HTA

In October 2021, the National Institute for Health and Care Excellence (NICE) published three new Interventional Procedure Guidance (genicular artery embolization for pain from knee osteoarthritis, laparoscopic renal denervation for loin pain hematuria syndrome, percutaneous endovascular forearm arteriovenous fistula creation for hemodialysis access), and one new Medical Technologies Guidance (DyeVert Systems for reducing the risk of acute kidney injury in coronary and peripheral angiography). Also, two new clinical guidelines were published.

In September 2021, the National Institute for Health Research (NIHR) in England released two MedTech-related reports in its Health Technology Assessment (HTA) Journal, which concerned non-invasive imaging software for coronary stenosis assessment (QAngio XA 3D/QFR and CAAS vFFR) and quantitative fetal fibronectin test to predict preterm labor. 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 2021, the National Institute for Health and Care Excellence (NICE) published three new Interventional Procedure Guidance (transapical transcatheter mitral valve-in-valve implantation for a failed surgically implanted mitral valve bioprosthesis, transapical transcatheter mitral valve-in-ring (TMVIR) after failed annuloplasty for mitral valve repair, and lateral elbow resurfacing for arthritis), and two new Medtech Innovation Briefings (Carnation Ambulatory Monitor, OrganOx metra for liver transplant). Also, one clinical guideline was updated.

On September 10, 2021, it was announced that the Government of Spain had increased the budget allocated to the Spanish Network of Agencies for the Evaluation of Health Technologies and Benefits (RedETS) by 48.2% (compared to last year) for the development of the annual work plan. In total, the 2021 budget for the evaluation of health technologies in the National Health System amounts to €6,149,510. As a consequence of the budget increase, the RedETS 2021 Work Plan has included three new lines of evaluation.

In September 2021, the National Institute for Health and Care Excellence (NICE) published three new Interventional Procedure Guidance on transapical transcatheter mitral valve-in-valve implantation for a failed surgically implanted mitral valve bioprosthesis, transapical transcatheter mitral valve-in-ring (TMVIR) after failed annuloplasty for mitral valve repair, and lateral elbow resurfacing for arthritis

On 17 September 2021, the European Health and Digital Executive Agency signed the Service Contract for the Provision of Joint Health Technology Assessment Work Supporting the Continuation of EU Cooperation on HTA. The contract has now been awarded to the EUnetHTA21 consortium, which comprises the following 13 organizations from the EUnetHTA. The project will start in September 2021 and will run for two years (until September 2023).

In August 2021, the National Institute for Health and Care Excellence (NICE) published three new Interventional Procedure Guidance (magnetic resonance therapy for knee osteoarthritis, laparoscopic removal of uterine fibroids with power morcellation, hysteroscopic mechanical tissue removal for uterine fibroids), and six new Medtech Innovation Briefings (PLASMA system with button electrode, Immunoscore, MMprofiler, Patient Status Engine, lung texture analysis, Colli-Pee). Also, five clinical guidelines were published.

At the end of August, the complete method assessment for continuous glucose measurement for patients with type I diabetes with the main focus on patients over 18 years old was initiated as a part of a “New Method” framework. The assessment will be carried out at the National Institute of Public Health; besides the use of continuous glucose monitoring, flash glucose monitoring is considered as well.

In August 2021, the mini-HTA evaluation of the robot-assisted percutaneous coronary intervention was released. The method was described as safe and effective. After the introduction into the clinical practice, the method should be followed up for two years with a sufficient number of procedures to understand the real benefit. All procedures are to be registered in the Norwegian Registry for Invasive Cardiology.

On August 17, 2021, the National Institute of Public Health released a rapid HTA report on the evaluation of PD-L1 assays in urothelial carcinoma commissioned by the Ordering Forum. This assessment does not provide any conclusions on the effectiveness of various treatment strategies in the treatment of urothelial carcinoma in adults.

At the end of August 2021, the Swedish Dental and Pharmaceutical Benefits Agency (TLV) has initiated a theme survey on digital image diagnostics to identify new and innovative technology that may become important in Swedish healthcare. This could lead to potential inclusion of the technology in the Orderly introduction of medical technologies framework. The suggestions could be submitted no later than September 24, 2021.