Quality-of-life effects of screening mammography in Norway.

Mammography screening may save women from dying of breast cancer, although it has not been shown to reduce all-cause mortality. Screening also leads to overdiagnosis and many false positive mammograms aggravating women's quality-of-life. Quality adjusted life years (QALY) analyses of mammography screening have so far, calculated life years gained assuming that all prevented breast cancer deaths translate into a reduction in all-cause mortality. We calculated net QALYs in two hypothesized cohorts of 100,000 Norwegian women; one screened biennially from age 50 to 69 years and one not screened. We followed both cohorts to age 85 years. We used EQ-5D and an alternative equity weighted QALY instrument to estimate utility losses. In the screening cohort, we assumed 20% false positive tests during screening, different levels of overdiagnosis (20-75%) and different levels of breast cancer mortality reduction (10-30%). We assumed that reductions in breast cancer mortality only to a limited extent (20, 50 or 80%), resulted in reductions in all-cause mortality. We calculated both undiscounted and discounted (4%) QALYs. Assuming that 50% of the reduction in breast cancer mortality translated to a reduction in all-cause mortality and using estimated levels of benefits and harms in modern screening programs (50-75% overdiagnosis and 10% reduction in breast cancer mortality), undiscounted equity weighted QALY loss varied from 437 to 875 per 100,000 women. Using the levels of benefit and harms as reported in 30-40 years old randomized trials (30% overdiagnosis and 15% reduction in breast cancer mortality), undiscounted equity weighted QALY gain was 535 per 100,000. Net QALY in modern mammography screening in Norway is negative. Results could also be representative for Sweden, Denmark, UK and the US.

Guidance on priority setting in health care (GPS-Health): the inclusion of equity criteria not captured by cost-effectiveness analysis.

This Guidance for Priority Setting in Health Care (GPS-Health), initiated by the World Health Organization, offers a comprehensive map of equity criteria that are relevant to health care priority setting and should be considered in addition to cost-effectiveness analysis. The guidance, in the form of a checklist, is especially targeted at decision makers who set priorities at national and sub-national levels, and those who interpret findings from cost-effectiveness analysis. It is also targeted at researchers conducting cost-effectiveness analysis to improve reporting of their results in the light of these other criteria. THE GUIDANCE WAS DEVELOP THROUGH A SERIES OF EXPERT CONSULTATION MEETINGS AND INVOLVED THREE STEPS: i) methods and normative concepts were identified through a systematic review; ii) the review findings were critically assessed in the expert consultation meetings which resulted in a draft checklist of normative criteria; iii) the checklist was validated though an extensive hearing process with input from a range of relevant stakeholders. The GPS-Health incorporates criteria related to the disease an intervention targets (severity of disease, capacity to benefit, and past health loss); characteristics of social groups an intervention targets (socioeconomic status, area of living, gender; race, ethnicity, religion and sexual orientation); and non-health consequences of an intervention (financial protection, economic productivity, and care for others).

A randomized controlled trial of a senior centre group programme for increasing social support and preventing depression in elderly people living at home in Norway.

BACKGROUND: Late-life depression is a common condition and a challenging public health problem. A lack of social support is strongly associated with psychological distress. Senior centres seem to be suitable arenas for community-based health promotion interventions, although few studies have addressed this subject. The objectives were to examine the effect of a preventive senior centre group programme consisting of weekly meetings, on social support, depression and quality of life. METHODS: A questionnaire was sent to a random sample of 4,000 persons over 65 in Oslo, and a total of 2,387 completed questionnaires were obtained. These subjects served as a basis for recruitment of participants for a trial, with scores on HSCL-10 being used as a main inclusion criterion. A total of 138 persons were randomized into an intervention group (N = 77) and control group (N = 61). Final analyses included 92 persons. Social support (OSS-3), depression (BDI), life satisfaction and health were measured in interviews at baseline and after 12 months (at the end of the intervention programme). Perceptions of benefits from the intervention were also measured. Mean scores, SD, SE and CI were used to describe the changes in outcomes. Effect sizes were calculated based on the original scales and as Cohen's d. Paired sample tests and ANOVA were used to test group differences. RESULTS: There was an increase in social support in both groups, but greatest in the intervention group. The level of depression increased for both groups, but more so in the control than the intervention group. There was a decrease in life satisfaction, although the decrease was largest among controls. There were almost no differences in reported health between groups. However, effect sizes were small and differences were not statistically significant. In contrast, most of the participants said the intervention meant much to them and led to increased use of the centre. CONCLUSIONS: In all probability, the intervention failed to meet optimistic targets, but possibly met quite modest ones. Since intention-to-treat analysis was not possible, we do not know the effect on the intervention group as a whole. A further evaluation of these programmes is necessary to expand the group programme. For the depressed, more specialized programmes to cope with depression may be a more appropriate intervention. TRIAL REGISTRATION: DRKS00003120 on DRKS.

