Home vs hospital narrowband UVB treatment by a hand-held unit for new-onset vitiligo: A pilot randomized controlled study.

PURPOSE: To compare the efficacy and safety of narrowband ultraviolet B (NB-UVB) phototherapy in home vs in hospital for the management of limited new-onset vitiligo. METHODS: Patients with new-onset vitiligo (<3 months) with <5% body surface area involvement were recruited and randomly assigned to either a home-based or a hospital-based treatment group. Both groups were administered NB-UVB phototherapy thrice a week. The body surface area (BSA) involved with vitiligo, Vitiligo Area Scoring Index (VASI), the effectiveness of repigmentation, Vitiligo Quality of Life index (VitiQoL), and the cost of treatment were examined. RESULTS: A total of 100 patients completed the study. Patients in both groups exhibited improvements demonstrated by BSA and VSAI decrease. No significant differences were found between the two groups in terms of skin repigmentation (P > 0.05). Improvements in the VitiQoL scores were reduced to the greatest degree at week 8 for all patients in both groups. Adverse events, such as painful erythema, burning, blistering, and excessive hyperpigmentation, were more frequently observed in the home-based treatment group than in the hospital-based treatment group. The cost of phototherapy in hospital exceeded the cost of home phototherapy after 7 weeks of treatment. CONCLUSIONS: Home NB-UVB phototherapy treatment was as effective as treatment in hospital, but exhibited cost-effective and a better compliance. However, the education of the patients should be strengthened to avoid excessive UVB exposure and related adverse events.

Therapies for Psoriasis: Clinical and Economic Comparisons.

BACKGROUND: Clinical and economic comparisons of therapies for plaque psoriasis are regularly updated following each new devel- opment in the field. With the recent availability of a novel accessory (Multi Micro DoseTM [MMD®] tip) for the 308nm excimer laser (XTRAC®, Strata Skin Sciences, Horsham, PA), which can determine and deliver an optimal therapeutic dose (OTDTM) of ultraviolet-B light in an improved protocol, the need for comparative health-economic assessment recurs. To this end, a comprehensive evaluation of treatment-related costs was undertaken from the payer perspective. Results show that outcomes are influenced by many factors; most importantly, the severity and extent of disease, treatment selection, and patient preference, as well as compliance, adherence, and persistence with care. Among study comparators, the 308nm excimer laser – XTRAC – with its latest MMD enhancement, is safe and delivers incremental clinical benefits with the potential for significant cost savings. These benefits are particularly relevant today in the context of SARS-CoV-2 virus and the COVid-19 pandemic. J Drugs Dermatol. 2020;19(11):1101-1108. doi:10.36849/JDD.2020.5510.

Narrowband ultraviolet B phototherapy improves quality of life of psoriasis and atopic dermatitis patients up to 3 months: Results from an observational multicenter study.

BACKGROUND/PURPOSE: Narrowband UVB phototherapy is a common treatment modality in psoriasis and atopic dermatitis, but evidence of its actual effect in clinical setting is sparse. Our aim was to assess the effectiveness and costs of narrowband UVB phototherapy in psoriasis and atopic dermatitis in clinical setting. METHODS: We observed 207 psoriasis patients and 144 atopic dermatitis patients in eight centers. SAPASI, PO-SCORAD, and VAS measures were used at baseline, at the end, and 3 months after the narrowband UVB phototherapy course. Quality of life was measured using Dermatology Life Quality Index (DLQI), and costs were assessed using a questionnaire. RESULTS: In both psoriasis and atopic dermatitis, the DLQI and Self-Administrated PASI (SAPASI)/Patient-Oriented SCORAD (PO-SCORAD) improved significantly and the results remained improved for at least 3 months in both groups. Alleviation of pruritus correlated with better quality of life in both patient groups. We reported slight redness and burning side effects which were due to lack of MED testing. Self-administered tools proved to be useful in evaluating pruritus and severity of the disease in psoriasis and atopic dermatitis. Mean patient costs were 310 € and 21 hours of time, and mean costs for the healthcare provider were 810 €. CONCLUSION: In psoriasis, narrowband UVB is a very efficient treatment in clinical setting, whereas in atopic dermatitis, more studies are needed to determine the best dosage.

