Cardiovascular devices

The Agency for Health Technology Assessment of Andalusia Autonomous Community in Spain (AETSA) systematically evaluates healthcare technologies and provides decision-makers with critically review information about their efficacy, safety, and effectiveness. Currently, the AETSA is working on assessments of laser-induced heat therapy in epilepsy surgery, stereotactic radiation therapy for the treatment of refractory ventricular tachycardia, implantable Holter monitor with ILink Online technology for prolonged cardiac monitoring, and other topics.

The HTA body of the Tuscany Regional Healthcare issues two types of documents: HTA forms and motivational forms. With a regional decree 6462 of April 21, 2021, Tuscany Regional Healthcare has published assessments of six medical devices of various therapeutic areas, including devices for the treatment of vaginal prolapse, cardiovascular conditions, an implant for vocal cord rehabilitation, and a cerebral embolic protective device.

On April 09, 2021, the Swedish Medical Technologies Product (MTP) Council decided to add more technologies to the ongoing evaluation for self-monitoring of atrial fibrillation within the Orderly introduction framework, initiated in December 2020. MTP Council commissioned the Dental and Pharmaceutical Benefits Agency (TLV) to perform a health-economic evaluation of five products (Coala, KardiaMobile, CardioMem CM 100 XT, PhysioMem PM 100, Zenicor). MTP Council will then make recommendations to the regions on whether to adopt these technologies or not.

On February 18, 2021, the updated List of Reimbursable Products and Services (LPPR) was published. It contains new devices included in the LPPR list in January-February 2021, as well as other modifications made during this period. The newly-included devices belong to the cardiovascular (TAVI), ENT (cochlear and brainstem implants), and diagnostic imaging (FFR) technology groups.

In March 2021, the new mini-HTAs of five technologies were initiated in Norway: Harpoon - transapical neochordae device, tricuspidal clip, portable hand-held spirometry, CGM device and insulin pump, and portable spirometry device. The final mini-method assessment will be published in the National Database for Mini-HTA.

The HTA body of the Tuscany Regional Healthcare issues two types of documents: HTA forms and motivational forms. With a regional decree 554 of January 18, 2021, Tuscany Regional Healthcare has published assessments of eight medical devices of various therapeutic areas, including devices for the treatment of cardiovascular conditions, personal diabetes management system, endoscopic devices, and pedicle screw system.

On January 18, 2021, a new version of the List of Reimbursable Products and Services (LPPR) was published. It contains new devices included in the LPPR list in November-December 2020, as well as other modifications made during this period. Newly-introduced devices belong to the cardiovascular (coronary stents), orthopedic, neuromodulation (deep brain stimulation), peripheral vascular (stent-grafts to treat aortic abdominal aneurysm), and other areas of care.

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.