Coverage Policy Manual - Arkansas Blue Cross and Blue Shield

Pulsed Pressure, Treatment for Meniere's Disease

Description:

Meniere's disease is an idiopathic disorder of the inner ear characterized by episodes of vertigo, fluctuating hearing loss, tinnitus, and ear pressure. The vertigo attacks are often unpredictable and incapacitating, and may prevent the activities of daily living. Therapy is symptomatic in nature and does not address the underlying pathophysiology. Although the pathophysiology of Meniere's disease is not precisely known, it is thought to be related to a disturbance in the pressure/volume relationship of the endolymph within the inner ear. Conservative therapy includes a low sodium diet and diuretics to reduce the fluid accumulation (i.e., hydrops), and pharmacologic therapy to reduce vestibular symptoms. Persons who do not respond to these conservative measures may receive gentamicin drops in the ear, as a technique of chemical labyrinthectomy to ablate vestibular function on the affected side. No therapy is available to restore hearing loss.

There has been interest in developing a more physiologic approach to treatment by applying local pressure treatment to restore the underlying fluid homeostasis. Researchers have noted that symptoms of Meniere's disease improve with fluctuations in ambient pressure, and patients with acute vertigo have been successfully treated in hypobaric chambers. It is hypothesized that the application of low-frequency, low-amplitude pressure pulse to the middle ear functions to evacuate endolymphatic fluids from the middle ear, thus relieving vertigo. In 1999, the Meniett device (Medronic Xomed) received clearance to market through a U.S. Food and Drug Administration (FDA) 510(k) process specifically as a symptomatic treatment of Meniere's disease. The device consists of a hand-held air pressure generator that delivers intermittent complex pressure pulses. Use of the device consists of 2 phases: 1. a conventional ventilation tube is surgically placed in the eardrum of the ear to be treated; and 2. patients are instructed to place an ear-cuff in the external ear canal to minimize leakage to the external environment. Patients are instructed to treat themselves 3 times daily for 3 minutes each time. The treatment is continued for as long as patients find themselves in a period of attacks of vertigo. During periods of remission, no treatment is needed.

Policy/
Coverage:

Effective February 2022

Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria

Transtympanic micropressure applications (e.g., Meniett device) as a treatment of Meniere disease does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.

For members with contracts without primary coverage criteria, transtympanic micropressure applications (e.g., Meniett device) as a treatment of Meniere disease is considered investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.

Effective prior to February 2022

The Meniett device used in the treatment of Ménière's disease does not meet member benefit certificate primary coverage criteria based on a lack of scientific evidence of effectiveness.

For contracts without primary coverage criteria, the Meniett device used in the treatment of Ménière's disease are not considered medically necessary.

Effective Prior to February 2016

The Meniett device used in the treatment of Ménière's disease does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes.

For contracts without primary coverage criteria, the Meniett device used in the treatment of Ménière's disease is considered investigational. Investigational services are an exclusion in the member certificate of coverage.

Rationale:

This policy was developed as a result of the FDA approval of the Meniett device.

Data submitted to the FDA as part of the FDA-approval process consisted of a case series of 20 patients. Other case series have also been published in the peer-reviewed literature. However, a randomized, placebo-controlled trial is necessary to distinguish any treatment effect from the intermittent natural history of Meniere's disease. In 2004, Gates and colleagues published the 4-month results of a randomized multi-institutional study that enrolled 67 patients with active unilateral Meniere’s disease refractory to a 3-month trial of medical management. All patients underwent tympanostomy, and patients were additionally randomized to either a sham device or a Meniett device. Outcomes were assessed using symptom report cards that focused on the severity and frequency of vertigo. Vertigo was assessed on a scale of 1 to 4, and vertigo scored as 2 or higher was considered definitive vertigo. The total number of days of definitive vertigo for all the participants was reported at each month. While an ANOVA analysis showed that over the entire 4-month trial, there was a significant difference in the total number of episodes of vertigo in the treatment group compared to the control group, it is apparent that the difference between the groups is most apparent at 1 month, while at 4 months the treatment effect has disappeared almost entirely. Similarly, overall, there was a significant decrease in the frequency of vertigo in the treatment group, but again this difference was most apparent at the 1-month interval and almost disappeared at 4 months. No statistical analysis is provided for the 1-month intervals. It is difficult to interpret these results, and longer term follow-up is required. For example, the results could suggest that the device is only associated with a short-term improvement in vertigo, or a delayed placebo effect in the control group, or perhaps reflect the cyclical nature of the natural history of Meniere’s disease. In the control group, the total number of days with definitive vertigo initially declines slowly, then increases again, and then sharply declines at 4 months. If these changes in vertigo are due to the cyclical nature of Meniere’s disease, one might expect to see the number of vertigo days again rise in the control group in subsequent months.

