[Translated article] Requirements for Accessing New Dermatology Drugs in Spain: Results of the EQUIDAD Study.

BACKGROUND: Although the Spanish Ministry of Health prepares national therapeutic positioning reports (TPRs) and drug reimbursement policies, each of the country's 17 autonomous communities (ACs) is responsible for health care services and prescription requirements in its territory. The aim of the EQUIDAD study was to describe and explore potential differences in prescription requirements for new dermatology drugs across the autonomous communities. MATERIAL AND METHODS: Cross-sectional study conducted in April and May, 2023. Two dermatologists with management responsibilities from each autonomous community reported on territorial and more local prescription requirements for drugs covered by national TPRs issued between 2016 and 2022. RESULTS: Thirty-three researchers from 17 autonomous communities participated. The data submitted revealed between-community inequities in access to new drugs. Overall, 64.7% of the regions imposed additional prescription requirements to those mentioned in the TPRs for psoriasis. This percentage was lower for atopic dermatitis (35.3%) and melanoma (11.8%). The most common requirement for accessing a new drug was a previous prescription for another drug. Differences and additional requirements were also detected at the local level (i.e., differences between hospitals within the same autonomous community). CONCLUSIONS: Spain's autonomous communities have multiple regional and local prescription requirements that are not aligned with national TPR recommendations. These differences result in inequitable access to new drugs for both patients and practitioners across Spain.

Requirements for Accessing New Dermatology Drugs in Spain: Results of the EQUIDAD Study. / Condicionantes de acceso a nuevos medicamentos dermatológicos en España: resultados del proyecto EQUIDAD.

BACKGROUND: Although the Spanish Ministry of Health prepares national therapeutic positioning reports (TPRs) and drug reimbursement policies, each of the country's 17 autonomous communities (ACs) is responsible for health care services and prescription requirements in its territory. The aim of the EQUIDAD study was to describe and explore potential differences in prescription requirements for new dermatology drugs across the autonomous communities. MATERIAL AND METHODS: Cross-sectional study conducted in April and May, 2023. Two dermatologists with management responsibilities from each autonomous community reported on territorial and more local prescription requirements for drugs covered by national TPRs issued between 2016 and 2022. RESULTS: Thirty-three researchers from 17 autonomous communities participated. The data submitted revealed between-community inequities in access to new drugs. Overall, 64.7% of the regions imposed additional prescription requirements to those mentioned in the TPRs for psoriasis. This percentage was lower for atopic dermatitis (35.3%) and melanoma (11.8%). The most common requirement for accessing a new drug was a previous prescription for another drug. Differences and additional requirements were also detected at the local level (i.e., differences between hospitals within the same autonomous community). CONCLUSIONS: Spain's autonomous communities have multiple regional and local prescription requirements that are not aligned with national TPR recommendations. These differences result in inequitable access to new drugs for both patients and practitioners across Spain.

Triple Dufourmentel hexagonal flap for scalp reconstruction.

Transposition flaps are some of the most commonly used flaps for reconstructing scalp defects. Limberg first described his rhomboid transposition flap in 1946. Dufourmentel flap was an improved version of the Limberg flap published in 1962 in which the base of the flap is widened to improve vascularisation. Transposition flaps are one of the best known and most widely used transposition flaps in reconstructive surgery. They have proven successful in different types of reconstructive and aesthetic situations as a full-thickness random transposition flap. Combination of three Dufourmentel flaps to reconstruct hexagonal defects has not been reported in the literature. It is a modification of the triple Limberg flap, in which, after removing a hexagonal defect, we reconstruct the primary defect with a triple Dufourmentel flap. This flap is very useful for reconstructing large scalp defects as it provides a large amount of skin tissue with high viability; however, given its versatility, it could be used in other anatomical areas. Ann Med Surg (Lond) 2021 7:102544; Plast Reconstr Surg 2015 136:163-164; Atlas Oral Maxillofac Surg Clin North Am 2020 28:17-22.

Unmet needs in patients with moderate-to-severe plaque psoriasis treated with methotrexate in real world practice: FirST study.