Narrowband ultraviolet B treatment for psoriasis is highly economical and causes significant savings in cost for topical treatments.

BACKGROUND: Narrowband ultraviolet B (NB-UVB) treatment for psoriasis is considered expensive. However, existing data are based on estimates and do not consider indirect cost savings. OBJECTIVES: To define the actual costs of NB-UVB incurred by the service provider, as well as treatment-associated cost savings. METHODS: We performed data linkage of (i) comprehensive treatment records and (ii) prescribing data for all NB-UVB treatment episodes spanning 6 years in a population of 420 000. We minimized data fluctuation by compiling data from four independent treatment sites, and using drug prescriptions unrelated to psoriasis as a negative control. RESULTS: National Health Service Tayside spent an average of £257 per NB-UVB treatment course (mean 257 ± 63, range 150-286, across four independent treatment sites), contrasting sharply with the estimate of £1882 used by the U.K. National Institute for Health and Care Excellence. The cost of topical treatments averaged £128 per patient in the 12 months prior to NB-UVB, accounting for 42% of the overall drug costs incurred by these patients. This was reduced by 40% to £53 per patient over the 12-month period following NB-UVB treatment, while psoriasis-unrelated drug prescription remained unchanged, suggesting disease-specific effects of NB-UVB. The data were not due to site-specific factors, as confirmed by highly similar results observed between treatment sites operated by distinct staff. Finally, we detail all staff hours directly and indirectly involved in treatment, allowing direct translation of cost into other healthcare systems. CONCLUSIONS: NB-UVB is a low-cost treatment; cost figures currently used in health technology appraisals are an overestimate based on the data presented here. Creating or extending access to NB-UVB is likely to offer additional savings by delaying or avoiding costly third-line treatments for many patients.

Trends in phototherapy utilization among Medicare beneficiaries in the United States, 2000 to 2015.

BACKGROUND: Phototherapy is a cost-effective treatment for many dermatoses, yet the emergence of alternative therapies such as biologics led many to think that phototherapy utilization was declining. OBJECTIVE: To characterize national, historical phototherapy utilization and costs among Medicare beneficiaries. METHODS: Longitudinal analysis of the Medicare Part B National Summary Data File from 2000 to 2015 for phototherapy billing codes. Geographic distribution of clinics and provider type obtained from the Medicare Provider Utilization and Payment Data for 2012 to 2015. RESULTS: The overall volume of phototherapy services billed to Medicare from 2000 to 2015 increased by 5% annually, from 334,670 to 692,093. Ultraviolet B therapy comprised 77% of phototherapy volume, utilization of psoralen plus ultraviolet A therapy declined by 9% annually, and excimer laser services grew by 29% annually. The number of phototherapy clinics is increasing but remains concentrated in only 11% of US counties. Between 2012 and 2015, dermatologists accounted for 92% of phototherapy volume. LIMITATIONS: Commercial payers and institutional claims (hospital-based physicians) are excluded. Clinical indications for phototherapy use are not reported in this database. CONCLUSION: Phototherapy utilization has grown, though the service mix has shifted toward ultraviolet B and laser excimer therapy and away from psoralen plus ultraviolet A therapy. Dermatologists manage most phototherapy. Uneven geographic distribution of phototherapy clinics limits access in nonurban areas, and further evaluation is needed to determine its impact on rural communities.

A Systematic Review of Light Emitting Diode (LED) Phototherapy for Treatment of Psoriasis: An Emerging Therapeutic Modality.

Background: Psoriasis is a chronic, inflammatory skin condition. The economic burden of psoriasis is approximately $35.2 billion in the United States per year, and treatment costs are increasing at a higher rate than general inflation. Light emitting diode (LED) phototherapy may represent a cost-effective, efficacious, safe, and portable treatment modality for psoriasis.

Objective: The goal of our manuscript is to review the published literature and provide evidence-based recommendations on LED phototherapy for the treatment of psoriasis.

Methods & Materials: A search of the databases Pubmed, EMBASE, Web of Science, and CINAHL was performed on April 5, 2016. Key search terms were related to psoriasis and LED-based therapies.

