Cost-effectiveness of lung transplantation in The Netherlands: a scenario analysis

STUDY OBJECTIVES: To calculate cost-effectiveness of scenarios concerning lung transplantation in The Netherlands. DESIGN: Microsimulation model predicting survival, quality of life, and costs with and without transplantation program, based on data of the Dutch lung transplantation program of 1990 to 1995. SETTING: Netherlands, University Hospital Groningen. PATIENTS: Included were 425 patients referred for lung transplantation, of whom 57 underwent transplantation. INTERVENTION: Lung transplantation. RESULTS: For the baseline scenario, the costs per life-year gained are G 194,000 (G=Netherlands guilders) and the costs per quality-adjusted life-year (QALY) gained are G 167,000. Restricting patient inflow ("policy scenario") lowers the costs per life-year gained: G 172,000 (costs per QALY gained: G 144,000). The supply of more donor lungs could reduce the costs per life-year gained to G 159,000 (G 135,000 per QALY gained; G1 =US $0.6, based on exchange rate at the time of the study). CONCLUSIONS: Lung transplantation is an expensive but effective intervention: survival and quality of life improve substantially after transplantation. The costs per life-year gained are relatively high, compared with other interventions and other types of transplantation. Restricting the patient inflow and/or raising donor supply improves cost-effectiveness to some degree. Limiting the extent of inpatient screening or lower future costs of immunosuppressives may slightly improve the cost-effectiveness of the program

Cost-effectiveness analysis in severe mental illness: Outcome measures selection

Background: Most economic evaluations conducted in mental healthcare did not include widely recommended preference-based health outcomes like the QALY (Quality-Adjusted Life Years). Instead, studies have mainly been designed as cost-effectiveness analyses that include single outcome measures aimed at a (disease) specific aspect of health. Aims of the Study: To raise awareness about the potential problems related to the selection of outcome measures for economic studies in patient populations with severe mental illness. Furthermore, to make suggestions that may prevent these problems in future economic evaluations. Methods: Data of a previously conducted economic evaluation assessing the cost-effectiveness of the HIT (Hallucination focused Integrative Treatment) intervention in patients with schizophrenia were used for the analyses presented in the current paper. Economic analyses based on the results of the selected primary health outcome (Positive and Negative Syndrome Scale: PANSS) were compared with results based on various other health outcomes assessed during the study, including QALYs. Results: No relevant differences between groups were found on the single primary health outcome initially included in the cost-effectiveness analysis. In contrast, relevant and significant differences were identified on three of the four additionally assessed health outcomes. Conclusions based on the results of multiple cost-effectiveness analyses and acceptability curves were strongly in favour of the experimental intervention when including these three additional. instruments. QALY results did not show differences between groups. Discussion: Selecting between outcome measures for cost-effectiveness analysis in the field of mental healthcare appears to be a complicated process, which may have considerable consequences for the results of economic studies and subsequent policy decisions. It was argued that inconsistent results across the selected primary health outcome and additionally assessed health outcomes should explicitly be presented to decision-makers. Until there is consensus on a preference-based instrument suited for severe mental illness, QoL instruments could be applied instead of instruments aimed at specific aspects of health. Implications for Health Policies: Decision-makers in the field of mental healthcare should be careful when interpreting results of economic studies that included outcome measures aimed at a specific aspect of health. Such instruments may provide too narrow a view on relevant changes in health and findings may be difficult to generalise. Due to current reservations on the use of QALYs in mental healthcare, QALY outcomes should be considered in the context of the results of additionally assessed health outcomes

Noninferiority testing in cost-minimization studies: Practical issues concerning power analysis

