Hannover, Germany
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Theidel U.,Herescon GmbH | Kuhlmann A.,Center for Health Economics Research Hanover
Deutsches Arzteblatt International | Year: 2013

Background: The German Standing Committee on Vaccination Recommendations (Ständige Impfkommission, STIKO) recommends standard vaccination against pneumococcal infections for all persons aged 60 or older, and for all persons of any age with an increased health risk. It is not known how many persons in the target group in Germany have actually been vaccinated.Methods: We used claims data of a German statutory health insurance (Deutsche BKK) to determine pneumococcal vaccination rates, stratified by age and risk, for the one-year period 1 July 2008 to 30 June 2009. The number of influenza vaccinations in the same period was analyzed for comparison. Because pneumococcal vaccination does not need to be performed annually, the calculated rates are an underestimate of the percentage of persons who have been vaccinated. A simulation model was used to correct for persons vaccinated at earlier times. The vaccination rates were estimated on the basis of various scenarios.Results: Data were obtained on 867 683 persons aged 18 or older. According to an optimistic estimate, the percentage of pneumococcal vaccination in the overall population is 3.75% for persons aged 18-59 and 50.89% for persons aged 60 and above (influenza: 8.80% and 41.15%, respectively). In persons at elevated risk, the rate of vaccination in the presence of at least one risk factor is 12.66% / 54.67% (influenza: 15.66% / 39.96%). In persons with moderate risk, the vaccination rate is 16.02% / 56.75% (influenza: 18.54% / 40.61%); in persons whose elevated risk was high, it is 8.93% / 52.21% (influenza: 7.37% / 37.78%). The limitations of this study are the short study period and the inability to define the population at risk unambiguously.Conclusion: The rate of pneumococcal vaccination in adults in Germany is too low; at best, it is comparable to that of influenza vaccination. These results should be validated by nationwide monitoring of the pneumococcal vaccination program. For example, questions about pneumococcal vaccination could be included in the GEDA study (German Health Update) that is conducted annually by the Robert Koch Institute.

Dorner T.,Charité - Medical University of Berlin | Strand V.,Stanford University | Castaneda-Hernandez G.,CINVESTAV | Ferraccioli G.,Catholic University of the Sacred Heart | And 7 more authors.
Annals of the Rheumatic Diseases | Year: 2013

The first biological therapeutics in rheumatology are approaching patent expiration, encouraging development of 'follow-on' versions, known as 'biosimilars'. Biological agents range from simple replacement hormones to complex monoclonal antibodies and soluble receptors: large, intricate proteins with unique tertiary and quaternary structures that are inherently difficult to replicate. Post-translational modifications, such as glycosylation, may occur from changes in cell lines and/or manufacturing processes, resulting in products that are highly similar, but not identical, to approved 'reference' agents, hence, the term 'biosimilar', rather than 'bioidentical'. Even minor modifications in manufacturing processes, which iteratively occur with reference products due to improvements in efficiency, scale up to meet commercial demands or changes in manufacturing sites, may alter biological function and/or immunogenicity, potentially changing their safety and efficacy profile. As biosimilars are now in randomised controlled trials for treatment of rheumatic diseases, rheumatologists face decisions regarding equipoise and will need to consider their clinical use versus reference products. A clear understanding of the inherent differences between reference antibodies and biosimilars, their clinical implications and the processes governing regulation, approval and clinical use of biosimilars, is paramount. A panel of international experts in the field of rheumatology recently convened to evaluate and discuss these issues.

Lange A.,Leibniz University of Hanover | Kasperk C.,University of Heidelberg | Alvares L.,Medtronic | Sauermann S.,Medtronic GmbH | Braun S.,Herescon GmbH
Spine | Year: 2014

