Spanish recommendations on economic evaluation of health technologies.

The economic evaluation of health technologies has become a major tool in health policy in Europe for prioritizing the allocation of health resources and the approval of new technologies. The objective of this proposal was to develop guidelines for the economic evaluation of health technologies in Spain. A group of researchers specialized in economic evaluation of health technologies developed the document reported here, following the initiative of other countries in this framework, to provide recommendations for the standardization of methodology applicable to economic evaluation of health technologies in Spain. Recommendations appear under 17 headings or sections. In each case, the recommended requirements to be satisfied by economic evaluation of health technologies are provided. Each recommendation is followed by a commentary providing justification and compares and contrasts the proposals with other available alternatives. The economic evaluation of health technologies should have a role in assessing health technologies, providing useful information for decision making regarding their adoption, and they should be transparent and based on scientific evidence.

Propuesta de guía para la evaluación económica aplicada a las tecnologías sanitarias / A proposed guideline for economic evaluation of health technologies

La evaluación económica de tecnologías sanitarias se ha convertido en los últimos años en Europa en una herramienta de primer orden para los gestores sanitarios en sus estrategias de asignación de recursos sanitarios y de adopción de nuevas tecnologías. España fue uno de los países pioneros en realizar propuestas de estandarización metodológica aplicable a estudios de evaluación económica. No obstante, la falta de decisión política y de apoyo de los gestores sanitarios a este tipo de herramientas hizo que las propuestas cayeran en desuso. Sin embargo, lo esperable es que a medio plazo sea cada vez más habitual que las nuevas tecnologías sanitarias financiadas por el Sistema Nacional de Salud deban aportar una adecuada evidencia de su valor terapéutico y social en comparación con su coste. Llegado ese momento, los actores del sistema requerirán una serie de reglas claras y consensuadas por parte de los agentes del sistema sobre las cuestiones técnicas o metodológicas que deben respetar los estudios de evaluación de tecnologías sanitarias. Por este motivo, las presentes recomendaciones orientan sobre cómo realizar y analizar los estudios de evaluación económica de calidad. Las recomendaciones aparecen bajo 17 encabezamientos o dominios, y bajo cada recomendación hay además un comentario, en el cual se justifican y discuten las propuestas en relación con otras opciones posibles (AU)

Over the last few years, economic evaluation of health technologies has become a major tool used by European health policy decision-makers to create strategies for prioritizing the allocation of health resources and the approval of new technologies. Spain was a pioneer in proposing the standardization of methodology applicable to economic evaluation studies. However, because health policy decision-makers refused to support the initiative, the methodology was never put into practice.AbstractIn the medium term, evidence of the economic value of new health technologies financed by the national health system will probably be increasingly required. At that time, stakeholders and decision-makers will have to agree upon a clear and concise set of rules on the technical and methodological issues that must be followed by economic evaluations of health technologies. Consequently, we have provided guidelines and recommendations for producing first-rate economic evaluations. The recommendations appear under seventeen headings or sections. In each case, the recommended requirements to be satisfied by an economic evaluation of health technologies are provided and each recommendation is followed by a commentary, providing a justification and comparing and contrasting the proposal with other available alternatives(AU)

[A proposed guideline for economic evaluation of health technologies]. / Propuesta de guía para la evaluación económica aplicada a las tecnologías sanitarias.

Over the last few years, economic evaluation of health technologies has become a major tool used by European health policy decision-makers to create strategies for prioritizing the allocation of health resources and the approval of new technologies. Spain was a pioneer in proposing the standardization of methodology applicable to economic evaluation studies. However, because health policy decision-makers refused to support the initiative, the methodology was never put into practice. In the medium term, evidence of the economic value of new health technologies financed by the national health system will probably be increasingly required. At that time, stakeholders and decision-makers will have to agree upon a clear and concise set of rules on the technical and methodological issues that must be followed by economic evaluations of health technologies. Consequently, we have provided guidelines and recommendations for producing first-rate economic evaluations. The recommendations appear under seventeen headings or sections. In each case, the recommended requirements to be satisfied by an economic evaluation of health technologies are provided and each recommendation is followed by a commentary, providing a justification and comparing and contrasting the proposal with other available alternatives.

Cost-effectiveness analysis of sacral neuromodulation (SNM) with Interstim for fecal incontinence patients in Spain.

