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Carbon Dioxide for Actinic

Lesions and Other Selected Indications AHM

Clinical Indications

(CO2) laser treatments are considered medically necessary for 1 or more of the following o Removal of superficial basal cell carcinomas of the skin o Removal of actinic keratoses for members who failed to adequately respond to topical imiquimod or 5-FU, or to cryosurgery • Current role remains uncertain. Based on review of existing evidence, there are currently no clinical indications for this technology. See Inappropriate Uses for more detailed analysis of the evidence base. The following treatments are considered cosmetic: CO2 laser treatments of other actinic lesions. CO2 is considered investigational for hidradenitis suppurativa scarring and onychomycosis because its effectiveness for these indications has not been established.

Evidence Summary

The CO2 laser is effective in removing actinic keratoses and superficial basal cell carcinomas

of the skin. Use of the CO2 laser to treat non-precancerous actinic lesions, such as skin wrinkling, is considered cosmetic, and thus subject to the standard contractual exclusion of coverage for cosmetic procedures.

A recent review on laser and photodynamic therapy for the treatment of non-melanoma skin cancer (Marmur et al, 2004) stated that at this time, because the reported recurrence rates are significantly higher than those achieved with standard therapies, laser and photodynamic therapy should be reserved for only those patients who can not undergo surgical therapy for basal cell carcinoma and squamous cell carcinoma.

Iyer et al (2004) evaluated the effectiveness of full face laser resurfacing (UPCO2 and/or Er:Yag laser) in reducing the number of facial actinic keratoses by comparing pre-operative and post-operative numbers of lesions present and to observe the incidence of non-melanoma skin cancer after full face laser resurfacing (n = 24). These investigators concluded that full face laser resurfacing provides long-term effective prophylaxis against actinic keratoses and

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may reduce the incidence of actinic keratoses-related squamous cell carcinoma. The findings of this study need to be validated by well-designed trials with long-term follow-up.

Krakowski et al (2014) noted that hidradenitis suppurativa (HS) is a chronic, relapsing, inflammatory skin condition that can have a significant psychosocial impact, both with the active disease and with residual scarring. Although a wide variety of treatment options exist for HS, to the authors’ knowledge there are no reported modalities aimed specifically at treating HS scarring. These researchers described the case of an adolescent female who received medical management of intra-mammary HS followed by successful treatment with fractionated 10,600-nm CO2 laser for her residual cribriform scarring. The authors believed there is great potential for the use of fractionated CO2 laser to improve short- and long-term psychosocial outcomes of HS, promote physical remodeling, and possibly alter the disease process itself.

In a systematic review, Ledon et al (2014) stated that onychomycosis is a prevalent and extremely difficult condition to treat. In older and diabetic populations, severe onychomycosis may possibly serve as a nidus for infection, and other more serious complications may ensue. Many treatment modalities for the treatment of onychomycosis have been studied, including topical lacquers and ointments, oral anti-fungals, surgical and chemical nail avulsion, and . Due to their minimally invasive nature and potential to restore clear nail growth with relatively few sessions, lasers have become a popular option in the treatment of onychomycosis for both physicians and patients. Laser or light systems that have been investigated for this indication include the CO2, neodymium-doped yttrium aluminum garnet, 870/930-nm combination, and femtosecond 800-nm lasers, in addition to photodynamic and ultraviolet light therapy.

Furthermore, an UpToDate review on “Onychomycosis” (Goldstein, 2014) states that “Although neodymium-doped:yttrium aluminum garnet (Nd:YAG) and diode lasers have emerged as treatment options for onychomycosis, data on the efficacy of these interventions are limited and the mechanisms of action and optimal regimens for these treatments remain unclear. Until more robust data supporting the efficacy of laser therapy for onychomycosis is available, we cannot recommend the routine use of this modality”.

