References on Reimbursement (Cost Calculation) for Regenerative Medical Products

  • Calculation Rules for Insurance Reimbursement Prices of Regenerative Medical Products
    • Although regenerative medical products are an independent category under Japanese regulations (PMD Act), there is no independent category under the rules for determining health insurance reimbursement prices (official prices). Therefore, judgments are made based on the calculation rules for either pharmaceuticals or medical devices, depending on the product's mechanism of action and actual usage.
    • 000887194.pdf　Handling of Regenerative Medical Products under Insurance 
    • "Regarding regenerative medical products, based on the characteristics of the individual product for which insurance application was requested, a decision is made on whether to handle it according to the example of pharmaceuticals or medical devices, based on the results of regulatory approval." 
    • Both follow the same point: adopting the comparable product method (similar efficacy comparison method) in principle, and using the cost calculation method if there are no similar products.
    • In either case, it is advisable to refer to information on each case example in addition to materials from the MHLW (Ministry of Health, Labour and Welfare), etc.
  • Those with strong pharmaceutical characteristics:
    • Products that exert effects mainly through pharmacological, metabolic, or immunological actions.    
    • Example: Human somatic cell-processed product "Alofisel Injection" 
    • → Calculated using pharmaceutical calculation rules (Drug Pricing Organization) 
  • Those with strong medical device characteristics:
    • Products that function mainly physically, mechanically, or as tissue replacement/repair.
    • Example: Human (autologous) oral mucosa-derived epithelial cell sheet using human amniotic membrane substrate "SAKRACY" 
    • → Calculated using medical device calculation rules (Insurance Medical Materials Specialist Organization)
  • Materials regarding cost calculation for pharmaceuticals 
    • 001218705.pdf　Criteria for Drug Price Calculation 
    • 001218706.pdf　Handling regarding Listing of Ethical Drugs in the Drug Price Standard 
    • 001575876.pdf Regarding the FY2026 (Reiwa 8) Drug Price Revision (3) 
  • Material regarding Alofisel Injection 
  • Materials regarding cost calculation for medical devices
  • Materials regarding SAKRACY
  • Consultation with MHLW
    • It is recommended to consult with the Medical Industry and Information Systems Division of the MHLW as necessary.
  • Utilizing Hands-on Support
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