Spinal cord stimulation

In the second quarter of 2024, the Dutch Healthcare Institute (ZIN) published four coverage positions on proton therapy in testicular cancer, pulmonary artery pressure remote monitoring in chronic heart failure and neuromodulation in polyneuropathy with positive recommendation for coverage under basic insurance package, and on physiotherapy and exercise therapy in primary care settings for lower back pain, which was not recommended for coverage under the basic insurance package.

On March 26, 2024, the Swedish Medical Technologies Product (MTP) Council recommended three spinal cord stimulation devices (Intellis, Proclaim, and WaveWriter) for patients with neuropathic pain and insufficient effect of conventional treatment. Devices have been evaluated as part of the Orderly introduction framework.

On November 07, 2023, the Dental and Pharmaceutical Benefits Agency (TLV) accomplished its work on health economic assessments of Intellis and WaveWriter Alpha – spinal cord stimulation systems used for the treatment of long-term, intractable pain. Overall, TLV assesses that the results uncertainty level is high.

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 July 2023. Sixteen recommendations were published in relation to the registration, modification of registration conditions, and renewal of registration for devices in the List of reimbursable products and services (LPPR). Opinions concern neuromodulation and surgical devices, as well as medical aids.

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 June 2023. Twenty-eight recommendations were published in relation to the registration, modification of registration conditions, and renewal of registration for devices in the List of reimbursable products and services (LPPR). Opinions concern cardiovascular and peripheral vascular, endocrine, ENT, orthopedic, spinal, and surgical devices, as well as medical aids.

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 and February 2023, Ordering Forum for the “New Methods” framework invited interested parties regarding several technologies proposed for evaluation within the framework. The technologies concern arteriovenous fistula for hemodialysis, deep brain stimulation, epidural spinal cord stimulation, and digital chest drain. Ordering Forum will decide whether the technology undergoes evaluation at the national level.

The French National Authority for Health released new recommendations about add-on reimbursement of medical devices from the meetings of the National Commission for Evaluation of Medical Devices and Health Technologies in November 2022. Twenty recommendations were published in relation to the registration, modification of registration conditions, and renewal of registration for devices in the List of reimbursable products and services. Opinions concern cardiovascular, neurovascular and neuromodulation, endocrine, ENT, endoscopic and dermatological devices, as well as devices for men’s health and medical aids.

Swedish Medical Technologies Product (MTP) Council is currently evaluating devices for spinal cord stimulation (SCS) as part of the Orderly introduction framework, a staged process aimed at managing the national introduction of novel technologies. On September 23, 2022, MTP Council commissioned the Dental and Pharmaceutical Benefits Agency (TLV) to perform a health economic evaluation of five SCS devices. Based on the TLV assessment, MTP Council will make recommendations to regions regarding the introduction of SCS devices and the criteria for use.

The French National Authority for Health 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 in September 2022. Thirty-eight recommendations were published in relation to the registration, modification of registration conditions, and renewal of registration for devices in the List of reimbursable products and services. Opinions concern cardiovascular and peripheral vascular, neurovascular and neuromodulation, orthopedic, endocrine, ENT, dermatological, and spine-related devices, as well as digital care and medical aids.

In August 2022, the National Institute for Health and Care Excellence (NICE) published five new Interventional Procedure Guidance (aortic remodeling hybrid stent insertion during surgical repair of aortic dissection, bioresorbable stent implantation to treat coronary artery disease, superficial venous arterialization for chronic limb ischemia, transcutaneous electrical neuromuscular stimulation for urinary incontinence, focal resurfacing implants to treat articular cartilage damage in the knee), and three new Medtech Innovation Briefings (Stockholm3 for prostate cancer screening, contrast-enhanced spectral mammography, differential target multiplexed spinal cord stimulation). Also, two Medical Technologies Guidance and two Medtech-related clinical guidelines were updated.

In late March 2021, multiple new procedure codes were introduced by the Code Service of the Finnish National Health and Wellbeing Institution (THL), including ten neuromodulation codes, 54 codes in the ophthalmology area, and three codes in the cardiovascular area.