Clinical Policy Title: Vitiligo and psoriasis

Transcription

1 Clinical Policy Title: Vitiligo and psoriasis Clinical Policy Number: Effective Date: October 1, 2017 Initial Review Date: September 17, 2016 Most Recent Review Date: September 17, 2016 Next Review Date: August 2017 Policy contains: Vitiligo and psoriasis. Related policies: None. ABOUT THIS POLICY: AmeriHealth Caritas Iowa has developed clinical policies to assist with making coverage determinations. AmeriHealth Caritas Iowa 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 peer-reviewed professional literature. These clinical policies along with other sources, such as plan benefits and state and federal 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 AmeriHealth Caritas Iowa 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 and/or regulatory requirements shall control. AmeriHealth Caritas Iowa 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. AmeriHealth Caritas Iowa s clinical policies are reflective of evidence-based medicine at the time of review. As medical science evolves, AmeriHealth Caritas Iowa will update its clinical policies as necessary. AmeriHealth Caritas Iowa s clinical policies are not guarantees of payment. Coverage policy AmeriHealth Caritas Iowa considers vitiligo and psoriasis to be remediable medical conditions, 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 and/or psoriasis by a primary care or specialty physician knowledgeable in the diagnosis (i.e., clinical evaluation, skin biopsy) and treatment of these conditions. Treatment administered is an established method of care for vitiligo: Excimer laser (e.g., XTRAC, PhotoMedex, Radnor, PA; EX-308, Ra Medical Systems, Inc., Carlsbad, CA). Narrow-band ultraviolet B (UVB). Topical and oral psoralen photochemotherapy (PUVA). Topical tacrolimus. Topical pimecrolimus Topical and systemic corticosteroids.

2 Treatment administered is an established method of care for psoriasis: Anthralin. Corticosteroids (e.g., betamethasone dipropionate ointment and fluocinonide cream). Keratolytic agents (e.g., lactic acid, salicylic acid, and urea). Retinoids (e.g., tazarotene). Tar preparations. Vitamin D derivatives (e.g., calcipotriene). Topical tacrolimus and pimecrolimus Systemic retinoids Methotrexate Systemic cyclosporine Biologic therapies as outlined by PerformRx in Specialty Biologic Agents for Psoriasis (Appendix A). Limitations: All other treatments for vitiligo and psoriasis 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 loss of functional melanocytes. Psoriasis is a common, chronic, disfiguring inflammatory and proliferative disorder of the skin. Topical and oral corticosteroids are among several therapeutic agents that have efficacy in these disorders. Very potent topical steroids are widely used to treat vitiligo and psoriasis 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 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. Anthralin (Dithranol, Drithocreme ) are adjunctive therapies but only a small proportion of patients seem to achieve cosmetically worthwhile results. Dithranol needs to be applied sufficiently frequently and in a high enough concentration to produce a brisk irritant reaction in order to be effective. Staining of hair limits its use in fair-haired 1

3 individuals. Tacrolimus has shown variable response in the treatment of vitiligo and psoriasis. Impressive therapeutic responses have also been seen in those with psoriasis treated with alefacept. In common with other immune-mediated complex diseases, there is no definitive cure for psoriasis, and available treatment is only to decrease disease activity and improve symptoms. Excimer laser in which excimer is a terminological reference of excited dimer, composed of a noble gas and halide (e.g., xenon and chloride) which 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 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 to be 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. Searches AmeriHealth Caritas Iowa 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. The Centers for Medicare & Medicaid Services (CMS). We conducted searches on August 2, 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 2

