A Sleeping Giant: Community Pharmacy's Potential Is Unrivaled.

DISCLOSURES: No funding was received for the writing of this commentary. The author has nothing to disclose.

What Was, Is No More: Community Pharmacy Economics.

DISCLOSURES: No funding supported the writing of this article. The author is an employee of AmerisourceBergen and leads its Good Neighbor Pharmacy program, which supports independent community pharmacy customers.

Reflections on the ISPOR Special Task Force on U.S. Value Frameworks: Implications of a Health Economics Approach for Managed Care Pharmacy.

In 2016, The Professional Society for Health Economics and Outcomes Research (ISPOR) formed a special task force (STF) to review approaches and methods to support the definition and use of high-quality U.S. value frameworks. As the leadership group of that initiative, we present our perspective, focusing on implications for the managed care pharmacy community. Our reflections are organized by 9 key observations and conclude with a summary recommendation. We begin by emphasizing the importance of distinguishing among "perspectives" and "decision contexts." Possible perspectives include patient, payer, provider, health care sector, and societal. Decision contexts range from formulary inclusion to guideline development to clinical shared decision making, and multiple perspectives can be taken on each of these decisions. The STF focused on value in the context of including a new medicine in a formulary and, thus, health plan, using a health economics approach that compares marginal benefit (gross value) and marginal (opportunity) cost, yielding the net value. Health care is unique compared with other markets. While economists often use market purchases as indicators of value, they also recognize that this does not work well in health care, since most patent-protected drugs are covered by insurance. To assess the likely health and economic impact, health economists often employ cost-effectiveness analysis, using the quality-adjusted life-year (QALY), a metric that combines mortality and morbidity into a single preference-based index. We strongly endorse the STF's recommendation that payers should use the cost-per-QALY metric as a starting point. However, like the STF, and many of those stakeholders who provided input, we recognize that this metric has some limitations in theory and in practice. Nonetheless, the cost-per-QALY metric is a pragmatic tool that can be augmented to address some of its limitations by integrating other elements of value, particularly those related to uncertainty, such as financial risk protection, health risk protection, the value of hope, real option value, and the value of knowing. The resulting adjusted ratio can be compared with a willingness-to-pay threshold or combined in a measure of net monetary benefit. Alternatively, the array of elements can be valued using multi-criteria decision analysis. We end with the key recommendation that further development and testing of these promising approaches is needed to improve the deliberative process of health technology assessment. DISCLOSURES: No outside funding supported the writing of this article. The authors are leaders of the ISPOR Special Task Force on U.S. Value Frameworks. Willke is employed by ISPOR. Garrison and Neumann have nothing to disclose. The opinions expressed in this article should be considered as belonging only to the authors.

Navigating joint HTA, procurement, and fair pricing: evidence-based insights and practical recommendations - A meeting report from ISPOR regional conference in Warsaw, 2019.

Introduction: The International Society for Pharmacoeconomics and Outcomes Research (ISPOR) organized its first Central Eastern European regional meeting in 2019 in Warsaw, Poland. Area covered: The scientific program of the two-day conference covered a broad range of topics presented from the perspective of the region. Specifically, the focus was on cross-country collaboration within different steps of health technology assessment (HTA) and the need for local HTA adaptations in decision-making. Expert commentary: Attended by approximately 200 delegates from many countries and by several high level ISPOR leaders, the conference provided a valuable opportunity to exchange knowledge and strengthen the scientific network among experts from different stakeholder groups on issues specific to the region.

Incentives and disincentives to drug innovation: evidence from recent literature.

