Left atrial appendage occlusion

The French National Authority for Health (HAS) released new recommendations about add-on reimbursement of medical devices and medical aids from the meetings of the National Commission for Evaluation of Medical Devices and Health Technologies (CNEDiMTS) in June 2024. Twelve recommendations were published concerning the registration of medical devices or modification of registration conditions/extension of indications for the medical devices in the List of Reimbursable Products and Services (LPPR). Opinions concern cardiovascular and endocrine devices, as well as medical aids.

The Draft Order amending the Common Package of Benefits of the National Health System was published in spring 2024. The proposed changes mostly concern screening, primary and community care, eHealth, cardiovascular, and medical aids fields.

In the fourth quarter of 2022, Health Technology Wales published three MedTech-related guidance (Left atrial appendage occlusion in patients with atrial fibrillation, continuous topical oxygen therapy, and virtual reality distraction therapy). Four Topic Exploration Reports were released as well (virtual wards, genetic testing for prostate cancer, autofluorescence imaging, and geniculate artery embolization); however, Health Technology Wales decided not to proceed with complete appraisals on these topics.

In November 2022, an annual update of the Swedish procedure coding system (Classification of Health Care Measures, KVÅ) was released to come into force from January 2023. A total of 119 new surgical procedure codes and 98 new medical procedure codes will be introduced concerning cardiovascular, diagnostic imaging, eHealth, endocrinology, endoscopy, ENT, gastrointestinal, IVD, nephrology and urology, peripheral vascular, and others.

The HTA body of the Tuscany Regional Healthcare issues two types of documents: HTA forms and motivational forms. With regional decree 10778 of June 01, 2022, Tuscany Regional Healthcare has published assessments of nine medical devices in various therapeutic areas, such as cardiovascular and peripheral vascular areas, surgical procedures, orthopedics, and dermatology.

In Q1 of 2022, Health Technology Wales (HTW) published one MedTech-related guidance on transcranial magnetic stimulation in depression treatment. A total of eleven Topic Exploration Reports (TERs) were released in Q1. Based on the TERs conclusions, HTW's Assessment Group decided to proceed with developing an Evidence Appraisal Report (EAR) and Guidance on one topic only - radiofrequency renal denervation for the treatment of resistant hypertension.

On June 18, 2020, the Dutch Healthcare Institute (Zorginstituut Nederland, ZIN) announced four medical procedures which received a subsidy under the new innovative payment scheme: FFRct technique in the diagnosis of patients with chest pain; oral esketamine in patients with severe, non-psychotic, treatment-resistant depression; left atrial appendage closure in patients with atrial fibrillation and endolymphatic duct blockage in patients with uncontrollable Meniere's disease.

In February 2020, the Andalusian Health Technology Assessment Department published an assessment report on the evaluation of effectiveness and safety of epicardial closure of left atrial appendage using clips by minimally invasive surgery for thromboembolism prevention in patients with atrial fibrillation. The scientific evidence about the effectiveness and safety of the left atrial appendage closure through minimally invasive epicardial clipping is inadequate and insufficient; further research is needed.

In early September 2019, the Innovation Committee of the Federal Joint Committee (G-BA) has published an overview of new research projects in the area of health services to be funded by the Innovation Fund in the future.

The report presents a summary of reimbursement situation for left atrial appendage occlusion for stroke prevention in atrial fibrillation in Europe. The following types of procedure will be considered: percutaneous transluminal left atrial appendage occlusion; thoracoscopic left atrial appendage closure. The analysis covers procedure coding, payment mechanism, reimbursement tariffs and policy restrictions in 11 EU countries including Austria, Belgium, Denmark, England, France, Germany, Italy, the Netherlands, Norway, Sweden and Switzerland. It is also possible to add analysis in Czech Republic, Finland, Hungary, Romania, Russia and Turkey.