Coverage Policy Manual
Policy #: 2013024
Category: Medicine
Initiated: July 2013
Last Review: January 2024
  Phototherapy for Vitiligo

Description:
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 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 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) of 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.
 
Regulatory Status
In 2001, XTRACTM (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-LightTM, and the Excilite™ and Excilite µ™ XeCl lamps. The intended use of all of these devices includes vitiligo among other dermatological indications. Some light-emitting devices are handheld.
 
FDA product code: GEX
 
The oral psoralen products Oxsoralen-Ultra® (methoxsalen soft gelatin capsules) has been approved by the FDA and is made by Bausch Health, a generic product is also available from various manufacturers. Topical psoralen products (Oxsoralen, Valeant Pharmaceuticals) and methoxsalen hard gelatin have been discontinued.
 
Coding
There is no specific CPT code for laser therapy for vitiligo. It should currently be reported using an unlisted CPT (96999) but the CPT codes for laser therapy for psoriasis (96920-96922) might be used.
 
CPT 96912 [Photochemotherapy; psoralens, and ultraviolet A (PUVA)] is specific for PUVA.

Policy/
Coverage:
Meets Primary Coverage Criteria Or Is Covered For Contracts Without Primary Coverage Criteria
 
PUVA for the treatment of vitiligo which is not responsive to other forms of conservative therapy (e.g., topical corticosteroids, coal/tar preparations, and ultraviolet light) meets member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes.
 
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
 
Targeted phototherapy (i.e., broadband (BB)-ultraviolet B (UVB) devices, narrowband (NB)-UVB devices, xenon chloride (XeCl) lasers and lamps) for the treatment of vitiligo does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness in improving health outcomes.
 
For members with contracts without primary coverage criteria, targeted phototherapy (i.e., broadband (BB)-ultraviolet B (UVB) devices, narrowband (NB)-UVB devices, xenon chloride (XeCl) lasers and lamps)  is considered investigational for the treatment of vitiligo. Investigational devices are specific contract exclusions in most member benefit certificates of coverage.
 

Rationale:
Targeted Phototherapy
In 2010, Whitton and colleagues published a Cochrane review of randomized controlled trials (RCTs) on treatments for vitiligo (Whitton, 2010). The investigators searched the literature through November 2009 and identified 5 trials on excimer laser therapy. None of these trials included a control group of individuals who did not receive excimer therapy, so the effect of laser therapy cannot be isolated. Four trials compared the combination of excimer laser therapy and a topical therapy to excimer lasers alone or excimer lasers plus a placebo topical treatment. The fifth trial compared different frequencies of excimer laser treatment (once, twice, or three times weekly). The Cochrane investigators did not pool findings of the studies on laser therapy for vitiligo.
 
In order to adequately evaluate the impact of laser treatment or other targeted phototherapy treatment on vitiligo, RCTs are needed that include a comparison group of patients who receive a treatment other than targeted phototherapy (i.e. an alternative treatment, no treatment, or sham treatment). Subsequent to the publication of the Whitton et al. Cochrane review, several RCTs with this design have been published and are described below.
 
Two trials were conducted by the same research group in Italy. In 2012, Nistico and colleagues published a non-blinded RCT that included 53 patients with localized and generalized vitiligo (Nistico, 2012). Patients were randomly assigned to one of 3 treatments for 12 weeks: 1) Excimer laser plus vitamin E (n=20); 2) excimer laser plus topical 0.1% tacrolimus ointment and vitamin E (n=20); 3) vitamin E only (control group, n=13). All patients in the 2 excimer laser groups completed treatment; 1 patient in the control group dropped out. Before and after treatment, 2 independent clinicians rated clinical response; 51-75% repigmentation was considered a ‘good’ response and >75% repigmentation was considered an ‘excellent’ response. The proportion of patients with a good or excellent response was 11/20 (55%) in the laser plus vitamin E group, 14/20 (70%) in the laser E plus tacrolimus plus vitamin E group, and 0 in the control group. The rate of good or excellent response did not differ significantly between the groups that received excimer laser therapy with and without topical treatment (p=0.36). The response rate was significantly better in both groups receiving laser treatment compared to the control group (p<0.001).
 
