| Coverage Policy Manual | |
| Policy #: | 2018028 |
| Category: | Surgery |
| Initiated: | November 2018 |
| Last Review: | November 2023 |
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| Absorbable Nasal Implant for Treatment of Nasal Valve Collapse | |
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| Description: |
Nasal valve collapse (NVC) is a readily identifiable cause of nasal obstruction. Specifically, the internal nasal valve represents the narrowest portion of the nasal airway with the upper lateral nasal cartilages present as supporting structures. The external nasal valve is an area of potential dynamic collapse that is supported by the lower lateral cartilages. Damaged or weakened cartilage will further decrease airway capacity and increase airflow resistance and may be associated with symptoms of obstruction. Patients with NVC may be treated with nonsurgical interventions in an attempt to increase the airway capacity but severe symptoms and anatomic distortion are treated with surgical cartilage graft procedures. The placement of an absorbable implant to support the lateral nasal cartilages has been proposed as an alternative to more invasive grafting procedures in patients with severe nasal obstruction. The concept is that the implant may provide support to the lateral nasal wall prior to resorption and then stiffen the wall with scarring as it is resorbed.
Nasal obstruction is defined clinically as a patient symptom that presents as a sensation of reduced or insufficient airflow through the nose. Commonly, patients will feel that they have nasal congestion or stuffiness. In adults, clinicians focus the evaluation of important features of the history provided by the patient such as whether symptoms are unilateral or bilateral. Unilateral symptoms are more suggestive of structural causes of nasal obstruction. A history of trauma or previous nasal surgery, especially septoplasty or rhinoplasty, is also important. Diurnal or seasonal variation in symptoms is associated with allergic conditions.
Etiology Nasal obstruction associated with the external nasal valve is commonly associated with post-rhinoplasty or traumatic sequelae and may require functional rhinoplasty procedures. A common cause of internal nasal valve collapse is septal deviation. Prior nasal surgery, nasal trauma, and congenital anomaly are additional causes.
Pathophysiology The internal nasal valve, bordered by the collapsible soft tissue between the upper and lower lateral cartilages, anterior end of the inferior turbinate, and the nasal septum, forms the narrowest part of the nasal airway. During inspiration, the lateral wall cartilage is dynamic and draws inward toward the septum and the internal nasal valve narrows providing protection to the upper airways. The angle at the junction between the septum and upper lateral cartilage is normally 10° to 15° in white populations. Given that the internal nasal valve accounts for at least half of the nasal airway resistance; even minor further narrowing of this area can lead to symptomatic obstruction for a patient. Damaged or weakened lateral nasal cartilage will further decrease airway capacity of the internal nasal valve area, increasing airflow resistance and symptoms of congestion (Howard, 2002).
Physical Examination A thorough physical examination of the nose, nasal cavity, and nasopharynx is generally sufficient to identify the most likely etiology for the nasal obstruction. Both the external and internal nasal valve areas should be examined. The external nasal valve is at the level of the internal nostril. It is formed by the caudal portion of the lower lateral cartilage, surrounding soft tissue, and the membranous septum.
The Cottle maneuver is an examination in which the cheek on the symptomatic side is gently pulled laterally with 1 to 2 fingers. If the patient is less symptomatic with inspiration during the maneuver, the assumption is that the nasal valve has been widened from a collapsed state or dynamic nasal valve collapse. An individual can perform the maneuver on oneself, and it is subjective. A clinician performs the modified Cottle maneuver. A cotton swab or curette is inserted into the nasal cavity to support the nasal cartilage and the patient reports whether there is an improvement in the symptoms with inspiration. In both instances, a change in the external contour of the lateral nose may be apparent to both the patient and the examiner.
Treatment of symptomatic nasal valve collapse includes the use of nonsurgical interventions such as the 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 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 patient’s nasal septum or ear.
The placement of an absorbable implant to support the lateral nasal cartilages has been proposed as an alternative to more invasive grafting procedures in patients with severe nasal obstruction.
In May 2016, LATERA® (Spirox) was cleared for marketing by the U.S. Food and Drug Administration through the 510(k) process (Food and Drug Administration product code: NHB) (Rhee, 2010). LATERA® is the only commercially available absorbable nasal implant for treatment of nasal valve collapse. It is a class II device. LATERA® absorbable implant (K161191), manufactured by Spirox (part of Stryker), is indicated for supporting nasal upper and lower lateral cartilage. Product Code NHB.
