In proceedings concerning the determination or modification of the amount and conditions of permanent reimbursement of medicinal products, where pharmacoeconomic evidence is submitted, comparative clinical efficacy and safety must be demonstrated against all relevant comparators. According to the methodology of the State Institute for Drug Control (SÚKL), relevant comparators may include therapies that are commonly or routinely used and reimbursed from public health insurance. These are not limited to medicinal products.
The requirement for relevant comparators was modified in 2022 for
proceedings on the reimbursement of orphan medicinal products (Section 39da),
when the advisory body of the Ministry of Health introduced the following
requirement for this specific type of proceedings: “…that any future application for reimbursement of an orphan
medicinal product for which comparators reimbursed from public health insurance
exist (whether with reimbursement determined by the Institute in administrative
proceedings or under Section 16 of Act No. 48/1997 Coll.) must include a
cost-effectiveness analysis against such comparators.”
As a result, in reimbursement proceedings for orphan medicinal
products conducted under Section 39da, therapies reimbursed not routinely but
under exceptional reimbursement pursuant to Section 16 are commonly
included among comparators—even in cases where their use is off-label
within the given indication.
This approach has also been identified in proceedings concerning
the determination of permanent reimbursement for a non-orphan medicinal
product, where SÚKL likewise accepted as a comparator a product reimbursed
under Section 16.
However, in another case involving the use of a comparator
reimbursed under Section 16, SÚKL argued in its assessment report, for example,
as follows: “…treatment provided under Section 16 of the Public Health
Insurance Act is, by its nature, exceptional and cannot be considered the least costly standard option for the purposes of general reimbursement
setting…’”
It remains to be seen whether, in the future, the approach to the use of Section 16 comparators will become harmonised across different groups of medicinal products, and whether the position of Section 16–reimbursed treatments will gain greater importance even in standard reimbursement proceedings.
Section 16 of Act No. 48/1997 Coll., on Public Health Insurance
The competent health insurance fund shall reimburse, pursuant to
Section 19(1)(a), in exceptional cases healthcare services otherwise not
covered by health insurance, provided that the provision of such healthcare
services constitutes the only option in view of the insured person’s health
condition.
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Articles 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).
The text was translated using ChatGPT 5.3.