The Ministry of Health (MoH) assessed whether the medicinal product under review met the criteria for being designated as a highly innovative medicinal product (VILP). In the proceedings on the determination of the amount and conditions of price and reimbursement, the Institute for Drug Control (SÚKL) had refused to grant initial temporary reimbursement, as it concluded that the product did not meet the VILP criteria.
The main reasons cited were:
According to the SÚKL,
unless the VILP criteria are met against all relevant comparators under
assessment, the product cannot be granted temporary reimbursement, even under
modified conditions.
The MoH upheld the SÚKL’s
decision and additionally highlighted the inappropriateness of relying on
abstracts, which are condensed summaries and do not provide sufficient detail
on the underlying data. On this basis, the administrative authority cannot
responsibly assess the presented evidence.
Furthermore, the MoH recommends not submitting key scientific
data under confidentiality restrictions if a detailed evaluation
is expected, as any public assessment of such protected data can only remain of
a general nature.
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Articles on decision-making practice are based on publicly available texts from the decisions of the Ministry of Health of the Czech Republic and the State Institute for Drug Control (SÚKL).
A continuously updated overview of decisions issued by SÚKL and the Ministry of Health in the field of pricing and reimbursement is available on the Pharmeca a.s. website.
The text was translated using ChatGPT 5.3.