Sacral nerve stimulation

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 May 25, 2022, the National Institute for Health and Disability Insurance (INAMI-RIZIV) published an updated List of reimbursable devices that came into force on June 01, 2022. A total of 12 new codes with the corresponding conditions of reimbursement were added to the List, which concerned sacral neurostimulation in fecal incontinence treatment, soft tissue markers, and osteosynthesis devices.

In May 2021, the National Institute for Health and Care Excellence (NICE) published five new Interventional Procedure Guidance (ex-situ machine perfusion for extracorporeal preservation of lungs for transplant, transvaginal laser therapy for stress urinary incontinence and for urogenital atrophy, electrohydraulic lithotripsy for difficult-to-treat bile duct stones, and permanent His-bundle pacemaker for heart failure), one new Medical Technologies Guidance (UroLift for benign prostatic hyperplasia), and two new Medtech Innovation Briefings (Axonics sacral neuromodulation system for faecal incontinence and KODEX-EPD for cardiac imaging during ablation of arrhythmias). Also, three clinical guidelines and two Medical Technologies Guidance were updated.

On April 20, 2021, the Dutch Healthcare Institute (ZIN) published an annual report on the progress of the conditional reimbursement program. In 2020, there were 13 ongoing projects under the program, six of which concerned medical technologies. Furthermore, in 2020, percutaneous transforaminal endoscopic discectomy for the treatment of lumbosacral radicular syndrome in lumbar disc herniation was included in the basic insurance package as regular care.

In March 2021, the National Institute for Health Research (NIHR) in England released six MedTech-related reports in its Health Technology Assessment (HTA) Journal, which concerned sacral nerve stimulation and magnetic sphincter augmentation device for fecal incontinence treatment, patch augmentation surgery for rotator cuff repair, in-vitro diagnostics, and eHealth. 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 inform National Institute for Health and Care Excellence (NICE) guidance.

On September 03, 2020, the National Institute for Health and Care Excellence (NICE) issued medical technologies guidance on Axonics sacral neuromodulation (SNM) system for treating refractory overactive bladder. NICE recommended Axonics SNM to be adopted in the NHS and considered as an alternative when another treatment is not effective.

Axonics sacral neuromodulation would be an option for people with symptoms of the overactive bladder who have not responded to conservative treatments or drug therapy. The Axonics could save the NHS around £6,200 per patient if the device lasts more than six years. Consultations are open to the stakeholders until March 13, 2020.

The report presents a summary of reimbursement situation for sacral nerve stimulation. The following indications will be considered: urge urinary incontinence, retention of urine, faecal incontinence. The analysis covers procedure coding, payment mechanism, reimbursement tariffs and policy restrictions in 11 EU countries including Austria, Belgium, Denmark, England, France, Germany, Italy, the Netherlands, Norway, Sweden and Switzerland.

In December 2018, the National Institute for Health and Care Excellence (NICE) published one new diagnostic guidance (for tumour profiling tests to guide adjuvant chemotherapy decisions in early breast cancer), two new interventional procedure guidance (for transcutaneous neuromuscular electrical stimulation for oropharyngeal dysphagia in adults and bronchial thermoplasty for severe asthma), and four MedTech innovation briefings.