BlueCross BlueShield of Tennessee Medical Policy Manual

Implantable Hypoglossal Nerve Stimulation

DESCRIPTION

Hypoglossal nerve stimulation is proposed as a treatment for obstructive sleep apnea in individuals who are unable to use CPAP. Stimulation of the hypoglossal nerve contracts the genioglossus muscle causing tongue protrusion and stiffening of the anterior pharyngeal wall, potentially decreasing apneic events. Implantable hypoglossal nerve stimulation systems, such as the Inspire® II Upper Airway Stimulation System, include respiratory sensing leads that permit intermittent stimulation during inspiration. Stimulation parameters are titrated during an in-laboratory polysomnography and can be adjusted during home use. The device is turned on only during sleep periods.

POLICY

MEDICAL APPROPRIATENESS

IMPORTANT REMINDERS

ADDITIONAL INFORMATION 

Hypoglossal nerve stimulation has shown increased success rates for about two-thirds of a subset of individuals who met selection criteria that included AHI, body mass index, and favorable pattern of palatal collapse. These results were maintained out to five years in the pivotal single-arm study. Clinical input supplements and informs the interpretation of the published evidence. Clinical input indicates that HNS leads to a meaningful improvement in health outcomes in appropriately selected adult individuals with a favorable pattern of non-concentric palatal collapse.

SOURCES

American Academy of Otolaryngology - Head and Neck Surgery. (2016). Position statement: hypoglossal nerve stimulation for treatment of obstructive sleep apnea (OSA). Retrieved July 10, 2017 from http://www.entnet.org/content/position-statement-hypoglossal-nerve-stimulation-treatment-obstructive-sleep-apnea-osa.

American Academy of Sleep Medicine. (2009). Clinical guideline for the evaluation, management and long-term care of obstructive sleep apnea in adults. Retrieved July 10, 2017 from http://www.aasmnet.org/Resources/clinicalguidelines/OSA_Adults.pdf.

BlueCross BlueShield Association. Evidence Positioning System. (1:2019). Surgical treatment of snoring and obstructive sleep apnea (7.01.101). Retrieved April 1, 2019 from https://www.evidencepositioningsystem.com. (28 articles and/or guidelines reviewed)

Certal, V., Zaghi, S., Riaz, M., Vieira, A., Pinheiro, C., Kushida, C., et al. (2015). Hypoglossal nerve stimulation in the treatment of obstructive sleep apnea: a systematic review and meta-analysis. Laryngoscope, 125 (5), 1254-1264. Abstract retrieved July 10, 2017 from PubMed database.

Dierks, G.R., Wentland, C., Keamy, D., Kinane, T.B., Skoto, B., Guzman, V.D., et al. (2017). Hypoglossal nerve stimulation in adolescents with down syndrome and obstructive sleep apnea. JAMA Otolaryngol Head Neck Surgery, 144 (1), 37-42. (Level 4 evidence)

Gillespie, M., Soose, R., Woodson, B., Strohl, K., Maurer, J., de Vries, N., et al. (2017). Upper airway stimulation for obstructive sleep apnea: patient-reported outcomes after 48 months of follow-up. Otolaryngology - Head Neck Surgery, 156 (4), 7658-771. Abstract retrieved July 14, 2017 from PubMed database.

Kompelli, A.R., Ni, J.S., Nguyen, S.A., Lentsch, E.J., Neskey, D.M., Meyer, T.A. (2018). The outcomes of hypoglossal nerve stimulation in the management of OSA: A systematic review and meta-analysis. The World Journal of Otorhinolaryngol Head Neck Surgery, 5 (1), 41-48. (Level 1 evidence)

Soose, R., Woodson, B., Gillespie, M., Maurer, J., de Vries, N., Steward, D. (2016). Upper airway stimulation for obstructive sleep apnea: self-reported outcomes at 24 months. Journal of Clinical Sleep Medicine, 12 (1), 43-48. (Level 3 evidence)

Steffen, A., Sommer, J., Hofauer, B., Maurer, J., Hasselbacher, K., & Heiser, C. (2017). Outcome after one year of upper airway stimulation for obstructive sleep apnea in a multicenter German post-market study. The Laryngoscope, Doi: 10.1002/lary.26688. [Epub ahead of print]. (Level 4 evidence)

Strollo, P., Gillespie, M., Soose, R., Maurer, J., de Vries, N., Cornelius, J., et al. (2015). Upper airway stimulation for obstructive sleep apnea: durability of the treatment effect at 18 months. Sleep, 38 (10), 1593-1598C. (Level 3 evidence)

Strollo, P., Soose, R., Maurer, J., de Vries, N., Cornelius, J., Froymovich, O., et al. (2014). Upper-airway stimulation for obstructive sleep apnea. The New England Journal of Medicine, 370, 139-149. (Level 3 evidence)

Winifred S. Hayes, Inc. Medical Technology Directory. (2018, October). Hypoglossal nerve stimulation for the treatment of obstructive sleep apnea. Retrieved April 3, 2019 from www.hayesinc.com/subscribers (63 articles and/or guidelines reviewed)

Woodson, B., Soose, R., Gillespie, M., Strohl, K., Maurer, J., de Vries, N., et al. (2016). Three-year outcomes of cranial nerve stimulation for obstructive sleep apnea: the STAR trial. Otolaryngology – Head and Neck Surgery, 154 (1), 181-188. (Level 3 evidence)

ORIGINAL EFFECTIVE DATE:  12/1/2017

MOST RECENT REVIEW DATE:  8/30/2019

ID_BT

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