UK

On June 27, 2023, the National Institute for Health and Care Excellence (NICE) launched a consultation on the updated health technology evaluation process manual, initially published in January 2022. Key changes concerned introducing a new faster approach to technology appraisal development. The deadline for comments submission is July 25, 2023.

In June 2023, the Clinical Coding and Schedule Development (CCSD) working group, which develops and maintains procedural and diagnostics nomenclatures for private payers in England, published Bulletins 190 and 086 with changes to be implemented no later than August 4, 2023. Fourteen new procedure codes (concerning cardiovascular, diagnostic imaging, endocrine, endoscopy, gastrointestinal, orthopedic and spine, peripheral vascular, robotic surgery, men's health, and radiotherapy fields) and six new diagnostic codes were introduced.

In May 2023, the latest set of guidance (List 3) of the Evidence-based Interventions (EBI) Programme was published. The program is run by the Academy of Medical Royal Colleges (AoMRC), supported by NHS England and NICE. Ten procedures were added to the List across a range of medical specialties, including breast surgery, gastrointestinal surgery, cardiovascular, urology, and ophthalmology. It is expected that where treatment criteria outlined in the List for the intervention are met, it would be routinely funded.

On June 1, 2023, NHS England issued an updated version of the National Genomic Test Directory, which lists genomic tests commissioned by NHS England via Genomic Laboratory Hubs. Three new codes (test-indication combinations) were introduced in the Test Directory for rare and inherited diseases.

In May 2023, the National Institute for Health and Care Research (NIHR) in England released two MedTech-related reports in its Health Technology Assessment (HTA) Journal, which endoscopic radiofrequency ablation in malignant biliary obstruction and screening for ovarian cancer. 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 May 2023, the National Institute for Health and Care Excellence (NICE) published one new Interventional Procedure Guidance (intramuscular diaphragm stimulation for ventilator-dependent chronic respiratory failure from high spinal cord injuries), two new Diagnostic Guidance (MRI fusion biopsy systems for diagnosing prostate cancer, automated ankle-brachial pressure index measurement devices to detect peripheral arterial disease), and three new Health Technology Evaluations (Digitally enabled therapies for adults with anxiety disorders / with depression, and point-of-care tests for urinary tract infections). Also, four clinical guidelines were updated.

In May 2023, NICE announced that the Medtech innovation briefing (MIB) program was discontinued. MIBs were a part of the advice program at NICE commissioned by NHS England in 2014 to support the 5-Year Forward View and accelerate innovations. NICE will now focus on introducing new approaches to evaluating the most promising health technologies.

On May 17, 2023, NHS England issued an updated version of the National Genomic Test Directory for cancer, which lists genomic tests commissioned by NHS England via Genomic Laboratory Hubs. Two new codes (test-indication combinations) were introduced.

On April 28, 2023, the NHS Cancer Programme awarded £12.1 million to six innovations that improve the early detection and diagnosis of cancer. Awarded medical devices, in-vitro diagnostics, and digital health solutions are used to diagnose bowel, skin, liver, breast, ovarian, and esophageal cancer. They have proven their efficacy and clinical effectiveness and will be funded over the next 18 months to support rollout and real-world testing.

In March 2023, Health Technology Wales published an Evidence Appraisal Report (EAR) and Guidance on photobiomodulation for the prevention and treatment of oral mucositis. Furthermore, seven Medtech-related Topic Exploration Reports (TER) were published, including single-pulse transcranial magnetic stimulation and AI-assisted ultrasound for deep vein thrombosis; however, Health Technology Wales will proceed with a full appraisal on one topic only - digital wound management tools.

In late April, NHS Accelerated Access Collaborative introduced the Health Technology Navigation Pathway Tool to help innovators adopt new technologies into the NHS. The Tool breaks the innovation journey down into 25 steps, themed around the five key phases of the product lifecycle, from creation to commissioning and adoption. For each step, the schematic flowchart outlines key organizations to engage with, regulatory insights, best practice approaches, policies, guidelines, to-do lists, and required outputs.

In April 2023, the National Institute for Health and Care Excellence (NICE) published seven new Interventional Procedure Guidance (concerned Daytime intraoral neuromuscular electrical tongue stimulation, endoscopic ultrasound-guided biliary drainage, maximal cytoreductive surgery in ovarian cancer, percutaneous thoracic duct embolization, radiofrequency ablation for spinal metastases, high-intensity focused ultrasound for prostate cancer), one new Medical Technologies Guidance (AposHealth for knee osteoarthritis), and one Medtech Innovation Briefing (Fasciotens for abdominal wall closure). Also, three clinical guidelines were updated.