BACKGROUND: Methotrexate (MTX) is frequently used in the treatment of moderate-to-severe psoriasis, however, there is limited data on health-related quality-of-life (HRQoL), psoriasis clinical outcomes and hepatic fibrosis in MTX-treated patients in routine clinical practice. OBJECTIVES: To investigate the impact of moderate-to-severe psoriasis in MTX-treated patients in Spain regarding to HRQoL, psoriasis clinical data and risk of hepatic fibrosis. METHODS: Observational, non-interventional, cross-sectional, retrospective, multicentre study, performed in Spain in moderate-to-severe plaque psoriasis patients treated with MTX > 16 weeks prior to inclusion. RESULTS: Despite ongoing treatment, 17.1% of 457 evaluable patients reported moderate-to-extreme impact on HRQoL (DLQI > 5); 21.4% BSA > 5 and 35.2% moderate-to-severe pruritus (VAS ≥ 4). Persistent severe psoriasis (PASI ≥ 10 and/or DLQI ≥ 10) was observed in 10.7%. Hepatic steatosis was identified in 64.1% of patients (HSI ≥ 36) and 37.2% of the patients were at-risk of advanced fibrosis which was associated to the MTX treatment duration. CONCLUSIONS: The study identified unmet needs in moderate-to-severe plaque psoriasis patients treated with MTX, revealing a significant proportion of sub-optimally controlled patients in terms of HRQoL and different domains of the disease. This study also found patients at-risk of advanced fibrosis, with evidence suggesting a correlation between longer exposures to MTX and higher risk of advanced fibrosis.

Enfermedad de Hansen / Hansen's disease

La lepra (enfermedad de Hansen) es una enfermedad granulomatosa crónica que afecta a la piel y a los nervios, fundamentalmente, producida por Mycobacterium leprae. Se considera un proceso preerradicado en España, con una prevalencia de 0,1 casos por 10.000 habitantes. Se ha visto un discreto incremento debido al fenómeno de inmigración desde países con mayor prevalencia de este proceso. El tratamiento que se emplea es una combinación de fármacos como rifampicina, dapsona y clofazimina (AU)

Leprosy (Hansen's disease) is a chronic granulomatous disease affecting the skin and nerves that is mainly produced by Mycobacterium leprae. It is considered a pre-eradicated condition in Spain, with a prevalence rate of 0.1 cases per 10,000 inhabitants. A slight increase has been observed due to the phenomenon of immigration from countries with higher prevalence of this condition. Current treatments used share a common base made up of several combined drugs, particularly rifampicin, dapsone, and clofazimin (AU)

Enfermedad de Hansen / Hansen's disease

La lepra (enfermedad de Hansen) es una enfermedad granulomatosa crónica que afecta a la piel y a los nervios, fundamentalmente, producida por Mycobacterium leprae. Se considera un proceso preerradicado en España, con una prevalencia de 0,1 casos por 10.000 habitantes. Se ha visto un discreto incremento debido al fenómeno de inmigración desde países con mayor prevalencia de este proceso. El tratamiento que se emplea es una combinación de fármacos como rifampicina, dapsona y clofazimina (AU)

Leprosy (Hansen's disease) is a chronic granulomatous disease affecting the skin and nerves that is mainly produced by Mycobacterium leprae. It is considered a pre-eradicated condition in Spain, with a prevalence rate of 0.1 cases per 10,000 inhabitants. A slight increase has been observed due to the phenomenon of immigration from countries with higher prevalence of this condition. Current treatments used share a common base made up of several combined drugs, particularly rifampicin, dapsone, and clofazimin (AU)

Nevus comedoniano: presentación de cinco casos / Naevus comedonicus: a report of five cases

El nevus comedoniano es un proceso infrecuente, hamartomatoso, de la unidad pilosebácea. Generalmente aparece como un grupo asintomático decomedones, que se distribuyen con un patrón lineal. Ocasionalmente se han descrito asociaciones con anomalías sistémicas. Presentamos una serie decinco pacientes con lesiones clínica y/o histología compatibles con nevus comedoniano. Se analiza la edad de los pacientes, edad de comienzo, la localizaciónde las lesiones, asociación a cuadros sistémicos y el tratamiento realizado (AU)

Naevus comedonicus represents an uncommon hamartomatous disorder of pilo-sebaceous unit. It appears as a usually asymptomatic group of comedones,wich may be arranged in a linear pattern. An occasional association with systemic abnormalities has been reported. A serie of five patients withlesions clinically and/or histologically consistent with naevus comedonicus is reported. The age of patients, the age of presentation, localization of thelesions, noncutaneous abnormalities associated treatment are analized (AU)

