An overview of the characteristics and quality assessment criteria in systematic review of pharmacoeconomics.

BACKGROUND: The systematic review of economic evaluations plays a critical role in making well-informed decisions about competing healthcare interventions. The quality of these systematic reviews varies due to the lack of internationally recognized methodological evaluation standards. METHODS: Nine English and Chinese databases including the Cochrane Library, PubMed, EMbase (Ovid), NHS economic evaluation database (NHSEED) (Ovid), Health Technology Assessment (HTA) database, Chinese National Knowledge Infrastructure (CNKI), WangFang, VIP Chinese Science & Technology Periodicals (VIP) and Chinese Biomedical Literature Database (CBM) were searched. Two reviewers independently screened studies and extracted data. The methodological quality of the literature was measured with modified AMSTAR. Data were narrative synthesized. RESULTS: 165 systematic reviews were included. The overall methodological quality of the literature was moderate according to the AMSTAR scale. In these articles, thirteen quality assessment tools and 32 author self-defined criteria were used. The three most widely used tools were the Drummond checklist (19.4%), the BMJ checklist (15.8%), the Consolidated Health Economic Evaluation Reporting Standards (CHEERS) statement (12.7%). Others included the Quality of Health Economic Studies (QHES), the Consensus on Health Economic Criteria (CHEC), the checklist of Center for Reviews and Dissemination (CRD), the Philips checklist, the World Health Organization (WHO) checklist, the checklist of Critical Appraisal Skills Program (CASP), the Pediatric Quality Appraisal Questionnaire (PQAQ), the Joanna Briggs Institute (JBI) checklist, Spanish and Chinese guidelines. The quantitative scales used in these literature were the QHES and PQAQ. CONCLUSIONS: Evidence showed that pharmacoeconomic systematic reviews' methodology remained to be improved, and the quality assessment criteria were gradually unified. Multiple scales can be used in combination to evaluate the quality of economic research in different settings and types.

Evaluation of quality of pharmacoeconomic studies involved in traditional Chinese medicine in China.

OBJECTIVES: The pharmacoeconomic studies of traditional Chinese medicine (TCM) are still in its infancy. Assessing the quality of pharmacoeconomic studies of TCM to improve the efficiency of health resource allocation and guide the rational use of medicine. METHODS: Four databases were searched from inception to January 2018. The Consolidated Health Economic Evaluation Reporting Standards statement (CHEERS) and the Quality of Health Economic Studies (QHES) were used to assess the reporting quality and methodological quality. STATA 12.0 and Meta analyst 3.13 were used to analyze the related data. RESULTS: A total of 178 studies were included. The methodological evaluation of the study found that the total score of QHES was 47.85 ± 8.09. The report quality evaluation results found that many studies did not report comprehensive information, such as lack of detailed reports on abstracts, study perspectives, time frames, discount rates, model selection, but the titles, study background and location, and health results, resource and cost estimates, analysis methods, and heterogeneity analysis are reported in more detail. Six of the ten stratification factors have statistically significant differences. CONCLUSION: The overall quality of pharmacoeconomic studies of TCM is low, and further standardization and improvement are needed to obtain reliable study results.

Interventional Pharmacoeconomics.

The increasing cost of health care is a major challenge around the world, but particularly in the United States. One reason for increased costs is the rapidly rising cost of oncology drugs. Potential solutions to this problem involve broad changes to health policy. However, an alternative solution is the development of lower-cost off-label treatment regimens, based on pharmacologic rationale, with significant potential economic impact. The pharmacologic and clinical properties of many drugs allow for a variety of different strategies. We describe this approach of interventional pharmacoeconomics and provide multiple individual examples.

Pharmacoeconomic Evaluations: Guidelines for Drug Purchasers.

