DESCRIPTION
Standard treatment of symptomatic nasal valve collapse includes the use of nonsurgical interventions such as adhesive strips applied externally across the nose (applying the principle of the Cottle maneuver) or use of nasal dilators, cones, or other devices that support the lateral nasal wall internally (applying the principle of the modified Cottle maneuver).
Severe cases of obstruction result from nasal valve deformities and are treated with surgical grafting to widen and/or strengthen the valve. Common materials include cartilaginous autografts and allografts, as well as permanent synthetic grafts. Cartilage grafts are most commonly harvested from the individual’s nasal septum or ear. The placement of an absorbable implant (e.g., LATERA®) to support the lateral nasal cartilages has been proposed as an alternative to more invasive grafting procedures in individuals with severe nasal obstruction.
POLICY
Absorbable nasal implant for the treatment of nasal valve collapse 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
There is a lack of quality evidence in the published literature that validates absorbable nasal implants in the treatment of nasal valve collapse. The evidence is insufficient to determine the effects of the technology on health outcomes.
SOURCES
Bikhazi, N., Ow, R.A., O’Malley, E M., Perkins, N., Sidle, D M., & Stolovitzky, P. (2022). Long–term follow-up from the treatment and crossover arms of a randomized controlled trial of an absorbable nasal implant for dynamic nasal valve collapse. Facial Plastic Surgery, 38 (5), 495-503. (Level 2 evidence)
BlueCross BlueShield Association. Evidence Positioning System. (11:2022). Absorbable nasal implant for the treatment of nasal valve collapse (7.01.163). Retrieved April 10, 2023 from https://www.evidencepositioningsystem.com/. (12 articles and/or guidelines reviewed)
Kim, D.H., Lee, H.H., Kim, S.H., & Hwang, S.H. (2020). Effectiveness of using a bioabsorbable implant (Latera) to treat nasal valve collapse in patients with nasal obstruction: systematic review and meta-analysis. International Forum of Allergy and Rhinology, 10 (6), 719-725. Abstract retrieved July 15, 2020 from PubMed database.
San Nicolό, M., Stelter, K., Sadick, H., Bas, M., & Berghaus, A. (2017). Absorbable implant to treat nasal valve collapse. Facial Plastic Surgery, 33 (2), 233-240. (Level 4 evidence)
Sidle, D. M., Stolovitzky, P., O'Malley, E. M., Ow, R. A., Nachlas, N. E., & Silvers, S. (2021). Bioabsorbable implant for treatment of nasal valve collapse with or without concomitant procedures. Facial Plastic Surgery: FPS, 37 (5), 673–680. (Level 4 evidence)
Sidle, D.M., Stolovitzky, P., Ow, RA., Silvers, S., Matheny, K., Bikhazi, N., et al. (2019). Twelve-month outcomes of a bioabsorbable implant for in-office treatment of dynamic nasal valve collapse. Laryngoscope, doi:1002/lary.28151. (Level 2 evidence)
Stolovitzky, P., Senior, B., Ow, R.A., Mehendale, N., Bikhazi, N., & Sidle, D.M. (2019). Assessment of bioabsorbable implant treatment for nasal valve collapse compared to a sham group: a randomized control trial. International Forum of Allergy and Rhinology, 9 (8), 850-856. (Level 2 evidence)
Stolovitzky, P., Sidle, D.M., Ow, R.A., Nachlas, N.E., & Most, S.P. (2018). A prospective study for treatment of nasal valve collapse due to lateral wall insufficiency: outcomes using a bioabsorbable implant. Laryngoscope, 128 (11), 2483-2489. (Level 4 evidence)
U.S. Food and Drug Administration. (2016, June). Centers for Devices and Radiological Health.510(k) Premarket Notification Database. K161191. Retrieved September 20, 2019 from https://www.accessdata.fda.gov/cdrh_docs/pdf16/K161191.pdf.
Winifred S. Hayes, Inc. Evolving Evidence Review. (2022, March). Absorbable nasal implant (Latera, Stryker) for the treatment of nasal valve collapse. Retrieved April 28, 2022 from www.Hayesinc.com/subscribers. (14 articles and/or guidelines reviewed)
ORIGINAL EFFECTIVE DATE: 1/30/2020
MOST RECENT REVIEW DATE: 5/11/2023
ID_BA
Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.
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