Objectives: In cost-minimization studies, it is important to establish noninferiority in the clinical effect of the treatments under investigation. The relationship between the proportion of patients reaching the end point in a study, equivalence limit (3), and power is investigated in the context of cost-minimization studies with dichotomous clinical end points. Two formulations of the null-hypothesis, absolute and relative formulations of 3, will be explored. Methods: Sensitivity analysis was performed, in which the effect of the predicted proportions and 3 on the power in a noninferiority setting was investigated. The patterns found are discussed in terms of the practical relevance within the cost-minimization framework. Results: Sensitivity analyses show different patterns of results for both null-hypotheses. The differences in these results originate from the way 6 is expressed. By expressing 6 as absolute difference, power grows quite fast when sample proportions are smaller than expected. In the case of a proportional 8 at small sample proportions, the power to establish noninferiority remains low. Conclusions: To obtain valid results from a cost-minimization study, care has to be taken to adapt the correct methodology for noninferiority testing in clinical outcomes. Defining 6 in terms of absolute differences between treatments can lead to obscured results. Although conservative, the expression of 8 as a proportion of the effectiveness of the treatment as usual is found to be closer to clinical practice. The inflated 6, resulting from smaller clinical effects than expected when absolute formulation is applied, thus can be avoided

Cost-effectiveness of a psychoeducational relapse prevention program for depression in primary care

BACKGROUND: Major depression is a prevalent mental disorder with a high risk of relapses and recurrences, which are associated with considerable burden for patients and high costs for society. Despite these negative consequences, only few studies have focused on interventions aimed at the prevention of recurrences in primary care patients with depression. AIMS OF THE STUDY: To assess the cost-effectiveness of a psychoeducational prevention program (PEP) aimed at improving the long-term outcome of depression in primary care. METHODS: Recruitment took place in the northern part of the Netherlands, patients were referred by general practitioners. In total 267 patients were included in the study and randomly assigned to usual care (UC) or UC with one of three forms of PEP; PEP alone, psychiatric consultation followed by PEP (psychiatrist-enhanced PEP), and cognitive behavioral therapy followed by PEP (CBT-enhanced PEP). Costs and health outcomes were registered at three month intervals during the 36 months follow-up of the study. Primary outcome measure was the proportion of depression-free time. RESULTS: Mean total costs during the 36 months of the study were 8200 euros in the UC group, 9816 euros in the PEP group, 9844 euros in the psychiatrist-enhanced PEP group, and 9254 euros in the CBT-enhanced PEP group. Costs of productivity losses, hospital admissions, contacts with regional institutions for mental healthcare, and medication use contributed substantially to the total costs in each group. Results of the primary outcome measure were less positive for PEP than for UC, but slightly better in the enhanced PEP groups. If decision-makers are willing to pay up to 300 euros for an additional proportion of depression-free time, UC is most likely to be the optimal intervention. For higher willingness to pay, CBT-enhanced PEP seems most efficient. DISCUSSION: The basic PEP intervention was not cost-effective in comparison with UC. The economic impact of productivity losses associated with depression, and the importance of including these costs in economic studies, was illustrated by the findings of this study. Due to the drop-out of patients during the 36 months follow-up period, economic analyses had to account for missing data, which may complicate the interpretation of the results. Although Quality-Adjusted Life Years (QALYs) could not be assessed for all the patients, the results of analyses focusing on QALYs supported the overall conclusion that PEP is not cost-effective. IMPLICATIONS FOR HEALTH CARE PROVISION AND POLICIES: Results indicated that PEP should not be implemented in the Dutch healthcare system. Furthermore, is seems highly unlikely that PEP could be cost-effective in other (comparable) European healthcare systems. IMPLICATIONS FOR FURTHER RESEARCH: The relatively positive economic results for CBT-enhanced PEP imply that UC enriched with CBT (but without PEP) might be cost-effective in preventing relapses in primary care patients with depression. The actual consequences of CBT for relapse prevention will have to be studied in further detail, both from a clinical and economic point of view

Rate control versus electrical cardioversion for atrial fibrillation: A randomised comparison of two treatment strategies concerning morbidity, mortality, quality of life and cost-benefit - the RACE study design

