Local radiation and phototherapy are the most cost-effective treatments for stage IA mycosis fungoides: A comparative decision analysis model in the United States.

BACKGROUND: Treatments for early-stage mycosis fungoides (MF) include topical steroids, topical nitrogen mustard, topical bexarotene, narrowband ultraviolet B (NBUVB), psoralen plus ultraviolet A (PUVA), and local radiation. The relative cost-effectiveness of each treatment given the differences in treatment failure, disease progression, and therapy escalation is not established. OBJECTIVE: To compare the cost-effectiveness (CE) of treatment options for stage IA MF. METHODS: A state-transition model was constructed with health states of stage IA to stage IV disease, no MF, and death. Treatment-specific remission and relapse rates were obtained from the literature. Lifetime costs were calculated by accounting for medications, office visits, laboratory monitoring, related procedures, work absences, and travel. RESULTS: The order of CE of the study treatments was determined to be as follows: local radiation, $225,399 for 15.40 life-years (LYs); NBUVB, $344,728 for 15.17 LYs; PUVA, $371,741 for 15.07 LYs; topical corticosteroids, $469,354 for 14.65 LYs; topical nitrogen mustard, $951,662 for 14.29 LYs; and topical bexarotene, 11,892,496 for 13.55 LYs. Sensitivity analyses confirmed the CE rankings. LIMITATIONS: We assumed a constant probability of response, relapse rates, and 3-month treatment intervals. CONCLUSIONS: Local radiation is the most cost-effective treatment for limited local disease, whereas phototherapy (NBUVB or PUVA) is cost-effective for generalized disease. Our findings can serve to inform future studies and recommendations regarding selection of therapy for stage IA MF.

[Cost Effectiveness of Treatments of Psoriasis with a PASI 75 and one Period of 12 Weeks]. / Coste efectividad de diferentes tratamiento para la psoriasis.

OBJECTIVE: The objective was to evaluate the efficiency (relation between the cost and the results in health) of the treatments in psoriasis, seeking a higher quality of economic evaluations, consistency and transparency in these studies. METHODS: We developed a model of economic evaluation in psoriasis collecting all the many direct and indirect costs of each treatment. The effectiveness indicator used was Psoriasis Area Severity Index [PASI 75] which is generally acceptable in studies of psoriasis. The effectiveness indicator was a PASI 75.Subsequently we calculated the Incremental Cost-Effectiveness Ratio (ICER) for the period of 12 weeks and PASI 75, ordering treatments by level of effectiveness at the expense of treatment costs. RESULTS: The most cost effective treatment was methotrexate (ICER -7.5) followed by acitretin (ICER 29.5). The least cost has proved effective PUVA (ICER 4,651), followed by UVB narrow band (2,886.1). CONCLUSIONS: when taking into account both direct and indirect costs together with efficiency, methotrexate is the most cost effective treatment.

OBJETIVO: Los nuevos tratamientos biológicos, si bien mejoran la calidad de vida del paciente, incrementan los costes exponencialmente en relación al resto de tratamientos. El objetivo fue calcular el tratamiento más coste efectivo de los existentes para la psoriasis. METODOS: Se desarrolló un modelo de evaluación económica en psoriasis recogiendo todos los costes directos e indirectos de cada tratamiento. El indicador de efectividad que se utilizó fue Psoriasis Area Severity Index (PASI 75), que es el aceptable de manera general en estudios de psoriasis. Posteriormente se realizó un análisis de incremento coste efectividad (ICER) para el periodo de 12 semanas y PASI 75, ordenando los tratamientos por nivel de efectividad en detrimento de los costes de los tratamientos. RESULTADOS: El tratamiento más coste efectivo fue el metotrexato (ICER -7,5) seguido de acitretina (ICER 29,5). El menos coste efectivo resultó ser PUVA (ICER 4.651) seguido de UVB de banda estrecha (2.886,1). CONCLUSIONES: Aunque el tratamiento más económico teniendo en cuenta solo los costes directos sería el UVBbe, al tener en cuenta los costes indirectos y ajustarlos por la efectividad, el tratamiento más coste efectivo es el metotexato.

Health care resource use, productivity, and costs among patients with moderate to severe plaque psoriasis in the United States.

