What is NIHO?
NIHO is an independent national HTA (Health Technology Assessment) institution. Its role is to bring transparency to the decision-making process in the field of health, especially in the reimbursement decision of new technologies (mainly medicines and medical devices).
It is a legal entity not registered in the Commercial Register, established by a special Act No. 358/2021 Coll., it is independent of political institutions or the medical technology industry.
Its independence is ensured in particular by the specific way of financing by health insurance companies, and this kind of financing has been used for another legally established independent institution in health care – the Healthcare Surveillance Authority.
Value for money in using scarce resources in health care
There is a limited amount of money in the health sector. It would be ideal if the state could pay each person for the most up-to-date medicines. However, when one million a year is spent on innovative treatment for one person, the amount may theoretically be lacking to pay for 200 hospital stays or the salaries of 40 new nurses in hospitals.
n this context, NIHO looks at whether the money spent on new technology, such as a new cancer medicine, brings sufficient added value compared to current treatments.
Internationally established and transparent procedures according to evidence-based medicine
In policy making, many decisions and arguments are based on impressions, history, relationships, political pressures, lobbying or medical practice, which may not always be in line with new scientific evidence. We bring analyses with a strong emphasis on evidence, not opinions: is the new medicine A really more effective than the older medicine B, regardless of what the pharmaceutical industry or anyone else says?
We evaluate the medical side of things based on the most up-to-date clinical studies of high quality. In particular, we focus on randomized controlled studies bound by strict rules. Opinions and experience stemming from clinical practice, data about patients from the past, etc. are other important components that we take into account for a complex view.
Like many foreign HTA institutions, we use the internationally established EUnetHTA methodology to produce our outputs, especially technology assessments, while striving to keep our procedures as transparent as possible.
Comprehensive expert assessments as a basis for political decisions
t is important for us to be clear about what our role is. NIHO does not make decisions, but comprehensively examines the subject. Our assessment is then passed to the respective reimbursement a committee, where its members issue a final recommendation and the minister of Health issue decisions, taking into account a wide range of factors, including political issues. In some countries, institutions like NIHO make decisions, but as a rule, HTA institutions are advisory bodies.
Independence of interest groups in order to get quality expert statements
It is logical that the health technologies industry wants to sell its products as profitably as possible. It uses all legal means at its disposal to do so, including lobbying for better assessment of its products. However, a truly expert position must not take such pressures into account. To the contrary, it may point to an unpleasant truth that is politically difficult to communicate. Therefore, NIHO has to be independent of political influence, too.
Multidisciplinary approach in cooperation with our partners
HTA has been developed as a highly practical multidisciplinary tool to provide clear and practical recommendations. Therefore, it also includes input from patients themselves and health care professionals, as well as consultations with experts at international level. Virtually all technologies used in our country are used and evaluated abroad, too. Joining forces where possible saves time and resources for all parties.
NIHO was founded on January 1st, 2022. The preparatory work was managed by the HTA Agency Department at the Ministry of Health of the Slovak Republic. The department´s main task was to prepare the legislative framework for the foundation of the new institute. The legislative process, which began in the fall of 2020, was completed on September 22th, 2021 by the approval of Act No. 358/2021 Coll. on the National Institute for Value and Technologies in Health Care. The HTA Agency Department contributed to the process of categorization of new medicines during its time at the Ministry of Health by preparing so-called summaries of assessments of foreign HTA institutions that had already evaluated given medicine (e.g. a summary of the categorization of Beovu medicine). These summaries concerned new medicines with a high impact on the public health insurance budget (VZP). Within the internal processes of the Ministry, the Department also contributed to the rationalization of a new division of reimbursement groups of medicines and worked on analyses in the field of lacking cancer medicinal products, or the system of exceptional reimbursement. It has also created a unit cost database for the purposes of reimbursement applications..