Description
Chronic rhinitis is a common medical condition that encompasses allergic rhinitis, nonallergic rhinitis, and mixed rhinitis and can severely impact quality of life. The initial treatment for chronic rhinitis often involves medical management with pharmacotherapy that may include steroids, anticholinergics, nasal decongestants, and antihistamines. For individuals who do not attain improvement in chronic rhinitis symptoms after receiving adequate medical therapy (referred to as refractory chronic rhinitis), invasive surgical options to block posterior nasal nerve may be considered. Historically, vidian neurectomy which targets the vidian nerve was offered for refractory rhinitis. Although vidian neurectomy was shown to be effective in reducing symptoms like rhinorrhea, it is associated with side effects of cheek and palate numbness and dry eyes (in nearly 50% of cases, ranging between 35 to 72%). In an effort to improve on complications of vidian neurectomy such as xerophthalmia, interventions that specifically target the posterior nasal nerve branches of the vidian nerve have been developed. These interventions range from surgical ablation of the post-ganglionic posterior nasal nerve to minimally invasive options of cryotherapy, radiofrequency, or laser ablation of the nerve. These minimally invasive procedures can be performed under endoscopy. The efficacy of ablation of posterior nasal nerve is thought to result from the interruption of efferent parasympathetic stimulation of the nasal mucosa, which leads to reduction in submucosal gland secretions and blood flow.

Summary of Evidence
For individuals with chronic rhinitis who receive cryoablation, the evidence includes a randomized controlled trial (RCT) and nonrandomized studies. Relevant outcomes are symptoms, change in disease status, quality of life, and treatment-related morbidity. One RCT that compared cryoablation using the ClariFix device with a sham procedure showed a statistical significant difference in response rate in favor of cryoablation group compared to the sham group. However, it is unclear if the trial enrolled individuals with chronic rhinitis who were refractory to medical management. This limitation precludes meaningful interpretation of these results as the intended use of ClariFix device is for individuals with chronic rhinitis who are refractory to medical management. Three single-arm prospective studies evaluated efficacy and safety of cryoablation for patients with chronic rhinitis. Out of the 3, 2 studies enrolled individuals who were refractory to medical management. The definition of refractory varied from symptoms not adequately controlled with a minimum of 4 weeks of topical nasal steroid treatment or failure of medical therapy for a duration of at least 3 months. Although all 3 single arm studies reported improvement in symptom control, the major limitation is lack of a comparator group and open-label nature of the study design, which likely introduces biases. Additionally, loss to follow-up was high. Randomized controlled trials with a clearly defined refractory patient population directly comparing cryoablation with sham surgery or other surgical interventions are needed to confirm the efficacy of cryoablation for treatment of chronic rhinitis. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals with chronic rhinitis refractory to medical management who receive radiofrequency ablation, the evidence includes an RCT and nonrandomized studies. Relevant outcomes are symptoms, change in disease status, quality of life, and treatment-related morbidity. One RCT that compared radiofrequency using the RhinAer device with a sham procedure showed a statistical significant difference in response rate in favor of radiofrequency ablation group compared to the sham group. However, it is unclear if the trial enrolled individuals with chronic rhinitis who were refractory to medical management. This limitation precludes meaningful interpretation of these results as the intended use of RhinAer device is for individuals with chronic rhinitis who are refractory to medical management. Two single-arm prospective studies evaluated efficacy and safety of radiofrequency ablation for patients with chronic rhinitis. Out of the 2, 1 study enrolled individuals who were refractory to medical management. Although both single arm studies reported improvement in symptom control, the major limitation is lack of a comparator group and open-label nature of the study design, which likely introduces biases. Randomized controlled trials with a clearly defined refractory patient population directly comparing radiofrequency with sham surgery or other surgical interventions are needed to confirm the efficacy of radiofrequency ablation for treatment of chronic rhinitis. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

For individuals with allergic or nonallergic chronic rhinitis who receive laser ablation, the evidence includes one nonrandomized study. Relevant outcomes are symptoms, change in disease status, quality of life, and treatment-related morbidity. Although the single-arm prospective study reported improvement in symptom control, the major limitation is lack of a comparator group and open-label nature of the study design, which likely introduces biases. In addition, the authors did not define how study participants were classified as refractory to medical management. Randomized controlled trials with a clearly defined refractory patient population directly comparing laser ablation with sham surgery or other surgical interventions are needed to confirm the efficacy of radiofrequency ablation for treatment of chronic rhinitis. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

Additional Information
Not applicable.