BACKGROUND: Comprehensive studies on costs of moderate to severe plaque psoriasis (MSPP) have not been conducted in the United States. OBJECTIVE: We sought to evaluate current health care resource use, productivity, and costs among patients with MSPP in routine practice. METHODS: A total of 200 adults seeking MSPP treatment enrolled in 9 US sites. Consented patients reported symptoms, treatment, lost productivity, and costs; 6-month retrospective chart review captured health care resource use and clinical characteristics. Costs were assigned to health care resource use and lost productivity using standard algorithms. Differences by Psoriasis Area and Severity Index (PASI) group, based on PASI score (≤10, >10-≤20, >20) at enrollment, were evaluated. Analyses included descriptive statistics and analysis of variance or Kruskal-Wallis tests. RESULTS: Most patients (79.5%) were prescribed 1 or more MSPP medications (mean: 1.5); 36.0% and 9.0% received self-administered biologics and systemic therapies, respectively. Mean number of nonprescription treatments was 12.3. Differences by PASI group were observed for overall work and activity impairment (P < .02). Six-month total MSPP direct costs per patient were $11,291; indirect costs were $2101 and differed across PASI groups (P = .0008). LIMITATIONS: This study enrolled patients with MSPP actively seeking care. CONCLUSION: Despite treatment, a number of patients with MSPP continue to experience moderate to severe PASI scores, impaired functioning, and high costs suggesting a need for new treatment options.

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.

Psoriasis treatment and management - a systematic review of full economic evaluations.

BACKGROUND: Psoriasis frequently requires lifetime control and current therapies vary significantly in price. High-quality economic evaluations are necessary to determine if higher-cost treatments are value for money. OBJECTIVES: This review aims to identify the cost-effectiveness of psoriasis care (whether more expensive interventions are associated with savings in health care and psoriasis management and/or improve patients' health); assess the level of uncertainty and transferability of this evidence to policy and practice; and, identify future research needs. METHODS: Searches of electronic databases Embase, MEDLINE and NHS EED for full economic evaluations were conducted in January 2012 (updated April 2014). Included articles were screened, selected and critically appraised using predefined inclusion criteria and data extraction forms: 1355 articles were identified; 37 papers reporting 71 comparisons met the inclusion criteria. Treatments evaluated were systemic (n = 45), topical (n = 22), phototherapies (n = 14) and combination (n = 4). RESULTS: Despite a significant number of recent economic evaluations, the cost-effectiveness of all therapies remains unclear. This uncertainty arises from a diversity in settings, perspective and design. Economic evaluations were constrained by limited availability of high-quality short- and long-term head-to-head comparisons of the effectiveness, safety and adherence of different interventions. CONCLUSIONS: The economic evidence is dominated by comparisons of interventions to placebo, with implicit comparisons of different therapies. There is a lack of evaluations of service model innovations to deliver complex packages of care for psoriasis. Primary and secondary integrated clinical and economic research is needed to address the limitations and to identify patient preferences and barriers/facilitators to treatment.

Comparison of clinical and cost-effectiveness of psoralen + ultraviolet A versus psoralen + sunlight in the treatment of chronic plaque psoriasis in a developing economy.

Psoralen + ultraviolet A (PUVA) therapy is an established modality for psoriasis. As India is a tropical country that has good availability of natural sunlight psoralen + sunlight (PUVAsol) may be a more convenient option. To compare the efficacy and cost-effectiveness of PUVA versus PUVAsol in chronic plaque psoriasis. Cases of chronic plaque psoriasis with body surface area ≥10% or Psoriasis Area and Severity Index (PASI) ≥10, excluding erythrodermic or pustular psoriasis, were randomized to receive either PUVA or PUVAsol, with endpoint being the achievement of PASI 90 or completion of 12 weeks treatment, whichever is earlier. Cost analysis was also undertaken. Thirty-six cases (16 in PUVA and 20 in PUVAsol group) completed treatment. In the PUVA group, 15 cases (93.75%) responded to therapy while in the PUVAsol group, 15 (75%) responded (P = 0.29). Mean baseline PASI in the PUVA and PUVAsol groups was 16 and 14.4, respectively, and at endpoint was 1.62 and 3.77. There was a significantly greater reduction in PASI in the PUVA group at 2 and 4 weeks but at 8 and 12 weeks and endpoint, it was comparable. Treatment failure occurred in 6.25% and 25% of cases respectively (P = 0.29). Side effects were higher with PUVA. Total cost of therapy was significantly higher in the PUVA group (P = 0.002). Cost-effectiveness ratio was US$0.72 with PUVA and US$0.37 with PUVAsol. Both PUVA and PUVAsol were equally efficacious, with PUVAsol being twice as cost effective. Hence, PUVAsol may be recommended as treatment for psoriasis in a developing economy such as India.

