HTA

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.

At the beginning of August 2021, the European Network for Health Technology Assessment, EUnetHTA, released a final report on the surgical procedures for the treatment of obesity. The results suggest little or no difference in the effects of different bariatric surgery procedures on weight loss and diabetes control. However, the results are based mainly on low to very low certainty evidence, with few or even single studies providing data for many of the comparisons.

In July 2021, the National Institute for Health and Care Excellence (NICE) published one new Interventional Procedure Guidance (inducing and maintaining normothermia using temperature modulation devices to improve outcomes after stroke or subarachnoid hemorrhage) and four new Medtech Innovation Briefings (HealthVCF for detecting vertebral compression fractures on CT scans, trublood-prostate for triaging and diagnosing people with prostate cancer symptoms, AI technologies for detecting diabetic retinopathy, and Acumen IQ sensor for predicting hypotension risk).

On July 16, 2021, NICE announced a new approach to prioritizing requests for NICE Scientific Advice. Because of the increased engagement, the waiting time for new scientific advice projects is currently several months. To address this, from December 2021, NICE will reserve priority slots in the work plan for companies developing high-priority technologies for the NHS.

In June 2021, the National Institute for Health Research (NIHR) in England released six MedTech-related reports in its Health Technology Assessment (HTA) Journal, which concerned tibial nerve stimulation for urinary incontinence treatment, imaging in ophthalmology, 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 informs National Institute for Health and Care Excellence (NICE) guidance.

In June 2021, the National Institute for Health and Care Excellence (NICE) published two new Interventional Procedure Guidance (laser lithotripsy for difficult-to-treat bile duct stones and percutaneous insertion of a closure device to repair a paravalvular leak around a replaced mitral or aortic valve), one new Medical Technologies Guidance (Plus Sutures for preventing surgical site infection), and four new Medtech Innovation Briefings (RapidAI for analyzing CT/MRI brain scans, WoundExpress, Magtrace and Sentimag, and SYNE-COV). Also, four clinical guidelines were updated, and two new published.