Coding
Previously there was no specific code for absorbable nasal implants. However, effective April 1, 2018, there is HCPCS C9749, which describes this device. Some facilities may still use the unlisted code C1889 (Implantable/insertable device for device intensive procedure, not otherwise classified). Physician work for the nasal implant placement would be billed with the unlisted CPT code 30999 (Unlisted procedure, nose). Some providers may use CPT 30465 (Repair of nasal vestibular stenosis [e.g., spreader grafting, lateral nasal wall reconstruction]) for this service; however, the unlisted code is appropriate.
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Policy/ Coverage: |
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
The insertion of an absorbable lateral nasal implant for the treatment of symptomatic nasal valve collapse does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
For members with contracts without primary coverage criteria, the insertion of an absorbable lateral nasal implant for the treatment of symptomatic nasal valve collapse is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
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| Rationale: |
Evidence reviews assess the clinical evidence to determine whether the use of a technology improves the net health outcome. Broadly defined, health outcomes are length of life, quality of life, and ability to function¾including benefits and harms. Every clinical condition has specific outcomes that are important to patients and to managing the course of that condition. Validated outcome measures are necessary to ascertain whether a condition improves or worsens; and whether the magnitude of that change is clinically significant. The net health outcome is a balance of benefits and harms.
To assess whether the evidence is sufficient to draw conclusions about the net health outcome of a technology, 2 domains are examined: the relevance and the quality and credibility. To be relevant, studies must represent one or more intended clinical use of the technology in the intended population and compare an effective and appropriate alternative at a comparable intensity. For some conditions, the alternative will be supportive care or surveillance. The quality and credibility of the evidence depend on study design and conduct, minimizing bias and confounding that can generate incorrect findings. The randomized controlled trial is preferred to assess efficacy; however, in some circumstances, nonrandomized studies may be adequate. Randomized controlled trials are rarely large enough or long enough to capture less common adverse events and long-term effects. Other types of studies can be used for these purposes and to assess generalizability to broader clinical populations and settings of clinical practice.
Absorbable Lateral Nasal Valve Implant
Clinical Context and Therapy Purpose
The purpose of insertion of an absorbable nasal valve implant in patients who have symptomatic nasal valve obstruction due to nasal valve collapse is to provide a treatment option that is an alternative to or an improvement on existing therapies.
The question addressed in this evidence review is: Does the use of an absorbable nasal valve implant in patients who have symptomatic nasal valve obstruction due to nasal valve collapse improve the net health outcome?
The following PICOTS were used to select literature to inform this review.
Patients
The relevant population of interest is adults who have severe symptomatic nasal obstruction symptoms due to internal nasal valve (also known as zone 1) collapse (NVC). NVC is one of the recognized structural causes of obstructed breathing and congestion, and the diagnosis is primarily clinical. NVC may be unilateral or bilateral and is typically constant with each inspiration. The condition may occur in association with prior trauma or rhinonasal surgery. The evaluation consists of clinical history to elicit alternative causes or co-occurring conditions such as obstructive sleep apnea or medication use. In addition to examination of the head and neck, the Cottle maneuver or modified Cottle maneuver (previously described) is used to rule in NVC. Anterior rhinoscopy and nasal endoscopy are used and rule out structural abnormalities such as septal deviation or mucosal conditions such as enlarged turbinates. Radiographic studies are not generally indicated (Fraser, 2009).
Interventions
The therapy being considered is unilateral or bilateral insertion of an absorbable nasal implant into the lateral nasal wall. The product is predominantly cylindrical in shape with a diameter of 1 mm and an overall length of 24 mm with a forked distal end for anchoring into the maxillary periosteum. It is composed of poly(L-lactide-co-D-L-lactide) 70:30 copolymer, which is absorbed in the body over approximately 18 months. It is packaged with a 16-gauge insertion device. The available product information describes the integrity of the implant to be maintained for 12 months after implantation while a fibrous capsule forms around the device. A remodeling phase where collagen replaces the implant within the capsule persists through 24 months and is the purported mechanism of support for the lateral nasal wall support (Spriox, 2017).