2005 Update

A literature search for the period of 2004 through June 2005 did not identify any additional published literature. The policy statement is unchanged.

2006–2007 Update

A search of the MEDLINE database for the period of May 2004 through February 2007 identified one randomized trial along with several case series. A multicenter, double-blind, placebo-controlled trial with 63 patients reported an improvement in functionality (American Academy of Otolaryngology–Head and Neck Surgery [AAO-HNS] criteria) and a trend (p=0.09) toward a reduction in episodes of vertigo compared with a group treated with ventilation tubes and sham pressure devices. The frequency of attacks decreased from 10.5 to 4.0 in the placebo group and from 9.6 to 1.9 in the active group. There were no changes in secondary outcome measures (patient’s perception of tinnitus, aural pressure, and hearing). In addition to a marginal improvement in efficacy over placebo, this study is limited by the high dropout rate (37%), lack of intent-to-treat analysis, and short (2-month) monitoring period.

Gates and colleagues reported 2-year follow-up of patients from their randomized trial. At the end of the randomized phase of the study, 61 of 67 patients from both the control and active treatment arms were treated openly with the Meniett device; 3 were subsequently lost to follow-up or excluded due to concurrent health problems. Vertigo episodes were reported on a daily symptom diary (44 patients) or by a structured telephone interview (17 patients). Of the 58 patients followed up for 2 years, 14 (24%) dropped out to seek alternative surgical treatment, 5 (9%) showed little or no improvement, and 39 (67%) reported being in remission or substantially improved. For patients who went into remission, there was an 80% probability of remaining in remission for the 2 years. This assessment is limited, however, by the lack of a control group with ventilation tubes followed up over the same period.

These 2 studies do not provide adequate support for a change in the existing policy statement. As illustrated in the trial described above, frequency of vertigo attacks has been reported to decrease with placement of ventilation tubes alone. It is therefore not clear if the improvement in vertigo reported by Gates and colleagues at 2-year follow-up is due to the Meniett device, the insertion of the ventilation tubes, or to variability in disease course. In addition, a common problem with ventilation tubes is plugging requiring reinsertion of the tube, and an increase in middle ear infections. Assessment of the long-term efficacy and adverse effects of this device will require study with appropriately treated controls over an adequate length of time.

2009 Update

An updated search of the MEDLINE database in August 2009 identified a small retrospective case series from Germany reporting improvement of vertigo in patients with Meniere’s disease with placement of ventilation tubes alone (Park, 2009). Patients with ipsilateral middle ear pressure less than -50 decapascals (1 decapascal is equivalent to the pressure of 1.02 mm H20) who did not show any response to medical therapy underwent transtympanic tube insertion. The preoperative duration of illness lasted from 6 months to 24 months. At a median of 20 months postoperatively 6 8% of patients reported improvement of symptoms. Nine percent of patients reported complete relief of vertigo, 59% reported partial relief, and 32% reported no relief of vertigo. No improvement in vestibular function was found with objective testing.

In 2008, the American Academy of Otolaryngology-Head and Neck Surgery issued the following position statement on the use of transtympanic micropressure: “We find that there is convincing and well controlled medical evidence to support the use of micropressure therapy (such as the Meniett device) in certain cases of Meniere’s disease. Micropressure therapy is best used as a second level therapy when medical treatment has failed. The device represents a largely non-surgical therapy that should be available as one of the many treatments for Meniere’s disease.” No supporting evidence was provided.

Overall, the scientific evidence does not permit conclusions concerning the effect of this technology on health outcomes. As illustrated in the trials described above, frequency of vertigo attacks has been reported to decrease with placement of ventilation tubes alone. It is therefore not clear if the improvement in vertigo is due to the Meniett device, the insertion of the ventilation tubes, or to variability in disease course. Assessment of the long-term efficacy and adverse effects of this device requires study with appropriately treated controls over an adequate length of time. Therefore, the policy statement remains unchanged.