Results: A total of 7,793 articles were generated from the initial search and 5 original articles met inclusion criteria for our review. Grade of recommendation: B for LED-blue light. Grade of recommendation: C for LED-ultraviolet B, LED-red light, and combination LED-near-infrared and LED-red light.

Conclusion: We envision further characterizing the effects of LED phototherapy to treat psoriasis in patients may increase adoption of LED-based modalities and provide clinicians and patients with new therapeutic options that balance safety, efficacy, and cost.

J Drugs Dermatol. 2017;16(5):482-488.

Phototherapy in dermatology: A call for action.

Of the wide range of treatment modalities available to dermatologists, few possess the history, efficacy, and safety of phototherapy. It should be emphasized that dermatologists are the only group of physicians optimally trained and qualified to understand the medical indications of phototherapy. Phototherapy, recognized for its cost-effectiveness, should remain a consideration in patient treatment. Continued training and education in residency and thereafter is needed to maintain the proficiency of physicians. In addition, payors need continued education to ensure that insurance coverage of phototherapy is not a barrier for patients to access this therapy. To further improve and optimize the outcome, phototherapy research needs to be supported.

Estimated cost efficacy of systemic treatments that are approved by the US Food and Drug Administration for the treatment of moderate to severe psoriasis.

BACKGROUND: Newer psoriasis treatments tout higher efficacy but are generally more expensive. OBJECTIVE: We sought to estimate the cost efficacy of systemic psoriasis treatments that have been approved by the US Food and Drug Administration (FDA). METHODS: A literature review of systemic psoriasis treatments that have been approved by the FDA was performed for the primary end point of a 75% reduction in the Psoriasis Area and Severity Index score (PASI 75). Medication cost was referenced by wholesale acquisition cost (WAC), laboratory fees were obtained from the American Medical Association, and office visit fees are standard at our university. Total expenses were standardized by calculating cost per month of treatment considering the number needed to treat (NNT) to achieve PASI 75. RESULTS: Methotrexate ($794.05-1502.51) and cyclosporine ($1410.14-1843.55) had the lowest monthly costs per NNT to achieve PASI 75. The most costly therapies were infliximab ($8704.68-15,235.52) and ustekinumab 90 mg ($12,505.26-14,256.75). Monthly costs per NNT to achieve PASI 75 for other therapies were as follows: narrowband ultraviolet B light phototherapy ($2924.73), adalimumab ($3974.61-7678.78), acitretin ($4137.71-14,148.53), ustekinumab 45 mg ($7177.89-7263.99), psoralen plus ultraviolet A light phototherapy ($7499.46-8834.98), and etanercept ($8284.71-10,674.89). LIMITATIONS: Drug rebates and incentives, potential adverse effects, comorbidity risk reduction, ambassador programs, and combination therapies were excluded. CONCLUSION: Our study provides meaningful cost efficacy data that may influence psoriasis treatment selection.

Home ultraviolet light therapy for psoriasis: why patients choose other options.

BACKGROUND: Psoriasis is a common inflammatory skin condition for which office-based and home phototherapy are safe and effective treatments. However, patients who are prescribed home phototherapy devices often choose other treatment options. OBJECTIVE: To determine the reasons why patients do not purchase a home phototherapy device after it has been recommended and prescribed by their physician. METHODS: Patients who were written a prescription for a home phototherapy device but did not fill the prescription were identified and contacted by the National Biological Corporation to participate in a telephone survey consisting of 4 questions regarding why they did not pursue a prescribed home ultraviolet device and how they were currently treating their psoriasis. RESULTS: The most common reason for not obtaining the prescribed home phototherapy device was using a biologic agent (31%). The second and third most frequently reported reasons were "cost share too high" and "insurance will not cover" (18% and 17%, respectively), together accounting for 35%. LIMITATIONS: The reason why patients were prescribed biologics while having an unfilled home phototherapy device prescription was not obtained. CONCLUSIONS: Out of pocket cost is a significant barrier to home phototherapy, even to patients who are well insured.

Summary of the Dutch S3-guidelines on the treatment of psoriasis 2011. Dutch Society of Dermatology and Venereology.

