In proceedings concerning orphan medicinal products, State Institue for Drug Controla (SÚKL) is authorised to assess the pharmacoeconomic analyses submitted by the parties but does not have the competence to generate such analyses itself.
Although, in proceedings under Section 39da initiated at the request of a health insurance fund, the marketing authorisation holder is not formally subject to an enforceable obligation to submit pharmacoeconomic analyses of a defined quality, the assessment of clinical benefit, cost-effectiveness and budget impact remains a key prerequisite for determining the appropriateness of reimbursement from public health insurance. The absence of a cost-effectiveness analysis is therefore considered a material deficiency.
While the results of the cost-effectiveness analysis (ICER) are not formally applied as a decision-making threshold, budget impact and value for money considerations remain implicitly present in the assessment of the public interest.
A declared intention to conclude budget cap agreements does not constitute a binding basis for a reimbursement decision unless such arrangements have been incorporated into SÚKL’s assessment report prior to the issuance of the opinion of the Ministry of Health.
Individual reimbursement granted under Section 16 for exceptional cases does not establish an automatic entitlement to system-wide reimbursement under Section 39da, where the existence of a public interest constitutes the primary statutory condition.
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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.
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