Background 
Chronic rhinitis is a common medical condition that encompasses allergic rhinitis, nonallergic rhinitis, and mixed rhinitis and can severely impact quality of life.1,The initial treatment for chronic rhinitis often involves medical management with pharmacotherapy that may include steroids, anticholinergics, nasal decongestants, and antihistamines. Although medications are the mainstay treatment option, approximately 10% to 22% of the patients with chronic rhinitis still have persistent symptoms despite medical therapy and may require further interventions.2,For individuals who do not attain improvement in chronic rhinitis symptoms after receiving adequate medical therapy (referred to as refractory chronic rhinitis), invasive surgical options to block posterior nasal nerve may be considered. Historically, vidian neurectomy which targets the vidian nerve was offered for refractory rhinitis.3,4, Although vidian neurectomy was shown to be effective in reducing symptoms like rhinorrhea, it is associated with side effects of cheek and palate numbness and dry eyes (in nearly 50% of cases, ranging between 35% to 72%).3, In an effort to improve on complications of vidian neurectomy such as xerophthalmia, interventions that specifically target the posterior nasal nerve branches of the vidian nerve have been developed. It is thought that such interventions would help to reduce the morbidity associated with vidian neurectomy.5,These interventions range from surgical ablation of the post-ganglionic posterior nasal nerve to minimally invasive options of cryotherapy, radiofrequency, or laser ablation of the nerve. These minimally invasive procedures can be performed under endoscopy. The efficacy of ablation of posterior nasal nerve is thought to result from the interruption of efferent parasympathetic stimulation of the nasal mucosa, which leads to reduction in submucosal gland secretions and blood flow.6,

To quantify the severity of chronic rhinitis and to assess treatment response, various outcome measures can be used, including radiologic scores, endoscopic grading, and patient-reported quality of life measures. The primary outcome measures relevant for the treatment of chronic rhinitis are patient-reported symptoms and quality of life. Examiner evaluation of the nasal and sinus appearance and polyp size may provide some information about treatment outcomes, but these evaluations are limited by the lack of universally accepted standards.

Frequently used outcome measures for treatments of chronic rhinitis in adults are shown in Table 1. A consensus on the minimally clinically important difference (MCID) for some of these outcomes has not been established. The U.S. Food and Drug Administration (FDA) guidance on drugs for rhinitis recommends patient-reported total nasal symptom scores as the primary measure of efficacy. The FDA guidance on drugs for rhinitis does not specify a MCID for patient-reported symptom measures, but notes that a MCID should be prespecified in studies and the rationale explained. Adverse events must be assessed immediately (perioperative complications and postoperative pain) and over the longer term.

Table 1. Outcome Measures for Chronic Rhinitis Interventions

Regulatory Status
In February 2019, the ClariFix™ device (Stryker) was cleared for use in adults with chronic rhinitis by the FDA through the 510(k) process (K190356).7, Clearance was based on substantial equivalence to the predicate device, ClariFix (K162608). The only modification to the subject device was an update to the indications for use to include adults with chronic rhinitis. As per the FDA 510K summary, the ClariFix device is intended to be used as a cryosurgical tool for the destruction of unwanted tissue during surgical procedures, including in adults with chronic rhinitis.

In December 2019, the RhinAer™ stylus (Aerin Medical) was cleared by the FDA through the 510(k) process as a tool to treat chronic rhinitis (K192471).8, Clearance was based on equivalence in design and intended use of a predicate device, the InSeca ARC Stylus™ (K162810). The RhinAer stylus includes modification of the InSeca ARC stylus shaft components and flexibility. As per the FDA 510K summary, the RhinAer is indicated for use in otorhinolaryngology surgery for the destruction of soft tissue in the nasal airway, including in posterior nasal nerve regions in patients with chronic rhinitis.

There are currently no laser ablation devices with FDA clearance for treatment of chronic rhinitis.

Policy
Cryoablation for chronic rhinitis (allergic or non-allergic) is investigational/unproven therefore is considered NOT MEDICALLY NECESSARY.

Radiofrequency ablation for chronic rhinitis (allergic or non-allergic) is investigational/unproven therefore is considered NOT MEDICALLY NECESSARY.

Laser ablation for chronic rhinitis (allergic and non-allergic) is investigational/unproven therefore is considered NOT MEDICALLY NECESSARY. 

NOTE: CPT 30117 may be considered medically necessary for diagnoses other than chronic rhinitis (allergic or non-allergic). This policy should NOT be used to address diagnoses other than chronic rhinitis.

Policy Guidelines
See the Codes table for details. 

Benefit Application 
State or federal mandates (e.g., Federal Employee Program) may dictate that certain U.S. Food and Drug Administration-approved devices, drugs, or biologics may not be considered investigational, and thus these devices may be assessed only by their medical necessity. 

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 function including 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 1 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 (RCT) 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.

Promotion of greater diversity and inclusion in clinical research of historically marginalized groups (e.g., People of Color [African-American, Asian, Black, Latino and Native American]; LGBTQIA (Lesbian, Gay, Bisexual, Transgender, Queer, Intersex, Asexual); Women; and People with Disabilities [Physical and Invisible]) allows policy populations to be more reflective of and findings more applicable to our diverse members. While we also strive to use inclusive language related to these groups in our policies, use of gender-specific nouns (e.g., women, men, sisters, etc.) will continue when reflective of language used in publications describing study populations.