This document provides a summary of the Dutch S3-guidelines on the treatment of psoriasis. These guidelines were finalized in December 2011 and contain unique chapters on the treatment of psoriasis of the face and flexures, childhood psoriasis as well as the patient's perspective on treatment. They also cover the topical treatment of psoriasis, photo(chemo)therapy, conventional systemic therapy and biological therapy.

The UPDATE trial (UVB Phototherapy in Dermatology for ATopic Eczema): study protocol for a randomized controlled trial of narrowband UVB with optimal topical therapy versus optimal topical therapy in patients with atopic eczema.

BACKGROUND: Narrowband ultraviolet B (NB-UVB) phototherapy is commonly prescribed for patients with moderate-to-severe atopic eczema (AE). The efficacy of NB-UVB, however, has not yet properly been established, as current evidence is of low certainty. Our aim is to assess the short-term and long-term (cost-)effectiveness and safety of NB-UVB in adult AE patients by performing a pragmatic, multicenter, prospective, randomized, open-label, blinded-endpoint (PROBE) trial. This protocol outlines its methodology. METHODS: A pragmatic, multicenter, PROBE trial will be performed with 1:1 randomization of 316 adult patients with moderate-to-severe AE who have inadequate disease control with topical therapy and who are eligible for optimal topical therapy (OTT) or NB-UVB in combination with OTT as a next step. Participants in the interventional arm will receive a minimum of 3 months of OTT combined with 8 to 16 weeks of NB-UVB. The control group receives 3 months of OTT. Following the interventional phase, follow-up will continue for 9 months. Physician-reported and patient-reported outcomes (according to the Harmonising Outcome Measures for Eczema (HOME) Core Outcome Set) and adverse events are assessed at 4 weeks, 3, 6, 9, and 12 months. DISCUSSION: The UPDATE trial aims to provide high-quality evidence regarding the (cost-)effectiveness and safety of NB-UVB phototherapy in moderate-to-severe AE patients. Challenges that are addressed in the protocol include the possible bias arising from applying open-label treatment and the necessity of introducing OTT into the study design to prevent a high dropout rate. TRIAL REGISTRATION: ClinicalTrials.gov NCT05704205. Registered on December 8, 2022.

Cost of illness from occupational hand eczema in Germany.

BACKGROUND: There is little knowledge about the costs of occupational hand eczema. OBJECTIVES: To estimate the societal costs of patients with occupational hand eczema in Germany. METHODS: Resource use during the past year, disease severity and quality of life [Dermatology Life Quality Index (DLQI)] were gathered for patients with occupational hand eczema before they entered a special rehabilitation programme. Costs were calculated from the societal perspective. The analysis focused on all patients and the severity groups no signs/mild (group A) and moderate to severe (group B). RESULTS: One hundred and fifty-one patients were analysed, with a mean age of 44.9~years and a mean DLQI score of 10.9; 64.9% were male. Sickness absence was recorded for 62.9% of all patients (76.4~days on average in the last 12~months). Annual societal costs were €8799 per patient. Indirect costs represented 70% of total costs. Quality of life (DLQI) was statistically different across both severity groups (group A, 7.9; group B, 12.9), but direct treatment costs were not (€2705 versus €2610, respectively). There was a trend towards higher indirect costs in patients in severity group B (group A, €5120; group B, €6796). CONCLUSION: The annual societal costs of patients with occupational hand eczema in this study are high, and similar to those for severe psoriasis and atopic dermatitis.

Explicit and implicit copayments for phototherapy: examining the cost of commuting.

BACKGROUND: Whereas phototherapy is a safe and cost-effective treatment modality for psoriasis, economic disincentives discourage its use, including both direct and indirect costs to the patient. PURPOSE: To determine when it may be cost-effective for patients to purchase a home light unit versus driving to clinic for outpatient phototherapy sessions. METHODS: Estimates of expenses associated with 3 months of outpatient phototherapy were determined and compared to the price of a home phototherapy unit. Factors examined included the cost of gasoline (based on the national average), fuel efficiency of the vehicle, cost of owning and operating a motor vehicle, lost wages, and copayments. RESULTS: The cost for a standard 6-bulb narrowband UVB home unit is approximately $2600. Direct and indirect expenses imposed on patients increase with distance travelled to the dermatologist. If a patient lives 20 or more miles away from the dermatologist, the expenses associated with travel can total more than the out of pocket expense of purchasing a home phototherapy unit. LIMITATIONS: This small analysis only accounted for the first 3 months of treatment and likely underestimates the total costs that patients would experience over a lifetime of treatment. CONCLUSIONS: It may be beneficial for physicians to educate patients on the cost-burden of in-office versus home phototherapy because patients can use these parameters to determine which option would be more cost-effective for them.