OBJECTIVE: To propose a set of guidelines for use by health care organizations in the United States that seek useful, comparative clinical information and economic analysis on pharmaceutical products to make sound drug purchasing decisions. PRACTICE INNOVATION: Based on a therapy intervention approach, the guidelines provide a structured framework to help managed care purchasers become more consistent in how they evaluate drug products for inclusion in the formulary. The guidelines factor in the need to examine the impact of new drug products on overall costs within the entire health system. PRACTICE SETTING: Intended for use by managed care organizations in the U.S. that purchase prescription drugs. INTERVENTION: Not applicable. MAIN OUTCOME MEASURE: Not applicable. RESULTS: The guidelines provide MCOs with a new systematic approach for identifying the overall cost and clinical outcomes impact of drug therapies. The guidelines are designed to take into account the characteristics of the patient population being treated and the fact that patients generally are redistributed among different treatment categories once a new drug product is introduced, thus offering MCOs an analysis model that extends beyond the traditional partial cost-outcomes approach. Emphasis is placed on looking at the cost-outomes impact of a new drug or therapy within a systems or disease area framework in which the redistribution of patients between therapy options is explicitly modelled. The guidelines specify that the following information elements be used in pharmacoeonomic analysis: product description, place in therapy, comparator products, therapy intervention framework, supporting clinical data, supporting pharmacoeconomic data, system impact assessments-costs-outcomes, overall assessment, and bibliography and supporting materials.

Ipragliflozin as an add-on therapy in type 2 diabetes mellitus patients: An evidence-based pharmacoeconomics evaluation.

AIM: To evaluate the efficacy, safety and cost-effectiveness of ipragliflozin as an add-on therapy in patients with type 2 diabetes mellitus (T2DM). METHODS: PubMed, EMBASE, the Cochrane Library, Web of Science and four Chinese databases, as well as the ClinicalTrials.gov website were searched from their inception through Jan 2019. Methodological quality was assessed using the Cochrane risk of bias, and meta-analysis was performed using RevMan5.3. RESULTS: A total of 11 randomized controlled trials with 1766 patients were included. Ipragliflozin administered (50 mg) once daily as an add-on therapy to other glucose-lowering medications (metformin, pioglitazone, sulfonylurea, α-glucosidase inhibitor, sitagliptin, insulin) was associated with reductions in hemoglobin A1c (HbA1c) of -0.74% (95% confidence interval (CI) -1.00 to -0.48), fasting plasma glucose (WMD -25.03 mg/dL; 95% CI -32.89 to -17.16), weight, waist circumference, blood pressure, and triglycerides levels. Neither the incidence of treatment-emergent adverse events (TEAEs) (RR 1.08; 95% CI 1.00 to 1.16) nor drug-related TEAEs (RR 1.19; 95% CI 0.93 to 1.54) was significantly increased. However, it was associated with an increased risk of hypoglycemia when added to insulin (RR 1.71; 95% CI 1.13 to 2.61). Compared with the pioglitazone group and the sitagliptin + metformin group, the incremental cost-effectiveness ratio of ipragliflozin add-on therapy group was $4976.89, $2089.76 per percentage of qualified HbA1c, respectively. CONCLUSION: Ipragliflozin as an add-on therapy is well tolerated and effective. Ipragliflozin as an add-on therapy do not appear cost-effective compared with metformin alone, but may be competitive against pioglitazone group and the sitagliptin + metformin group.

Assessing Data Sources for Medicine Price Studies.

OBJECTIVES: There is no established methodology to assess the feasibility of medicine price data sources. Against this backdrop, a framework to guide the selection of most appropriate price data sources for pharmacoeconomic research has been developed. METHODS: A targeted literature review was carried out. Dimensions discussed in literature as relevant for medicine price comparisons and practical experience of the authors in medicine price studies informed the conceptional work of the framework development. A draft version of the framework was reviewed by peer pricing experts. The feasibility of the framework was tested in case studies. RESULTS: According to the developed framework (called Re-ADAPT), a medicine price data source should meet the following criteria: reliability and sustainability; accessibility at a cost that users can afford; provision of medicine price information at the date(s) required; information for the defined geographic area, or at least in a representative way; coverage of the pharmaceuticals and at the price type(s) required. Easy handling and provision of additional information were defined as supportive assets of candidate data sources (secondary criteria). The case studies confirmed the feasibility of the Re-ADAPT framework. In some cases, however, it can be difficult to disentangle assessment criteria (particularly geographic area, scope of pharmaceuticals and price types) for separate consideration, given their interlinkage. CONCLUSIONS: While selection of the most appropriate data sources will remain a challenge, the Re-ADAPT framework aims to provide practical guidance and thus contribute to a more careful, balanced, and evidence-based selection of data sources for medicine price studies.

Evaluation of Quality of Pharmacoeconomic Studies in Asia-Pacific Region and Identification of Influencing Variables.

