BCBSNJ Medical Policy for - (Medicine) Policy Number

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Horizon BCBSNJ
Uniform Medical Policy Manual	Section:	Medicine
	Policy Number:	037
	Effective Date:	01/07/2011

	Original Policy Date:	05/13/2008
	Last Review Date:	01/14/2020
	Date Published to Web:	12/06/2010

Subject:
Vitiligo

Description:
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IMPORTANT NOTE:

The purpose of this policy is to provide general information applicable to the administration of health benefits that Horizon Blue Cross Blue Shield of New Jersey and Horizon Healthcare of New Jersey, Inc. (collectively “Horizon BCBSNJ”) insures or administers. If the member’s contract benefits differ from the medical policy, the contract prevails. Although a service, supply or procedure may be medically necessary, it may be subject to limitations and/or exclusions under a member’s benefit plan. If a service, supply or procedure is not covered and the member proceeds to obtain the service, supply or procedure, the member may be responsible for the cost. Decisions regarding treatment and treatment plans are the responsibility of the physician. This policy is not intended to direct the course of clinical care a physician provides to a member, and it does not replace a physician’s independent professional clinical judgment or duty to exercise special knowledge and skill in the treatment of Horizon BCBSNJ members. Horizon BCBSNJ is not responsible for, does not provide, and does not hold itself out as a provider of medical care. The physician remains responsible for the quality and type of health care services provided to a Horizon BCBSNJ member.

Horizon BCBSNJ medical policies do not constitute medical advice, authorization, certification, approval, explanation of benefits, offer of coverage, contract or guarantee of payment.
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Vitiligo is an idiopathic skin disorder that causes depigmentation of sections of skin, most commonly on the extremities. Topical corticosteroids, alone or in combination with topical vitamin D₃ analogues, are common first-line treatments for vitiligo. Alternative first-line therapies include topical calcineurin inhibitors, systemic steroids, and topical antioxidants. Treatment options for vitiligo recalcitrant to first-line therapy include, among others, ultraviolet B, light box therapy and psoralen plus ultraviolet A (PUVA). Targeted phototherapy is also being evaluated.

Populations	Interventions	Comparators	Outcomes
Individuals: With vitiligo	Interventions of interest are: Targeted phototherapy	Comparators of interest are: Topical medications Narrow-band ultraviolet B light box therapy	Relevant outcomes include: Change in disease status Quality of life Treatment-related morbidity
Individuals: With vitiligo who have not responded to conservative therapy	Interventions of interest are: Psoralen plus ultraviolet A (photochemotherapy)	Comparators of interest are: Topical medications Narrow-band ultraviolet B light box therapy	Relevant outcomes include: Change in disease status Quality of life Treatment-related morbidity

BACKGROUND

Vitiligo

Vitiligo is an idiopathic skin disorder that causes depigmentation of sections of skin, most commonly on the extremities. Depigmentation occurs because melanocytes are no longer able to function properly. The cause of vitiligo is unknown; it is sometimes considered an autoimmune disease. The most common form of the disorder is nonsegmental vitiligo in which depigmentation is generalized, bilateral, symmetrical, and increases in size over time. In contrast, segmental vitiligo, also called asymmetric or focal vitiligo, covers a limited area of skin. The typical natural history of vitiligo involves stepwise progression with long periods in which the disease is static and relatively inactive, and relatively shorter periods in which areas of pigment loss increase.

Treatment

There are numerous medical and surgical treatments aimed at decreasing disease progression and/or attaining repigmentation. Topical corticosteroids, alone or in combination with topical vitamin D₃analogues, are common first-line treatments for vitiligo. Alternative first-line therapies include topical calcineurin inhibitors, systemic steroids, and topical antioxidants. Treatment options for vitiligo recalcitrant to first-line therapy include, among others, light box therapy with narrowband ultraviolet B and psoralen plus ultraviolet A (PUVA).