Comparators
The following therapies and practices are currently being used to treat NVC: nonsurgical treatments include the use of externally applied adhesive strips or intranasal insertion of nasal cones. The basic mechanism of action of these treatments is to widen the nasal valve and permit increased airflow. Surgical grafting using either autologous cartilage (typically from the nasal septum, ear, or homologous irradiated rib cartilage) or a permanent synthetic implant may be performed to provide structural support to the lateral wall support defect.
Outcomes
The general outcomes of interest are change in symptoms and disease status, treatment-related morbidity, functional status, and change in quality of life. The Nasal Obstruction Symptom Evaluation (NOSE) score is an accepted symptom questionnaire for research purposes. The score can also be stratified to indicate the degree of severity of the nasal obstruction symptoms. The insertion of the absorbable implant is performed under local anesthesia and the adverse event profile includes mild pain, irritation, bruising and inflammation, awareness of the presence of the implant, infection, and the need for device retrieval prior to complete absorption.
Timing
The duration of follow-up to assess early procedural outcomes is 1 month and at least 24 months would be required to evaluate the durability of symptom improvement as well as to confirm the association with the purported device mechanism of action.
Setting
Insertion of an absorbable nasal implant is performed in the outpatient setting by an otolaryngologist or plastic surgeon.
Study Selection Criteria
No randomized comparative studies were identified to evaluate the absorbable nasal implant. The best available evidence consists of 2 nonrandomized prospective industry-sponsored studies of the commercially available absorbable nasal implant.
Nonrandomized Studies
Stolovitzky (2018) reported on 6-month outcomes for 101 patients with severe-to-extreme class of NOSE scores were enrolled at 14 U.S. clinics between September 2016 and March 2017. In the total cohort, 40.6% had a history of allergic rhinitis and 32.7% had a history of sinus disease. The types and rates of prior rhinologic surgeries were septoplasty (26.7%), turbinate reduction (29.7%), endoscopic sinus surgery (22.8%), and rhinoplasty (10.9%). The rate of prior septoplasty was 53.5% in the group that received the absorbable implant alone and 87.9% in the group that received implant plus adjunctive surgery. Overall, fifty-eight (57%) patients had adjunctive procedures (not expressly reported) in addition to the implant placement. In addition to the NOSE score, patients were assessed pre- and postoperatively with the Lateral Wall Insufficiency score, which is based on a review of a lateral wall motion video. Patients reported visual analog scale scores for nasal congestion at each follow-up visit.
Summary of Evidence
For individuals with symptomatic nasal obstruction due to internal nasal valve collapse who receive an absorbable lateral nasal valve implant, the evidence includes 2 nonrandomized prospective, single-cohort industry-sponsored studies. Relevant outcomes are symptoms, change in disease status, treatment-related morbidity, functional outcomes, and quality of life. Both studies are limited by the heterogeneity of the populations evaluated. Specifically, the types and rates of prior nasal procedures were not well described, nor was the clinical rationale for alternative or adjunctive procedural interventions. Overall, improvements in the Nasal Obstruction Symptom Evaluation score have been demonstrated in the study reports. However, a clinically significant difference may not be consistently apparent in small study populations. Some patients meeting the positive responder criteria still reported severe symptoms, and many patients reported some loss of improvement at 1 year. Data elements are missing or difficult to determine for important outcomes. As reported, adverse events appeared to be mild in severity and self-limiting, but still appeared common. Device retrievals are incompletely characterized. They occurred in 10% of patients in the primary cohort study, and it is not known, eg, whether a device retrieval occurred in a patient who had only a unilateral nasal implant. The need for device retrievals appears to occur early in the course of follow-up (1 month); suggesting technical experience limitations on the part of the operator or inappropriate patient selection. The duration of outcomes reporting is less than the duration of absorption of the device (18 months) and the purported completion of tissue remodeling phase (24 months). Randomized controlled trials with a sham control are feasible and should be performed. The evidence is insufficient to determine the effects of the technology on health outcomes.
