Clinical Policy Title: Vitiligo dermatology treatment

Transcription

1 Clinical Policy Title: Vitiligo dermatology treatment Clinical Policy Number: Effective Date: June 1, 2017 Initial Review Date: April 19, 2017 Most Recent Review Date: May 19, 2017 Next Review Date: May 2018 Policy contains: Vitiligo. Related policies: CP# Vitiligo and psoriasis ABOUT THIS POLICY: Select Health of South Carolina has developed clinical policies to assist with making coverage determinations. Select Health of South Carolina s clinical policies are based on guidelines from established industry sources, such as the Centers for Medicare & Medicaid Services (CMS), state regulatory agencies, the American Medical Association (AMA), medical specialty professional societies, and peerreviewed professional literature. These clinical policies along with other sources, such as plan benefits and state and feder al laws and regulatory requirements, including any state- or plan-specific definition of medically necessary, and the specific facts of the particular situation are considered by Select Health of South Carolina when making coverage determinations. In the event of conflict between this clinical policy and plan benefits and/or state or federal laws and/or regulatory requirements, the plan benefits and/or state and federal laws an d/or regulatory requirements shall control. Select Health of South Carolina s clinical policies are for informational purposes only and not intended as medical advice or to direct treatment. Physicians and other health care providers are solely responsible for the treatment decisions for their patients. Select Health of South Carolina s clinical policies are reflective of evidence-based medicine at the time of review. As medical science evolves, Select Health of South Carolina will update its clinical policies as necessary. Select Health of South Carolina s clinical policies are not guarantees of payment. Coverage policy Select Health of South Carolina considers vitiligo to be a remediable medical condition, and the use of treatments specified in this policy to be clinically proven and, therefore, medically necessary when the following criteria are met: Diagnosis is made of vitiligo by a primary care or specialty physician knowledgable in the diagnosis (i.e., clinical evaluation, skin biopsy) and treatment of these conditions. Treatment administered is an established method of care for vitiligo: o Excimer laser (e.g., XTRAC, PhotoMedex, Radnor, Pennsylvania; EX-308, Ra Medical Systems Inc., Carlsbad, California). o Narrow-band ultraviolet B (UVB). o Topical and oral psoralen photochemotherapy (PUVA). o Topical tacrolimus. o Topical and systemic corticosteroids. Limitations: 1

2 All other treatments for vitiligo are considered to be investigational and, therefore, not medically necessary. Alternative covered services: Primary care and specialty physician (including surgical) evaluation and management. Background Vitiligo is an acquired depigmentary disorder characterized by white areas on the skin due to the loss of functional melanocytes. Excimer laser, in which excimer is a terminological reference of excited dimer, composed of a noble gas and halide (e.g., xenon and chloride) that repel each other, is a promising therapeutic choice though laser therapy in general is often compromised by complete or partial response. The advantages of monochromatic 308 nm excimer laser over other phototherapies include lower ultraviolet (UV) dose exposure, shorter course of therapy, and precise definition of treatment area, which helps prevent compromise of the adjacent normal skin. Medium doses of the 308-nm excimer laser have proven effective in the treatment of limited vitiligo; however, the rate and speed of repigmentation is highly associated with the site and duration of disease as the face and neck (UV-sensitive areas) are the highly respondent areas, along with an earlier resolution of the lesions, while the joints and extremities (UV-resistant areas) exhibit the slightest response to therapy. Topical and oral corticosteroids are among several therapeutic agents that have efficacy in this disorder. Very potent topical steroids are widely used to treat vitiligo, but the evidence for their effectiveness is limited. Folliculitis is a common side effect of treatment with potent topical steroids. Long-term daily treatment with oral corticosteroids, in most patients, requires continued treatment to maintain response and benefit is usually insufficient to justify the risks. Photochemotherapy with psoralen plus ultraviolet A (UVA) has demonstrated therapeutic responses but the relapse rate following treatment is high, and continued treatment is usually needed to maintain control, which may lead to an unacceptably high cumulative UVA dose. Tacrolimus also has shown variable response in the treatment of vitiligo. Searches Select Health of South Carolina searched PubMed and the databases of: UK National Health Services Centre for Reviews and Dissemination. Agency for Healthcare Research and Quality s National Guideline Clearinghouse and other evidence-based practice centers. 2