Ablative Procedures for Chronic Rhinitis
Clinical Context and Therapy Purpose
The purpose of ablative procedures (cryoablation, radiofrequency ablation, and laser ablation) in individuals with chronic rhinitis who are refractory to medical management is to provide a treatment option that is an alternative to or an improvement on existing surgical invasive options. Chronic rhinitis is a common medical condition that can severely impact quality of life. While the initial medical treatment comprising of pharmacotherapy is adequate for majority of individuals, approximately 10% to 22% individuals may still have persistent symptoms despite medical therapy. Treatment options for individuals with chronic rhinitis that is refractory to medical management are limited and include vidian neurectomy and invasive surgical options to block posterior nasal nerve. However, these surgical interventions are associated with high frequency of post operative complications and requirement of general anesthesia. To overcome some of these limitations, minimally invasive ablative procedures using cryo, radiofrequency or laser based-interventions have been developed. These interventions do not require general anesthesia and can be performed using an endoscope. In order to evaluate if these minimally invasive ablative interventions improve the net health outcome, trials must enroll individuals with chronic rhinitis who are refractory to medical management and compare these ablative interventions with sham surgery or conventional surgical procedures to block posterior nasal nerve ideally in the setting of a RCT. Nonrandomized trials in similar populations can inform the durability of response after initial efficacy is demonstrated via RCTs.

The following PICO was used to select literature to inform this review.

Population
The relevant population of interest is adults age 18 years of age and older with chronic allergic or nonallergic rhinitis refractory to medical management.

Rhinitis is defined as symptomatic inflammation of the paranasal sinuses and nasal cavity. Chronic rhinitis is usually defined as rhinorrhea with or without nasal congestion symptoms despite medical therapy lasting longer than 3 months. Allergic rhinitis is defined as an immunoglobulin E (IgE)–mediated inflammatory response of the nasal mucous membranes after exposure to inhaled allergens. Symptoms include rhinorrhea (anterior or post nasal drip), nasal congestion, nasal itching, and sneezing. Allergic rhinitis can be seasonal or perennial, with symptoms being intermittent or persistent.

Interventions
The therapies being considered are cryoablation, radiofrequency ablation and laser ablation. Procedure involves destruction of tissue in the posterior nasal nerve region and is thought to correct the imbalance of autonomic input to the nasal mucosa, reducing nasal antigen responses and vascular hyperreactivity.

• Cryoablation: The ClariFix system uses nitrous oxide to freeze nasal tissue, causing nerve damage. The procedure can be performed under local anesthesia.
• Radiofrequency ablation: The RhinAer Stylus is a handheld device designed for use under local anesthesia. The device delivers radiofrequency energy at a temperature of 60 degrees Celsius to the posterior nasal nerve region.
• Laser ablation: There are currently no laser ablation devices with FDA clearance for treatment of chronic rhinitis.

Comparators
The comparator of interest is other surgical procedures.

Outcomes
The general outcomes of interest are symptoms, change in disease status, quality of life, and treatment-related morbidity.

To quantify the severity of chronic rhinitis and to assess treatment response, various outcome measures can be used, including radiologic scores, endoscopic grading, and patient-reported quality of life measures. The primary outcome measures relevant for the treatment of chronic rhinitis are patient-reported symptoms and quality of life. Examiner evaluation of the nasal and sinus appearance and polyp size may provide some information about treatment outcomes, but these evaluations are limited by the lack of universally accepted standards.

Frequently-used outcome measures for treatments of chronic rhinitis in adults are shown above in Table 1 (see Background). Adverse events must be assessed immediately (perioperative complications and postoperative pain) and over the longer term.

Study Selection Criteria
Methodologically credible studies were selected using the following principles:

• To assess efficacy outcomes, comparative controlled prospective trials were sought, with a preference for RCTs;
• In the absence of such trials, comparative observational studies were sought, with a preference for prospective studies.
• To assess long-term outcomes and adverse events, single-arm studies that capture longer periods of follow-up and/or larger populations were sought.
• Studies with duplicative or overlapping populations were excluded.

Cryoablation
Review of Evidence
Randomized Controlled Trials
One RCT conducted by Del Signore et al (2021)9, compared cryoablation using the ClariFix device with a sham procedure in 133 adults (age ≥21 years) with chronic rhinitis (Tables 2 and 3 ). Duration of follow-up was 3 months. Although the trial results showed a statistical significant difference in response rate in favor of cryoablation group compared to the sham group, it is unclear if the trial enrolled individuals with chronic rhinitis who were refractory to medical management. This limitation precludes interpretation of results.

Table 2. RCT of Cryoablation for Chronic Rhinitis - Characteristics

RCT: randomized controlled trial; rTNSS: reflective Total Nasal Symptom Score.

Table 3. RCT of Cryoablation for Chronic Rhinitis - Results

^a p-value calculated by BCBSA staff.
CI: confidence interval; RCT: randomized controlled trial; RQLQ: Rhinoconjunctivitis Quality of Life Questionnaire; rTNSS: reflective Total Nasal Symptom Score.
The purpose of the study limitations tables (see Tables 4 and 5 ) is to display notable limitations identified in each study. This information is synthesized as a summary of the body of evidence following each table and provides the conclusions on the sufficiency of evidence supporting the position statement. The major limitation is the lack of clarity on whether the enrolled study participants were refractory to medical management or not. An adequately powered randomized sham-controlled trial that enrolls participants who are refractory to medical management is necessary to clearly ascertain effect of cryoablation on the net health outcome in patients with chronic rhinitis.

