SÚKL, in the reimbursement review, assessed the expansion of JAK
inhibitors reimbursement for rheumatoid arthritis ("RA") with
moderate disease activity as sufficiently supported by clinical data and
desirable for clinical practice in the Czech Republic.
Given that such an expansion of reimbursement conditions would result in
an increase in the number of treated patients, it is necessary to evaluate the
cost-effectiveness and the budget impact. Since SÚKL did not receive a
pharmacoeconomic evaluation from the participants in the required scope, the
expansion of reimbursement for rheumatoid arthritis with moderate disease
activity was carried out by setting the reimbursement for JAKi at the cost
level of another therapy that is (at least) equally effective and already
reimbursed for the target group of patients with RA and moderate disease
activity. The approach chosen by SÚKL in the ongoing reimbursement review,
therefore, by setting two reimbursement levels, ensures that JAKi remain
reimbursed for RA with high disease activity in the second and subsequent lines
of treatment with higher reimbursement, while JAKi are also newly reimbursed
for moderate disease activity, though at a lower reimbursement amount.
The participant argued that a medicinal product may only have one
additional increased reimbursement level set, alongside the basic reimbursement
(not multiple increased reimbursement levels, as SÚKL did). SÚKL refers to
Section 39b, paragraph 11 of the Health Insurance Act, which does not exclude
the possibility of applying it based on the evaluation of a medicinal
substance, product, or pharmaceutical form for several selected indications or
for multiple patient groups.
SÚKL also states that during the ongoing reimbursement review, no
statements were received from payers regarding any difficulties in reporting
healthcare when establishing multiple reimbursement levels.
Articles from decision-making practice are based on publicly available
texts from decisions by the Ministry of Health of the Czech Republic and
decisions by SÚKL.
On the website of Pharmeca a.s., you can continuously follow an overview of the pricing and reimbursement decisions issued by SÚKL and the Ministry of Health of the Czech Republic.
Articles on decision-making practice are based on publicly available texts of the Ministry of Health and SÚKL decisions.
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Pharmeca a.s.? Feel free to contact us.
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