Health technology assessment

Health Information and Quality Authority (HIQA) is an independent statutory authority that develops national health technology assessments to support decision-making in Ireland. In the second quarter of 2023, HIQA published one new Med Tech-related assessment concerning slot-scanning biplanar digital X-ray imaging systems for orthopedic conditions.

In early August 2023, the Polish Agency for Health Technology Assessment and Tariff System (AOTMiT) announced the start of the evaluation of several technologies in men’s health, neuromodulation and in-vitro diagnostics fields.

In July 2023, Health Technology Wales completed one full appraisal on wearable cardioverter defibrillators with the publication of Evidence Appraisal Report (EAR) and Guidance. Furthermore, in July 2023, Health Technology Wales decided to proceed with a full appraisal of radiofrequency renal denervation in the treatment of resistant hypertension based on the published Topic Exploration Report.

In late June 2023, the Belgian Health Care Knowledge Center (KCE) published a report on relevance of transversal budget impact analysis. This type of analysis should be submitted as part of the application to the National Institute for Health and Disability Insurance (INAMI-RIZIV) to obtain reimbursement for implants and invasive medical devices.

In July 2023, the National Institute for Health and Care Research (NIHR) in England released one MedTech-related report in its Health Technology Assessment (HTA) Journal concerning MRI-based technologies for diagnosing non-alcoholic fatty liver disease. 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 informs National Institute for Health and Care Excellence (NICE) guidance.

On July 17, 2022, the Austrian Institute for HTA (AIHTA) published four decision support documents, which provide recommendations regarding the inclusion of new medical interventions in the catalog of individual medical services of the performance-oriented hospital financing (Leistungsorientierten Krankenanstaltenfinanzierung, LKF) model, as well as three updates to previous decision support documents.

In June 2023, the National Institute for Health and Care Excellence (NICE) published one new Interventional Procedure Guidance (irreversible electroporation for treating prostate cancer) and one new Diagnostic Guidance (AI-derived computer-aided detection (CAD) software for detecting and measuring lung nodules in CT scan images). Also, three clinical guidelines were 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 13989 of June 29, 2023, Tuscany Regional Healthcare has published assessments of nine medical devices in the cardiovascular, peripheral vascular, diagnostic imaging areas, and surgical procedures.

In June 2023, the National Institute for Health and Care Excellence (NICE) published five new Interventional Procedure Guidance (intraoperative electron beam radiotherapy, minimally invasive fusionless posterior-approach surgery to correct idiopathic scoliosis, endoscopic ultrasound-guided gallbladder drainage, radiofrequency denervation for osteoarthritic knee pain, and Botulinum toxin type A injections into the urethral sphincter), two new Diagnostic Guidance (transperineal biopsy for prostate cancer, and FibroScan for liver fibrosis and cirrhosis), and two Medtech Innovation Briefings (MiraQ cardiac TTFM, Proov Confirm; their development started before April 2023). Also, four clinical guidelines were updated.

On June 27, 2023, the National Institute for Health and Care Excellence (NICE) launched a consultation on the updated health technology evaluation process manual, initially published in January 2022. Key changes concerned introducing a new faster approach to technology appraisal development. The deadline for comments submission is July 25, 2023.

On June 13, 2023, the Swedish Medical Technologies Product (MTP) Council recommended that all regions delay the introduction of robotic systems for knee, hip, and spine surgery until they have been evaluated as part of the Orderly introduction framework. For now, MTP Council recommends robotic systems in these indications only to be used in the context of research.

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 11957 of June 07, 2023, Tuscany Regional Healthcare has published assessments of two medical devices in the cardiovascular and spine areas.