Description
Light therapy for psoriasis and vitiligo includes both targeted phototherapy and photochemotherapy with psoralen plus ultraviolet A (PUVA). Targeted phototherapy describes the use of ultraviolet light that can be focused on specific body areas or lesions. PUVA uses a psoralen derivative in conjunction with long wavelength ultraviolet A (UVA) light (sunlight or artificial) for photochemotherapy of skin conditions.

Psoriasis is a common chronic immune-mediated disease characterized by skin lesions ranging from minor localized patches to complete body coverage. There are several types of psoriasis; most common is plaque psoriasis, which is associated with red and white scaly patches on the skin. In addition to being a skin disorder, psoriasis can negatively impact many organ systems and is associated with an increased risk of cardiovascular disease, some types of cancer and autoimmune diseases, such celiac disease and Crohn's disease. 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 directly applying the psoralen to the skin with subsequent exposure to UVA light. Bath PUVA is used in some European countries for generalized psoriasis, but the agent used, trimethylpsoralen, is not approved by the U.S. Food and Drug Administration (FDA). Paint PUVA and soak PUVA are other forms of topical application of psoralen and are often used for psoriasis localized to the palms and soles. In paint PUVA, 8-methoxypsoralen (8-MOP) in an ointment or lotion form is put directly on the lesions. With soak PUVA, the affected areas of the body are placed in a basin of water containing psoralen. With topical PUVA, UVA exposure is generally administered within 30 minutes of psoralen application.

PUVA has most commonly been used to treat severe psoriasis for which there is no generally accepted first-line treatment. Each treatment option (e.g., systemic therapies such as methotrexate, phototherapy, biologic therapies, etc.) has associated benefits and risks. Common minor toxicities associated with PUVA include erythema, pruritis, irregular pigmentation and gastrointestinal tract symptoms; these generally can be managed by altering the dose of psoralen or UV light. Potential long-term effects include photoaging and skin cancer, particularly squamous cell carcinoma (SCC) and possibly malignant melanoma. PUVA is generally considered more effective than targeted phototherapy for the treatment of psoriasis. However, the requirement of systemic exposure and the higher risk of adverse reactions (including a higher carcinogenic risk) have generally limited PUVA therapy to patients with more severe cases.

Potential advantages of targeted phototherapy include the ability to use higher treatment doses and to limit exposure to surrounding tissue. Broadband ultraviolet B (BB-UVB) devices, which emit wavelengths from 290 to 320 nm, have been largely replaced by narrowband (NB)-UVB devices. NB-UVB devices eliminate wavelengths below 296 nm, which are considered erythemogenic and carcinogenic but not therapeutic. NB-UVB is more effective than BB-UVB and approaches PUVA in efficacy. Original NB-UVB devices consisted of a Phillips TL-01 fluorescent bulb with a maximum wavelength (lambda max) at 311 nm. Subsequently, xenon chloride (XeCl) lasers and lamps were developed as targeted NB-UVB treatment devices; they generate monochromatic or very narrow band 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 to a light box, which could result in fewer treatments to produce clearing.

The original indication of the excimer laser was for patients with mild to moderate psoriasis, defined as involvement of less than 10% of the skin. Typically, these patients have not been considered candidates for light box therapy, since the risks of exposing the entire skin to the carcinogenic effects of UVB light may outweigh the benefits of treating a small number of lesions. Newer XeCl laser devices are faster and more powerful than the original models, which may allow treatment of patients with more extensive skin involvement, 10 – 20% of body surface area.

The American Academy of Dermatology does not recommend phototherapy for patients with mild localized psoriasis whose disease can be controlled with topical medications. A variety of topical agents are available, including steroids, coal tar, vitamin D analogues (e.g., calcipotriol and calcitriol), tazarotene and anthralin.

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 to be an autoimmune disease. The most common form of the disorder is non-segmental vitiligo (NSV) in which depigmentation is generalized, bilateral, symmetrical and increases in size over time. In contrast, segmental vitiligo (SV), 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.

