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1.  Impact of BMI and BMI change on future drug expenditures in adults: results from the MONICA/KORA cohort study 
Background
The evidence on the long-term economic effects of obesity is still scarce. This study aims to analyse the impact of body mass index (BMI) and BMI-change on future pharmaceutical utilisation and expenditures.
Methods
Based on data from 2,946 participants in a German population-based health survey (MONICA/KORA, 1994/95) and the follow-up study (2004/05), drug intake and expenditures were estimated using a bottom-up approach. Using univariate and multivariate methods, we analysed the impact of baseline BMI and BMI-change on drug utilisation and expenditures after 10 years.
Results
The use of pharmaceuticals was more likely in moderately and severely obese compared to the normal weight group (OR 1.8 and 4.0, respectively). In those who reported pharmaceutical intake, expenditures were about 40% higher for the obese groups. A 1-point BMI-gain in 10 years was, on average, associated with almost 6% higher expenditures compared to a constant BMI.
Conclusion
The results suggest that obesity as well as BMI-gain are strong predictors of future drug utilisation and associated expenditures in adults, and thus highlight the necessity of timely and effective intervention and prevention programmes. This study complements the existing literature and provides important information on the relevance of obesity as a health problem.
doi:10.1186/1472-6963-13-424
PMCID: PMC3854520  PMID: 24139278
Obesity; Overweight; Expenditures; Pharmaceuticals; Weight gain
2.  Specific guidelines for assessing and improving the methodological quality of economic evaluations of newborn screening 
Background
Economic evaluation of newborn screening poses specific methodological challenges. Amongst others, these challenges refer to the use of quality adjusted life years (QALYs) in newborns, and which costs and outcomes need to be considered in a full evaluation of newborn screening programmes. Because of the increasing scale and scope of such programmes, a better understanding of the methods of high-quality economic evaluations may be crucial for both producers/authors and consumers/reviewers of newborn screening-related economic evaluations. The aim of this study was therefore to develop specific guidelines designed to assess and improve the methodological quality of economic evaluations in newborn screening.
Methods
To develop the guidelines, existing guidelines for assessing the quality of economic evaluations were identified through a literature search, and were reviewed and consolidated using a deductive iterative approach. In a subsequent test phase, these guidelines were applied to various economic evaluations which acted as case studies.
Results
The guidelines for assessing and improving the methodological quality of economic evaluations in newborn screening are organized into 11 categories: “bibliographic details”, “study question and design”, “modelling”, “health outcomes”, “costs”, “discounting”, “presentation of results”, “sensitivity analyses”, “discussion”, “conclusions”, and “commentary”.
Conclusions
The application of the guidelines highlights important issues regarding newborn screening-related economic evaluations, and underscores the need for such issues to be afforded greater consideration in future economic evaluations. The variety in methodological quality detected by this study reveals the need for specific guidelines on the appropriate methods for conducting sound economic evaluations in newborn screening.
doi:10.1186/1472-6963-12-300
PMCID: PMC3459803  PMID: 22947299
3.  Programme Costing of a Physical Activity Programme in Primary Prevention: Should the Costs of Health Asset Assessment and Participatory Programme Development Count? 
This analysis aims to discuss the implications of the “health asset concept”, introduced by the WHO, and the “investment for health model” requiring a “participatory approach” of cooperative programme development applied on a physical activity programme for socially disadvantaged women and to demonstrate the related costing issues as well as the relevant decision context. The costs of programme implementation amounted to €48,700. Adding the costs for developing the programme design of €48,800 results in total costs of €97,500; adding on top of that the costs of asset assessment running to €35,600 would total €133,100. These four different cost figures match four different types of potentially relevant decisions contexts. Depending on the decision context the total costs, and hence the incremental cost-effectiveness ratio of a health promotion intervention, could differ considerably. Therefore, a detailed cost assessment and the identification of the decision context are of crucial importance.
doi:10.1155/2012/601631
PMCID: PMC3318195  PMID: 22536517
4.  Health care use and costs of adverse drug events emerging from outpatient treatment in Germany: A modelling approach 
Background
This study's aim was to develop a first quantification of the frequency and costs of adverse drug events (ADEs) originating in ambulatory medical practice in Germany.
Methods
The frequencies and costs of ADEs were quantified for a base case, building on an existing cost-of-illness model for ADEs. The model originates from the U.S. health care system, its structure of treatment probabilities linked to ADEs was transferred to Germany. Sensitivity analyses based on values determined from a literature review were used to test the postulated results.
Results
For Germany, the base case postulated that about 2 million adults ingesting medications have will have an ADE in 2007. Health care costs related to ADEs in this base case totalled 816 million Euros, mean costs per case were 381 Euros. About 58% of costs resulted from hospitalisations, 11% from emergency department visits and 21% from long-term care. Base case estimates of frequency and costs of ADEs were lower than all estimates of the sensitivity analyses.
Discussion
The postulated frequency and costs of ADEs illustrate the possible size of the health problems and economic burden related to ADEs in Germany. The validity of the U.S. treatment structure used remains to be determined for Germany. The sensitivity analysis used assumptions from different studies and thus further quantified the information gap in Germany regarding ADEs.
Conclusions
This study found costs of ADEs in the ambulatory setting in Germany to be significant. Due to data scarcity, results are only a rough indication.
doi:10.1186/1472-6963-11-9
PMCID: PMC3032652  PMID: 21232111
5.  Points to consider in assessing and appraising predictive genetic tests 
Journal of community genetics  2010;1(4):185-194.
