RESUMO
Guidance from the Institute for Quality and Efficiency in Health Care (IQWiG) on cost estimation in cost-benefit assessments in Germany acknowledges the need for standardization of costing methodology. The objective of this review was to assess current methods for deriving clinical event costs in German economic evaluations. A systematic literature search of 24 databases (including MEDLINE, BIOSIS, the Cochrane Library and Embase) identified articles, published between January 2005 and October 2009, which reported cost-effectiveness or cost-utility analyses. Studies assessed German patients and evaluated at least one of 11 predefined clinical events relevant to patients with diabetes mellitus. A total of 21 articles, describing 199 clinical cost events, met the inclusion criteria. Year of costing and time horizon were available for 194 (97%) and 163 (82%) cost events, respectively. Cost components were rarely specified (32 [16%]). Costs were generally based on a single literature source (140 [70%]); where multiple sources were cited (32 [16%]), data synthesis methodology was not reported. Cost ranges for common events, assessed using a Markov model with a cycle length of 12 months, were: acute myocardial infarction (nine studies), first year, 4,618-17,556 ; follow-up years, 1,006-3,647 ; and stroke (10 studies), first year; 10,149-24,936 ; follow-up years, 676-7,337 . These results demonstrate that costs for individual clinical events vary substantially in German health economic evaluations, and that there is a lack of transparency and consistency in the methods used to derive them. The validity and comparability of economic evaluations would be improved by guidance on standardizing costing methodology for individual clinical events.
RESUMO
Coronary heart disease (CHD) remains the leading cause of death in Germany despite statin use to reduce low-density lipoprotein cholesterol (LDL-C) levels; improving lipids beyond LDL-C may further reduce cardiovascular risk. A fixed-dose combination of extended-release niacin (ERN) with laropiprant (LRPT) provides comprehensive lipid management. We adapted a decision-analytic model to evaluate the economic value (incremental cost-effectiveness ratio [ICER] in terms of costs per life-years gained [LYG]) of ERN/LRPT 2 g over a lifetime in secondary prevention patients in a German setting. Two scenarios were modelled: (1) ERN/LRPT 2 g added to simvastatin 40 mg in patients not at LDL-C goal with simvastatin 40 mg; (2) adding ERN/LRPT 2 g compared with titration to simvastatin 40 mg in patients not at LDL-C goal with simvastatin 20 mg. In both scenarios, adding ERN/LRPT was cost-effective relative to simvastatin monotherapy at a commonly accepted threshold of 30,000 per LYG; ICERs for ERN/LRPT were 13,331 per LYG in scenario 1 and 17,684 per LYG in scenario 2. Subgroup analyses showed that ERN/LRPT was cost-effective in patients with or without diabetes, patients aged ≤ 65 or >65 years and patients with low baseline high-density lipoprotein cholesterol levels; ICERs ranged from 10,342 to 15,579 in scenario 1, and from 14,081 to 20,462 in scenario 2. In conclusion, comprehensive lipid management with ERN/LRPT 2 g is cost-effective in secondary prevention patients in Germany who have not achieved LDL-C goal with simvastatin monotherapy.
Assuntos
Anticolesterolemiantes/uso terapêutico , Dislipidemias/tratamento farmacológico , Hipolipemiantes/uso terapêutico , Indóis/uso terapêutico , Niacina/uso terapêutico , Sinvastatina/uso terapêutico , Idoso , Idoso de 80 Anos ou mais , Anticolesterolemiantes/administração & dosagem , Anticolesterolemiantes/economia , Análise Custo-Benefício , Quimioterapia Combinada/economia , Dislipidemias/economia , Feminino , Alemanha , Custos de Cuidados de Saúde , Humanos , Hipolipemiantes/administração & dosagem , Hipolipemiantes/economia , Indóis/administração & dosagem , Indóis/economia , Expectativa de Vida , Masculino , Pessoa de Meia-Idade , Modelos Econômicos , Niacina/administração & dosagem , Niacina/economia , Medição de Risco , Prevenção Secundária/economia , Sinvastatina/administração & dosagem , Sinvastatina/economiaRESUMO
BACKGROUND: Chemotherapy-induced nausea and vomiting (CINV) remains a major adverse effect of cancer therapy. We aimed to determine outcomes associated with use of aprepitant in outpatients undergoing highly emetogenic chemotherapy in Germany from a patient's and payer's perspective. METHODS: A decision-analytic model compared an aprepitant regimen (aprepitant/ondansetron/dexamethasone) to a control regimen (ondansetron/dexamethasone) over a five days period. Clinical results and resource utilisation observed in aprepitant phase III clinical trials were assigned German unit cost data. RESULTS: Complete response over one chemotherapy cycle was observed in 68% of patients in the aprepitant group (N=514) compared to 48% of patients in the control group (N=518). Patients were estimated to have gained an equivalent of 15 additional hours of perfect health per cycle (0.63 quality-adjusted life days) with aprepitant-based regimen compared to control regimen. Cost per quality-adjusted life year gained with aprepitant was estimated at euro28,891. CONCLUSIONS: Aprepitant substantially improved CINV-related health outcomes in patients undergoing highly emetogenic chemotherapy. Incremental benefits materialised in a cost-effective fashion.
