In an administrative procedure conducted by the State Institute
for Drug Control (SÚKL), objections raised by payers regarding
cost-effectiveness were not upheld. The payers argued that the evaluated
therapy could not be considered cost-effective due to the existence of
cost-reducing agreements concluded between insurers and the marketing
authorization holders of comparably effective medicinal products.
SÚKL, in its first-instance decision, did not take these
cost-limiting agreements into account, reasoning that the agreements were not
decisive for the reimbursement of the comparably effective therapies, which
were cost-effective even without such arrangements.
The correctness of this approach was confirmed by the Ministry of
Health (MoH) during the appeals process, stating that administrative
proceedings must be based on verifiable data. SÚKL cannot rely on claimed cost
levels of comparably effective therapies if such data is not available to it.
Therefore, SÚKL rightly based its assessment on publicly available
reimbursement data listed in the Price and Reimbursement List.
Following this MoH decision, another ministerial ruling was issued
concerning the reimbursement of a product included in the same reimbursement
group as in the aforementioned case.
Again, SÚKL justified its decision not to consider the existence
of agreements in setting the reimbursement for the comparably effective therapy
in a similar manner to the previous case.
The MoH confirmed this approach as well, reasoning that essential
parts of the agreements—specifically the agreed manufacturer’s maximum
price—were confidential. As such, these agreements could not be taken into
consideration during the procedure.
The Ministry of Health’s reasoning may influence SÚKL’s approach
in cases involving confidential agreements affecting the reimbursement of a
comparator/reference product/comparably effective therapy.
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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 4o.