The Italian research group also published a similar 12-week study in 2009 in which topical 4% khellin ointment was used instead of tacrolimus ointment (Saraceno, 2009). This study included 48 patients (16 per group), of which 45 (94%) completed treatment. The proportion of patients with a good or excellent response (see definitions above) was 14/16 (88%) in the excimer laser plus vitamin E group, 14/16 (88%) in the excimer laser plus khellin plus vitamin E group, and 1/16 (6%) in the vitamin E only (control) group. The clinical response rates in the 2 groups receiving laser treatment were significantly higher than in the control group.
 
In 2012, El-Zawahry and colleagues in Egypt published findings of a study comparing ultraviolet A (UVA) treatment and targeted narrowband ultraviolet B (NB-UVB) phototherapy in 40 patients with vitiligo (El-Zawahry, 2012). Phototherapy sessions occurred 3 times a week for 12 weeks. The primary efficacy outcome was change in the Vitiligo Area Scoring Index (VASI) before and after treatment. After the 36 treatment sessions, the median percent change in VASI score was 0% (range: -13.3% to 37.5%) in the UVA group and -6.7% (range: -50.9% to 26.4%) in the NB-UVB group. The difference between groups was statistically significant, favoring the NB-UVB group (p=0.000). Several secondary outcomes also favored the NB-UVB group. For example, a significantly higher proportion of patients in the NB-UVB were judged by a blinded physician to have a moderate to excellent response compared to patients in the UVA group (80% vs. 25%, p=0.000).
 
Conclusions: Most published RCTs evaluating targeted phototherapy for vitiligo treated patients in all groups with targeted phototherapy and thus the effect of phototherapy treatment cannot be isolated. There are 3 small RCTs, 2 from the same research group, which found that excimer laser treatment produced better results than a comparison intervention (vitamin E or UVA).
 
Psoralens with Ultraviolet A (PUVA)
The 2010 Cochrane review of trials on treatments for vitiligo, discussed above in the section on targeted phototherapy, identified 10 RCTs evaluating oral PUVA (Whitton, 2010). Two trials assessed oral PUVA alone, and 8 assessed PUVA in combination with other treatments e.g., calcipotriol, azathioprine, polypodium leucotomos, khellin, or surgical treatment. Seven of the 8 studies used 9 methoxypsoralen. Six trials were identified on oral PUVA plus sunlight; 2 of these used placebo as the comparison. Due to differences among studies, findings of trials on oral PUVA and on oral PUVA plus sunlight were not pooled.
 
An earlier meta-analysis of treatments for vitiligo was published in 1998 by Njoo and colleagues (Njoo, 1998). A pooled analysis of 2 RCTs on oral unsubstituted psoralen plus sun for generalized vitiligo (total n=97) found a statistically significant treatment benefit of active treatment compared to placebo (pooled odds ratio [OR]: 19.9, 95% confidence interval [CI]: 2.4 to 166.3). A pooled analysis of 3 RCTs, 2 on oral methoxsalen plus sun and 1 on oral trioxsalen plus sun (total n=181) also found a significant benefit of active treatment versus placebo on generalized vitiligo (OR: 3.8, 95% CI: 1.3 to 11.3). All studies were published prior to 1985, had relatively small sample sizes (confidence intervals were wide), and used sun exposure rather than artificial UVA.
 
A 2007 RCT, using a psoralen formulation available in the U.S. was published by Yones and colleagues (Yones, 2007). The study used data on 56 patients in the U.K. who had non-segmental vitiligo. Outcome assessment was blinded. Patients were randomly assigned to receive twice-weekly treatments with methoxsalen hard gelatin capsules (8-MOP) psoralen plus UVA (n=28) or narrow band (NB)-ultraviolet B (UVB) therapy (n=28). The NB-UVB treatments were administered in a Waldmann UV500 cabinet containing 24 Phillips 100 NB-UVB fluorescent tubes. In the PUVA group, the starting dose of irradiation was 0.5 J/cm2, followed by 0.25 J/cm2 incremental increases if tolerated. Patients were evaluated after every 16 sessions and followed for up to 1 year. Treatment was discontinued if there was complete or near complete resolution of vitiligo, no or minimal improvement after 32 treatments, completion of 200 lifetime treatments, or upon patient request. All patients were included in the analysis. The median number of treatments received was 49 in the PUVA group and 97 in the NB-UVB group. At the end of treatment, the median improvement body surface area with vitiligo (BSA-V) was 23% in the PUVA group and 61% in the NB-UVB group. In addition, 5 of 25 (20%) of patients in the PUVA group and 8 of 25 (32%) in the NB-UVB group had at least 75% improvement in BSA-V at the end of follow-up. The authors did not provide p-values in their outcome table. They stated though, that the difference in improvement in BSA-V did not differ significantly between groups. A total of 24 (96%) patients in the PUVA group and 17 (68%) in the NB-UVB group developed erythema at some point during treatment; this difference was statistically significant, p=0.02.
 