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 D3 analogs, is a common first-line treatment 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, psoralens with ultraviolet A and targeted light therapy.

Regulatory Status 
In 2001, the XeCl excimer laser (XTRAC^™ by PhotoMedex) received 510(k) clearance from the U.S. Food and Drug Administration (FDA) 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) and the Excilite^™ and Excilite μ^™ XeCl lamps. The intended use of all of these devices includes vitiligo, among other dermatological indications.

In 2010, the Levia Personal Targeted Phototherapy^® UVB device (Daavlin Co., Bryan, OH, previously manufactured by Lerner Medical Devices, Los Angeles, CA) was cleared by FDA for home treatment of psoriasis.

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, e.g., Oxsoralen (Valeant Pharmaceuticals). 

***Note: This Medical Policy is complex and technical. For questions concerning the technical language and/or specific clinical indications for its use, please consult your physician. 

Policy 
Light therapy for dermatologic conditions is considered MEDICALLY NECESSARY when the medical criteria and guidelines shown below are met:

PUVA may be considered medically necessary for the treatment of the following conditions:

• Severe, disabling psoriasis, which is not responsive to other forms of conservative therapy (e.g., topical corticosteroids, coal/tar preparations and ultraviolet light) 
• Severe refractory atopic dermatitis that is not responsive to other forms of conservative therapy (e.g., topical corticosteroids, coal/tar preparations and ultraviolet light) 
• Severe refractory pruritus that is not responsive to other forms of conservative therapy (e.g., topical corticosteroids, coal/tar preparations and ultraviolet light) 
• Cutaneous T-cell lymphoma (e.g., mycosis fungoides and Sezary syndrome) 
• Vitiligo that is not responsive to other forms of conservative therapy (e.g., topical corticosteroids, coal/tar preparations and ultraviolet light) 
• Lichen planus or lichen sclerosus that is not responsive to other forms of conservative therapy, including topical.
• Eczema that is not responsive to other forms of conservative therapy, including topical

Targeted phototherapy (e.g. Excimer Laser) may be considered medically necessary for the treatment of the following conditions: 

• Moderate to severe psoriasis (comprising less than 20% body area) for which NB-UVB or PUVA are indicated 
• Mild to moderate localized psoriasis that is unresponsive to conservative treatment 
• Cutaneous T-cell lymphoma (e.g., mycosis fungoides and Sezary syndrome)

Targeted phototherapy(e.g. Excimer Laser)is considered NOT MEDICALLY NECESSARY for conditions not addressed as medically necessary under the section above, including, but not limited to: 

• First-line treatment of mild psoriasis.
• Generalized psoriasis or psoriatic arthritis. 
• Vitiligo, except as described above.
• Alopecia.

Rationale
For individuals who have mild localized psoriasis who receive targeted phototherapy, there is little evidence. The relevant outcomes are symptoms, change in disease status, quality of life, and treatment-related morbidity. The evidence is lacking on the use of targeted phototherapy as firstline treatment of mild psoriasis. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals who have mild psoriasis that is resistant to topical medications who receive targeted phototherapy, the evidence includes small within-subject studies. The relevant outcomes are symptoms, change in disease status, quality of life, and treatment-related morbidity. The available pre-post studies have shown that targeted phototherapy can improve mild localized psoriasis (< 10% body surface area) that has not responded to topical treatment. Targeted phototherapy is presumed to be safer or at least no riskier than whole body phototherapy, due to risks of exposing the entire skin to the carcinogenic effects of UVB light. The evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcome.