Patient-reported reasons for the discontinuation of commonly used treatments for moderate to severe psoriasis.

BACKGROUND: Despite widespread dissatisfaction and low treatment persistence in moderate to severe psoriasis, patients' reasons behind treatment discontinuation remain poorly understood. OBJECTIVES: We sought to characterize patient-reported reasons for discontinuing commonly used treatments for moderate to severe psoriasis in real-world clinical practice. METHODS: A total of 1095 patients with moderate to severe plaque psoriasis from 10 dermatology practices who received systemic treatments completed a structured interview. Eleven reasons for treatment discontinuation were assessed for all past treatments. RESULTS: A total of 2231 past treatments were reported. Median treatment duration varied by treatment, ranging from 6.0 to 20.5 months (P < .001). The frequency of each cited discontinuation reasons differed by treatment (all P < .01). Patients who received etanercept (odds ratio [OR] 5.19; 95% confidence interval [CI] 3.23-8.33) and adalimumab (OR 2.10; 95% CI 1.20-3.67) were more likely to cite a loss of efficacy than those who received methotrexate. Patients who received etanercept (OR 0.34; 95% CI 0.23-0.49), adalimumab (OR 0.48; 95% CI 0.30-0.75), and ultraviolet B phototherapy (OR 0.21; 95% CI 0.14-0.31) were less likely to cite side effects than those who received methotrexate, whereas those who received acitretin (OR 1.56; 95% CI 1.08-2.25) were more likely to do so. Patients who underwent ultraviolet B phototherapy were more likely to cite an inability to afford treatment (OR 7.03; 95% CI 3.14-15.72). LIMITATIONS: The study is limited by its reliance on patient recall. CONCLUSIONS: Different patterns of treatment discontinuation reasons are important to consider when developing public policy and evidence-based treatment approaches to improve successful long-term psoriasis control.

Topical steroids versus PUVA therapy in moderate plaque psoriasis: a clinical trial along with cost analysis.

BACKGROUND: Psoriasis is a common chronic disease. It is estimated that between US$1.6 billion and US$3.2 billion is spent per year to treat psoriasis. OBJECTIVE: To compare psoralen plus UV-A (PUVA) therapy with topical steroids in moderate plaque psoriasis. METHODS: In this randomized, clinical trial with cost analysis, 88 patients with moderate plaque psoriasis were recruited in two equal groups to receive either PUVA therapy or topical steroids. The induction phase was applied for 4 months and the patients were followed-up for another 3 months, while the maintenance therapy continued. Outcome, direct cost (related to medications, phototherapy, laboratory tests, and medical consultation), indirect cost (related to transportation and other extra expenditures) and total cost (direct plus indirect costs) were compared between the two groups. RESULTS: The outcome was equally satisfactory in both groups. The indirect cost was significantly higher in the PUVA group, while the direct and total costs as well as the patients' satisfaction rate were comparable. Recurrence was significantly more frequent in the topical group. CONCLUSION: Although both PUVA therapy and topical steroids are equally efficient and cost-effective in moderate plaque psoriasis, the recurrence rate is higher in the latter group.

Review of home phototherapy.

BACKGROUND: Outpatient phototherapy is a safe, effective, and low-cost treatment modality for moderate to severe psoriasis. Barriers to outpatient phototherapy including patient inconvenience, patient co-pays, decreased physician compensation, and insurance disincentive structures have led to decreased use and underutilization of phototherapy. Home phototherapy can potentially overcome many of the barriers associated with outpatient treatment but is not widely used because of concerns over safety and efficacy, lack of resident and physician education, and lack of insurance coverage. PURPOSE: The purpose of this study is to review the use of phototherapy with emphasis on the safety, efficacy, and practical use of home phototherapy. METHODS: A comprehensive Pubmed literature search was done using the keywords NB-UVB, narrowband UVB, BB-UVB, broadband UVB, PUVA, psoralen and UVA, UVA, history of phototherapy, mechanism of phototherapy, phototherapy in dermatology, home phototherapy, and phototherapy for psoriasis. All relevant articles were reviewed. CONCLUSIONS: Home NB-UVB phototherapy can be as safe, effective, and cost-effective as outpatient phototherapy. Further, home UVB is more convenient for patients, has higher patient satisfaction, and a lower treatment burden compared to outpatient phototherapy. Home NB-UVB should be considered as a treatment option for patients eligible for phototherapy.