Conclusions: There is some evidence from randomized studies, mainly those published prior to 1985, that PUVA is more effective than placebo for treating vitiligo. A 2007 RCT did not find a statistically significant difference in efficacy between PUVA and NB-UVB.
 
Summary
Light therapy for vitiligo includes both targeted phototherapy and psoralen plus ultraviolet A (PUVA). There is some evidence from randomized studies, mainly those published prior to 1985, that PUVA is more effective than placebo for treating vitiligo. PUVA for vitiligo is recommended in British guidelines for adults who do not respond to more conservative treatments.
 
For targeted phototherapy, there is a lack of clinical trial evidence that compares this technique to more conservative treatments or no treatment/placebo, with only one small RCT identified. This evidence is insufficient to determine the efficacy of targeted phototherapy.
 
Practice Guidelines and Position Statements
In 2008, a guideline on the diagnosis and management of vitiligo was published by several organizations in the U.K. including the British Association of Dermatologists, the Royal College of Physicians of London, and the Cochrane Skin Group (Gawkrodger, 2008). The guideline included the following statements:
 
PUVA therapy should be considered for treatment of vitiligo only in adults who cannot be adequately managed with more conservative treatments. PUVA is not recommended in children. (Grade of recommendation D, Level of evidence 4)
 
If phototherapy is to be used for treating nonsegmental vitiligo, NB-UVB should usually be used in preference to oral PUVA. (Grade of recommendation A, Level of evidence 1+)
 
A trial of PUVA therapy should be considered only for adults with widespread vitiligo, or localized vitiligo associated with a significant impact on patient's QoL (quality of life). Ideally, this treatment should be reserved for patients with darker skin types. (Grade of recommendation D, Level of evidence 3)
 
Before starting PUVA treatment, patients should be made aware that there is no evidence that this treatment alters the natural history of vitiligo. They should also be made aware that not all patients respond, and that some body sites, such as the hands and feet, respond poorly in all patients. They should also be informed of the limit to the number of treatments due to possible side-effects. (Grade of recommendation D, Level of evidence 3)
 
2014 Update
A 2013 RCT used a psoralen formulation available in India, which has the active ingredient methoxsalen; this ingredient is available in the U.S (Bansal, 2013). The study included 45 patients with vitiligo covering more than 5% of their body surface area; 40 patients completed the study. Patients were randomized to receive 3 weekly treatments of either NB-UVB or PUVA. Treatments continued for 60 sessions or 6 months, whichever came first. At the end of follow-up, the mean percentage reduction in the Vitiligo Area Severity Index (VASI) score was 21.7 in the NB-UVB group and 29.2 in the PUVA group. The difference between groups in the VASI score was statistically significant, favoring the PUVA group (p=004). Four patients in the NB-UVB group and 10 in the PUVA group developed adverse effects; none of these were serious enough to lead to discontinuation of phototherapy.
 
In 2013, consensus guidelines on management of vitiligo were published by the European Dermatology Forum (Taieb, 2013). The guidelines state that oral PUVA is commonly used in adults with generalized vitiligo as second-line treatment. The guideline also state that targeted phototherapy is indicated for localized vitiligo, particularly small lesions of recent onset and childhood vitiligo, to avoid adverse effects due to total body irradiation and when total body irradiation is contraindicated. The guidelines were based on expert opinion and not on a systematic review of the literature.
 
