HTA

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.

In the middle of February 2021, the Swedish Dental and Pharmaceutical Benefits Agency (TLV) launched the assessment on the following prognostic platforms for gene diagnostics in breast cancer: Oncotype DX, MammaPrint, ProSigna. The evaluation is planned for the spring of 2021.

In February 2021, the National Institute for Health and Care Excellence (NICE) published one new medical technologies guidance (Leukomed Sorbact for preventing surgical site infection) and seven new Medtech innovation briefings (PROPEL sinus implants, URO17 for detecting bladder cancer, Faecal microbiota transplant, DOAC Dipstick for detecting oral anticoagulants, CytoSorb for reducing the risk of bleeding during cardiac surgery, and others).

In February 2021, NICE announced the launch of a new 5-year strategic plan that will be presented at the virtual event on April 19, 2021. Registration is free but mandatory to attend the event.

In February 2021, the Health Technology Assessment Agency of the Health Institute Carlos III published the report for the efficacy and safety of robotic spinal surgery compared to manual surgery in spinal fusion.