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      Cystic fibrosis outpatient treatment and medical costs: a retrospective analysis Translated title: Tratamiento ambulatorio de fibrosis quística y costes médicos: un análisis retrospectivo

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          Abstract

          SUMMARY Background: Cystic fibrosis (CF) is the most serious and frequent hereditary autosomal disease that causes respiratory, hepatic and pancreatic dysfunction. The aim of the study was to assess the pharmaceutical and medical cost in CF outpatients from the Adult Cystic Fibrosis Unit at third level hospital. Material and methods: Retrospective observational study in adult CF patients throughout the year 2017. Demographic and clinical variables were included. All of the medical variables considered were directly related to the disease. Considered cost were laboratory selling price notified in Nomenclator. Medical costs were calculated based on laboratory's price list and hospital medical procedures. Results: 89 CF patients enter the study, and 57 patients were finally included. The mean age was 32.5 years, 56.1% were female. 36.5% patients were homozygous for Phe508del, 40.4% heterozygous, and 22.8% had another mutation. The average FEV1 was 72.2%. 33.3% patients were colonized by sensitive Pseudomonas aeruginosa (PA) and 7.0% by multidrug-resistant PA. Total costs per year was EUR 623,981.3, (87.6% drug costs and 12.4% medical costs). Medical, drug and total costs were higher in Phe508del/Phe508del mutation group than Phe508del/other and other/other (p<0.05). Microbial colonization increased costs (p<0.05); colonized by sensitive PA had statistically significant higher drug and total costs, similar in multidrug resistant PA. Medical costs increase with severity level of lung function (p=0.001), also drug and total costs with the exception of severe patients. Conclusion: CF is a relative costly disease for the healthcare system. In our study homozygous Phe508del mutation patients, lows values of FEV1 and colonization had higher cost.

          Translated abstract

          RESUMEN Introducción: La fibrosis quística (FQ) es la enfermedad autosómica hereditaria más grave y frecuente que cursa con disfunción respiratoria, hepática y pancreática. El objetivo del estudio fue evaluar el coste farmacéutico y médico directo en pacientes ambulatorios de FQ de la Unidad de Fibrosis Quística de Adultos en un hospital de tercer nivel. Material y métodos: Estudio observacional, retrospectivo, en pacientes adultos con FQ a lo largo del año 2017. Se recogieron variables demográficas y clínicas. Todas las variables médicas consideradas estaban directamente relacionadas con la enfermedad. Los costes considerados fueron los precios de venta de laboratorio notificado en Nomenclator. Los costes médicos se calcularon en base a la lista de precios del laboratorio y los procedimientos médicos hospitalarios. Resultados: Se realizó el screening en 89 pacientes con FQ, y finalmente se incluyeron 57 pacientes. La edad media fue de 32,5 años, el 56,1% eran mujeres. El 36,5% de los pacientes eran homocigotos para Phe508del, el 40,4% heterocigoto y el 22,8% tenían otra mutación. El FEV1 medio fue de 72,2%. El 33,3% de los pacientes estaban colonizados por Pseudomonas aeruginosa (PA) sensibles y 7,0% por PA multirresistentes. Los costes totales anuales fueron de 623.981,3 euros (87,6% de costes de medicamentos y 12,4% de gastos médicos directos). Los costes médicos, farmacéuticos y totales fueron mayores en el grupo de mutación Phe508del/Phe508del, que en Phe508del/otro y otros (p<0.05). La colonización microbiana aumentó los costes (p<0,05); la colonización por PA sensibles supuso costes más altos de fármacos y totales, de manera similar para PA multirresistentes, todas las diferencias estadísticamente significativas. Los costes médicos aumentaron con el nivel de gravedad de la función pulmonar (p<0,001), también los costes de medicamentos y totales, con la excepción de los pacientes más graves. Conclusión: La CF es una enfermedad relativamente costosa para el sistema de salud. En nuestro estudio, los pacientes con mutación homocigota Phe508del, los valores bajos de FEV1 y la colonización tuvieron un costo más alto.

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          Evaluation of a new definition for chronic Pseudomonas aeruginosa infection in cystic fibrosis patients.