Targeted phototherapy with handheld lamps or lasers is also being evaluated. Potential advantages of targeted phototherapy include the ability to use higher treatment doses and to limit exposure to surrounding tissue. Original ultraviolet B devices consisted of a Phillips TL-01 fluorescent bulb with a maximum wavelength (lambda max) of 311 nm. Subsequently, xenon chloride lasers and lamps were developed as targeted ultraviolet B treatment devices; they generate monochromatic or very narrowband radiation with a lambda max of 308 nm. Targeted phototherapy devices are directed at specific lesions or affected areas, thus limiting exposure to the surrounding normal tissues. They may, therefore, allow higher dosages compared with a lightbox, which could result in fewer treatments.

PUVA uses a psoralen derivative in conjunction with long-wavelength ultraviolet A (UVA) light (sunlight or artificial) for photochemotherapy of skin conditions. Psoralens are tricyclic furocoumarins that occur in certain plants and can also be synthesized. They are available in oral and topical forms. Oral PUVA is generally given 1.5 hours before exposure to UVA radiation. Topical PUVA therapy refers to the direct application of psoralen to the skin with subsequent exposure to UVA light. With topical PUVA, UVA exposure is generally administered within 30 minutes of psoralen application.

Regulatory Status

In 2001, XTRAC™ (PhotoMedex), a xenon chloride (XeCl) excimer laser, was cleared for marketing by the U.S. Food and Drug Administration (FDA) through the 510(k) process for the treatment of skin conditions such as vitiligo. The 510(k) clearance has subsequently been obtained for a number of targeted UVB lamps and lasers, including newer versions of the XTRAC system including the XTRAC Ultra™, the VTRAC™ lamp (PhotoMedex), the BClear™ lamp (Lumenis), the 308 excimer lamp phototherapy system (Quantel Medical), MultiClear Multiwavelength Targeted Phototherapy System, Psoria-Light^TM, and the Excilite™ and Excilite µ™ XeCl lamps. The intended use of all of these devices includes vitiligo among other dermatologic indications. Some light-emitting devices are handheld. FDA product code: GEX.

The oral psoralen products Oxsoralen-Ultra® (methoxsalen soft gelatin capsules) and 8-MOP® (methoxsalen hard gelatin capsules) have been approved by the FDA; both are made by Valeant Pharmaceuticals. Topical psoralen products have also received FDA approval (eg, Oxsoralen® [Valeant]).

Related Policies

Dermatologic Applications of Photodynamic Therapy (Policy #064 in the Treatment Section)
Phototherapy for Psoriasis (Policy #067 in the Treatment Section)

Policy:
(NOTE: Coverage eligibility for vitiligo treatment may be subject to member contract benefit exclusion regarding cosmetic services.

For : For Medicare Advantage, Medicaid and FIDE-SNP, please refer to the Coverage Sections below for coverage guidance.)

I. The following established therapies are considered medically necessary for the treatment of vitiligo:

II. Home phototherapy for the treatment of vitiligo is considered investigational because there is lack of published evidence regarding the safety and effectiveness of home phototherapy for this condition.

III. Melanocyte transplantation for the treatment of vitiligo is considered investigational because there is very limited published data regarding its effectiveness in the treatment of vitiligo.

IV. Skin grafts for the treatment of vitiligo is considered investigational because the long term durability of this treatment has not been established in the published, peer-reviewed literature.

V. Micropigmentation (tattooing) for the treatment of vitiligo is considered cosmetic because it does not affect the underlying cause of the condition.

Medicare Coverage:
There is no National Coverage Determination (NCD) for treatment of Vitiligo. In the absence of an NCD, coverage decisions are left to the discretion of Local Medicare Carriers. Novitas Solutions, Inc, the Local Medicare Carrier for jurisdiction JL, has not issued a determination for treatment Vitiligo. Therefore, Medicare Advantage Products will follow the Horizon BCBSNJ Medical Policy for treatment of Vitiligo.