OBJECTIVES: To assess the quality of pharmacoeconomic studies and identify different variables influencing the quality of these studies conducted in the Asia-Pacific (APAC) region. METHODS: A systematic literature search was performed with PubMed and Cochrane using different combinations of terms for cost-effectiveness, cost-utility, and cost-minimization analyses. The Quality of Health Economic Studies (QHES) instrument was used for quality assessment of included studies. Logistic regression was performed to determine the association of factors with high-quality studies (QHES score ≥75). RESULTS: Of 262 retrieved studies, 128 met the inclusion criteria. The mean QHES score was 67.4 ± 1.35. The distribution of studies in each quality quartile was as follows: high (n = 59 [46.09%]), fair (n = 50 [39.06%]), and poor (n = 19 [14.83%]). Most of the high-quality studies (n = 80 [62.5%]) were conducted in Japan and Australia. Only 11 high-quality studies (18.64%) were published in specialty journals and 4 (6.78%) in Asian journals. Primary authors who had advanced training in health economics were associated with a higher number of high-quality studies (n = 51 [86.44%]). Training of primary authors was significantly associated with high-quality studies (odds ratio 7.1; 95% confidence interval 2.9-19.23). Impact factor of journal, per-capita expenditure on health care, and out-of-pocket expense on health did not have a significant association with high-quality scores. CONCLUSIONS: High-quality pharmacoeconomic research is confined to a few countries of the APAC; it can be improved by advance training of authors in public health or health economics. Also, a greater interest of various stakeholders in funding the research and the introduction of specialty journals in the APAC are warranted.

A systematic review of pharmacoeconomic guidelines.

OBJECTIVE: To review, summarize, and analyze both similarities and differences of pharmacoeconomic (PE) guidelines, to enable researchers to access their characteristics and the current state of PE guidelines; furthermore, to learn which methodological issues still remain contested and to promote the methodological development of PE guidelines. MATERIALS AND METHODS: The authors performed a search for PE guidelines using PubMed, the Cochrane library database, and the websites of the International Society for Pharmacoeconomics and Outcomes Research. Information of each guideline was extracted using a pre-designed extraction template, which included 22 aspects; the guidelines were summarized in the forms of charts, and their characteristics have been described. RESULTS: A total of 40 PE guidelines were studied. The most common methodological issues include the types of analysis, sources for effectiveness, use of quality-adjusted life-years (QALYs) to measure outcomes, and use of incremental cost effectiveness ratios to present results. The majority of the guidelines preferred a cost utility analysis with outcomes expressed in terms of QALYs. Most of the guidelines preferred meta-analysis or meta-analysis of the randomized controlled trials, and required a systematic review of all evidence. Issues that varied most in the guidelines were the choice of the comparator, recommended costs to be included, methods related to indirect cost calculations, methods of sensitivity analysis, and discounting rate. CONCLUSION: A comparison of these guidelines revealed that a number of differences exist among them in several key aspects, and some critical methodological issues still exist, for which no best solution is available. Furthermore, efforts need to be made to develop harmonious methods for the PE, and to improve the transferability of the outcomes of PE evaluations.

Good practices for real-world data studies of treatment and/or comparative effectiveness: Recommendations from the joint ISPOR-ISPE Special Task Force on real-world evidence in health care decision making.

PURPOSE: Real-world evidence (RWE) includes data from retrospective or prospective observational studies and observational registries and provides insights beyond those addressed by randomized controlled trials. RWE studies aim to improve health care decision making. METHODS: The International Society for Pharmacoeconomics and Outcomes Research (ISPOR) and the International Society for Pharmacoepidemiology (ISPE) created a task force to make recommendations regarding good procedural practices that would enhance decision makers' confidence in evidence derived from RWD studies. Peer review by ISPOR/ISPE members and task force participants provided a consensus-building iterative process for the topics and framing of recommendations. RESULTS: The ISPOR/ISPE Task Force recommendations cover seven topics such as study registration, replicability, and stakeholder involvement in RWE studies. These recommendations, in concert with earlier recommendations about study methodology, provide a trustworthy foundation for the expanded use of RWE in health care decision making. CONCLUSION: The focus of these recommendations is good procedural practices for studies that test a specific hypothesis in a specific population. We recognize that some of the recommendations in this report may not be widely adopted without appropriate incentives from decision makers, journal editors, and other key stakeholders.