Discounting future health benefits: the poverty of consistency arguments.

In economic evaluation of health care, main stream practice is to discount benefits at the same rate as costs. But main papers in which this practice is advocated have missed a distinction between two quite different evaluation problems: (1) How much does the time of program occurrence matter for value and (2) how much do delays in health benefits from programs implemented at a given time matter? The papers have furthermore focused on logical and arithmetic arguments rather than on real value considerations. These 'consistency arguments' are at best trivial, at worst logically flawed. At the end of the day, there is a sensible argument for equal discounting of costs and benefits rooted in microeconomic theory of rational, utility maximising consumers' saving behaviour. But even this argument is problematic, first because the model is not clearly supported by empirical observations of individuals' time preferences for health, second because it relates only to evaluation in terms of overall individual utility. It does not provide grounds for claiming that decision makers with a wider societal perspective, which may include concerns for fair distribution, need to discount Copyright © 2010 John Wiley & Sons, Ltd.

QALYs: is the value of treatment proportional to the size of the health gain?

In societal priority setting between health programs for different patient groups, many people are reluctant to discriminate too strongly between those who can benefit much from treatment and those who can benefit moderately. We suggest that this view of distributive fairness has a counterpart in personal valuations of gains in health. Such valuations may be influenced by psychological reference points and diminishing marginal utility such that the individual utility of care in patient groups with different potentials may be more similar than what conventional QALY estimates suggest. In interviews in three convenience samples, there is some support for the hypothesis. Most respondents do not think that desire for treatment is significantly less in those who stand to gain only moderately compared with those who stand to gain much - even when the treatment is associated with a mortality risk. When stating insurance preferences, a majority of subjects express a greater concern for avoiding the worst states in question than for maximising expected value for money in terms of treatment effects. The tendency applies to outcomes in terms of both quality and quantity of life. Choices between prefixed response options fit well with oral explanations of these choices.

The efficiency frontier approach to economic evaluation of health-care interventions.

BACKGROUND: IQWiG commissioned an international panel of experts to develop methods for the assessment of the relation of benefits to costs in the German statutory health-care system. PROPOSED METHODS: The panel recommended that IQWiG inform German decision makers of the net costs and value of additional benefits of an intervention in the context of relevant other interventions in that indication. To facilitate guidance regarding maximum reimbursement, this information is presented in an efficiency plot with costs on the horizontal axis and value of benefits on the vertical. The efficiency frontier links the interventions that are not dominated and provides guidance. A technology that places on the frontier or to the left is reasonably efficient, while one falling to the right requires further justification for reimbursement at that price. This information does not automatically give the maximum reimbursement, as other considerations may be relevant. Given that the estimates are for a specific indication, they do not address priority setting across the health-care system. CONCLUSION: This approach informs decision makers about efficiency of interventions, conforms to the mandate and is consistent with basic economic principles. Empirical testing of its feasibility and usefulness is required.

Socio-demographic, psychosocial and health characteristics of Norwegian senior centre users: a cross-sectional study.