INTRODUCTION: Fecal incontinence (FI) is a condition with a high impact on the psychological and social life of healthy people. Interstim, the sacral neuromodulation (SNM) therapy, has shown higher effectiveness and safety rates than surgical procedures like dynamic graciloplasty or artificial anal sphincter in patients with intact anal sphincter (IAS) and after sphincteroplasty in patients with structurally deficient anal sphincter (SDAS). OBJECTIVE: To assess the cost-effectiveness of FI management in two scenarios - with and without SNM - and to estimate the potential budget impact of its progressive introduction in the Spanish setting. METHODS: Two decision analytical models were developed (IAS and SDAS patients) representing the possible clinical paths for each of the scenarios (with and without SNM), as well as its clinical and economic consequences in the mid-to long term with a Markov model. Clinical and resource use data were retrieved from the literature and validated by a clinician expert panel. Effectiveness was measured with both QALYs and symptom-free years (SFY). A 3% discount rate was used for future costs and benefits (time horizon = 5 years). Prevalence figures were combined with Interstim sales forecasts to estimate the total number of patients to receive therapy over the next 5 years and the associated budget impact. RESULTS: The introduction of Interstim in the therapeutic management of FI has an associated cost-effectiveness of euro16 181 (IAS patients) and euro22 195 (SDAS patients) per QALY gained. The progressive introduction of Interstim in 75 to 100 patients/year will have an estimated budget impact of 0.1% of incremental costs in patients with FI. CONCLUSIONS: Introducing Interstim in the management of FI in IAS and SDAS patients in the Spanish setting has shown to be an efficient measure with an incremental cost-effectiveness ratio below the accepted Spanish threshold (around euro35 000/QALY), and with a relatively low additional cost for the Spanish NHS.

[Distribution of the public healthcare budget of Catalonia (Spain) for 2005 among the 17 ICD-9-CM categories]. / Distribución del presupuesto sanitario público de Cataluña del año 2005 entre las 17 categorías CIE-9-MC.

OBJECTIVES: To describe the distribution of the Catalan public healthcare budget for 2005 among the 17 ICD-9-CM (International Classification of Diseases, Ninth revision, clinical modification) categories. MATERIAL AND METHOD: The methodology comprised 2 phases: an initial phase in which the global budget was distributed by type of healthcare (hospital, outpatient or pharmacological care), and a second phase in which the expenditure was distributed by the type of care among the ICD-9-CM categories. In the first phase, this distribution was based on information enabling the various budget items to be assigned to the different types of care. Various elements were used for the distribution by categories, depending on each type of care: hospital stay, outpatient visit or consumption by therapeutic subgroup. RESULTS: Distribution of the budget was as follows: 46.6% for specialized care, 27.5% for pharmacological care, and 20.0% for primary care; 5.9% was not distributed. Of the 17 categories, that accounting for the largest percentage (17.3%) was "diseases of the circulatory system" (VII), followed by category VIII, "diseases of the respiratory system" which totaled 10.9%. The budget was concentrated in 5 categories, the 2 mentioned above plus category V "mental disorders" (9.4%), category II "tumors" (9.1%) and category IX "disorders of the digestive system" (7.7%), which accounted for 54.4% of the total budget. The internal composition of each category showed major variations. CONCLUSION: The distribution of the budget offers a point of reference for health planning and management.

Distribución del presupuesto sanitario público de Cataluña del año 2005 entre las 17 categorías CIE-9-MC / Distribution of the public healthcare budget of Catalonia [Spain] for 2005 among the 17 ICD-9-CM categories

Objetivos: La distribución del presupuesto sanitario público de Cataluña del año 2005 entre las 17 categorías CIE-9-MC (Clasificación Internacional de Enfermedades, novena revisión, modificación clínica). Material y método: La metodología consta de 2 fases: una primera fase en la que se realiza una distribución del presupuesto global por tipo de atención sanitaria (atención hospitalaria, ambulatoria o farmacológica), y una segunda fase en que se distribuye el gasto por tipo de atención entre las categorías CIE-9-MC. Para esta distribución se utilizan, en la primera fase, informaciones que permitan asignar las diferentes partidas del presupuesto a los distintos tipos de atención. Por lo que respecta a la distribución por categorías, se utilizan diferentes elementos según el tipo de atención, la estancia hospitalaria, la visita ambulatoria o el consumo por subgrupo terapéutico. Resultados: El presupuesto se divide de la forma siguiente: un 46,6% corresponde a la atención especializada, un 27,5% a la atención farmacológica, un 20% a la atención primaria y un 5,9% queda sin distribuir. De las 17 categorías, la que representa el porcentaje mayor (17,3%) es la que corresponde a las enfermedades del aparato circulatorio (VII). En segundo lugar, aparece la categoría VIII «enfermedades del aparato respiratorio», que alcanza un 10,9%. El presupuesto se concentra en 5 categorías, las 2 anteriores más V «trastornos mentales» (9,4%), II «tumores» (9,1%) y IX «trastornos del aparato digestivo» (7,7%), que representan el 54,4% del presupuesto total. La composición interna para cada categoría presenta variaciones muy notorias. Conclusión: La distribución del presupuesto aporta un punto de referencia para la planificación y la gestión sanitarias

