Health technology assessment

In August 2022, the National Institute for Health and Care Research (NIHR) in England released two MedTech-related reports in its Health Technology Assessment (HTA) Journal, which concerned the treatment of urodynamic stress incontinence after prostate surgery and closure techniques after surgery for colorectal cancer. 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.

In August 2022, the National Institute for Health and Care Excellence (NICE) published five new Interventional Procedure Guidance (aortic remodeling hybrid stent insertion during surgical repair of aortic dissection, bioresorbable stent implantation to treat coronary artery disease, superficial venous arterialization for chronic limb ischemia, transcutaneous electrical neuromuscular stimulation for urinary incontinence, focal resurfacing implants to treat articular cartilage damage in the knee), and three new Medtech Innovation Briefings (Stockholm3 for prostate cancer screening, contrast-enhanced spectral mammography, differential target multiplexed spinal cord stimulation). Also, two Medical Technologies Guidance and two Medtech-related clinical guidelines were updated.

In August 2022, the Finnish Coordinating Center for Health Technology Assessment published an article regarding the implementation of a new Digi-HTA process for digital health technologies in Finland. This study aimed to determine whether it would be possible to use Digi-HTA recommendations to support healthcare decision-makers. Secondly, from the perspective of companies offering different types of digital health technology products, this study assessed the suitability of using the Digi-HTA framework to perform HTAs for their products.

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 15937 of August 4, 2022, Tuscany Regional Healthcare has published assessments of six medical devices in various therapeutic areas, such as cardiovascular and peripheral vascular areas, neurovascular procedures, gastroenterology, and dermatology.

On August 26, 2022, Swedish Medical Technologies Product (MTP) Council announced ongoing horizon scanning within the Orderly introduction framework for products that promote the transition to so-called “Close care” (Nära vård). Products of interest should enable diagnosis, treatment, and follow-up outside a healthcare facility, for example, remote monitoring. The Dental and Pharmaceutical Benefits Agency (TLV) initiated a theme survey, accepting suggestions until September 28, 2022.

On July 27, 2022, the EUnetHTA 21 released the assessment framework for high-risk medical devices (MDs) and in-vitro-diagnostics (IVDs). The objective of this deliverable is to define the framework for Joint Clinical Assessments of high-risk MDs and IVDs with a view to fostering national uptake of the Joint Clinical Assessments reports early in the life cycle of a single technology.

On August 09, 2022, NICE updated the Evidence standards framework for digital health technologies, initially published in 2018. Artificial intelligence and data-driven technologies with adaptive algorithms are now included in the framework and user guide. NICE also aligned digital health technology classifications with regulatory requirements and outlined a subset of early deployment standards that can be used within evidence generation programs.

In July 2022, the French National Authority for Health (HAS) published seven new opinions which were based on health technology assessment reports. These are related to endoscopy, IVD tests, neuromodulation, and primary care settings. The main goal of these HTA reports was to spoort decision-making for the creation of new procedure codes in the Common Classification of Medical Procedures (CCAM) and the Nomenclature of Medical Biology Procedures (NABM).

In the second quarter of 2022, Health Technology Wales (HTW) published four MedTech-related guidance (extreme hypofractionated radiotherapy for localized prostate cancer, video laryngoscopes for use in pre-hospital care, electronic blood management systems, and stereotactic ablative radiotherapy for the treatment of renal cell carcinoma). A total of 12 MedTech-related Topic Exploration Reports (TERs) were released in Q2. Based on the TERs conclusions, HTW decided to proceed with a full appraisal on three topics – photobiomodulation, topical oxygen therapy (NATROX) in chronic wounds, and video feedback interventions.

On July 15, 2022, the Austrian Institute for HTA (AIHTA) published five 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 four updates to previous decision support documents. The decisions relate mainly to cardiovascular and gastrointestinal technology groups.

On July 20, 2022, Health Institute Carlos III released two HTA reports regarding endoanchoring systems in endovascular aortic aneurysm repair and transanal irrigation in bowel dysfunction.

The Scottish Health Technologies Group (SHTG) is a national health technology assessment (HTA) agency providing advice to NHSScotland on using new and existing health technologies, likely to significantly impact healthcare. In July 2022, SHTG published three reports (KardiaMobile for detecting atrial fibrillation, complex endovascular aneurysm repair, and Togetherall platform). Currently, the SHTG is working on assessments of technologies in the field of cancer, radiotherapy, musculoskeletal diseases, transplantation, and other topics.