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."
This project was carried out by the Spanish Health Technology Assessment Agency (AETS-ISCIII) and the Romanian National School of Public Health, Management, and Professional Development (NSPHMPD). The dedicated reviewers are the Romanian National Institute of Public Health (NIPHB), Swiss Network for Health Technology Assessment (SNHTA), and Health Service of Canary Islands (SESCS).
The study objective was to assess whether the use of HGNS is effective and safe in adult patients with moderate to severe obstructive sleep apnea (OSA) who present inadequate adherence to positive airway pressure systems or other non-invasive procedures, compared to no treatment.
Continuous Positive Airway Pressure (CPAP) is considered the therapy of choice for moderate-to-severe OSA. HGNS is an alternative in case of poor compliance and some long-term complications. There are three HGNS products available for use in Europe: Inspire® Upper Airway Stimulation (UAS) System, aura6000™ System, and Nyxoah's Genio™ system.
A systematic literature search in PubMed, MEDLINE, EMBASE, the Cochrane Central Register of Controlled Trials and the Cochrane Database for Systematic Reviews, as well as a manual search, was performed and closed in January 2020. One randomized comparative study on Inspire® UAS effectiveness and six observational prospective single-arm studies assessing safety and adherence were selected for the final analysis. Single-arm studies examined not only Inspire®, but also aura6000™ System, Apnex, and Nyxoah's Genio™.
The quality of the evidence was very low, both for effectiveness and safety.
A comparative randomized withdrawal study contains data on effectiveness, but not on safety. A bias in selecting patients was identified, which affected the results. The study found a significant worsening in the Apnea-Hypopnea Index (AHI) and the Oxygen Desaturation Index (ODI) when the device was disconnected for one week. Significant differences were also found in Hypoxemia Time. There was a significant worsening after one week with the device deactivated group compared to the device activated group in ESS (Epworth Sleepiness Scale) and FOSQ (Functional Outcomes of Sleep Questionnaire) scores.
Neither the RCT nor the observational single-arm studies reported any deaths related to the procedure or device. No evidence was found regarding the cardio- or cerebrovascular morbidity and long-term effects on quality of life.
In relation to safety, no comparative evidence shows whether HGNS is safer than no treatment. Observational single-arm studies report a significant number of adverse events, related both to the device and the procedure. An average of 1.02 adverse events per patient was reported, and 3.45% of patients suffered a serious adverse event. Surgical interventions due to replacement and repositioning or explanation of the device were the most frequent serious adverse events. The most frequent non-serious adverse event was discomfort or pain associated with a device.
The report also provides regulatory and reimbursement status for the HGNS in European countries.
The full details in English can be found here.
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