Hospitalizaciones y análisis económico en pacientes psicóticos con palmitato de paliperidona de larga duración / Hospitalizations and economic analysis in psychotic patients with paliperidone palmitate long-acting injection

Objetivo del estudio. Prevenir las hospitalizaciones en los trastornos psicóticos es un objetivo importante, por eso los antipsicóticos de larga duración son una buena opción debido a que aseguran un mayor control de la adherencia. Por otra parte, en el actual contexto económico, los estudios farmacoeconómicos son necesarios. Nosotros hemos estimado el efecto del palmitato de paliperidona de larga duración (PP-LAI) en la prevención y hemos calculado el coste económico en los 12 meses que preceden al inicio del tratamiento con PP-LAI y los 12 meses posteriores. Métodos. Estudio de imagen en espejo de 71 pacientes diagnosticados de trastorno psicótico y tratados con PP-LAI. En el primer análisis medimos a lo largo de un año: número de hospitalizaciones/año, número de hospitalizaciones en días, número de atenciones en Urgencias/año y si hay medicación antipsicótica asociada al tratamiento de larga duración. Después de esta fase, aplicamos la Ley de Tasas de la Generalitat Valenciana para el análisis económico y estimamos el gasto por hospitalización (5.640,41 Euros) y por urgencia hospitalaria (187,61 Euros). Resumen de los resultados. Después de un año de tratamiento con PP-LAI (dosis media = 130,65 mg/mes) obtuvimos mejores datos de las variables asistenciales: reducción del total de hospitalizaciones, 78,8% (p=0,009); acortamiento en los días de hospitalización, 89,4% (p=0,009); disminución en el número de asistencias en Urgencias, 79,1% (p=0,002); reducción en la proporción de antipsicóticos asociados al tratamiento de larga duración, 21% (p<0,0001); incremento de la monoterapia, 53,8% (p<0,0001). Además, después de 12 meses de tratamiento con PP-LAI obtuvimos una reducción en el gasto de los pacientes hospitalizados (ahorro de 175.766,54 Euros) y un incremento en el gasto de los antipsicóticos del 32% (equivalente a 151.126,92 Euros). Conclusiones. PP-LAI puede ser una terapia efectiva para el tratamiento de pacientes con trastornos psicóticos severos: mejora la estabilidad sintomática y puede prevenir las hospitalizaciones con un control sintomático coste-efectivo (AU)

Purpose of the study. Prevent hospitalizations in psychotic disorders is an important aim, so long-acting antipsychotic is a good option that can control better the correct adherence. Moreover, in the current economic context pharmacoeconomic studies are necessary. We estimate the effect in prevention of paliperidone palmitate long-acting injection (PP-LAI) and calculate the economic cost in the 12 months preceding the start of treatment with PP-LAI and 12 months later. Methods. Mirror image study of 71 outpatients diagnosed with psychotic disorders and treated with PP-LAI. In a first analysis, we measured along one year: number of hospitalizations/year, number of hospitalization in days, number of emergency assists/year and if there is antipsychotics associated to long-acting treatment. After this phase, we applied Fees Act of Valencia for economic analysis and estimate of the cost per hospitalization (Euros 5,640.41) and hospital emergency (Euros 187.61). Summary of results. fter one year of treatment with PP-LAI (mean dose=130.65mg/month), we obtained greater numbers in assistance variables: total hospitalizations decrease, 78.8% (P=.009); shortening in hospitalization days, 89.4% (P=.009); abridgement of number of emergency assists, 79.1% (P=.002); decrease of rate of antipsychotics associated to long-acting treatment, 21% (P<.0001); increase in monotherapy, 53.8% (P<.0001). Therefore, after 12 months of treatment with PP-LAI we obtained a reduction in inpatient spending (savings of Euros 175,766.54) and increased spending on antipsychotics 32% (equivalent to Euros 151,126.92). Conclusions. PP-LAI can be an effective therapy for the treatment of patients with severe psychotic disorders: improves symptomatic stability and can prevent hospitalizations with cost-effective symptom control (AU)

Assessment of the quality of pharmacoeconomic evaluation literature in China.

