Latest Review Date: February 2024

Category: Medical                                                               

POLICY:

Intratympanic dexamethasone for the treatment of Ménière’s disease may be considered medically necessary for the following:

• Individual has tried and failed conservative treatment such as

  • Dietary salt restriction and diuretics;

  • Treatment of allergies;

  • Anticholinergics;

  • Vestibular sedatives (e.g., Antivert);

  • High dose oral steroids.

OR

• Individual has a medical condition that prohibits the use of oral steroids, including but not limited to the following:

  • Diabetes mellitus;

  • Immunosuppressed patients;

  • Hypertension;

  • Active or latent peptic ulcer disease;

  • Renal insufficiency;

  • Osteoporosis;

  • Myasthenia gravis;

  • Some psychiatric disorders (e.g., severe depression or psychosis);

  • Ocular herpes;

  • Active tuberculosis;

  • Serious infections;

  • Systemic fungal infections, varicella;

  • Administration of liver virus vaccines;

  • Pregnancy;

  • Lactation;

  • Known hypersensitivity or adverse reaction.

Intratympanic dexamethasone for the treatment of sudden hearing loss may be considered medically necessary for the following:

• Individual has tried and failed conservative treatments such as:

  • Aspirin;

  • Antiviral mediations;

  • Diuretics;

  • Vasodilators;

  • High dose oral steroids;

OR

• Individual has a medical condition that prohibits the use of oral steroids, including but not limited to the following:

  • Diabetes mellitus;

  • Immunosuppressed patients;

  • Hypertension;

  • Active or latent peptic ulcer disease;

  • Renal insufficiency;

  • Osteoporosis;

  • Myasthenia gravis;

  • Some psychiatric disorders (e.g. severe depression or psychosis);

  • Ocular herpes;

  • Active tuberculosis;

  • Serious infections;

  • Systemic fungal infections, varicella;

  • Administration of liver virus vaccines;

  • Pregnancy;

  • Lactation;

  • Known hypersensitivity or adverse reaction.

DESCRIPTION OF PROCEDURE OR SERVICE:

Ménière’s disease, also known as endolymphatic hydrops, is a disorder of the inner ear of unknown origin. It is speculated the Ménière’s disease may be an immune-mediated disorder. Symptoms include tinnitus, vertigo, heightened sensitivity to loud sounds, fluctuating loss of hearing, headache, and aural fullness. In acute phases, nausea, vomiting, and disabling dizziness may occur. Usually, attacks are sudden and may last several hours. The disease usually lasts a few years and in most cases, occurs in only one ear. Diagnosis is difficult because its symptoms are often present in other conditions. 

Treatment initially consists of diuretics, elimination of nicotine and a low-sodium, non-caffeine diet to reduce fluid retention. Acute exacerbations may be treated with antiemetics, anti-vertigo medications and systemic steroids. When these medical and dietary treatments are unsuccessful, other medical and surgical interventions may be considered which include labyrinthectomy, endolymphatic sac shunt or decompression, vestibular neurectomy, and intratympanic gentamicin (which ablates vestibular function).

Oral steroids are frequently employed in the treatment of sudden sensorineural hearing loss (SSHL) and autoimmune inner ear disease (AIED). Individuals who can tolerate systemic steroids are initially treated with oral steroids first. If individuals do not fully respond after two weeks of oral steroids, then inner ear perfusion with dexamethasone can be used. It is proposed that individuals who have a medical contraindication to steroids such as diabetes, hypertension, or peptic ulcer disease can be treated primarily with direct inner ear perfusion while avoiding the systemic effects of the drug.

KEY POINTS:

The literature search for this policy was performed through February 15, 2024.

Summary of Evidence:

Intratympanic dexamethasone has been used for anti-inflammation and immunosuppression to decrease the incidence of acute attacks.  Intratympanic dexamethasone may be considered in individuals who wish to avoid surgical procedures and systemic steroid use.  Intratympanic dexamethasone injections are made via tympanostomy or myringotomy with or without placement of ventilation tubes.  Disadvantages of intratympanic dexamethasone may include the need for repeated offices visits, potential infection, and potential persistent perforation of the tympanic membrane. 

Practice Guidelines and Position Statements:

In 2020, the American Academy of Otolaryngology-Head and Neck Surgery published a clinical practice guideline on Meniere’s Disease. The guidelines are for all healthcare providers who diagnose, treat and monitor individuals with this condition. The authors concluded, “The primary purpose of this CPG is to improve the quality of the diagnostic workup and treatment outcomes of Meniere’s disease”. To achieve this goal, the guideline is to be the best available published, scientific and/or clinical evidence to enhance diagnostic accuracy and appropriate therapeutic interventions while reducing unindicated diagnostic testing.

U.S. Preventive Services Task Force Recommendations

Not applicable.