Table 4. Study Relevance Limitations

The study limitations stated in this table are those notable in the current review; this is not a comprehensive gaps assessment.
^a Population key: 1. Intended use population unclear; 2. Study population is unclear; 3. Study population not representative of intended use; 4, Enrolled populations do not reflect relevant diversity; 5. Other.
^b Intervention key: 1. Not clearly defined; 2. Version used unclear; 3. Delivery not similar intensity as comparator; 4. Not the intervention of interest (e.g., proposed as an adjunct but not tested as such); 5: Other.
^c Comparator key: 1. Not clearly defined; 2. Not standard or optimal; 3. Delivery not similar intensity as intervention; 4. Not delivered effectively; 5. Other.
^d Outcomes key: 1. Key health outcomes not addressed; 2. Physiologic measures, not validated surrogates; 3. Incomplete reporting of harms; 4. Not establish and validated measurements; 5. Clinically significant difference not prespecified; 6. Clinically significant difference not supported; 7. Other.
^e Follow-Up key: 1. Not sufficient duration for benefit; 2. Not sufficient duration for harms; 3. Other.

Table 5. Study Design and Conduct Limitations 

The study limitations stated in this table are those notable in the current review; this is not a comprehensive gaps assessment.
^a Allocation key: 1. Participants not randomly allocated; 2. Allocation not concealed; 3. Allocation concealment unclear; 4. Inadequate control for selection bias; 5. Other.
^b Blinding key: 1. Participants or study staff not blinded; 2. Outcome assessors not blinded; 3. Outcome assessed by treating physician; 4. Other.
^c Selective Reporting key: 1. Not registered; 2. Evidence of selective reporting; 3. Evidence of selective publication; 4. Other.
^d Data Completeness key: 1. High loss to follow-up or missing data; 2. Inadequate handling of missing data; 3. High number of crossovers; 4. Inadequate handling of crossovers; 5. Inappropriate exclusions; 6. Not intent to treat analysis (per protocol for noninferiority trials); 7. Other.
^e Power key: 1. Power calculations not reported; 2. Power not calculated for primary outcome; 3. Power not based on clinically important difference; 4. Other.
^f Statistical key: 1. Analysis is not appropriate for outcome type: (a) continuous; (b) binary; (c) time to event; 2. Analysis is not appropriate for multiple observations per patient; 3. Confidence intervals and/or p values not reported; 4. Comparative treatment effects not calculated; 5. Other.

Nonrandomized Studies
Three single-arm prospective studies including 149 patients evaluated efficacy and safety of cryoablation for patients with chronic rhinitis. Characteristics and results of these studies are shown in Tables 6 and 7. Out of the 3 studies, 2 studies enrolled individuals who were refractory to medical management. The definition of refractory varied from symptoms not adequately controlled with a minimum of 4 weeks of topical nasal steroid treatment or failure of medical therapy for a duration of at least 3 months. Key limitations of these studies are summarized in Tables 8 and 9. Although all 3 studies reported improvement in symptom control, the major limitation is lack of a comparator group and open-label nature of the study design, which likely introduces biases. Additionally, loss to follow-up was high and minimally clinically important differences (MCID) were not prespecified for important outcome measures.

Table 6. Nonrandomized Studies of Cryoablation for Chronic Rhinitis - Characteristics

rTNSS: reflective Total Nasal Symptom Score ; SD: standard deviation; TNSS: Total Nasal Symptom Score. 

Table 7. Nonrandomized Studies of Cryoablation for Chronic Rhinitis - Results 

IQR: interquartile range; RQLQ: Rhinoconjunctivitis Quality of Life Questionnaire; rTNSS: reflective Total Nasal Symptom Score ; SD: standard deviation; TNSS: Total Nasal Symptom Score.

Table 9. Study Relevance Limitations

The study limitations stated in this table are those notable in the current review; this is not a comprehensive gaps assessment. 
^a Population key: 1. Intended use population unclear; 2. Clinical context is unclear; 3. Study population is unclear; 4. Study population not representative of intended use.
^b Intervention key: 1. Not clearly defined; 2. Version used unclear; 3. Delivery not similar intensity as comparator; 4.Not the intervention of interest.
^c Comparator key: 1. Not clearly defined; 2. Not standard or optimal; 3. Delivery not similar intensity as intervention; 4. Not delivered effectively.
^d Outcomes key: 1. Key health outcomes not addressed; 2. Physiologic measures, not validated surrogates; 3. No CONSORT reporting of harms; 4. Not establish and validated measurements; 5. Clinical significant difference not prespecified; 6. Clinical significant difference not supported.
^e Follow-Up key: 1. Not sufficient duration for benefit; 2. Not sufficient duration for harms.

