FY2024 New Medtech and Regeneriative Medicine Listings

*The government fiscal year in Japan is from April to March, so fiscal year 2025 is from April 2025 to March 2026

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.

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.

The 212: Peptide-derived absorbent localized hemostatic agent functional category was established in FY 2021 with the listing of 3-D Matrix's PureStat product. At the time they referenced another hemostat functional category, 151: Starch-derived absorbent localized hemostatic agent which was established in FY 2010.
The reimbursement of this product was based on the assumption that 20g is to be used per procedure, meaning that reimbursement per procedure would be 52,800 JPY (2640 JPY x 20g).
Reimbursement of the delivery system much also be covered by those fees. If the volume used exceed 20g then the medical rationales needs to be stated in the reimbursement filing / report.
The manufacturer asked for 176,000 JPY per unit based on the Cost Calculation Method and a Usefulness premium of 15%. This would have led to a ratio of 1.42 relative to the average foreign reference price, which was 124,150 JPY and ranged from 98,604 JPY in Australia to 386,250 JPY in the United States. So, unfortunately, they ended up with a much lower reimbursement amount than they requested.

This product seems to have a similar indication as Cook Medical's Hemospray Endoscopic Hemostat above but used a different peak year and peak volume assumption. Our understanding is that manufactures are allowed to submit their own assumptions concerning the peak annual volume (patients) and there are no specific guidelines on how to calculate that figure.
Up to 3 grams used per procedure was assumed - or 52,800 JPY (17,600 JPY x 3 grams).
Reimbursement of the delivery system much also be covered by those fees. If the volume used exceed 3g then the medical rationales needs to be stated in the reimbursement filing / report.
The manufacturer asked for 21,000 JPY per gram based on the Cost Calculation Method and an Improvement premium of 10%. This would have led to a ratio of 0.63 relative to the average foreign reference price, which was 33,400 JPY and ranged from 40,600 JPY in US to 30,100 JPY in Germany and France.

DNA methylation involves the addition of methyl groups to cytosine bases, which can influence gene expression without altering the DNA sequence. Aberrant methylation patterns are implicated in various diseases, including cancer, where hypermethylation of tumor suppressor genes or hypomethylation of oncogenes can drive tumorigenesis. Methylation detection kits, like this one are designed to identify these patterns for diagnostic, prognostic, or research purposes.
The manufacturer asked for a reimbursement of 50,000 JPY per test based on the D006-4 Genetic testing (2) complex processing testing code, but the D004-2 Malignant tumor tissue test code was used instead similar to many other companion diagnostic tests.