[Analysis of the cost effectiveness of home-based phototherapy with narrow-band UV-B radiation compared with biological drugs for the treatment of moderate to severe psoriasis]. / Análisis coste-efectividad de la fototerapia domiciliaria con ultravioleta B de banda estrecha frente a fármacos biológicos en el tratamiento de la psoriasis moderada-grave.

BACKGROUND: Psoriasis is associated with high treatment costs due to the increasing use of biologic drugs. Phototherapy has been demonstrated to be safe and cost effective for the treatment of psoriasis, although it is limited by the requirement for patients to visit a hospital various times a week. OBJECTIVES: To evaluate the efficiency of home-based phototherapy with narrow-band UV-B radiation compared with biologic drugs for the treatment of moderate to severe psoriasis under normal practice conditions in our setting. METHODS: A retrospective cost-effectiveness study was undertaken in 12 patients with moderate to severe psoriasis. Half of the patients were treated with biologic drugs (2 with etanercept, 2 with adalimumab, and 2 with infliximab) and the other half with home-based phototherapy using a Waldmann UV100L-TL01 lamp. Clinical effectiveness was determined on the basis of achieving a 75% improvement in Psoriasis Area and Severity Index (PASI 75) within 16 weeks of treatment. RESULTS: Treatment was considered to be effective in 5 out of 6 patients (83%) treated with biologics and 4 out of 6 patients (66%) treated with home-based phototherapy. The direct costs required to achieve PASI 75 were 8256€ per patient for biologics and 903€ per patient for home-based phototherapy. The costs associated with effective treatment using biologic drugs in a single patient would provide effective home-based phototherapy for 9.1 patients. LIMITATIONS: The study included a limited number of patients analyzed over a short time period (16 weeks) and the comparison group included multiple treatments with different predicted responses. CONCLUSIONS: Although biologic drugs exhibited greater efficacy, home-based phototherapy was more efficient for the treatment of moderate to severe psoriasis. Home-based phototherapy represents a cost-effective treatment option for patients with psoriasis and may be appropriate for use in the Spanish health care system.

Cost-of-illness of patients with chronic hand eczema in routine care: results from a multicentre study in Germany.

BACKGROUND: It is broadly assumed that costs caused by chronic hand eczema (CHE) are significant. However, there is a lack of cost-of-illness studies on CHE. OBJECTIVES: To determine the direct and indirect costs of CHE under routine conditions in Germany from the societal perspective. METHODS: A cross-sectional survey was conducted in 24 outpatient practices and clinics across Germany. Patients with CHE refractory to potent topical steroids and insured by statutory health insurance were eligible. Clinical and cost data were collected using standardized questionnaires. Severity classes were defined according to a photographic guide and physician global assessment (PGA). Four treatment stages were defined based on the German CHE guidelines: topical treatments only (stage I), additionally ultraviolet (UV) radiation therapy (II), systemic therapy (III) and inpatient treatment (IV). Bivariate associations between costs and severity as well as treatment stage were assessed. RESULTS: Two hundred and twenty-three patients with CHE (mean age 45·7years, 56% women) enrolled in the study, of whom 63·2% were treated only with topical treatments, 15·7% additionally with UV radiation and 11·7% with systemic treatments. Of all patients, 9·4% had been admitted to hospital. Total costs per year and patient were €2128, including €1742 direct costs and €386 indirect costs. The total costs increased with treatment stages I-IV (P<0·001): €1044, €2307, €2697 and €8407, respectively. Accordingly, costs also correlated with clinical severity. CONCLUSIONS: Patients with CHE refractory to topical steroids incur marked costs to society. The costs increase disproportionately with escalating treatment stages, especially in patients admitted to hospital. Hence, new treatments may help to reduce the societal costs of CHE.

