Neuromodulation

On November 29, 2023, the Swiss Federal Office of Public Health published the changes that will occur to the Services Ordinance (KLV/OPre), which determines coverage of medical services in Switzerland. The updates will enter into force on January 1 or July 1, 2024, and they relate to the list of explicitly evaluated services (Annex 1 of KLV/OPre), outpatient-before-hospital services (Annex 1a), List of Tools and Equipment (Annex 2), and List of Analyses (Annex 3).

On November 30, 2023, the entity managing the DRG system in Switzerland, SwissDRG, published the final version of the 2024 DRG system. In total, 34 new DRGs were introduced, and they concern cardiovascular, endocrine, gastrointestinal, men’s health, nephrology and urology, neurology and neurosurgery, neuromodulation, obstetrics and gynecology, orthopedics, pulmonary, and some other technology groups. Also, two new add-on reimbursement categories were introduced.

The French National Authority for Health (HAS) released new recommendations about add-on reimbursement of medical devices and medical aids from the meetings of the National Commission for Evaluation of Medical Devices and Health Technologies (CNEDiMTS) in October 2023. Twelve recommendations were published in relation to the registration of medical devices in the List of reimbursable products and services (LPPR). Opinions concern cardiovascular, e-health, endocrine, gastrointestinal, neurology and neurosurgery, neuromodulation, and orthopedic devices, as well as medical aids.

On October 5, 2023, the Health Technology Council initiated the evaluation aimed to investigate whether Transcranial Magnetic Stimulation should be used as a treatment option for adult patients with treatment-resistant depression. The expected publication date is not announced yet.

In early August 2023, the Polish Agency for Health Technology Assessment and Tariff System (AOTMiT) announced the start of the evaluation of several technologies in men’s health, neuromodulation and in-vitro diagnostics fields.

On July 17, 2022, the Austrian Institute for HTA (AIHTA) published four decision support documents, which provide recommendations regarding the inclusion of new medical interventions in the catalog of individual medical services of the performance-oriented hospital financing (Leistungsorientierten Krankenanstaltenfinanzierung, LKF) model, as well as three updates to previous decision support documents.

The “New Methods” framework invited interested parties to submit information regarding microcurrent treatment for anxiety, depression, and sleep problems before August 8, 2023. Ordering Forum will then decide whether the method will undergo evaluation at the national level.

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 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.

The Dental and Pharmaceutical Benefits Agency is currently conducting several health economic assessments of products for electrical spinal cord stimulation. The assessments were commissioned by the Medical Technology Product Council as the first step of the national Orderly Introduction process for new medical devices. The evaluations are planned to be accomplished during 2023.

In January-February 2023, Health Technology Wales published sixteen Medtech-related Topic Exploration Reports (TER), including stereotactic radiosurgery, percutaneous implantation of pulmonary artery pressure sensors, ambulatory patch ECG devices, and others; however, Health Technology Wales will not proceed with full appraisals on these topics. No Guidance was released for Medtech in January-February 2023.

On January 30, 2023, the Institute for the Hospital Remuneration System (InEK) published the list of the requests for innovation funding (NUB) that were submitted by the hospitals in 2022. The medical technologies belonging to the cardiovascular, eHealth, gastrointestinal, neuromodulation, neurovascular, peripheral vascular, orthopedic, and other technology groups obtained positive status 1.