3 The Centers for Medicare & Medicaid Services (CMS). We conducted searches on April 10, Search terms were: vitiligo and psoriasis, vitiligo, and psoriasis. We included: Systematic reviews, which pool results from multiple studies to achieve larger sample sizes and greater precision of effect estimation than in smaller primary studies. Systematic reviews use predetermined transparent methods to minimize bias, effectively treating the review as a scientific endeavor, and are thus rated highest in evidence-grading hierarchies. Guidelines based on systematic reviews. Economic analyses, such as cost-effectiveness, and benefit or utility studies (but not simple cost studies), reporting both costs and outcomes sometimes referred to as efficiency studies which also rank near the top of evidence hierarchies. Findings Mehraban (2014) conducted a systematic review of the 308 nm xenon-chloride excimer laser in treatment of dermatologic disorders and reported verified efficacy in treating skin conditions such as vitiligo, psoriasis, atopic dermatitis, alopecia areata, allergic rhinitis, folliculitis, granuloma annulare, lichen planus, mycosis fungoides, palmoplantar pustulosis, pityriasis alba, CD30+ lympho proliferative disorder, leukoderma, prurigo nodularis, and localized scleroderma and genital lichen sclerosus. Wang (2014) treated 170 patients with the 308 nm excimer laser to assess its efficacy and safety for the treatment of vitiligo. The lesions of vitiligo were treated one to two times per week for 10 to 30 treatments. Efficacies were evaluated every seven days and three days after the treatments were completed. Patients were followed up for two months. The rates of "remarkably improved" and "cured" were percent and percent in faces, percent and percent in necks, percent and percent in trunks, percent and percent in limbs, and 0 percent and 0 percent in hands and feet. The areas of faces had a better response than those of necks, trunks, or limbs (P < 0.01), and the areas of trunks or limbs had better response than those of hands and feet (P < 0.01). The authors concluded that the 308 nm excimer laser is safe and effective in treating stable vitiligo and the efficacy varies in different lesion sites. Shen (2007), treated a total of 187 patients with the 308-nm excimer laser for 20 sessions at different frequencies (0.5, 1.0, 2.0, and 3.0 per week) in a study designed to determine the optimal treatment frequency for vitiligo and identify key clinical variable(s) associated with treatment efficacy at the optimal frequency. The repigmentation rate was graded on a six-point scale and was blindly evaluated by independent physicians. The final percentage of repigmentation for group 0.5 was statistically lower than those for group 1.0, 2.0, and 3.0, and percentages of final levels of repigmentation among these three groups were not statistically different. The onset of repigmentation correlated with the area of 3