          Patients were defined each successive month as either 'chronic' when more than 50% of the preceding 12 months were PA culture positive, 'intermittent' when < or =50% of the preceding 12 months were PA culture positive, 'free of PA', with no growth of PA for the previous 12 months, having previously been PA culture positive, or 'never infected', when PA had never been cultured. Cross-sectional analysis of 146 children attending the Leeds Regional Cystic Fibrosis Centre was performed to assess relationship between the new definition and clinical scores and investigations. The response variable was regressed on age and sex and the residuals analysed using the Kruskal-Wallis test. The 'chronic' group (18% of patients) had significantly worse Shwachman-Kulczycki (SK) and Northern chest X-ray scores, and % predicted FEV(1) values than the 'free' (28%) or 'never' (20%) categories (P<0.004). The 'intermittent' group (34%) had a significantly higher SK score than the 'chronic' group (P<0.0001), and a significantly lower % predicted FEV(1) value than the 'free' or 'never' groups (P<0.0003). 'Chronic' patients were significantly associated with a positive, and 'never' patients with a negative, PA antibody result (P<0.001). The validity and importance of identifying these four subgroups is demonstrated. Previous definitions may over-estimate the prevalence of chronic infection.
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            Efficacy and safety of ivacaftor in patients aged 6 to 11 years with cystic fibrosis with a G551D mutation.

            Ivacaftor (VX-770), a cystic fibrosis transmembrane conductance regulator (CFTR) potentiator, has been shown to improve lung function, pulmonary exacerbation rate, respiratory symptoms, and weight gain compared with placebo in patients with cystic fibrosis aged 12 years or older with a G551D-CFTR mutation. This randomized, double-blind, placebo-controlled trial evaluated ivacaftor in patients with cystic fibrosis aged 6-11 years with a G551D-CFTR mutation on at least one allele. Patients were randomly assigned to receive ivacaftor administered orally at 150 mg (n = 26) or placebo (n = 26) every 12 hours for 48 weeks in addition to existing prescribed cystic fibrosis therapies. Despite near-normal mean baseline values in FEV1, patients receiving ivacaftor had a significant increase in percent predicted FEV1 from baseline through Week 24 versus placebo group (treatment effect, 12.5 percentage points; P < 0.001). Effects on pulmonary function were evident by 2 weeks, and a significant treatment effect was maintained through Week 48. Patients treated with ivacaftor gained, on average, 2.8 kg more than those receiving placebo at Week 48 (P < 0.001). The change from baseline through Week 48 in the concentration of sweat chloride, a measure of CFTR activity, with ivacaftor was -53.5 mmol/L (P < 0.001) versus placebo. The incidence of adverse events was similar in the two groups. In patients who are younger and healthier than those in previously studied populations, ivacaftor demonstrated a significant improvement in pulmonary function, weight, and CFTR activity compared with placebo. Clinical trial registered with www.clinicaltrials.gov (NCT00909727).
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              Tezacaftor/Ivacaftor in Subjects with Cystic Fibrosis and F508del/F508del-CFTR or F508del/G551D-CFTR.

              Tezacaftor (formerly VX-661) is an investigational small molecule that improves processing and trafficking of the cystic fibrosis transmembrane conductance regulator (CFTR) in vitro, and improves CFTR function alone and in combination with ivacaftor.
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                Author and article information

                Journal
                ofil
                Revista de la OFIL
                Rev. OFIL·ILAPHAR
                Organización de Farmacéuticos Ibero-Latinoamericanos (Madrid, Madrid, Spain )
                1131-9429
                1699-714X
                2020
                : 30
                : 4
                : 283-290
                Affiliations
                [3] Madrid orgnameLa Princesa University Hospital orgdiv1Pneumology Department Spain
                [4] Madrid orgnameLa Princesa University Hospital orgdiv1Pneumology Department Spain
                [5] Madrid orgnameLa Princesa University Hospital orgdiv1Pneumology Department Spain
                [1] Madrid orgnameLa Princesa University Hospital orgdiv1Pneumology Department Spain
                [2] Madrid orgnameLa Princesa University Hospital orgdiv1Pharmacy Department Spain
                Article
                S1699-714X2020000400006 S1699-714X(20)03000400006
                10.4321/s1699-714x2020000400008
                79d04a53-0d69-4aac-9789-ac7e4ecb83e5

                This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.

                History
                : 18 February 2020
                : 04 February 2020
                Page count
                Figures: 0, Tables: 0, Equations: 0, References: 24, Pages: 8
                Product

                SciELO Spain

                Categories
                Originals

                Pseudomonas aeruginosa,FEV,cystic fibrosis,costs analysis,CFTR mutation,Antibiotic,fibrosis quística,análisis de coste,mutación CFTR,Antibiotico

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