Changes to TAVI reimb criteria… TAVI mkt intensifies

Effective June 22, reimbursement is approved upon the medical consensus of multidisciplinary heart teams

Relaxed staffing criteria are expected to improve patient access for patients aged 70

Amid market dominance by Edwards Lifesciences, new products by Medtronic become a variable

Patient access to aortic stenosis therapies is set to expand following a reform of South Korea's National Health Insurance reimbursement criteria for Transcatheter Aortic Valve Implantation (TAVI).

Attention is turning to whether this criteria change will accelerate market growth, as the policy transitions from restricting reimbursement to patients aged 80 and older or those deemed inoperable to a system allowing the medical consensus of multidisciplinary Heart Teams.  

Transitioning from "patients aged 80" and "inoperable" to "clinical necessity"

The Ministry of Health and Welfare (MOHW) has issued a revised administrative notice on 'Detailed Criteria and Methods for Applying Reimbursement' and effective June 22, reimbursement criteria for TAVI will undergo reform. The core reform shifts the criteria from "inoperable" to "clinical necessity," as adjudicated by institutional multidisciplinary Heart Teams.

TAVI is a minimally invasive structural heart procedure that treats aortic stenosis by deploying a bioprosthetic valve via a catheter, eliminating the need for open-heart surgery. While initially targeted at elderly patients with high surgical risk, accumulating global clinical evidence has expanded its therapeutic indications to broader patient populations, both domestically and internationally.  

Previously, national health insurance reimbursement for TAVI was approved only for patients in high-risk categories with a Society of Thoracic Surgeons (STS) score exceeding 8%, those aged 80 or older, or cases where all cardiovascular thoracic surgeons on the institutional Heart Team explicitly signed off on the patient's surgical inoperability.  

The reform preserves the reimbursement criteria for high-risk surgical patients and individuals aged 80 and older. Crucially, however, it expands eligibility to include any patient for whom the entire multidisciplinary Heart Team agrees that a TAVI procedure is clinically necessary. This updates the regulatory method from a rigid system reliant solely on age or operability thresholds to a nuanced approach centered on patient-specific clinical needs.  

Consequently, this reform is highly likely to improve access for patients in their 70s, a cohort that previously fell into a regulatory blind spot. Under the old rules, septuagenarian patients seeking TAVI had to either incur an extraordinary out-of-pocket financial burden or navigate the high procedural barrier of securing an inoperable consensus from at least 2 cardiovascular thoracic surgeons.

The operational mandates for institutional Heart Teams have also been streamlined to fit clinical realities. Previously, the system required at least two cardiovascular thoracic surgeons with over 5 years of post-fellowship cardiovascular surgical experience. The amendment now allows hospitals to meet this staffing requirement with a single surgeon with more than 10 years of experience in cardiovascular surgery.  

Furthermore, the mandatory in-person attendance requirement for anesthesiologists and radiologists has been changed to an "as-needed" consultation basis, with virtual video conferencing explicitly permitted in unavoidable circumstances. Another notable shift introduces a formalized re-deliberation mechanism: if the Heart Team fails to reach unanimous consensus initially, the team must engage in subsequent discussions to finalize an aligned therapeutic pathway.  

Professor Sung-jin Hong of the Department of Cardiology at Severance Hospital (insurance committee member for the Korean Society of Cardiology·the Korean Society of Interventional Cardiology) said, "This revision clarifies the decision-making architecture of the multidisciplinary Heart Team while realigning staffing criteria and operational rules with real-world settings. It will alleviate some of the procedural and personnel burdens that previously hindered practical clinical deployment."

Improved patient access, emerges as a variable of market expansion

This reform of reimbursement criteria is likely to directly influence the structural heart market alongside expanding patient access. Broadening the criteria for reimbursed procedures allows patients who previously deferred treatment due to intense cost pressures or restrictive institutional thresholds to enter the reimbursed clinical pool.  

The prevalence of aortic stenosis has been accelerating rapidly alongside demographic aging. According to National Health Insurance data, the number of documented aortic stenosis (ICD-10: I35.0) patients escalated by approximately 56% over a four-year window, growing from 16,537 in 2020 to 25,826 in 2024. Within the same timeframe, ultra-elderly patients aged 80 and older surged by roughly 90%, from 6,283 to 11,944 individuals.

Patients in their late 70s are regarded as the key market variable. While patients aged 80 and older already enjoyed robust therapeutic access within the existing coverage framework, the 70s cohort faced severe regulatory constraints despite being optimal clinical candidates for TAVI. By enabling reimbursement whenever the Heart Team establishes clinical utility, this reform is expected to resolve deferred procedural demand.  

Shifts are also anticipated at the institutional level. Lowering the minimum surgeon requirements and permitting remote participation will substantially reduce the operational burden of running a Heart Team. However, because TAVI is a highly complex intervention requiring advanced capital equipment, specialized hybrid theater setups, and extensive operator experience, the regulatory relaxation alone will not translate into an immediate, decentralized explosion of procedures across all community hospitals.  

The rationalization of procedural tariffs remains unresolved. Industry stakeholders have consistently noted that the current fee schedule does not adequately capture the intrinsic complexity and the intense multidisciplinary coordination of TAVI. Even with wider reimbursement boundaries, the velocity of real-world market expansion could remain constrained unless hospital fee margins and cost allocations are structurally improved.

Despite this, the revision is widely evaluated as the critical regulatory inflection point for long-term category growth. Positioned at the intersection of a rising patient census, demographic aging, and a global trend toward expanded clinical indications, the relaxation of reimbursement rules is highly likely to enlarge the total addressable market.  

Edwards maintains market dominance as Medtronic chases after

With anticipation over market expansion mounting, commercial competition among global medtech giants is garnering attention. According to industry sources, the domestic TAVI market is currently dominated by Edwards Lifesciences, which commands a majority share, pursued closely by Medtronic. Abbott and MicroPort also maintain active footholds as they attempt to scale their respective market shares.  

The reimbursement expansion is initially expected to play to the strengths of incumbent leader Edwards Lifesciences. Companies with deep clinical track records and established brand equity are historically best positioned to capture the immediate influx of newly unlocked demands.

However, Medtronic is introducing aggressive competitive variables. This past March, Medtronic commercially launched its next-generation TAVI system, the Evolut FX+, in South Korea. The platform features an advanced design engineered to optimize future coronary access, facilitating subsequent percutaneous coronary interventions (PCI). This product strategy is interpreted as a strategy to target long-term survivors and younger patient demographics.  

As the TAVI target population changes from extreme-risk, elderly patients to a broader clinical demographic, competitive differentiators are evolving beyond immediate procedural success toward long-term post-procedural management and cross-departmental treatment access. Medtronic’s focus on a "lifetime management" framework for its new platform aligns directly with this shifting clinical trend. 

Professor Hong stated, "As we transition deeper into a super-aged society, the clinical need for TAVI will continue to intensify," and added, "Streamlining the multi-disciplinary decision-making process will provide clinical utility, ensuring patients receive optimal interventions without missing critical therapeutic windows."  

Professor Hong emphasized, "While this regulatory shift is a starting point, it must be followed by an established system to expand reimbursement scope, enabling patient access to appropriate care at the right time."