The Institute
initiated an ex officio abbreviated reimbursement review on the grounds
of the entry of the first similar medicinal product into the
reimbursement system, without undue delay after verifying that the product
concerned had been placed on the Czech market.
However, one of
the affected marketing authorisation holders appealed against the initiation of
the proceedings, arguing that the entering product was not the first similar
medicinal product and referring to earlier proceedings in which the newly
entering product had not been assessed as similar.
The Ministry of
Health (MoH) rejected this objection, stating that although in the referenced
proceedings the assessed product and the reference (originator) product
contained the same active substance, they differed in dosage, standardisation
units and pharmaceutical forms. At the same time, the products were assessed
against additional criteria—such as therapeutic indications or pharmacological
properties—and, on that basis as well, were not considered similar.
In the present
case, however, the MoH considers the medicinal product concerned to be a generic
within the meaning of the Act on Medicinal Products. The products involved in
the proceedings contain the same active substance and a comparable
pharmaceutical form as the reference product, and the appellant repeatedly
failed to demonstrate otherwise.
In the case under
review, the conditions for initiating a review on the grounds of the entry of
the first similar medicinal product were therefore met.
The MoH further notes that although, under the legislation applicable at the time, SÚKL could have initiated the proceedings earlier, the appellate authority considers the approach whereby SÚKL waited for the first actual supply of the medicinal product concerned to be appropriate and well justified. This prevented a reduction in reimbursement for similar products based on a first similar medicinal product that was not yet commercially available.
Pursuant to the amendment to the Public Health Insurance Act, in abbreviated reviews initiated after 1 January 2026, there is now an obligation to verify market availability at a minimum level of 5%, or 2% for ZÚLP.
Are you interested in reading regular commentaries on decisions by
Pharmeca a.s.? Feel free to contact us.
At Pharmeca, we help you navigate the complex landscape of
pharmaceutical and medical device information. We also offer flexible services
that can be tailored to your needs at any time.
Our market position and experience allow us to support you whenever you
need expert guidance.
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 State Institute for Drug Control (SÚKL) has published an updated, already 3rd version of Guideline CAU-08 – Requirements for the structure of expert documentation supplementing an application and for the structure of statements of other participants when submitting evidence in proceedings on the determination or change of the amount and conditions of reimbursement of medicinal products / partially reimbursed medicinal products, effective as of 2 January 2026.
The main change is the introduction of a new Annex No. 5 – Structured Submission A for marketing authorisation holders – immunisation.
SÚKL has published an updated version of guideline CAU-08 - Requirements on the structure of technical documentation to be submitted along with applications and on the structure of opinions of...
The State Institute for Drug Control (SÚKL) has published an updated, already 3rd version of Guideline CAU-08 – Requirements for the structure of expert documentation supplementing an application and for the structure of statements of other participants when submitting evidence in proceedings on the determination or change of the amount and conditions of reimbursement of medicinal products / partially reimbursed medicinal products, effective as of 2 January 2026.
The main change is the introduction of a new Annex No. 5 – Structured Submission A for marketing authorisation holders – immunisation.
SÚKL has published an updated version of guideline CAU-08 - Requirements on the structure of technical documentation to be submitted along with applications and on the structure of opinions of...
The State Institute for Drug Control (SÚKL) has published an updated, already 3rd version of Guideline CAU-08 – Requirements for the structure of expert documentation supplementing an application and for the structure of statements of other participants when submitting evidence in proceedings on the determination or change of the amount and conditions of reimbursement of medicinal products / partially reimbursed medicinal products, effective as of 2 January 2026.
The main change is the introduction of a new Annex No. 5 – Structured Submission A for marketing authorisation holders – immunisation.
SÚKL has published an updated version of guideline CAU-08 - Requirements on the structure of technical documentation to be submitted along with applications and on the structure of opinions of...
The Ministry of Health (MoH) assessed whether the conditions
for increasing reimbursement on the grounds of ensuring at least one fully
reimbursed medicinal product within a group of substitutable products had been
met in the context of a comprehensive review (Section 39c(5) of the Public
Health Insurance Act).
According to the MoH, it was not possibleto designate the
product referenced in the proceedings as a relevant fully reimbursed medicinal
product for two main reasons:
the referenced product had
reported an interruption of its placing on the domestic market effective as of
25 December 2023, i.e. prior to the date on which the contested decision
(issued on 27 November 2023) became enforceable. In the case of a product with
a notified interruption, a temporary supply disruption may reasonably be
assumed, and consequently the practical impossibility of its full
reimbursement;
the referenced product is also
reimbursed for the treatment of bladder cancer. The products for which the
reimbursement increase was assessed are reimbursed exclusively for patients
with renal cancer and soft tissue sarcoma. Although bladder cancer and renal
cancer both fall under carcinomas of the urogenital tract, the MoH does not
consider them to constitute diseases of the same type within the meaning of the
legal opinion of the Constitutional Court.
Full reimbursement for the group of patients with the
indication of bladder cancer could therefore not be ensured through the
assessed product but was secured through other medicinal products.
Are you interested in reading regular commentaries on decisions by
Pharmeca a.s.? Feel free to contact us.
At Pharmeca, we help you navigate the complex landscape of
pharmaceutical and medical device information. We also offer flexible services
that can be tailored to your needs at any time.
Our market position and experience allow us to support you whenever you
need expert guidance.
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 State Institute for Drug Control (SÚKL) has published an updated, already 3rd version of Guideline CAU-08 – Requirements for the structure of expert documentation supplementing an application and for the structure of statements of other participants when submitting evidence in proceedings on the determination or change of the amount and conditions of reimbursement of medicinal products / partially reimbursed medicinal products, effective as of 2 January 2026.
The main change is the introduction of a new Annex No. 5 – Structured Submission A for marketing authorisation holders – immunisation.
SÚKL has published an updated version of guideline CAU-08 - Requirements on the structure of technical documentation to be submitted along with applications and on the structure of opinions of...
The State Institute for Drug Control (SÚKL) has published an updated, already 3rd version of Guideline CAU-08 – Requirements for the structure of expert documentation supplementing an application and for the structure of statements of other participants when submitting evidence in proceedings on the determination or change of the amount and conditions of reimbursement of medicinal products / partially reimbursed medicinal products, effective as of 2 January 2026.
The main change is the introduction of a new Annex No. 5 – Structured Submission A for marketing authorisation holders – immunisation.
SÚKL has published an updated version of guideline CAU-08 - Requirements on the structure of technical documentation to be submitted along with applications and on the structure of opinions of...
The State Institute for Drug Control (SÚKL) has published an updated, already 3rd version of Guideline CAU-08 – Requirements for the structure of expert documentation supplementing an application and for the structure of statements of other participants when submitting evidence in proceedings on the determination or change of the amount and conditions of reimbursement of medicinal products / partially reimbursed medicinal products, effective as of 2 January 2026.
The main change is the introduction of a new Annex No. 5 – Structured Submission A for marketing authorisation holders – immunisation.
SÚKL has published an updated version of guideline CAU-08 - Requirements on the structure of technical documentation to be submitted along with applications and on the structure of opinions of...
