Improving cost assessment and health economic evaluation of a new medical technology during clinical approbation: the role of a structured costing tool

Objective. To improve cost assessment and health economic evaluation of a new medical technology during clinical approbation. Material and methods. We reviewed the scientific literature on the implementation of clinical approbation (CA) published between 2015 and 2025 and conducted a content analysis of regulatory legal acts governing the organization and financing of CA. We also analyzed materials from an expert forum organized by the Center for Expertise and Quality Control of Medical Care of the Ministry of Health of the Russian Federation in 2025 to mark the tenth anniversary of CA. In addition, we analyzed data from a pilot project on the use and implementation of a structured costing tool in the routine process of calculating the costs per CA case at the Dmitry Rogachev National Medical Research Center for Pediatric Hematology, Oncology and Immunology of the Ministry of Health of the Russian Federation. Results. Two systemic problems were identified: the lack of a standardized approach to estimating the costs of the investigational method and the inability to subsequently conduct a valid health economic evaluation. A structured costing tool adapted to CA was developed to calculate the cost per CA case. The tool enables transparent planning of the costs associated with the investigational method and their comparison with the costs of the comparator method based on a unified methodology. The pilot project generated data supporting the validity of the costing tool adapted to the specific objectives of CA. The tool can therefore be considered a promising instrument, although further evaluation in a larger number of medical organizations is warranted. Conclusion. Implementation of a standardized costing tool in clinical approbation practice ensures methodological consistency in economic calculations and provides a basis for the evidence-based transition of innovative medical technologies into the public healthcare financing system. The proposed methodology can be scaled up across medical organizations involved in the planning and implementation of CA.