STUDY DESIGN.: Observational study. OBJECTIVE.: Examine the overall survival and treatment costs from a third-party-payer perspective for patients with osteoporotic vertebral compression fractures (OVCFs) treated by vertebral augmentation or conservative treatment in Germany. SUMMARY OF BACKGROUND DATA.: OVCFs are associated with increased morbidity, mortality and thus reduced quality of life. Vertebral augmentation has been shown to be effective in these fractures. The association between treatment and survivorship as well as cost per life year gained for balloon kyphoplasty (BKP) and percutaneous vertebroplasty (PVP) was analyzed in the Medicare population. Replication of these analyses is warranted for confidence in findings. METHODS.: Claims data from a major health insurance fund were used. Mortality risk differences between operated (BKP, PVP) and nonoperated cohorts were assessed by Cox regression. Operated patient groups were established by propensity score matching adjusting for covariates. For the matched operated patients with OVCF, (2006-2010) survival was estimated by Kaplan-Meier method. RESULTS.: A total of 598 newly diagnosed patients with OVCF were operated of 3607 patients with OVCF. The operated cohort was 43% less likely to die than the nonoperated one in the 5-year study period (hazard ratio = 0.57; P < 0.001). Patients who received BKP had higher 60-month adjusted survival rate (66.7%) than those who received PVP (58.7%) (P = 0.68). Cumulative 4-year mean overall costs after first diagnosis were lower for the BKP cohort (PVP: &OV0556;42,510 vs. BKP: &OV0556;39,014). Initial upfront higher costs driven by surgical treatment for patients who received BKP are offset by considerable pharmacy costs in patients who received PVP. There were differences between the values of painkiller consumption (PVP: &OV0556;3321 vs. BKP: &OV0556;2224). CONCLUSION.: Results suggest a higher overall survival rate for operated than nonoperated patients with OVCF and indicate a potential survival benefit for patients who received BKP compared with patients who received PVP. The reasons merit further investigation. Total costs were lower after 4 years for patients who received BKP versus PVP due to less consumption of pharmaceuticals. © 2014 Lippincott Williams and Wilkins.

Hodek J.-M.,Bielefeld University | von der Schulenburg J.-M.,Leibniz University of Hanover | Mittendorf T.,Herescon GmbH
Health Economics Review | Year: 2011

This study aims to identify the impact of a preterm birth on financial and emotional burden from the families' perspective. Additionally, a comprehensive schedule of recommendations for a sufficient evaluation of all aspects of burden is developed. Based on the results of a literature search relevant categories and sub-domains for a questionnaire covering multiple aspects of associated financial and emotional burden are identified and converted into a recommendation scheme. Results of the literature search illustrate the large extend of burden of prematurity on parents. This results in substantial out-of-pocket expenditures (OOPE) and emotional distress to the parents besides the medical problems and further financial costs to the health insurance system. According to the results on infants' state of health, OOPE and emotional distress are significantly increased with decreasing gestational age. OOPE for transportation often amounts to the main parental cost dimension. Moreover there is some evidence for a high magnitude of reduced income and missed work days. The family perspective has to be taken into account when calculating the overall costs of preterm births from a societal point of view. However, in recent years economic evaluations were performed rather inhomogeneously in this field. For future studies a) direct medical costs, b) direct non-medical costs, c) indirect costs as well as d) intangible costs (in terms of emotional distress and reduced quality of life for caregivers and children) are the main categories that should be evaluated measuring personal burden of preterm birth on families adequately. A detailed list of specific sub-domains is given. Additionally, the recommendations are not restricted to application in infants born preterm and/or at low birth weight. © 2011 Hodek et al; licensee Springer.

Nuijten M.,Ars Accessus Medica | Mittendorf T.,Herescon gmbh | Mittendorf T.,Leibniz University of Hanover
Clinical Therapeutics | Year: 2010

Objective: This analysis compared the cost-effectiveness of interferon beta-1a (IFNβ-1a) 44 μg SC with that of other available first-line treatments for relapsing-remitting multiple sclerosis (RRMS) from the German societal perspective in 2008. Methods: A decision-analytic model was used to estimate the cost-effectiveness of IFNβ-1a 44 μg SC given 3 times weekly compared with that of IFNβ-la 30 μg IM given once weekly, IFNβ-1b 8 mIU given every other day, and glatiramer acetate 20 mg SC given once daily. Data sources included the published literature, clinical trials, German price/tariff lists, and national population statistics. The time horizon of the model was 4 years, which was the maximum duration of follow-up in published clinical trials. Results: The cost-effectiveness (cost per relapse avoided) of IFNβ-la 44 μg SC compared with no active treatment was €51,250, which compared favorably with that of IFNβ-la 30 μg IM (€133,770), glatiramer acetate (€71,416), and IFNβ-1b (€54,475). When the cost of disease progression was excluded, the cost per relapse avoided remained favorable for IFNβ-1a 44 μg SC (€54,292) compared with the other options (€143,186, €72,809, and €56,816, respectively). Indirect comparison of each available treatment option with the next best alternative indicated that the incremental cost-effectiveness of IFNβ-la 44 μg SC (€23,449) was consistent with accepted thresholds. Sensitivity analyses in which the discount rate, frequency of relapse and disease progression, costs of relapse and disease progression, and adherence were varied did not affect the relative outcomes. Conclusion: In this analysis from the German societal perspective, IFNβ-la 44 μg SC had favorable overall cost-effectiveness versus no active treatment compared with other available disease-modifying drugs for the treatment of RRMS. © 2010 Excerpta Medica Inc.