Paradoxical effects of cost reduction measures in managed care systems for treatment of severe psoriasis.

BACKGROUND: Insurance companies vary widely in their coverage policies for severe psoriasis therapies. Unfortunately, coverage policies for psoriasis therapies do not necessarily follow current treatment paradigms, such that more expensive second or third line treatments may be more easily obtained than first line treatments. METHODS: We reviewed insurance policy bulletins, statements of coverage/medical necessity, and prior authorization forms for three large insurance carriers regarding psoriasis treatment with biologic agents and phototherapy. A cost comparison was performed to estimate total costs to patients and insurer under the current system as well as a hypothetical system in which co-pays and deductibles are eliminated. Additionally, we reviewed the total cost to an insurer for placing a patient on a trial of home phototherapy before approving use of expensive biologics. RESULTS: Requirements for coverage for phototherapy treatments are often the same, if not more stringent, than those for biologics. On an annual per patient basis, insurance companies pay an estimated $5, $76, and $23,408 for home phototherapy, office phototherapy, and biologics, respectively. The first year cost to patients, however, is estimated to be $2,590, $3,040, and $920 for home phototherapy, office phototherapy, and biologics, respectively. An initial 3-month trial of home phototherapy yields a graded annual cost savings to insurers of $21,610 to $2,110 per patient. DISCUSSION: The evolution of psoriasis treatment has resulted in a paradoxical situation in which the use of lower-cost psoriasis treatments, with longer safety track records, is discouraged relative to newer options. If co-pays, deductibles, and prior authorization requirements that discourage phototherapy were reduced or eliminated, more patients and physicians would likely choose phototherapy over biologics. This has the potential to reduce overall healthcare costs for psoriasis management.

[Cost-effectiveness analysis comparing methotrexate with PUVA therapy for moderate-severe psoriasis in the sanitary area of Badajoz]. / Análisis de coste-efectividad modelizado comparando metotrexato con fototerapia tipo PUVA para la psoriasis moderada-severa en el Area de Salud de Badajoz.

OBJECTIVE: To perform a cost-effectiveness analysis, by using a decision tree model, comparing methotrexate with PUVA therapy for moderate to severe chronic plaque psoriasis in the sanitary area of Badajoz (south-western Spain) over a one-year period. MATERIAL AND METHODS: The following variables and data sources were included: efficacy (a 50 % reduction in the PASI) and safety (adverse reactions). Data were retrieved from the dermatologic medical literature, mainly general reviews, systematic reviews and randomized clinical trials. Therapy schedules followed current guidelines from work task teams and consensus documents. Direct costs included unitary costs of medical consults, costs of laboratory tests, pharmacy, phototherapy sessions and costs derived from adverse reactions. Indirect costs included travel expenses and costs of lost productive work time. RESULTS: Unitary cost of methotrexate therapy would be 952.79 euros per treatment (direct cost: 796.48; indirect cost: 156.31). Unitary cost of PUVA therapy would be 899.70 euros per treatment (direct cost: 383.36; indirect cost: 516.34). Total cost of a one-year treatment with methotrexate would be 255,202.73 euros. Total cost of a one-year treatment with PUVA would be 266,406.88 euros. The average cost-effectiveness ratios per case effectively treated would be 1,519.06 euros for methotrexate therapy, and 1,085.18 euros for PUVA therapy. The incremental cost-effectiveness ratio of PUVA/methotrexate would be 150.65 euros for each additional case effectively treated. CONCLUSIONS: One-year treatment for moderate to severe psoriasis in the sanitary area of Badajoz would be more expensive but also more cost-effective with PUVA than with methotrexate. However, indirect costs (borne by patients), are higher for PUVA therapy, a fact that raises an issue of equity. The results should be interpreted taking into account the methodological limitations of a modelling study.

