2025.1.14

Technology Focus Series: Guiding Catheter Market Access [Functional Category 132]

In this Technology Focus Series post, we will discuss market access issues for guiding catheters which are reimbursed in Japan based on the “132 Guiding catheters” functional category grouping. Let’s begin with a brief overview of guiding catheters, for those with less experience in the area. A guiding catheter is a long, flexible, and hollow tube (shaft) that can be inserted into blood vessels to allow access for other, narrower catheters, for example. They have a proximal end, which is handled by the physician, and a distal end / tip that is designed for optimal placement and control near a lesion or area in the body. They are often made from materials like polyurethane (PU) or polyethylene (PE), which allows for flexibility and pushability - i.e., the ability to transmit force between the proximal end and the distal end / tip. In some cases, more than one guiding catheter may be used per patient / procedure.

As their name implies, guiding catheters are used to help navigate through the vascular system to reach specific areas like the heart, brain, kidney, limbs, etc. and to provide support and stability when delivering other devices such as balloons, stents, and ablation catheters that are used to treat lesions, calcifications, thrombi, etc. in the blood vessels. In that sense, guiding catheters are an essential tool for many interventional (minimally invasive) procedures and have reduced the need to rely on surgical intervention.

Note: There is another device called a guidewire which can serve a similar function as guiding catheters. However, guidewires differ in their design and function from guiding catheters. As an analogy, if guiding catheters are the transport vehicles or armored personnel carriers (APCs) for the staging of interventional procedures, then guidewires are reconnaissance units that also support with initial transport tasks for the assault teams (e.g., balloons and stents). Similar to guiding catheters, guidewires are long, thin devices that differ in their diameter and length, as well as stiffness. They act as a rail for the insertion of catheters, including guiding catheters, and different guidewires may be used for different types of blood vessels and locations. We may cover guidewires in a future Technology Focus Series post, but they tend to be spread out across different functional category groups as opposed to having a stand-alone group like “132 Guiding catheters”.

Below is a table showing the different functional categories included in the “132 Guiding catheter” group including information on when they were established, examples of products they include, examples of relevant procedures, their approximate volume in fiscal year (FY) 2022, and their initial and current reimbursement in Japan (as of FY 2024). The two oldest functional categories in this group are “132 (1) For coronary arteries” and “132 (2)-1 For cerebral blood vessels: standard type” which were both established in FY 2002. Guiding catheters reimbursed as “132 (1) For coronary arteries” include products like Medtronic’s Sherpa NX, Terumo’s Heartrail II, and Boston Scientific’s Mach I, for example. Those reimbursed as “132 (2)-1 For cerebral blood vessels: standard type” include products used to deliver endovascular microcatheters, for example, safely to the surgical site of the cerebral blood vessel when performing cerebrovascular surgery. This includes products like Medikit’s Axcelguide, Asahi Intec’s FUBUKI XF, and Terumo’s VIA series, for example.

Initially the market for guiding catheters for coronary arteries was dominated by multinational manufacturers like J&J (Cordis), Medtronic, and Boston Scientific. But, in recent decades, it seems that domestic manufacturers like Terumo and Asahi Intec have gained a lot of market share. The market for guiding catheters for the cerebral (and peripheral) blood vessels, on the other hand, has always had several strong domestic players. However, both of these two oldest functional categories in this group now have 10+ manufacturers for Japan. Moreover, their reimbursement price has fallen substantially since initially established with a 78% decline for the “132 (1) For coronary arteries” functional category and 30% decline for “132 (2)-1 For cerebral blood vessels: standard type” functional category.

The second largest functional category for guiding catheters in FY 2022 was the “132 (3) For other blood vessels” functional category, which was introduced in 2018. Similar to the “132 (2)-1 For cerebral blood vessels: standard type” functional category, this category includes products used to the deliver endovascular microcatheters safely to the surgical site of the blood vessel when performing procedures for peripheral blood vessels – particularly those other than coronary artery and cerebral blood vessels. Examples of those products include Medikit’s Parent series, Goodman’s Profit series, and Cook Medical’s FLEXOR SHUTTLE / ANSEL product. For this functional category there are also 10+ manufacturers in Japan. Moreover, the reimbursement price has declined by 10% since it was established.

More recently established functional categories in this group include the “132 (2)-4 For cerebral blood vessels: radial artery puncture compatible” functional category and the “132 (4) For bronchial tube” which were both established in FY 2024. Both appear to have only one product / manufacturer at the moment, namely the Rist™ radial access system and the Chartis Pulmonary Function Assessment system, respectively. The former requested reimbursement with the “132 (2)-2 For cerebral blood vessels: highly-flexible type” functional category used as the baseline comparator and a 10% Improvement premium, which would have allowed for a reimbursement price of 96,200 JPY. But they were instead reimbursed using the cost-based approach and ended up with a reimbursement of 63,200 JPY and no premiums. They had shown a substantially lower rate of bleeding at the puncture site (0.3% vs. 5.57%) compared to the standard transfemoral access (TFA) approach.

The Chartis Pulmonary Function Assessment system was listed together with Pulmonx’s Zephyr for COPD patients with severe emphysema. Prime Fine had requested reimbursement with the “169 (2) Material with pressure sensor for angiography: Catheter with pressure sensor for angiography” functional category used as the baseline and a 10% Usefulness premium, which would have allowed for a reimbursement price of 140,000 JPY. But they were instead reimbursed in comparison with the “132 (2)-2 For cerebral blood vessels: high flexible type” functional category and ended up with a reimbursement of 90,300 JPY and no premiums. (Note: Asking for a higher reimbursement but ending up with something less is very common in Japan.)

Closing thoughts:

A substantial decline in reimbursement over time is not uncommon for reimbursed medical devices in Japan. There are thought to be several drivers for this including greater competition and foreign reference pricing, for example. The reimbursement price of reimbursed medical devices is reviewed at least every two years in Japan based on the results of a wholesaler and provider survey to consider the gap between the market price and the reimbursement price. To the extent that manufacturers discount their products to hospitals due to competition, for example, they may face a reduction in their reimbursement price. Moreover, unlike pharmaceutical products, reimbursement prices for most reimbursed medical devices are reviewed relative to the foreign reference price (US, UK, Germany, France, and Australia) at least every two years – not just at initial listing - and reduction may apply if the price in Japan is higher by more than 1.3 times the average foreign reference price taking into consideration local consumption taxes.

Another notable aspect of the reimbursement of guiding catheters in Japan, and indeed many other medical devices in Japan, is that even though a similar technology may be used, the reimbursement price in Japan may differ depending on the purpose and area that the device is used for. This appears to be the case for Goodman’s Profit series, for example, which has products for both the “132 (1) For coronary arteries” functional category and “132 (2)-1 For cerebral blood vessels: standard type” functional category, which have very different reimbursement prices (8,220 JPY vs. 21,800 JPY). But there are other examples as well. This raises the question about whether these devices (and many others) are priced according to their value. On the other hand, these product after have subtle differences in terms of design and materials used, so it could be argued that while the once-fits-all, functional category approach to reimbursement may be simpler, it may not be appropriate for areas where material and manufacturing costs can be vary greatly by the specific design (e.g., length / diameter, etc.).

Please contact GinePro if you would like a detailed description of the reimbursement for a specific medical device area in Japan.

Reimbursement of Guiding Catheters in Japan [Functional Category 132]

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