Nuijten M.,Ars Accessus Medica | Mittendorf T.,Herescon GmbH
Aktuelle Ernahrungsmedizin | Year: 2012

Purpose: To assess the health economic impact of oral nutritional supplement (ONS), being a medical nutrition product in the community setting in Germany in 2007. Methods: This health economic analysis is based on a comparison of the use of ONS versus no use of ONS in patients, who are eligible for ONS due to (risk of) disease-related malnutrition (DRM). The costs of the two treatment strategies, "ONSo" versus "no ONSo" were assessed using a linear decision analytic model reflecting cost functions related with DRM. Data sources are based on the published literature, clinical trials, official national price/tariff lists and national population statistics. Results: This study shows that the extra costs for ONS ( 534) are off-set by a reduction of hospitalisation costs ( 768) leading to total cost savings of 234 per patient. A scenario analysis based on length of hospital stays and per diem costing instead of DRG costs shows that the extra costs for ONS ( 534) are also off-set by a reduction of hospitalisation costs ( 791) leading to cost savings of 257 per patient. Additional scenarios showed similar and consistent results. Conclusions: This health economic analysis shows that the use of ONS leads to cost savings for the cost of DRM in Germany in the community setting. In addition the use of ONS leads also to better clinical outcomes due to a reduction of hospitalisations. As a consequence the use of ONS might be considered cost-effective at a patient and also a population level, which could be shown also in extensive sensitivity analyses. © Georg Thieme Verlag KG Stuttgart · New York.

Strutton D.R.,Pfizer | Farkouh R.A.,Pfizer | Earnshaw S.R.,RTI Health Solutions | Hwang S.,Pfizer | And 4 more authors.
Journal of Infection | Year: 2012

Background: Seven-valent pneumococcal conjugate vaccine (PCV7) had profound public-health impacts and is considered cost-effective and potentially cost saving. Two new PCVs have been launched, a 10-valent vaccine (PCV10) and a 13-valent vaccine (PCV13). We examined public-health and economic impacts of PCV pediatric national immunization programs (NIPs) in Germany, Greece, and the Netherlands. Methods: A decision-analytic model was developed to estimate the impact of PCV13, PCV7, and 10-valent pneumococcal conjugate vaccine (PCV10) on invasive pneumococcal disease (IPD), pneumonia (PNE), and acute otitis media (AOM). Using epidemiological data, we calculated the cases of IPD, PNE, and AOM, using country-specific incidence, serotype coverage, disease sequelae, mortality, vaccine effectiveness, indirect effects, costs, and utilities. Direct effects for PCV13- and PCV10-covered serotypes were assumed similar to PCV7. PCV13 was assumed to confer an indirect effect, while PCV10 was not. Assumptions were tested in sensitivity analyses. Results: In a NIP, PCV13 was estimated to eliminate 31.7%, 46.4%, and 33.8% of IPD in Germany, Greece, and the Netherlands, respectively. Compared with PCV7 and PCV10, PCV13 was found to be cost-effective or cost saving in all cases when PCV13 indirect effects were included. Conclusions: Pediatric NIPs with PCV13 in Europe are expected to have dramatic public-health impacts and be cost-effective or cost saving. © 2011 The British Infection Association.

Frank M.,Leibniz University of Hanover | Mittendorf T.,Herescon GmbH
PharmacoEconomics | Year: 2013

