Steroid-Eluting and Non-Steroid-Eluting Sinus Stents
DESCRIPTION
Steroid-eluting sinus stents are devices used postoperatively following endoscopic sinus surgery (ESS) or for treatment of recurrent sinonasal polyposis following ESS. These devices (e.g., PROPEL®, PROPEL® mini, PROPEL® Contour, Sinuva™) are proposed to maintain patency of the sinus openings and/or serve as a local drug delivery vehicle. Reducing postoperative inflammation and maintaining patency of the sinuses may be important in achieving optimal sinus drainage and may impact recovery from surgery and/or reduce the need for additional surgery. Standard management includes topical steroid, packing and irrigation.
POLICY
The use of steroid-eluting and non-steroid eluting sinus stents for sinus-related conditions, including, but not limited to, the following: postoperative treatment following endoscopic sinus surgery, treatment of recurrent sinonasal polyposis is considered investigational.
IMPORTANT REMINDERS
Any specific products referenced in this policy are just examples and are intended for illustrative purposes only. It is not intended to be a recommendation of one product over another and is not intended to represent a complete listing of all products available. These examples are contained in the parenthetical e.g. statement.
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits, or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the Medical Policy and a health plan or government program (e.g., TennCare), the express terms of the health plan or government program will govern.
ADDITIONAL INFORMATION
Long-term studies for drug-eluting sinus implants are limited, and the results of comparative studies are conflicting. The evidence for implantable drug-eluting sinus stents in those individuals that experience recurrent sinonasal polyposis is scant, and the risk of bias is very high due to unblinded outcome assessment.
SOURCES
American Academy of Otolaryngology – Head & Neck Surgery. (2023, January). Position Statement: The use of biomaterials in sinonasal procedures. Retrieved June 5, 2023 from http://www.entnet.org.
American Rhinologic Society. (2023, January). ARS Position Statement: Criteria for drug-eluting implants. Retrieved June 5, 2023 from https://www.american-rhinologic.org/index.php?option=com_content&view=article&id=32:drugeluting-implants&catid=26:position-statements&Itemid=197.
BlueCross BlueShield Association. Evidence Positioning System. (3:2023). Steroid-eluting sinus stents. (7.01.134). Retrieved June 5, 2023 from www.bcbsaoca.com/eps/. (17 articles and/or guidelines reviewed)
Forwith, K. D., Han, J. K., Stolovitzky, J. P., Yen, D. M., Chandra, R. K., Karanfilov, B., Matheny, K. E. (2016). RESOLVE: bioabsorbable steroid-eluting sinus implants for in-office treatment of recurrent sinonasal polyposis after sinus surgery: 6-month outcomes from a randomized, controlled, blinded study. International Forum of Allergy & Rhinology, 6 (6), 573-581. Abstract retrieved October 20, 2016 from PubMed database.
Goshtasbi, K., Abouzari, M., Abiri, A., Yasaka, T., Sahyouni, R., Bitner, B., et al. (2019). Efficacy of steroid eluting stents in management of chronic rhinosinusitis following endoscopic sinus surgery: updated meta-analysis. International Forum of Allergy & Rhinology, 9 (12),1443-1450. (Level 2 evidence)
Han, J K., Forwith, K D., Smith, T L., Kern, R C., Brown, W J., Miller, S K., et al. (2014). RESOLVE: a randomized, controlled, blinded study of bioabsorbable steroid-eluting sinus implants for in-office treatment of recurrent sinonasal polyposis. International Forum of Allergy & Rhinology, 4 (11), 861-870. Abstract retrieved June 8, 2023 from PubMed database.
Hoffman, V., Mortimer, K M., Mulder, K., Topuria, L., Gliklich, R., & Kallman, J E. (2022). Real-world evidence analysis of the impact of steroid-eluting implants on healthcare resource use among chronic rhinosinusitis patients undergoing sinus surgery. Current Medical Research and Opinion, 38 (3), 375-381. (Level 4 evidence)
International Forum of Allergy & Rhinology. (2021, March). International consensus statement on allergy and rhinology: rhinosinusitis 2021. Retrieved June 7, 2023 from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10108565/pdf/ALR-12-1225.pdf.
Kern, R C., Stolovitzky J P., Silvers, S L., Singh, A., Lee, J T., Yen, D M., et al. (2018). A phase 3 trial of mometasone furoate sinus implants for chronic sinusitis with recurrent nasal polyps. International Forum of Allergy & Rhinology, 8 (4), 471-481. (Level 1 evidence)
Lee, V S., Patel, P., O’Brien, D., Scangas, G A., Campbell, R. G., Chandra, R., et al. (2022). Indications for absorbable steroid-eluting sinus implants: viewpoint via the delphi method. International Forum of Allergy and Rhinology, 12 (10), 1225-1231. (Level 5 evidence)
Luong, A., Ow, R.A., Singh, A., Weiss, R.L., Han, J.K., Gerencer, R., et al. (2018). Safety and effectiveness of a bioabsorbable steroid-releasing implant for the paranasal sinus ostia – a randomized clinical trial. JAMA Otololaryngology – Head & Neck Surgery, 144 (1), 28-35. (Level 2 evidence)
Massey, C.J., Suh, J.D., Tessema, B., Gray, S.T., & Singh, A. (2016). Biomaterials in rhinology. Otolaryngology – Head and Neck Surgery, 154 (4), 606-617. Abstract retrieved June 8, 2018 from PubMed database.
Narwani, V., Torabi, S J., Kasle, D A., Patel, R A., Lerner, M Z., & Manes, R P. (2022). Adverse events associated with corticosteroid-eluting sinus stents: a MAUDE database analysis. Otolaryngology-Head and Neck Surgery: Official Journal of American Academy of Otolaryngology, 166 (1), 179-182. Abstract retrieved June 7, 2023 from PubMed database.
National Institute for Health and Clinical Excellence. (2016, March). Interventional procedural guidance: Corticosteroid-eluting bioabsorbable stent or spacer insertion during endoscopic sinus surgery to treat chronic rhinosinusitis. Retrieved October 20, 2016 from https://www.nice.org.uk/guidance/ipg551.
Sedaghat, A.R. (2017). Chronic rhinosinusitis. American Family Physician, 96 (8), 500-506. (Level 2 evidence)
Smith, T. L., Singh, A., Luong, A., Ow, R. A., Shotts, S. D., Sautter, N. B., et al. (2016). Randomized controlled trial of a bioabsorbable steroid-releasing implant in the frontal sinus opening. Laryngoscope, 126 (12), 2659-2664. Abstract retrieved June 8, 2018 from PubMed database.
U. S. Food and Drug Administration. (2011, August). Center for Devices and Radiological Health. Premarket approval decision P100044 (PROPEL ™). Retrieved October 20, 2016 from http://www.accessdata.fda.gov.
Winifred S. Hayes, Inc. Health Technology Assessment. (2021, April; last update search March 2023). Sinuva (Intersect ENT Inc) steroid-releasing sinus implant for the treatment of nasal polyps after ethmoid sinus surgery (ESS). Retrieved June 6, 2023 from www.Hayesinc.com/subscribers. (43 articles and/or guidelines reviewed)
Zhang, M., Ryan, P J., & Shashinder, S. (2021). Efficacy of absorbable steroid-impregnated nasal packing in functional endoscopic sinus surgery for chronic rhinosinusitis: a systematic review. The Laryngoscope, 131 (8), 1704-1714. Abstract retrieved June 7, 2023 from PubMed database.
ORIGINAL EFFECTIVE DATE: 6/8/2013
MOST RECENT REVIEW DATE: 8/10/2023
ID_BA
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