Aim: Drug innovation is strongly driven by economic incentives. How these incentives work in determining or changing the level of activity of innovators and the direction of their innovation remains understudied. We seek to address these issues in reviewing recent literature on drug innovation, which offers one major unifying theme of pharmacoeconomic scholarship presented at the 2019 AEA-ASSA annual convention. Methods: Drawn from three AEA-ASSA convention panel sessions, papers were reviewed for newly charted research terrains and new research trajectories, and their theoretical and practical implications on efficiency, effectiveness, and value in the production and utilization of pharmaceutical products. Results: While high and continuously rising drug prices are typically claimed as the price of scientific innovation, the reviewed literature finds that this link only partially accounts for the problem. High risk aversion owing to information asymmetries and vastly intractable uncertainties is prevalent among innovating firms. Predatory business models abound. Reverse predatory strategies also exist to maintain product exclusivity without much added clinical benefits, and to constrain generic competition. CEO compensation practices contribute to rising drug prices. Finally, the US government's hands-off policy on drug list prices leave the forces of supply and demand to allocate them and reward innovation (at times perversely), even as the government extensively regulates or over-regulates practically every other aspect of innovation. Conclusions: Price-elasticity of demand is critical in drug innovation. The drug value chain is price-sensitive to the balance of incentives and disincentives to innovation. American health policy should consider charting a middle course that introduces some form of regulatory price control, while stimulating and sustaining the benefits of market competition. That should incentivize stakeholders to take into account both resources and value for money in making decisions based on best-quality, clinical-economic evidence.

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.

Crowdfunding pharmacy- and medication-related products: How successful is it?

OBJECTIVE: To determine whether crowdfunding of pharmacy-related products through popular online platforms is a viable means to attain funding and what factors influence success. METHODS: Kickstarter and Indiegogo were searched for projects related to pharmacy using select key words. Projects were included for analysis if they were a device or system relevant to pharmacy care and excluded if found to be nonrelevant to medication management purposes or were of an artistic nature. Projects were assessed for their success in reaching their primary funding goals and also whether they were still in business following completion of their crowdfunding phase. RESULTS: Subsequent to the application of the inclusion and exclusion criteria to the dataset, 40 projects were identified, of which 13 reached their desired crowdfunding funding amounts. The most commonly created crowdfunded projects were those involving medication adherence or storage tools. Anecdotal evidence points to media attention leading to continued success beyond the initial crowdfunding phase of the business. The presence of a medical professional on the project team or the inclusion of a product demonstration did not lead to a different rate of success. CONCLUSION: The crowdfunding of pharmacy care-related products appear to have a low success rate, although Indiegogo might offer a higher success rate compared with Kickstarter in this niche product area. The products' ability to garner media attention seems to be a primary driver in the business surviving past the crowdfunding stage and becoming a lasting success.

Impacto económico asociado a la implementación de las recomendaciones con grado de evidencia A-I del documento de consenso de GeSIDA/PNS (2015) relativas a la optimización del tratamiento antirretroviral en adultos infectados por virus de la inmunodeficiencia humana con carga viral suprimida en España / Economic impact of optimising antiretroviral treatment in human immunodeficiency virus-infected adults with suppressed viral load in Spain, by implementing the grade A-1 evidence recommendations of the 2015 GESIDA/National AIDS Plan

Introducción: El objetivo de este estudio es estimar el impacto económico en España de la optimización del tratamiento antirretroviral (TAR) triple en pacientes con carga viral suprimida según las recomendaciones GeSIDA/PNS (2015) y su aplicabilidad en la práctica clínica. Métodos: A partir de los datos de prescripción del TAR de la encuesta hospitalaria 2014, siguiendo las recomendaciones de GeSIDA/PNS de optimización de TAR con grado de evidencia A-I, se desarrolló un modelo farmacoeconómico. Las pautas de optimización, la voluntad de optimización y demás asunciones y resultados del modelo fueron validados por un panel de expertos en la infección por VIH (infectológos y farmacéuticos hospitalarios). El análisis se realizó desde la perspectiva del SNS, considerando el coste farmacológico anual, precio de venta del laboratorio notificado, deducción RD-Ley-8/2010 e IVA. Resultados: El panel seleccionó 6 estrategias de optimización y estimó que en España de los 80.859 pacientes actualmente en TAR triple, 10.863 (13,4%) serían candidatos a optimizar su TAR según estas estrategias, generando ahorros de 15,9M euros /año (2,4% del coste farmacológico del TAR triple). Las estrategias más factibles (>40% del total de pacientes candidatos a optimizar, n=4.556) y asociadas a mayores reducciones del gasto (ahorro entre 653 y 4.797 euros /paciente-año según el TAR triple de partida) serían las optimizaciones a ATV/r+3TC. Conclusión: La aplicación a la práctica clínica española de las principales estrategias de optimización recomendadas en el documento GeSIDA/PNS (2015) generaría ahorros sustanciales, especialmente aquellas basadas en biterapia con ATV+3TC, contribuyendo así al control del gasto farmacéutico y a la sostenibilidad del SNS (AU)

