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This paper reports the most cost-effective policy options to support and improve breast cancer control in Costa Rica and Mexico. Total costs and effects of breast cancer interventions were estimated using the health care perspective and WHO-CHOICE methodology. Effects were measured in disability-adjusted life years (DALYs) averted. Costs were assessed in 2009 United States Dollars (US$). To the extent available, analyses were based on locally obtained data. In Costa Rica, the current strategy of treating breast cancer in stages I to IV at a 80% coverage level seems to be the most cost-effective with an incremental cost-effectiveness ratio (ICER) of US$4,739 per DALY averted. At a coverage level of 95%, biennial clinical breast examination (CBE) screening could improve Costa Rica's population health twofold, and can still be considered very cost-effective (ICER US$5,964/DALY). For Mexico, our results indicate that at 95% coverage a mass-media awareness raising program (MAR) could be the most cost-effective (ICER US$5,021/DALY). If more resources are available in Mexico, biennial mammography screening for women 50-70 yrs (ICER US$12,718/DALY), adding trastuzumab (ICER US$13,994/DALY) or screening women 40-70 yrs biennially plus trastuzumab (ICER US$17,115/DALY) are less cost-effective options. We recommend both Costa Rica and Mexico to engage in MAR, CBE or mammography screening programs, depending on their budget. The results of this study should be interpreted with caution however, as the evidence on the intervention effectiveness is uncertain. Also, these programs require several organizational, budgetary and human resources, and the accessibility of breast cancer diagnostic, referral, treatment and palliative care facilities should be improved simultaneously. A gradual implementation of early detection programs should give the respective Ministries of Health the time to negotiate the required budget, train the required human resources and understand possible socioeconomic barriers.

Background: There is an increased interest in the monetary value of a quality-adjusted life-year (QALY). Past studies commonly derived willingness to pay (WTP) for certain future QALY gains. However, obtaining valid WTP per QALY estimates proved to be difficult., Objective: We conducted a contingent valuation study and estimated the individual WTP per QALY under risk. We demonstrate the impact of probability weighting on WTP per QALY estimates in the Netherlands., Results: Our estimates of the value of a QALY are in the range of €80,000-110,000 when the weighting correction was applied, and €250,500 without correction. The validity of these estimates, applying probability weighting, appears to be good., Conclusions: Given the reasonable support for their validity and practical meaningfulness, the estimates derived while correcting for probability weighting may provide valuable input for the debate on the consumption value of health. While decision makers should not apply these estimates without further consideration, since strictly individual valuations may not carry all relevant information and values for societal decision-making, the current estimates may provide a good and informed basis for further discussion and study of this important topic.

Interpreting the outcomes of cost utility analyses requires an appropriately defined threshold for costs per quality-adjusted life year (QALY). A common view is that the threshold should represent the (consumption) value a society attaches to a QALY. So far, individual valuations of personal health gains have mainly been studied rather than potentially relevant social values. In this study, we present the first direct empirical estimates of the willingness to pay for a QALY from a societal perspective. We used the contingent valuation approach, valuing QALYs under uncertainty and correcting for probability weighting. The estimates obtained in a representative sample of the Dutch population (n = 1004) range from €52,000 to €83,000, depending on the specification of the societal perspective. The scale sensitivity was weak, however., (Copyright © 2012 John Wiley & Sons, Ltd.)

Background: A commonly held view of the decision rule in economic evaluations in health care is that the final incremental cost-effectiveness ratio needs to be judged against some threshold, which is equal for all quality-adjusted life-year (QALY) gains. This reflects the assumption that "a QALY is a QALY" no matter who receives it, or the equity notion that all QALY gains are equally valuable, regardless of the context in which they are realized. If such an assumption does not adequately reflect the distributional concerns in society, however, different thresholds could be used for different QALY gains, whose relative values can be seen as "equity weights.", Aim: Our aim was to explore the relationship between equity or distributional concerns and the social value of QALYs within the health economics literature. In light of the empirical interest in equity-related concerns as well as the nature and height of the incremental cost-effectiveness ratio threshold, this study investigates the "common ground" between the two streams of literature and considers how the empirical literature estimating the incremental cost-effectiveness ratio threshold treats existing distributional considerations., (Copyright © 2012 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.)

Objectives: In 2000, the first "Dutch Manual for Costing: METHODS and Reference Prices for Economic Evaluations in Healthcare" was published, followed by an updated version in 2004. The purpose of the Manual is to facilitate the implementation and assessment of costing studies in economic evaluations. New developments necessitated the publication of a thoroughly updated version of the Manual in 2010. The present study aims to describe the main changes of the 2010 Manual compared with earlier editions of the Manual., Methods: New and updated topics of the Manual were identified. The recommendations of the Manual were compared with the health economic guidelines of other countries, eliciting strengths and limitations of alternative methods., Results: New topics in the Manual concern medical costs in life-years gained, the database of the Diagnosis Treatment Combination (DBC) casemix System, reference prices for the mental healthcare sector and the costs borne by informal care-givers. Updated topics relate to the friction cost method, discounting future effects and options for transferring cost results from international studies to the Dutch situation., Conclusions: The Action Plan is quite similar to many health economic guidelines in healthcare. However, the recommendations on particular aspects may differ between national guidelines in some respects. Although the Manual may serve as an example to countries intending to develop a manual of this kind, it should always be kept in mind that preferred methods predominantly depend on a country's specific context.