In a Cochrane review, Kaushik et al (2014) evaluated the safety and effectiveness of surgical interventions in women with high-grade vulval intraepithelial neoplasia (VIN). These investigators searched the Cochrane Gynaecological Cancer Group Trials Register and the Cochrane Central Register of Controlled Trials (CENTRAL) Issue 11, 2013 and MEDLINE and EMBASE up to December 2013. They also searched registers of clinical trials, abstracts of scientific meetings and reference lists of included studies, and contacted experts in the field. Randomized controlled trials (RCTs) that compared surgical interventions in adult women diagnosed with high-grade VIN were selected for analysis. Two review authors independently abstracted data and assessed risk of bias. They identified 1 RCT (n = 30) that

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met the inclusion criteria; this trial reported data on CO2 laser surgery versus cavitational ultrasonic surgical aspiration (CUSA). There were no statistically significant differences in the risks of disease recurrence after 1 year of follow-up, pain, scarring, dysuria or burning, adhesions, infection, abnormal discharge or eschar between women who underwent CO2 laser surgery and those who received CUSA. The trial lacked statistical power due to the small number of women in each group and the low number of observed events, but was at low risk of bias. The authors concluded that the included trial lacked statistical power due to the small number of women in each group and the low number of observed events. The absence of reliable evidence regarding the safety and effectiveness of the 2 surgical techniques (CO2 laser surgery and CUSA) for the management of VIN therefore precluded any definitive guidance or recommendations for clinical practice.

References:

1. Schwartz RA, Stoll HL. Epithelial precancerous lesions. In: Dermatology in General Medicine. 4th ed. TB Fitzpatrick, AZ Eisen, K Wolff, et al., eds. New York, NY: McGraw-Hill, Inc.; 1993. 2. Wheeland RG. Clinical uses of lasers in dermatology. Lasers Surg Med. 1995;16(1):2-23. 3. FDC Reports, Inc. Laser Industries gets FDA okay for wrinkle treatment indication. MDDI Reports. 1996 May 6: I&W-3 - I&W-4. 4. Stanley RJ, Roenigk PK. Actinic chelitis. Treatment with the carbon dioxide laser. Mayo Clinic Proc. 1988;63(3):230-235. 5. Robinson RK. Actinic cheilitis: A prospective study comparing four treatment methods. Arch Otolaryngol Head Neck Surg. 1989;115:848-852. 6. Rubach BW, Schoenrock LD. Histological and clinical evaluation of facial resurfacing using a carbon dioxide laser with the computer pattern generator. Arch Otolaryngol Head Neck Surg. 1997;123(9):929-934. 7. Bernstein LJ, Kauvar AN, Grossman MC, et al. The short- and long-term side effects of carbon dioxide laser resurfacing. Dermatol Surg. 1997;23(7):519-525. 8. Roenigk HH. The place of laser resurfacing within the range of medical and surgical skin resurfacing techniques. Semin Cutan Med Surg. 1996;15(3):208-213. 9. Ragland HP, McBurney E. Complications of resurfacing. Semin Cutan Med Surg. 1996;15(3):200-207. 10. Coleman WP, Narins RS. Combining surgical methods for skin resurfacing. Semin Cutan Med Surg. 1996;15(3):194-199. 11. Goodman GJ. Facial resurfacing using a high-energy, short-pulse carbon dioxide laser. Australas J Dermatol. 1996;37(3):125-131. 12. Fulton JE. Dermabrasion, chemabrasion, and laserabrasion. Historical perspectives, modern dermabrasion techniques, and future trends. Dermatol Surg. 1996;22(7):619-628. 13. Hruza GJ, Dover JS. Laser skin resurfacing. Arch Dermatol. 1996;132(4):451-455. 14. Lawrence N. New and emerging treatments for photoaging. Dermatol Clin. 2000;18(1):99-112.