Table 8. Study Design and Conduct Limitations

The study limitations stated in this table are those notable in the current review; this is not a comprehensive gaps assessment.
^a Allocation key: 1. Participants not randomly allocated; 2. Allocation not concealed; 3. Allocation concealment unclear; 4. Inadequate control for selection bias.
^b Blinding key: 1. Not blinded to treatment assignment; 2. Not blinded outcome assessment; 3. Outcome assessed by treating physician.
^c Selective Reporting key: 1. Not registered; 2. Evidence of selective reporting; 3. Evidence of selective publication.
^d Data Completeness key: 1. High loss to follow-up or missing data; 2. Inadequate handling of missing data; 3. High number of crossovers; 4. Inadequate handling of crossovers; 5. Inappropriate exclusions; 6. Not intent to treat analysis (per protocol for noninferiority trials).
^e Power key: 1. Power calculations not reported; 2. Power not calculated for primary outcome; 3. Power not based on clinically important difference.
^f Statistical key: 1. Analysis is not appropriate for outcome type: (a) continuous; (b) binary; (c) time to event; 2. Analysis is not appropriate for multiple observations per patient; 3. Confidence intervals and/or p values not reported; 4. Comparative treatment effects not calculated.

Section Summary: Cryoablation
Evidence for the use of cryoablation for the treatment individuals with chronic rhinitis who are refractory to medical management includes one RCT and several nonrandomized studies. One RCT that compared cryoablation using the ClariFix device with a sham procedure showed a statistical significant difference in response rate in favor of the cryoablation group compared to the sham group. However, it is unclear if the trial enrolled individuals with chronic rhinitis who were refractory to medical management. This limitation precludes meaningful interpretation of these results as the intended use of ClariFix device is for individuals with chronic rhinitis who are refractory to medical management. Three single-arm prospective studies evaluated efficacy and safety of cryoablation for patients with chronic rhinitis. Out of the 3, 2 studies enrolled individuals who were refractory to medical management. The definition of refractory varied from symptoms not adequately controlled with a minimum of 4 weeks of topical nasal steroid treatment to failure of medical therapy for a duration of at least 3 months. Although all 3 single arm studies reported improvement in symptom control, the major limitation is lack of a comparator group and open-label nature of the study design, which likely introduces biases. Additionally, loss to follow-up was high.

Radiofrequency Ablation
Randomized Controlled Trials
Stolovitsky et al (2021) conducted an RCT comparing radiofrequency ablation using the RhinAer device with sham treatment.14, The trial enrolled 117 adults (age, 18 to 85 years; mean age, 57 years) with chronic rhinitis. Use of medication to treat chronic rhinitis throughout the trial was allowed in both groups (Table 10 ). Approximately 72.7% of patients in the active treatment group and 71.8% in the sham group were using antihistamines at baseline. Although the trial results showed a statistical significant difference in response rate in favor of radiofrequency ablation group compared to the sham group, it is unclear if the trial enrolled individuals with chronic rhinitis who were refractory to medical management. This limitation precludes interpretation of results. The study was unblinded at 3 months, and individuals in the control group were allowed to crossover to the active intervention group. Takashima et al (2022) reported 12-month follow-up for patients (n=77) initially randomized to the active intervention group.15, Study results for the active intervention group at 6- and 12-months are reported in Table 11. The study is ongoing, with planned 3-year follow-up.

Table 10. RCT of Radiofrequency Ablation for Chronic Rhinitis - Characteristics

RCT: randomized controlled trial; rTNSS: reflective Total Nasal Symptom Score.

Table 11. RCT of Radiofrequency Ablation for Chronic Rhinitis - Results

^a p-value calculated by BCBSA staff.
CI: confidence interval; RCT: randomized controlled trial; rTNSS: reflective Total Nasal Symptom Score; VAS: visual analog scale.

The purpose of the study limitations tables (see Tables 12 and 13) is to display notable limitations identified in each study. This information is synthesized as a summary of the body of evidence following each table and provides the conclusions on the sufficiency of evidence supporting the position statement. The major limitation is the lack of clarity on whether the enrolled study participants were refractory to medical management or not. An adequately powered randomized sham-controlled trial that enrolls participants who are refractory to medical management is necessary to clearly ascertain effect of radiofrequency ablation on the net health outcome in patients with chronic rhinitis.

Table 12. Study Relevance Limitations

The study limitations stated in this table are those notable in the current review; this is not a comprehensive gaps assessment.
^a Population key: 1. Intended use population unclear; 2. Study population is unclear; 3. Study population not representative of intended use; 4, Enrolled populations do not reflect relevant diversity; 5. Other.
^b Intervention key: 1. Not clearly defined; 2. Version used unclear; 3. Delivery not similar intensity as comparator; 4. Not the intervention of interest (e.g., proposed as an adjunct but not tested as such); 5: Other.
^c Comparator key: 1. Not clearly defined; 2. Not standard or optimal; 3. Delivery not similar intensity as intervention; 4. Not delivered effectively; 5. Other.
^d Outcomes key: 1. Key health outcomes not addressed; 2. Physiologic measures, not validated surrogates; 3. Incomplete reporting of harms; 4. Not establish and validated measurements; 5. Clinically significant difference not prespecified; 6. Clinically significant difference not supported; 7. Other.
^e Follow-Up key: 1. Not sufficient duration for benefit; 2. Not sufficient duration for harms; 3. Other.