2015 Update
A literature search conducted through June 2014 did not reveal any new information that would prompt a change in the coverage statement. Two publications identified are summarized below.
 
In 2015, Whitton et al published an updated Cochrane review of randomized controlled trials (RCTs) on treatments for vitiligo (Whitton, 2015). The investigators searched the literature through October 2013 and identified 12 trials on laser light devices. Six trials evaluated the combination of laser light devices and a topical therapy and 2 evaluated the combination of laser devices and surgical therapy. Three trials compared regimens of laser monotherapy. The remaining trial compared a helium neon (HeNe) laser and a 290 to 320 nm UVB flurorescent lamp. Due to heterogeneity across studies, the Cochrane authors did not pool study findings. In most trials, all groups received laser light treatment, alone or as part of combination therapy, and thus the effect of targeted phototherapy could not be isolated.
 
In 2015, Sun et al published a systematic review of RCTs that focused on treatment of vitiligo with the 308 nm excimer laser (Sun, 2015). Review authors identified 7 RCTs with a total of 390 patients. None of the studies were conducted in the United States; 5 were from Asia. Three of the trials compared the excimer laser with an excimer lamp, and 4 studies compared the excimer laser with NB-UVB. The 4 studies with the comparison to NB-UVB are of greatest interest to this review. However, 2 of these were not published in English, and 1 had a sample size of only 14 patients. The fourth study, published by Yang et al in 2010 (Yang, 2010), did not report efficacy outcomes such as clinical response rate or repigmentation rate. Instead, the investigators reported on the proportion of patients with various types of repigmentation: perifollicular, marginal, diffuse, or combined. Repigmentation rates did not differ significantly between groups treated with the excimer laser versus NB-UVB. The authors of the systematic review conducted a meta-analysis of the 2 studies that were not published in English; thus, results cannot be verified. They reported that the likelihood of a minimum 50% repigmentation rate was significantly higher with the excimer laser compared with NB-UVB (risk ratio [RR]: 1.39, 95% confidence interval [CI]: 1.05 to 1.85). Review authors also stated that, in qualitative analysis, neither of these studies showed significant benefit of the excimer laser for achieving a minimum 75% repigmentation rate.  
 
2017 Update
A literature search conducted using the MEDLINE database through June 2017 did not reveal any new literature that would prompt a change in the coverage statement.
 
A 2016 systematic review identified 3 studies that compared targeted phototherapy with a 308 nm excimer lamp to NB-UVB and 3 studies that compared the excimer lamp to the excimer laser (Lopes, 2016). No differences between the excimer lamp and NB-UVB were identified for the outcome of 50% or greater repigmentation (RR=1.14; 95% CI, 0.88 to 1.48). For repigmentation of 75% or greater, only 2 small studies were identified and the relative risk was 1.81 (95% CI, 0.11 to 29.52), showing a lack of precision in the estimate. For the 3 studies that compared the excimer lamp to the excimer laser, there were no significant differences between treatments for either 50% or greater repigmentation (RR=0.97; 95% CI, 0.84 to 1.11) or 75% or greater repigmentation (RR=0.96; 95% CI, 0.71 to 1.30). All treatments were most effective in lesions located on the face, with the worst response being lesions on the extremities. There was some evidence of an increase in adverse events such as blistering with targeted phototherapy.
 
2018 Update
A literature search was conducted through June 2018.  There was no new information identified that would prompt a change in the coverage statement.  The key identified literature is summarized below.
 
TARGETED PHOTOTHERAPY
 
Randomized Controlled Trials
Zhang et al published an RCT evaluating the use of the 308-nm targeted laser with and without Yiqiqubai granule for the treatment of vitiligo (Zhang, 2017). Yiqiqubai granule is a therapy in traditional Chinese medicine, which is believed to activate blood circulation. The trial had 3 arms: 75 patients received twice- daily oral Yiqiqubai alone, 78 received weekly laser treatments alone, and 80 received both twice-daily oral Yiqiqubai and weekly laser treatments. All groups received treatment for 6 months. Two dermatologists not involved in the treatment assessed before and after pictures of the patients. Quality of life measures consisted of embarrassment, dress, social, and work components, measured on a 5-point scale. Following the 6 months of treatment, the percentages of patients achieving 50% or more repigmentation were 43%, 47%, and 51% for the Yiqiqubai alone, laser alone, and combined Yiqiqubai and laser groups, respectively (p<0.05). While the quality of life improved in all 3 treatment arms, patients in the combined treatment arm reported significantly larger improvements than the arms receiving laser or Yiqiqubai alone.
 
