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.”
This project is being executed 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 rationale of this assessment is to collaboratively produce structured (rapid) core HTA information on other technologies. Also, the aim is to apply those collaboratively produced assessments in the national or regional context.
This rapid assessment addresses the research question of whether the use of Hypoglossal Nerve Stimulation (HGNS) is effective and safe in adult patients with moderate to severe obstructive sleep apnea (OSA) who present inadequate adherence to a positive airway pressure systems or other non-invasive procedures, compared to no treatment.
This topic is of relevance to the Spanish common services portfolio of the National Health System. The HGNS has been requested to be included and further reimbursed in the Spanish common services portfolio.
The HTA Core Model Application for rapid Relative Effectiveness Assessment (REA) (4.2) will be the primary source for selecting assessment elements.
For Effectiveness (EFF) and Safety (SAF) domains, a systematic literature search will be performed using the bibliographic databases PubMed, MEDLINE, EMBASE and Cochrane Central Register of Controlled Trials and Cochrane Database for Systematic Reviews, according to the predefined search strategy. A search in the clinical trials registries ClinicalTrials.gov, EU Clinical Trials Register, and International Clinical Trials Registry Platform (ICTRP) will be carried out for ongoing studies. In addition to the electronic search, a hand search (in reference lists of relevant studies), as well as an internet search, including guidelines databases GIN, and HTA agencies websites, will be performed. A search of regulatory documents will be carried out in the US Food and Drugs Administration.
The final version of this rapid assessment is expected to be published at the end of April 2020.
The full details in English can be found here.
On our website, you can order a ready-made report on reimbursement situation for use of hypoglossal nerve stimulation system for the treatment of Obstructive Sleep Apnea Syndrome. The report includes the reimbursement situation of:
- implantation of hypoglossal nerve stimulation system;
- replacement of hypoglossal nerve stimulation system;
- removal of hypoglossal nerve stimulation system.
Click here to see details.
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