Introduction: The objective of this study is to estimate the economic impact associated with the optimisation of triple antiretroviral treatment (ART) in patients with undetectable viral load according to the recommendations from the GeSIDA/PNS (2015) Consensus and their applicability in the Spanish clinical practice. Methods: A pharmacoeconomic model was developed based on data from a National Hospital Prescription Survey on ART (2014) and the A-I evidence recommendations for the optimisation of ART from the GeSIDA/PNS (2015) consensus. The optimisation model took into account the willingness to optimise a particular regimen and other assumptions, and the results were validated by an expert panel in HIV infection (Infectious Disease Specialists and Hospital Pharmacists). The analysis was conducted from the NHS perspective, considering the annual wholesale price and accounting for deductions stated in the RD-Law 8/2010 and the VAT. Results: The expert panel selected six optimisation strategies, and estimated that 10,863 (13.4%) of the 80,859 patients in Spain currently on triple ART, would be candidates to optimise their ART, leading to savings of 15.9M euros /year (2.4% of total triple ART drug cost). The most feasible strategies (>40% of patients candidates for optimisation, n=4,556) would be optimisations to ATV/r+3TC therapy. These would produce savings between 653 euros and 4,797 euros per patient per year depending on baseline triple ART. Conclusion: Implementation of the main optimisation strategies recommended in the GeSIDA/PNS (2015) Consensus into Spanish clinical practice would lead to considerable savings, especially those based in dual therapy with ATV/r+3TC, thus contributing to the control of pharmaceutical expenditure and NHS sustainability (AU)

Proyecto "Revisa(R)". Impacto del servicio de revisión del uso de los medicamentos en España. Informe de tiempos y costes / The "I-VALOR" program: standardized, protocolized, and registered drug indications for community pharmacy

En el año 2013 la Sociedad Española de Farmacia Familiar y Comunitaria (SEFAC), mediante la subcomisión de revisión del uso de los medicamentos (RUM), integrada en la comisión de servicios profesionales e inspirada en el servicio británico MUR (Medicines Use Review), puso en marcha el proyecto Revisa(R) con el fin de implantar este servicio en España. Desde entonces se han realizado cursos de capacitación, elaborado documentos de especificaciones y protocolos normalizados que permitan al farmacéutico comunitario prestar de manera adecuada y homogénea este servicio a la población. También se desarrolló un módulo para la gestión de este servicio en SEFAC e_XPERT, aplicación informática desarrollada por SEFAC para la gestión de los servicios profesionales farmacéuticos. En 2016 SEFAC llevó a cabo el primer estudio de investigación relacionado con el servicio de revisión del uso de los medicamentos con el fin de pilotar su prestación en la práctica farmacéutica. En este informe se presentan los resultados de tiempo y costes obtenidos del análisis de los datos del proyecto Revisa(R) realizado en 64 farmacias de España durante los meses de marzo a julio de 2016. Se pretende con ello facilitar al farmacéutico comunitario la información necesaria para permitirle establecer unos honorarios para la prestación de este servicio apoyado en la evidencia obtenida en la práctica farmacéutica (AU)

