countries in Europe and discuss these in terms of some challenges in the face of HTA comparing with high-income countries. This is a retrospective, desktop study of already published official inquiries of national or international institutions, scientific publications, and reports from national governing bodies who regulate and monitor HTA in low- and middleincome economies in Europe, with further regards to HTA of orphan medicinal products. Among all selected low- and middle-income countries in Europe - Bulgaria, Serbia, North Macedonia, Moldova, Ukraine, and Georgia, have available and up-to-date information regarding their health care legislation. During 2000-2019 EMA approves 164 orphan medicines and out of them from 23 to 133 were found in the selected countries. We found that Bulgaria has a special HTA body. Since 2015 in Ukraine the health care system is experienced dynamic reform. In particular, a legislative framework has been adopted that regulates pharmaceutical pricing and reimbursement policies, the introduction of health technology assessment (HTA), etc. Despite the fact that Serbia is not part of the European Union there is an HTA commission established by the Ministry of Health where members of the HTA committee have 5- year mandates. According to our research, Georgia and North Macedonia do not use HTA. Meanwhile, United Kingdom is well known to show a strong interest in evidence health care. system. On the other hand, Тhe Statutory health insurance system (SHI reform), since 2000, established a federally funded HTA program with a database of relevant HTA results. Even though that the high-income countries have more developed HTA guidelines and stronger and more secure health systems, all the countries mentioned in this work are facing similar challenges. All the countries have limited budgets that have to be specifically spent for OMPs. Countries with less-developed HTA should take all the knowledge for good practices from countries like the United Kingdom for a more rigid framework. On the other hand, the adoption of public health plans with support from the World Bank, WHO, and the EU as adopted by Serbia and other comparable countries, represent model examples to be shared in greater depth from all the low-income countries.