Fiscal Year 2025 New Listings*

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

New medical device listings

TVC NIRS Catheter

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.

Hot AXIOS™ Stent System

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.

Cook Hemospray Endoscopic Hemostat

GinePro Notes

  • 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.

GinePro Notes

  • 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.

Gore TAG Thoracic Aortic Branch Stent Graft System

GinePro Notes

  • This device enables less invasive treatment of thoracic descending aorta lesions with a central neck located at the position of the aortic arch branch by ensuring blood flow to the left subclavian artery (LSA) using a side branch component. It eliminates the need for hybrid repair using thoracic endovascular aortic repair TEVAR and surgical bypass surgery to the LSA.

  • The manufacturer asked for a Usefulness premium of 20% was only allowed a Usefulness premium of 15% which was reduced to 3% due to low disclosure of the inputs for the cost calculation. Based on that rule, disclosure levels of 50-80% lead to only 50% of the premium being applied and disclosure levels less than 50% lead to only 20% of the premium being applied.

Propel Nasal Stent

GinePro Notes

  • This product is a drug-eluting, bioabsorbable sinus stent. It consists of a self-expanding, bioabsorbable stent and a delivery system for placement. The stent surface is coated with a corticosteroid drug, which is slowly released over approximately 30 days post-surgery. Additionally, it is biodegradable, with approximately 90% decomposing and being absorbed within 30–45 days post-implantation, and all of it decomposing and being absorbed within 60 days.

  • In the future, the Japanese Rhinological Society plans to publish appropriate usage guidelines for this product, including target patients, facility criteria, physician criteria, etc.

  • The manufacturer asked for a Usefulness premium of 15% was only allowed a Usefulness premium of 10% which, similar to the Gore TAG TAB stent graft system above, was reduced to 2% due to low disclosure of the inputs for the cost calculation. Again, based on that rule, disclosure levels of 50-80% lead to only 50% of the premium being applied and disclosure levels less than 50% lead to only 20% of the premium being applied.

CureApp AUD Alcohol Reduction Treatment Support App

GinePro Notes

  • This product is a software as a medical device (SaMD) product that assists in reducing alcohol consumption in patients with alcohol dependence. It allows for intervention outside of consultation hours at appropriate times, frequencies, and amounts tailored to each patient - which is not possible with psychosocial treatment in outpatient settings. It also assists in medical treatment by collecting patient information outside of consultation hours and presenting it to doctors and medical staff during consultations.

  • The manufacturer asked for a Usefulness premium of 5% relative to the hypertension treatment support app functional category, but it was not allowed.

  • This reimbursement is a one-time fee when the product is prescribed. Separately, however, there is a program medical equipment guidance and management fee (B005-14) that allows for 500 JPY for the hospital at initiation and 900 JPY per for the hospital. But a new technical fee will be established for this device so that may change.

  • Currently, CureApp's smoking cessation app there is another technical fees association with nicotine addiction management fee (B001-3-2), so they may allow something like that for treatment using this app as well given that it allows for collecting patient information outside of consultation hours and may involve more treatment management tasks (e.g., review of the data) by physicians.

Conamon PVP Kit

GinePro Notes

  • This is a medical device consisting of bone cement (20g of powdered polymer and 9.4g of liquid monomer), a cement mixer, an injector, and a needle. It is produced by Tecres S.p.A. (Italy).

  • Use of this product for PVP does do not require that a balloon catheter be used to secure the bone cement injection space and can be performed under local anesthesia.

  • Regarding the distinction between this product and percutaneous kyphoplasty (“BKP: balloon kyphoplasty”) for osteoporotic vertebral fractures, the Japanese Society of Interventional Radiology, the Neurospinal Society of Japan, and the Japanese Society for Spine Surgery and Related Research jointly established the “Guidelines for the Appropriate Use of Percutaneous Vertebroplasty (PVP) for Osteoporotic Vertebral Fractures”.

  • It is not entirely clear how they got to 19,800 per gram for the product, but since 20 grams of powder is used one of the reference categories, 164 Vertebral body formation material set, is currently reimbursed at 386,000 JPY they may have referenced that as 20g x 19,800 JPY is close to 386,000 JPY. In fact, the manufacturer asked for a reimbursement of 396,700 JPY, which is also close to the 20g x 19,800 JPY calculation.

