Latest Review Date: January 2024

Category: Medicine

POLICY:

Laser treatment of onychomycosis is considered 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

Onychomycosis is a common chronic fungal infection of the nail. It is estimated to cause up to 50% of all nail diseases 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 nondermatophytic 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. Also, various medical conditions increase the risk of comorbid onychomycosis. They 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 1 prospective study with diabetic patients found onychomycosis to be an independent predictor of foot ulcers. Moreover, onychomycosis, especially more severe cases, may adversely impact the quality of life. Patients with onychomycosis have reported pain, uncomfortable nail pressure, embarrassment, and discomfort wearing shoes.

Diagnosis

The diagnosis of onychomycosis can be confirmed by potassium hydroxide preparation, culture or histology.

Treatment

Treatments for onychomycosis include topical antifungals such as nail paints containing ciclopirox (ciclopiroxolamine), efinaconazole, tavaborole, or amorolfine(not available in the US) and oral antifungals such as terbinafine and itraconazole. These have low-to-moderate efficacy and a high relapse rate. Topical antifungals and some long-available oral medications (e.g., 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 the 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 1 or several sessions and, thus, require less long-term patient compliance.

Laser treatment of onychomycosis uses the principle of selective photothermolysis, defined as the precise targeting of 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 for onychomycosis is to heat the nail bed to temperatures required to disrupt fungal growth (approximately 40°-60°C) and at the same time avoid pain and necrosis to surrounding tissues.

Characteristics of laser systems used to treat onychomycosis are listed in Table 1.

Table 1. Characteristics of Lasers for Treating Onychomycosis

KEY POINTS:

The most recent update with literature review covered the period through October 18, 2023.

Summary of Evidence

For individuals who have onychomycosis who receive treatment with laser therapy, the evidence includes randomized controlled trials (RCTs). Relevant outcomes are symptoms, change in disease status, medication use, and treatment-related morbidity. The RCTs 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. Additionally, some registered clinical trials are completed without publication of results, indicating potential publication bias. Additional well-designed, adequately powered, and well-conducted RCTs are needed. The evidence is insufficient to determine that the technology results in an improvement in the net health outcomes.

Practice Guidelines and Position Statements

No Practice Guidelines or Position Statements regarding issued by, or jointly by, a US professional society, an international society with US representation, or National Institute for Health and Care Excellence (NICE) were identified.

U.S. Preventive Services Task Force Recommendations

Not applicable.

KEY WORDS:

• Onychomycosis, laser treatment, laser therapy, nail fungus, PinPointe™ FootLaser®, GenesisPlus™, VARIABreeze™, GentleMax Family of Laser Systems, Nordlys, Q-Clear™, JOULE ClearSense™, Cutera®, excel V™, excel HR™, xeo®, enlighten™, truSculpt, CO2RE®, CO2RE® Intima, Exceed™, eTwo®, Frax Pro®, Gentle Pro™Series, Matrix™, Nordlys™, Profound®, PicoWay®, Vbeam Prima®, Vbeam Perfecta®, Sirius™, Noveon®Toenail Laser.

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
• JOULE ClearSense™ (Sciton): 2011
• GentleMax Family of Laser Systems (Candela): 2014
• Nordlys (Ellipse A/S): 2016

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

• Q-Clear™ (Light Age, Inc.): 2011

BENEFIT APPLICATION:

Coverage is subject to the 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 the member’s benefit plan.

CURRENT CODING:

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

REFERENCES:

1. Boyko, 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.
2. Bristow IR. The effectiveness of lasers in the treatment of onychomycosis: a systematic review. J Foot Ankle Res. 2014; 7:34.
3. Bunyaratavej, et al. Randomized controlled trial comparing long-pulsed 1064-Nm neodymium: Yttrium-aluminum-garnet laser alone, topical amorolfine nail lacquer alone, and a combination for nondermatophyte onychomycosis treatment. J Cosmet Dermatol. Sep 2020; 19(9): 2333-2338.
4. Drake, 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. 2015 Oct;26(5):461-464.
6. Elewski BE. Onychomycosis. Treatment, quality of life, and economic issues. Am J Clin Dermatol. 2000 Jan-Feb;1(1):19-26.
7. Gupta A, Simpson F. Device-based therapies for onychomycosis treatment. Skin Therapy Lett. Oct 2012; 17(9):4-9.
8. Hamed Khater M, Khattab FM. Combined long-pulsed Nd-Yag laser and itraconazole versus itraconazole alone in the treatment of onychomycosis nails. J Dermatolog Treat. Jun 2020; 31(4): 406-409.
9. IOM (Institute of Medicine). 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press.
10. Karsai, 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.
11. Kim, et al. A randomised comparative study of 1064 nm Neodymium-doped yttrium aluminium garnet (Nd:YAG) laser and topical antifungal treatment of onychomycosis. Mycoses. Dec 2016; 59 (12):803-810.
12. Nasif GA, Amin AA, Ragaie MH. Q-switched Nd:YAG laser versus itraconazole pulse therapy in treatment of onychomycosis: A clinical dermoscopic and mycologic study. J Cosmet Dermatol. Jun 2023; 22(6): 1757-1763.
13. Nijenhuis, et al. Laser therapy for onychomycosis in patients with diabetes at risk for foot ulcers: a randomized, quadruple-blind, sham-controlled trial (LASER-1). J Eur Acad Dermatol Venereol. Nov 2019; 33(11): 2143-2150.
14. Rodgers P, Bassler M. Treating onychomycosis. Am Fam Physician. 2001; 63(4): 663-673.
15. Sabbah, et al. A Randomized, Double-Blind, Controlled Trial Evaluating the Efficacy of Nd:YAG 1064 nm Short-Pulse Laser Compared With Placebo in the Treatment of Toenail Onychomycosis. J Cutan Med Surg. Sep/Oct 2019; 23(5): 507-512.
16. Xu, 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): 1201-7.

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.

Medical Policy Panel, December 2020

Medical Policy Group, January 2021 (5): Updates to Description, Key Points, and References. No change to Policy Statement.

Medical Policy Panel, December 2021

Medical Policy Group, December 2021 (5): Updates to Description, Key Points, Key Words, Practice Guidelines and Position Statements, Approved by Governing Bodies, and References. Policy Statement updated to remove “not medically necessary,” no change to policy intent.

Medical Policy Panel, December 2022

Medical Policy Group, December 2022 (5): Updates to Description, Key Points, Practice Guidelines and Position Statements, and References. No change to Policy Statement.

Medical Policy Panel, December 2023

Medical Policy Group, January 2024 (9): Updates to Key Points, Key Words, Benefit Application and References. 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.