Estimates of WTP per QALY can be taken as an indication of the monetary value of health gains, which may carry information regarding the appropriate height of the cost-effectiveness threshold. Given the far-reaching consequences choosing a particular threshold, and thus the potential relevance of WTP per QALY estimates, it is important to address the validity of these estimates. This study addresses this issue. Our findings offer little support to the validity of WTP per QALY estimates obtained in this study. Implications for general WTP per QALY estimates and further research are discussed., (Copyright © 2011 Elsevier B.V. All rights reserved.)

Rationale, Aims and Objectives: The consideration of economic evidence in guideline development may be particularly important in health care management when different (drug) therapies show similar efficacy on clinical endpoints, such as in cardiovascular diseases. This article investigates to what extent the Dutch guideline 'cardiovascular risk management' (2006) considers cost-effectiveness and budget impact according to the most recent economic evidence., Method: We carried out a systematic review of economic evaluations on cholesterol-lowering drugs and antihypertensives followed by an assessment of guideline recommendations., Results: The guideline does not consider the most recent economic evidence but does consider cost-effectiveness based on economic evaluations performed in conjunction with clinical trials. Their conclusions are largely in agreement with the most recent economic evidence. An innovative aspect in the guideline is the application of a budget impact analysis to take accessibility and affordability constraints into account when considering cost-effectiveness., Conclusions: Based on the most recent economic evidence, the guideline could be improved by more firmly formulating recommendations in favour of cost-effective drug therapies (simvastatin, pravastatin and low-dose diuretics) to stimulate compliance to the guideline in clinical practice., (© 2010 Blackwell Publishing Ltd.)

Background: Pompe disease is an orphan disease for which enzyme replacement therapy (ERT) recently became available. This study aims to estimate all relevant aspects of burden of illness--societal costs, use of home care and informal care, productivity losses, and losses in health-related quality of life (HRQoL)--for adult Pompe patients only receiving supportive care., Methods: We collected data on all relevant aspects of burden of illness via a questionnaire. We applied a societal perspective in calculating costs. The EQ-5D was used to estimate HRQoL., Results: Eighty adult patients (87% of the total Dutch adult Pompe population) completed a questionnaire. Disease severity ranged from mild to severe. Total annual costs were estimated at 22,475 (range 0-169,539) per adult Pompe patient. Patients on average received 8 h of home care and 19 h of informal care per week. Eighty-five percent of the patients received informal care from one or more caregivers; 40% had stopped working due to their disease; another 20% had reduced their working hours. HRQoL for Pompe patients who only received supportive care was estimated at 0.72, 17% lower than the Dutch population at large., Conclusions: Adult Pompe disease is associated with a considerable burden of illness at both the societal and patient levels. The disease leads to substantial costs and dependency on medical devices, home care, and informal care, and has a high impact on the patient's social network. In addition, patients are limited in their ability to work and have significantly reduced HRQoL.

Background: Changes in the health of patients may affect the health of so-called "significant others" in 2 distinct ways. First, an individual may provide informal care to the patient and be burdened by the process of care giving. We label this indirect effect of a patient's health on the health of the care giver the "care-giving effect." Second, a person may suffer from health losses because someone in his or her social environment is ill, regardless of his or her care-giving status. The health of the patient then directly affects the health of this significant other, which we label the "family effect.", Methods: We investigate the occurrence of the family and care-giving effect in a convenience sample of Dutch care givers (n = 751). The family effect was approximated by the health status of the patient (measured on EuroQol-VAS), and the care-giving effect by the number of the care-giving tasks was provided. It was assumed that care givers' health is positively associated with patients' health, that is, the family effect, and negatively associated with care-giving burden, that is, the care-giving effect. Relationships are studied using multivariate regressions., Results: Our results support the existence of both types of health effects. The analysis shows that the 2 effects are separable and independently associated with the health of care givers. Not accounting for the family effect conflates the care-giving effect., Conclusions: If the goal of health care policy is to optimize health, all important effects should be captured. The scope of economic evaluations should also include health effects in significant others. This study suggests that significant others include both care givers and broader groups of affected individuals, such as family members.

When a new medical technology, for example a new drug, is introduced onto the market there should be a discussion of the balance between "uncertainty versus value to society and demand". The new technology is sometimes given the benefit of the doubt due to a lack of information. Follow-up investigation is actually essential but is seldom mandatory and hardly ever spontaneously initiated. Specific measures, based on stimulation or penalization, could reduce the degree of uncertainty concerning the efficacy, safety and efficiency of a new technology. A serious option when a new drug produces disappointing results is to pay the manufacturer less.