Positive effect of modified Goeckerman regimen on quality of life and psychosocial distress in moderate and severe psoriasis.

Psoriasis is a chronic inflammatory skin disease with a profound effect on quality of life and psychosocial stress. The relationship between clinical improvement and psycho-social impact after treatment is complex. The objective of this study was to compare changes in quality of life and psychosocial distress, and overall cost-effectiveness, in patients with psoriasis receiving the modified Goeckerman regimen (UV irradiation and coal tar) with those receiving conventional treatment. Patients with moderate/severe psoriasis receiving the Goeckerman regimen were followed from admission to discharge. Clinical severity, was evaluated weekly using the Psoriasis Area and Severity Index (PASI). Psoriasis Disability Index (PDI) and Hospital Anxiety and Depression Scale (HADS) questionnaires were applied at admission and one month after discharge. Thirty-six patients with psoriasis receiving conventional treatment and 48 patients receiving the Goeckerman regimen were recruited to the study. The mean PASI score in the Goeckerman group decreased from 27.1 to 6.9 and PDI scores decreased from 25.3 to 13.8. HADS scores for anxiety and depression decreased significantly from 9.8 to 6.3 and 9.1 to 6.8, respectively. In comparison with conventional therapy, the modified Goeckerman regime showed similar clinical efficacy, with additional benefits in improving overall quality of life and psychosocial distress in patients with moderate/severe psoriasis, and more cost-effectiveness.

Home-based narrowband UVB, topical corticosteroid or combination for children and adults with vitiligo: HI-Light Vitiligo three-arm RCT.

BACKGROUND: Systematic reviews suggest that narrowband ultraviolet B light combined with treatments such as topical corticosteroids may be more effective than monotherapy for vitiligo. OBJECTIVE: To explore the clinical effectiveness and cost-effectiveness of topical corticosteroid monotherapy compared with (1) hand-held narrowband ultraviolet B light monotherapy and (2) hand-held narrowband ultraviolet B light/topical corticosteroid combination treatment for localised vitiligo. DESIGN: Pragmatic, three-arm, randomised controlled trial with 9 months of treatment and a 12-month follow-up. SETTING: Sixteen UK hospitals - participants were recruited from primary and secondary care and the community. PARTICIPANTS: Adults and children (aged ≥ 5 years) with active non-segmental vitiligo affecting ≤ 10% of their body area. INTERVENTIONS: Topical corticosteroids [mometasone furoate 0.1% (Elocon®, Merck Sharp & Dohme Corp., Merck & Co., Inc., Whitehouse Station, NJ, USA) plus dummy narrowband ultraviolet B light]; narrowband ultraviolet B light (narrowband ultraviolet B light plus placebo topical corticosteroids); or combination (topical corticosteroids plus narrowband ultraviolet B light). Topical corticosteroids were applied once daily on alternate weeks and narrowband ultraviolet B light was administered every other day in escalating doses, with a dose adjustment for erythema. All treatments were home based. MAIN OUTCOME MEASURES: The primary outcome was self-assessed treatment success for a chosen target patch after 9 months of treatment ('a lot less noticeable' or 'no longer noticeable' on the Vitiligo Noticeability Scale). Secondary outcomes included blinded assessment of primary outcome and percentage repigmentation, onset and maintenance of treatment response, quality of life, side effects, treatment burden and cost-effectiveness (cost per additional successful treatment). RESULTS: In total, 517 participants were randomised (adults, n = 398; and children, n = 119; 52% male; 57% paler skin types I-III, 43% darker skin types IV-VI). At the end of 9 months of treatment, 370 (72%) participants provided primary outcome data. The median percentage of narrowband ultraviolet B light treatment-days (actual/allocated) was 81% for topical corticosteroids, 77% for narrowband ultraviolet B light and 74% for combination groups; and for ointment was 79% for topical corticosteroids, 83% for narrowband ultraviolet B light and 77% for combination. Target patch location was head and neck (31%), hands and feet (32%), and rest of the body (37%). Target patch treatment 'success' was 20 out of 119 (17%) for topical corticosteroids, 27 out of 123 (22%) for narrowband ultraviolet B light and 34 out of 128 (27%) for combination. Combination treatment was superior to topical corticosteroids (adjusted risk difference 10.9%, 95% confidence interval 1.0% to 20.9%; p = 0.032; number needed to treat = 10). Narrowband ultraviolet B light was not superior to topical corticosteroids (adjusted risk difference 5.2%, 95% confidence interval -4.4% to 14.9%; p = 0.290; number needed to treat = 19). The secondary outcomes supported the primary analysis. Quality of life did not differ between the groups. Participants who adhered to the interventions for > 75% of the expected treatment protocol were more likely to achieve treatment success. Over 40% of participants had lost treatment response after 1 year with no treatment. Grade 3 or 4 erythema was experienced by 62 participants (12%) (three of whom were using the dummy) and transient skin thinning by 13 participants (2.5%) (two of whom were using the placebo). We observed no serious adverse treatment effects. For combination treatment compared with topical corticosteroids, the unadjusted incremental cost-effectiveness ratio was £2328.56 (adjusted £1932) per additional successful treatment (from an NHS perspective). LIMITATIONS: Relatively high loss to follow-up limits the interpretation of the trial findings, especially during the post-intervention follow-up phase. CONCLUSION: Hand-held narrowband ultraviolet B light plus topical corticosteroid combination treatment is superior to topical corticosteroids alone for treatment of localised vitiligo. Combination treatment was relatively safe and well tolerated, but was effective in around one-quarter of participants only. Whether or not combination treatment is cost-effective depends on how much decision-makers are willing to pay for the benefits observed. FUTURE WORK: Development and testing of new vitiligo treatments with a greater treatment response and longer-lasting effects are needed. TRIAL REGISTRATION: Current Controlled Trials ISRCTN17160087. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 24, No. 64. See the NIHR Journals Library website for further project information.

