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 is not clear what improvement was claimed.

• 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.

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.

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.

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.

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.

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.

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.

GinePro Notes

• The GORE® EXCLUDER® Thoracoabdominal Aortic Branch Stent Graft System (referred to as the "TAMBE" system), is an aortic stent graft system designed to prevent aneurysm expansion and rupture by occluding blood flow to thoracoabdominal aortic aneurysms and para-renal abdominal aortic aneurysms while preserving blood flow to the celiac artery, superior mesenteric artery, and bilateral renal arteries. The GORE® VAIBAHN® VBX® Balloon-Expandable Stent Graft was listed before but its definition was updated to allow for use with the TAMBE system.

• The GORE® Tri-Lumen® Catheter is used to pass guidewires through each branch vessel when placing the stents into the abdominal aortic branches.

• The manufacturer asked for a much higher reimbursement price for the TAMBE system, which would have been 1.61 times the US price, but it ended up with around 50% of the price it requested.

• It received a small premium due to a rapid launch in Japan of about 0.5% (which was calculated based on 50% of the its final Usefulness premium of 1%). However, that premium is limited to a 2-year period following its listing.

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.

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 poxvirus 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.

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.

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.

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.

GinePro Notes

• This is an IVD device intended for the detection of Entamoeba histolytica antibodies in serum to assist in the diagnosis of Entamoeba histolytica infection. The measurement principle is the ELISA method, which utilizes antigen-antibody reactions to capture Entamoeba histolytica antibodies in serum specimens.

• Amoebic dysentery is a Category V infectious disease in Japan under the Infectious Diseases Control Law. It is classified into three forms: colitis (intestinal tract), liver abscess (extraintestinal), and fulminant form (intestinal tract).

• Category V infectious diseases also include 40+ other conditions which require prevention of spread such as hepatitis E, hepatitis A, carbapenem-resistant Enterobacteriaceae infection, severe invasive streptococcal infection, acquired immunodeficiency syndrome, invasive Haemophilus influenzae disease, invasive meningococcal disease, invasive pneumococcal disease, varicella that require hospitalization, syphilis, tetanus, vancomycin-resistant Staphylococcus aureus infection, vancomycin-resistant enterococcal infection, pertussis, rubella, measles, etc.

• Guidelines for the use of this product, titled “Guidelines for the Proper Use of Serum Ameba Antigen Test Kits,” are scheduled to be issued through a collaboration with 5 academic societies in Japan: the Japanese Society for AIDS Research, the Japanese Society of Parasitology, the Japanese Society of Tropical Medicine, the Japanese Society for Clinical Microbiology, and the Japanese Society for Infectious Diseases).

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

GinePro Notes

• Dystrophic epidermolysis bullosa (DEB) is a rare genetic disorder. It is the most common type of epidermolysis bullosa (EB) comprising about 50% all EB cases. EB as a whole is recognized as one of 330 specified intractable diseases in Japan, meaning that those that require treatment typically receive support with all or nearly all of their out-of-pocket treatment costs.

• There are autologous cultured epidermis products in Japan that are classified as regenerative medicine / cellular therapies, such as Japan Tissue Engineering's JACE, but Vyjuvek gel is considered the first topical gene therapy.

• This is an example of a drug lag in Japan in the sense that Vyjuvek has been available for patients in the US since 2011 and in the EU since 2013, but was not approved in Japan until July of this year. While Vyjuvek was not part of the conditional approval program like several other regenerative medicined and cellular therapies in Japan, its long-term safety and efficacy must be shown in approximately 200 cases as part of its post-marketing surveillance requirements with a follow-up period of 3 years and 6 months for each patient enrolled. The survey period will be 9 years and 6 months from the start of sales.

• Regenerative medicine treatments may be reimbursed using the drug or device reimbursement pathway depending on which they are closer to. Last year Aurion Biotech's Vyznova was reimbursed using the device pathway, but Vyjuvek was reimbursed using the drug reimbursement pathway similar to CAR-T therapies, Zolgensma (onasemnogene abeparvovec) and several other cellular and gene therapy products.

• Vyjuvek received a Usefulness I premium of 50% for its novelty and Market Size I premium of 15% for having received

  orphan designation and conducting a clinical trial in Japan. But none of that was applied to its reimbursement price due to low disclosure of its cost inputs for the cost-based reimbursement calculation, which is a common issue for products that are not manufactured in Japan. The receipt of orphan designation, however, did qualify it for the price maintenance premium (PMP), which will defer most or all of its biennial price cuts for up to 15 years.

• Despite having a reimbursement nearly 3 million JPY (nearly 20,000 USD) for two vials and annual treatment costs of nearly 49 million JPY (nearly 390,000 USD) per patient per year and despite having nominally received a high premium and being reimbursed using the cost-based approach, Vyjuvek was not selected for an HTA review. As DEB is a intractable disease the threshold for selection under the H1 and H2 selection criteria is an estimated peak sales of 35 billion JPY per year in Japan. Moreover, the treatment cost was not considered high enough for selection under the H3 selection criteria.

• Note that, while this product was not approved based on the conditional and time-limited approval system like some other regenerative medicine and cellular therapies, the reimbursement authorities in Japan, namely the Chuikyo, are currently debating whether premiums should be allowed for products approved under that system. Moreover (yet again) some Chuikyo members have suggested that a separate reimbursement approach should considered for regenerative medicine and cellular therapies in Japan given their high cost and difficulty of development.

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