4 Mehraban (2014) conducted a systematic review of the 308nm 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 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 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 that 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. A narrative review (DiMeglio, 2014) identified classic therapies of psoriasis that span from topical treatments (emollients, topical corticosteroids, vitamin D analogs) used in mild-to-moderate psoriasis, to UVA/UVB phototherapy or systemic therapies reserved to moderate-to-severe cases. Among systemic therapies, which include retinoids, methotrexate, and cyclosporine, the folic acid antagonist methotrexate, which has immunosuppressive, cytostatic, and anti-inflammatory activity and is rather inexpensive, is often used as first line of treatment. However, classic therapy has not completely met patients needs, especially in the most severe cases. In the past decade, a better understanding of disease immunopathogenesis has been successfully translated into new drugs, known as biologics, targeting key inflammatory mediators and currently representing an effective third-line therapy in moderate-to-severe psoriasis patients, unresponsive to nonbiologic systemic agents. Leonardi (2003) demonstrated that tumor necrosis factor (TNF) blockade, using etanercept, is an effective therapeutic strategy for psoriasis. Etanercept is a human p75 TNF receptor fusion protein, similar in therapeutic concept to infliximab, a humanized chimeric anti-tnf monoclonal antibody, or adalimumab, a fully human monoclonal antibody. Etanercept efficacy has been shown in three phase III trials with about 50 percent of patients achieving good responses at week 12 of therapy. TNF neutralization causes early down-modulation of myeloid cell-related genes, with decrease of Th17 cell products and downstream molecules in just 2 weeks after commencing therapy. Interestingly, only patients who downregulate the expression of Th17 pathway genes successfully respond to etanercept treatment. The latest biologic to be approved for psoriasis, ustekinumab, is a monoclonal antibody simultaneously blocking the heterodimeric proteins IL-12 and IL- 23 via its biding to the shared subunit p40. Its efficacy is quite high, with 67 percent of patients achieving response at 12 weeks of treatment (Leonardi 2008). 3

5 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 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 percent repigmentation, 10/44 (22.7 percent) showed percent repigmentation and 3/44 (6.8 percent) showed 1 25 percent repigmentation. Of the 44 patches of vitiligo, 20/27 (74.1 percent) lesions on the face/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/neck and trunk were much higher than that in the extremities (P<0.05). The repigmentation 50 percent) in disease duration of 2 years and >2 years were percent and 46.2 percent (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/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 308nm excimer laser in dermatology. Di Meglio (2014) Psoriasis Zhang (2010) 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: Narrative review of lassic therapies of psoriasis identified topical treatments (emollients, topical corticosteroids, vitamin D analogs) used in mild-to-moderate psoriasis, to UVA/UVB phototherapy or systemic therapies reserved to moderate-to-severe cases. Among systemic therapies, which include retinoids, methotrexate, and cyclosporine, the folic acid antagonist methotrexate, which has immunosuppressive, cytostatic, and antiinflammatory activity is often used as first line of treatment. Targeting key inflammatory mediators currently represents an effective third-line therapy in moderate-to-severe psoriasis patients, unresponsive to nonbiologic systemic agents. Key points: 4

6 Clinical efficacy of a 308 nm excimer laser in the treatment of vitiligo Wang (2009) Efficacy and safety of 308 nm excimer laser for vitiligo. Leonardi (2008) PHOENIX 1 study investigators. Shen (2007) Optimal frequency of treatment with the 308- nm excimer laser for vitiligo on the face and neck Leonardi (2003) Etanercept as monotherapy in patients with psoriasis 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/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 2 years and >2 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). 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 that 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: Multicenter study of TNF blockade, using etanercept, a human p75 TNF receptor fusion protein. Etanercept achieved response in 50% of patients at week 12. Key points: 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. Key points: Clinical trial report suggested TNF blockade is an effective therapeutic strategy for psoriasis. Three phase III trials with about 50% of patients achieved good responses at week 12 of therapy. Glossary 5

7 Phototherapy Uses UVB light, categorized as either wide-band or narrow-band, which refers to the wavelengths included in the UV light source. The Goeckerman regimen combines UVB treatments with coal tar applications. Photochemotherapy Uses UVA in conjunction with a photosensitizer called psoralen (also known as psoralen with ultraviolet A, or PUVA. The photo-sensitizer is a medication that can be applied directly to the skin or taken orally and makes the skin more sensitive to the ultraviolet light. PUVA is usually a second-line treatment, reserved for patients who have failed to improve with conventional therapy. PUVA may be used to treat psoriasis, atopic dermatitis (eczema) and other conditions. Complications of PUVA may include skin damage, premature skin aging, cataracts and increased risk of melanoma and squamous cell carcinoma. References Professional society guidelines/other: Menter A, Korman NJ, Elmets CA, et al. Guidelines of care for the management of psoriasis and psoriatic arthritis. Section 6: guidelines of care for the treatment of psoriasis and psoriatic arthritis: case-based presentations and evidence-based conclusions. J Am Acad Dermatol. 2011;65(1): 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: 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:

8 Asawanonda P, Anderson RR, Chang Y, Taylor CR nm excimer laser for the treatment of psoriasis: a doseresponse study. Arch Dermatol. 2000;136: Baltás E, Csoma Z, Bodai L, Ignácz F, Dobozy A, Kemény L. Treatment of atopic dermatitis with the xenon chloride excimer laser. J Eur Acad Dermatol Venereol. 2006;20: Barahmani N, Schabath MB, Duvic M. History of atopy or autoimmunity increases risk of vitiligo and psoriasis. J Am Acad Dermatol 2009; 61: Brenninkmeijer EE, Spuls PI, Lindeboom R, van der Wal AC, Bos JD, Wolkerstorfer A. Excimer laser vsclobetasol propionate 0 05% ointment in prurigo form of atopic dermatitis: a randomized controlled trial, a pilot. Br J Dermatol. 2010;163: Bronfenbrener R, Ragi J, Milgraum S. Granuloma annulare treated with excimer laser. J Clin Aesthet Dermatol. 2012;5:43 5. 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: Di Meglio P, Villanova F, Nestle FO. Psoriasis. Cold Spring Harbor Perspectives in Medicine. 2014;4(8):a Dong J, He Y, Zhang X, Wang Y, Tian Y, Wang J. Clinical efficacy of flumetasone/salicylic acid ointment combined with 308-nmexcimer laser for treatment of psoriasis vulgaris. Photodermatol Photoimmunol Photomed. 2012;28(3): Feily A, Baktash D, Mohebbipour A, Feily A. Potential advantages of simvastatin as a novel anti-vitiligo 7

9 arsenal. Eur Rev Med Pharmacol Sci. 2013;17: Feily A, Namazi MR. Cissampelos sympodialis Eichl (Menispermaceae) leaf extract as a possible novel and safe treatment for psoriasis. Sao Paulo Med J. 2009;127: Feily A, Namazi MR. Vitamin A + D ointment is not an appropriate emollient for atopic dermatitis. Dermatitis. 2010;21: Feily A, Pazyar N. Why vitiligo is associated with fewer risk of skin cancer?: providing a molecular mechanism. Arch Dermatol Res. 2011;303: Feily A, Pazyar N, Khazanee A, Ghassemi MR, Rafiee E, Safarpoor M. Potential advantages of topical phenytoin as a novel anti psoriasis arsenal. Niger J Med. 2011;20: 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: Furuhashi T, Torii K, Kato H, Nishida E, Saito C, Morita A. Efficacy of excimer light therapy (308 nm) for palmoplantar pustulosis with the induction of circulating regulatory T cells. Exp Dermatol. 2011;20: 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: Goldinger SM, Dummer R, Schmid P, Prinz Vavricka M, Burg G, Lauchli S. Excimer laser versus narrowband UVB (311 nm) in the treatment of psoriasis vulgaris. Dermatology. 2006;213: 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: 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: Han L, Somani AK, Huang Q, Fang X, Jin Y, Xiang LH, Zheng ZZ. Evaluation of 308-nm monochromatic excimer light in the treatment of psoriasis vulgaris and palmoplantar psoriasis. Photodermatol Photoimmunol Photomed. 2008;24: 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:

10 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: Housman TS, Pearce DJ, Feldman SR. A maintenance protocol for psoriasis plaques cleared by the 308 nm excimer laser. J Dermatolog Treat. 2004;15:94 7. Huang J, Cowper S, Moss J, Girardi M. Case experience of 308-nm excimer laser therapy compatibility with PUVA and oral bexarotene for the treatment of cutaneous lesions in mycosis fungoides. J Drugs Dermatol. 2013;12: 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: Köllner K, Wimmershoff MB, Hintz C, Landthaler M, Hohenleutner U. Comparison of the 308-nm excimer laser and a 308-nm excimer lamp with 311-nm narrowband ultraviolet B in the treatment of psoriasis. Br J Dermatol. 2005;152: Köllner K, Wimmershoff M, Landthaler M, Hohenleutner U. Treatment of oral lichen planus with the 308-nm UVB excimer laser--early preliminary results in eight patients. Lasers Surg Med. 2003;33: Laing ME, Fallis B, Murphy GM. Anaphylactic reaction to intralesional corticosteroid injection. Contact Dermatitis 2007;57: 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): Leonardi CL, Kimball AB, Papp KA, et al. PHOENIX 1 study investigators. Lancet. 2008; 371(9625): Leonardi CL, Powers JL, Matheson RT, et al. Etanercept as monotherapy in patients with psoriasis. N Engl J Med 349:

11 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: Meisenheimer JL. Novel use of 308-nm excimer laser to treat a primary cutaneous CD30+ lymphoproliferative nodule. J Drugs Dermatol. 2007;6: Meisenheimer JL. Treatment of mycosis fungoides using a 308-nm excimer laser: two case studies. Dermatol Online J. 2006;12(7):11. 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: Nisticò S, Costanzo A, Saraceno R, Chimenti S. Efficacy of monochromatic excimer laser radiation (308 nm) in the treatment of early stage mycosis fungoides. Br J Dermatol. 2004;151: Nisticò SP, Saraceno R, Capriotti E, Felice CD, Chimenti S. Efficacy of monochromatic excimer light (308 nm) in the treatment of atopic dermatitis in adults and children. Photomed Laser Surg. 2008;26:14 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: Nisticò SP, Saraceno R, Stefanescu S, Chimenti S. A 308-nm monochromatic excimer light in the treatment of palmoplantar psoriasis. J Eur Acad Dermatol Venereol. 2006;20: Omidian M, Ayoobi A, Mapar MA, Feily A, Cheraghian B. Efficacy of sulfasalazine in the treatment of generalized lichen planus: randomized double-blinded clinical trial on 52 patients. J Eur Acad Dermatol Venereol. 2010;24: 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: Pahlajani N, Katz BJ, Lozano AM, Murphy F, Gottlieb A. Comparison of the efficacy and safety of the 308 nm excimer laser for the treatment of localized psoriasis in adults and in children: a pilot study. Pediatr 10

12 Dermatol 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: Rogalski C, Grunewald S, Schetschorke M, et al. Treatment of plaque-type psoriasis with the 308 nm excimer laser in combination with dithranol or calcipotriol. Int J Hyperthermia. 2012;28: 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: Taylor CR, Racette AL. A 308-nm excimer laser for the treatment of scalp psoriasis. Lasers Surg Med. 2004;34: 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: Trehan M, Taylor CR. Low-dose excimer 308- nm laser for the treatment of oral lichen planus. Arch Dermatol. 2004;140: Trott J, Gerber W, Hammes S, Ockenfels HM. The effectiveness of PUVA treatment in severe psoriasis is significantly increased by additional UV 308-nm excimer laser sessions. Eur J Dermatol. 2008;18(1):

13 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: 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): Clinical trials: Searched clinicaltrials.gov on August 17, 2016 using terms vitiligo and psoriasis, Open Studies. Five studies found, two relevant. University of British Columbia. Topical Psoralen Ultraviolet Light A Versus Narrow Band Ultraviolet Light B Treatment for Recalcitrant Dermatoses of the Hand. ClinicalTrials.gov Web site. NCT Published February 6, Updated June Accessed August 17, University of California, Davis. Potential Research Study Participant Registry. ClinicalTrials.gov Web site. NCT Published July 2, Updated April Accessed August 17, CMS National Coverage Determinations (NCDs): No NCDs found for treatment of vitiligo and psoriasis. Local Coverage Determinations (LCDs): No LCDs found for treatment of vitiligo and psoriasis. 12