AIMS: The senior centre is the only welfare service in Norwegian elder care serving both fit and less functional pensioners over 65 years. The aim of the study was to determine the socio-demographic, psychosocial and health characteristics of users of the senior centres in relation to non-users in order to find out who can benefit from the senior centre service. METHODS: Data was collected from the Population Register for all persons living at home over 65 years in two municipal districts in Oslo. A random sample was drawn limited to 4,000 of the total number of residents over 65 years, 2,000 from each district. Questionnaires were sent by post. The response rate was 64% (n = 2,387). Psychological ailments were assessed using Hopkins Symptom Checklist-10 and social support with Oslo-3 Social Support Scale. RESULTS: The percentage of users was 44 among the survey respondents. Age was the most significant variable explaining use of the senior centre; increased age led to greater use. Single women used the senior centre more than married women while single men used it less than married men. Other predictors for women included osteoporosis, memory impairment and participation/interest from others. Memory impairment was a predictor for men. CONCLUSIONS: High age and specific health problems led to increased use. Living alone predicted greater use among women but less use among men. The association with age could not be explained through socio-demographic, psychosocial or health variables.

Determining Value in Health Technology Assessment: Stay the Course or Tack Away?

The economic evaluation of new health technologies to assess whether the value of the expected health benefits warrants the proposed additional costs has become an essential step in making novel interventions available to patients. This assessment of value is problematic because there exists no natural means to measure it. One approach is to assume that society wishes to maximize aggregate health, measured in terms of quality-adjusted life-years (QALYs). Commonly, a single 'cost-effectiveness' threshold is used to gauge whether the intervention is sufficiently efficient in doing so. This approach has come under fire for failing to account for societal values that favor treating more severe illness and ensuring equal access to resources, regardless of pre-existing conditions or capacity to benefit. Alternatives involving expansion of the measure of benefit or adjusting the threshold have been proposed and some have advocated tacking away from the cost per QALY entirely to implement therapeutic area-specific efficiency frontiers, multicriteria decision analysis or other approaches that keep the dimensions of benefit distinct and value them separately. In this paper, each of these alternative courses is considered, based on the experiences of the authors, with a view to clarifying their implications.

Beyond QALYs: Multi-criteria based estimation of maximum willingness to pay for health technologies.

The QALY is a useful outcome measure in cost-effectiveness analysis. But in determining the overall value of and societal willingness to pay for health technologies, gains in quality of life and length of life are prima facie separate criteria that need not be put together in a single concept. A focus on costs per QALY can also be counterproductive. One reason is that the QALY does not capture well the value of interventions in patients with reduced potentials for health and thus different reference points. Another reason is a need to separate losses of length of life and losses of quality of life when it comes to judging the strength of moral claims on resources in patients of different ages. An alternative to the cost-per-QALY approach is outlined, consisting in the development of two bivariate value tables that may be used in combination to estimate maximum cost acceptance for given units of treatment-for instance a surgical procedure, or 1 year of medication-rather than for 'obtaining one QALY.' The approach is a follow-up of earlier work on 'cost value analysis.' It draws on work in the QALY field insofar as it uses health state values established in that field. But it does not use these values to weight life years and thus avoids devaluing gained life years in people with chronic illness or disability. Real tables of the kind proposed could be developed in deliberative processes among policy makers and serve as guidance for decision makers involved in health technology assessment and appraisal.

[Economic evaluation of a course in coping with depression]. / Helseøkonomisk vurdering av kurs i mestring av depresjon.

BACKGROUND: A course in coping with depression was reported to have documented effects in terms of shortening periods of depression. An economic evaluation of the course was conducted. MATERIALS AND METHODS: The estimate of medical effect derives from a randomized controlled trial in 155 subjects with depression. On average subjects in the intervention group improved 3-4 points more on the Beck Depression Inventory than subjects in the control group. A value estimate is provided for this effect given what is known about the weight that society places on severity of illness and effect of treatment when prioritising among patient groups. The value estimate is compared with the costs of the course. RESULTS AND INTERPRETATION: It is estimated that if 200 people take the course, the improvements in quality of life for all these people taken together may be regarded as equally valuable and worthy of priority as an intervention that provides an extra life year to one person. The cost of giving the course to 200 people is estimated at USD 45,000-60,000. This is within the limits of what society is generally willing to pay in order to gain life years. Because of possible reductions in sick leave, societal net costs may be modest.