In 2013, the Sociedad Española de Farmacia Familiar y Comunitaria (SEFAC) [Spanish Society of Community Pharmacy] launched the Revisa(R) project. Managed by the Medicines Use Review (MUR) Subcommittee, part of the Professional Services Committee, the project takes its inspiration from the British MUR service and seeks to introduce a similar service throughout Spain. Since then, training courses have been delivered, specification documents drawn up, and protocols standardized, to enable community pharmacy to deliver the service to the public in an appropriate and consistent manner. A module to manage the service has also been developed in SEFAC e_XPERT, a computer program designed by SEFAC to manage professional pharmaceutical services. In 2016, SEFAC completed the first research study linked to the medicines use review service, designed to pilot its work in pharmaceutical practice. This report presents the time and cost results obtained by analyzing the data collected as part of the Revisa(R) project from 64 pharmacies in Spain between March and July 2016. The aim is to provide community pharmacy with the information required to establish the appropriate fees for the delivery of this service, based on evidence obtained from pharmaceutical practice (AU)

Principales variables que determinan el coste económico en el tratamiento de una infección / Main variables in the economic cost of treating an infection

El coste económico del tratamiento de una infección puede estar condicionado por múltiples factores relacionados con las características del paciente, el tipo de infección, el aislamiento de determinados microorganismos y la presencia de algunos mecanismos de resistencia. De todos ellos, la resistencia bacteriana es la que ha dado lugar a un mayor número de estudios, si bien muchos de ellos no exentos de importantes limitaciones. Se ha propuesto que los programas de optimización de antimicrobianos pueden tener un impacto positivo en el control de los costes hospitalarios del tratamiento de las infecciones. Sin embargo existe la necesidad de efectuar evaluaciones de estos programas que analicen tanto su impacto clínico como en costes, con el fin de identificar qué acciones son las más coste-efectivas. Los análisis de coste-efectividad se consideran, en un número elevado de países, como una buena fuente de información sobre la relación entre el coste de adquisición del fármaco y su reembolso. El resultado terapéutico basado en una correcta elección del antibiótico empírico, y no en el coste de adquisición del fármaco, parece ser el condicionante más importante del impacto en los costes del tratamiento de las infecciones. La estancia hospitalaria suele ser la variable más sensible cuando se efectúan estudios farmacoeconómicos. De entre el resto de variables, la que más se ha estudiado y relacionado con una disminución en los costes del tratamiento de las infecciones es la instauración de estrategias que promuevan la terapia secuencial, desde la administración del antimicrobiano por vía intravenosa a la vía oral (AU)

The economic cost of treating an infection can be influenced by multiple factors related to patient characteristics, the type of infection, the isolated microorganism and some mechanisms of bacterial resistance. Of these, the factor generating the largest number of studies is bacterial resistance but many of these studies show major limitations. Antimicrobial stewardship has been proposed as a means to reduce the economic cost of treating infections. However, the strategies included in antibiotic stewardship should be assessed to identify both their clinical impact and their cost-effectiveness. In many countries, cost-effectiveness analysis is considered a good source of information on the relationship between drug acquisition cost and its reimbursement. The therapeutic result based on a correct choice of empirical antimicrobial therapy rather than on drug acquisition cost may be the most important factor determining the cost of treating infections. Length of hospital stay is usually the most sensitive variable in pharmacoeconomics studies. Among the remaining variables, the most widely studied is the implementation of strategies promoting intravenous-to-oral switch therapy, which has been related to a decrease in infection treatment costs (AU)

[Consensus document: a model of integrated management of patients with psycomotor agitation]. / Documento di consenso: modello di gestione integrata del paziente con agitazione psicomotoria.

Psychomotor agitation (PMA) is a heterogeneous clinical syndrome associated with a widenumber of pathological conditions. The currently available recommendations and guidelines on PMA correct assessment and management are significantly dishomogeneous and suffer from a lack of standardization, especially regarding pharmacological interventions. Based on this deficiency, and on multidisciplinary nature of PMA, that includes factors shared by different health professionals other than pharmacoeconomic and risk management aspects, we started a project aimed to elaborate a shared model of integrated management for PMA patients. The model, developed by a scientific board and a multidisciplinary panel using the consensus Delphi-RAND method, aims to give indications of good clinical practice for the management of these patients. The present document reports the results of this consensus process, whose main principles are the centrality of the patient, as an active and collaborating subject, the importance of prompt and not coercive interventions able to block the escalation to violence and to allow a correct diagnostic and therapeutic workup, the appropriate use of pharmacological interventions based on the severity of symptoms and the importance of an integrated and harmonized approach by the different professionals involved in PMA management.