Retrospective Studies
Fa et al published a retrospective analysis of 979 Chinese patients (3478 lesions) treated with the 308-nm targeted laser for vitiligo (Fa, 2017). Patients had Fitzpatrick skin phototype III or IV and were followed for 2 years after last treatment. Repigmentation was assessed by 2 dermatologists. A total of 1374 (39%) lesions reached at least 51% repigmentation, with 1167 of the lesions reaching over 75% repigmentation. Complete repigmentation was seen in 219 lesions. Among the cured lesions, the recurrence rate was 44%. Patients with longer disease duration and older age experienced significantly lower efficacy rates. Application of 16 to 20 treatments resulted in higher repigmentation rates than fewer treatments, and increasing the number of treatments beyond 21 did not appear to improve repigmentation rates. There was no discussion of adverse events.
 
Dong et al evaluated the use of a medium-band (304-312 nm) targeted laser for treating pediatric patients (age 16 years) with vitiligo (Dong, 2017). Twenty-seven patients (95 lesions) were evaluated by 2 dermatologists following a mean of 20 treatments (range, 10-50 treatments). After 10 treatment sessions, 37% of the lesions reached 50% or more repigmentation. After 20 treatment sessions, 54% of the lesions achieved 50% or more repigmentation. Six children experienced adverse events such as asymptomatic erythema, pruritus, and xerosis, all resolving in a few days.
 
Section Summary: Targeted Phototherapy
A number of RCTs and retrospective analyses have evaluated targeted phototherapy for treating vitiligo. The studies have tended to have small sample sizes, and few were designed to isolate the effect of laser therapy. Moreover, studies were heterogeneous (eg, duration and frequency of therapy sessions, different interventions or combinations of interventions, different comparison interventions). These characteristics made it difficult to pool study findings or to draw conclusions about the efficacy of targeted phototherapy for vitiligo. Two meta-analyses were attempted; however, one 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. Also, studies have suggested a potential for blistering and slight erythema with targeted phototherapy. Larger studies with representative patient populations and standard of care comparators (eg, NB-UVB) are needed to evaluate efficacy and adverse outcomes.
 
PSORALENS WITH ULTRAVIOLET A
 
Systematic Reviews
Bae et al published a systematic review and meta-analysis on the use of phototherapy for the treatment of vitiligo (Bae, 2017). The literature search, conducted through January 2016, identified 35 unique studies for inclusion with 1201 patients receiving NB-UVB and 227 patients receiving PUVA. Category of evidence and strength of recommendation were based on study design of the selected studies. The outcome of interest was repigmentation rate. Adverse events were not discussed.
 
Vitiligo Working Group
The Vitiligo Working Group is supported by the National Institute of Arthritis and Musculoskeletal and Skin Diseases, part of the National Institutes of Health. In 2017, the group published guidelines on current and emerging treatments for vitiligo (VWG, 2017). The Working Group indicated that psoralens with ultraviolet A has largely been replaced by narrowband ultraviolet B, but that “PUVA may be considered in patients with darker Fitzpatrick skin phototypes or those with treatment-resistant vitiligo (level I evidence).” The Working Group also stated that “Targeted phototherapy (excimer lasers and excimer lamps) can be considered when <10% of body surface area is affected (level II evidence).”
 
2019 Update
A literature search was conducted through June 2019.  There was no new information identified that would prompt a change in the coverage statement.
 
2020 Update
A literature search was conducted through June 2020.  There was no new information identified that would prompt a change in the coverage statement.    
 
2021 Update
Annual policy review completed with a literature search using the MEDLINE database through June 2021. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
 
Poolsuwan et al compared treatment of 36 paired vitiligo lesions with either targeted phototherapy (308-nm excimer light) or NB-UVB in a single-blind study of 36 patients (Poolsuwan, 2020). Treatment of lesions with targeted phototherapy led to significant reductions in the Vitiligo Area Scoring index (VASI) score and significantly improved repigmentation grade compared to treatment with NB-UVB; however, the difference between groups in these outcomes were marginal and may not be clinically significant.
 