Determining the value of medical technologies to treat ultra-rare disorders: a consensus statement.

BACKGROUND: In most jurisdictions, policies have been adopted to encourage the development of treatments for rare or orphan diseases. While successful as assessed against their primary objective, these policies have prompted concerns among payers about the economic burden that might be caused by an annual cost per patient in some cases exceeding 100,000 Euro. At the same time, many drugs for rare disorders do not meet conventional standards for cost-effectiveness or 'value for money'. Owing to the fixed (volume-independent) cost of research and development, this issue is becoming increasingly serious with decreasing prevalence of a given disorder. METHODS: In order to critically appraise the problems posed by the systematic valuation of interventions for ultra-rare disorders (URDs), an international group of clinical and health economic experts was convened in conjunction with the Annual European ISPOR Congress in Berlin, Germany, in November 2012. Following this meeting and during subsequent deliberations, the group achieved a consensus on the specific challenges and potential ways forward. RESULTS: The group concluded that the complexities of research and development for new treatments for URDs may require conditional approval and reimbursement policies, such as managed entry schemes and coverage with evidence development agreements, but should not use as justification surrogate end point improvement only. As a prerequisite for value assessment, the demonstration of a minimum significant clinical benefit should be expected within a reasonable time frame. As to the health economic evaluation of interventions for URDs, the currently prevailing logic of cost-effectiveness (using benchmarks for the maximum allowable incremental cost per quality-adjusted life year gained) was considered deficient as it does not capture well-established social preferences regarding health care resource allocation. CONCLUSION: Modified approaches or alternative paradigms to establish the 'value for money' conferred by interventions for URDs should be developed with high priority.

Concerns for the worse off: fair innings versus severity.

The original fair innings argument is about claims on length of life. Alan Williams has suggested that the argument also should apply to quality of life. His 'generalised fair innings approach' on the one hand, and the severity approach on the other, are two ways of incorporating concerns for fairness in economic evaluation of health care. They are based on different ethical arguments and therefore partly lead to different results. Both approaches incorporate concerns for current and future severity. There is strong support for this in formal theories of justice and government guidelines, and a number of public surveys even indicate the strength of these concerns. The generalised fair innings approach additionally incorporates concerns for past suffering. Intuitively, this is not unreasonable, but there is at this point little ethical theory or empirical evidence to suggest the strength of such concerns. The fair innings argument can be decomposed in an 'equal innings argument' and a 'sufficient innings argument'. When the fair innings argument is applied to quality of life, its sufficient innings component implies that young people should have priority over old people when it comes to functional improvements and symptom relief for non-fatal conditions. This runs counter to both moral intuitions and official goverment guidelines in Norway and Sweden.

Cost-value analysis of health interventions: introduction and update on methods and preference data.

According to the consensus statement from the International Society for Pharmacoeconomics and Outcomes Research Quality-Adjusted Life-Year (QALY) workshop in Philadelphia in 2007 "concerns for fairness may cause social resource allocation preferences to deviate considerably from the ranking that consideration of costs per QALY would suggest." Salient concerns for fairness include the view that priority should be given to the severely ill over the less severely ill, that people have a right to realize their potential for health even if their capacity to benefit from treatment is moderate, and that everybody has the same right to treatment that averts premature death, even if their health and functional level is less than perfect. Cost-value analysis incorporates these concerns in formal economic evaluation of health interventions and programs and thus has a potential for ranking interventions and programs in a way that is more consistent with societal values. Data on the strength of public concerns for fairness are now sufficient to be useful in formal economic evaluation. The data may, within a context of fair and open deliberations, help societal decision makers to roughly indicate the societal value of a QALY in different circumstances and thus determine a tentative grading of willingness to pay for a QALY.