Background: Metastatic colorectal cancer (mCRC) imposes a substantial health burden on individual patients and society. Furthermore, rising costs in oncology cause a growing concern about reimbursement for innovations in this sector. The promise of pharmacogenomic profiling and related stratified therapies in mCRC is to improve treatment efficacy and potentially save costs. Among other examples, the commonly used epidermal growth factor receptor (EGFR) antibodies cetuximab and panitumumab are only effective in patients with kirsten rat sarcoma viral oncogene homolog (KRAS) wild-type cancers. Hence, the adaptation of predictive biomarker testing might be a valid strategy for healthcare systems worldwide. Objective: This study aims to review the clinical and economic evidence supporting pharmacogenomic profiling prior to the administration of pharmaceutical treatment in mCRC. Moreover, key drivers and areas of uncertainty in cost-effectiveness evaluations are analysed. Methods: A systematic literature review was conducted to identify studies evaluating the cost effectiveness of predictive biomarkers and the result dependent usage of pharmaceutical agents in mCRC. Results: The application of predictive biomarkers to detect KRAS mutations prior to the administration of EGFR antibodies saved treatment costs and was cost effective in all identified evaluations. However, because of the lack of data regarding cost-effectiveness analyses for predictive biomarker testing, e.g. for first-line treatment, definitive conclusions cannot be stated. Key drivers and areas of uncertainty in current cost-effectiveness analyses are, among others, the consideration of predictive biomarker costs, the characteristics of single predictive biomarkers and the availability of clinical data for the respective pharmaceutical intervention. Especially the cost effectiveness of uridine diphosphate-glucuronyl transferase 1A1 (UGT1A1) mutation analysis prior to irinotecan-based chemotherapy remains unclear. Conclusion: Pharmacogenomic profiling has the potential to improve the cost effectiveness of pharmaceutical treatment in mCRC. Hence, quantification of the economic impact of stratified medicine as well as cost-effectiveness analyses of pharmacogenomic profiling are becoming more important. Nevertheless, the methods applied in cost-effectiveness evaluations for the usage of predictive biomarkers for patient selection as well as the level of evidence required to determine clinical effectiveness are areas for further research. However, mCRC is one of the first indications in which stratified therapies are used in clinical practice. Thus, clinical and economic experiences could be helpful when adopting pharmacogenomic profiling into clinical practice for other indications. © 2013 Springer International Publishing Switzerland.

Damm K.,Leibniz University of Hanover | Roeske N.,Leibniz University of Hanover | Jacob C.,Herescon GmbH
Health Economics Review | Year: 2013

Background: Lung cancer is one of the leading causes of cancer deaths. Treatment goals are the relief of symptoms and the increase of overall survival. With the rising number of treatment alternatives, the need for comparable assessments of health-related quality of life (HRQoL) parameters grows. The aim of this paper was to identify and describe measurement instruments applied in lung cancer patients under drug therapy. Methods: We conducted a systematic literature review at the beginning of 2011 using the electronic database Pubmed. Results: A total of 43 studies were included in the review. About 17 different measurement instruments were identified, including 5 generic, 5 cancer-specific, 4 lung cancer-specific and 3 symptom-specific questionnaires. In 29 studies at least 2 instruments were used. In most cases these were cancer and lung cancer-specific ones. The most frequently used instruments are the EORTC QLQ-C30 and its lung cancer modules LC13 or LC17. Only 5 studies combined (lung) cancer-specific questionnaires with generic instruments. Conclusions: The EORTC-C30 and EORTC-LC13 are the most frequently used health-related quality of life measurement instruments in pharmacological lung cancer trials. © 2013 Damm et al.; licensee Springer.

Huscher D.,A Leibniz Institute | Huscher D.,Charite University Hospital | Mittendorf T.,Herescon GmbH | Von Hinuber U.,Private Practice | And 6 more authors.
Annals of the Rheumatic Diseases | Year: 2015

Objective To estimate the changes in direct and indirect costs induced by patients with rheumatoid arthritis (RA) in German rheumatology, between 2002 and 2011. To examine the impact of functional status on various cost domains. To compare the direct costs incurred by patients at working age (18-64 years) to patients at an age of retirement (≥65 years). Methods We analysed data from the National Database of the German Collaborative Arthritis Centres with about 3400 patients each year. Costs were calculated using fixed prices as well as annually updated cost factors. Indirect costs were calculated using the human capital as well as the friction cost approaches. Results There was a considerable increase in direct costs: from €4914 to €8206 in patients aged 18-64, and from €4100 to €6221 in those aged ≥65, attributable to increasing prescription of biologic agents (18-64 years from 5.6% to 31.2%, ≥65 years from 2.8% to 19.2%). This was accompanied by decreasing inpatient treatment expenses and indirect costs due to sick leave and work disability. The total growth of cost, on average, was €2437-2981 for patients at working age, and €2121 for patients at retirement age. Conclusions The increase in treatment costs for RA over the last decade was associated with lower hospitalisation rates, better functional status and a lower incidence of work disability, offsetting a large proportion of risen drug costs. Since the rise in drug costs has manifested a plateau from 2009 onwards, no relevant further increase in total costs for patients with RA treated in German rheumatology is expected.

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