14 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 Comment Unlisted special dermatological service or procedure [excimer laser] Photochemotherapy; tar and ultraviolet B (Goeckerman treatment) or petrolatum and ultraviolet B Photochemotherapy: psoralens and ultraviolet A (PUVA) Photochemotherapy (Goeckerman and/or PUVA) for severe photoresponsive dermatoses requiring at least four to eight hours of care under direct supervision of the physician (includes application of medication and dressings) 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 Comment L40.0-L40.9 L80 Psoriasis Vitiligo HCPCS Level II J0135 J1438 J1745 J3357 J3380 J8449 Injection, adalimumab, 20 mg Injection, etanercept, 25 mg Injection, infliximab, 10 mg Injection, ustekinumab, 1 mg Injection, vedolizumab, 1 mg Apremilast 30 mg tablet Description Comment Not covered for Medicare when self-administered J7507 J7508 Tacrolimus, immediate release, oral 1 mg Tacrolimus, extended release, oral 0.1 mg Appendix A 13

15 PERFORMRx PRIOR AUTHORIZATION CRITERIA for Specialty Biological Agents for Psoriasis PREFERRED STATUS: Preferred Biological Agents- Require Prior Authorization ENBREL (etanercept): 25 mg vial, 50 mg/ml single-use prefilled syringe HUMIRA (adalimumab): 40 mg/0.8 ml kit, available as pen or syringe, 20 mg prefilled syringe PREFERRED STATUS: Non-Preferred Biological Agents- Require Prior Authorization (Second Line) REMICADE (infliximab): 100 mg/20ml vial ENTYVIO (Vedolizumab): 300mg/20ml Vial OTEZLA (Apremilast): 30mg tablet COSENTYX (Secukinumab): 150mg/ml prefilled syringe STELARA (ustekinumab): 45mg/0.5mL vial PA CRITERIA FOR APPROVAL FOR PSORIASIS: The member is an adult ( 18 y/o) and has a documented clinical diagnosis of moderate to severe plaque psoriasis. Documentation that the patient has had (consistent with pharmacy claims data, OR for new members to the health plan consistent with medical chart history) adequate trials (including dates and dose s) of at least 3 of the treatment bullet points listed below: o The use of topical steroids or has a documented medical reason for not using this therapy to manage their medical condition. o The use of a topical medication [i.e. Dovonex (calcipotriene), Tazorac (tazorotene), anthralin or a coal tar preparation] that is indicated for the treatment of psoriasis or has a documented medical reason for not using any of these therapies to manage their medical condition. o The use of methotrexate or has a documented medical reason (e.g. history of liver or kidney disease, pregnancy, severe cytopenia, alcoholism) for not using this therapy to manage their medical condition. o The use of cyclosporine or has a documented medical reason for not using this therapy to manage their medical condition. o The use of Soriatane (acitretin) or has a documented medical reason for not using this therapy to manage their medical condition. o The use of UVB phototherapy or PUVA (psoralen oral or topical methoxsalen plus UVA therapy) or has a documented medical reason (e.g. pregnancy, skin cancer, hypersensitivity due to preexisting disease state - e.g. systemic lupus erythematus, cataracts) for not undergoing UVB phototherapy or PUVA to manage their medical condition. Documentation was submitted indicating that the member was evaluated for active or latent TB infection (i.e. tuberculin skin test). The medication requested has an FDA approved indication for use in patients with moderate to severe plaque psoriasis and is being recommended or prescribed by a dermatologist at an FDA-approved dosage. If the request is for a non-preferred agent, documented (consistent with pharmacy claims data, OR for new members to the health plan consistent with medical chart history) If the request is for a non-preferred agent, documented (consistent with pharmacy claims data, OR for new members to the health plan consistent with medical chart history) adequate trial of the preferred biological agents. If all of the above conditions are met, the request will be approved for up to a 6 month duration. If all of the above criteria are not met, the request is referred to a Medical Director/clinical reviewer for medical necessity review. PA CRITERIA FOR RE-AUTHORIZATION FOR PSORIASIS: The medication is being recommended and prescribed by a dermatologist at an FDA-approved dosage. The member has been receiving the medication and documentation was provided that the prescriber has evaluated the member and recommends continuation of therapy. Documentation submitted indicates that the member has obtained clinical benefit from the medication. If all of the above conditions are met, the request will be approved for a 6-month duration for Remicade requests and for a 12 month duration for requests for all other medications. If all of the above criteria are not met, the request is referred to a Medical director/clinical reviewer for medical necessity review. 14

16 NOTE: Medical Director/clinical reviewer must override criteria when, in his/her professional judgment, the requested item is medically necessary. Revision/Review Date: 9/