Tratamiento del linfoma cutáneo de células T con ligandos selectivos del receptor retinoide X: alteraciones endocrinológicas y metabólicas / Treatment of cutaneous T-cell lymphoma with retinoid receptor x- selective ligands: endocrine and metabolic disorders

Los ligandos selectivos del receptor retinoide X se utilizan actualmente en el tratamiento de estadios avanzados del linfoma cutáneo de células T resistentes a otros tratamientos sistémicos, siendo el bexaroteno el primer fármaco de este grupo aprobado en Europa. Se han descrito numerosos efectos adversos asociados a su utilización, entre los que destacan las alteraciones endocrino-metabólicas. Presentamos a 2 pacientes con linfoma cutáneo de células T, tratados con bexaroteno, que desarrollaron hipotiroidismo central y dislipemia de forma precoz tras su inicio. Se describen también la respuesta de estas alteraciones al tratamiento y su remisión completa tras suspender el bexaroteno (AU)

The retinoid X receptor-selective ligands has been used for advanced stages of cutaneous T-cell lymphoma refractory to previous systemic therapy, being bexarotene the first drug in this group approved in Europe. Multiple drug-related adverse events has been reported such as endocrine-metabolic disorders. We report 2 patients with cutaneous T-cell lymphoma, treated with bexarotene, that developed central hypothyroidism and dyslipidaemia immediately after the beginning of this treatment. We also showed the successfully treatment response of these alterations and the total clinical remission after discontinuing the drug (AU)

Leiomioma cutáneo zosteriforme. Tratamiento satisfactorio con doxazosina oral / Zosteriform cutaneous leiomyoma. Satisfactory treatment with oral doxazosine

Describimos el caso de un paciente varón de 50 años de edad que presentaba leiomioma cutáneo zosteriforme de región facial izquierda, intensamente doloroso, y que obtuvo mejoría clínica espectacular tras la administración diaria de 4 mg de doxazosina oral. Este tratamiento fue bien tolerado y no presentó ningún efecto adverso asociado. En la literatura médica de habla inglesa se han publicado sólo dos casos tratados con doxazosina que demostraron excelente resultado terapéutico

We report a 50-year-old man that presented a zosteriform cutaneous leiomyoma in the left facial region, intensely painful, that showed great improvement after the administration of a daily dose of 4 mg of oral doxasozine. The therapy was well tolerated and did not present any associated adverse effect. In the English medical literature only two cases successfully treated with doxasozine have been reported

[Zosteriform cutaneous leiomyoma. Satisfactory treatment with oral doxazosin]. / Leiomioma cutáneo zosteriforme. Tratamiento satisfactorio con doxazosina oral.

We report a 50-year-old man that presented a zosteriform cutaneous leiomyoma in the left facial region, intensely painful, that showed great improvement after the administration of a daily dose of 4 mg of oral doxasozin. The therapy was well tolerated and did not present any associated adverse effect. In the English medical literature only two cases successfully treated with doxasozin have been reported.

Síndrome de Stevens-Johnson, radioterapia y probable relación con amifostina / Steven-Johnson syndrome after radiotherapy and probably related to amifostine

El síndrome de Stevens-Johnson es una enfermedad inflamatoria aguda originada por una hipersensibilidad que incluye la piel y las membranas mucosas.Puede ser inducida por muchos factores precipitantes, desde agentes farmacológicos hasta una infección. La incidencia de reacciones cutáneasseveras secundarias a amifostina es inferior al 1%, siendo el síndrome de Stevens-Johnson una de ellas. Nosotros comunicamos un caso de síndromede Stevens-Johnson en probable relación con la administración subcutánea de amifostina subcutánea durante radioterapia

The Stevens-Johnson syndrome is an acute inflammatory disease, caused by hipersensitivity of the skin and mucous membrane. It can be induced bymany precipitant factors, including pharmacological agents and infections. The incidence rate of severe secondary cutaneous reactions is less than1%, the Stevens-Johnson syndrome being one of them. We report a case of Stevens-Johnson syndrome probably related to subcutaneous amifostineadministration during radiotherapy procedure

Síndrome de Bazex (acroqueratosis paraneoplásica) / Bazex syndrome (acrokeratosis paraneoplastica)

El síndrome de Bazex es una dermatosis paraneoplásica caracterizada por lesiones acrales psoriasiformes que se asocia a una neoplasia subyacente. Presentamos el caso de un paciente varón de 72 años, con lesiones queratósicas, simétricas, en los pabellones auriculares, las manos y los pies, compatibles con síndrome de Bazex. En el estudio que se le realizó, se detectó una recidiva de carcinoma epidermoide de paladar blando y carcinoma de esófago poco diferenciado

