In-vitro diagnostic tests

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.

In April and May 2023, it was announced that the Galician Agency for Health Technology Assessment (AVALIA-T) initiated several HTAs, including the evaluations in the e-health, nephrology and urology, men’s health, IVD, obstetrics and gynecology, pulmonary and airways, surgical procedures, and some other fields.

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 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.

On April 14, 2023, a repository of innovative acts outside the nomenclature of biology and anatomopathology (RIHN) and a Supplementary list of IVD tests were published. Minor changes were introduced in the 2023 RIHN list.

On April 19, 2023, the Italian Ministry of Health announced that the State-Regions Conference approved the national tariffs for outpatient specialist care and prosthetic care. These tariffs will be applied to Annexes 4 (outpatient specialist care) and 5 (prosthetic care) of the Essential Levels of Care (LEA) document from 2017. New tariffs for outpatient specialist care will enter into force in January 2024, and the tariffs for prosthetic care will enter into force on April 1, 2024.

In April 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 189 and 085 with changes to be implemented no later than June 15, 2023. Eighteen new procedure codes (concerning cardiovascular, endocrine, endoscopy, gastrointestinal, interventional radiology, neuromodulation, peripheral vascular, robotic surgery, men's health, and general surgery fields) and eight new diagnostic codes were introduced.

The revised EBM (German Uniform Evaluation Standard) catalog came into force on April 1, 2023. The most significant changes concern introducing the new EBM codes for follow-up and evaluation of the “Invirto” health app, high-frequency endometrium ablation, and reducing the tariff for COVID-19 PCR tests.

In March 2023, the National Institute for Health and Care Excellence (NICE) published two new Interventional Procedure Guidance (percutaneous transluminal renal sympathetic denervation for resistant hypertension, endoluminal gastroplication for gastro-oesophageal reflux disease), three new Health Technology Evaluations via piloted early value assessment approach (CaRi-Heart for predicting cardiac risk in suspected coronary artery disease, ProKnow cloud-based system for radiotherapy data storage, and Genedrive MT-RNR1 ID Kit for detecting a genetic variant), and two new MedTech Innovation Briefings (QBTest and BPMpathway). No new clinical guidelines were published.

In late March 2023, the Norwegian Directorate of e-Health released an updated version of the National Laboratory code (NLK) system and associated tariffs for state and private laboratories to be implemented no later than May 1, 2023. Twenty-one new codes were added, 122 codes were changed, and one code was terminated.

A new preeclampsia screening algorithm has been evaluated within the "New Method" framework since 2021. The algorithm helps to predict the risk of preeclampsia in the first trimester based on several parameters, including ultrasound examination and measurement of the Placenta Growth Factor (PIGF). In March 2023, the Decision Forum for "New Method" was held and commissioned to perform the implementation study of a new screening algorithm at St. Olav's Hospital.