KEY WORDS:

Intratympanic, intratympanic dexamethasone, intratympanic steroids, IT dexamethasone, IT steroids, Ménière’s disease, sudden hearing loss, sudden loss of hearing, MicroWick

APPROVED BY GOVERNING BODIES:

U.S. Food and Drug Administration has granted approval for Dexamethasone.

BENEFIT APPLICATION:

Coverage is subject to member’s specific benefits.  Group-specific policy will supersede this policy when applicable.

ITS: Home Policy provisions apply

FEP contracts: Special benefit consideration may apply. Refer to member's benefit plan. 

CURRENT CODING: 

CPT codes:

REFERENCES:

1. American Academy of Otolaryngology-Head and Neck Surgery. Clinical Practice Guideline: Meiere’s Disease. www.entnet.org/quality-practice/quality-products/clinical-practice-guidelines/menieres-disease/.

2. Banerjee A, Parnes LS. The biology of intratympanic drug administration and pharmacodynamics of round window drug absorption. Otolaryngol Clin N Am 2004; 27:1035-51.

3. Banerjee A, Parnes LS. Intratympanic Corticosteroids for sudden idiopathic sensorineural hearing loss. Otol Neurotol 2005; 26:878-81.

4. Barrs DM. Intratympanic corticosteroids for Ménière’s disease and vertigo. Otolaryngol Clin N Am 2004; 37(5).

5. Barrs DM, Keyser JS, et al. Intratympanic steroid injections for intractable Ménière’s disease. Laryngoscope 2001; 111(12):2100-4.

6. Basil M.N. Saeed, Mohammed Tawalbeh, Alyaa Farouk Al-Omari, Intratympanic dexamethasone in Meniere’s disease, Egyptian Journal of Ear, Nose, Throat and Allied Sciences, Volume 17, Issue 2, 2016, Pages 63-69, ISSN 2090-0740, https://doi.org/10.1016/j.ejenta.2016.05.002.

7. Choung YH, Park K, Shin YR and Cho MJ. Intratympanic dexamethasone injection for refractory sudden sensorineural hearing loss. Laryngoscope 2006; 116(5): 747-752.

8. Cochrane Review. Steroids for idiopathic sudden sensorineural hearing loss. www.medscape.com/viewarticle/534092_print. Accessed March 19, 2008.

9. Doyle KJ, Bauch C, Battista R, et al. Intratympanic steroid treatment: a review. Otol Neurotol 2004; 25(6):1034-39.

10. Garduño-Anaya MA, De Toledo HC, Hinojosa-González, et al. Dexamethasone inner ear perfusion by intratympanic injection in unilateral Ménière’s disease: a two-year prospective, placebo-controlled, double-blind, randomized trial. Otolaryngol Head Neck Surg 2005; 133(2):285-94.

11. Gianoli GJ, et al. Transtympanic steroids for treatment of sudden hearing loss. Otolaryngol Head Neck Surg 2001; 125(3):142-6.

12. Hilton, A., McClelland, A., McCallum, R. et al. Duration of symptom control following intratympanic dexamethasone injections in Meniere’s disease. Eur Arch Otorhinolaryngol 279, 5191–5198 (2022). https://doi.org/10.1007/s00405-022-07368-w

13. Ho HG. Effectiveness of intratympanic dexamethasone injection in sudden-deafness patients as salvage treatment. Laryngoscope 2004; 114(7):1184-9.

14. IOM (Institute of Medicine). 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press

15. Itoh A, Sakata E. Treatment of vestibular disorders. Acta Otolaryngol Suppl 1991; 481:617-23.

16. Jackson LE, Silverstein H. Chemical perfusion of the inner ear. Otolaryngol Clin North Am 2002; 35(3):639-53.

17. Kopke RD, Hoffer ME, Wester D, et al. Targeted topical steroid therapy in sudden sensorineural hearing loss. Otol Neurotol 2001; 22(4):475-9.

18. Light JP. Transtympanic perfusion: indications and limitations. Curr Opin Otolaryngol Head Neck Surg 2004; 12(5):378-83.

19. Lustig LR.  The history of intratympanic drug therapy in otology. Otolaryngol Clin N Am 2004; 37:1001-17.

20. Maksoud, A.A., Hassan, D.M., Nafie, Y. et al. Intratympanic dexamethasone injection in Meniere’s disease. Egypt J Otolaryngol 31, 128–134 (2015).

21. McEvoy GK, ed. AHFS: Drug Information. Bethesda, MD: American Society of Health-System Pharmacist; 2004:2885-98.

22. Phillips J, et al. Efficacy of Intratympanic OTO-104 for the Treatment of Ménière's Disease: The Outcome of Three Randomized, Double-Blind, Placebo-Controlled Studies. Otol Neurotol. 2023 Jul 1;44(6):584-592.

23. Pradhan P, Lal P, Sen K. Long Term Outcomes of Intratympanic Dexamethasone in Intractable Unilateral Meniere's Disease. Indian J Otolaryngol Head Neck Surg. 2019 Nov;71(Suppl 2):1369-1373. doi: 10.1007/s12070-018-1431-3. Epub 2018 Jun 24.

