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Laser Treatment of Onychomycosis

Policy Number: MP-528

Latest Review Date: December 2019

Category:  Medicine                                                              

Policy Grade:  C

POLICY:

Laser treatment of onychomycosis is considered not medically necessary and investigational.

 

DESCRIPTION OF PROCEDURE OR SERVICE:

Onychomycosis is a common fungal infection of the nail. Currently available treatments for onychomycosis, including systemic and topical antifungal medications, have relatively low efficacy and require a long course of treatment. Laser systems are proposed as another treatment option.

 

Onychomycosis is a chronic condition that is estimated to cause up to 50% of all nail disease and 33% of cutaneous fungal infections.  The condition can affect toenails or fingernails but is more frequently found in toenails. Primary infectious agents include dermatophytes (e.g., Trichophyton species), yeasts (e.g., Candida albicans) and non-dermatophytic molds. In temperate Western countries, infections are generally caused by dermatophytes.

 

Aging is the most common risk factor for onychomycosis, most likely due to decreased blood circulation, longer exposure to fungi, and slower nail growth. In addition, various medical conditions increase the risk of comorbid onychomycosis. These include diabetes, obesity, peripheral vascular disease, immunosuppression, and HIV infection. In certain populations, onychomycosis may lead to additional health problems. Although there is limited evidence of a causal link between onychomycosis and diabetic foot ulcers, at least one prospective study with diabetic patients found onychomycosis to be an independent predictor of foot ulcers.  Moreover, onychomycosis, especially more severe cases, may adversely impact quality of life. Patients with onychomycosis have reported pain, uncomfortable nail pressure, embarrassment, and discomfort wearing shoes.

 

The diagnosis of onychomycosis can be confirmed by potassium hydroxide preparation, culture or histology. Treatments for onychomycosis include topical antifungals such as nail paints containing ciclopirox (ciclopiroxolamine) or amorolfine, and oral antifungals such as terbinafine and itraconazole. These generally have low to moderate efficacy and a high relapse rate. Topical antifungals and some long-available oral medications such as griseofulvin require a long course of treatment, which presents issues for patient compliance. Moreover, oral antifungal medications have been associated with adverse effects such as a risk of hepatotoxicity.

 

Several types of device-based therapies are under investigation for treatment of onychomycosis, including ultrasound, iontophoresis, photodynamic therapy and laser systems. A potential advantage of lasers is that they have greater tissue penetration than antifungal medication and thus may be more effective at treating infection embedded within the nail. Another potential advantage is that laser treatments are provided in a clinical setting in only one or several sessions and thus long-term patient compliance is less of an issue than with medications.

 

Laser treatment of onychomycosis uses the principle of selective photothermolysis, defined as the precise targeting of a tissue using a specific wavelength of light. The premise is that light is absorbed into the target area and heat generated by that energy is sufficient to damage the target area while sparing the surrounding area. The aim of laser treatment of onychomycosis is to heat the nail bed to temperatures required to disrupt fungal growth (approximately 40-60oC) and at the same time avoid pain and necrosis to surrounding tissues.

 

Characteristics of laser systems used to treat onychomycosis are as follows:

 

Table 1. Characteristics of Lasers for Treating Onychomycosis

Variables

Characteristics

Wavelength

Lasers are single-wavelength light sources. There needs to be sufficient tissue penetration to adequately treat nail fungus. The near-infrared spectrum tends to be used because this part of the spectrum has maximum tissue penetrance in the dermis and epidermis and the nail plate is similar to the epidermis. To date, most laser systems for treating onychomycosis have been Neodymium yttrium aluminum garnet (Nd:YAG) lasers that are typically operate at 1064 nm; 940- to 1320-nm and 1440-nm wavelengths are also options.

Pulse duration

Pulses need to be short to avoid damaging the tissue surrounding the target area. For example, short-pulse systems have microsecond pulse durations and Q-switched lasers have nanosecond pulse durations.

Repetition rate (frequency of pulses, in hertz)

Spot size to the diameter of the laser beam. For treating onychomycosis, laser spot sizes range from 1 to 10 nm.

Fluence (in J/cm2)

Fluence refers to the amount of energy delivered into the area

 

KEY POINTS:

This policy has been updated regularly with searches of the MEDLINE database. The most recent update with literature review covered the period through October 14, 2019.