Per LCD L35090 Cosmetic and Reconstructive Surgery, cosmetic surgery performed purely for the purpose of enhancing one's appearance is not eligible for coverage. For additional information, refer to LCD L35090 Cosmetic and Reconstructive Surgery. Available to be accessed at Novitas Solutions, Inc., Medical Policy Search page: https://www.novitas-solutions.com/webcenter/portal/MedicareJL/LcdSearch?_afrLoop=90769712476969#!%40%40%3F_afrLoop%3D90769712476969%26centerWidth%3D100%2525%26leftWidth%3D0%2525%26rightWidth%3D0%2525%26showFooter%3Dfalse%26showHeader%3Dfalse%26_adf.ctrl-state%3D63y7eftob_46.

Medicaid Coverage:

For members enrolled in Medicaid and NJ FamilyCare plans, Horizon BCBSNJ applies the above medical policy.

FIDE SNP:

For members enrolled in a Fully Integrated Dual Eligible Special Needs Plan (FIDE-SNP): (1) to the extent the service is covered under the Medicare portion of the member’s benefit package, the above Medicare Coverage statement applies; and (2) to the extent the service is not covered under the Medicare portion of the member’s benefit package, the above Medicaid Coverage statement applies.

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Horizon BCBSNJ Medical Policy Development Process:

This Horizon BCBSNJ Medical Policy (the “Medical Policy”) has been developed by Horizon BCBSNJ’s Medical Policy Committee (the “Committee”) consistent with generally accepted standards of medical practice, and reflects Horizon BCBSNJ’s view of the subject health care services, supplies or procedures, and in what circumstances they are deemed to be medically necessary or experimental/ investigational in nature. This Medical Policy also considers whether and to what degree the subject health care services, supplies or procedures are clinically appropriate, in terms of type, frequency, extent, site and duration and if they are considered effective for the illnesses, injuries or diseases discussed. Where relevant, this Medical Policy considers whether the subject health care services, supplies or procedures are being requested primarily for the convenience of the covered person or the health care provider. It may also consider whether the services, supplies or procedures are more costly than an alternative service or sequence of services, supplies or procedures that are at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of the relevant illness, injury or disease. In reaching its conclusion regarding what it considers to be the generally accepted standards of medical practice, the Committee reviews and considers the following: all credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, physician and health care provider specialty society recommendations, the views of physicians and health care providers practicing in relevant clinical areas (including, but not limited to, the prevailing opinion within the appropriate specialty) and any other relevant factor as determined by applicable State and Federal laws and regulations.

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Index:
Vitiligo
PUVA, Vitiligo
Psoralens with ultraviolet A (PUVA), Vitiligo
Ultraviolet A (UVA), Vitiligo
Ultraviolet B (UBV), Vitiligo
Narrow-Band Ultraviolet B, Vitiligo
Excimer Laser, Vitiligo

References:
1. ECRI Institute. Custom Hotline Response: Relationship between vitiligo and risk of skin cancer. Updated: 03/07/08.

2. ACP (American College of Physicians) Medicine. Dermatology: Disorders of Pigmentation. Chapter XV. April 2007 Update.

3. Schallreuter KU, Levenig C, Berger J. Vitiligo and cutaneous melanoma. A case study. Dermatologica. 1991;183(4):239-45.

4. Schallreuter KU. Decreased photodamage and low incidence of non-melanoma skin cancer in 136 sun-exposed caucasian patients with vitiligo. Dermatology. 2002;204(3):194-201.

5. American Academy of Dermatology. Public Center: Vitiligo. Available at: http://www.aad.org/public/publications/pamphlets/common_vitilgo.html (last accessed 04/02/08).

6. National Institutes of Health (NIH). National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS). Questions and Answers about Vitiligo. NIH Publication No. 07-4909. Revised October 2006. Available at: http://www.niams.nih.gov/Health_Info/Vitiligo/vitiligo_qa.pdf (last accessed 04/02/08)

7. National Vitiligo Foundation, Inc. Vitiligo Patient Handbook. Available at: http://www.nvfi.org/pages/info_patient_handbook.html (last accessed 04/02/08).