Bazex syndrome is a paraneoplastic dermatosis characterized by acral psoriasiform lesions associated with an underlying neoplasm. We present the case of a 72 year old male patient with keratosic, symmetric lesions in the auricular external ears, hands and feet, consistent with Bazex Syndrome. The study conducted detected recurrent squamous cell carcinoma of soft palate and undifferentiated esophageal carcinoma

Mácula hiperpigmentada en mucosa gingival / Hyperpigmented macule in gingival mucosa

No disponible

No disponible

[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.

Infección cutánea por Microsporum nanum / Skin infection due to Microsporum nanum

Microsporum nanum es un hongo zoófilo capaz de producir enfermedad en humanos y animales, aunque en humanos se han descrito muy pocos casos. Presentamos un paciente de 35 años que mostraba una lesión pruriginosa en antebrazo izquierdo que se diagnosticó de Tinea corporis y en cuyo cultivo para hongos se aisló Microsporum nanum

Microsporun namum is a zoofilic fungi capable of causing disease in humans and animals, although it has rarely been described in humans. We present a case of a 35 year old patient. He had an itchy lesion on the left forearm and was diagnosed of Tinea corporis: Microsporum nanum was isolated in the culture for fungi

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

Objetivo. Realizar un análisis de coste-efectividad modelizado, usando un árbol decisión, comparando metotrexato y fototerapia tipo PUVA para la psoriasis crónica en placas moderadas-severas en el Área de Salud (AS) de Badajoz, durante el periodo de un año, desde la perspectiva societaria. Material y métodos. Se consideraron las variables eficacia (PASI50 [descenso del 50 % del PASI basal]) y seguridad (reacciones adversas). Se valoró como eficaz la mejoría del PASI50. Se tomaron datos de la literatura médica dermatológica, fundamentalmente revisiones generales, revisiones sistemáticas y ensayos clínicos aleatorizados. Los regímenes de tratamiento se obtuvieron de las recomendaciones de grupos de trabajo y documentos de consenso, recogidos en publicaciones médicas. Como costes directos se consideraron los costes unitarios por consulta, los de las pruebas de monitorización, los de la medicación y las sesiones de fototerapia y los de las reacciones adversas. En los costes indirectos se valoraron los costes por desplazamiento, y los de productividad debidos a la pérdida de horas de trabajo de la jornada laboral. Resultados. El coste unitario por tratamiento con metotrexato sería de 952,79 euros (directos: 796,48; indirectos: 156,31). El coste unitario por tratamiento con PUVA sería 899,70 euros (directos: 383,36; indirectos: 516,34). El coste total del tratamiento durante un año con metotrexato sería 255.202,73 euros, y con PUVA 266.406,88 euros. Las ratios medias de coste-efectividad serían, para cada uno de los tratamientos: metotrexato 1.519,06 euros, y PUVA 1.085,18 euros por caso tratado eficazmente. La ratio incremental PUVA/metotrexato sería: 150,65 euros por cada caso añadido eficazmente tratado. Conclusiones. El tratamiento de la psoriasis durante un año en el AS de Badajoz con PUVA sería más caro, pero también más coste-efectivo que el tratamiento con metotrexato. Sin embargo, los costes indirectos (soportados por el paciente) del tratamiento con PUVA son más altos, lo que plantea un problema de equidad. Estos resultados deben considerarse a la luz de las limitaciones metodológicas de un estudio modelizado

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

[Treatment of cutaneous T-cell lymphoma with retinoid receptor X-selective ligands: endocrine and metabolic disorders]. / Tratamiento del linfoma cutáneo de células T con ligandos selectivos del receptor retinoide X: alteraciones endocrinológicas y metabólicas.

The retinoid X receptor-selective ligands has been used for advanced stages of cutaneous T-cell lymphoma refractory to previous systemic therapy, being bexarotene the first drug in this group approved in Europe. Multiple drug-related adverse events has been reported such as endocrine-metabolic disorders. We report 2 patients with cutaneous T-cell lymphoma, treated with bexarotene, that developed central hypothyroidism and dislipidaemia inmediately after the begining of this treatment. We also showed the successfully treatment response of these alterations and the total clinical remission after discontinuing the drug.