Objective: The aim of this study was to elicit the individual willingness to pay (WTP) for a quality-adjusted life-year (QALY)., Methods: In a Web-based questionnaire containing contingent valuation exercises, respondents valued health changes in five scenarios. In each scenario, the respondents first valued two health states on a visual analog scale (VAS) and expressed their WTP for avoiding a decline in health from the better health state to the worse, using a payment scale followed by a bounded open contingent valuation question., Analysis: WTP per QALY was calculated for QALY gains calculated using VAS valuations, as well as the Dutch EQ-5D tariffs, the two steps in the WTP estimations and each scenario. Heterogeneity in WTP per QALY ratios was examined from the perspective of: 1) household income; and 2) the level of certainty in WTP indicated by respondents. Theoretical validity was analyzed using clustered multivariate regressions., Results: A total of 1091 respondents, representative of the Dutch population, participated in the survey. Mean WTP per QALY was € 12,900 based on VAS valuations, and € 24,500 based on the Dutch EuroQoL tariffs. WTP per QALY was strongly associated with income, varying from € 5000 in the lowest to € 75,400 in the highest income group. Respondents indicating higher certainty exhibited marginally higher WTP. Regression analyses confirmed expected relations between WTP per QALY, income, and other personal characteristics., Conclusion:   Individual WTP per QALY values elicited in this study are similar to those found in comparable studies. The use of individual valuations in social decision-making deserves attention, however., (© 2010, International Society for Pharmacoeconomics and Outcomes Research (ISPOR).)

Prevention of unhealthy lifestyles has sometimes been promoted as simultaneously reducing costs and improving public health but this will unlikely prove to be true. Additional medical costs in life years gained due to treatment of unrelated diseases may offset possible savings in related diseases, but are often ignored both in health promotion policies and in economic evaluations of life-prolonging interventions. Many national guidelines explicitly recommend excluding these costs from economic evaluations or leave inclusion up to the discretion of the analyst. This may result in too favorable estimations of cost-effectiveness, feeding the unjustified optimism among policymakers regarding lifestyle interventions as a cost-saving option. However, prevention may still be a cost-effective way to improve public health, even when it does not result in cost savings, but this should be judged taking all future costs into account and be based on the true value for money provided by lifestyle interventions.

Background: For the treatment of depression in diabetes patients, it is important that depression is recognized at an early stage. A screening method for depression is the patient health questionnaire (PHQ-9). The aim of this study is to validate the 9-item Patient Health Questionnaire (PHQ-9) as a screening instrument for depression in diabetes patients in outpatient clinics., Methods: 197 diabetes patients from outpatient clinics in the Netherlands filled in the PHQ-9. Within 2 weeks they were approached for an interview with the Mini Neuropsychiatric Interview. DSM-IV diagnoses of Major Depressive Disorder (MDD) were the criterion for which the sensitivity, specificity, positive- and negative predictive values and Receiver Operator Curves (ROC) for the PHQ-9 were calculated., Results: The cut-off point of a summed score of 12 on the PHQ-9 resulted in a sensitivity of 75.7% and a specificity of 80.0%. Predictive values for negative and positive test results were respectively 93.4% and 46.7%. The ROC showed an area under the curve of 0.77., Conclusions: The PHQ-9 proved to be an efficient and well-received screening instrument for MDD in this sample of diabetes patients in a specialized outpatient clinic. The higher cut-off point of 12 that was needed and somewhat lower sensitivity than had been reported elsewhere may be due to the fact that the patients from a specialized diabetes clinic have more severe pathology and more complications, which could be recognized by the PHQ-9 as depression symptoms, while instead being diabetes symptoms.

Besides patients' health and well-being, healthcare interventions may affect the well-being of significant others. Such 'spill over effects' in significant others may be distinguished in two distinct effects: (i) the caregiving effect and (ii) the family effect. The first refers to the welfare effects of providing informal care, i.e., the effects of caring for someone who is ill. The second refers to a direct influence of the health of a patient on others' well-being, i.e., the effects of caring about other people. Using a sample of Dutch informal caregivers we found that both effects exist and may be comparable in size. Our results, while explorative, indicate that economic evaluations adopting a societal perspective should include both the family and the caregiving effects measured in the relevant individuals.

Background: The effectiveness of collaborative care for patients with major depressive disorder in primary care has been established. Assessing its cost-effectiveness is important for deciding on implementation. This review therefore evaluates the cost-effectiveness of collaborative care for major depressive disorder in primary care., Methods: A systematic search on economic evaluations of collaborative care was conducted in Pubmed and PsychInfo. Quality of the studies was measured with the Cochrane checklist and the CHEC-list for economic evaluations. Cost-effectiveness and costs per depression-free days were reported., Results: 8 studies were found, involving 4868 patients. The quality of the cost effectiveness studies, according to the CHEC-list, could be improved. Generally, the studies did not include all relevant costs and did not perform sensitivity analysis. Only 4 out of 8 studies reported cost per QALY, 6 out of 8 reported costs per depression-free days. The highest costs per QALY reported were $49,500, the highest costs per depression-free day were $24., Conclusions: Although studies did not fulfil all criteria of the CHEC-list, collaborative care is a promising intervention and it may be cost-effective. However, to conclude on the cost-effectiveness, depression research should follow economic guidelines to improve the quality of the economic evaluations.