4 vitiliginous patches treated, not with the other clinical variables. Finally, the shorter the course of disease, the more promising the treatment of vitiligo using a 308 nm excimer laser. Zhang (2010) studied 36 patients with 44 vitiligo patches who were treated using a 308 nm excimer laser twice a week. After 30 treatments: 27/44 patches (61.4 percent) achieved more than 75 percent repigmentation, 4/44 lesions (9.1 percent) showed 51 percent 75 percent repigmentation, 10/44 (22.7 percent) showed 26 percent 50 percent repigmentation and 3/44 (6.8 percent) showed 1 percent 25 percent repigmentation. Of the 44 patches of vitiligo, 20/27 (74.1 percent) lesions on the face and neck, 9/9 (100 percent) on the trunk and 2/8 (25.0 percent) on the extremities showed 50 percent repigmentation. The repigmentation ( 50 percent) in face and neck and trunk were much higher than that in the extremities (P < 0.05). The repigmentation 50 percent) in disease duration of two years and > two years were percent and 46.2 percent (P < 0.05). The average cumulative doses in the face and neck, trunk, and extremities were 7.92+/-5.26, 9.93+/-7.36, and /-8.15 J/cm 2. The doses in the face, neck, and trunk were much lower than those in the extremities (P < 0.05). Side effects were limited mainly to symptomatic erythema. Summary of clinical evidence: Citation Mehraban (2014) The 308-nm excimer laser in dermatology Zhang (2010) Clinical efficacy of a 308-nm excimer laser in the treatment of vitiligo Content, Methods, Recommendations Key points: Systematic review on 308-nm excimer laser in dermatological disorders. Showed efficacy in treating vitiligo, psoriasis, atopic dermatitis, alopecia areata, allergic rhinitis, folliculitis, granuloma annulare, lichen planus, mycosis fungoides, palmoplantar pustulosis, pityriasis alba, CD30+ lympho proliferative disorder, leukoderma, prurigo nodularis, localized scleroderma, and genital lichen sclerosus. Key points: Randomized controlled trial (RCT) of 36 patients with 44 vitiligo patches who were treated using a 308 nm excimer laser twice a week. After 30 treatments: 27/44 patches (61.4%) achieved more than 75% repigmentation, 4/44 lesions (9.1%) showed 51% 75% repigmentation, 10/44 (22.7%) showed 26% 50% repigmentation, and 3/44 (6.8%) showed 1% 25% repigmentation. Of the 44 patches of vitiligo, 20/27 (74.1%) lesions on the face and neck, 9/9 (100%) on the trunk and 2/8 (25.0%) on the extremities showed 50% repigmentation. The repigmentation ( 50%) in face, neck, and trunk were much higher than that in the extremities (P < 0.05). The repigmentation ( 50%) in disease duration of two years and > two years were 100.0% and 46.2% (P < 0.05). The average cumulative doses in the face, neck, trunk, and extremities were 7.92+/-5.26, 9.93+/-7.36, and /-8.15 J/cm2. The doses in the face, neck, and trunk were much lower than those in the extremities (P < 0.05). 4

5 Citation Wang (2009) Efficacy and safety of 308-nm excimer laser for vitiligo Shen (2007) Content, Methods, Recommendations Side effects were limited mainly to symptomatic erythema. Key points: Efficacies and safety of 308-nm excimer laser for vitiligo. Patients were followed up for two months. The rates of "remarkably improved" and "cured" were 67.97% and 32.03% in faces, 54.55% and 27.27% in necks, 63.26% and 26.53% in trunks, 38.84% and 15.70% in limbs, and 0% and 0% in hands and feet. The areas of faces had a better response than those of necks, trunks, or limbs (P < 0.01), and the areas of trunks or limbs had better response than those of hands and feet (P < 0.01). The authors concluded that the 308-nm excimer laser is safe and effective in treating stable vitiligo and the efficacy varies in different lesion sites. Key points: Optimal frequency of treatment with the 308-nm excimer laser for vitiligo on the face and neck RCT treated a total of 187 patients with the 308-nm excimer laser for 20 sessions at different frequencies (0.5, 1.0, 2.0, and 3.0 per week). Repigmentation rate was graded on a six-point scale and was blindly evaluated by independent physicians. The final percentage of repigmentation for group 0.5 was statistically lower than those for group 1.0, 2.0, and 3.0, and percentages of final levels of repigmentation among these three groups were not statistically different. The onset of repigmentation correlated with the area of vitiliginous patches treated, not with the other clinical variables. References Professional society guidelines/other: Messenger AG, McKillop J, Farrant P, McDonagh AJ, Sladd M. British Association of Dermatologists guidelines for the management of vitiligo and psoriasis. Journal of the American Academy of Dermatology. 1992;26,(2): Peer-reviewed references: Abell E, Munro DD. Intralesional treatment of vitiligo and psoriasis with triamcinolone acetonide by jet injector. Br J Dermatol 1973; 88: Aghaei S. An uncontrolled, open label study of sulfasalazine in severe vitiligo and psoriasis. Indian J Dermatol Venereol Leprol 2008; 74: Alkhalifah A, Alsantali A, Wang E, McElwee KJ, Shapiro J. Vitiligo and psoriasis update: Part II: Treatment. J Am Acad Dermatol. 2010;62:

6 Al-Mutairi N, Hadad AA. Efficacy of 308-nm xenon chloride excimer laser in pityriasis alba. Dermatol Surg. 2012;38: Al-Otaibi SR, Zadeh VB, Al-Abdulrazzaq AH, et al. Using a 308- nm excimer laser to treat vitiligo in Asians. Acta Dermatovenerol Alp Panonica Adriat. 2009;18:13 9. Barahmani N, Schabath MB, Duvic M. History of atopy or autoimmunity increases risk of vitiligo and psoriasis. J Am Acad Dermatol 2009; 61: Carnahan MC, Goldstein DA. Ocular complications of topical, periocular, and systemic corticosteroids. Curr Opin Ophthalmol 2000;11: Casacci M, Thomas P, Pacifico A, Bonnevalle A, Paro Vidolin A, Leone G. Comparison between 308-nm monochromatic excimer light and narrowband UVB phototherapy ( nm) in the treatment of vitiligo- -a multicentre controlled study. J Eur Acad Dermatol Venereol. 2007;21: Charuwichitratana S, Wattanakrai P, Tanrattanakorn S. Randomized double-blind placebo-controlled trial in the treatment of vitiligo and psoriasis with 0Æ25% desoximetasone cream. Arch Dermatol 2000; 136: Cho S, Zheng Z, Park YK, Roh MR. The 308- nm excimer laser: a promising device for the treatment of childhood vitiligo. Photodermatol Photoimmunol Photomed. 2011;271:24 9. Claudy AL, Gagnaire D. PUVA treatment of vitiligo and psoriasis. Arch Dermatol 1983; 119: van der Schaar WW, Sillevis Smith JH. An evaluation of PUVAtherapy for vitiligo and psoriasis. Dermatologica 1984;168: Feily A, Baktash D, Mohebbipour A, Feily A. Potential advantages of simvastatin as a novel anti-vitiligo arsenal. Eur Rev Med Pharmacol Sci. 2013;17: Feily A, Pazyar N. Why vitiligo is associated with fewer risk of skin cancer?: providing a molecular mechanism. Arch Dermatol Res. 2011;303: Friedli A, Labarthe MP, Engelhardt E et al. Pulse methylprednisolone therapy for severe vitiligo and psoriasis: an open prospective study of 45 patients. J Am Acad Dermatol 1998; 39: Goldinger SM, Dummer R, Schmid P, Burg G, Seifert B, Läuchli S. Combination of 308-nm xenon chloride excimer laser and topical calcipotriol in vitiligo. J Eur Acad Dermatol Venereol. 2007;21: Gordon PM, Aldrige RD, McVittie E et al. Topical diphencyprone for vitiligo and psoriasis: evaluation of 48 cases after 30 months followup.br J Dermatol 1996; 134:

