E Mueller

Prolonged Prophylaxis With Valganciclovir Is Cost Effective in Reducing Posttransplant Cytomegalovirus Disease Within the United States

Background. Cytomegalovirus (CMV) disease in transplant patients is known to have a substantial clinical and economic burden, and its prevention is expected to have long-term benefits. Evidence from the Improved Protection Against CMV in Transplant trial proved that prolonged prophylaxis of 200 days with valganciclovir compared with 100 days significantly reduces the incidence of CMV in high-risk kidney transplant seropositive donors/seronegative recipients. The aim of this study was to develop a cost-effectiveness model to evaluate prolonged prophylaxis of 200 days with valganciclovir and its long-term economic impact. Methods. An economic model was designed to simulate long-term costs and outcomes of prolonged prophylaxis with valganciclovir (200 vs. 100 days) in a cohort of 10,000 high-risk renal transplant patients over 5 and 10 years. The first year of the model was based on the results of the Improved Protection Against CMV in Transplant trial and the extension to the long-term periods (5 and 10 years); and quality of life data were based on evidence retrieved through a systematic literature search. This analysis was conducted from the US healthcare payer perspective. Results. For the 5-year time horizon, the incremental cost-effectiveness ratio of US

Influenza treatment with neuraminidase inhibitors

14,859/quality-adjusted life year (QALY) suggests that 200-day valganciclovir prophylaxis is cost effective over the 100-day regimen considering a threshold of US

Societal cost savings through bevacizumab-based treatment in non-small cell lung cancer (NSCLC).

50,000/QALY. The 10-year analysis revealed the 200-day prophylaxis as cost saving with a 2380 QALY gain and simultaneously lower cost. Conclusion. Prolonged prophylaxis with valganciclovir reduces the incidence of events associated with CMV infection in high-risk kidney transplant recipients and is a cost-effective strategy in CMV disease management.

Editorial: Comparative efficacy and cost associated with new agents in the treatment of non-small cell lung cancer (NSCLC)

We assessed the cost-effectiveness and cost-utility of treating influenza with neuraminidase inhibitors (oseltamivir and zanamivir) from a health care payer’s and societal perspective in the United Kingdom. A simulation model was developed to predict morbidity and mortality due to influenza and its specified complications, comparing neuraminidase inhibitors with usual care in an otherwise healthy adult population. Robustness of the results was tested by one-way and multiway as well as probabilistic sensitivity analyses. Treatment with either neuraminidase inhibitor results in reduced morbidity and faster return to normal activities. However, oseltamivir dominates zanamivir in cost-utility analysis due to its lower costs. Comparing oseltamivir with usual care, the costs are £14.36 per day of normal activity gained and £5,600 per quality-adjusted life-year gained from the healthcare payer perspective. Oseltamivir dominates usual care from the societal perspective. Treatment with oseltamivir is a cost-effective strategy for otherwise healthy adults in the UK from both the healthcare payer and societal perspective.

Cost-effectiveness of Capsule Endoscopy in Diagnosing Obscure Gastrointestinal Bleeding: An International Comparison

Bevacizumab in combination with platinum-based chemotherapy is associated with increased survival outcomes compared to chemotherapy alone in patients with non-squamous metastatic non-small cell lung cancer (mNSCLC). The objective of this study was to estimate potential economic benefits from a societal perspective in patients returning to work when treated with bevacizumab-based combination therapy. These economic benefits were assessed with respect to reduced productivity losses and described in terms of per patient cost savings. The analysis was conducted for France, Germany, Italy and Spain. Clinical outcomes in terms of progression-free survival (PFS) were based on two phase III clinical trials (E4599 and AVAiL) comparing bevacizumab + chemotherapy vs. chemotherapy alone. Potential cost savings due to reduction in productivity losses were assessed in progression-free patients who return back to work (human capital approach). It was assumed that 20% of all progression-free patients with performance status 0 or 1 and below 55 years of age would return back to work after the induction therapy maintaining their prior employment status (60% part-time, 40% full-time). Savings were calculated over 1 and 1.5 year time horizons. Mean savings, per progression-free patient ranged from 12,401 euro in Spain at year 1 to 39,001 euro in France at year 1.5. Respective findings proved to be fairly sensitive to the change of employment patterns and labour costs. This analysis shows that bevacizumab-based treatment can result in substantial cost savings in progression-free patients with mNSCLC.