Supplemental Information Practice Guidelines and Position Statements
American Academy of Otolaryngology - Head Neck Surgery
The American Academy of Otolaryngology - Head Neck Surgery released a clinical consensus statement on the diagnosis and management of nasal valve compromise (Rhee, 2010). The statement also iAndicated that nasal endoscopy and nasal photography were both deemed useful but not routinely required.
U.S. Preventive Services Task Force Recommendations
Not applicable.
Ongoing and Unpublished Clinical Trials
A search of ClinicalTrials.gov in September 2018 identified an ongoing trial that might influence this review. Summary of the trial is listed below.
NCT03400787 Latera Absorbable Nasal Implant vs. Sham Control for Lateral Nasal Valve Collapse
Planned Enrollment: 150 Completion Date: Feb 2020
2019 Update
Annual policy review completed with a literature search using the MEDLINE database through October 2019. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
A sham-controlled randomized trial with a three month follow-up by Stolovitzky et al randomized 137 patients with severe to extreme NOSE scores to an office-based nasal implant or sham control procedure (Stolovitzky, 2019). Followup at three months showed a significant improvement in responder rate, change in NOSE score, and visual analog scale compared to the sham group, although over half of the control group also were considered responders. Six patients (8.6% of 70), had the implant removed by 3 months and analysis was not intent-to-treat or last observation carried forward. Other adverse events included pain (n=4), foreign body sensation (n=3), localized swelling (n=2), inflammation (n=1), skin puncture (n=1), and vasovagal response (n=2). The follow-up of the implant group will continue through 24 months.
Sidle et al reported 12-month outcomes for 160 patients with severe-to-extreme NOSE scores who were enrolled at 14 U.S. clinics between September 2016 and July 2017 (Sidle, 2019). Insertion of a Latera implant alone was reported for 105 patients and insertion of the implant plus adjunctive procedure was reported for 61 patients. San Nicoló et al reported 24-month outcomes for 30 patients who were treated at 3 clinical sites in Germany (San Nicolo, 2017; San Nicolo, 2018). In the larger study by Sidle et al, 5.3% of patients had the implant removed. In the study by San Nicoló et al, 13.3% of patients had the implant removed (Sidle, 2019. The improvement in symptoms was consistent for the studies, with a mean change of over 40 points from baseline on the NOSE score. Results were reported for patients who retained the implant, and neither study used the last observation carried forward. The 24-month outcomes from the smaller study by San Nicoló et al are the most relevant, as resorption and remodeling are expected to occur within that time frame (San Nicolo, 2017; San Nicolo, 2018). At enrollment, 30 patients were classified as severe to the extreme on the NOSE scale. At the 24 month follow-up, 4 patients had an additional procedure, 8 were classified as severe to extreme, and 17 had improved to mild to moderate. Follow-up beyond 18 months in a larger number of patients is needed.
2020 Update
Annual policy review completed with a literature search using the MEDLINE database through October 2020. No new literature was identified that would prompt a change in the coverage statement.
2021 Update
Annual policy review completed with a literature search using the MEDLINE database through October 2021. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
Sidle, Stolovitzky, and colleagues reported outcomes from 2 post-marketing studies that enrolled a total of 277 patients with severe-to-extreme NOSE scores at 19 U.S. clinics between September 2016 and July 2017 (Stolovitzky, 2018; Sidle, 2020; Sidle, 2021). One of the trials (NCT02964312) was conducted in an office setting and enrolled 166 participants. The second study (NCT02952313) implanted the device in the operating room and included 113 participants. Concomitant procedures (septoplasty and/or inferior turbinate reduction) were at the discretion of the investigators.
The most recent publication from these studies included data from 177 patients who were followed for 24 months under a protocol extension (Sidle, 2021). NOSE scores through 24 months were reported separately for patients who received an implant alone (n = 69, NOSE = 30.4 [24.6 standard deviation {sd}), implant plus inferior turbinate reduction (n=39, NOSE = 27.6 [23.1 sd]), or an implant combined with septoplasty and inferior turbinate reduction (n=69, NOSE = 16.0 [20.7 sd]). The data presented by Sidle et al is described further (Sidle, 2021). The mean change from baseline for the 177 patients with 24-month data was -53.6 (95% confidence interval [CI], -57.0 to -50.1), with a responder rate of around 90%. Loss to follow-up in these cohorts was high, with 100 of 277 participants discontinuing the study before 24 months (44 were lost to follow-up, 17 withdrew due to lack of response, 38 withdrew or did not consent to the extension study, and 2 died). Sensitivity analysis, performed with a worst-case scenario with all missing 24-month data assigned no change from baseline, showed a mean change from baseline in the NOSE score of -34.2 (95% CI, -38.1 to -30.2), representing an improvement of 1 class.
