HTA

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.

On March 31, 2021, NICE published Technology Appraisal Guidance on selective internal radiation therapies (SIRT) for treating hepatocellular carcinoma (HCC). Technology Appraisal is the only NICE program that has a direct link with the acceptance of technologies by payers. Payers need to implement the recommended technologies within three months after the publication of the guidance. Medical devices are very rarely evaluated within the Technology Appraisal program. SIR-Spheres and TheraSphere were recommended to treat unresectable advanced HCC under certain conditions, while QuiremSpheres was not recommended.

In March 2021, the National Institute for Health and Care Excellence (NICE) published four new Interventional Procedure Guidance (transcervical ultrasound-guided radiofrequency ablation for symptomatic uterine fibroids, extracorporeal whole liver perfusion, free-functioning gracilis transfer to restore upper limb function, cytoreduction surgery with hyperthermic intraoperative peritoneal chemotherapy), two Medical Technologies Guidance (Danis stent for acute oesophageal variceal bleeding, Alpha-Stim AID for anxiety disorders), two Medtech Innovation Briefings (Sonata system for symptomatic uterine fibroids, Butterfly iQ+ for diagnostic ultrasound), and one Diagnostic Guidance (QAngio XA 3D QFR and CAAS vFFR imaging software for assessing coronary stenosis). Also, five clinical guidelines were updated.

In March 2021, the National Institute for Health Research (NIHR) in England released six MedTech-related reports in its Health Technology Assessment (HTA) Journal, which concerned sacral nerve stimulation and magnetic sphincter augmentation device for fecal incontinence treatment, patch augmentation surgery for rotator cuff repair, 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 inform National Institute for Health and Care Excellence (NICE) guidance.