Health technology assessment

In September 2022, the French National Authority for Health (HAS) published four new opinions, which were based on health technology assessment reports. They are related to neuromodulation and cardiovascular areas. The main goal of these HTAs was to support decision-making for the creation of new procedure codes in the Common Classification of Medical Procedures (CCAM) and to update the indications for implantable cardiac defibrillators with endocavitary lead(s) in the Intra-DRG list.

In September 2022, the National Institute for Health and Care Research (NIHR) in England released one MedTech-related report in its Health Technology Assessment (HTA) Journal, which concerned early computed tomography coronary angiography in acute coronary syndrome. 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 September 2022, the National Institute for Health and Care Excellence (NICE) published three new Interventional Procedure Guidance (removal, preservation and subsequent reimplantation of ovarian tissue, prostatic urethral temporary implant insertion, neurostimulation of lumbar muscles), and one new Medtech Innovation Briefings (iTind). Also, one Medical Technologies Guidance and three Medtech-related clinical guidelines were updated.

The Dental and Pharmaceutical Benefits Agency (TLV) has planned a theme survey on products for the diagnosis or treatment of lung cancer and colorectal cancer to identify products that may be relevant for health economic assessments at TLV. The survey is planned to be carried out in September – October 2022. No further information has been provided yet.

In August 2022, the Scottish Health Technology Group, SHTG, released two MedTech-related assessments: vCreate Neuro for the diagnosis and management of adults and children with epilepsy and other neurological disorders and Bluetooth Tagging of medical equipment.

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.