Assuntos
Antieméticos/uso terapêutico , Protocolos de Quimioterapia Combinada Antineoplásica/efeitos adversos , Morfolinas/uso terapêutico , Neoplasias/tratamento farmacológico , Ondansetron/uso terapêutico , Antieméticos/economia , Aprepitanto , Cisplatino/administração & dosagem , Cisplatino/efeitos adversos , Ensaios Clínicos Fase III como Assunto , Análise Custo-Benefício , Dexametasona/administração & dosagem , Dexametasona/efeitos adversos , Método Duplo-Cego , Quimioterapia Combinada , Recursos em Saúde/economia , Recursos em Saúde/estatística & dados numéricos , Humanos , Morfolinas/economia , Estudos Multicêntricos como Assunto , Náusea/induzido quimicamente , Náusea/economia , Náusea/prevenção & controle , Neoplasias/economia , Ondansetron/economia , Ensaios Clínicos Controlados Aleatórios como Assunto , Resultado do Tratamento , Vômito/induzido quimicamente , Vômito/economia , Vômito/prevenção & controleRESUMO
BACKGROUND AND PURPOSE: The number of stroke patients and the healthcare costs of strokes are expected to rise. The objective of this study was to determine the direct costs of first ischemic stroke and to estimate the expected increase in costs in Germany. METHODS: An incidence-based, bottom-up, direct-cost-of-ischemic-stroke study from the third-party payer's perspective was performed, incorporating 10-year survival data and 5-year resource use data from the Erlangen Stroke Registry. Discounted lifetime year 2004 costs per case were obtained and applied to the expected age and sex evolution of the German resident population in the period 2006 to 2025. RESULTS: The overall cost per first-year survivor of first-ever ischemic stroke was estimated to be 18,517 euros (EUR). Rehabilitation accounted for 37% of this cost, whereas in subsequent years outpatient care was the major cost driver. Discounted lifetime cost per case was 43,129 EUR overall and was higher in men (45,549 EUR) than in women (41,304 EUR). National projections for the period 2006 to 2025 showed 1.5 million and 1.9 million new cases of ischemic stroke in men and women, respectively, at a present value of 51.5 and 57.1 billion EUR, respectively. CONCLUSIONS: The number of stroke patients and the healthcare costs of strokes in Germany will rise continuously until the year 2025. Therefore, stroke prevention and reduction of stroke-related disability should be made priorities in health planning policies.
Assuntos
Efeitos Psicossociais da Doença , Custos de Cuidados de Saúde , Acidente Vascular Cerebral/economia , Idoso , Feminino , Alemanha , Custos de Cuidados de Saúde/tendências , Humanos , Masculino , Fatores Sexuais , Acidente Vascular Cerebral/epidemiologia , Acidente Vascular Cerebral/prevenção & controleRESUMO
PURPOSE: Knowledge of the existence, position, and magnitude of barriers to equitable healthcare is an important consideration in shaping healthcare policies. METHODS: The authors developed a novel three-dimensional person-time-related hurdle model and followed a cohort of 7358 statutorily (SHI) and 457 privately health insured (PHI) patients with migraine headaches at 377 primary-care practices (MediPlus, IMS Health) in the second to fourth year of the HealthCare Structural Reform Act in Germany. RESULTS: For SHI compared with PHI migraine patients, there was a hurdle to receiving sumatriptan at all (2.4-fold lower hazard, 95% confidence interval, 1.8-3.2). Among patients who received sumatriptan, frequency and intensity of use differed only minimally between SHI and PHI patients. CONCLUSIONS: These findings have implications for healthcare researchers and healthcare policies. The framework extends traditional hurdle models and can serve as a model for quantifying barriers to receipt of services under different funding policies.
Assuntos
Acessibilidade aos Serviços de Saúde , Seguro Saúde , Padrões de Prática Médica/estatística & dados numéricos , Adolescente , Adulto , Idoso , Estudos de Coortes , Tomada de Decisões , Feminino , Alemanha , Política de Saúde , Humanos , Cobertura do Seguro , Masculino , Pessoa de Meia-Idade , Transtornos de Enxaqueca/tratamento farmacológico , Modelos Teóricos , Atenção Primária à Saúde , Sumatriptana/uso terapêutico , Vasoconstritores/uso terapêuticoRESUMO
BACKGROUND: We present a novel application of the concept of risk or rate advancement to compute the extent of delay in adoption of an effective new drug in 2 German health insurance systems. METHODS: We identified individuals with migraines, age 18 to 65 years, in 371 primary care practices in Germany in 1994 (MediPlus, IMS Health database). These included 8173 persons covered under the statutory health insurance system and 503 persons covered by private health insurance. We derived risk and population risk advancement periods for sumatriptan compared with nonserotoninergic acute migraine therapy using multiplicative risk regression and generalized estimating equations, adjusted for patient, physician, and practice cofactors. RESULTS: For patients at the mean age of the cohort, 43 years of age, sumatriptan was prescribed 1.2 (95% confidence interval [CI] = 0.3-2.0) years later among those in the statutory health insurance system compared with those who had private insurance. The lag increased by 0.6 (-0.1 to 1.3) years for every 10 years of patient age. In the age-mix of our sample, access to the health benefits of sumatriptan therapy lagged nearly 1.5 years behind in the statutory health insurance system and for Germany as a whole. CONCLUSIONS: Migraine patients' access to sumatriptan therapy lagged substantially in the statutory health insurance system and in the country as a whole. Risk advancement periods provide a useful methodology for communicating major healthcare issues in a meaningful way to society and policymakers.