Objectives: Type 2 diabetes (T2D) treatment involves complex interactions between biological, psychological, and behavioral factors of care, requiring multifaceted efforts in clinical practice and disease management to reduce health and economic burdens. We aimed to quantify correlations among these factors and characterize their level of inclusion in economic analyses that are part of informed medical decision-making., Methods: A comprehensive, stepwise systematic literature review was performed on published articles dated 1993 to 2008 using medical subject heading and keyword searches in electronic reference libraries. Data were collected using standardized techniques and were analyzed descriptively., Results: A total of 97 articles fulfilling all inclusion criteria were reviewed, including 16 on economic models (17% of articles). Most studies were retrospective (41 of 97; 42%) and from managed care perspectives (66%). Oral antidiabetic drugs were a central focus, appearing in 83% of studies. Patient behaviors, particularly medication adherence and persistence in real-world settings, are well researched (n=65) and may influence diabetes outcomes, cardiovascular risk, mortality rates, and treatment-specific resource use (e.g., hospitalizations) and costs (

Background: Increasing costs have generated concern among governments and healthcare providers who have realized the need for cost containment measures and more efficient resource utilization. Health economics is one potential source of information that can make healthcare more efficient., Scope: This review article summarizes the published literature on self-reported attitudes of healthcare decision-makers towards economic evaluations of medical technologies and examines the extent to which economic evaluations are used in health policy decisions., Methods: A systematic literature review of published English language studies was conducted using MEDLINE, EMBASE, and HEED from January 1995 to December 2007., Findings: Fifty-five articles investigated the use of economic evaluations on three levels of decision-making: central, local, and physician level. Results indicate the use of economic evaluation information increased from limited/minor to moderate use. The influence of economic evaluations increased with the level of centralization of healthcare system. Barriers to use health economics research varied across levels and included health economics research-related barriers such as timely availability, lack of credibility, insufficient methodological quality and decision-context-related barriers including limited decision makers' knowledge, inflexibility in healthcare budgets and variability among healthcare organizations., Conclusions: For consistent policy-making it is important that similar recommendations for cost-effective interventions and programs are developed at all levels and that implementation is promoted by incorporating the appropriate incentives in healthcare provision.

Background: Major depressive disorder (MDD) has major consequences for both patients and society, particularly in terms of needlessly long sick leave and reduced functioning. Although evidence-based treatments for MDD are available, they show disappointing results when implemented in daily practice. A focus on work is also lacking in the treatment of depressive disorder as well as communication of general practitioners (GPs) and other health care professionals with occupational physicians (OPs). The OP may play a more important role in the recovery of patients with MDD. Purpose of the present study is to tackle these obstacles by applying a collaborative care model, which has proven to be effective in the USA, with a focus on return to work (RTW). From a societal perspective, the (cost)effectiveness of this collaborative care treatment, as a way of transmural care, will be evaluated in depressed patients on sick leave in the occupational health setting., Methods/design: A randomised controlled trial in which the treatment of MDD in the occupational health setting will be evaluated in the Netherlands. A transmural collaborative care model, including Problem Solving Treatment (PST), a workplace intervention, antidepressant medication and manual guided self-help will be compared with care as usual (CAU). 126 Patients with MDD on sick leave between 4 and 12 weeks will be included in the study. Care in the intervention group will be provided by a multidisciplinary team of a trained OP-care manager and a consultant psychiatrist. The treatment is separated from the sickness certification. Data will be collected by means of questionnaires at baseline and at 3, 6, 9 and 12 months after baseline. Primary outcome measure is reduction of depressive symptoms, secondary outcome measure is time to RTW, tertiary outcome measure is the cost effectiveness., Discussion: The high burden of MDD and the high level of sickness absence among people with MDD contribute to the relevance of this study. The intervention is an innovative approach, with trained OPs in a new role as care managers in the treatment of MDD. If this intervention proves to be cost-effective, implementation will be very relevant for individual patients as well as for society., Trial Registration: ISRCTN78462860.

Objectives: To quantify the uncertainty in the cost-effectiveness of lifestyle intervention versus standard care in overweight and obese people in Switzerland and to determine if further research is necessary based on current information. There has been an increasing interest in using value of information analysis in medical decision-making to quantify the uncertainty in decision-making, and to identify the need for further research., Methods: Value of information analysis was applied on a probabilistic cost-effectiveness model to evaluate the uncertainty by calculating the patient expected value of perfect information (EVPI), population EVPI, and partial EVPI. The costs were expressed in Swiss Francs (CHF), price year 2006., Results: Overall, the EVPI was higher in overweight than in obese people. The maximum population EVPI was CHF 6.8 million in overweight people and CHF 3.2 million in moderate obese people, representing the upper limit on costs associated with decision uncertainty. The partial EVPI estimated a higher uncertainty in the model parameters such as utilities, body mass index, cardiovascular risk factors, and systolic blood pressure in overweight and moderate obese subjects., Conclusions: The EVPI analysis indicates that there is some uncertainty regarding the choice between lifestyle intervention and standard care. The parameter EVPI suggests that if further research is commissioned, this should focus on the effectiveness of lifestyle intervention on cardiovascular risk factors and utilities.

'Extra-welfarism' has received some attention in health economics, yet there is little consensus on what distinguishes it from more conventional 'welfarist economics'. In this paper, we seek to identify the characteristics of each in order to make a systematic comparison of the ways in which they evaluate alternative social states. The focus, though this is not intended to be exclusive, is on health. Specifically, we highlight four areas in which the two schools differ: (i) the outcomes considered relevant in an evaluation; (ii) the sources of valuation of the relevant outcomes; (iii) the basis of weighting of relevant outcomes and (iv) interpersonal comparisons. We conclude that these differences are substantive.

