Real-World Experience on the Use of Mepolizumab from the Severe Asthma Registry of the German Asthma Net (MepoGAN-Study).

Purpose: The German Asthma Net (GAN) operates a Severe Asthma Registry that provides an overview of the clinical presentation and management of patients with severe asthma. Based upon data from the GAN registry, the MepoGAN study aimed to describe clinical profiles and treatment outcomes of patients who were treated with the anti-IL-5 monoclonal antibody mepolizumab (NucalaTM) in routine practice in Germany. Patients and Methods: The MepoGAN study is a descriptive retrospective non-interventional cohort study. Mepolizumab patients enrolled in the GAN registry were evaluated with results being described in two different data sets: Cohort 1 (n=131) started on mepolizumab when the patients entered the registry. Results were reported after 4 months of therapy. Patients in Cohort 2 (n=220) were on treatment with mepolizumab at the time of enrollment and follow-up data were collected after a further year of treatment. Outcome measures included asthma control, lung function, disease symptoms, OCS use, and exacerbations. Results: Patients enrolled in the registry who started on mepolizumab in Cohort 1 had a mean age of 55 years, were former smokers in 51% of the cases, had a mean blood eosinophil count of 500 cells/µL, and frequently had maintenance OCS use (55%). In this real-world setting, mepolizumab therapy was associated with a clinically relevant reduction in blood eosinophils (-445.7 cells/µL), OCS use (-30%), and improvement in asthma control. Fifty-five percent (vs 10% at baseline) of the patients reported controlled or partially controlled asthma 4 months after starting therapy. In patients who were already treated with mepolizumab at registry enrollment (Cohort 2), asthma control and lung function remained stable after a further year of observation. Conclusion: The GAN registry data confirm the effectiveness of mepolizumab in a real-world setting. Treatment benefits are maintained over time. While the asthma of patients treated in routine practice was more severe, the results observed with mepolizumab are broadly consistent with RCTs.

Resource use and cost implications of implementing a heart failure program for patients with systolic heart failure in Swedish primary health care.

AIM: Heart failure (HF) is a common but serious condition which involves a significant economic burden on the health care economy. The purpose of this study was to evaluate cost and quality of life (QoL) implications of implementing a HF management program (HFMP) in primary health care (PHC). METHODS AND RESULTS: This was a prospective randomized open-label study including 160 patients with a diagnosis of HF from five PHC centers in south-eastern Sweden. Patients randomized to the intervention group received information about HF from HF nurses and from a validated computer-based awareness program. HF nurses and physicians followed the patients intensely in order to optimize HF treatment according to current guidelines. The patients in the control group were followed by their regular general practitioner (GP) and received standard treatment according to local management routines. No significant changes were observed in NYHA class and quality-adjusted life years (QALY), implying that functional class and QoL were preserved. However, costs for hospital care (HC) and PHC were reduced by EUR 2167, or 33%. The total cost was EUR 4471 in the intervention group and EUR 6638 in the control group. CONCLUSIONS: Introducing HFMP in Swedish PHC in patients with HF entails a significant reduction in resource utilization and costs, and maintains QoL. Based on these results, a broader implementation of HFMP in PHC may be recommended. However, results should be confirmed with extended follow-up to verify long-term effects.

Cost-effectiveness of rosuvastatin in comparison with generic atorvastatin and simvastatin in a Swedish population at high risk of cardiovascular events.

BACKGROUND: To assess the long-term cost-effectiveness of rosuvastatin therapy compared with generic simvastatin and generic atorvastatin in reducing the incidence of cardiovascular events and mortality in a Swedish population with Framingham risk ≥20%. METHODS: A PROBABILISTIC MONTE CARLO SIMULATION MODEL BASED ON DATA FROM JUPITER (THE JUSTIFICATION FOR THE USE OF STATINS IN PREVENTION: an Intervention Trial Evaluating Rosuvastatin) was used to estimate the long-term cost-effectiveness of rosuvastatin 20 mg daily versus simvastatin or atorvastatin 40 mg for the prevention of cardiovascular death and morbidity. The three- stage model included cardiovascular event prevention simulating the 4 years of JUPITER, initial prevention beyond the trial, and subsequent cardiovascular event prevention. A Swedish health care payer perspective (direct costs only) was modeled for a lifetime horizon, with 2008/2009 as the costing period. Univariate and probabilistic sensitivity analyses were performed. RESULTS: The incremental cost per quality-adjusted life-year (QALY) gained with rosuvastatin 20 mg over simvastatin or atorvastatin 40 mg ranged from SEK88,113 (rosuvastatin 20 mg versus simvastatin 40 mg; Framingham risk ≥30%; net avoidance of 34 events/1000 patients) to SEK497,542 (versus atorvastatin 40 mg: Framingham risk ≥20%; net avoidance of 11 events/1000 patients) over a lifetime horizon. Probabilistic sensitivity analyses indicated that at a willingness-to-pay threshold of SEK500,000/QALY, rosuvastatin 20 mg would be cost-effective for approximately 75%-85% of simulations relative to atorvastatin or simvastatin 40 mg. Sensitivity analyses indicated the findings to be robust. CONCLUSION: Rosuvastatin 20 mg is cost-effective over a lifetime horizon compared with generic simvastatin or atorvastatin 40 mg in patients at high cardiovascular risk in Sweden.