The Home Interventions and Light therapy for the treatment of vitiligo (HI-Light Vitiligo) trial aimed to find out whether or not treating vitiligo at home with a narrowband ultraviolet B light, either by itself or with a steroid ointment, is better than treatment using a steroid ointment only. We enrolled 517 children (aged ≥ 5 years) and adults who had small, active (i.e. recently changing) patches of vitiligo into the study. Participants received one of three possible treatment options: steroid ointment (plus dummy light), hand-held narrowband ultraviolet B light therapy (plus placebo ointment) or both treatments used together. We asked participants to judge how noticeable their target vitiligo patch was after 9 months of treatment. We considered the treatment to be successful if the participants' responses were either 'a lot less noticeable' or 'no longer noticeable'. The results showed that using both treatments together was better than using a steroid ointment on its own. Around one-quarter of participants (27%) who used both treatments together said that their vitiligo was either 'no longer noticeable' or 'a lot less noticeable' after 9 months of treatment. This was compared with 17% of those using steroid ointment on its own and 22% of those using narrowband ultraviolet B light on its own. All treatments were able to stop the vitiligo from spreading. Patches on the hands and feet were less likely to respond to treatment than patches on other parts of the body. The trial found that the vitiligo tended to return once treatments were stopped, so ongoing intermittent treatment may be needed to maintain the treatment response. The treatments were found to be relatively safe and easy to use, but light treatment required a considerable time commitment (approximately 20 minutes per session, two or three times per week). This trial showed that using steroid ointment and narrowband ultraviolet B light together is likely to be better than steroid ointment alone for people with small patches of vitiligo. Steroid ointment alone can still be effective for some people and remains a useful treatment that is able to stop vitiligo from spreading. The challenge is to make hand-held narrowband ultraviolet B light treatment available as normal care in the NHS for people with vitiligo.

Home Narrowband Ultraviolet B Phototherapy for Photoresponsive Skin Conditions: A Health Technology Assessment.