Psoriasis y enfermedades afines: experiencia con Re-PUVA en el manejo de psoriasis moderada-severa / Psoriasis and related diseases: experience with Re-PUVA in the treatment of moderate-to-severe psoriasis

Introducción: El manejo de la psoriasis moderada-severa es complejo, y un importante número de pacientes considera que el tratamiento indicado por su médico tratante no es suficientemente agresivo. El uso de tratamientos combinados ha demostrado mayor efectividad que las monoterapias, logrando aclaración de las lesiones en menor tiempo, con dosis más bajas de agentes terapéuticos y menos efectos adversos. Objetivos: Presentar nuestra experiencia con terapia combinada de retinoides más PUVA (Re-PUVA) en pacientes con psoriasis moderada-severa. Pacientes y Métodos: Se trató a nueve pacientes con psoriasis moderada-severa, mayores de 18 años, con terapia combinada de acitretín+PUVA, evaluando respuesta clínica bajo protocolo y seguimiento fotográfico al inicio 8ª y 16ª semana de tratamiento. Se estimaron dosis requeridas, costos, y efectos adversos del tratamiento. Resultados: El tiempo de tratamiento requerido para conseguir aclaración en el 90 por ciento de los pacientes fue de siete semanas. La dosis promedio de acitretín fue de 033 mg/kg/ día y la dosis acumulada de UVA fue de 139 J/cm². El costo estimado para conseguir aclaramiento en el 90 por ciento de los pacientes fue de US$ 634. No se observaron efectos adversos severos. Conclusión: La terapia combinada Re-PUVA demostró ser una excelente opción terapéutica para psoriasis moderada-severa, lográndose óptimos resultados en un corto plazo, a un costo razonable, y sin efectos adversos severos.

[The laundry-basket project--gender differences to the very skin. Different treatment of some common skin diseases in men and women]. / Tvättsäcksprojektet-- genusskillnader in på bara skinnet. Olika behandling för män och kvinnor vid några vanliga hudsjukdomar.

In this study, we have analysed the treatment traditions in a dermatological outpatient clinic, from a gender perspective. Eczema and psoriasis were of similar frequency in male and female patients, while a higher number of female patients had eczema of the hands. Ultraviolet light (UV) treatment was given to a higher number of male patients in all diagnostic groups including eczema of the hands. In addition, a higher number of given treatments was given to the male patients than to the female patients. As for prescriptions to male and female patients from our department and in Stockholm county (1.8 mill.), a much larger amount of preparations for local treatment was received by female patients, especially emollients. Male patients had received more of calcipotriol creme in addition to their being treated more intensively at the clinic. In a sub-group analysis on patients with psoriasis vulgaris on our clinic and in a patient cooperation-based treatment department, we found the same relation between male and female treatment as in the larger group. On follow-up, the number of female patients with psoriasis who were given treatment at our clinic had increased, but the number of treatments given to men was still higher than for female patients. An economic analysis of these findings show a great overweight of clinic-based treatment costs for male patients, while female patients receive emollients for self-care to a greater extent. We conclude that more studies are needed to clarify the basis of these findings.

Systemic treatment for moderate to severe psoriasis: estimates of failure rates and direct medical costs in a north-eastern US managed care plan.

BACKGROUND: Estimates of US medical costs related to psoriasis treatment are limited and tend to understate the economic burden of moderate to severe psoriasis, which often requires the use of systemic agents, phototherapy or both. OBJECTIVE: To estimate treatment failure rates and direct medical costs associated with the use of systemic agents and phototherapy in US patients with psoriasis. METHODS: Claims records from a large New England-based health insurer were used to obtain patient-level data. Eligible patients with at least one claim listing an ICD-9-CM code for psoriasis (696.0; 696.1) were identified. Patients not receiving systemic treatments (methotrexate, cyclosporine, acitretin) or phototherapy (ultraviolet B with or without tar or petrolatum, psoralen and ultraviolet A [PUVA]) were excluded. Treatment failure was defined as a switch in therapy, augmentation with non-topical therapies, discontinuation following uptitration of dose or discontinuation following hospitalization. Medical costs included those related to pharmacy (over-the-counter medication excluded), institutional services (inpatient and outpatient) and professional services. RESULTS: A total of 2068 patients with moderate to severe psoriasis were included in the analysis. Over a 1-year period, approximately 20% of patients experienced treatment failure. The mean time to failure among patients who switched therapy ranged from 3 to 6 months. Mean annual pharmacy costs in the various treatment groups (categorized according to initial therapy received) ranged from 257 dollars to 1992 dollars per patient. Mean annual costs for institutional and professional services ranged from 156 dollars to 799 dollars and 183 dollars to 481 dollars per patient, respectively. The 99th percentile annual pharmacy and institutional costs exceeded 10,000 dollars and 18,000 dollars, respectively. CONCLUSION: Treatment of moderate to severe psoriasis with traditional systemic agents or phototherapy is associated with a high likelihood of treatment failure and a considerable economic burden.