BACKGROUND: Persistent atrial fibrillation (AF) does not terminate spontaneously and may cause left ventricular dysfunction and thromboembolic complications. For restoration of sinus rhythm electrical cardioversion (ECV) is most effective. However, AF frequently relapses, necessitating re-ECV and institution of potentially harmful antiarrhythmic drugs. If AF is accepted, rate control and prevention of thromboembolic complications using negative chronotropic drugs and warfarin is pursued. It is our hypothesis that rate control therapy is not inferior to ECV therapy in preventing morbidity and mortality. METHODS: RACE (RAte Control versus Electrical cardioversion for atrial fibrillation) is a randomised comparison of serial ECV therapy (repeat ECV as soon as possible after a relapse and institution of an antiarrhythmic drug: sotalol, class IC drug and amiodarone) and rate control therapy (resting heart rate <100 bpm using digitalis, calcium channel blockers and/or β-blockers) in patients with persistent AF. Morbidity (heart failure, side effects of drugs, thromboembolic complications, bleeding and pacemaker implantation), mortality, quality of life and cost-effectiveness are primary and secondary endpoints. Included are patients with a recurrence of persistent AF, present episode <1 year and a maximum of two previous successful ECVs during the last two years. This study is a multicentre study in 31 centres throughout the Netherlands. All 520 patients have now been included. Follow-up is two years. The results are expected this year

Rate control efficacy in permanent atrial fibrillation: a comparison between lenient versus strict rate control in patients with and without heart failure. Background, aims, and design of RACE II

Background Recent studies demonstrated that rate control is an acceptable alternative for rhythm control in patients with persistent atrial fibrillation (AF). However, optimal heart rate during AF is still unknown. Objective To show that in patients with permanent AF, lenient rate control is not inferior to strict rate control in terms of cardiovascular mortality, morbidity, neurohormonal activation, New York Heart Association class for heart failure, left ventricular function, left atrial size, quality of life, and costs. Methods The RACE 11 study is a prospective multicenter trial in The Netherlands that will randomize 500 patients with permanent AF (<= 12 months) to strict or lenient rate control. Strict rate control is defined as a mean resting heart rate < 80 beats per minute (bpm) and heart rate during minor exercise < 110 bpm. After reaching the target, a 24-hour Halter monitoring will be performed. If necessary, drug dose reduction and/or pacemaker implantation will be performed. Lenient rate control is defined as a resting heart rate < 110 bpm. Patients will be seen after 1, 2, and 3 months (for titration of rate control drugs) and yearly thereafter. We anticipate a 25% 2.5-year cardiovascular morbidity and mortality in both groups. Results Enrollment started in January 2005 in 29 centers in The Netherlands and is expected to be concluded in June 2006. Follow-up will be at least 2 years with a maximum of 3 years. Conclusion This study should provide data how to treat patients with permanent AF

Prospective study of long-term impact of adjuvant high-dose and conventional-dose chemotherapy on health-related quality of life

PURPOSE: To evaluate and compare health-related quality of life (HRQOL) after conventional- and high-dose adjuvant chemotherapy in patients with high-risk breast cancer. PATIENTS AND METHODS: Patients were randomly assigned to either a conventional or high-dose chemotherapy regimen; both regimens were followed by radiotherapy and tamoxifen. HRQOL was evaluated until disease progression using the Short Form-36 (SF-36), Visual Analog Scale, and Rotterdam Symptom Checklist and assessed every 6 months for 5 years after random assignment. For the SF-36, data from healthy Dutch women with the same age distribution served as reference values. RESULTS: Eight hundred four patients (conventional-dose chemotherapy, n = 405; high-dose chemotherapy, n = 399) were included. Median follow-up time was 57 months. Directly after high-dose chemotherapy, HRQOL decreased more compared with conventional chemotherapy for all SF-36 subscales. After 1 year, the reference value of healthy women was reached in both groups. Small differences were observed between the two groups in the role-physical and role-emotional subscales, but 1 year after treatment, these differences were minor and not clinically relevant. During follow-up, patients with a lower educational level and many complaints before chemotherapy experienced a worse HRQOL. CONCLUSION: Shortly after high-dose chemotherapy, HRQOL was more affected than after conventional-dose chemotherapy. One year after random assignment, differences were negligible. Identifying patients who have a higher chance of persistent impaired quality of life after treatment (which, in the present study, included patients with a lower educational level and many complaints before chemotherapy) is important and may open the way for better patient-tailored prevention strategies