Assuntos
Indicadores Básicos de Saúde , Transtornos de Enxaqueca/tratamento farmacológico , Agonistas do Receptor de Serotonina/uso terapêutico , Sumatriptana/uso terapêutico , Adulto , Idoso , Intervalos de Confiança , Feminino , Alemanha , Humanos , Masculino , Pessoa de Meia-Idade , Programas Nacionais de Saúde , Fatores de TempoRESUMO
BACKGROUND: Drug provision within the German statutory health insurance system has undergone several reforms, including the introduction of drug macrobudgets in 1993. OBJECTIVE: The objective of this study was to investigate the extent to which statutorily (SHI) and fully privately (PHI) health-insured patients were provided with new medication recommended by professional bodies in an equitable fashion using the example of migraine patients. RESEARCH DESIGN: We conducted a retrospective cohort study. SETTING: A total of 367 primary-care practices (MediPlus, IMS Health) in Germany in the second year of the HealthCare Structural Reform Act were studied. SUBJECTS: Subjected consisted of 7703 SHI and 470 PHI migraineurs (International Classification of Diseases, 10th edition G43) aged 18 to 65 years at their first migraine prescription visit in 1994. OUTCOME MEASURE: We compared prescription of oral or subcutaneous serotonin 5HT1B/1D receptor agonist sumatriptan with nonserotoninergic migraine therapy. RESULTS: In multiplicative risk regression with variance estimation accounting for clustering of patients within practices, PHI patients were 2.3 times (95% confidence interval [CI], 1.6-3.3) more likely to receive sumatriptan than their SHI counterparts at the mean age of the cohorts (43 years) adjusted for incident versus prevalent migraine treatment, the gender of the patient, the age, gender, and primary care specialist group of the physician, and the type and the community size class of the practice. This disparity widened by 38% (95% CI, 1-88%) every 10 years of patient age. CONCLUSION: Even though virtually everyone in Germany has health insurance and drug coverage, use of new and recommended migraine medicines was less common among those with SHI compared with their privately insured counterparts. Systematic studies of access to health care recommended by professional bodies will be critically important to ensure delivery of high-quality health care for all patients.
Assuntos
Prescrições de Medicamentos/estatística & dados numéricos , Acessibilidade aos Serviços de Saúde , Seguro Saúde/estatística & dados numéricos , Transtornos de Enxaqueca/tratamento farmacológico , Agonistas do Receptor de Serotonina/uso terapêutico , Sumatriptana/uso terapêutico , Adolescente , Adulto , Idoso , Prescrições de Medicamentos/economia , Feminino , Alemanha , Pesquisa sobre Serviços de Saúde , Humanos , Masculino , Pessoa de Meia-Idade , Padrões de Prática Médica/estatística & dados numéricos , Atenção Primária à Saúde , Estudos Retrospectivos , Agonistas do Receptor de Serotonina/economia , Sumatriptana/economiaRESUMO
BACKGROUND: Despite the growing use of statins, many hypercholesterolaemic patients fail to reach their lipid goal and remain at elevated risk of coronary heart disease (CHD). Alternative treatment strategies, such as ezetimibe coadministration and statin titration, can help patients achieve greater lipid control, and thereby lower their CHD risk. But is it cost effective to more aggressively lower cholesterol levels across a broad range of current statin users? METHODS: Using a decision-analytic model based on epidemiological and clinical trials data, we project the lifetime benefit and cost of alternative lipid-lowering treatment strategies for CHD and non-CHD diabetic patients in Germany, Spain and Norway. RESULTS: It is projected that from 40% to 76% of these patients who have failed to reach their lipid goal with their current statin treatment will be able to reach their goal with ezetimibe coadministration; this represents a gain of up to an additional absolute 14% who will be able to reach their goal compared with a 'titrate to goal' strategy where patients are titrated in order to reach their lipid goal (up to the maximum approved dose). For CHD patients, the estimated incremental cost-effectiveness ratio for ezetimibe coadministration is under Euro 18 000 per life-year gained (Euro/LYG) and 26 000 Euro/LYG compared with strategies based on the observed titration rates and the aggressive 'titrate to goal' strategy, respectively; for non-CHD diabetic patients, these ratios are under 26 000 Euro/LYG and 48 000 Euro/LYG for ezetimibe coadministration compared with the two titration strategies. CONCLUSION: Compared with statin titration, ezetimibe coadministration is projected to be cost effective in the populations and countries studied.