Health technology assessment

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.

The Treatment Council (Behandlingsråd) is a new model for assessing treatment methods and health technologies, expected to become fully operational during 2021. The first meeting of the Treatment Council is planned to be conducted in May 2021. On April 15, 2021, the method and process frameworks of the Treatment Council (Behandlingsråd) were sent for consultation to the parties who have previously submitted consultation responses regarding these documents.

The National Institute for Health and Care Excellence (NICE) is currently developing health technology assessments concerning eHealth technologies in its Medical Technologies Guidance, Diagnostic Guidance, and Medtech Innovation Briefing programs. As of late April 2021, there are thirteen ongoing assessments.

Health Information and Quality Authority (HIQA) develops national HTA guidelines to support decision-making in Ireland. In the first quarter of 2021, Health Information and Quality Authority published only one assessment on the topic of Extended Interval Screening by the Diabetic RetinaScreen Programme.

On April 19, 2021, NICE has presented a new 5-year strategic plan at the virtual event. NICE provided clarifications and answered the questions on its strategy for 2021 to 2026 published in April that identified key trends and four strategic pillars indicating the significant changes NICE wants to make.

On March 31, 2021, NICE published Technology Appraisal Guidance on selective internal radiation therapies (SIRT) for treating hepatocellular carcinoma (HCC). Technology Appraisal is the only NICE program that has a direct link with the acceptance of technologies by payers. Payers need to implement the recommended technologies within three months after the publication of the guidance. Medical devices are very rarely evaluated within the Technology Appraisal program. SIR-Spheres and TheraSphere were recommended to treat unresectable advanced HCC under certain conditions, while QuiremSpheres was not recommended.

Healthcare Improvement Scotland develops HTAs and clinical guidelines to support decision-making. In the first quarter of 2021, Healthcare Improvement Scotland published assessments of targeted screening for early lung cancer in adults at high risk, gammaCore for cluster headache, and other topics, which mostly concern eHealth technologies.

In March 2021, the National Institute for Health and Care Excellence (NICE) published four new Interventional Procedure Guidance (transcervical ultrasound-guided radiofrequency ablation for symptomatic uterine fibroids, extracorporeal whole liver perfusion, free-functioning gracilis transfer to restore upper limb function, cytoreduction surgery with hyperthermic intraoperative peritoneal chemotherapy), two Medical Technologies Guidance (Danis stent for acute oesophageal variceal bleeding, Alpha-Stim AID for anxiety disorders), two Medtech Innovation Briefings (Sonata system for symptomatic uterine fibroids, Butterfly iQ+ for diagnostic ultrasound), and one Diagnostic Guidance (QAngio XA 3D QFR and CAAS vFFR imaging software for assessing coronary stenosis). Also, five clinical guidelines were updated.

In March 2021, the National Institute for Health Research (NIHR) in England released six MedTech-related reports in its Health Technology Assessment (HTA) Journal, which concerned sacral nerve stimulation and magnetic sphincter augmentation device for fecal incontinence treatment, patch augmentation surgery for rotator cuff repair, in-vitro diagnostics, and eHealth. HTA Journal publishes research reports on the effectiveness, costs, and broader impact of health technologies for those who use, manage, and provide care in the NHS and inform National Institute for Health and Care Excellence (NICE) guidance.

To give researchers more tools to assess healthcare innovations' efficiency and demonstrate the effectiveness of novel technologies, the Dutch Organization for Health Research and Development (ZonMw), in collaboration with the National Health Care Institute (ZIN), initiated the new HTA Methodology Program for 2021-2024.

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.