8. Vitiligo Support International. Frequently Asked Questions About Vitiligo (FAQ). Available at: http://www.vitiligosupport.org/faq.cfm (last accessed 04/02/08)

9. Vitiligo Society. I love fresh air and I work out of doors. Do I need to take any special precautions to protect my skin? Available at: http://www.vitiligosociety.org.uk/treatment.html (accessed 04/16/2008)

10. Cavallari V, Cannavo SP et al. Vitiligo associated with metastatatic malignant melanoma. Int J Dermatol. 1996 Oct;35(10):738-40.

11. Kovacs SO. Vitiligo. J Am Acad Dermatol.1998 May;38(5 Pt 1):647-66.

12. Porter J, Beuf AH et al. Response to cosmetic disfigurement: patients with vitiligo. Cutis. 1987 Jun;39(6):493-4.

13. Schwartz RA, Janniger CK. Vitiligo. Cutis. 1997 Nov;60(5):239-44.

14. Hacker SM. Common disorders of pigmentation: when are more than cosmetic cover-ups required? Postgrad Med. 1996 Jun;99(6):177-86.

15. Seo SL, Kim IH. Squamous cell carcinoma in a patient with generalized vitiligo. J Am Acad Dermatol. 2001 Dec;45(6 Suppl):S227-9.

16. Prognostic significance of autoimmunity during treatment of melanoma with interferon. N Engl J Med. 2006 Feb 16;354(7):709-18.

17. Grimes PE. New insights and new therapies in vitiligo. JAMA. 2005 Feb 9;293(6):730-5. Available at: http://jama.ama-assn.org/cgi/reprint/293/6/730

18. National Guideline Clearinghouse NGC). Guideline synthesis: Skin Cancer. Part I. Screening and Prevention. In: National Guideline Clearinghouse (NGC) [http://www.guideline.gov/Compare/pdf.aspx?file=SKIN_CANCER4.inc&out=1]. Rockville (MD): 2005 May 30 (revised 2009 Feb). (last accessed 4/6/09)

19. Gawkrodger DJ, Ormerod AD, Shaw L et al; Therapy Guidelines and Audit Subcommittee, British Association of Dermatologists; Clinical Standards Department, Royal College of Physicians in London; Cochrane Skin Group; Vitiligo Society. Guideline for the Diagnosis and management of vitiligo. Br J Dermatol. 2008 Nov;159(5):1051-76.

20. Taieb A, Picardo M. Clinical practice. Vitiligo. N Engl J Med. 2009 Jan 8;360(2):160-9.

21. Gawkrodger DJ, Ormerod AD et al. Vitiligo: concise evidence based guidelines on diagnosis and management. Postgrad Med J. 2010 Aug;86(1018):466-71.

22. Whitton ME, Pinart M, Batchelor J et al. Interventions for vitiligo. Cochrane Database Syst Rev 2010; (1):CD003263.

23. Shi Q, Li K, Fu J et 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):27-33.

24. Nistico S, Chiricozzi A, Saraceno R et al. Vitiligo treatment with monochromatic excimer light and tacroliums: results of an open randomized controlled study. Photomed Laser Surg 2012; 30(1):26-30.

25. Saraceno R, Nistico S, Capriotti E et al. Monochromatic excimer light 308nm in monotherapy and combined with topical khellin 4% in the treatment of vitiligo: a controlled study. Dermatol Ther 2009; 22(4):391-4.

26. Njoo MD, Spuls PI, Bos JD et al. Nonsurgical repigmentation therapies in vitiligo. Arch Dermatol 1998; 134(12):1532-40. \

27. Yones SS, Palmer RA, Garibaldinos TM et al. Randomized double-blind trial for treatment of vitiligo. Arch Dermatol 2007; 143(5):578-84.

