On September 20, 2024, the Swedish Medical Technologies Product (MTP) Council commissioned the Dental and Pharmaceutical Benefits Agency (TLV) to perform a health economic evaluation of hybrid closed-loop systems for adults with type 1 diabetes. This evaluation is a part of the Orderly introduction framework, a staged process aimed at managing the national introduction of novel technologies. Based on the TLV assessment, the MTP Council will make recommendations to regions regarding the implementation of the technology and the criteria for use.

In August 2024, the National Institute for Health and Care Research (NIHR) in England released eight MedTech-related assessments in its Health Technology Assessment (HTA) Journal, which concerned automated devices for identifying peripheral arterial disease, left ventricular assist devices as destination therapy, cerclage suture type to prevent pregnancy loss, gynecological cancer surveillance in Lynch syndrome, multiparametric MRI in bladder cancer pathway, in-home monitoring for people with glaucoma, real-time ultrasound elastography of thyroid nodules, and AI-based software for analyzing chest X-ray images. 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.

On September 23, 2024, the Norwegian Directorate of Health released an updated version of the Norwegian Laboratory Code (NLK) system. Sixty-nine new codes were added, and 209 codes were changed.

On September 2, 2024, NHS England published service specifications for same-day emergency care (SDEC). The SDEC model allows patients to be assessed, diagnosed, and treated on the same day of arrival instead of being admitted to a hospital. The specification defines the scope, care pathways, patient selection, referral to SDEC, and requirements for staff and quality.

The HTA body of the Tuscany Regional Healthcare issues three types of documents: full HTA reports, rapid HTA reports, and motivational forms. With regional decree 20315 of September 9, 2024, Tuscany Regional Healthcare published two new rapid HTA reports of medical devices in the orthopedics and surgical procedures areas.

On September 6, 2024, the new version of the Nomenclature of Medical Biology Acts (NABM 92) was released in France. Various changes were implemented, including the introduction of one new code, modification of the coefficient B rating for a number of codes, and deletion of Article 4 "Minimum quotations" from the general provisions section of the NABM with 18 codes of this section.

In August 2024, NICE published its position statement on the use of artificial intelligence (AI) methods in the generation and reporting of evidence considered by NICE evaluation programs. According to it, any use of AI should be done judiciously, leveraging the strengths of AI to support and enhance decision-making only when it is suitable and adds value. The use of AI methods should augment human involvement, not replace it.

On September 2, 2024, the Institute for Hospital Remuneration Systems (INeK) announced the start of the application process according to §6 (2) KHEntgG (New Examination and Treatment Methods, NUB) for 2025.

Our goal at MTRC is to inform the decision-making of our clients and to support their market access activities. Below is a snapshot of our planned activities for the next two weeks. This can help our existing and prospective clients to better understand the potential scope of our support. From the week of September 23rd, we are planning to work on 17 projects. Review the full list of planned activities in this post.

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 July 2024, the Dutch Organization for Health Research and Development (ZonMw) awarded thirteen projects under the 2025 round of the Efficiency Research program, including one project on e-health, one project on extracorporeal treatments, one project in orthopedics, one project in neurology, one project in urology, two projects in obstetrics and gynecology, one project in radiotherapy and one project in the cardiovascular area.

On September 2, 2024, the French Ministry of Health released further details on the renewed support for innovation in medical biology and anatomopathology procedures via the Repository of Innovative Services outside the Nomenclature of biology and anatomopathology (RIHN) 2.0 including criteria for application.