Targeted Phototherapy and Psoralen with Ultraviolet A for Vitiligo

POLICY NUMBER

L.2.01.443

DESCRIPTION

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.

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 non-segmental vitiligo in which depigmentation is generalized, bilateral, symmetrical and increases in size over time. In contrast, segmental vitililgo, 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 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, light box therapy with narrowband ultraviolet B (NB-UVB) 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) at 311 nm. Subsequently, xenon chloride lasers and lamps were developed as targeted ultraviolet B treatment devices; these devices 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 light box, which could result in fewer treatments.

Psoralen plus ultraviolet A 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. No topical psoralen formulation is currently available in the US.

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™, 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.

The oral psoralen product, methoxsalen soft gelatin capsules (previously available under the brand name Oxsoralen Ultra), has been approved by the FDA.

Related policies are –

POLICY

PUVA for the treatment of vitiligo that is not responsive to other forms of conservative therapy (e.g., topical corticosteroids, coal/tar preparations, and ultraviolet light) may be considered medically necessary.

Targeted phototherapy is considered investigational for the treatment of vitiligo.

POLICY EXCEPTIONS

Federal Employee Program (FEP) may dictate that all FDA-approved devices, drugs or biologics may not be considered investigational and thus these devices may be assessed only on the basis of their medical necessity.

POLICY GUIDELINES

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.

During PUVA therapy, the individual needs to be assessed on a regular basis to determine the effectiveness of the therapy and the development of side effects. These evaluations are essential to ensure that the exposure dose of radiation is kept to the minimum compatible with adequate control of the disease. Therefore, PUVA is generally not recommended for home therapy.

Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Mental Health Disorders, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:

A.  consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and

B.  appropriate with regard to standards of good medical practice; and

C.  not solely for the convenience of the Member, his or her Provider; and

D.  the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.

For the definition of medical necessity, “standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary.

Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.

POLICY HISTORY

07/19/2012: Approved by Medical Policy Advisory Committee.

08/07/2013: Policy reviewed; no changes.

06/05/2014: Policy reviewed; description updated. Policy statement unchanged. Corrected the policy number in the Sources section by changing "2.01.84" to "2.01.86."

08/18/2015: Medical policy revised to add ICD-10 codes.

09/10/2015: Policy description updated. Policy statements unchanged. Policy guidelines section updated to add medically necessary and investigative definitions.

01/12/2016: Policy description updated. Policy statements unchanged.

06/01/2016: Policy number A.2.01.86 added.

01/13/2017: Policy description updated. Policy statements unchanged.

01/15/2018: Policy description updated regarding devices. Policy statements unchanged.

01/11/2019: Policy title changed from "Light Therapy for Vitiligo" to "Targeted Phototherapy and Psoralen with Ultraviolet A for Vitiligo." Policy description updated. Policy statements unchanged.

01/15/2020: Policy reviewed; no changes.

02/01/2021: Policy description updated regarding psoralen products. Policy statements unchanged.

02/02/2022: Policy description updated. Policy statements unchanged. Policy Guidelines updated to change "Nervous/Mental Conditions" to "Mental Health Disorders" and "Medically Necessary" to "medical necessity."

01/24/2023: Policy reviewed; no changes.

01/08/2024: Policy description updated regarding products. Policy statements unchanged. Policy Guidelines updated to change "patient" to "individual."

03/18/2025: Policy number changed from "A.2.01.86" to "L.2.01.443." Policy reviewed. Policy statements unchanged.

SOURCE(S)

Blue Cross Blue Shield Association policy # 2.01.86

CODE REFERENCE

This may not be a comprehensive list of procedure codes applicable to this policy.

The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.

Covered Codes

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