Health technology assessment

In January-February 2023, Health Technology Wales published sixteen Medtech-related Topic Exploration Reports (TER), including stereotactic radiosurgery, percutaneous implantation of pulmonary artery pressure sensors, ambulatory patch ECG devices, and others; however, Health Technology Wales will not proceed with full appraisals on these topics. No Guidance was released for Medtech in January-February 2023.

In March 2023, a new ‘AI and Digital Regulations Service’ for developers and adopters of artificial intelligence (AI) and digital technologies was launched in England. Four organizations provide this multi-agency advisory service: NICE, Care Quality Commission, Medicines and Healthcare products Regulatory Agency, and Health Research Authority. The website is currently in public beta and focused on information for developers.

The Ministry of Health has commissioned the Agency for Health Quality and Assessment of Catalonia (AQuAS) to develop, with the collaboration of the various agencies that make up the Spanish Network of Agencies for the Evaluation of Health Technologies and Benefits (RedETS), a specific methodological framework for the evaluation of digital health technologies that would allow a comprehensive assessment of this type of technology. The methodological framework is in the final phase of development.

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.

In February 2023, the National Institute for Health and Care Excellence (NICE) published two new Interventional Procedure Guidance (transvenous obliteration for gastric varices, biodegradable spacer to reduce rectal toxicity during radiotherapy for prostate cancer), one new Health Technology Evaluation (guided self-help digital cognitive behavioural therapy), and two new Medtech Innovation Briefings (LIVERFASt, and Ambu aScope 4 RhinoLaryngo). Also, one new clinical guideline was published, and one was updated.

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 1756 of January 25, 2023, Tuscany Regional Healthcare has published assessments of two medical devices in the orthopedics, surgical procedures, and cardiovascular treatment areas.

On February 17, 2023, the National Agency for Regional Health Services (AGENAS) invited applicants to submit proposals for the evaluation of medical technologies within the National HTA Program for Medical Devices (PNHTADM).

On February 1, 2023, the Treatment Council made its first two recommendations based on the major analysis reports regarding handheld focused ultrasound in emergency medicine and artificial intelligence as decision support for colonoscopy. The adoption of these technologies was not recommended.

In February 2023, Swedish Medical Technologies Product (MTP) Council announced ongoing horizon scanning within the Orderly introduction framework for medical technologies to be used in benign prostatic hyperplasia. The Dental and Pharmaceutical Benefits Agency (TLV) initiated a theme survey, accepting suggestions until March 31, 2023.

In February 2023, NICE completed its first early value assessment (EVA) within the medical technologies evaluation program concerning digital cognitive behavioral therapy. EVA guidance aimed to provide quicker conditional recommendations on promising medical technologies (digital products, medical devices, and diagnostics) that address unmet national needs while more evidence is generated.

In February 2023, it was announced that the Basque Office for Health Technology Assessment (OSTEBA) initiated several HTAs, including evaluations in the e-health, radiology, nephrology and urology, cardiovascular, IVD, obstetrics and gynecology, diagnostic imaging, radiotherapy, neurovascular, ENT, interventional radiology, surgical procedures, and some other fields.

In the fourth quarter of 2022, Health Technology Wales published three MedTech-related guidance (Left atrial appendage occlusion in patients with atrial fibrillation, continuous topical oxygen therapy, and virtual reality distraction therapy). Four Topic Exploration Reports were released as well (virtual wards, genetic testing for prostate cancer, autofluorescence imaging, and geniculate artery embolization); however, Health Technology Wales decided not to proceed with complete appraisals on these topics.