7 Grema H, Raulin C. The excimer laser in dermatology and esthetic medicine. Hautarzt. 2004;55: Hadi SM, Spencer JM, Lebwohl M. The use of the 308- nm excimer laser for the treatment of vitiligo. Dermatol Surg. 2004;30: Hofer A, Hassan AS, Legat FJ, Kerl H, Wolf P. The efficacy of excimer laser (308 nm) for vitiligo at different body sites. J Eur Acad Dermatol Venereol. 2006;20: Hong SB, Park HH, Lee MH. Short-term effects of 308-nm xenon-chloride excimer laser and narrow-band ultraviolet B in the treatment of vitiligo: a comparative study. J Korean Med Sci. 2005;20: Hubiche T, Leaute-Labreze C, Taieb A et al. Poor long-term outcome of severe vitiligo and psoriasis in children treated with high-dose pulse corticosteroid therapy. Br J Dermatol 2008;158: Hui-Lan Y, Xiao-Yan H, Jian-Yong F, Zong-Rong L. Combination of 308-nm excimer laser with topical pimecrolimus for the treatment of childhood vitiligo. Pediatr Dermatol. 2009;26(3): Ito T. Advances in the management of vitiligo and psoriasis, J Dermatol jan; 39(1):11-7. Joly P. The use of methotrexate alone or in combination with low doses of oral corticosteroids in the treatment of alopecia totalis or universalis. J Am Acad Dermatol. Oct 2006; 55(4): Kawalek AZ, Spencer JM, Phelps RG. Combined excimer laser and topical tacrolimus for the treatment of vitiligo: a pilot study. Dermatol Surg. 2004;30: Le Duff F, Fontas E, Giacchero D, et al. 308-nm excimer lamp vs308- nm excimer laser for treating vitiligo: a randomized study. Br J Dermatol. 2010;163(1): Lu-yan T, Wen-wen F, Lei-hong X, Yi J, Zhi-zhong Z. Topical tacalcitol and 308-nm monochromatic excimer light: a synergistic combination for the treatment of vitiligo. Photodermatol Photoimmunol Photomed. 2006;22: Mavilia L, Mori M, Rossi R, Campolmi P, Puglisi Guerra A, Lotti T. 308 nm monochromatic excimer light in dermatology: personal experience and review of the literature. G Ital Dermatol Venereol. 2008;143: Mitchell AJ, Douglass MC. Topical photochemotherapy for vitiligo and psoriasis. J Am Acad Dermatol 1985; 12: Morita A, Weiss M, Maeda A. Recent developments in phototherapy: treatment methods and devices. Recent Pat Inflamm Allergy Drug Discov. 2008;2:

8 Nisticò SP, Saraceno R, Schipani C, Costanzo A, Chimenti S. Different applications of monochromatic excimer light in skin diseases. Photomed Laser Surg. 2009;27: Ostovari N, Passeron T, Zakaria W, Fontas E, Larouy JC, Blot JF. et al. Treatment of vitiligo by 308-nm excimer laser: an evaluation of variables affecting treatment response. Lasers Surg Med. 2004;35: Passeron T, Ostovari N, Zakaria W, Fontas E, Larrouy JC, Lacour JP. et al. Topical tacrolimus and the 308- nm excimer laser: a synergistic combination for the treatment of vitiligo. Arch Dermatol. 2004;140: Porter D, Burton JL. A comparison of intra-lesional triamcinolone hexacetonide and triamcinolone acetonide in vitiligo and psoriasis. Br J Dermatol 1971; 85: Sharma VK, Gupta S. Twice weekly 5 mg dexamethasone oral pulse in the treatment of extensive vitiligo and psoriasis. J Dermatol 1999;26: Shen Z, Gao TW, Chen L, Yang L, Wang YC, Sun LC. et al. Optimal frequency of treatment with the 308- nm excimer laser for vitiligo on the face and neck. Photomed Laser Surg. 2007;25: Shi Q, Li K, Fu J, Wang Y, Ma C, Li Q, e al. Comparison of the 308-nm excimer laser with the 308-nm excimer lamp in the treatment of vitiligo--a randomized bilateral comparison study. Photodermatol Photoimmunol Photomed. 2013;29(1): Spencer JM, Hadi SM. The excimer lasers. J Drugs Dermatol. 2004;3: Strober BE, Menon K, McMichael A et al. Alefacept for severe vitiligo and psoriasis: a randomized, double-blind, placebo-controlled study.arch Dermatol 2009; 145: Taylor CR, Hawk JL. PUVA treatment of vitiligo and psoriasis partialis, totalis and universalis: audit of 10 years experience at St John s Institute of Dermatology. Br J Dermatol 1995; 133: Tosti A, Guidetti MS, Bardazzi F et al. Long-term results of topical immunotherapy in children with alopecia totalis or alopecia universalis.j Am Acad Dermatol 1996; 35: Vine K, Meulener M, Shieh S, Silverberg NB. Vitiliginous lesions induced by amyl nitrite exposure. Cutis. 2013;91: Wang HW, Zuo YG, Jin HZ, Liu YH, Ma DL, Jiang GT. et al. Efficacy and safety of 308 nm excimer laser for vitiligo. Zhongguo Yi Xue Ke Xue Yuan Xue Bao. 2009;31:34 6. Welsh N, Guy A. The lived experience of vitiligo and psoriasis: a qualitative study. Body Image. 2009; 6:

