GinePro Notes

• This is one of the first products to have received the newly introduced Economic Efficiency premium. Please see the update here for more information on that.

• Evidence from an expert consensus statement was used as the baseline for the evidence submission. The statement itself can be found here.

GinePro Notes

• Although is covers a broader indication than VARIPULSE, it received the same reimbursement.

• The manufacturer requested a reimbursement of 796,000 JPY based on a 15% Usefulness premium but only received 681,000 JPY - possibly because the reimbursement requested by VARIPULSE was much lower (670,000 JPY).

GinePro Notes

• Moderate-to-severe paravalvular leaks (PVLs) can have a substantial impact on quality of life (QOL) for patients (essentially similar to heart failure) and studies have shown that percutaneous PVL closure is associated with better QoL for patients. So it seems to me that a higher premium was warranted. In fact, they had asked for 10% Usefulness premium relative to "131 Percutaneous atrial septal defect closure set" functional category which would have allowed for a reimbursement of 849,000 JPY. But the reimbursement received was at par with the reference markets.

• The Usefulness (c)-(i) rationale is one of the most commonly use rationale for a Usefulness premium.

GinePro Notes

• Reimbursement received for Japan was substantially lower than the reference markets (0.53) despite the Cost Calculation Method being used. About 1 out of 4 newly listed reimbursed medical devices receive a reimbursement that is 75% or less than the average foreign reference price, but very few fall below the 60% level.

• They had asked for reimbursement of 1,938,000 JPY based on the Cost Calculation Method and 20% Usefulness premium. However, only one product (Medtronic Sofamor Danek's SHILLA Growth Guidance System) has received a Usefulness premium that high since 2015. So the lower premium is not surprising. So it may have been an issue with the cost calculation itself not be high enough due to a low import price, for example.

GinePro Notes

• The manufacturer asked for a much higher reimbursement (756,000 JPY) based on the same reimbursement approach so there must have been an adjustment in the cost calculation.

• The improvement shown seems meaningful, but the evidence may have been perceived as being limited since it was based on an overseas study and the incidence of complications is low to begin with.

GinePro Notes

• The manufacturer asked for a much higher reimbursement based on the Cost Calculation Method and a Usefulness premium of 25%. But the 133-(2)-(1) functional category was said to be close enough to justify the comparison method. Also, no medical device product has received a Usefulness premium of more than a 20% in recent years.

• This product is manufactured and sold by BD outside Japan and materials published by BD outside Japan suggest that the it is superior to its major competitor on many design / performance points.

• Curiously, a new technical fee is to be established for the use of this product. This might relate to the fact that it must be used according to proper use guidelines set by relevant academic societies, requiring special considerations.

GinePro Notes

• The manufacturer asked for a much higher reimbursement (112,000 JPY for the Ti rod and 128,000 JPY for the CoCr rod) based on the same reimbursement approach so there must have been an adjustment in the cost calculation.

• The device can be used with a novel AI-driven surgical planning system to achieve better alignment. When this is used the if 90,000 JPY applies to the procedure fees based on the addition for patient-compatible deformity correction guide usage. (That addition has been available since at least 2021, so it is not clear whether the reimbursement is reasonable or not.)

GinePro Notes

• This device is likely to establish a new functional category for guiding catheters. We have recently provided a detailed overview the reimbursement of guiding catheters in Japan here for those interested. It likely to be "cerebrovascular, self-expanding" among the "132(2) For cerebral blood vessels" classification. However, the reimbursement amount established is substantially higher than other types of guiding catheters in that group.

• The manufacture asked for a reimbursement of 364,000 JPY based on the same reimbursement approach (Cost Calculation Method), but received a lower amount of 284,000 JPY.

• Note: At the time of preparing this overview the PMDA submission information was not available (not found).

GinePro Notes

• Unlike traditional methods where access is gained through the femoral artery, this system is designed for direct insertion into the common carotid artery, which is expected to reduce procedural risks and improve outcomes.

• The manufacturer asked for a higher reimbursement of 792,000 JPY based on a foreign reference pricing, but it seems that the foreign reference price adjustment was not allowed. Only the reference price for the US was included in the reimbursement report, so it may be that the market prices for the other reference markets (UK, Germany, France, and Australia) were not available or were not accepted for some reason. If there is only a price for one of the reference markets then a reimbursement adjustment does not apply.

GinePro Notes

• While the manufacturer received the reimbursement it asked for, the reimbursement received was substantially lower than the average foreign reference price, which was driven somewhat by a particularly high price in Germany (431,820 JPY).

• Receipt of a premium based on improvement in durability and long-term use shown through a clinical trial [Improvement (f)-(i)] is surprisingly rare among devices, so it is nice to see the product recognized for that kind of benefit.

GinePro Notes

• This is essentially an improved version of a previously listed product. It offers a better battery life (10.2 years vs. 4.4 years) and it received a modest premium for that.

• The predecessor product was listed in April 2014 and was reimbursed using the Cost Calculation Method with the "184 Sacral nerve stimulator" functional category newly established at that time. Since then, there has been no major change in the reimbursement prices for that functional category. Then, in 2022, a rechargeable "micro" version of that product listed, which also received an Improvement premium of 10% relative to the standard type. This is new version, InterStim X, offers a non-rechargeable version with an extended battery life relative.

GinePro Notes

• While the manufacturer received the reimbursement it asked for, the reimbursement received was substantially lower than the average foreign reference price (60,900 JPY vs. 165,345 JPY). But, among the reference markets, the product was only available in the US at the time of listing.

• The device is similar to an already listed product, but incorporation of the VersaCross Connect system allows three critical functions to be combined into one platform: (1) Guidewire navigation, (2) RF-powered transseptal puncture, and (3) Direct sheath delivery. This 3-in-1 functionality allows physicians to maintain continuous access without device changes and allows for reduction of the used of an angiographic sheath introducer set. This led to application of the Economic Efficiency premium.

