GinePro Notes

• The manufacturer asked for reimbursement using the Cost Calculation Method and a Usefulness premium of 15% but it was not allowed - presumably because it was not perceived as being different enough from the existing products in the "149 Catheter for intravascular optical tomography" functional category. That functional category was established in 2010 and has fallen from 148,000 JPY to 132,000 JPY since that time.

• The denial of a new functional category for this product seems a bit strange given that the "149 Catheter for intravascular optical tomography" includes primarily optical coherence tomography (OCT) devices such as Abbott's Dragonfly OpStar imaging catheter and Terumo's FastView intravascular optical tomography catheter and this new devices is somewhat different from that that. The TVC NIRS catheter, on the other hand, is a dual-modality intravascular imaging system that combines ultrasound and spectroscopy technologies. It serves a distinct purpose that differs from optical tomography catheters, focusing on plaque characterization and vessel structure assessment rather than high-resolution tissue imaging.

GinePro Notes

• This product was approved for marketing as an improved technology relative to the original Hot Axios System which was listed in FY 2018. For this new version, the manufacturer asked for reimbursement based on the existing functional category (201: Pancreatic fistula formation prosthetic implantation system) without any premiums, suggesting that they may have been aiming for the establishment of a new technical fee (see our update here for details on that approach). It was approved last last year for partial change of the approved items with the extension of its application to include acute cholecystitis.

• The 201: Pancreatic fistula formation prosthetic implantation system functional category itself was established in FY 2018 with the listing of the original Hot Axios System, which was reimbursed using the Cost Calculation Method. Its reimbursement has remained the same since that time.

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