Table 13. Study Design and Conduct Limitations

The study limitations stated in this table are those notable in the current review; this is not a comprehensive gaps assessment.
^a Allocation key: 1. Participants not randomly allocated; 2. Allocation not concealed; 3. Allocation concealment unclear; 4. Inadequate control for selection bias; 5. Other.
^b Blinding key: 1. Participants or study staff not blinded; 2. Outcome assessors not blinded; 3. Outcome assessed by treating physician; 4. Other.
^c Selective Reporting key: 1. Not registered; 2. Evidence of selective reporting; 3. Evidence of selective publication; 4. Other.
^d Data Completeness key: 1. High loss to follow-up or missing data; 2. Inadequate handling of missing data; 3. High number of crossovers; 4. Inadequate handling of crossovers; 5. Inappropriate exclusions; 6. Not intent to treat analysis (per protocol for noninferiority trials); 7. Other.
^e Power key: 1. Power calculations not reported; 2. Power not calculated for primary outcome; 3. Power not based on clinically important difference; 4. Other.
f Statistical key: 1. Analysis is not appropriate for outcome type: (a) continuous; (b) binary; (c) time to event; 2. Analysis is not appropriate for multiple observations per patient; 3. Confidence intervals and/or p values not reported; 4. Comparative treatment effects not calculated; 5. Other.

Nonrandomized Studies
Two single-arm prospective studies including 179 patients evaluated efficacy and safety of radiofrequency ablation for patients with chronic rhinitis.16,17, Characteristics and results of these studies are shown in Tables 14 and 15. Out of the 2 studies, 1 study enrolled individuals who were refractory to medical management.17, Refractory was defined as an inadequate response after at least 4 weeks usage of intranasal steroids and rTNSS score ≥6. Results of long term follow-up for 2-years were reported in an extension study of 34 patients.Ehmer D, McDuffie CM, McIntyre JB, et al. Long-ter.... 526575221096045. PMID 35663498] Key limitations of these studies are summarized in Tables 16 and 17. Although both studies reported improvement in symptom control, the major limitation is lack of a comparator group and open-label nature of the study design, which likely introduces biases. Additionally, loss to follow-up was high and minimally clinically important differences (MCID) were not prespecified for important outcome measures.

Table 14. Nonrandomized Studies of Radiofrequency Ablation for Chronic Rhinitis - Characteristics

rTNSS: reflective Total Nasal Symptom Score; SD: standard deviation.

Table 15. Nonrandomized Studies of Radiofrequency Ablation for Chronic Rhinitis - Results

CI: confidence interval; miniRQLQ: mini Rhinoconjunctivitis Quality of Life Questionnaire; NR: not reported; rTNSS: reflective Total Nasal Symptom Score ; VAS: visual analog score.

Table 16. Study Relevance Limitations

The study limitations stated in this table are those notable in the current review; this is not a comprehensive gaps assessment. 
^a Population key: 1. Intended use population unclear; 2. Clinical context is unclear; 3. Study population is unclear; 4. Study population not representative of intended use.
^b Intervention key: 1. Not clearly defined; 2. Version used unclear; 3. Delivery not similar intensity as comparator; 4.Not the intervention of interest.
^c Comparator key: 1. Not clearly defined; 2. Not standard or optimal; 3. Delivery not similar intensity as intervention; 4. Not delivered effectively.
^d Outcomes key: 1. Key health outcomes not addressed; 2. Physiologic measures, not validated surrogates; 3. No CONSORT reporting of harms; 4. Not establish and validated measurements; 5. Clinical significant difference not prespecified; 6. Clinical significant difference not supported.
^e Follow-Up key: 1. Not sufficient duration for benefit; 2. Not sufficient duration for harms.

Table 17. Study Design and Conduct Limitations

The study limitations stated in this table are those notable in the current review; this is not a comprehensive gaps assessment.
^a Allocation key: 1. Participants not randomly allocated; 2. Allocation not concealed; 3. Allocation concealment unclear; 4. Inadequate control for selection bias.
^b Blinding key: 1. Not blinded to treatment assignment; 2. Not blinded outcome assessment; 3. Outcome assessed by treating physician.
^c Selective Reporting key: 1. Not registered; 2. Evidence of selective reporting; 3. Evidence of selective publication.
^d Data Completeness key: 1. High loss to follow-up or missing data; 2. Inadequate handling of missing data; 3. High number of crossovers; 4. Inadequate handling of crossovers; 5. Inappropriate exclusions; 6. Not intent to treat analysis (per protocol for noninferiority trials).
^e Power key: 1. Power calculations not reported; 2. Power not calculated for primary outcome; 3. Power not based on clinically important difference.
^f Statistical key: 1. Analysis is not appropriate for outcome type: (a) continuous; (b) binary; (c) time to event; 2. Analysis is not appropriate for multiple observations per patient; 3. Confidence intervals and/or p values not reported; 4. Comparative treatment effects not calculated.