OBJECTIVE: To evaluate the quality of Chinese pharmacoeconomic-evaluation literature published between 2012-2014 retrieved from the Chinese National Knowledge Infrastructure (CNKI) in order to assess their adherence to recommendations of the Chinese Pharmacoeconomic Guidelines. METHODS: Identified literature was screened according to pre-specified criteria to access legibility for inclusion. Each included piece of literature was systematically compared against the recommendations proposed by the relevant Chinese guidelines. RESULTS: After culling, 259 studies were included in the comparative analysis. When compared to a previous study evaluating the quality of similar literature published between 1997-2007, the results showed improvements in certain technical aspects over the years. Particularly, an improvement was observed in more diverse evaluation methods being used, increased use of cost-utility analysis (2.43% in 2012-2014 vs 0.26% in 1997-2007) and use of discounting (45% in 2012-2014 vs 4.35% in 1997- 2007). In addition, a small number of studies were starting to apply modeling. CONCLUSION: The quality of economic evaluation literature has improved in recent years, with more researchers realizing the importance and necessity of using discounting, sensitivity analysis, and modeling when conducting economic evaluation. This study also highlights certain important areas needing further attention when conducting economic evaluations in China. These include the ICER threshold of economic analysis, more detailed guidance in performing sensitivity analysis and modeling, as well as transferability of cost data across different regions. Overall, the results would support the positive contribution of the Chinese Economic Guideline in promoting economic evaluations in China.

Cost-consequence analysis of Pharmaceutical Care program for systemic arterial hypertension in the public health system in Brazil

ABSTRACT In Brazil, 80% of hypertensive patients have no blood pressure controlled, this fact has caused severe financial consequences for the public health system (PHS) and the Pharmaceutical Care (PC) has emerged as an effective alternative. The aim of this study was to analyze the costs and outcomes of systemic arterial hypertension (SAH) for conventional assistance compared to assistance with PC in the PHS. This is a pharmacoeconomic study with cost-consequence analysis nested to clinical trial. Hypertensives patients were followed-up from 2006 to 2012. During 2009 they were assisted by the PC program in Ribeirão Preto-SP, Brazil. Clinical indicators, systolic and diastolic blood pressure (SBP and DBP), triglycerides, total cholesterol (TC) and its fractions and healthcare indicators, consumption of antihypertensive medication and consultations were analyzed. Costs were listed as direct medical and direct non-medical. The average cost of conventional care for 104 patients followed-up was US$ 198.97, in the PC period and after discharge was US$ 407.91 and US$ 214.96 patient/year. After discharge of patients from PC there was reduction of SBP, DBP, TC and cardiovascular risk, 9.4 mmHg, 4.6 mmHg, 12.0 mg/dL, and 23% [p<0.005], respectively. The PC program optimized clinical and healthcare indicators and impacted in the SAH costs for the PHS.

Quality of pharmacoeconomic research in China: A systematic review.

BACKGROUND: The number of pharmacoeconomic publications in the literature from China has risen rapidly, but the quality of pharmacoeconomic publications from China has not been analyzed. OBJECTIVES: This study aims to identify all recent pharmacoeconomic publications from China, to critically appraise the reporting quality, and to summarize the results. METHODS: Four databases (PubMed, Web of Science, Medline, and EmBase) were searched for original articles published up to December 31, 2014. The Consolidated Health Economic Evaluation Reporting Standards statement including 24 items was used to assess the quality of reporting of these articles. RESULTS: Of 1046 articles identified, 32 studies fulfilled the inclusion criteria. They were published in 23 different journals. Quality of reporting varied between studies, with an average score of 18.7 (SD = 4.33) out of 24 (range 9-23.5). There was an increasing trend of pharmacoeconomic publications and reporting quality over years from 2003 to 2014. According to the Consolidated Health Economic Evaluation Reporting Standards, the reporting quality for the items including "title," "comparators of method," and "measurement of effectiveness" are quite low, with less than 50% of studies fully satisfying these reporting standards. In contrast, reporting was good for the items including "introduction," "study perspective," "choice of health outcomes," "study parameters," "characterizing heterogeneity," and "discussion," with more than 75% of the articles satisfying these reporting criteria. The remaining items fell in between these 2 extremes, with 50% to 75% of studies satisfying these criteria. CONCLUSION: Our study suggests the need for improvement in a number of reporting criteria. But the criteria for which reporting quality was low seem to be limitations that would be straightforward to correct in future studies.

