[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.

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)

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

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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

Alteraciones ungueales y lesiones cutáneas en pliegues / Nail abnormalities and cutaneous lessions

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Cordón indurado en la pared torácica anterior / Indurated cord in the anterior thoracic wall

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