Cardiovascular devices

In December 2020, the National Institute for Health and Care Excellence (NICE) published one new medical technologies guidance (Zio XT for detecting cardiac arrhythmias), three Medtech innovation briefings (ReStore Soft Exo-Suit for gait rehabilitation, Cytosponge for detecting abnormal cells in the esophagus, and Evoke Spinal Cord Stimulator for managing chronic neuropathic or ischemic pain). Also, nine clinical guidance documents were updated.

In December 2020, Swedish Medical Technologies Product (MTP) Council decided to evaluate new technologies for self-monitoring of atrial fibrillation within the Orderly introduction framework. MTP Council commissioned the Swedish Dental and Pharmaceutical Benefits Agency (TLV) to perform a health-economic evaluation of Coala Heart Monitor Pro and KardiaMobile; however, other products may also be considered later.

On December 22, 2020, the Swiss Federal Office of Public Health announced the changes that will occur to the Services Ordinance (KLV/OPre). The changes concern the general part of the Services Ordinance (KLV/OPre), and all four of its Annexes, which define the coverage of services (List of explicitly evaluated services, List of Medical Aids and Equipment, List of Analyses, List of Medications with Tariff). The updates will enter into force on January 1, 2021. Updates concern among others bariatric surgery, Autologous Chondrocyte Transplantation, ultrasound focused therapy for neurological indications.

The HTA body of the Tuscany Regional Healthcare issues two types of documents: HTA forms and motivational forms. With a regional decree 19274 of November 24, Tuscany Regional Healthcare has published assessments of twelve medical devices of various therapeutic areas. See the list of evaluated devices in the post from MTRC.

On October 30, 2020, the Swiss Federal Statistics Office (UFS) published the 2021 version of the procedure code (CHOP) nomenclature in French and Italian. The version in the German language was published in July 2020. The most important changes regard cardiovascular and peripheral vascular interventions.

On November 9, 2020, in accordance with §137h Paragraph 6 SGB V, the Federal Joint Committee (G-BA) has initiated an evaluation procedure for endovascular implantation of a stent-graft with valve element in tricuspid valve insufficiency within the framework of the early benefit assessment.

In October 2020, a completed mini-method assessment for the coronary sinus reducer stent (Neovasc) implantation in refractory angina pectoris treatment was published within the New Methods framework. The Oslo University Hospital carried out the evaluation. The technology was recommended for routine use in hospitals.

The French National Authority for Health (HAS) released new decisions about intra-DRG reimbursement of medical devices from the meetings of the National Commission for Evaluation of Medical Devices and Health Technologies (CNEDiMTS) in July 2020. Decisions concern cardiac sutureless valve bioprostheses and implantable devices for the treatment of urinary incontinence.

The HTA body of the Tuscany Regional Healthcare issues two types of documents: HTA forms and motivational forms. With a regional decree 12735 of August 13, 2020, Tuscany Regional Healthcare has published assessments of eleven medical devices of various therapeutic areas, including peripheral nerve stimulator, catheter for renal denervation, EKOS technology and others.

The French National Authority for Health (HAS) released new decisions about add-on and medical aid reimbursement of many medical devices from the meetings of the National Commission for Evaluation of Medical Devices and Health Technologies (CNEDiMTS) in July 2020. Decisions concern drug-eluting coronary stents, TAVI, orthopedic appliances, wound dressing, stoma obturator, toric intraocular lens.

The Swedish Dental and Pharmaceutical Benefits Agency (TLV) is currently performing a theme survey for medical technology products for ischemic heart disease and heart failure. The submissions in relation to this survey will be closed on August 21, 2020

In July 2020, the Austrian Institute for Health Technology Assessment (AIHTA) published five decision support documents. The assessed technologies included implantation of a wireless pulmonary artery pressure sensor in patients with advanced heart failure, intrauterine ultrasound-guided transcervical radiofrequency ablation, percutaneous transvascular implantation of a coronary sinus reducing stent, radiofrequency-induced intravesical chemohyperthermia for non-muscle invasive bladder cancer, and Vascular photodynamic therapy with Padeliporfin (Tookad® solution).