2012 Update

A search of the MEDLINE database was conducted through August 2012. There was non new information identified that would prompt a change in the coverage statement. Only small case series were identified. Notably, one small (n=22) retrospective case series from Germany reported improvement of vertigo in patients with Meniere’s disease with placement of ventilation tubes alone (Park, 2009). Patients with ipsilateral middle ear pressure less than -50 decapascals (1 decapascal is equivalent to the pressure of 1.02 mm water) who did not show any response to medical therapy underwent transtympanic tube insertion. The preoperative duration of illness lasted from 6 months to 24 months. At a median of 20 months postoperatively (range, 6–26 months), 68% of patients reported improvement of symptoms. Nine percent of patients reported complete relief of vertigo, 59% reported partial relief, and 32% reported no relief of vertigo. No improvement in vestibular function was found with objective testing.

2014 Update

A literature search conducted through September 2014 did not reveal any new information that would prompt a change in the coverage statement.

2015 Update

A literature search conducted through September 2015 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.

Van Sonsbeek and colleagues searched the Cochrane Cochrane Ear, Nose and Throat Disorders Group Trials Register; the Cochrane Central Register of Controlled Trials (CENTRAL); PubMed; EMBASE; CINAHL; Web of Science; Cambridge Scientific Abstracts; ICTRP and additional sources for published and unpublished trials. The date of the search was 6 June 2014 (van Sonsbeek, 2015). The search criteria was randomized controlled trials (RCTs) comparing positive pressure therapy (using the Meniett or a similar device) with placebo in patients with Ménière's disease. The primary outcome was control of vertigo; secondary outcomes were loss or gain of hearing, severity of tinnitus, perception of aural fullness, functional level, complications or adverse effects, and sick days. Two authors independently selected studies, assessed risk of bias and extracted data. We contacted authors for additional data. Where possible, we pooled study results using a fixed-effect, mean difference (MD) meta-analysis and tested for statistical heterogeneity using both the Chi² test and I² statistic. This was only possible for the secondary outcomes loss or gain of hearing and sick days. The results presented using forest plots with 95% confidence intervals (Cl). Five randomized clinical trials were included with 265 participants. All trials were prospective, double-blind, placebo-controlled randomized controlled trials on the effects of positive pressure therapy on vertigo complaints in Ménière's disease. Overall, the risk of bias varied: three out of five studies were at low risk, one was at unclear risk and one was at high risk of bias. Control of vertigo For the primary outcome, control of vertigo, it was not possible to pool data due to heterogeneity in the measurement of the outcome measures. In most studies, no significant difference was found between the positive pressure therapy group and the placebo group in vertigo scores or vertigo days. Only one study, at low risk of bias, showed a significant difference in one measure of vertigo control in favour of positive pressure therapy. In this study, the mean visual analogue scale (VAS) score for vertigo after eight weeks of treatment was 25.5 in the positive pressure therapy group and 46.6 in the placebo group (mean difference (MD) -21.10, 95% CI -35.47 to -6.73; scale not stated - presumed to be 0 to 100). For the secondary outcomes two pooled analyses were carried out. Statistically significant results were found for loss or gain of hearing. Hearing was 7.38 decibels better in the placebo group compared to the positive pressure therapy group (MD) (95% CI 2.51 to 12.25; two studies, 123 participants). The severity of tinnitus and perception of aural fullness were either not measured or inadequate data were provided in the included studies. For the secondary outcome functional level, it was not possible to perform a pooled analysis. One included study showed less functional impairment in the positive pressure group than the placebo group (AAO-HNS criteria, one- to six-point scale: MD -1.10, 95% CI -1.81 to -0.39, 40 participants); another study did not show any significant results. In addition to the predefined secondary outcome measures, sick days were included as an additional outcome measure, as two studies used this outcome measure and it is a complementary measurement of impairment due to Ménière's disease. Statistically significant differences were not found in sick days. No complications or adverse effects were noted by any study.

There is no evidence, from five included studies, to show that positive pressure therapy is effective for the symptoms of Ménière's disease. There is some moderate quality evidence, from two studies, that hearing levels are worse in patients who use this therapy. The positive pressure therapy device itself is minimally invasive. However, in order to use it, a tympanostomy tube (grommet) needs to be inserted, with the associated risks. These include the risks of anaesthesia, the general risks of any surgery and the specific risks of otorrhoea and tympanosclerosis associated with the insertion of a tympanostomy tube. Notwithstanding these comments, no complications or adverse effects were noted in any of the included studies.

2016 Update

A literature search conducted through January 2016 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.

Assessment of efficacy for a therapeutic intervention involves a determination of whether the intervention improves health outcomes compared to available alternatives. The optimal study design for this purpose is a randomized controlled trial (RCT) that compares the therapeutic intervention with existing alternative treatments, uses a placebo control, and includes clinically relevant measures of health outcomes.

