Objective: The paper analyzes the types of dosing uncertainty in drug medical insurance access and proposes optimized pathways for cost estimation. Methods: Based on policy documents and literature analysis, dosing uncertainty was categorized from the perspective of annual treatment cost estimation, and major practices regarding dosing assumptions and evidence requirements in different countries were compared. Results: Dosing uncertainty can be classified into five types: fixed-dose escalation, weight/body surface area dependence, variable treatment duration, indication/subgroup stratification, and dose reduction due to combination therapy. International experience suggests that dosing assumptions should be determined based on the target population and real treatment pathways, with dynamic validation through scenario analysis, stratified accounting, and post-marketing surveillance. Conclusion: It is recommended to establish rules for type-based identification and stratified estimation, strengthen dosing precision requirements in economic evaluation, and implement dynamic validation linked to payment mechanisms, so as to enhance the scientific rigor and feasibility of medical insurance access assessment.
Key words
medical insurance access /
drug dosing /
annual treatment cost /
estimation bias /
classification framework
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