2022 Update
Annual policy review completed with a literature search using the MEDLINE database through June 2022. No new literature was identified that would prompt a change in the coverage statement.
 
2023 Update
Annual policy review completed with a literature search using the MEDLINE database through June 2023. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
 
Wu et al compared the treatment of 83 paired vitiligo lesions with either 308-nm excimer laser or topical tacrolimus, with both arms receiving concomitant intramuscular betamethasone injections, in a single-blind study of 138 patients (Wu, 2019). Excimer laser therapy was associated with a significantly higher proportion of patients with at least 50% repigmentation at 3 months compared to topical tacrolimus. However, interpretation of study results is limited by inadequate description of methods and use of per-protocol analysis, with an evident high rate of patient dropout.
 
In a randomized trial by Oh et al, matched lesions in 16 patients were randomized to 308-nm excimer laser alone, topical tacalcitol alone, or the combination of excimer laser and topical tacalcitol (Oh, 2011). Excimer laser therapy alone and in combination with topical tacalcitol were associated with a significantly higher repigmentation response quartile at 16 weeks compared to topical tacalcitol alone. However, interpretation of study results is limited by inadequate description of methods, and it is unclear whether tacalcitol is comparable to other standard-of-care topical vitamin D3 analogues.
 
2024 Update
Annual policy review completed with a literature search using the MEDLINE database through December 2023. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
 
The international Vitiligo Task Force published a 2023 consensus statement on the management of vitiligo (Seneschal, 2023). First-line recommendations include topical corticosteroids or immunomodulators. The task force does not recommend oral psoralen plus ultraviolet A (PUVA) but recommends topical PUVA as an option for localized lesions. The statement includes recommendations for the use of excimer devices in patients with localized disease.

CPT/HCPCS:
96912Photochemotherapy; psoralens and ultraviolet A (PUVA)
96920Laser treatment for inflammatory skin disease (psoriasis); total area less than 250 sq cm
96921Laser treatment for inflammatory skin disease (psoriasis); 250 sq cm to 500 sq cm
96922Laser treatment for inflammatory skin disease (psoriasis); over 500 sq cm
96999Unlisted special dermatological service or procedure

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

Dong DK, Pan ZY, Zhang J, et al.(2017) 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

El-Zawahry BM, Bassiouny DA, Sobhi RM et al.(2012) A comparative study on efficacy of UVA1 vs. narrow-band UVB phototherapy in the treatment of vitiligo. Photodermatol Photoimmunol Photomed 2012; 28(2):84-90.

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

Oh SH, Kim T, Jee H, et al.(2011) Combination treatment of non-segmental vitiligo with a 308-nm xenon chloride excimer laser and topical high-concentration tacalcitol: a prospective, single-blinded, paired, comparative study. J Am Acad Dermatol. Aug 2011; 65(2): 428-430. PMID 21763570

Poolsuwan P, Churee C, Pattamadilok B.(2020) Comparative efficacy between localized 308-nm excimer light and targeted 311-nm narrowband ultraviolet B phototherapy in vitiligo: A randomized, single-blind comparison study. Photodermatol Photoimmunol Photomed. Oct 12 2020. PMID 33047405

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

Saraceno R, Nistico S, Capriotti E et al.(2009) 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.

Seneschal J, Speeckaert R, Taïeb A, et al.(2023) Worldwide expert recommendations for the diagnosis and management of vitiligo: Position statement from the international Vitiligo Task Force-Part 2: Specific treatment recommendations. J Eur Acad Dermatol Venereol. Sep 15 2023. PMID 37715487

Sun Y, Wu Y, Xiao B, et al.(2015) 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

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

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Wu Y, Sun Y, Qiu L, et al.(2019) A multicentre, randomized, split face and/or neck comparison of 308-nm excimer laser and 0·1% tacrolimus ointment for stable vitiligo plus intramuscular slow-releasing betamethasone for active vitiligo. Br J Dermatol. Jul 2019; 181(1): 210-211. PMID 30644997

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