The conditions for
reimbursement of off-label indications are governed by Section 39b(3) of the
Act on Public Health Insurance. To establish reimbursement, it is necessary to
demonstrate that the use of the assessed medicinal product in the given off-label
indication is sufficiently justified by current scientific knowledge and that
its use represents the only available treatment option.
If it is not the only
treatment option, reimbursement can still be granted provided that the
applicant demonstrates cost-effectiveness compared to existing therapies.
If
the condition of sufficient scientific justification is not met during the
procedure, the Institute does not assess compliance with the remaining
conditions.
Sufficient scientific
knowledge is evaluated based on the evidence related to the specific
indication. Recently, the State Institute for Drug Control (SÚKL) reached
different conclusions on this condition for two indications of the same
product: the treatment of high-grade squamous intraepithelial lesions of the
vulva (HSIL) and extramammary Paget’s disease of the vulva (EMPD). Both
proposed indications, HSIL and EMPD, are off-label.
The Institute determined that,
based on available evidence, the use of the product in the treatment of vulvar
HSIL is sufficiently supported by current scientific knowledge. Additionally,
the product was found to be cost-effective, and therefore the reimbursement
conditions for this off-label indication can be established.
In contrast, for EMPD, the use of the product was deemed
insufficiently justified. The studies provided exhibited several methodological
limitations, such as small patient samples, lack of a control arm, and
observational design. As a result, the Institute proposes not to grant
reimbursement for the EMPD indication.
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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.