Evaluación económica de la desvenlafaxina en el tratamiento de la depresión mayor en España / Economic evaluation of desvenlafaxine in the treatment of major depressive disorder in Spain

INTRODUCCIÓN: El objetivo del análisis fue evaluar el valor clínico y económico del uso de desvenlafaxina-50 mg comparado con la práctica médica (pool de pacientes tratados con duloxetina o venlafaxina) tras el fracaso del tratamiento de primera línea de la depresión mayor en España. MATERIALES Y MÉTODOS: Modelo Markov que sigue una cohorte de pacientes diagnosticados con depresión mayor, tras el fracaso del tratamiento de primera línea con inhibidores selectivos de la recaptación de serotonina y estima la respuesta al tratamiento (porcentaje de remisión y días libres de depresión) y los costes directos incurridos durante el tratamiento. Los datos de eficacia considerados en el análisis fueron obtenidos de ensayos clínicos a partir de una revisión de la literatura. Los principales supuestos del modelo, así como el uso de recursos, fueron validados por expertos clínicos. El análisis de realizó en el año 2014 desde la perspectiva del Sistema Nacional de Salud. RESULTADOS: Debido al menor número de discontinuaciones, iniciar el tratamiento de segunda línea con desvenlafaxina se asoció a un mayor número de días libres de depresión (+1,7) y un mayor porcentaje de pacientes en remisión (+0,5%). Esto se tradujo en un menor coste farmacológico y del manejo de los eventos y en un ahorro total para el Sistema Nacional de Salud de 108 €. CONCLUSIONES: En pacientes no respondedores al tratamiento con inhibidores selectivos de la recaptación de serotonina en primera línea de la depresión mayor, desvenlafaxina-50 mg mostró una efectividad clínicamente similar a los otros tratamientos usados en la práctica médica, pero con un menor coste para el Sistema Nacional de Salud

INTRODUCTION: The objective of this analysis was to evaluate the clinical and economic value of the use of 50 mg-desvenlafaxine compared to the usual care (mix of duloxetine and venlafaxine) in the outpatient treatment of major depressive disorder after first line treatment failure (relapse) in Spain. MATERIALS AND METHODS: A Markov model was used to follow up a cohort of major depressive disorder patients for one year after failure of first-line treatment with a serotonin-specific reuptake inhibitor and estimate outcome measures (percentage remission and depression-free days) and accrued and direct costs incurred during outpatient treatment of major depressive disorder. In order to obtain the efficacy data related to the treatment alternatives, a literature review of clinical trials was performed. A panel of clinical experts validated the use of clinical resources employed in the estimation of economic outcomes together with model assumptions. The analysis was performed in 2014 from the perspective of the National Health System. RESULTS: Due to fewer discontinuations, initiating second line treatment with desvenlafaxine was associated with more depression-free days and a higher percentage of patients in remission versus usual care: 1.7 days and 0.5%, respectively. This was translated into lower drug and events management costs, and an overall cost reduction of € 108 for the National Health System. CONCLUSIONS: In patients who have not responded to a first-line serotonin-specific reuptake inhibitor therapy, desvenlafaxine-50 mg was clinically similar in effectiveness, but a less costly option, compared with a weighted average of duloxetine and venlafaxine for the second-line treatment of major depressive disorder patients from a payer (National Health System) perspective in Spain

Calidad de vida del paciente asmático con beclometasona/formoterol. Análisis de coste-utilidad / Quality of life of patients with asthma on beclomethasone/formoterol. Cost-utility analysis

Objetivo. Realizar un estudio de coste-utilidad en pacientes asmáticos en tratamiento con beclometasona/formoterol en combinación fija en Atención Primaria de Salud. Material y métodos. Se seleccionó de forma no probabilística un grupo de pacientes asmáticos con severidad persistente moderada/grave (GEMA 2009), en tratamiento con beclometasona/formoterol a dosis fijas, mayores de 18 años, que habían otorgado su consentimiento informado. El período de observación del estudio fue de 6 meses. Las variables estudiadas fueron: edad, sexo, duración de la enfermedad, recursos sanitarios empleados, análisis de la calidad de vida relacionada con la salud mediante EQ-5D y SF-36, y el cuestionario específico Asthma Quality of Life Questionnaire. Para las variables cualitativas se analizó la frecuencia y la proporción. Para las cuantitativas, la media, la DE y el IC 95%. En la estadística inferencial se utilizaron los test de Chi-cuadrado, t de Student y ANOVA. Las comparaciones se realizaron con una significación estadística de 0,05. Resultados. Sesenta y cuatro pacientes completaron el estudio; el 59,4% eran mujeres. La edad media fue de 49 años y la duración media de la enfermedad fue de 93 meses. Para el control del asma el 53% de los pacientes tenían una pauta prescrita de uno/12 h. Todas las escalas de calidad de vida relacionada con la salud se modificaron respecto del inicio del estudio y las diferencias fueron estadísticamente significativas. Nuestros pacientes lograron mejores puntuaciones en calidad de vida relacionada con la salud que la cohorte española de asma. El coste-utilidad incremental de beclometasona/formoterol frente a la opción habitual de tratamiento fue de 6.256 €/AVAC (AU)

