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Percutaneous valve replacement and repair

An overview of market access challenges for percutaneous valve replacement and repair in European countries

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Procedure coding

Procedure coding for percutaneous procedures on aortic and mitral valves is well-established. In contrast, percutaneous replacement and repair of tricuspid and pulmonary valves are not specifically coded in most European countries. 

Procedure codes for percutaneous replacement of aortic and mitral valves in most countries differ depending on the type of approach (transfemoral or transapical). For example, in Denmark, there are two SKS codes for percutaneous mitral valve replacement: code KFKD11 “Transapical insertion of the biological mitral valve prosthesis” and code KFKD14 “Percutaneous insertion of the biological mitral valve prosthesis”. 

Percutaneous mitral valve repair is specifically coded in most European countries. In some countries, procedure coding specifies the number of clips used (e.g., Germany, the Netherlands, Switzerland).

The status of coding for percutaneous procedures on the tricuspid valve differs depending on the type of intervention: percutaneous repair of the tricuspid valve is specifically coded in some European countries, whereas there is no coding for percutaneous tricuspid valve replacement in almost all countries. The exception is Switzerland with specific CHOP codes for both percutaneous tricuspid valve repair (code 35.E4.14 for transapical approach, code 35.E4.15 for transarterial approach, and code 35.E4.16 for transvenous approach) and percutaneous tricuspid valve repair (code 35.F4.23 for endovascular access and code 35.F4.24 for transapical access).

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Payment mechanism

The payment model and reimbursement situation for percutaneous heart valve procedures varies by country and anatomical site.

In most EU countries, the key reimbursement model for percutaneous heart valve procedures is DRG, with higher DRG tariffs for percutaneous interventions compared to analogous open procedures on heart valves.  For example, In Germany, percutaneous aortic valve replacement is allocated to the DRG F98B for complex minimally invasive operations on heart valves with a tariff that is 1.5 times higher than the one for the DRG F03E for open aortic valve replacement.

In some countries (e.g., France and England), the devices for percutaneous valve repair and replacement procedures attract additional reimbursement, paid on top of the DRG tariff (e.g., LPPR List in France and High Cost Device List in England). For example, in England, a specific category in the High Cost Devices List "Transcatheter and percutaneous valve repair and replacement devices", includes TAVI devices.

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Policy considerations

Percutaneous valve repair and replacement procedures can be subject to specific policies from payers or national decision-makers in the countries where such frameworks exist. 

For example, in England, the national payer, NHS England, is currently developing a Clinical Commissioning Policy on the Transcatheter Edge to Edge Repair (TEER) / percutaneous mitral valve leaflet repair for secondary mitral regurgitation in adults. 

For percutaneous tricuspid valve repair and replacement procedures, the coverage policies are under development or planned in several European countries (e.g., Germany, the Netherlands, Norway). In the Netherlands, transcatheter tricuspid valve repair, which is currently not covered under basic health insurance, was awarded the "Subsidy scheme for promising care" (coverage with evidence development program) in 2022 and will be assessed for coverage at the national level upon the completion of the study (approximately in 2028). 

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Health technology assessment

Due to the innovative origin and high cost, percutaneous valve replacement and repair procedures frequently become a subject of HTA in European countries. 

For example, on March 7, 2022, Health Institute Carlos III in Spain released an HTA report aiming to analyze the safety, efficacy, and cost-effectiveness of the percutaneous repair of the tricuspid valve compared to conventional surgery which concluded that more robust clinical studies with more significant numbers of patients, comparators, and longer follow-up time, as well as better information on both the epidemiology of tricuspid pathologies and the results of this type of intervention are needed to conclude which technique of percutaneous tricuspid valve repair is more effective and whether they are superior to standard clinical treatment.

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Future challenges 

Percutaneous aortic and mitral valve repair and replacement have established reimbursement and funding in most European countries. New health technology assessments are unlikely to be relevant. The key challenge for these technologies is the extension of indications on novel groups of patients.

For percutaneous tricuspid and pulmonary valve repair and replacement procedures, there is a need to establish procedure coding, reimbursement, and funding and obtain support in the HTA in many European countries. 

MTRC has experience with more than 32 projects related to percutaneous valve replacement and repair in Europe

News and insights

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On May 23, 2024, the 2024 working plan was published by the Spanish Network of HTA Agencies (RedETS). Topics in cardiovascular, diagnostic imaging, e-health, endoscopy, ENT, extracorporeal treatments, ICU/OR, in-vitro diagnostics, interventional radiology, men’s health, neurology and neurosurgery, neuromodulation, obstetrics and gynecology, orthopedics, peripheral vascular, pulmonary and airways, radiology, radiotherapy, robotic surgery, spine, surgical procedures, and some other fields are included in the plan.

Recommendations about add-on reimbursement for medical devices in France in March 2024

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Rapid HTAs of four medical devices released in Tuscany

The HTA body of the Tuscany Regional Healthcare issues three types of documents: full HTA reports, rapid HTA reports, and motivational forms. With regional decree 6700 of March 27, 2024, Tuscany Regional Healthcare published three new assessments and one re-assessment of medical devices in the cardiovascular, men’s health, nephrology and urology, and surgical procedures areas.

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