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The amendment introduced a new type of reimbursement procedure for products intended for immunisation (vaccines), designed primarily for non-mandatory vaccination. As of 1 May 2026, according to information from the State Institute for Drug Control (the Institute), 10 administrative proceedings had been initiated and are currently at various stages of progress.

This type of procedure is intended to apply the principle of multi-criteria assessment, placing emphasis not only on economic but primarily on non-economic criteria reflecting broader societal needs and interests.
In addition to the standard reimbursement criteria (safety, efficacy and, in the case of vaccines, immunogenicity), the criteria assessed also include, for example:

• the severity of the disease targeted by the vaccine,
• the broader societal importance of prevention,
• the public health benefit, including increased herd immunity, prevention of threats to public health, and support for and improvement of population health,
• recommendations issued by professional societies and institutions.

A different approach also applies to budget impact, where a high budget impact may reflect high vaccination uptake, which is desirable in this context. Budget impact is therefore assessed as the difference between the costs of prevention and the costs of treatment, diagnostics and broader societal costs that would arise in the absence of immunisation.

The Institute’s assessment report will also include an opinion of the National Institute of Public Health (SZÚ). SZÚ has already provided opinions in the first two administrative proceedings, focusing in detail on the epidemiology of the diseases concerned. It also addresses the health, societal and economic impacts of the diseases and the extent to which these may be mitigated through vaccination. The opinion further includes a recommended time horizon for the budget impact analysis, taking into account the characteristics of the disease, as well as an overview of currently applicable vaccination recommendations.

As in the case of orphans, the assessment report will subsequently be reviewed by the advisory body of the Ministry of Health (MoH) during a closed session, in which a conciliation procedure will take place.

The subsequently issued binding opinion of the MoH will then be incorporated into the final decision issued by the Institute. 

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The article is based on publicly available information concerning administrative proceedings conducted by SÚKL in the area of pricing and reimbursement.

The text was translated using ChatGPT 5.2.