Objectives: To describe the distribution of the Catalan public healthcare budget for 2005 among the 17 ICD-9-CM (International Classification of Diseases, Ninth revision, clinical modification) categories. Material and method: The methodology comprised 2 phases: an initial phase in which the global budget was distributed by type of healthcare (hospital, outpatient or pharmacological care), and a second phase in which the expenditure was distributed by the type of care among the ICD-9-CM categories. In the first phase, this distribution was based on information enabling the various budget items to be assigned to the different types of care. Various elements were used for the distribution by categories, depending on each type of care: hospital stay, outpatient visit or consumption by therapeutic subgroup. Results: Distribution of the budget was as follows: 46.6% for specialized care, 27.5% for pharmacological care, and 20.0% for primary care; 5.9% was not distributed. Of the 17 categories, that accounting for the largest percentage (17.3%) was «diseases of the circulatory system» (VII), followed by category VIII, «diseases of the respiratory system» which totaled 10.9%. The budget was concentrated in 5 categories, the 2 mentioned above plus category V «mental disorders» (9.4%), category II «tumors» (9.1%) and category IX «disorders of the digestive system» (7.7%), which accounted for 54.4% of the total budget. The internal composition of each category showed major variations. Conclusion: The distribution of the budget offers a point of reference for health planning and management

Costs of chronic bronchitis and COPD: a 1-year follow-up study.

OBJECTIVE: This study attempted to determine the total direct costs derived from the management of chronic bronchitis and COPD in an ambulatory setting through a prospective, 1-year, follow-up study. METHOD: A total of 1,510 patients with chronic bronchitis and COPD were recruited from 268 general practices located throughout Spain. Patients were followed up for 1 year. All direct medical costs incurred by the cohort and related to their respiratory disease were quantified. Costs were calculated for patients with confirmed COPD according to the degree of severity of airflow obstruction. RESULTS: The global mean direct yearly cost of chronic bronchitis and COPD was $1,876. The cost generated by patients with COPD was $1,760, but the cost of severe COPD ($2,911) was almost double that of mild COPD ($1,484). Hospitalization costs represented 43.8% of costs, drug acquisition costs were 40.8%, and clinic visits and diagnostic tests represented only 15.4% of costs. CONCLUSION: This is the first prospective follow-up study on a large cohort of patients with chronic bronchitis and COPD aimed at quantifying direct medical costs under usual clinical practice in the community. Costs of chronic bronchitis and COPD were almost twofold those reported for asthma. Patterns of COPD management in the community differ from those recommended in guidelines. COPD represents a great health-care burden in developed countries, and aging of the population and continuing smoking habits predict that it will continue to do so in the future.

Pharmacoeconomic evaluation of acute exacerbations of chronic bronchitis and COPD.

BACKGROUND: Although exacerbations are the main cause of medical visits and hospitalizations of patients with chronic bronchitis and COPD, little information is available on the costs of their management. OBJECTIVE: This study attempted to determine the total direct costs derived from the management of exacerbations of chronic bronchitis and COPD in an ambulatory setting. METHOD: A total of 2,414 patients with exacerbated chronic bronchitis and COPD were recruited from 268 general practices located throughout Spain. Patients were followed up for 1 month. RESULTS: A total of 507 patients (21%) relapsed; of these, 161 patients (31.7%) required attention in emergency departments and 84 patients (16.5%) were admitted to the hospital. The total direct mean cost of all exacerbations was $159; patients who were hospitalized generated 58% of the total cost. Cost per failure was $477.50, and failures were responsible for an added mean cost of $100.30/exacerbation. Exacerbations of the 1,130 patients with COPD had a mean cost of $141. Sensitivity analysis showed that a 50% reduction in the failure rate (from 21 to 10.5%) would result in a total cost of exacerbation of $107 (33% reduction). CONCLUSION: Exacerbations of chronic bronchitis and COPD are costly, but the greatest part of costs derives from therapeutic failures, particularly those that end in hospitalization.