Strategy to manage the treatment of severe psoriasis: considerations of efficacy, safety and cost.

Psoriasis is a common, unpredictable, chronic immune-mediated disease characterised by skin lesions and frequently associated with arthritis. Although rarely fatal, psoriasis has a tremendous impact on a patients' quality of life. Traditional therapies for severe psoriasis include phototherapy, methotrexate, oral retinoids and cyclosporin. New biological agents add to the treatment options for psoriasis; however, they raise the already considerable cost of managing the disease. In considering efficacy, safety and cost-effectiveness, ultraviolet Type B (UVB) phototherapy appears to be the best first-line agent for the control of psoriasis. Methotrexate, psoralen plus UVA, alefacept, etanercept and infliximab are appropriate second-line agents, the choice of which requires considerable patient input and physician judgement. Developing rational, effective and acceptable strategies to manage psoriasis treatments would encourage cost-effective psoriasis management.

Balneo-phototherapy: a new holistic approach to treating psoriasis.

PURPOSE: To present and describe a new holistic therapy for the treatment of psoriasis and demonstrate its outcomes through a case study presentation. DATA SOURCES: Selected scientific literature and patient case study. CONCLUSION: Balneo-phototherapy, through new to the United States, has effective, safe outcomes as a new holistic treatment for psoriasis. IMPLICATIONS FOR PRACTICE: Nurse practitioners (NPs) and patients have an additional choice in psoriasis treatment that provides efficacious outcomes with fewer side effects compared to current therapies.

[Usefulness and necessity of unsynchronized photosolotherapy and bath-PUVA--two variants of balneophototherapy--in funded ambulatory health care]. / Nutzen und Notwendigkeit der nicht-synchronen Photosoletherapie und Bade-PUVA.--zweier Varianten der Balneophototherapie--in der ambulanten vertragsärztlichen Versorgung.

The Standing Committee of Statutory Health Insurance Physicians and Sickness Funds is the legal body that makes decisions on reimbursement for health care services in the German ambulatory health care sector. In 1994 the committee declined the reimbursement of balneophototherapy. Balneophototherapy comprises a bath in a saline solution followed by ("non-synchronous") or simultaneous ("synchronous") UVB-irradiation. Photochemotherapy with bath-water delivery of psoralens combined with UVA light is also covered by the term balneophotherapy. The main indication for both procedures is serious psoriasis. Bath PUVA was also recommended for atopic dermatitis, pityriasis lichenoides, lichen ruber and mycosis fungoides. An effectiveness study sponsored by the sickness funds with rather poor methodological design and conduct was not able to show an unbiased effect of balneophototherapy despite inclusion of thousands of patients. On the contrary, a poor adherence of patients and doctors was documented, since 63% of patients suffering from psoriasis and treated with saline bath followed by UVB-irradiation stopped early or used additional therapies like cortisone or vitamin D3 derivatives. Only 43% of patients suffering from psoriasis and treated by bath PUVA did not stop the initial therapy and did not receive additional therapy (UVB, cortisone). In addition, the committee also conducted a thorough review of the literature, guidelines and status in other health care systems. Finally the two modifications of balneophototherapy were again declined from reimbursement in the German ambulatory health care sector. There were no controlled clinical trials showing efficacy of saline bath followed by UVB irradiation. Up to now bath PUVA was only evaluated in small equivalence trials which despite the fact that a drug was tested did not apply basic ICH standards (international conference on harmonisation) for equivalence trials. Additionally, the long-term cancer risk inherent to the application of psoralenes must be considered. Since the definition of "severe psoriasis" is not trivial a wide use of bath PUVA in ambulatory health care has to be based on the results of rigorously conducted clinical trials showing the effectiveness, safety and appropriateness in comparison to other treatment modalities. In reaction to the decision of of the committee two randomised controlled trials for the evaluation of the efficacy of balneophototherapy are planned.