Stroke

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).

In Sweden, the Priority Council of Skåne Region prepares and presents suggestions for new methods, routines, and treatments, to be included in the healthcare system. In April 2019, the HTA report for thrombectomy 6 to 24 hours after stroke was released. The health economic analysis showed that the use of thrombectomy during extended time frames is expected to be cost-saving in a socio-economic perspective and increases patient benefit measured in terms of won quality-adjusted life years.

On the Interterritorial Council that took place March 4th, 2019, the Working Plan for the Spanish Network for Health Technology Assessment was agreed and published. The working plan includes 22 health technology assessment reports, 7 monitoring studies, 9 clinical practice guidelines, and 1 evidence-based product.

In December 2018, the National Institute for Health and Care Excellence (NICE) published one new diagnostic guidance (for tumour profiling tests to guide adjuvant chemotherapy decisions in early breast cancer), two new interventional procedure guidance (for transcutaneous neuromuscular electrical stimulation for oropharyngeal dysphagia in adults and bronchial thermoplasty for severe asthma), and four MedTech innovation briefings.

In the second half of July, the National Institute for Health and Care Excellence (NICE) published five new Interventional Procedure Guidance for low-intensity pulsed ultrasound to promote healing of fresh fractures at low risk of non-healing, fresh fractures at high risk of non-healing, superior capsular augmentation for massive rotator cuff tears, transaxial interbody lumbosacral fusion for severe chronic low back pain and two new Medtech Innovation Briefings for remote ECG interpretation consultancy services for cardiovascular disease and mechanical thrombectomy devices for acute ischaemic stroke.

In January 2018, the Galician HTA body, Avalia-T, released the technical review of The Vivistim® system, an implantable device for upper-limb rehabilitation after stroke. Evidence was found to be very limited to advice on the implementation of the technology.

The Andalusian Agency for Health Technology Assessment (AETSA) performed evaluation of transcranial Doppler ultrasonography in patients with acute ischemic stroke. Available evidence was considered as insufficient for formulation of final conclusion. However, AETSA prepared recommendations for evidence generation strategy for this procedure.

The current guideline replaces the previous version of the document of 2010. The Norwegian Directorate of Health decided to update the guideline because new methods of treatment and rehabilitation of stroke became avaliable in recent years.