Mortality rates in neonatal surgery have dropped markedly, illustrating the enormous progress made. Yet, new questions have arisen. To mention one, health care budgets have tightened. It follows that the effects of medical interventions should be weighted against their costs. As evidence was particularly sparse, we set out to analyse cost-effectiveness of neonatal surgery. The purpose of this article is to summarise our findings and to review recent studies. Moreover, this article explains the relevance of cost-effectiveness analysis and explores how cost-effectiveness interacts with other determinants of health care priority setting. Our research revealed that treatments for two common diagnostic categories in neonatal surgery (congenital anorectal malformations and congenital diaphragmatic hernia) produce good cost-effectiveness. Other groups also published cost-effectiveness studies in the field of neonatal surgery, although their number is still small. Contemporaneously, the economic aspects of health care have captured the interest of policy makers. Importantly, this is not to say that there are no other factors playing a role in priority setting, foremost among which are ethical questions and arguments of equity. This article concludes that, according to present evidence, neonatal surgery yields good value for money and contributes to equity in health.

Objectives: To estimate the long-term impact of treatment with perindopril on costs and health effects in patients with stable coronary artery disease in Poland., Methods: The cost-effectiveness analysis was based on data from a randomized double-blind, placebo-controlled trial. A decision-tree analysis was employed, including Monte Carlo and bootstrapping techniques. This study was a sub-study of the EUROPA (European Trial on Reduction of Cardiac Events with Perindopril in Stable Coronary Artery Disease) trial (n = 12,218; mean follow-up 4.2 years). Resource use was based on data from Polish EUROPA study patients (n = 1251), while effectiveness was based on the whole EUROPA study. The health gain of perindopril in life-years was based on overall EUROPA study results, and the adapted Polish life expectancy of patients not dying during the trial. Costs were calculated in new Polish zloty (PLN), year 2003 values; euro1 = PLN4.053. Only direct healthcare costs related to cardiovascular events and medication use were studied., Results: When observed mortality was combined with life expectancy beyond the end of the study, perindopril use showed a gain in life expectancy of 0.182 life-years (SD +/- 0.129) at a cost of PLN1983 (SD +/- 103) with discounting of 5% per annum on costs and no discounting on effects. This resulted in an incremental cost-effectiveness ratio (ICER) of PLN10 896 per life-year gained. The probability that the ICER for perindopril was below the threshold of PLN60 000 was 88%. The overall results were insensitive to discount rates for costs and life-years., Conclusions: Perindopril leads to a reduction in the risk of coronary events among patients with stable heart disease. When the expected improvement in life expectancy is combined with associated medical costs, there is a high probability that perindopril is cost effective, given the threshold of PLN60 000 per life-year gained.

Dental fillings represent an established procedure to treat tooth decay. The present paper provides a cost comparison of dental filling procedures across nine European countries. More specifically, the paper aims to estimate the costs and prices (i.e. reimbursement fees) of a single dental filling procedure in an approximately 12-year-old child with a toothache in a lower molar who presents at a dental practice, as described in a case vignette. Both amalgam and composite fillings were examined. Total costs were determined by identifying resource use and unit costs for the following cost components: diagnostic procedures, labour, materials, drugs, and overheads. Altogether, 49 practices provided data for the cost calculations. Mean total costs per country varied considerably, ranging from 8 euros to 156 euros. Labour costs were the most important cost driver in all practices, comprising 58% of total costs. Overhead costs were the second-most important cost component in the majority of countries. Actual cost differences across practices within countries were relatively small. Cost variations between countries were primarily due to differences in unit costs, especially for labour and overheads, and only to a lesser extent to differences in resource use. Finally, cost estimates for a single dental filling procedure based on reimbursement fees led to an underestimation of the total costs by approximately 50%., (Copyright 2008 John Wiley & Sons, Ltd.)

Which costs and benefits to consider in economic evaluations of healthcare interventions remains an area of much controversy. Unrelated medical costs in life-years gained is an important cost category that is normally ignored in economic evaluations, irrespective of the perspective chosen for the analysis. National guidelines for pharmacoeconomic research largely endorse this practice, either by explicitly requiring researchers to exclude these costs from the analysis or by leaving inclusion or exclusion up to the discretion of the analyst. However, the inclusion of unrelated medical costs in life-years gained appears to be gaining support in the literature.This article provides an overview of the discussions to date. The inclusion of unrelated medical costs in life-years gained seems warranted, in terms of both optimality and internal and external consistency. We use an example of a smoking-cessation intervention to highlight the consequences of different practices of accounting for costs and effects in economic evaluations. Only inclusion of all costs and effects of unrelated medical care in life-years gained can be considered both internally and externally consistent. Including or excluding unrelated future medical costs may have important distributional consequences, especially for interventions that substantially increase length of life. Regarding practical objections against inclusion of future costs, it is important to note that it is becoming increasingly possible to accurately estimate unrelated medical costs in life-years gained. We therefore conclude that the inclusion of unrelated medical costs should become the new standard.

