Presentation (CTI)

OBJECTIVES: This analysis aimed to evaluate the alignment between the 2026 update of the Polish HTA guidelines and methodological documents developed under the EU HTA framework, and to assess the implications for the use of Joint Clinical Assessment (JCA) reports in national reimbursement processes.
METHODS: A comparative analysis was conducted between the updated Polish HTA guidelines in scoping and clinical analysis and EU HTA methodological guidance, dossier templates, and Commission Implementing Regulations. Similarities and differences were identified and assessed regarding their potential impact on the applicability of JCA within the Polish HTA process.
RESULTS: The updated Polish guidelines incorporate a few concepts reflected in EU HTA guidance in terms of outcomes and comparators. They also refer to EU methodological recommendations on indirect treatment comparisons, meta-analyses, and reporting of multiplicity issues. Nevertheless, a few methodological differences were identified, such as discrepancies in literature search requirements, with Polish guidelines specifying three core bibliographic databases compared to a minimum of two in EU guidance. Unlike JCA requirements, the Polish guidelines allow clinical effectiveness assessments based on single-arm studies when indirect comparisons are not feasible and require descriptive analyses when quantitative synthesis cannot be performed. Furthermore, they require presentation of relevant systematic reviews, allow broader inclusion of evidence for safety assessment, and do not explicitly permit exclusion of lower-certainty evidence when higher-quality studies sufficiently address the research question.
CONCLUSIONS: Although increasing methodological convergence between Polish and EU HTA requirements can be observed, significant differences persist, which may limit the direct use of JCA reports in national reimbursement assessments and necessitate supplementary analyses. While Polish reimbursement legislation allows JCA reports to replace the national clinical assessments, practical experience gained during HTAR implementation will be essential to determine the extent to which JCA can support decision-making in Poland.