Cost-effectiveness of rosuvastatin 20 mg for the prevention of cardiovascular morbidity and mortality: a Swedish economic evaluation of the JUPITER trial.

OBJECTIVE: This study estimated the long-term health outcomes, healthcare costs, and cost-effectiveness of rosuvastatin 20 mg therapy in primary prevention of major cardiovascular disease (CVD) in a Swedish population. METHODS: Based on data from the JUPITER trial, long-term CVD outcomes with rosuvastatin vs no active treatment were estimated for patients with an elevated baseline CVD risk (Framingham CVD score >20%, sub-population of JUPITER population) and for a population similar to the total JUPITER population. Using a decision-analytic model, trial CVD event rates were combined with epidemiological and cost data specific for Sweden. First and subsequent CVD events and death were estimated over a lifetime perspective. The observed relative risk reduction was extrapolated beyond the trial duration. Incremental effectiveness was measured as life-years gained (LYG) and quality-adjusted life-years (QALYs) gained. RESULTS: Treating 100,000 patients with rosuvastatin 20 mg was estimated to avoid 14,692 CVD events over the lifetime (8021 non-fatal MIs, 3228 non-fatal strokes, and 4924 CVD deaths) compared to placebo. This translated into an estimated gain of 42,122 QALYs and 36,865 total life years (LYG). Rosuvastatin was both more effective and less costly over a lifetime perspective, and rosuvastatin is subsequently a dominant alternative compared to no treatment in the assessed population. Using the overall JUPITER population, rosuvastatin was dominant for the lifetime horizon. In the sensitivity analysis, rosuvastatin was the dominant treatment strategy over a 20-year time horizon, and cost-effective with an incremental cost-effectiveness ratio (cost per QALY) of SEK 1783 over a 10-year time horizon. LIMITATIONS: Some model inputs were derived from literature or other data sources, but uncertainty was controlled by sensitivity analyses. CONCLUSIONS: Results indicate that rosuvastatin 20 mg treatment is a cost-effective option vs no-treatment in patients with Framingham CVD risk >20% in Sweden and might even be cost saving if taking a long-term perspective.

Cost-effectiveness of single agent, uptitration and switching statin treatment strategies for lipid lowering in Sweden.

OBJECTIVES: To assess which alternative treatment strategies are optimum in terms of cost-effectiveness (EUR/patient treated to target, EUR/PTT) in lowering cholesterol in high-risk patients with elevated LDL-cholesterol (LDL-C) in Sweden. METHODS: A probabilistic cost-effectiveness model was developed to estimate the mean expected costs and proportion of patients reaching goal attainment (defined as LDL-C < or =2.5 mmol/L [96.5 mg/dL]) at some point in time within a 52-week period following the initiation of statin therapy. Eight different statin treatment strategies were evaluated. Key data sources used in the modeling were the scientific literature, hospital tariffs and medicine price databases. RESULTS: Depending on baseline LDL-C and the willingness-to-pay per additional PTT, the cost-effective alternative is always found among four out of the eight assessed treatment strategies (i.e. Simva10 --> Simva20 --> Simva40, Rosu10, Simva20 --> Rosu10 --> Rosu20 --> Rosu40, or Simva20 --> Simva40 --> Rosu20 --> Rosu40). An important finding was that when LDL-C level exceed 4.0 mmol/L (154mg/dL) and when willingness to pay is less than 500 EUR per additional PTT, the optimal treatment strategy would be to initiate cholesterol-lowering treatment directly with rosuvastatin 10 mg. CONCLUSIONS: The results of this study indicate that the optimal approach to initiate lipid-lowering therapy would be to treat patients with the lower baseline LDL-C levels with the least costly treatment strategies, while initiating lipid-lowering treatment with a high-potency statin (rosuvastatin) in patients with moderately high or high baseline LDL-C levels. This recommendation can be assumed to be relevant particularly when the fact that after treatment initiation the majority of Swedish patients will not have any changes in their lipid-lowering medication or dose is taken into account. Finally, since only the short-term results are presented here, it would be valuable to conduct further studies of the long-term cost-effectiveness of different statin treatment strategies that focus on treatment persistence and LDL-C goal attainment in real practice.

Quality-adjusted life year weights among elderly patients with heart failure.

BACKGROUND: When assessing health-related quality of life (HRQoL) in elderly patients with heart failure (HF), the process of obtaining quality-adjusted life year (QALY) weights is generally complicated and time-consuming. AIM: To evaluate whether information regarding HRQoL and QALY weights can be derived directly from the established and widely used New York Heart Association (NYHA) functional classification system. METHODS: NYHA functional status was assessed independently both by the individual patients and by the examining cardiologist in 323 elderly patients with symptoms of HF recruited from primary care. HRQoL was evaluated using the SF-36 questionnaire and a time trade-off (TTO) scenario. The TTO technique generates direct QALY weights. RESULTS: Both the TTO technique and SF-36 values demonstrated a statistically significant correlation with NYHA functional status. The TTO values also correlated with all SF-36 dimensions. Increasing impairment was associated with statistically significant drops in both SF-36 values and TTO-based QALY weights. For patients in NYHA classes I-IV the QALY weights were 0.77, 0.68, 0.61, and 0.50, respectively. Thus in elderly patients, symptoms of HF have a major impact on perceived quality of life. CONCLUSION: The results of the present study show that QALY weights, an important instrument in the health economic evaluation of treatment strategies, can be derived directly from NYHA classification in elderly HF patients.