BACKGROUND: Skin conditions are photoresponsive if they respond to ultraviolet (UV) radiation with partial or complete clearing. Ultraviolet phototherapy is performed by exposing the skin to UV radiation on a regular basis under medical supervision. Three types of UV radiation are used to treat photoresponsive skin conditions: broadband ultraviolet B (BB-UVB), psoralen plus ultraviolet A (PUVA), and narrowband ultraviolet B (NB-UVB). Narrowband UVB phototherapy is generally more effective than BB-UVB and safer than PUVA in the management of several photoresponsive skin conditions. While typically performed in an outpatient clinic setting, home NB-UVB phototherapy may be a viable option for people with limited access to outpatient treatment. We conducted a health technology assessment of home NB-UVB phototherapy for people with photoresponsive skin conditions that included an evaluation of the effectiveness, safety, cost-effectiveness, and budget impact of publicly funding home NB-UVB phototherapy, and patient preferences and values. METHODS: We performed a systematic literature search of the clinical evidence. We assessed the risk of bias of each included study using version 2 of the Cochrane risk-of-bias tool for randomized studies, and we assessed the quality of the body of evidence according to the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) Working Group criteria. We performed a systematic economic literature search and conducted a cost-utility analysis with a 10-year horizon from a public payer perspective. The cost-utility analysis was conducted for psoriasis based on the available clinical evidence. We also analyzed the budget impact of publicly funding home NB-UVB phototherapy in people with photoresponsive skin conditions in Ontario. To contextualize the potential value of NB-UVB phototherapy, we spoke with people with photoresponsive skin conditions. RESULTS: We included one randomized controlled trial in the clinical evidence review. We found that home NB-UVB phototherapy is at least as effective as outpatient clinic NB-UVB phototherapy for the treatment of mild to severe psoriasis (the only photoresponsive skin condition investigated in the included study). In the included study, 82% of participants were treated at home, compared with 79% treated in an outpatient clinic setting (many participants had experience with both treatment settings). They demonstrated an improvement in baseline Psoriasis Area and Severity Index 50 (mean difference 2.8%, 95% confidence interval -8.6% to 14.2%), with the mean difference exceeding the preset noninferiority margin of -15%. Similar results were observed for other psoriasis area and severity indices (GRADE: Moderate). Episodes of mild erythema, burning sensation, severe erythema, and blistering were reported in both treatment groups, but were too few to allow a comparative safety assessment (GRADE: Low).The primary economic evaluation showed that home NB-UVB phototherapy is more costly (incremental cost $4,509) and has higher quality-adjusted life-years (QALYs; incremental QALY 0.29) than outpatient clinic NB-UVB. Our best estimate of the incremental cost-effectiveness ratio of home NB-UVB compared with outpatient clinic NB-UVB is $15,675 per QALY gained. The probability of home NB-UVB being cost-effective versus outpatient clinic NB-UVB is 77% at a willingness-to-pay of $50,000 per QALY gained. Publicly funding home NB-UVB phototherapy in the psoriasis population would lead to about $0.7 million each year and a total 5-year net budget impact of about $3.3 million. Publicly funding home treatment for people with photoresponsive skin conditions would lead to about $1.3 million each year and a total 5-year net budget impact of $6.3 million; however, this scenario accounted for the cost of phototherapy only (it did not include treatment-specific medical costs for conditions other than psoriasis).People with photoresponsive skin conditions with whom we spoke viewed home NB-UVB phototherapy as beneficial for those with health conditions that make it difficult to travel, for those with busy schedules, and for those who may not have the means to pay for travel to clinics. CONCLUSIONS: Home NB-UVB phototherapy is at least as effective as outpatient clinic NB-UVB phototherapy for the treatment of mild to severe psoriasis (GRADE: Moderate). We are uncertain if adverse events happen more often or less often with home NB-UVB phototherapy than outpatient clinic NB-UVB phototherapy (GRADE: Low).Home NB-UVB phototherapy has an ICER of $15,675 per QALY gained, and the probability of home NB-UVB phototherapy being cost-effective is 77% at a willingness-to-pay of $50,000 per QALY gained. When accounting for the cost of phototherapy and other psoriasis-specific treatment costs (e.g., physician visits and adjuvant treatments), publicly funding home NB-UVB phototherapy in the psoriasis population would lead to a total 5-year net budget impact of about $3.3 million. Funding home NB-UVB phototherapy to people with photoresponsive skin conditions would lead to a total 5-year net budget impact of $6.3 million.People with photoresponsive skin conditions with whom we spoke viewed both outpatient clinic and home NB-UVB phototherapy to be effective treatment options.