Aim. To perform a cost-utility analysis on asthmatic patients on beclomethasone/formoterol fixed combination in Primary Health Care. Material and methods Non-probability sampling was used to select a group of asthmatic patients with moderate/severe persistent severity (GEMA 2009), treated with beclomethasone/formoterol fixed combination, over 18 years, had given their informed consent. The study observation period was 6 months. The variables studied were: age, sex, duration of disease, health resources used, analysis of health related quality of life by EQ-5D and SF-36, and the specific Asthma Quality of Life Questionnaire. For the qualitative variables, the frequency and percentages were calculated, and for the quantitative variables, the mean, SD and 95% CI. Chi-square, Student t-test and ANOVA were used for statistical inference. Comparisons were made with a statistical significance of 0.05. Results. Of the 64 patients that completed the study, 59.4% were female. The mean age was 49 years, and mean disease duration was 93 months. For asthma control, 53% of patients had a prescription pattern of one/12 h. All health related quality of life scales were modified with respect to the baseline and the differences were statistically significant. Our patients had a better health related quality of life than Spanish asthma cohort. The incremental cost utility beclomethasone/formoterol versus usual treatment option was € 6,256/QALY (AU)

Farmaeconomía en asma / Pharmaeconomics in asthma

No disponible

¿Es posible medir la calidad de vida en el ámbito asistencial? Historia, límites y posibilidades / Can quality of life be measured in a health care setting? History, constraints and possibilities

Los conceptos y escalas de calidad de vida relacionada con salud (CVRS) comienzan a ser habituales en la práctica clínica, y juegan hoy un importante papel en discusiones bioéticas, especialmente en el manejo de pacientes terminales. En este artículo estudiamos la evolución que ha sufrido dicho concepto y la relación que guarda con el binomio salud-enfermedad. En este sentido, mostramos algunos importantes inconvenientes que arrastra la noción de calidad de vida (CV) desde sus orígenes y que se traducen en una difícil aplicabilidad en las ciencias de la salud y, sobre todo, que conllevan enormes sesgos. En nuestras conclusiones defendemos que es necesario mejorar el concepto de CV a partir de la inclusión de dimensiones y factores relacionados con el bienestar que, a pesar de no ser enteramente cuantificables, dotan de coherencia y sentido a los datos que, sobre el paciente, el profesional de la salud maneja habitualmente

Quality of life concepts and scales related to health (QLRH) are beginning to be customary in clinical practice and now play an important role in bioethical discussions, particularly concerning the management of terminal patients. This paper looks at how that concept has evolved and how it relates to the health-illness binomial. We illustrate some important complexities the notion of quality of life (QL) has borne since its inception and that make applicability in the health sciences difficult and, most of all, lead to tremendous biases. In our conclusions, we argue it is necessary to improve the concept of QL by including aspects and factors related to well-being. Although not entirely quantifiable, they give coherence and meaning to the patient data health professionals normally work with

Modelo de eficiencia de los fármacos biológicos en el tratamiento de la psoriasis moderada-grave durante un año en las condiciones de uso en España / Model for assessing the efficiency of biologic drugs in the treatment of moderate to severe psoriasis for one year in clinical practice in Spain