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15. Biesman BS. Carbon dioxide laser skin resurfacing. Semin Ophthalmol. 1998;13(3):123- 135. 16. Karrer S, Szeimies RM, Hohenleutner U, et al. Role of lasers and photodynamic therapy in the treatment of cutaneous malignancy. Am J Clin Dermatol. 2001;2(4):229-237. 17. Dover JS, Arndt KA, Dinehart SM, et al. Guidelines of care for laser surgery. American Academy of Dermatology. Guidelines/Outcomes Committee. J Am Acad Dermatol. 1999;41(3 Pt 1):484-495. 18. Marmur ES, Schmults CD, Goldberg DJ. A review of laser and photodynamic therapy for the treatment of nonmelanoma skin cancer. Dermatol Surg. 2004;30(2 Pt 2):264-271. 19. Iyer S, Friedli A, Bowes L, et al. Full face laser resurfacing: Therapy and prophylaxis for actinic keratoses and non-melanoma skin cancer. Lasers Surg Med. 2004;34(2):114-119. 20. Helfand M, Gorman AK, Mahon S, et al. Actinic keratoses. Final Report. Submitted to the Agency for Healthcare Research and Quality (AHRQ) under contract 290-97-0018, task order no. 6. Oregon Health & Science University Evidence-based Practice Center, Portland, OR. Rockville, MD: AHRQ; May 19, 2001. 21. Gupta AK, Inniss K, Wainwright R, et al. Interventions for actinic keratoses (Protocol for Cochrane Review). Cochrane Database Syst Rev. 2003;(4):CD004415. 22. Ostertag JU, Quaedvlieg PJ, Neumann MH, Krekels GA. Recurrence rates and long-term follow-up after laser resurfacing as a treatment for widespread actinic keratoses on the face and scalp. Dermatol Surg. 2006;32(2):261-267. 23. Sherry SD, Miles BA, Finn RA. Long-term efficacy of carbon dioxide laser resurfacing for facial actinic keratosis. J Oral Maxillofac Surg. 2007;65(6):1135-1139. 24. Manriquez J, Grinberg DM, Diaz CN. Wrinkles (updated). In: BMJ Clinical Evidence. London, UK: BMJ Publishing Group; April 2008. 25. Samuel M, Brooke RCC, Hollis S, Griffiths CEM. Interventions for photodamaged skin. Cochrane Database Syst Rev. 2005;(1):CD001782. 26. Krupashankar DS; IADVL Dermatosurgery Task Force. Standard guidelines of care: CO2 laser for removal of benign skin lesions and resurfacing. Indian J Dermatol Venereol Leprol. 2008;74 Suppl:S61-S67. 27. Castineiras I, Del Pozo J, Mazaira M, et al. Actinic cheilitis: Evolution to squamous cell carcinoma after carbon dioxide laser vaporization. A study of 43 cases. J Dermatolog Treat. 2010; 21(1):49-53. 28. Togsverd-Bo K, Haak CS, Thaysen-Petersen D, et al. Intensified photodynamic therapy of actinic keratoses with fractional CO2 laser: A randomized clinical trial. Br J Dermatol. 2012;166(6):1262-1269. 29. Krakowski AC, Admani S, Uebelhoer NS, et al. Residual scarring from hidradenitis suppurativa: Fractionated CO2 laser as a novel and noninvasive approach. Pediatrics. 2014;133(1):e248-e251. 30. 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. 31. Goldstein AO. Onychomycosis. Last reviewed March 2014. UpToDate Inc., Waltham, MA. 32. Kaushik S, Pepas L, Nordin A, et al. Surgical interventions for high-grade vulval intraepithelial neoplasia. Cochrane Database Syst Rev. 2014;3:CD007928.

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Reviewed by a Board Certified Internist Reviewed by David Evans, MD, Medical Director, Active Health Management- July 2016 Copyright 2016 ACTIVEHEALTH MANAGEMENT No part of this document may be reproduced without permission.

Codes

17000 17003 17004 17260 17261 17263 17264 17266 17270 17271 17272 17273 17274 17276 17280 17281 17282 17283 17284 17286

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