Estudio farmacoeconómico del tratamiento de la enfermedad de Parkinson avanzada / Pharmacoeconomic study of the treatment of advanced Parkinson’s disease

Introducción. Cuando el tratamiento farmacológico oral o transdérmico de la enfermedad de Parkinson pierde eficacia, se dispone de tres terapias mediante dispositivos asistidos que pueden reducir las complicaciones motoras y no motoras: la apomorfina en infusión subcutánea (ASBI), la bomba de infusión duodenal continua de levodopa/carbidopa (IDL) y la estimulación cerebral profunda (ECP). Objetivo. Efectuar un análisis farmacoeconómico comparativo del uso de ASBI con IDL y ECP; como objetivo secundario, discutir el perfil del candidato ideal para cada una de las técnicas. Pacientes y métodos. Se extrajo información sobre datos de años de vida ganados y años de vida ganados ajustados por calidad (AVAC) según la escala de Hoehn y Yahr, e información sobre costes y consumo de recursos para cada alternativa. La perspectiva del análisis fue la del Sistema Nacional de Salud, y el horizonte temporal fue de cinco años para los costes y toda la vida del paciente para las utilidades. Las medidas de resultado utilizadas fueron los años de vida ganados y AVAC, y en su comparación se usó la ratio coste-utilidad incremental. Resultados. El coste-utilidad obtenido para cada opción fue: 31.956 euros/AVAC para la ECP, 38.249 euros/AVAC para la ASBI y 75.206 euros/AVAC para la IDL. Conclusiones. Los resultados permiten evaluar la efectividad y utilidad de los diferentes tratamientos para la enfermedad de Parkinson avanzada, pues se presentan en ganancias de años vividos en plena salud. Los datos obtenidos contribuyen a la toma de decisiones que determinen la planificación y gestión de cada caso, sin olvidar las preferencias del paciente y del neurólogo, así como las limitaciones presupuestarias (AU)

Introduction. When oral or transdermal drug therapy in Parkinson’s disease becomes less effective, there are three therapies using assisted devices that can reduce motor and non-motor complications: subcutaneous apomorphine infusion pump (SAIP), continuous levodopa/carbidopa duodenal infusion (LDI) and deep brain stimulation (DBS). Aim. Conduct a comparative pharmacoeconomic analysis of the use of SAIP, with LDI and DBS. As a secondary objective arises discuss the profile of the ideal candidate for each of the technicals. Patients and methods. Information on life years gained and quality adjusted life years (QALY) according to Hoehn & Yahr scale was obtained, as well as data on costs and resource use for each of the alternatives. The perspective of the analysis was the National Health System and the time horizon was 5 years for costs and patient´s lifetime for utilities. Outcome measures used were life years gained and QALYs, and incremental cost/utility ratio for comparison. Results. Cost/utility ratio was obtained for each option: 31,956 euros/QALY for DBS, 38,249 euros/QALY for SAIP, and 75,206 euros/QALY for LDI. Conclusions. Our results allow us to add information about effectiveness of different treatments, as these are presented in gain of years lived in full health (QALY). Data obtained contribute to decision making that determine planning and management of each case, without forgetting patient and neurologist preferences, as well as budgetary limitations (AU)

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)

Economic evaluation in collaborative hospital drug evaluation reports / Evaluación económica en los informes de medicamentos realizados de forma colaborativa

