HTA

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.

In May 2021, the National Institute for Health and Care Excellence (NICE) published five new Interventional Procedure Guidance (ex-situ machine perfusion for extracorporeal preservation of lungs for transplant, transvaginal laser therapy for stress urinary incontinence and for urogenital atrophy, electrohydraulic lithotripsy for difficult-to-treat bile duct stones, and permanent His-bundle pacemaker for heart failure), one new Medical Technologies Guidance (UroLift for benign prostatic hyperplasia), and two new Medtech Innovation Briefings (Axonics sacral neuromodulation system for faecal incontinence and KODEX-EPD for cardiac imaging during ablation of arrhythmias). Also, three clinical guidelines and two Medical Technologies Guidance were updated.

The Health Sciences Institute in Aragon (IACS) systematically evaluates healthcare technologies and facilitates the promotion of research, effective innovation, and decision-making in health services through knowledge management. Currently, the IACS is working on assessments of efficacy, effectiveness, and safety of intraoperative radiation therapy in breast cancer, determination of preeclampsia biomarkers SFlt-1 and PlGF, treatment of congenital ventricular septal defect by cardiac catheterization, and others.

The National Institute for Health and Care Excellence (NICE) is currently developing health technology assessments concerning in-vitro diagnostics in its Diagnostic Guidance and Medtech Innovation Briefing programs. As of June 08, 2021, there are ten ongoing assessments.

In May 2021, NICE published an impact report on diagnostic pathology, which provides an uptake analysis of several NICE-recommended pathology diagnostics, including high-sensitivity troponin tests, placental growth factor (PIGF)-based tests for suspected pre-eclampsia, faecal immunochemical test (FIT) for colorectal cancer, and others.

In May 2021, the Agency for Health Quality and Assessment of Catalonia (AQuAS) published a report on next-generation sequencing (NGS) for molecular diagnosis and selection of therapeutic targets in oncological diseases. The studies identified present favorable results on the diagnostic efficacy of the NGS-based gene panels; the evidence on the clinical effectiveness of NGS panels remains limited. The authors emphasize the need for further studies.

For the first time in three years, the Institute for Quality and Efficiency in Health Care (IQWiG) received data within the framework of the early benefit assessment of new examination and treatment methods (NUB) with high-risk medical devices according to §137h of Social Code Book (SGB) V. This involves seven invasive therapeutic cardiovascular, pulmonary, neurological, gastrointestinal, and urological procedures.

On April 29, 2021, the National Institute for Health Research (NIHR) HTA Programme opened NICE Rolling Call for first-stage applications that should meet research recommendations provided by NICE guidance published from 2015 onwards. The first-stage application deadline is September 01, 2021.