PDB33 EAGLE—DIABETES MODEL: BASIC FEATURES AND INTERNAL VALIDATION OF SIMULATING LONG-TERM DIABETIC OUTCOMES AND RELATED COSTS

Lung cancer and its manifestations remains one of the most common cancer types and is one of the leading causes of cancer mortality [1]. In Europe alone it represents one-fifth of all cancer-related deaths with an incidence of about 200,000 new cases each year [2]. Approximately 85% of all lung cancer cases are clinically classified as non-small cell lung cancer (NSCLC) and about 65% of patients have locally advanced or metastatic disease at the time of diagnosis [3,4]. Advanced NSCLC is a progressive disease with a poor prognosis. It affects patients both physically and emotionally, and the symptoms worsen as the disease progresses. Most patients with NSCLC already have advanced disease at diagnosis, and chemotherapy was the mainstay of management until recently. Since a meta-analysis published in 1995 demonstrated a significant improvement in overall survival (OS) compared to best supportive care (BSC) [5], platinumbased chemotherapy has been considered the standard firstline treatment for patients with advanced NSCLC. Platinumbased single agent or doublet therapy including cisplatin or carboplatin in combination with a so-called third-generation drug (paclitaxel, docetaxel, gemcitabine and vinorelbine) were considered to be standard therapies with fairly predictable outcomes in terms of OS and progression-free survival (PFS) [6 8]. None of the aforementioned therapies seem to harbor a clinical advantage over the other [9] and the reported median OS did not exceed more than 10 months. However, crossnational differences in preferences for treatment strategies exist. In Europe, cisplatin plus gemcitabine (CG) is the

Rapid Relative Effectiveness Assessment of Pharmaceuticals: Transferability and Completeness of Information Derived From Global Value Dossiers To Complete A Eunethta Submission

Cost-effectiveness of Capsule Endoscopy in Diagnosing Obscure Gastrointestinal Bleeding: An International Comparison Elvira Mueller, Bjoern Schwander, Rito Bergemann PURPOSE: To analyze the cost-effectiveness of capsule endoscopy (CE) in diagnosing obscure gastrointestinal bleeding from a health care payer perspective in the United States, France, the United Kingdom, Switzerland and Germany. METHODS: Based on clinical trial data and more than 20 publications available through December 1, 2003, a microsimulation model incorporating firstand second-order Monte Carlo simulation was developed. The model calculates the costs per correctly diagnosed case in patients with obscure gastrointestinal bleeding. Sensitivity and specificity values for CE and the comparator push enteroscopy (PE) as well as kind and number of other procedures performed prior to diagnosis were evaluated from 7 controlled clinical trials (n=184) and confirmed by published data. Procedure cost, the cost of diagnostic failure (false positive and false negative diagnosis) are considered and incremental costeffectiveness ratios dependent on disease prevalence are given. Cost data were estimated from a healthcare payer perspective using the Medicare fee schedule (United States), Assurance Maladie fee schedule (France), NHS Reference Cost (UK), EBM fee schedule (Germany), and the TARMED fee schedule (Switzerland). All costs refer to 2003 EURO. RESULTS: Sensitivity for CE was 89-99% and 27-60% for PE. Specificity values were 90-99% for CE and 50-70% for PE respectively. In all five countries CE was cost saving, i.e. more effective and less costly compared to push enteroscopy, when the prevalence of the disease was 30% or higher. Most common use for CE is at a prevalence of 50%. Cost savings at a prevalence of 50% are for example 517 EUR (Germany), 1004 EUR (US) and 2240 EUR (Switzerland). Probabilistic sensitivity analyses approved a high robustness for these results. CONCLUSIONS: CE proved to have a higher effectiveness than its comparator when diagnosing obscure bleeding. Though procedure costs vary substantially from country to country incremental analysis shows that the use of CE has a cost-saving potential in all five countries. From a health-economic perspective the use of capsule endoscopy is recommended in the work-up of patients with obscure gastrointestinal bleeding after upper and lower GI endoscopy.

PDB35 ECONOMIC ANALYSIS OFTHE TREATMENT WITH INSULIN GLARGINE PLUS ORAL ANTIDIABETICS (BOT) COMPARED TO TWICE DAILY PREMIXED INSULIN (CT) BASED ONTHE LAPTOPTRIAL