Background: Depressive disorder is currently one of the most burdensome disorders worldwide. Evidence-based treatments for depressive disorder are already available, but these are used insufficiently, and with less positive results than possible. Earlier research in the USA has shown good results in the treatment of depressive disorder based on a collaborative care approach with Problem Solving Treatment and an antidepressant treatment algorithm, and research in the UK has also shown good results with Problem Solving Treatment. These treatment strategies may also work very well in the Netherlands too, even though health care systems differ between countries., Methods/design: This study is a two-armed randomised clinical trial, with randomization on patient-level. The aim of the trial is to evaluate the treatment of depressive disorder in primary care in the Netherlands by means of an adapted collaborative care framework, including contracting and adherence-improving strategies, combined with Problem Solving Treatment and antidepressant medication according to a treatment algorithm. Forty general practices will be randomised to either the intervention group or the control group. Included will be patients who are diagnosed with moderate to severe depression, based on DSM-IV criteria, and stratified according to comorbid chronic physical illness. Patients in the intervention group will receive treatment based on the collaborative care approach, and patients in the control group will receive care as usual. Baseline measurements and follow up measures (3, 6, 9 and 12 months) are assessed using questionnaires and an interview. The primary outcome measure is severity of depressive symptoms, according to the PHQ9. Secondary outcome measures are remission as measured with the PHQ9 and the IDS-SR, and cost-effectiveness measured with the TiC-P, the EQ-5D and the SF-36., Discussion: In this study, an American model to enhance care for patients with a depressive disorder, the collaborative care model, will be evaluated for effectiveness in the primary care setting. If effective across the Atlantic and across different health care systems, it is also likely to be an effective strategy to implement in the treatment of major depressive disorder in the Netherlands.

Background: Depressive disorder is one of the most common disorders, and is highly prevalent in chronically ill patients. The presence of comorbid depression has a negative influence on quality of life, health care costs, self-care, morbidity, and mortality. Early diagnosis and well-organized treatment of depression has a positive influence on these aspects. Earlier research in the USA has reported good results with regard to the treatment of depression with a collaborative care approach and an antidepressant algorithm. In the UK 'Problem Solving Treatment' has proved to be feasible. However, in the general hospital setting this approach has not yet been evaluated., Methods/design: CC: DIM (Collaborative Care: Depression Initiative in the Medical setting) is a two-armed randomised controlled trial with randomisation at patient level. The aim of the trial is to evaluate the treatment of depressive disorder in general hospitals in the Netherlands based on a collaborative care framework, including contracting, 'Problem Solving Treatment', antidepressant algorithm, and manual-guided self-help. 126 outpatients with diabetes mellitus, chronic obstructive pulmonary disease, or cardiovascular diseases will be randomised to either the intervention group or the control group. Patients will be included if they have been diagnosed with moderate to severe depression, based on the DSM-IV criteria in a two-step screening method. The intervention group will receive treatment based on the collaborative care approach; the control group will receive 'care as usual'. Baseline and follow-up measurements (after 3, 6, 9, and 12 months) will be performed by means of questionnaires. The primary outcome measure is severity of depressive symptoms, as measured with the PHQ-9. The secondary outcome measure is the cost-effectiveness of these treatments according to the TiC-P, the EuroQol and the SF-36., Discussion: Earlier research has indicated that depressive disorder is a chronic, mostly recurrent illness, which tends to cluster with physical comorbidity. Even though the treatment of depressive disorder based on the guidelines for depression is proven effective, these guidelines are often insufficiently adhered to. Collaborative care and 'Problem Solving Treatment' will be specifically tailored to patients with depressive disorders and evaluated in a general hospital setting in the Netherlands.

Aim: To quantify the lifetime health and economic consequences of preventing and treating obesity with lifestyle intervention in Switzerland., Methods: A Markov model was developed comparing lifestyle intervention and standard care in overweight and obese people. Changes in weight and cardiovascular risk factors over time were modeled from reduction in body mass index, systolic blood pressure, total cholesterol and high density lipoprotein in three-year active treatment period. A probabilistic sensitivity analysis was performed. Three groups of people were followed in the analysis: overweight, borderline and moderate obese. The cost-effectiveness of interventions was compared using incremental cost-effectiveness ratio., Results: Lifestyle intervention resulted in increased survival duration and quality of life over lifetime. Compared with standard care, the average incremental cost of lifestyle intervention was lower in borderline and obese and higher in overweight. Lifestyle intervention dominated standard care in borderline female age 35 to 55 years, borderline male age 25 to 60 years, obese female age 45 years and obese male age 55 years., Conclusion: Our economic analysis suggests that lifestyle intervention is cost-effective in the long-term prevention and treatment of obesity.

It is normally stated that an economic evaluation should take the societal perspective and that this implies the incorporation of all costs and effects, regardless of where these occur. Nevertheless, this broad perspective may be in conflict with the narrower perspective of the health-care decision-makers we are usually trying to aid. In this article, it is argued that not all costs have to be considered equally important for health-care decision-making and that there is a discrepancy between the economically preferred societal perspective and the aim of aiding health-care decision-makers. This is related to the concept of local rationality. Three reasons why some costs may be considered more important for health-care decision-makers than others are: 1) relevance; 2) equity; and 3) responsibility. We suggest that it may be useful to adopt a two-perspective approach as a standard, presenting one cost-effectiveness ratio following a strict health-care perspective and one following the common societal perspective. The health-care perspective may assist the health-care policymaker better in achieving health-care goals, while the societal perspective indicates whether the local rationality of the narrow health-care perspective is also in line with societal optimality. More research on actual decisions should provide more insight into the relative weights attached to different types of costs.

