2025.1.28

Technology Focus Series: Occluder Device Market Access [Functional Categories: 131, 153, 204, and 205]

In this Technology Focus Series post, we will discuss market access issues for occluder devices in Japan. An occluder device is a self-expandable, medical implant used for minimally invasive closure of certain heart defects and other anatomical issues related to the heart. These devices, typically made from a nitinol wire mesh with polyester fabric to enhance closure, are designed for delivery and deployment via catheter in percutaneous, transcatheter procedures.

But what conditions are these devices used to treat? To answer that let’s start with a basic review of the human heart. The human heart is a muscular pump with four chambers: two upper chambers called “atria” and two lower chambers called “ventricles”. Moreover, it can be divided into a left side and a right side, each containing an atrium and a ventricle which are separated by a wall of muscle called the septum. But like any complex structure, the heart can have defects – many of which are congenital in nature, meaning that they formed early on and were present at birth. Some of these defects can resolve on their own and some can be corrected through surgery. But occluder devices offer a minimally invasive option to close holes in the heart formed due to defects – as well as areas of the heart that may be problematic. If left untreated, these issues can lead to things like pulmonary hypertension, heart failure, arrhythmia, stroke, endocarditis, etc.

A common defect that occluder devices are used to treat is when a hole forms in the septum between the two upper chambers of the heart (i.e., the atria). This is referred to as an atrial septal defect (ASD). Next, another common defect that occluder devices are used to treat is the formation of a patent foramen ovale (PFO), which is an opening between the left and right atria that failed to close after birth. Similarly, another defect for which occluder devices may be used to treat is when the patent ductus arteriosus (PDA) fails to close. During fetal development, this vessel serves a crucial role of allowing blood to bypass the non-functioning lungs. After birth, however, when the baby starts breathing, this blood vessel is no longer needed and typically closes within the first few days of life. A PDA defect occurs when this vessel fails to close after birth. Lastly, another congenital defect that occluder devices could be used to treat is when a hole forms in the septum between the two lower chambers of the heart (i.e., the ventricles). This is referred to as a ventricular septal defect (VSD) and is the most common structural defect of its kind. However, as we will discuss later, there is currently no reimbursement in Japan for occluder devices to treat VSD.

Occluder devices may also be used to seal off the left atrial appendage (LAA), which is a small sac in the muscle wall of the left atrium that can lead to blood clotting and then strokes in atrial fibrillation (AF) patients. While the LAA is not a defect, it is said to be the most common site of thrombus formation in AF patients. Using an occluder device to close off the LAA can prevent blood clots from forming and entering the bloodstream.

Unlike guiding catheters discussed in the previous post below, the reimbursement codes for occluder devices in Japan are spread across four main functional categories depending on the kind of defect or issue they address. Those functional categories broadly include the “131 Percutaneous atrial septal defect (ASD) occluder sets”, “153 Percutaneous ductus arteriosus occluder sets”, “204 Percutaneous left atrial appendage closure (LAAC) systems”, and “205 Percutaneous patent foramen ovale (PFO) occluder sets” functional categories. The “153 Percutaneous ductus arteriosus occluder sets” functional category is further subdivided into “aperture-retaining type” devices and “implantable in the ductus arteriosus” devices. The table below shows a detailed overview of those functional categories.

The “131 Percutaneous atrial septal defect (ASD) occluder sets” and “153 (1) Percutaneous ductus arteriosus occluder sets: aperture retaining type” functional categories are the oldest categories both having been established over 10 years ago. However, both have relatively few manufacturers in Japan. The reimbursement price for “131 Percutaneous atrial septal defect (ASD) occluder sets” has fallen by 4.6% overall since it was established in 2006, which is relatively small compared to the reductions observed for some of the older guiding catheter functional categories mentioned below. The reimbursement price for “153 (1) Percutaneous ductus arteriosus occluder sets: aperture-retaining type” functional category has increased by 4.5% since it was established, likely due to an increase in consumption taxes in Japan – suggesting very little, if any, decline in its reimbursement price since it was first established.

Two out of 3 of the more recently established functional categories have received a somewhat higher reimbursement price than the older products. The “204 Percutaneous left atrial appendage closure (LAAC) systems” functional category was established in 2019 with the listing of Boston Scientific’s Watchman™ LAAC system in September 2019. That product was reimbursed using a cost-based reimbursement approach and ultimately received a reimbursement price in Japan that was 0.89 times the average foreign reference price. It did not receive a premium, but it showed based on a meta-analysis of two international clinical trials that it allows for reduced risk of hemorrhagic stroke and major bleeding compared to warfarin. While it may not have been part of the initial submission, a later published study showed that over a lifetime time horizon, LAAC is less costly than treatment with warfarin and direct oral anticoagulants (DOACs) in Japan and that it also provides for better incremental quality-adjusted life years (QALYs) than warfarin and DOACs.

The “205 Percutaneous patent foramen ovale (PFO) occluder sets” functional category was established in 2020 with the listing of Abbott’s Amplatzer PFO Occluder device in December 2019. That product was reimbursed using the comparator-based reimbursement approach. It received a reimbursement price in Japan that was only 0.51 times the average foreign reference price, although the manufacturer had only requested 0.56 times that price. It received a Usefulness premium of 10% relative to the “131 Percutaneous atrial septal defect (ASD) occluder sets” functional category based on showing efficacy in patients for whom existing treatment methods are inadequate and for being positioned as a standard treatment method for the target disease in the future. This claim was based on results from an event-driven, open-label, randomized trial conducted in the United States and Canada (RESPECT trial) which showed that the device allows for a 45% relative risk reduction in nonfatal stroke compared to drug therapy and PFO closure rate at 6 months of 94.2% for effective closure and 71.3% for complete closure. Like LAAC, a subsequently published cost-effectiveness study showed that PFO closure is cost-effective (dominant) relative to drug therapy when it comes to preventing secondary ischemic stroke in Japan and a later study showed that it is cost-effective for preventing cryptogenic stroke.

Notably, at the time of this post there does not appear to be a functional category for occluder devices for VSD, despite some mention in medical publications in Japan that Abbott’s Amplatzer Muscular VSD Occluder device is effective for treating VSD and despite the fact that Abbott’s device was selected as a high need medical device in Japan in 2012. A Ministry of Health, Labor, and Welfare (MHLW) report in 2017 suggested that the company was prioritizing development for other products.

Closing thoughts:

Unlike the guiding catheter device area discussed earlier this month, there appears to be much fewer manufacturers of occluder devices in Japan, even though it is not that much older as a device area. The three most recently introduced functional categories – namely 153 (2), 204, and 205 – still appear to have only one manufacturer in Japan. This may be because there are relatively few manufacturers of occlude devices globally for those conditions. Market entry of other competitors, however, might lead to a reduction in the reimbursement prices for these functional categories due to price competition and subsequent repricing.

The fact that there are presently no reimbursed occluder devices for VSD in Japan even though it is said to be the most common congenital heart defect in Japan is somewhat surprising. However, it may be that many of these cases resolve naturally or can be adequately managed. Some cardiovascular treatment centers and local guidelines mention the use the pulmonary artery banding (PAB) for VSD, for example, suggesting that other treatment methods may be sufficient. Moreover, other methods may be preferred due to concerns about safety such as the risk for conduction disturbances. Nonetheless, it seems like the medical community desires a minimally invasive option given that Abbott’s Amplatzer Muscular VSD Occluder device has remained on the MHLW’s high medical need list for over a decade now.

Reimbursement of Occluder Devices in Japan [Functional Categories: 131, 153, 204, and 205]

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