PDB32 LONG-TERM DIABETES COMPLICATIONS: INFLUENCE OF DELAY IN STARTING INTENSIFIED THERAPY AND OF PATIENT RATES TREATED TO TARGET A1C.ANALYSES WITH THE DIABETES MELLITUS MODEL (DMM) Bergemann R, Huppertz E, Mueller E, Maxion-Bergemann S Analytica International, Loerrach, Germany; Aventis Pharma Deutschland GmbH, Bad Soden, Germany OBJECTIVES: The Diabetes Mellitus Model can be used to simulate the cumulative incidences of short and long-term diabetes complications over 10 years in patients with type-2 diabetes. In this study, the DMM was used to investigate the influence of ‘rate of patients treated to target A1c’ (responder rate) and ‘delay in starting intensified therapy’ on the cumulative incidence of longterm complications in patients with type-2 diabetes. METHODS: A population of virtual patients was simulated based on published demographic and physiological baseline values at the start of the simulation (mean baseline A1c 9%), on which two analyses were carried out. In the first analysis, the responder rate was varied in 20% steps from 0–100% and 5 cohorts were simulated. The second analysis comprised 10 simulated cohorts evaluating the ‘delay in starting intensified therapy, which was varied in 1-year steps between 1 and 10 years. For all simulated patients, HbA1c increased by 0.1% per year. RESULTS: Both parameters have a large impact on the cumulative incidence of long-term complications in patients with type-2 diabetes, especially on macrovascular complications. After 10 years, the simulated cohort of 100% responders showed a 43% and 24% risk reduction for micro and macro-vascular complications compared to the cohort of 0% responders. Patients who started intensified therapy (target A1c < 6.5%) in year 1 of the simulation showed 77% and 33% risk reduction for micro and macro-vascular complications compared to patients who started intensified therapy in the tenth. A 3-year delay in initiation of intensified therapy gave a 20% risk reduction for microvascular complications versus initiation in year 10. CONCLUSIONS: This analysis highlights the importance of responder rate and the early initiation of intensified glycaemic control therapy in patients with type 2-diabetes with respect to long-term clinical outcomes.

PGI14 COST-EFFECTIVENESS EVALUATION FOR A NEW DIAGNOSTIC TEST CONSIDERING ALSO COSTS FOR FALSE NEGATIVE AND FALSE POSITIVE DIAGNOSES AT VARIOUS PREVALENCE RATES

of the HTA process in Japan, which is excluded from this analysis. NICE, PBAC and the SMC all require the number of patients with the indicated disease and a clear statement of patient numbers eligible for treatment per year for 5 years. Beyond this, the requirements of the Australian PBC and the SMC were similar, specifying prevalence, incidence and mortality data, whereas NICE requires a measure of disease burden (not clearly defined) and life expectancy among those with the disease. The epidemiology requirements did not differ by disease area. ConClusions: HTA bodies stipulate the inclusion of epidemiological data to estimate economic impact of interventions. Some requirements are common to all agencies, but there are also some important differences. Specific epidemiological data needs for individual agencies must be considered by drug developers when planning and gathering information for HTA submissions.

PGI4 USE OF CAPSULE ENDOSCOPY IN DIAGNOSING OBSCURE GASTROINTESTINAL BLEEDING: COST-EFFECTIVENESS EVALUATION FROM A EUROPEAN PERSPECTIVE

and body weight (BMI 0.52 kg.m-2). The aim of this analysis was to estimate the long-term clinical and cost implications associated with therapy conversion from insulin glargine to detemir in type 2 diabetes patients in Germany. METHODS: A previously published and validated diabetes model (CORE Diabetes Model) was used to make long-term projections of clinical and cost outcomes based on patient characteristics (age 62.3 years, duration of diabetes 7 years, HbA1c 8.30%, 50.4% male) and treatment effects from the German part of PREDICTIVE. The model was used to estimate life-expectancy, quality-adjusted life expectancy and to account direct medical costs (pharmacy, patient management and complication costs). Costs were derived from published sources and expressed in 2006 Euros. Future costs and clinical benefits were discounted at 5% annually. RESULTS: Therapy conversion from insulin glargine to insulin detemir was projected to improve life expectancy by approximately 0.13 years (7.08 0.13 versus 6.95 0.12 years) and quality-adjusted life expectancy by 0.29 quality-adjusted life years (QALYs) (4.53 0.09 versus 4.24 0.08 QALYs). Direct costs associated with insulin detemir treatment were projected to be lower over patient lifetimes than with glargine (€ 54,807 1,788 versus € 55,839 1,749 per patient, difference € 1,032). Cost savings were driven by lower complication costs (due to HbA1c improvements) associated with insulin detemir. CONCLUSION: Modeling the long-term implications of therapy conversion from insulin glargine to detemir based on data from German patients in PREDICTIVE indicates that insulin detemir is associated with benefits in terms of life expectancy, qualityadjusted life expectancy and complication rates, as well as reducing costs from a third-party health care payer perspective in Germany.