This contribution describes the entitlements in Dutch health care and explores how these entitlements are determined and to whom they apply. The focus is on services of curative care. No comprehensive positive or negative list of individual services is included in formal laws. Instead, the legislation states only what general types of medical services are covered and generally the "usual care" criterion determines to which interventions patients are entitled. This criterion is not very restrictive and yields local variations in service provision, which are moderated by practice guidelines. It is conceivable, however, that the recent introduction of the DBC financing system will change the reimbursement and therefore benefit-setting policy.

In this paper, we describe the Dutch pharmaceutical market, which is heavily regulated by the government. Through the regulation of prices and promoting prudent use, the Dutch government tries to bring down the cost of pharmaceuticals, which increases every year at a higher rate than total health care expenditure. The complex system of regulation, especially aimed at cost containment, is not very effective, particularly with respect to controlling outpatient pharmaceutical expenditure. Moreover, the system has few incentives towards efficiency. Though the market share of generic pharmaceuticals is rapidly growing, pharmaceutical expenditure has not decreased accordingly. The discounts offered by wholesalers of generic products to pharmacists produce private rather than societal gains from generic prescriptions. Dismantling the current regulatory system, boosting competition and efficiency with insurers in a leading role, seems to be the way forward.

The aim of this paper is to discuss the use of stochastic league tables approach in cost-effectiveness analysis of diabetes interventions. It addresses the common grounds and differences with other methods of presenting uncertainty to decision-makers. This comparison uses the cost-effectiveness results of medical guidelines for Dutch diabetes type 2 patients in primary and secondary care. Stochastic league tables define the optimum expansion pathway as compared to baseline, starting with the least costly and most cost-effective intervention mix. Multi-intervention cost-effectiveness acceptability curves are used as a way to represent uncertainty information on the cost-effectiveness of single interventions as compared to a single alternative. The stochastic league table for diabetes interventions shows that in case of low budgets treatment of secondary care patients is the most likely optimum choice. Current care options of diabetes complications are shown to be inefficient compared to guidelines treatment. With more resources available one may implement all guidelines and improve efficiency. The stochastic league table approach and multi-intervention cost-effectiveness acceptability curves in uncertainty analysis lead to similar results. In addition, the stochastic league table approach provides policy makers with information on affordability by budget level. It fulfils more adequately the information requirements to choose between interventions, using the efficiency criterion., (Copyright 2004 John Wiley & Sons, Ltd)

Objectives: Portfolio theory has been suggested as a means to improve the risk-return characteristics of investments in health-care programs through diversification when costs and effects are uncertain. This approach is based on the assumption that the investment proportions are not subject to uncertainty and that the budget can be invested in toto in health-care programs., Methods: In the present paper we develop an algorithm that accounts for the fact that investment proportions in health-care programs may be uncertain (due to the uncertainty associated with costs) and limited (due to the size of the programs). The initial budget allocation across programs may therefore be revised at the end of the investment period to cover the extra costs of some programs with the leftover budget of other programs in the portfolio., Results: Once the total budget is equivalent to or exceeds the expected costs of the programs in the portfolio, the initial budget allocation policy does not impact the risk-return characteristics of the combined portfolio, i.e., there is no benefit from diversification anymore., Conclusion: The applicability of portfolio methods to improve the risk-return characteristics of investments in health care is limited to situations where the available budget is much smaller than the expected costs of the programs to be funded.

In this paper it is argued that the separation of elements associated with the time spent by the patient is not conducted in a consistent way. This is the case for income (for which there at least has been some attention) and for other time elements like lost unpaid work, leisure and role-functioning. The use of general rather than specific preferences in health state assessments makes the separation of time-elements into costs and effects difficult. While costs are calculated specifically for the patient group under study, effects are normally derived from preferences in the general public. The characteristics of these two groups in terms of (the opportunity of) spending time on activities need not coincide. The use of specific time-group valuations of health states may be a good alternative to using general health state valuations., (Copyright 2002 John Wiley & Sons, Ltd.)

This article provides a broad outline of developments in the Dutch health-care policy related to the costs, budgeting, and reimbursement of pharmaceuticals. In-hospital drugs costs are part of hospital budgets, whereas for the main part of costs, nonhospital drugs, no strict budget exists. The government sets a goal for the annual cost increase of nonhospital drugs, but has only limited means to enforce that goal. Two measures were implemented to reduce drug prices: a reference price system and a price law. Both measures had a modest and temporary impact on drug prices during the 1990s. In limiting the utilization of drugs, the package of reimbursed drugs has been restricted. This led to a shift from public to private costs and possible substitution of cheaper not reimbursed drugs by more expensive reimbursed drugs. An electronic prescription system was implemented to encourage rational prescription. Although 70% of the Dutch general practitioners reported to use the system, the estimated savings on drug costs appear to be modest and far less than expected. The use of economic evaluation for reimbursement decisions will increase. From 2005 onward a pharmacoeconomic study and budget impact analysis is formally required for new nonclustered drugs seeking a premium price. Furthermore, in the future the health-care insurers will get a more prominent role in limiting the costs of drugs and enhancing the efficient use of drugs within their overall budgets. Health-care insurers may choose which drugs to purchase and reimburse and they can negotiate drug prices with the pharmaceutical industry, wholesalers, and local pharmacists.

