Health technology assessment

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.

On February 23, 2021, NHSX launched Digital Technology Assessment Criteria for health and social care (DTAC), the new national criteria designed to provide suppliers and healthcare organizations a clear direction on building and buying good digital health technologies. DTAC will apply to all types of digital health technologies, from public-facing health apps to digital systems used within hospitals. The assessment criteria are focused on five areas: digital technologies will receive a pass or fail in four categories - clinical safety, data protection, technical security and interoperability, and a score on usability and accessibility.

In late February 2021, eleven out of fifteen needed members and three observers of the Treatment Council (Behandlingsråd) were appointed in Denmark. The Treatment Council is a new model for assessing treatment methods and health technologies, expected to become fully operational in early 2021. Earlier in February 2021, the final method and process framework of the Treatment Council was approved.

In February 2021, the National Institute for Health and Care Excellence (NICE) published one new medical technologies guidance (Leukomed Sorbact for preventing surgical site infection) and seven new Medtech innovation briefings (PROPEL sinus implants, URO17 for detecting bladder cancer, Faecal microbiota transplant, DOAC Dipstick for detecting oral anticoagulants, CytoSorb for reducing the risk of bleeding during cardiac surgery, and others).

The Swedish Agency for Health Technology Assessment and Assessment of Social Services (SBU) systematically evaluates healthcare technologies and practices from medical, economic, ethical, and social standpoints. Currently, the SBU is working on assessments of treatment methods of gastrointestinal conditions, musculoskeletal disorders, pain treatment, medical aids, e-health technologies, and other topics.

Healthcare Improvement Scotland develops HTAs and clinical guidelines to support decision-making. In the fourth quarter of 2020, Healthcare Improvement Scotland published assessments of continuous glucose monitoring in pregnant women with type 1 diabetes, endobronchial valves for lung volume reduction in patients with severe emphysema, and other topics.

In February 2021, NICE announced the launch of a new 5-year strategic plan that will be presented at the virtual event on April 19, 2021. Registration is free but mandatory to attend the event.

In February 2021, the Health Technology Assessment Agency of the Health Institute Carlos III published the report for the efficacy and safety of robotic spinal surgery compared to manual surgery in spinal fusion.

On February 4, 2021, the guide on dossier submission to the Medical Device and Health Technology Evaluation Committee (CNEDiMTS) for the inclusion of the device in the List of Reimbursable Products and Services (LPPR) was published in English. Furthermore, the guide was recently updated with the information dedicated to the technologies falling within the scope of artificial intelligence.

In early February 2021, the final method and process frameworks of the Treatment Council (Behandlingsråd) were approved in Denmark. The Treatment Council is a new model for assessing treatments and health technologies, expected to become fully operational in early 2021.

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.

In Finland, the Health Care Services Selection Council (Terveydenhuollon palveluvalikoimaneuvosto, PALKO) is responsible for making recommendations regarding the research, treatment, and rehabilitation methods. Currently, the Council is working on assessments of chronic low back pain treatment and screening for severe combined immune deficiency in a neonatal heel sample.