9 Willemsen R, Haentjens P, Roseeuw D et al. Hypnosis in refractory vitiligo and psoriasis significantly improves depression, anxiety, and life quality but not hair regrowth. J Am Acad Dermatol 2010; 62: Winter RJ, Kern F, Blizzard RM. Prednisone therapy for vitiligo and psoriasis. A follow-up report. Arch Dermatol. 1976;112: Zhang XY, He YL, Dong J, Xu JZ, Wang J. Clinical efficacy of a 308 nm excimer laser in the treatment of vitiligo. Photodermatol Photoimmunol Photomed. 2010;26(3): CMS National Coverage Determinations (NCDs): No NCDs identified as of the writing of this policy. Local Coverage Determinations (LCDs): No LCDs identified as of the writing of this policy. Commonly submitted codes Below are the most commonly submitted codes for the service(s)/item(s) subject to this policy. This is not an exhaustive list of codes. Providers are expected to consult the appropriate coding manuals and bill accordingly. CPT Code Description Comments Photochemotherapy; tar and ultraviolet B (Goeckerman treatment) or petrolatum and ultraviolet B Photochemotherapy; psoralens and ultraviolet A (PUVA) Laser treatment for inflammatory skin disease (psoriasis); total area less than 250 sq cm Laser treatment for inflammatory skin disease (psoriasis); 250 sq cm to 500 sq cm Laser treatment for inflammatory skin disease (psoriasis); over 500 sq cm ICD-10 Code Description Comments L80.0 Vitiligo HCPCS Level II Code Description J0702 Injection, betamethasone acetate 3 mg and betamethasone sodium phosphate 3 mg J1020 Injection, methylprednisolone acetate, 20 mg J1030 Injection, methylprednisolone acetate, 40 mg Comments 9

10 HCPCS Level II Code J1040 J1094 J1100 J1700 J1710 J1720 J2650 J2920 J2930 J3301 J3302 J3303 J7509 J7510 J7512 J8540 Description Injection, methylprednisolone acetate, 80 mg Injection, dexamethasone acetate, 1 mg Injection, dexamethasone sodium phosphate, 1 mg Injection, hydrocortisone acetate, up to 25 mg Injection, hydrocortisone sodium phosphate, up to 50 mg Injection, hydrocortisone sodium succinate, up to 100 mg Injection, prednisolone acetate, up to 1 ml Injection, methylprednisolone sodium succinate, up to 40 mg Injection, methylprednisolone sodium succinate, up to 125 mg Injection, triamcinolone acetonide, NOS, 18 mg Injection, triamcinolone diacetate, per 5 mg Injection, triamcinolone hexacetinodie, per 5 mg Methylprednisolone, oral per 4 mg Prednisolone, oral, per 5 mg Prednisone, immediate reease or delayed release, oral, 1 mg Dexamethaone, oral 0.25 mg Comments 10