Neuromodulation

In April 2021, the National Institute for Health and Care Excellence (NICE) published three new Interventional Procedure Guidance (repetitive short-pulse transscleral cyclophotocoagulation for glaucoma, deep brain stimulation for chronic, severe, treatment-resistant obsessive-compulsive disorder in adults, and Melphalan chemosaturation for primary or metastatic cancer in the liver) and two Medtech Innovation Briefings (microINR for anticoagulation therapy and RenalSense Clarity RMS for acute kidney injury), and two clinical guidelines (for atrial fibrillation and chronic pain in over 16s).

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 and Care Excellence (NICE) published four new Interventional Procedure Guidance (transcervical ultrasound-guided radiofrequency ablation for symptomatic uterine fibroids, extracorporeal whole liver perfusion, free-functioning gracilis transfer to restore upper limb function, cytoreduction surgery with hyperthermic intraoperative peritoneal chemotherapy), two Medical Technologies Guidance (Danis stent for acute oesophageal variceal bleeding, Alpha-Stim AID for anxiety disorders), two Medtech Innovation Briefings (Sonata system for symptomatic uterine fibroids, Butterfly iQ+ for diagnostic ultrasound), and one Diagnostic Guidance (QAngio XA 3D QFR and CAAS vFFR imaging software for assessing coronary stenosis). Also, five 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.

On January 29, 2021, the Institute for the Hospital Remuneration System (InEK) has published the List of the requests for innovation funding (NUB) that were submitted by the hospitals in 2020. The medical technologies belonging to the cardiovascular, ENT, eHealth, gastrointestinal, neuromodulation, neurovascular, orthopedic, and other technology groups obtained positive status 1.

On January 18, 2021, a new version of the List of Reimbursable Products and Services (LPPR) was published. It contains new devices included in the LPPR list in November-December 2020, as well as other modifications made during this period. Newly-introduced devices belong to the cardiovascular (coronary stents), orthopedic, neuromodulation (deep brain stimulation), peripheral vascular (stent-grafts to treat aortic abdominal aneurysm), and other areas of care.

In 2013, Norway established a framework “New Method” for the introduction of innovations into the health care system through either a national or hospital-based health technology assessment. In this framework, all innovations should undergo HTA before being funded. In the second half of 2020, eight new mini-HTA projects of medical technologies were launched in Norway: tissue allotransplantation, pain treatment via neuromodulation, among others.

On June 18, 2020, the network of European HTA agencies, EUnetHTA, published the final report for the rapid assessment OTCA21 "Hypoglossal Nerve Stimulation (HGNS) for treatment of obstructive sleep apnea."

The report presents a summary of the reimbursement situation for occipital nerve stimulation in Europe. The following indications are considered: migraine with aura; cluster headache syndrome. 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. It is also possible to add analysis in the Czech Republic, Finland, Hungary, Romania, Russia and Turkey.

In late January 2020, the network of European HTA agencies, EUnetHTA, announced the final plan of the project OTCA21 “Hypoglossal nerve stimulation systems for treatment of obstructive sleep apnoea.”

MTRC has developed three reports on the key market access topics, including innovation funding, health technology assessment and funding frameworks for medical devices. These reports help to understand the relevance of these frameworks to certain types of medical technologies, including neuromodulation technologies. This post provides some key facts about the HTA, funding and innovation payment landscape for neuromodulation devices in Europe.

The report presents a summary of the reimbursement situation for use of hypoglossal nerve stimulation system for the treatment of Obstructive Sleep Apnea Syndrome in Europe. The analysis will cover adult patients only. The following stages of procedure will be considered for hospital settings: implantation, replacement, removal of hypoglossal nerve stimulation system. 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. It is also possible to add analysis in the Czech Republic, Finland, Hungary, Romania, Russia and Turkey.