A medicinal product entered the reimbursement system as the first similar medicinal product to the reference product, even without submitting the confidential agreements that ensure the cost-effectiveness of the reference product.
During the
proceedings, health insurance funds pointed out that, in practice, a situation
may arise where, even after the statutory 40% price reduction of the first
similar medicinal product, its price would still remain higher than the actual
(contractual) price of the originator product. According to the insurers, such
a situation would result in a breach of the requirement for an efficient
therapeutic intervention.
From the payer’s
perspective, this approach is considered unacceptable in terms of budget
stability and contrary to the public interest.
The State Institute for Drug Control rejected the insurers’ objections with reference to the amendment to the Public Health Insurance Act effective from 1 January 2026. Under this amendment, a similar medicinal product is deemed cost-effective even where the reimbursement of the reference medicinal product of another marketing authorisation holder was influenced by an agreement concluded between that holder and health insurance funds, while no comparable agreement was concluded for the assessed medicinal product.
Part of the
amended statutory provision states:
“Similar medicinal
products shall be deemed to fulfil the conditions of an efficient therapeutic
intervention pursuant to Section 15(6)(d), and the Institute shall not assess
them, except for similar medicinal products of the same marketing authorisation
holder who concluded an agreement with health insurance funds, where such
agreement was decisive for granting reimbursement to the originally reimbursed
medicinal product.”
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.
Our knowledge, your opportunity.
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 5.3.