2025.7.21

Technology Focus Series: Heart Valve Market Access [Functional Categories: 119, 120, 121, 122, 182, 196, and 215]

In this Technology Focus Series post, we will consider market access issues for prosthetic heart valve devices and related devices in Japan. Prosthetic heart valves are used to treat conditions whereby the heart's natural valves are diseased or damaged, preventing proper blood flow, such as valvular stenosis (narrowing of the valve) or valvular regurgitation (leaking of the valve). They are used in procedures such as valve replacement surgery (e.g., surgical aortic valve replacement - SAVR, or transcatheter aortic valve replacement - TAVR) or valve repair surgery. According to the 2024 report of The Japanese Registry Of All cardiac and vascular Diseases (JROAD), there were about 17,207 valve replacement surgeries conducted in Japan in 2024.

There are prosthetic heart valves to replace all four heart valves included the aortic, mitral, tricuspid, and pulmonary heart valves. Since prosthetic heart valves are implanted into the human body, they are typically categorized as Class IV devices in Japan - meaning they involve a level of risk that is considered extremely high - and typically require a clinical trial to be conducted to obtain approval in Japan.

Prosthetic heart valves primarily consist of mechanical and biological heart valves. Mechanical prosthetic heart valves were first used in humans in the 1960s. They are designed for durability, often exceeding 20 years in patients. Because of this, they are often recommended for younger patients who have a longer life expectancy. Mechanical valves are reimbursed in Japan based on the “119: Mechanical valves” functional category. All mechanical valves receive the same reimbursement based on this functional category. They are sold by about 5 different manufacturers with more than 10 different device series available. Those devices differ in their specific design features such as blood flow dynamics, minimization of clot formation, and ease of implantation. Mechanical valves have been reimbursed in Japan since at least 1997. Since then, their reimbursement level has fallen by about 38% to its current level of 659,000 JPY per valve.

Biological prosthetic heart valves are derived from animal tissues (e.g., porcine or bovine pericardium) and offer some advantages over mechanical valves, such as a lower risk of blood clots, reducing the need for long-term anticoagulation like warfarin. However, they may have also come with durability issues, as calcium deposits can cause valve degeneration over time. Biological valves are reimbursed in Japan based on the three different functional categories: the “120 (1): heterologous aortic valves”, “120 (2): heterologous pericardial valve (II)”, and “120 (3): heterologous pericardial valve (II) system”.

Heterologous aortic valves are derived from the aortic valve of an animal (other than humans). They have also been reimbursed in Japan since at least 1997 and there are currently about 2 manufacturers of those valves. Since 1997, their reimbursement level has fallen by about 24% to its current level of 780,000 JPY per valve. Heterologous pericardial valves are derived from the pericardium of animals (other than humans) and have undergone a tissue heating process to prevent calcification. They were first reimbursed in 2010 in Japan and there are currently about 5 manufacturers of those valves. Their reimbursement has fallen by about 2% since that time. The “120 (3): heterologous pericardial valve (II) system” includes a delivery device. Those systems were first reimbursed in 2019 and there are currently about 2 manufacturers for them. Their reimbursement levels have remained the same since 2019.

Although they are only used in a small number of patients each year, valve-equipped graft devices are also available from two companies and are reimbursed based on the “121: Valve-equipped graft (biological valve)” functional category. Those valves include an artificial blood vessel (including blood vessels made of biological materials). They have been reimbursed in Japan since at least 1997. Since then, their reimbursement level has fallen by about 30% to its current level of 825,000 JPY per valve.

The first transcatheter aortic valve implantation (TAVI) for a bioprosthetic valve without open-heart surgery was conducted in 2002. They were first reimbursed in Japan in 2012. The initial functional category was the “182: Transcatheter artificial heart valve set: Balloon-expandable” functional category. However, in 2024 the category was split into the “182 (1)-1: Transcatheter artificial heart valve set: Balloon-expandable (without temporary premium)” and the “182 (1)-2: Transcatheter artificial heart valve set: Balloon-expandable (with temporary premium)” functional categories based on the listing of Edward’s Sapien 3 Ultra RESILIA system. That device received a temporary premium because it incorporates a stable capping anti-calcification process and tissue preservation with glycerol. Lastly, the “182 (2): Transcatheter artificial heart valve set: Self-expanding system” functional category was reimbursed in 2016. Since then, its reimbursement level has fallen by about 2%.

In 2020 Medtronic introduced the Harmony Transcatheter Pulmonary Valve which was reimbursed based on the Cost Calculation Method. This is an artificial biological valve that is sutured to a self-expanding stent graft and is intended for percutaneous placement of an artificial valve in patients with severe pulmonary regurgitation. Based on that, the “215: Transcatheter artificial heart valve set (with stent graft)” functional category was established in 2021 and its reimbursement level has not changed since that time.

In addition to prosthetic heart valves, there are other devices used for valve repairs which deserve some mention. Artificial valve rings, also known as annuloplasty rings, are used in heart valve repair surgery to reshape, tighten, or reinforce the annulus. These devices were reimbursed in 1997 at the latest with at least 5 manufacturers currently offering them. The “122 (1): Artificial valve ring: for mitral valve” functional category was the earliest established reimbursement category for these devices. Since 1997, the reimbursement level for devices in that category has fallen by 18% to its current level of 268,000 JPY. Then in 2012, the “122 (2): Artificial valve ring: for tricuspid valve” and “122 (3): Artificial valve ring: for mitral valve and tricuspid valve” functional categories were established. Since then, their reimbursement levels have fallen by 24% and 13%, respectively. The latter are artificial valve rings that can be used for both mitral and tricuspid valves.

Lastly, for mitral valve repairs, there is also the “196: Transcutaneous mitral valve clip system” functional category, which was established in 2018 with the listing the Abbot’s MitraClip NT system that year. That system was also reimbursed using the Cost Calculation Method. Devices in this functional category are intended to be inserted percutaneously into the mitral valve to join the anterior and posterior leaflets of the mitral valve to reduce mitral valve regurgitation in patients with symptomatic severe mitral regurgitation for whom open heart surgery is difficult. They also include a guiding catheter and a delivery system used for delivering the clip. Since 2018, the reimbursement for that functional category has fallen by 2%.

Closing thoughts:

Prosthetic heart valves are innovative devices that tend to have a high estimated peak annual market size relative to other reimbursed devices. For example, Edward’s Inspiris RESILIA aortic valve, which was listed in 2018 in Japan, projected an annual market size of 6.2 billion JPY at 2-year peak annual sales. Moreover, Edward’s SAPIEN 3 Ultra RESILIA transcatheter valve device, which was listed in 2023 in Japan, projected an annual market size of 88.5 billion JPY at 10-year peak annual sales. One of the main criteria for selection for a formal HTA review in Japan is having an estimated peak annual market size of 5 billion JPY or more. This implies that new prosthetic heart valve devices - and especially transcatheter valves – are likely to trigger a formal HTA review in Japan. So it is important to take this into consideration when planning development for Japan to ensure that the data needed for the HTA review is available. Please see our post here for examples of reviews have been conducted for Japan. Please also contact us to discuss evidence generation for the HTA evaluation process in Japan.

Reimbursement of Heart Valve Devices & Related Devices in Japan [Functional Categories: 119, 120, 121, 122, 182, 196, 215]

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