24. Rauch SD. Intratympanic steroids for sensorineural hearing loss. Otolarynogol Clin North Am 2004; 37(5):1061-74.

25. Ren H, Yin T, Lu Y, Kong W, Ren J. Intratympanic dexamethasone injections for refractory Meniere' s disease. Int J Clin Exp Med. 2015 Apr 15;8(4):6016-23. 

26. Seidman MD & Vivek P. Intratympanic treatment of hearing loss with novel and traditional agents. Otolarynogol Clin North AM 2004; 37)5).

27. Selivanova OA, Gouveris H, Victor A, et al. Intratympanic dexamethasone and hyaluronic acid in patiens with low-frequency and Ménière’s-associated sudden sensorineural hearing loss. Otol Neurotol 2005; 26:890-95.

28. Sennaroglu L, Sennaroglu G, et al. Intratympanic dexamethasone, intratympanic gentamicin, and endolymphatic sac surgery for intractable vertigo in Ménière’s disease. Otolaryngol Head Neck Surg. 2001; 125(5):537-43.

29. Sennaroglu L, Dini FM, et al.  Transtympanic dexamethasone application in Ménière’s disease: an alternative treatment for intractable vertigo. J Laryngol Otol 1999; 113(3):217-21.

30. Shea J, Ge X. Dexamethasone perfusion of the labyrinth plus intravenous dexamethasone for Ménière’s disease. Otolaryn Clin N Am 1996; 29:353-358.

31. Silverstein H, Isaacson JE, Olds MJ, et al. Dexamethasone inner ear perfusion for the treatment of Ménière’s disease: a prospective, randomized, double-blind, crossover trial. Am J Otol 1998; 19(2):196-201.

32. Slattery WH, Fisher LM, Iqbal Z, et al. Intratympanic steroid injection for treatment of idiopathic sudden hearing loss. Otolaryngol Head Neck Surg 2005; 133(2):251-259.

33. Sudden deafness treatment trial (SSNHL). www.clinicaltrials.gov/study/NCT00097448?cond=sudden%20deafness%20treatment%20trial&rank=1.

34. Weber PC. Sudden sensorineural hearing loss. www.uptodate.com/contents/sudden-sensorineural-hearing-loss-in-adults-evaluation-and-management?search=Sudden%20deafness%20treatment%20trial%20(SSNHL&source=search_result&selectedTitle=1~150&usage_type=default&display_rank=1.

35. Xenellis J, Papadimitriou N, et al. Intratympanic steroid treatment in idiopathic sudden sensorineural hearing loss: A control study. Otolaryngology Head and Neck Surgery, June 2006; 134(6): 940-945.

POLICY HISTORY:

Medical Policy Group, June 2005 (2)

Medical Policy Administration Committee, July 2005

Available for comment July 28-September 10, 2005

Medical Policy Group, October 2005

Medical Review Committee, December 2005

Medical Policy Group, January 2006 (2)

Medical Review Committee, March 2006

Medical Policy Administration Committee, May 2006

Available for comment April 25-June 8, 2006

Medical Policy Group, April 2008 (1)

Medical Policy Group, April 2010 (1):  No studies identified to change policy

Medical Policy Group, December 2010, 2011 Code update

Medical Policy Group, September 2012 (3): Effective September 14, 2012 this policy is no longer scheduled for regular literature reviews and updates.

Medical Policy Group, October 2013 (3): Removed ICD-9 Diagnosis codes; Removed reference to Medical Policy Reference Manual;  no change to policy statement.

Medical Policy Group, November 2019 (6): Updates to Key Points. No change to Policy Statement. Reviewed by consensus. No new published peer-reviewed literature available that would alter the coverage statement in this policy.

Medical Policy Group, March 2021 (3): Updates to Key Points. No change to Policy Statement. Reviewed by consensus. No new published peer-reviewed literature available that would alter the coverage statement in this policy.

Medical Policy Group, January 2023 (6): Reviewed by consensus. References added. No new published peer-reviewed literature available that would alter the coverage statement in this policy. Updates to Description, Key Points, Practice Guidelines, USPSTF and References.

Medical Policy Group, Februay 2024 (9): Reviewed by consensus. No new published peer-reviewed literature is available that would alter the coverage statement in this policy. Updates to Key Points, Practice Guidelines, Benefit Application and References. No change to policy intent.

This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.

The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.

As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.

The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:

1. The technology must have final approval from the appropriate government regulatory bodies;

2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;

3. The technology must improve the net health outcome;

4. The technology must be as beneficial as any established alternatives;

5. The improvement must be attainable outside the investigational setting.

Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:

1. In accordance with generally accepted standards of medical practice; and

2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and

3. Not primarily for the convenience of the patient, physician or other health care provider; and

4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.