England

In August 2024, the National Institute for Health and Care Excellence (NICE) published three new Interventional Procedures Guidance concerning caval valve implantation for tricuspid regurgitation and phrenic nerve pacing for ventilator-dependent high cervical spinal cord injury and for congenital central hypoventilation syndrome. Furthermore, two new clinical guidelines were published for diabetic retinopathy and adrenal insufficiency.

In August 2024, NICE prioritization board decisions were published regarding the following Med Tech-related topics: clinical guidelines on lower urinary tract symptoms in men (prioritized), NPi-200 for pupillary light reflex in critical care (not prioritized), Aquablation robotic therapy in benign prostatic hyperplasia (not prioritized), and tumor treating fields in glioblastoma (not prioritized).

On September 1, 2024, the application window opened to join the NHS Innovation Accelerator (NIA) program in 2025. NIA supports the development of individuals ('Fellows') and the spread of their innovation nationally. For the 2025 intake, the NIA seeks high-impact, evidence-based innovations that can address any challenge the healthcare system faces. The application deadline is October 14, 2024.

On July 31, 2024, NHS England and the National Institute for Health and Care Excellence (NICE) published a consultation document that proposes to increase the Budget Impact Test (BIT) threshold from £20 million to £40 million. The BIT applies during NICE's technology evaluation process. The deadline for comments submission is September 25, 2024.

On July 25, 2024, the National Institute for Health and Care Research (NIHR) launched a funding call within the HTA Programme concerning ambitious data-enabled trial proposals (or “e-trials”). Proposed interventions need to be mature enough to be tested on a national scale. The application deadline is November 27, 2024.

NICE recently introduced a new centralized approach to prioritizing topics for its guidance and a decision-making body - a prioritization board. In July 2024, the decisions of the prioritization board were first published by NICE. Sixteen topics were prioritized, twenty were not prioritized, and one was withdrawn.

On August 8, 2024, the Clinical Coding and Schedule Development (CCSD) working group, which develops and maintains procedural and diagnostics nomenclatures for private payers in England, published Bulletins 197 and 093 with changes to be implemented no later than October 4, 2024. Thirteen new procedure codes related to cardiovascular, endoscopy, gastrointestinal, interventional radiology, neurology, gynecology, orthopedics, spine, and robotic surgery areas, and four new diagnostic codes were introduced.

In July 2024, NHS England issued an updated version of the 2024/25 National Genomic Test Directory, which lists genomic tests commissioned by NHS England via Genomic Laboratory Hubs. A total of 58 new codes (test-indication combinations) were introduced in the Test Directory for cancer, and ten new codes in the Test Directory for rare and inherited diseases.

In July 2024, the National Institute for Health and Care Research (NIHR) in England released five MedTech-related assessments in its Health Technology Assessment (HTA) Journal, which concerned cloud-based device (CaRi-Heart) for predicting cardiac risk, remote continuous monitoring of Parkinson's disease, home-monitoring for neovascular age-related macular degeneration, treatment of pilonidal sinus disease, and cystatin C in glomerular filtration rate-estimating. 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 July 2024, the National Institute for Health and Care Excellence (NICE) released a report on proposed approaches to the economic evaluation of multi-indication health technologies (MIHTs) developed by the HTA Lab. Examples of MIHTs include circulating tumor DNA tests, polygenic risk scores, and virtual ward platform technologies, which can be used across multiple disease areas or multiple indications. This report proposes approaches that NICE could adopt for future economic evaluations of MIHTs and provides recommendations for implementing the approaches on pilot topics.

In July 2024, the National Institute for Health and Care Excellence (NICE) published one new Diagnostics Guidance (CYP2C19 genotype testing to guide clopidogrel use after ischaemic stroke or transient ischaemic attack) and one Technology Appraisal Guidance (Selective internal radiation therapy with QuiremSpheres for treating unresectable advanced hepatocellular carcinoma).

In July 2024, the UK National Screening Committee (UK NSC) released an annual report from April 1, 2023 to March 31, 2024. The report provides a summary of the Committee’s ongoing work and accomplishments, including recommendations regarding the introduction of national population screening programs.