 

Summary of Evidence

For individuals who have onychomycosis who receive treatment with laser therapy, the evidence includes small, randomized controlled trials. The relevant outcomes are symptoms, change in disease status, medication use, and treatment-related morbidity. The randomized controlled trials reported inconsistent results and had methodologic limitations. Clinical and mycologic outcomes differed across the trials, lacked consistent blinding of outcome assessments, and often reported outcomes on a per-nail basis without accounting for correlated measurements. The published evidence to date does not permit determining whether laser treatment improves health outcomes in patients with onychomycosis. Additional well-designed, adequately powered, and well-conducted randomized controlled trials are needed. The evidence is insufficient to determine the effects of the technology on health outcomes.

 

PRACTICE GUIDELINES AND POSITION STATEMENTS

British Association of Dermatologists

The British Association of Dermatologists (2014) issued guidelines on the management of onychomycosis. Due to the limited nature of the evidence, the Association concluded that “lasers are showing promising results in the treatment of onychomycosis, but recommendations cannot be made at this stage” (level of evidence 1-).

 

U.S. PREVENTIVE SERVICES TASK FORCE RECOMMENDATIONS

Not applicable.

 

KEY WORDS:

Onychomycosis, laser treatment, laser therapy, nail fungus, PinPointe FootLaser, GenesisPlus™, VARIABreeze™

 

APPROVED BY GOVERNING BODIES:

Multiple Nd:YAG laser systems have been cleared by the FDA for marketing for the temporary increase of clear nail in patients with onychomycosis (product code:  GEX). The FDA determined that these devices were substantially equivalent to existing devices. Cleared devices and year of FDA decision are as follows:

 

Nd:YAG 1064nm laser systems:

  • PinPointe FootLaser (PinPointe USA, acquired by NuvoLase in 2011): 2010
  • GenesisPlus™ (Cutera): 2011
  • VARIABreeze™ (CoolTouch Inc.): 2011
  • JOULE ClearSense™ (Sciton): 2011

Dual wavelength Nd:YAG 1064nm and 532nm laser system:

  • Q-Clear™ (Light Age, Inc.): 2011

 

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:  Special benefit consideration may apply.  Refer to member’s benefit plan.  FEP does not consider investigational if FDA approved and will be reviewed for medical necessity.

 

CODING:

CPT Codes:     No comparable CPT code exists for this procedure, and would likely be reported using the following unlisted codes:

17999              Unlisted procedure, skin, mucous membrane and subcutaneous tissue

96999              Unlisted special dermatological service or procedure

 

 

REFERENCES:

  1. Ameen M, Lear JT, Madan V, et al. British Association of Dermatologists' guidelines for the management of onychomycosis 2014. Br J Dermatol. Nov 2014; 171(5):937-958.
  2. Boyko EJ, Ahroni JH, Cohen V et al. Prediction of diabetic foot ulcer occurrence using commonly available clinical information: the Seattle Diabetic Foot Study. Diabetes Care. Jun 2006; 29(6):1202-1207.
  3. Bristow IR. The effectiveness of lasers in the treatment of onychomycosis: a systematic review. J Foot Ankle Res. 2014; 7:34.
  4. Drake LA, Scher RK, Smith EB et al. Effect of onychomycosis on quality of life. J Am Acad Dermatol. May 1998; 38(5 Pt 1):702-704.
  5. El-Tatawy RA, Abd El-Naby NM, El-Hawary EE, et al. A comparative clinical and mycological study of Nd-YAG laser versus topical terbinafine in the treatment of onychomycosis. J Dermatolog Treat. Feb 11 2015:1-4.
  6. Elewski BE. Onychomycosis. Treatment, quality of life, and economic issues. Am J Clin Dermatol. Jan-Feb 2000; 1(1):19-26.
  7. Food and Drug Administration (FDA). 510(k) Summary: Light Age, Inc. Q-ClearM Nd:YAG Laser (K110370). Available online at: www.accessdata.fda.gov/cdrh_docs/pdf11/K110370.pdf.
  8. Gupta A, Simpson F. Device-based therapies for onychomycosis treatment. Skin Therapy Lett. Oct 2012; 17(9):4-9.
  9. Gupta AK, Simpson FC. Laser therapy for onychomycosis. J Cutan Med Surg 2013; 17(5):301-307.
  10. Gupta AK, Simpson FC. Medical devices for the treatment of onychomycosis. Dermatol Ther 2012; 25(6):574-581.
  11. Karsai S, Jager M, Oesterhelt A, et al. Treating onychomycosis with the short-pulsed 1064-nm-Nd:YAG laser: results of a prospective randomized controlled trial. J Eur Acad Dermatol Venereol. Jan 2017;31(1):175-180.
  12. Kim TI, Shin MK, Jeong KH, et al. A randomised comparative study of 1064 nm Neodymium-doped yttrium aluminium garnet (Nd:YAG) laser and topical antifungal treatment of onychomycosis. Mycoses. Jul 12 2016;59(12):803-810.
  13. Landsman AS, Robbins AH. Treatment of mild, moderate, and severe onychomycosis using 870- and 930-nm light exposure: some follow-up observations at 270 days. J Am Podiatr Med Assoc. Mar-Apr 2012; 102(2):169-171.
  14. Landsman AS, Robbins AH, Angelini PF et al. Treatment of mild, moderate, and severe onychomycosis using 870- and 930-nm light exposure. J Am Podiatr Med Assoc. May-Jun 2010; 100(3):166-77.
  15. Ledon JA, Savas J, Franca K et al. Laser and light therapy for onychomycosis: a systematic review. Lasers Med Sci 2014; 29(2):823-829.
  16. Morais OO, Costa IM, Gomes CM. The use of the Er:YAG 2940nm laser associated with amorolfine lacquer in the treatment of onychomycosis. An Bras Dermatol 2013; 88(5):847-849.
  17. Ortiz AE, Avram MM, Wanner MA. A review of lasers and light for the treatment of onychomycosis. Lasers Surg Med 2014; 46(2):117-24.
  18. Rodgers P, Bassler M. Treating onychomycosis. Am Fam Physician. Feb 15 2001; 63(4):663-672, 677-678.
  19. Sponsored by Brasilia University Hospital. Erbium-doped Yttrium Aluminium Garnet Laser(Er:Yag)Associated With Amorolfine Lacquer in the Treatment of Onychomycosis (NCT01528813) Available online at: www.clinicaltrials.gov.
  20. Sponsored by Cambridge Health Alliance. Evaluation Study for the Efficacy and Safety of PinPointe FootLaser in Treatment for Onychomycosis (NCT01920178) Available online at: www.clinicaltrials.gov.
  21. Sponsored by Stanford University. Treatment of Onychomycosis Using a 0.65 Millisecond Pulsed Nd:YAG 1064 nm Laser (NCT01666002). Available online at: www.clinicaltrials.gov.
  22. Zhang RN, Wang DK, Zhuo FL et al. Long-pulse Nd:YAG 1064-nm laser treatment for onychomycosis. Chin Med J (Engl) 2012; 125(18):3288-3291.
  23. Xu Y, Miao X, Zhou B, et al. Combined oral terbinafine and long-pulsed 1,064-nm Nd: YAG laser treatment is more effective for onychomycosis than either treatment alone. Dermatol Surg. Nov 2014; 40(11):1201-1207.

 

 

POLICY HISTORY:

Medical Policy Panel, May 2013

Medical Policy Group, May 2013 (3): New Policy adopted; investigational per policy statement

Medical Policy Administration Committee, May 2013

Available for comment May 21 through July 5, 2013

Medical Policy Panel, May 2014

Medical Policy Group, June 2014 (3):  2014 Updates to Key Points, Governing Bodies & References; no change in policy statement

Medical Policy Panel, May 2015

Medical Policy Group, June 2015 (3):  2015 Updates to Key Points, Approved by Governing Bodies, Key Words and References; no change in policy statement.

Medical Policy Panel, December 2016

Medical Policy Group, December 2016 (7): 2016 Updates to Key Points and References. No change in Policy Statement.

Medical Policy Panel, December 2017

Medical Policy Group, December 2017 (7): 2017 No new literature updates. No change to policy statement.

Medical Policy Panel, December 2018

Medical Policy Group, January 2019 (7): No new literature updates. No change to policy statement.

Medical Policy Panel, December 2019

Medical Policy Group, December 2019 (5): Updates to Description, and Key Points. No change to Policy Statement.

 

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.