The Supreme Administrative Court (SAC) confirmed that a current cost-effectiveness analysis (CEA) must be submitted in cases where the requested reimbursement corresponds to the base reimbursement of the reference group, but exceeds the reimbursement granted to other therapeutically interchangeable medicinal products. According to the Court, the decisive factor is whether the proposed change will generate savings for the system or, conversely, increase expenditure.
In the administrative proceedings, the marketing
authorisation holder applied for an increase in the reimbursement of its
medicinal product. In its view, the request merely sought to align
reimbursement with the level of the base reimbursement established for the
relevant group in a previous review and therefore did not require new economic
evidence.
However, both SÚKL and the Ministry of Health insisted on
the submission of supporting analyses and discontinued the proceedings due to
their absence.
According to the administrative authorities, the Public Health Insurance Act requires a cost-effectiveness assessment and budget impact analysis whenever the proposed change in reimbursement is expected to increase expenditure from the public health insurance system and the requested reimbursement exceeds that of other medicinal products that are essentially therapeutically interchangeable.
The SAC stated that such analyses are not required where a
medicinal product generates savings for the public health insurance system.
However, where no savings are expected and the proposal results in a negative
budget impact, their submission is necessary.
In the case at hand, the proposed reimbursement increase
demonstrably showed signs of an expected negative budget impact (higher costs),
while the requested reimbursement exceeded that of the only therapeutically
interchangeable medicinal product. Since both statutory conditions were met,
the applicant was required to submit a cost-effectiveness analysis.
The Court therefore definitively confirmed the approach established under the legislation effective since 2022: whenever the requested reimbursement exceeds that of other therapeutically interchangeable medicines on the market, its cost-effectiveness must be demonstrated through updated evidence.
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The article is based on publicly available court decisions published on official judicial websites.
The text was translated using ChatGPT 5.3.