A 2015 Cochrane review on positive pressure therapy for Meniere’s disease included 5 double-blind, placebo-controlled RCTs (total N=265 patients) (van Sonsbeek, 2015). Three of the studies were considered to be at low risk of bias, 1 was at unclear risk, and 1 study was at high risk of bias. Results on the primary outcome measure, control of vertigo, could not be pooled due to heterogeneity in measurement, but most trials showed no significant difference in vertigo between Meniette therapy and placebo. This review supports the conclusion that there is no evidence that positive pressure therapy is effective for the treatment of Meniere disease, and that there is some evidence that hearing is impaired with this treatment. Another systematic review, which included 4 of the same RCTs that specifically used the Meniett device, also found no significant difference between low pressure therapy and placebo for the frequency of vertigo (Syed, 2015).

Ongoing and Unpublished Clinical Trials

A search of ClinicalTrials.gov in January 2016 did not identify any ongoing or unpublished trials that would likely influence this review.

2017 Update

A literature search conducted through January 2017 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.

Russo and colleagues reported an industry-sponsored, multicenter, double-blind RCT of the Meniett device (Russo, 216). A total of 129 patients with Meniere disease not controlled by medical treatment were withdrawn from any vertigo treatment and received placement of a transtympanic tube. Patients (n=97 [75%]) who continued to have symptoms (at least 2 vertigo episodes during a 6-week period) after placement of a transtympanic tube were randomized to an active or sham device for 6 weeks, and then were followed for an additional 6 weeks. The number of vertigo episodes during the baseline period did not differ significantly between groups (p=0.07). The trial was powered to detect a 30% difference in vertigo episodes compared to the sham group. Per protocol analysis showed a significant decrease in vertigo episodes in both group, but no between-group difference (p=0.11), suggesting a possible effect of the transtympanic tube. Vertigo-related quality of life also did not differ between groups.

ONGOING AND UNPUBLISHED CLINICAL TRIALS

A search of ClinicalTrials.gov in January 2017 did not identify any ongoing or unpublished trials that would likely influence this review.

2018 Update

Annual policy review completed with a literature search using the MEDLINE database through January 2018. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.

Russo et al reported on an industry-sponsored, multicenter, double-blind RCT of the Meniett device in 2017 (Russo, 2017). A total of 129 patients with Meniere disease not controlled by medical treatment were withdrawn from any vertigo treatment and received placement of a transtympanic tube. Patients (n=97 [75%]) who continued to have symptoms (≥2 vertigo episodes during a 6-week period) after placement of a transtympanic tube were randomized to an active or sham device for 6 weeks, and then were followed for an additional 6 weeks. The number of vertigo episodes during the baseline period did not differ significantly between groups (p=0.07). The trial was powered to detect a 30% difference in vertigo episodes compared to the sham group. Per protocol analysis showed a significant decrease in vertigo episodes in both groups, but no between-group difference (p=0.11), suggesting a possible effect of the transtympanic tube. Vertigo-related quality of life also did not differ between groups.

2019 Update

Annual policy review completed with a literature search using the MEDLINE database through January 2019. 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 January 2021. No new literature was identified that would prompt a change in the coverage statement.

2022 Update

Annual policy review completed with a literature search using the MEDLINE database through January 2022. No new literature was identified that would prompt a change in the coverage statement.

2023 Update

Annual policy review completed with a literature search using the MEDLINE database through January 2023. No new literature was identified that would prompt a change in the coverage statement.

2024 Update

Annual policy review completed with a literature search using the MEDLINE database through January 2024. No new literature was identified that would prompt a change in the coverage statement.

CPT/HCPCS:

References:

American Academy of Otolaryngology- Head and Neck Surgery. AAO-HNS position on micropressure therapy. Available at: http://www.entnet.org/Practice/micropressure.cfm. Last viewed July 2008.

Ayache D, Plouin-Gaudon I, et al.(2002) Perilymphatic pressure measurement in Meniere's disease. Ann Otol Rhinol Laryngol 2002; 111:653-6.

Barbara M, Consagra C, Monini S et al.(2001) Local pressure protocol, including Meniett, in the treatment of Meniere's disease: short-term results during the active stage. Acta Otolaryngol 2001; 121(8):939-44.

Barbara M, Consagra C, Monini S, et al.(2001) Local pressure protocol, including Meniett, in the treatment of Meniere's disease: short term results during the active stage. Acta Otolaryngol 2001; 121:939-44.

