Stroke

In the fourth quarter of 2023, two new health technology assessments were initiated by the Agency for Health Technology Assessment and Tariff System (AOTMiT). The assessments belong to the cardiovascular and neurovascular technology groups.

In the middle of March 2023, the updated version of the intra-DRG list was published. Changes include the introduction of several devices for thrombo-aspiration into the list and the deletion of a few devices from the list.

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 3844 of March 02, 2023, Tuscany Regional Healthcare has published assessments of four medical devices in the cardiovascular and neurovascular treatment areas.

The French National Authority for Health 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 in October 2022. Fourteen recommendations were published in relation to the registration, modification of registration conditions, and renewal of registration for devices in the List of reimbursable products and services. Opinions concern cardiovascular, neurovascular, orthopedic, and ENT devices, as well as medical aids.

Dutch Organization for Health Research and Development, ZonMw awarded eight projects under the "Healthcare Evaluation and Appropriate Use" program, including two projects for geriatric care, two projects for cancer, per one project for cardiovascular, neurovascular, and dermatology care.

In August 2021, 22 Russian clinical guidelines in the fields of ENT, cardiovascular, obstetrics and gynecology, orthopedics and others, were released. Furthermore, the order on the approval of the standard of medical care for adults with urolithiasis disease entered into force.

In July 2021, the National Institute for Health and Care Excellence (NICE) published one new Interventional Procedure Guidance (inducing and maintaining normothermia using temperature modulation devices to improve outcomes after stroke or subarachnoid hemorrhage) and four new Medtech Innovation Briefings (HealthVCF for detecting vertebral compression fractures on CT scans, trublood-prostate for triaging and diagnosing people with prostate cancer symptoms, AI technologies for detecting diabetic retinopathy, and Acumen IQ sensor for predicting hypotension risk).

In early January 2021, the new reimbursable health app was introduced on the Directory of digital health applications (DiGAs) at the Federal Office for Drugs and Medical Devices (BfArM). These applications can be prescribed by physicians and psychotherapists and will be reimbursed by health insurers.

In November 2020, the Swedish Dental and Pharmaceutical Benefits Agency (TLV) launched a theme survey for medical technology products in stroke, focusing on products for diagnostic/assessment in case of suspected stroke. The submissions in relation to this survey will be closed on December 16, 2020

In August 2019, the Decision Forum conducted the meeting towards the funding decisions for new methods, where concluded that prehospital CT ("stroke ambulance") for early diagnosis and treatment of suspected stroke can be used within the framework of controlled studies with a sufficient number of patients. The protocol of the Decision Forum meeting was released on the website of the New Method.

In June 2019, the Norwegian Institute of Public Health (NIPH) has released an HTA report for prehospital CT for early diagnosis and treatment of suspected acute stroke or severe head injury to evaluate the documentation for clinical efficacy, safety and possible initiation of treatment prior to arrival in hospitals, compared with current hospital practice. Although the mobile stroke unit care increases the number of patients who receive thrombolysis, its efficacy is unknown due to the lack of evidence.

In May 2019, the National Institute for Health and Care Excellence (NICE) published one new diagnostics guidance for Lead-I ECG devices for detecting symptomatic atrial fibrillation using single time point testing in primary care, three new interventional procedure guidance (for therapeutic hypothermia for acute ischaemic stroke, collagen paste for closing an anal fistula, and percutaneous mitral valve leaflet repair for mitral regurgitation), two new Medical technologies guidance, and three new MedTech innovation briefings (for SEM Scanner for pressure ulcer prevention, Peezy Midstream for urine collection,and DuraGraft for preserving vascular grafts).