28. Bansal S, Sahoo B, Garg V. Psoralen-narrowband UVB phototherapy in treatment of vitiligo in comparison to narrowband UVB phototherapy. Photodermatol Photoimmunol Photomed 2013.

29. Gawkrodger DJ, Ormerod AD, Shaw L et al. Guideline for the diagnosis and management of vitiligo. Br J Dermatol 2008; 159(5):1051-76.

30. Yang YS, Cho HR, Ryou JH, et al. Clinical study of repigmentation patterns with either narrow-band ultraviolet B (NBUVB) or 308 nm excimer laser treatment in Korean vitiligo patients. Int J Dermatol. Mar 2010;49(3):317-323. PMID 20465673

31. Taieb A, Alomar A, Bohm M et al. Guidelines for the management of vitiligo: the European Dermatology Forum consensus. Br J Dermatol 2013; 168(1):5-19.

32. Whitton ME, Pinart M, Batchelor J, et al. Interventions for vitiligo. Cochrane Database Syst Rev. 2015;2:CD003263. PMID 25710794

33. Sun Y, Wu Y, Xiao B, et al. Treatment of 308-nm excimer laser on vitiligo: A systemic review of randomized controlled trials. J Dermatolog Treat. Jan 30 2015:1-7. PMID 25428573

34. Lopes C, Trevisani VF, Melnik T. Efficacy and safety of 308-nm monochromatic excimer lamp versus other phototherapy devices for vitiligo: a systematic review with meta-analysis. Am J Clin Dermatol. Feb 2016;17(1):23-32. PMID 26520641

35. Zhang C, Zhou L, Huang J, et al. A combination of Yiqiqubai granule and 308-nm excimer laser in treatment of segmental vitiligo: a prospective study of 233 patients. J Dermatolog Treat. Nov 2017;28(7):668-671. PMID 28320220

36. Fa Y, Lin Y, Chi XJ, et al. Treatment of vitiligo with 308-nm excimer laser: our experience from a 2-year follow-up of 979 Chinese patients. J Eur Acad Dermatol Venereol. Feb 2017;31(2):337-340. PMID 27538097

37. Dong DK, Pan ZY, Zhang J, et al. Efficacy and safety of targeted high-intensity medium-band (304-312 nm) ultraviolet B light in pediatric vitiligo. Pediatr Dermatol. May 2017;34(3):266-270. PMID 28318054

38. Bae JM, Jung HM, Hong BY, et al. Phototherapy for vitiligo: a systematic review and meta-analysis. JAMA Dermatol. Jul 01 2017;153(7):666-674. PMID 28355423

39. Rodrigues M, Ezzedine K, Hamzavi I, et al. Current and emerging treatments for vitiligo. J Am Acad Dermatol. Jul 2017;77(1):17-29. PMID 28619557

Codes:
(The list of codes is not intended to be all-inclusive and is included below for informational purposes only. Inclusion or exclusion of a procedure, diagnosis, drug or device code(s) does not constitute or imply authorization, certification, approval, offer of coverage or guarantee of payment.)

CPT*

HCPCS

* CPT only copyright 2020 American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.

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Medical policies can be highly technical and are designed for use by the Horizon BCBSNJ professional staff in making coverage determinations. Members referring to this policy should discuss it with their treating physician, and should refer to their specific benefit plan for the terms, conditions, limitations and exclusions of their coverage.

The Horizon BCBSNJ Medical Policy Manual is proprietary. It is to be used only as authorized by Horizon BCBSNJ and its affiliates. The contents of this Medical Policy are not to be copied, reproduced or circulated to other parties without the express written consent of Horizon BCBSNJ. The contents of this Medical Policy may be updated or changed without notice, unless otherwise required by law and/or regulation. However, benefit determinations are made in the context of medical policies existing at the time of the decision and are not subject to later revision as the result of a change in medical policy
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