Section Summary: Radiofrequency Ablation
Evidence for the use of radiofrequency ablation for the treatment individuals with chronic rhinitis who are refractory to medical management includes one RCT and several nonrandomized studies. One RCT that compared radiofrequency using the RhinAer device with a sham procedure showed a statistical significant difference in response rate in favor of radiofrequency ablation group compared to the sham group. However, it is unclear if the trial enrolled individuals with chronic rhinitis who were refractory to medical management. This limitation precludes meaningful interpretation of these results as the intended use of RhinAer device is for individuals with chronic rhinitis who are refractory to medical management. Two single-arm prospective studies evaluated efficacy and safety of radiofrequency ablation for patients with chronic rhinitis. Out of the 2, 1 study enrolled individuals who were refractory to medical management. Although both single arm studies reported improvement in symptom control, the major limitation is lack of a comparator group and open-label nature of the study design, which likely introduces biases.

Laser Ablation
Nonrandomized studies
Krespi et al (2020) reported the results of a nonrandomized study evaluating laser ablation for treatment of chronic rhinitis.19, The study enrolled 32 adults who were treated with an endoscopic diode laser in an outpatient setting. While the study stated that study participants were resistant to medical management, the authors did not define treatment resistance. Duration of follow-up was 3 months. Mean rTNSS was reduced from 6.0 (standard deviation [SD], 0.7) at baseline to 2.3 (SD, 0.4) at 3-month follow-up. Adverse events were not reported. Although the study reported improvement in symptom control, the major limitation is lack of a comparator group and open-label nature of the study design, which likely introduces biases.

Section Summary: Laser Ablation
Evidence for the use of laser ablation for the treatment individuals with chronic rhinitis who are refractory to medical management includes one nonrandomized study. Although the single-arm prospective study reported improvement in symptom control, the major limitation is lack of a comparator group and open-label nature of the study design, which likely introduces biases. In addition, the authors did not define how study participants were classified as refractory to medical management.

The purpose of the following information is to provide reference material. Inclusion does not imply endorsement or alignment with the evidence review conclusions.

Practice Guidelines and Position Statements
Guidelines or position statements will be considered for inclusion in ‘Supplemental Information' if they were issued by, or jointly by, a US professional society, an international society with US representation, or National Institute for Health and Care Excellence (NICE). Priority will be given to guidelines that are informed by a systematic review, include strength of evidence ratings, and include a description of management of conflict of interest.

American Academy of Allergy, Asthma, and Immunology
The 2023 International Consensus Statement on Allergy and Rhinology stated the following for cryotherapy/radiofrequency ablation of posterior nasal nerve. 20,

• Aggregate grade of evidence: C (Level 3: 2 studies, level 4: 4 studies, level 5: 5 studies)
• Benefit: Improvement in rhinorrhea.
• Harm: Risk of complications (e.g., epistaxis, temporary facial pain and swelling, headaches), limited long-term results.
• Cost: Surgical/procedural costs, cost of device, potential time off from work.
• Benefits-harm assessment: Potential benefit must be balanced with low risk of harm, especially considering limited long-term results.
• Value judgments: Patients may experience an improvement in symptoms.
• Policy level: Option.
• Intervention: Cryoablation and radiofrequency ablation of the posterior nasal nerve may be considered in allergic rhinitis patients that have failed medical management, particularly for rhinorrhea.

Grade of evidence "C" implies that body of evidence consisted of observational studies (case control and cohort design). Policy level "Option" implies "either that the evidence quality that exists is suspect or that well-designed, well conducted studies have demonstrated little clear advantage to one approach versus another. Options offer clinicians flexibility in their decision-making regarding appropriate practice, although they may set boundaries on alternatives. Patient preference should have a substantial role in influencing clinical decision-making, particularly when policies are expressed as options." As per the consensus statement, "because the current evidence is primarily based on industry-sponsored studies with limited long-term data, these office-based interventions remain an option for properly selected patients".

American Academy of Otolaryngology
In January 2023, the American Academy of Otolaryngology issued a position statement on peripheral nerve ablation for the treatment of chronic rhinitis.21, The position statement was not based on a systematic review or strength of evidence rating. According to the position statement, " Based on these safety and efficacy data, the American Academy of Otolaryngology endorses the use of posterior nasal nerve ablation for the treatment of medically-refractory chronic rhinitis. We do not consider these treatments to be experimental."

American Rhinologic Society
In January 2022, the American Rhinologic Society issued a position paper on posterior nasal nerve ablation.22, The position statement was not based on a systematic review or strength of evidence rating. According to the position statement, "The American Rhinologic Society supports the use of posterior nasal nerve ablation for the treatment of chronic rhinitis, including both allergic and non-allergic subtypes. This procedure should not be considered experimental, but should be considered as an effective option in treating chronic rhinitis and improving patient quality of life in those suffering from rhinorrhea and nasal congestion based on the following data."

U.S. Preventive Services Task Force Recommendations
Not applicable.

Ongoing and Unpublished Clinical Trials
Some currently ongoing and unpublished trials that might influence this review are listed in Table 18.

Table 18. Summary of Key Trials

NCT: national clinical trial.
^a Denotes industry-sponsored or cosponsored trial.