GinePro Notes

• This device was assessed and listed together with the Epsila EV MRI lead below.

• Receipt of a premium based on faster efficacy, prolonged efficacy, and/or improved patient convenience [Usefulness (c)-1-(iii)] is somewhat rare among devices. It is not entirely clear what part of the device allowed for that premium, but on a whole the product incorporate several design and functional elements that could address efficacy, longevity, and patient convenience - including the ability to terminate 70–77% of ventricular tachycardia episodes without the need for high-voltage shocks.

GinePro Notes

• This device was assessed and listed together with the Aurora EV ICD MRI device above.

• The manufacturer asked for separate reimbursement for the introducer system, the sternum tunneling tool, and the subcutaneous transverse tunneling tool that goes with the device, but a separate reimbursement was not permitted. Rather, the reimbursement of those parts was said to be included in the procedure fee itself.

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 is companion diagnostic (CDx) kit for the Vyloy (zolvetuximab), which was listed in Japan in June 2024. for CLDN18.2-positive, unresectable, advanced or recurrent gastric cancer. (At present it is the only test available for Vyloy.

• It was provisionally given the same reimbursement as CDx for PD-1 inhibitors like Keytruda (pembrolizumab), but a new reimbursement code may be established during the next reimbursement revisions.

GinePro Notes

• At present, only azole antifungal drugs such as itraconazole and voriconazole are effective for aspergillus infections. However, in recent years, the emergence of azole-resistant Aspergillus has been of particular concern.

• This test (assay) uses recombinant purified Aspergillus antigens, while the existing Aspergillus precipitin test uses purified antigens from culture extracts. This leads to better sensitivity.

• It was provisionally given the same reimbursement as immulonological testing for (1→3)-β-D-glucan which is used to select a treatment method for a patient suspected of having a deep fungal infection, but a new reimbursement code may be established during the next reimbursement revisions.

GinePro Notes

• This is the first commercially available immunoassay that simultaneously detects and independently determines both HCV core antigen (HCV Ag) and antibodies to HCV (anti-HCV) from a single serum or plasma sample. It thus makes earlier detection possible compared to traditional antibody-only assays. It may also reduce the number of clinic visits needed for additional testing, and alleviate some of the testing burden on healthcare system. But the evidence on that is not clear.

• It was provisionally given the same reimbursement as standard antibody test but a new reimbursement code is likely to be established during the next reimbursement revisions.

GinePro Notes

• This test assesses the degree of daratumumab interference for patients undergoing treatment with daratumumab for multiple myeloma. Its ability to mitigate interference from this monoclonal antibody enhances diagnostic accuracy and ensures more reliable treatment evaluations.

• It was provisionally given the same reimbursement as plasma protein immunology testing for immunoglobuin free L chain kappa/lamba ratio, but a new reimbursement code will probably be established during the next reimbursement revisions.

GinePro Notes

• At present, this is the only companion diagnostic for Tasfygo (tasugratinib).

• This is one of the first IVD devices to benefit from a new rule that allows a higher reimbursement for devices that are used for patients with a rare disease. Please see the following update for more information on that.

• It was provisionally given the same reimbursement as a N005-2 ALK fusion gene specimen preparation, but a new reimbursement code will probably be established during the next reimbursement revisions.

GinePro Notes

• Like the item above, this is one of the first IVD devices to benefit from a new rule that allows a higher reimbursement for devices that are used for patients with a rare disease. Please see the following update for more information on that.

• It was provisionally given the same reimbursement as the D104 autoantibody test for anti-GM1IgG / anti-GQ1blgG antibodies. But a new reimbursement code will probably be established during the next reimbursement revisions.

GinePro Notes

• This test can identify both the presence of MG infections and potential drug resistance in a single test

• It was provisionally given the same reimbursement as the D023 microbial nucleic acide identification and quantitative testing for trichomonas vaginalis and Mycoplasma genitalium. But a new reimbursement code will probably be established during the next reimbursement revisions.

GinePro Notes

• This is the CINtex Histology test which provides tests for the biomarker for p16 overexpression which can lead to more accurate and consistent diagnoses of cervical neoplasia.

• It was provisionally given the same reimbursement as the N002 immunostaining histopathology specimen preparation for estrogen receptor test, but a new reimbursement code will probably be established during the next reimbursement revisions.

GinePro Notes

• Comprehensive genome profiling test kits already exist for certain solid tumors, but this is the first comprehensive genome profiling test kit for hematopoeitic tumors. It received a similar reimbursement as the tests for solid tumors.

• This diagnostic kit was listed together with Otsuka's newly listed HemeSight Analysis Program which did not receive a separate reimbursement.

• The reimbursement fee was said to be too high to be included in Japan's inpatient prospective payment system (referred as the DPC system). If it were included then hospitals may not be able to carry out the test when patients are hospitalized. To avoid that, it will be reimbursed on a fee-for-service basis until the next round of reimbursement revisions in 2026 and will be added to the DPC system then.

GinePro Notes

• Regenerative medicine treatments may be reimbursed as either a drug or a device depending on which they are closer to and, generally speaking, cell-based therapies that aim to restore, replace, or regenerate damaged tissue like Vyznova, the autologous cultured epidermis product, JACE, and cell sheets like HeartSheet have been reimbursed as medical devices.

• The manufacturer requested a much higher reimbursement of 11,932,800 JPY with a higher Usefulness premium of 10%.

• Despite having a reimbursement of nearly 10,000,000 JPY per use it was not selected for an HTA review suggesting that the unofficial threshold for HTA selection based having a "remarkably high" reimbursement price (H3) is higher than that level.

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