Densert B, Sass K.(2001) Control of symptoms in patients with Meniere's disease using middle ear pressure applications: two years follow-up. Acta Otolaryngol 2001; 121(5):616-21.

Densert B, Sass K.(2001) Control of symptoms in patients with Meniere's Disease using middle ear pressure applications: Two years follow-up. Acta Otolaryngol 2001; 121:616-621.

FDA.(1999) 510(k) Summary - K991562. www.fda.gov/search.html; 1999.

Gates GA, Green HJD Jr, Tucci DL, et al.(2004) The effects of transtympanic micropressure treatment in people with unilateral Meniere's disease. Arth Otolaryngol Head Neck Surg 2004; 130(6):718-25.

Gates GA, Green JD Jr.(2002) Intermittent pressure therapy of intractable Meniere's disease using the Meniett device: a preliminary report. Laryngoscope 2002; 112(8 Pt 1):1489-93.

Gates GA, Green JD, Tucci DL, et al.(2004) The effects of transtympanic micropressure treatment in people with unilateral Meniere’s disease. Arch Otolaryngol Head Neck Surg 2004; 130(6):718-25.

Gates GA, Green JD.(2002) Intermittent pressure therapy of intractable Meniere's disease using the Meniett device: a preliminary report. Laryngoscope 2002; 112(8 pt 1):1489-93.

Gates GA, Verrall A, et al.(2006) Meniett clinical trial: long-term follow-up. Arch Otolaryngol Head Neck Surg, 2006; 132:1311-6.

Meniett Device for Treatment of Meniere's Disease. HAYES Alert Newsletter Vol VI, Number 4, April 2003.

Meniett low-pressure pulse generator for Meniere's disease. National Horizon Scanning Centre 2003.

Odkvist L.(2001) Pressure treatment versus gentamicin for Meniere's disease. Acta Otolaryngol 2001; 121:266-8.

Odkvist LM, Arlinger S, Billermark E, et al.(2000) Effects of middle ear pressure changes on clinical symptoms in patients with Meniere's Disease - a clinical multicenter placebo-controlled study. Acta Otolaryngol 2000; S543:99-101.

Park JJ, Chen YS, Westhofen M. Park JJ, Chen YS, Westhofen M.(2009) Meniere's disease and middle ear pressure - vestibular function after transtympanic tube placement. Acta Otolaryngol 2009 Mar 4:1-6. [Epub ahead of print].

Park JJ, Chen YS, Westhofen M.(2009) Meniere's disease and middle ear pressure - vestibular function after transtympanic tube placement. Acta Otolaryngol 2009; 129(12):1408-13.

Rajan GP, Din S, Atlas MD.(2005) Long-term effects of the Meniett device in Meniere's disease: the Western Australian experience. Laryngol Otol 2005; 119(5):391-5.

Russo FY, Nguyen Y, De Seta D, et al.(2016) Meniett device in meniere disease: Randomized, double-blind, placebo-controlled multicenter trial. Laryngoscope. Aug 12 2016. PMID 27515294

Russo FY, Nguyen Y, De Seta D, et al.(2017) Meniett device in Meniere disease: Randomized, double-blind, placebo-controlled multicenter trial. Laryngoscope. Feb 2017;127(2):470-475. PMID 27515294

Syed MI, Rutka JA, Hendry J, et al.(2015) Positive pressure therapy for Meniere's syndrome/disease with a Meniett device: a systematic review of randomised controlled trials. Clin Otolaryngol. Jun 2015;40(3):197-207. PMID 25346252

Thomsen J, Sass K, Odkvist L, et al.(2005) Local overpressure treatment reduces vestibular symptoms in patients with Meniere's disease: a clinical, randomized, multicenter, double-blind, placebo-controlled study. Otol Neurotol 2005; 26(1):68-73.

Van de Heyning PH, Wuyts F, Boudewyns A.(2005) Surgical treatment of Meniere's disease. Curr Opin Neurol 2005; Feb;18(1):23-8.

van Sonsbeek S, Pullens B, van Benthem PP.(2015) Positive pressure therapy for Meniere's disease or syndrome. Cochrane Database Syst Rev. 2015;3:CD008419. PMID 25756795

van Sonsbeek S, Pullens B, van Benthem PP.(2015) Positive pressure therapy for Ménière's disease or syndrome. Cochrane Database Syst Rev. 2015 Mar 10;3:CD008419.

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.
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