For individuals who have vitiligo who receive targeted phototherapy, the evidence includes systematic reviews of randomized controlled trials. The relevant outcomes are change in disease status, quality of life, and treatment-related morbidity. The studies tend to have small sample sizes, and few were designed to isolate the effect of laser therapy. Two meta-analyses were attempted; however, results from a meta-analysis could not be verified because the selected studies were not available in English, and one estimate was imprecise due to the small number of studies and participants. There is a lack of clinical trial evidence that compares this technique with more conservative treatments or no treatment/placebo. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals who have vitiligo who have not responded to conservative therapy who receive PUVA (photochemotherapy), the evidence includes systematic reviews and randomized control trials. The relevant outcomes are change in disease status, quality of life, and treatment-related morbidity. There is some evidence from randomized studies, mainly those published before 1985, that PUVA is more effective than placebo for treating vitiligo. When compared with narrowband ultraviolet B in meta-analyses, results have shown that patients receiving narrowband ultraviolet B experienced higher rates of repigmentation than patients receiving PUVA, though the differences were not statistically significant. Based on the available evidence and clinical guidelines, PUVA may be considered in patients with vitiligo who have not responded adequately to conservative therapy. The evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcome.

For individuals who have moderate-to-severe localized psoriasis who receive targeted phototherapy, the evidence includes randomized controlled trials (RCTs) and systematic reviews of RCTs. The relevant outcomes are symptoms, change in disease status, quality of life, and treatment-related morbidity. Systematic reviews of small RCTs and non-RCTs in patients with moderate-to-severe psoriasis have found that targeted phototherapy has efficacy similar to whole body phototherapy and supports the use of targeted phototherapy for the treatment of moderateto-severe psoriasis comprising less than 20% of body surface area for which narrowband UVB or phototherapy with PUVA are indicated. The evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcome.

For individuals who have generalized psoriasis who receive PUVA, the evidence includes RCTs and systematic reviews. The relevant outcomes are symptoms, change in disease status, quality of life, and treatment-related morbidity. RCTs and systematic reviews of RCTs have found that PUVA is more effective than narrowband UVB, topical steroids, or ultraviolet A without psoralens in patients with generalized psoriasis. The evidence is sufficient to determine that the technology results in a meaningful improvement in the net health outcome.

References 

1. Menter A, Korman NJ, Elmets CA et al. American Academy of Dermatology: Guidelines of care for the management of psoriasis and psoriatic arthritis: Section 5. Guidelines of care for the treatment of psoriasis with phototherapy and photochemotherapy 2010. Retrieved on April 19, 2012 from http://www.guideline.gov/content.aspx?id=15651&search=american+academy+of+dermatology+and+puva
2. Eleftheriadou V, Whitton ME, Gawkrodger DJ, et al., Future research into the treatment of vitiligo: where should our priorities lie? Results of the vitiligo priority setting partnership. Br J Dermatol. 2011 March; 164(3): 530–536. Retrieved on April 19, 2012 from http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3084501/?tool=pubmed
3. Gawkrodger DJ, Ormerod AD, Shaw L et al. Therapy Guidelines and Audit Subcommittee, British Association of Dermatologists, Clinical Standards Department, Royal College of Physicians of London, Cochrane Skin Group, Vitiligo Society. Guideline for the diagnosis and management of vitiligo. Br J Dermatol 2008; 159(5):1051-76. Retrieved on April 19, 2012 from http://www.guideline.gov/content.aspx?id=13567&search=psoriasis+and+vitiligo
4. Koek MB, Buskens E, van Weelden H, Steegmans PH, Bruijnzeel-Koomen CA, Sigurdsson V. Home versus outpatient ultraviolet B phototherapy for mild to severe psoriasis: pragmatic multicentre randomised controlled non-inferiority trial (PLUTO study). BMJ. 2009 May 7; 338:b1542. doi: 10.1136/bmj.b1542. Retrieved on April 19, 2012 from http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2857750/?tool=pubmed

Coding Section

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive. 

This medical policy was developed through consideration of peer-reviewed medical literature generally recognized by the relevant medical community, U.S. FDA approval status, nationally accepted standards of medical practice and accepted standards of medical practice in this community, Blue Cross Blue Shield Association technology assessment program (TEC) and other nonaffiliated technology evaluation centers, reference to federal regulations, other plan medical policies, and accredited national guidelines.

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