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Hannover, Germany

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. Source


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. Source


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. Source


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. Source


Dorner T.,Charite - Medical University of Berlin | Strand V.,Stanford University | Castaneda-Hernandez G.,CINVESTAV | Ferraccioli G.,Catholic University of the Sacred Heart | And 6 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. Source

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