This study was performed to assess the main reasons for the unfavorable cost effectiveness of lung transplantation compared with that of heart and liver transplantation. Costs, effects, and cost-effectiveness ratios of Dutch lung, heart, and liver transplantation programs were compared. The data are based on three Dutch technology assessments of transplantation, with minor adjustments for time and methods. In result, mainly follow-up costs of lung transplantation are higher than costs of heart and liver transplantation-- 50,300 US dollars, 121,500 US dollars, and 95,300 US dollars, respectively--in the first 3 years after transplantation. The survival gain realized by lung transplantation is small (4.4 years) compared with heart (8.8 years) and liver (14.7 years) transplantation. Costs per life-year gained were 77,000 US dollars, 38,000 US dollars, and 26,000 US dollars for lung, heart, and liver transplantation, respectively. The unfavorable cost effectiveness of lung transplantation is largely related to a relatively small survival gain and high follow-up costs.

Background: Costs of inpatient days in hospitals are frequently the main drivers of total treatment costs, and their unit cost can markedly affect the outcomes of an economic evaluation. In many countries, the availability of unit cost data is limited and unit costs are often based on data from hospitals participating in clinical trials., Objective: To provide data about unit costs of inpatient hospital days in The Netherlands from a healthcare provider's perspective and to give an insight into the extent to which cost categories and total costs differ between hospitals., Design: Unit costs were collected from 22 wards and 11 intensive care units (ICUs) of general and university hospitals involved in clinical trials with 'piggybacked' economic evaluations. Direct costs, such as costs of nursing and medical materials, were calculated by dividing the annual cost per category of the nursing department by the annual number of inpatient days. Indirect costs, such as overheads and accommodation, were allocated to the nursing departments by applying direct allocation. All costs were expressed in 1998 euros (EUR)., Results: The mean costs per inpatient day were EUR230 (range: EUR154-EUR311) in general hospitals and EUR323 (range: EUR209-EUR400) in university hospitals. The mean costs per inpatient day in an ICU were EUR1125 (EUR919-EUR1560). Between 38-48% of the total costs were made up of nursing costs. All cost categories showed wide variations between hospitals., Conclusions: The results of this study were used to develop standard costs for inpatient days in The Netherlands and may contribute to the comparability and generalisability of economic evaluations.

The lack of a uniform costing methodology is often considered a weakness of economic evaluations that hinders the interpretation and comparison of studies. Standardisation is therefore an important topic within the methodology of economic evaluations and in national guidelines that formulate the formal requirements for studies to be considered when deciding on the reimbursement of new medical therapies. Recently, the Dutch Manual for Costing: Methods and Standard Costs for Economic Evaluations in Health Care (further referred to as "the manual") has been published, in addition to the Dutch guidelines for pharmacoeconomic research. The objectives of this article are to describe the main content of the manual and to discuss some key issues of the manual in relation to the standardisation of costs. The manual introduces a six-step procedure for costing. These steps concern: the scope of the study;the choice of cost categories;the identification of units;the measurement of resource use;the monetary valuation of units; andthe calculation of unit costs. Each step consists of a number of choices and these together define the approach taken. In addition to a description of the costing process, five key issues regarding the standardisation of costs are distinguished. These are the use of basic principles, methods for measurement and valuation, standard costs (average prices of healthcare services), standard values (values that can be used within unit cost calculations), and the reporting of outcomes. The use of the basic principles, standard values and minimal requirements for reporting outcomes, as defined in the manual, are obligatory in studies that support submissions to acquire reimbursement for new pharmaceuticals. Whether to use standard costs, and the choice of a particular method to measure or value costs, is left mainly to the investigator, depending on the specific study setting. In conclusion, several instruments are available to increase standardisation in costing methodology among studies. These instruments have to be used in such a way that a balance is found between standardisation and the specific setting in which a study is performed. The way in which the Dutch manual tries to reach this balance can serve as an illustration for other countries.

Background: Estimating the probability of pregnancy leading to delivery and the influence of clinical factors on that probability is of fundamental importance in the treatment counselling of infertile couples. A variety of statistical techniques have been used to analyse fertility data, many borrowed from survival analysis., Methods and Results: We propose an alternative method of analysis which is based on a discrete time Markov chain approach, with states 'pregnancy (leading to a delivery)', 'not pregnant', and 'censored' and in which the transition probabilities are dependent both on the clinical characteristics of the patient and the treatment given., Conclusions: We believe that the method of analysis presented here may be preferable to standard analyses in that it better reflects the clinical situation, it is a truly discrete time analysis applied to a discrete time situation, it explicitly models the censoring process (a process which in itself provides information of interest to the physician) and can be readily extended to a variety of clinical situations.