2022 Update
Annual policy review completed with a literature search using the MEDLINE database through October 2022. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
Bikhazi et al reported results from a 24-month uncontrolled follow-up phase of the RCT (Bikhazi, 2021). Participants randomized to the control group were given the option to crossover to the treatment group following the 3-month randomized phase. There were a total of 137 participants in the randomized cohort. 71 received treatment and 66 were sham participants. 111 participants enrolled in the long-term follow-up phase. (71 received treatment and 40 were sham participants). After 12 months, 90 participants remained, 75 at the 18-month visit, and 70 at the 24-month visit. The Key RCT results at 24 months are as follows:
2023 Update
Annual policy review completed with a literature search using the MEDLINE database through October 2023. No new literature was identified that would prompt a change in the coverage statement.
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| References: |
Bikhazi N, Ow RA, O'Malley EM, et al.(2021) 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 Plast Surg. Dec 29 2021. PMID 34965603 Fraser L, Kelly G.(2009) An evidence-based approach to the management of the adult with nasal obstruction. Clin Otolaryngol. Apr 2009;34(2):151-155. PMID 19413614 Howard BK, Rohrich RJ.(2002) Understanding the nasal airway: principles and practice. Plast Reconstr Surg. Mar 2002;109(3):1128-1146; quiz 1145-1146. PMID 11884847 Howard BK, Rohrich RJ.(2002) Understanding the nasal airway: principles and practice. Plast Reconstr Surg. Mar 2002;109(3):1128-1146; quiz 1145-1146. PMID 11884847 Lipan MJ, Most SP.(2013) Development of a severity classification system for subjective nasal obstruction. JAMA Facial Plast Surg. Sep-Oct 2013;15(5):358-361. PMID 23846399 Rhee JS, Weaver EM, Park SS, et al.(2010) Clinical consensus statement: Diagnosis and management of nasal valve compromise. Otolaryngol Head Neck Surg. Jul 2010;143(1):48-59. PMID 20620619 San Nicoló M, Stelter K, Sadick H, et al.(2017) Absorbable implant to treat nasal valve collapse. Facial Plast Surg. Apr 2017;33(2):233-240. PMID 28388804 Sidle DM, Stolovitzky P, O'Malley EM, et al.(2021) Bioabsorbable Implant for Treatment of Nasal Valve Collapse with or without Concomitant Procedures. Facial Plast Surg. Oct 2021; 37(5): 673-680. PMID 33853139 Sidle DM, Stolovitzky P, Ow RA et al.(2019) Twelve-month outcomes of a bioabsorbable implant for in-office treatment of dynamic nasal valve collapse. Laryngoscope, 2019 Jun 30. PMID 31254279 Spirox.(2017) Latera. 2017; http://www.spiroxmed.com/latera. Accessed September 10, 2018. Stewart MG, Witsell DL, Smith TL, et al.(2004) Development and validation of the Nasal Obstruction Symptom Evaluation (NOSE) scale. Otolaryngol Head Neck Surg. Feb 2004;130(2):157-163. PMID 14990910 Stolovitzky P, Senior B, Ow RA et al.(2019) Assessment of bioabsorbable implant treatment for nasal valve collapse compared to a sham group: a randomized control trial. Int Forum Allergy Rhinol, 2019 Jun 22;9(8). PMID 31226238 Stolovitzky P, Sidle DM, Ow RA, et al.(2018) A prospective study for treatment of nasal valve collapse due to lateral wall insufficiency: Outcomes using a bioabsorbable implant. Laryngoscope. May 14 2018. PMID 29756407 |
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Group specific policy will supersede this policy when applicable. This policy does not apply to the Wal-Mart Associates Group Health Plan participants or to the Tyson Group Health Plan participants.
CPT Codes Copyright © 2024 American Medical Association. |
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