Surflo Midela

GinePro Notes

  • This midline catheter (“MC”) has a structure combining a catheter and a metal inner needle, and is inserted into the vein of the upper arm under echo guidance without a guidewire, with the tip of the catheter positioned near the axilla. It serves as an alternative to central venous catheters (“CVC”) and peripherally inserted central catheters (“PICC”) that are inserted for the purpose of establishing venous access for administering medications intended for peripheral veins. It is a single-lumen catheter with a hemostatic valve, enabling high-pressure injection of contrast medium. (The only medications that can be administered with it are those intended for peripheral veins.)

  • The manufacturer asked for a 25% Improvement premium based several factors, such as a smaller impact on the environment (e.g., its disposal after use, etc.), structural improvements that lead to improved safety or effective / less invasive treatment / fewer complications - as shown by improved function and through an approach with strong objectivity and reliability (e.g., a controlled trial), shortening the procedure time healthcare professionals, etc. That would have led to a reimbursement of 6,980 JPY, but a premium was not allowed.

New in-vitro diagnostic device listings

OncoGuide™ EpiLight™ Methylation Detection Kit

GinePro Notes

  • 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.

GENECUBE MPXV

GinePro Notes

  • Mpox has been spreading globally since May 2022. In Japan, the peak of the outbreak occurred in 2023, with a total of 252 cases reported as of 23 May 2025, including one fatality. This test detects pox virus DNA by amplifying target nucleic acids using PCR targeting the F3L gene region of poxvirus and detecting target nucleic acids using a fluorescently labelled probe.

  • The manufacturer received the reimbursement level it requested for the test.

ConcizuTrace ELISA Kit

GinePro Notes

  • This test is used to measure the concentration of concizumab in plasma to assist in determining the appropriate dosage of concizumab in patients with hemophilia A and hemophilia B who are receiving concizumab (brand name: Alhemo subcutaneous injection). Novo Nordisk's Alhemo (concizumab) was reimbursed in Japan in November 2023 for suppression of bleeding in patients with congenital hemophilia who have inhibitors to blood coagulation Factor VIII (hemophilia A)or Factor IX (hemophilia B). The maintenance dose Alhemo (concizumab) is tailored based on plasma concentrations to achieve therapeutic efficacy and this tests supports that.

  • The manufacturer received the reimbursement level it requested for the test.

ipsogen IDH1 Mutation Detection Kit RGQ [Qiagen]

GinePro Notes

  • This test uses real-time PCR to detect five types of IDH1 gene mutations in genomic DNA extracted from peripheral blood or bone marrow aspiration fluid (as an adjunct to determining the suitability of ivosidenib (brand name: Tibsovo) for patients with acute myeloid leukemia. Tibsovo (ivosidenib) was reimbursed in Japan in May 2025 for acute myeloid leukemia with IDH1 gene mutation positivity.

  • Based on the Japanese Society of Hematology's guidelines for the diagnosis and treatment of hematologic tumors, this test is used to determine the presence or absence of IDH1 gene mutations in patients who are untreated and not eligible for intensive chemotherapy.

  • The manufacturer received the reimbursement level it requested for the test.

Elecsys reagent β-amyloid 1-42 / Elecsys reagent Phosphorylated tau 181

GinePro Notes

  • The Optimal Use Guidelines (OUG) established by the Ministry of Health, Labour and Welfare require findings suggestive of amyloid positivity by either evaluation of PET drug uptake in the brain using amyloid PET imaging or evaluation of the t-tau/Aβ (1-42) ratio in CSF in order for Eisai's novel Alzheimer's treatment, Leqembi (lecanemab), to be initiated or re-started. Eisai's Leqembi (lecanemab) was reimbursed in Japan in December 2023.

  • This test measures β-amyloid 1-42 (“Aβ42”) and 181-position phosphorylated tau protein (“pTau”) in cerebrospinal fluid using the electrochemiluminescence immunoassay (ECLIA) method. By calculating the pTau/Aβ42 ratio based on the measurement values, this test assists in assessing the accumulation status of amyloid β in the brain.

  • The manufacturer received the reimbursement level it requested for the test.

New regenerative medicine listings

There have been no new listings for regenerative medicine / cellular therapies since 1 April 2025

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three person walking on stairs between green trees