INTRODUCCIÓN: La mayoría de las evaluaciones económicas publicadas sobre terapias biológicas en el tratamiento de la psoriasis no reflejan la práctica clínica habitual ni incorporan el coste asociado al manejo de los pacientes. OBJETIVO: El objetivo del presente estudio es establecer un modelo de la eficiencia de los fármacos biológicos en el tratamiento de la psoriasis, incorporando el coste asociado al manejo de los pacientes en función de la respuesta que se hace en la práctica clínica habitual. MÉTODOS: Se ha desarrollado un modelo de árbol de decisión que incorpora la probabilidad de respuesta y fracaso de adalimumab, etanercept, infliximab y ustekinumab tras 24 semanas de tratamiento (final de la fase de inducción) obtenida a partir de un metaanálisis. Se han considerado costes sanitarios directos: farmacológicos y de administración (euros, 2015). Este análisis se ha llevado a cabo desde la perspectiva del hospital, considerando un horizonte temporal de un año. RESULTADOS: Según el modelo propuesto, el coste medio anual por estrategia de tratamiento de inicio más bajo corresponde a aquellos pacientes que inician tratamiento con ustekinumab, aunque las diferencias porcentuales con infliximab y adalimumab no llegan al 3%. Considerando un presupuesto fijo de 1.000.000€, la estrategia de inicio que permite tratar con éxito a mayor número de pacientes durante un año según este modelo sería ustekinumab (66), seguido de infliximab (62), adalimumab (59) y etanercept (50). Los análisis de sensibilidad confirman la consistencia de estos resultados, aunque, teniendo en cuenta los intervalos de confianza de la eficacia incremental observada en el metaanálisis, las diferencias encontradas probablemente no sean significativas en todas las posibles comparaciones binarias, y las posibles modificaciones en la estructura real de precios, en las características de la población o en las estrategias y objetivos terapéuticos en cada centro pueden dar lugar a variaciones importantes en la vida real. CONCLUSIONES: El coste del manejo de los pacientes que no alcanzan una respuesta adecuada durante la fase de inducción no debe ser ignorado, puesto que es determinante a la hora de establecer la eficiencia del tratamiento. La información que proporciona este análisis debe contrastarse con los datos reales de la práctica clínica española en cada contexto geográfico y hospitalario para optimizar la asignación de recursos y tratar a un mayor número de pacientes de manera eficiente

INTRODUCTION: Most economic evaluations in the literature on the subject of biologic therapy for the treatment of psoriasis do not reflect normal clinical practice or consider the cost of patient management. OBJECTIVE: The objective of the present study is to establish a model for assessing the efficiency of biologic therapies in the treatment of psoriasis taking into account the cost of managing treatment which, in routine clinical practice, depends on patient response. METHODS: We developed a model based on a decision tree that incorporates the probability of treatment response or failure with adalimumab, etanercept, infliximab, and ustekinumab after 24 weeks of therapy (end of the induction phase). The probability in each case was calculated using data from a meta-analysis. The following direct health costs were taken into account: the cost of drugs and their administration in euro (2015). Our analysis was based on the cost of 12 months of treatment administered in a hospital setting. RESULTS: According to the proposed model, the mean cost per year by initial treatment strategy was lowest for patients who started treatment with ustekinumab, although the percentage cost difference between ustekinumab and infliximab or adalimumab was less than 3%. With a fixed budget of €1,000,000, the initial treatment option that would achieve success in the largest number of patients for one year would, according to this model, be ustekinumab (66 patients), followed by infliximab (n = 62), adalimumab (n = 59), and etanercept (n = 50). Sensitivity analysis confirmed the reliability of these results. However, considering the confidence intervals of the incremental efficacy observed in the meta-analysis, the differences found are probably not significant in all the possible binary comparisons. Likewise, possible differences in actual price structures, populations, and the strategies and therapeutic objectives of each hospital could all give rise to considerable variations in real life. CONCLUSIONS: The cost of managing treatment in patients who fail to achieve an acceptable response during the induction phase should also be considered since such costs are a determining factor in any assessment of treatment efficiency. To achieve the optimum allocation of resources and to treat more patients efficiently, the information provided by this analysis should be cross-checked with real data taken from actual clinical practice in Spain collected in each geographical region and hospital

Adherence With Therapeutic Regimens: Behavioral and Pharmacoeconomic Perspectives.

There is an extensive literature regarding nonadherence with both therapeutic regimens and medication. This literature includes reviews of empirical research regarding the factors associated with nonadherence. Health care system, provider, and patient factors as well as the nature of the illness and therapeutic regimen all effect adherence rates. Different behavioral models for adherence counseling such as the Health Belief Model, the Theory of Reasoned Action, the Medication Interest Model, and Motivational Interviewing have also been reported in the research literature. This article will discuss the development of a brief model for patient counseling with specific techniques illustrated for pharmacists based on empirical findings that have demonstrated effectiveness in the adherence research literature. In addition, the article will address the measurement of the economic impact of medication nonadherence and propose a framework for assessing the cost-effectiveness of pharmacist counseling to increase adherence. The problem of nonadherence has significant effects upon health care expenditures through increase in physician's visits, emergency department incidents, rehospitalizations, and nursing home readmissions. Thus, the overall goal is to assist the pharmacist in developing a brief adherence counseling program in community pharmacy and evaluating the economic feasibility of the intervention demonstrating the value-added proposition of pharmacist intervention.