HTA

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.

In April 2021, the National Institute for Health and Care Excellence (NICE) published three new Interventional Procedure Guidance (repetitive short-pulse transscleral cyclophotocoagulation for glaucoma, deep brain stimulation for chronic, severe, treatment-resistant obsessive-compulsive disorder in adults, and Melphalan chemosaturation for primary or metastatic cancer in the liver) and two Medtech Innovation Briefings (microINR for anticoagulation therapy and RenalSense Clarity RMS for acute kidney injury), and two clinical guidelines (for atrial fibrillation and chronic pain in over 16s).

On May 10, 2021, NICE announced the update of the evidence standards framework (ESF) for digital health technologies with changes in response to an ESF user survey that ran from October to December 2019. Furthermore, NICE launched a new Office for Digital Health to coordinate its digital health activities and strategic projects and manage collaboration with external partners.

The Galician Scientific and Technical Advice Unit in Spain (AVALIA-T) systematically evaluates healthcare technologies and provides decision-makers with critically reviewed information about their efficacy, safety, and effectiveness. Currently, the AVALIA-T is working on assessments of ventricular assist devices in pediatric patients with an indication for permanent destination therapy, bronchial thermoplasty for severe acute asthma, effectiveness and safety of epiduroscopy in the treatment of failed back surgery syndrome, and other topics.

The National Institute for Health and Care Excellence (NICE) is currently developing health technology assessments concerning eHealth technologies in its Medical Technologies Guidance, Diagnostic Guidance, and Medtech Innovation Briefing programs. As of late April 2021, there are thirteen ongoing assessments.