References 

1. Settipane RA, Charnock DR. Epidemiology of rhinitis: allergic and nonallergic. Clin Allergy Immunol. 2007; 19: 23-34. PMID 17153005
2. Lieberman P, Kaliner MA, Wheeler WJ. Open-label evaluation of azelastine nasal spray in patients with seasonal allergic rhinitis and nonallergic vasomotor rhinitis. Curr Med Res Opin. Apr 2005; 21(4): 611-8. PMID 15899111
3. Halderman A, Sindwani R. Surgical management of vasomotor rhinitis: a systematic review. Am J Rhinol Allergy. 2015; 29(2): 128-34. PMID 25785754
4. Marshak T, Yun WK, Hazout C, et al. A systematic review of the evidence base for vidian neurectomy in managing rhinitis. J Laryngol Otol. Jul 2016; 130 Suppl 4: S7-S28. PMID 27488341
5. Senanayake P, Wong E, McBride K, et al. Efficacy of Vidian Neurectomy and Posterior Nasal Neurectomy in the Management of Nonallergic Rhinitis: A Systematic Review. Am J Rhinol Allergy. Nov 2022; 36(6): 849-871. PMID 35695191
6. Zubair A, Lasrado S. Vidian Neurectomy. [Updated 2023 May 14]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK563142/]
7. Food & Drug Administration. Clarifix 510(k) Premarket Notification. 2019 (K190356). https://www.accessdata.fda.gov/cdrh_docs/pdf19/K190356.pdf. Accessed February 11, 2024.
8. Food & Drug Administration. RhinAer (RHIN1 Stylus) 510(k) Premarket Notification. 2019 (K192471). Accessed December 18, 2023.
9. Del Signore AG, Greene JB, Russell JL, et al. Cryotherapy for treatment of chronic rhinitis: 3-month outcomes of a randomized, sham-controlled trial. Int Forum Allergy Rhinol. Jan 2022; 12(1): 51-61. PMID 34355872
10. Hwang PH, Lin B, Weiss R, et al. Cryosurgical posterior nasal tissue ablation for the treatment of rhinitis. Int Forum Allergy Rhinol. Oct 2017; 7(10): 952-956. PMID 28799727
11. Chang MT, Song S, Hwang PH. Cryosurgical ablation for treatment of rhinitis: A prospective multicenter study. Laryngoscope. Aug 2020; 130(8): 1877-1884. PMID 31566744
12. Ow RA, O'Malley EM, Han JK, et al. Cryosurgical Ablation for Treatment of Rhinitis: Two-Year Results of a Prospective Multicenter Study. Laryngoscope. Sep 2021; 131(9): 1952-1957. PMID 33616224
13. Gerka Stuyt JA, Luk L, Keschner D, et al. Evaluation of In-Office Cryoablation of Posterior Nasal Nerves for the Treatment of Rhinitis. Allergy Rhinol (Providence). 2021; 12: 2152656720988565. PMID 33598336
14. Stolovitzky JP, Ow RA, Silvers SL, et al. Effect of Radiofrequency Neurolysis on the Symptoms of Chronic Rhinitis: A Randomized Controlled Trial. OTO Open. 2021; 5(3): 2473974X211041124. PMID 34527852
15. Takashima M, Stolovitzky JP, Ow RA, et al. Temperature-controlled radiofrequency neurolysis for treatment of chronic rhinitis: 12-month outcomes after treatment in a randomized controlled trial. Int Forum Allergy Rhinol. Feb 2023; 13(2): 107-115. PMID 35714267
16. Lee JT, Abbas GM, Charous DD, et al. Clinical and Quality of Life Outcomes Following Temperature-Controlled Radiofrequency Neurolysis of the Posterior Nasal Nerve (RhinAer) for Treatment of Chronic Rhinitis. Am J Rhinol Allergy. Nov 2022; 36(6): 747-754. PMID 35818709
17. Ehmer D, McDuffie CM, Scurry WC, et al. Temperature-Controlled Radiofrequency Neurolysis for the Treatment of Rhinitis. Am J Rhinol Allergy. Jan 2022; 36(1): 149-156. PMID 34382444
18. Ehmer D, McDuffie CM, McIntyre JB, et al. Long-term Outcomes Following Temperature-Controlled Radiofrequency Neurolysis for the Treatment of Chronic Rhinitis. Allergy Rhinol (Providence). 2022; 13: 21526575221096045. PMID 35663498
19. Krespi YP, Wilson KA, Kizhner V. Laser ablation of posterior nasal nerves for rhinitis. Am J Otolaryngol. 2020; 41(3): 102396. PMID 31948695
20. Wise SK, Damask C, Roland LT, et al. International consensus statement on allergy and rhinology: Allergic rhinitis - 2023. Int Forum Allergy Rhinol. Apr 2023; 13(4): 293-859. PMID 36878860
21. American Academy of Otolaryngology. Position Statement: PNN ablation for the treatment of chronic rhinitis. January 2023. Accessed February 11, 2024.
22. American Rhinologic Society. Posterior Nasal Nerve Ablation ARS Position Statement. January 2022. Accessed February 11, 2024.

Coding Section 

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive. 

This medical policy was developed through consideration of peer-reviewed medical literature generally recognized by the relevant medical community, U.S. FDA approval status, nationally accepted standards of medical practice and accepted standards of medical practice in this community and other nonaffiliated technology evaluation centers, reference to federal regulations, other plan medical policies and accredited national guidelines.

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