The use of predictive genetic tests is expanding rapidly. Given limited health care budgets and few national coverage decisions specifically for genetic tests, evidence of benefits and harms is a key requirement in decision making; however, assessing the benefits and harms of genetic tests raises a number of challenging issues. Frequently, evidence of medical benefits and harms is limited due to practical and ethical limitations of conducting meaningful clinical trials. Also, clinical endpoints frequently do not capture the benefit appropriately because the main purpose of many genetic tests is personal utility of knowing the test results, and costs of the tests and counseling can be insufficient indicators of the total costs of care. This study provides an overview of points to consider for the assessment of benefits and harms from genetic tests in an ethically and economically reflected manner. We discuss whether genetic tests are sufficiently exceptional to warrant exceptional methods for assessment and appraisal.
doi:10.1007/s12687-010-0028-7
PMCID: PMC3186003  PMID: 22460301
Resource allocation; Genetic testing; Costs and cost analysis
6.  Excess direct medical costs of severe obesity by socioeconomic status in German adults 
Objective: Excess direct medical costs of severe obesity are by far higher than of moderate obesity. At the same time, severely obese adults with low socioeconomic status (SES) may be expected to have higher excess costs than those with higher SES, e.g. due to more comorbidities. This study compares excess costs of severe obesity among German adults across different SES groups.
Methods: In a subsample (N=947) of the KORA-Survey S4 1999/2001 (a cross-sectional health survey in the Augsburg region, Germany; age group: 25–74 years), visits to physicians, inpatient days in hospital, and received and purchased medication were assessed via computer-assisted telephone interviews (CATI) over half a year. Body mass index (BMI in kg/m²) was measured anthropometrically. SES was determined via reports of education, income, and occupational status from computer-assisted personal interviews (CAPI) (used both as single indicators, and as indexed by the Helmert algorithm); due to small subsample sizes all were median-split. Data of respondents in normal weight (18.5 ≤ BMI < 25), preobese (25 ≤ BMI < 30), moderately (class 1:30 ≤ BMI < 35) and severely obese (classes 2–3: BMI ≥ 35) range were analysed by generalized linear models with mixed poisson-gamma (Tweedie) distributions. Physician visits and inpatient days were valuated as recommended by the Working Group Methods in Health Economic Evaluation (AG MEG), and drugs were valuated by actual costs. Sex, age, kind of sickness fund (statutory/private) and place of residence (urban/rural) were adjusted for, and comorbidities were considered by the Physical Functional Comorbidity Index (PFCI).
Results: Excess costs of severe obesity were higher in respondents with high SES, regardless of the SES indicator used. For instance, annual excess costs were almost three times higher in those with an above-median SES-Index as compared with those with a median or lower SES-Index (plus € 2,966 vs. plus € 1,012; contrast significant at p<.001). Mediation of excess costs of severe obesity by physical comorbidities pertained to the low SES-Index and the low occupational status groups: differences in costs between severe obesity and normal weight were still positive, but statistically insignificant, in the lower status groups after adjusting for the PFCI, but still positive and significant given higher SES. For example, severe obesity’s excess costs were € 2,406 after PFCI-adjustment in the high SES-Index group (p<.001), but € 539 in the lower status group (p=.17). At the same time, physical comorbidities as defined by the PCFI increased with BMI and decreased with SES, however the factors BMI and SES did not significantly interact in this context.
Conclusions: To our knowledge, this is the first study to show in Germany that excess direct medical costs of severe obesity are not distributed equitably across different SES groups, do not reflect comorbidity status, and are significantly higher in those with high SES than in those with lower SES. Thus, allocation of health care resources spent on severely obese adults seems to be in need of readjustment towards an equitable utilization across all socioeconomic groups.
doi:10.3205/psm000063
PMCID: PMC2858876  PMID: 20421952
obesity; health care costs; socioeconomic status; comorbidities; Germany
7.  Clearing up the hazy road from bench to bedside: A framework for integrating the fourth hurdle into translational medicine 
Background
New products evolving from research and development can only be translated to medical practice on a large scale if they are reimbursed by third-party payers. Yet the decision processes regarding reimbursement are highly complex and internationally heterogeneous. This study develops a process-oriented framework for monitoring these so-called fourth hurdle procedures in the context of product development from bench to bedside. The framework is suitable both for new drugs and other medical technologies.
Methods
The study is based on expert interviews and literature searches, as well as an analysis of 47 websites of coverage decision-makers in England, Germany and the USA.
Results
Eight key steps for monitoring fourth hurdle procedures from a company perspective were determined: entering the scope of a healthcare payer; trigger of decision process; assessment; appraisal; setting level of reimbursement; establishing rules for service provision; formal and informal participation; and publication of the decision and supplementary information. Details are given for the English National Institute for Health and Clinical Excellence, the German Federal Joint Committee, Medicare's National and Local Coverage Determinations, and for Blue Cross Blue Shield companies.
Conclusion
Coverage determination decisions for new procedures tend to be less formalized than for novel drugs. The analysis of coverage procedures and requirements shows that the proof of patient benefit is essential. Cost-effectiveness is likely to gain importance in future.
doi:10.1186/1472-6963-8-194
PMCID: PMC2569930  PMID: 18816378

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