Objective: economic evaluation is a fundamental criterion when deciding a drug’s place in therapy. The MADRE method (Method for Assistance in making Decisions and Writing Drug Evaluation Reports) is widely used for drug evaluation. This method was developed by the GENESIS group of the Spanish Society of Hospital Pharmacy (SEFH), including economic evaluation. We intend to improve the economic aspects of this method. As for the direction to take, we have to first analyze our previous experiences with the current methodology and propose necessary improvements. Method: economic evaluation sections in collaboratively conducted drug evaluation reports (as the scientific society, SEFH) with the MADRE method were reviewed retrospectively. Results: thirty-two reports were reviewed, 87.5% of them included an economic evaluation conducted by authors and 65.6% contained published economic evaluations. In 90.6% of the reports, a Budget impact analysis was conducted. The cost per life year gained or per Quality Adjusted Life Year gained was present in 14 reports. Twenty-three reports received public comments regarding the need to improve the economic aspect. Main difficulties: low quality evidence in the target population, no comparative studies with a relevant comparator, non-final outcomes evaluated, no quality of life data, no fixed drug price available, dosing uncertainty, and different prices for the same drug. Conclusions: proposed improvements: incorporating different forms of aid for non-drug costs, survival estimation and adapting published economic evaluations; establishing criteria for drug price selection, decision-making in conditions of uncertainty and poor quality evidence, dose calculation and cost-effectiveness thresholds depending on different situations (AU)

Objetivo: la evaluación económica es un criterio fundamental en el posicionamiento de medicamentos. El método MADRE (Método de Ayuda para la toma de Decisiones y la Realización de Evaluaciones de medicamentos) es ampliamente utilizado en la evaluación de medicamentos. Fue desarrollado por el grupo GENESIS de la Sociedad Española de Farmacia Hospitalaria (SEFH), e incluye una evaluación económica. Con objeto de mejorar los aspectos económicos de este método, analizaremos la experiencia previa con esta metodología y propondremos mejoras. Método: revisión retrospectiva de las evaluaciones económicas en los informes de evaluación de medicamentos realizados de forma colaborativa (como SEFH) con el método MADRE. Resultados: se revisaron 32 informes, el 87,5% incluían una evaluación económica realizada por los autores y un 65,6% una publicada. El 90,6% incluían un análisis de impacto presupuestario. 14 informes incluían el coste por año de vida o por año de vida ganado ajustado por calidad. 23 informes recibieron alegaciones relacionadas con la evaluación económica. Las principales dificultades fueron: baja calidad de la evidencia en la población diana, falta de estudios comparativos con el comparador relevante, resultados finales no evaluados, falta de datos de calidad de vida, precio del medicamento no fijado, incertidumbre en la dosis y diferentes precios del medicamento. Conclusiones: mejoras propuestas: incorporar ayudas para inclusión de costes no farmacológicos, estimación de la supervivencia y adaptación de evaluaciones económicas publicadas; establecer criterios para: selección de precios, toma de decisiones en condiciones de incertidumbre o evidencia pobre, cálculo de dosis y umbrales de coste-efectividad en diferentes situaciones (AU)

Reimbursement Decisions for Pharmaceuticals in Sweden: The Impact of Disease Severity and Cost Effectiveness.

OBJECTIVE: The Swedish Dental and Pharmaceutical Benefits Agency (TLV) is the government body responsible for deciding whether outpatient drugs are to be included in the pharmaceutical benefits scheme. This paper analyzes the impact of cost effectiveness and severity of disease on reimbursement decisions for new pharmaceuticals. METHODS: Data has been extracted from all decisions made by the TLV between 2005 and 2011. Cost effectiveness is measured as the cost per quality-adjusted life-year (QALY) gained, whereas disease severity is a binary variable (severe-not severe). In total, the dataset consists of 102 decisions, with 86 approved and 16 declined reimbursements. RESULTS: The lowest cost per QALY of declined reimbursements is Swedish kronor (SEK) 700,000 (€ 79,100), while the highest cost per QALY of approved reimbursements is SEK1,220,000 (€ 135,600). At a cost per QALY of SEK702,000 Swedish kronor (non-severe diseases) and SEK988,000 (severe diseases), the likelihood of approval is estimated to be 50/50 (€ 79,400 and € 111,700). CONCLUSIONS: The TLV places substantial weight on both the cost effectiveness and the severity of disease in reimbursement decisions, and the implied willingness to pay for a QALY is higher than the often cited 'rule of thumb' in Swedish policy debates.