@misc{Hessel2012, author = {Hessel, Franz}, title = {Gesundheitsmanagement}, year = {2012}, abstract = {Keine Angabe No details}, language = {de} } @incollection{HesselBiermannKerkemeyeretal.2013, author = {Hessel, Franz and Biermann, Janine and Kerkemeyer, Linda and Korff, Lasse and Mostardt, Sarah and Neumann, Anja}, title = {Arzneimittelversorgung}, series = {Medizinmanagement: Grundlagen und Praxis}, booktitle = {Medizinmanagement: Grundlagen und Praxis}, editor = {Wasem, J{\"u}rgen}, publisher = {Medizinisch Wissenschaftliche Verlagsgesellschaft}, address = {Berlin}, publisher = {SRH Berlin University of Applied Sciences}, pages = {355 -- 391}, year = {2013}, abstract = {Keine Angabe - No details}, language = {de} } @article{Hessel2013, author = {Hessel, Franz}, title = {Personalized Medicines: worth the Effort and Investment?}, series = {Pharmaceutical Executive}, volume = {11}, journal = {Pharmaceutical Executive}, url = {http://nbn-resolving.de/urn:nbn:de:0298-opus4-5479}, pages = {2 -- 6}, year = {2013}, abstract = {Prof. Dr. Franz Hessel questions whether personalized medicine and companion diagnostics are actually enhancing the drug development process.}, language = {en} } @inproceedings{Hessel2013, author = {Hessel, Franz}, title = {The relevance of the analytic validity of genetic tests in personalized medicine technologies for reimbursement decision making in Germany}, series = {EACME Annual Conference, Bochum}, booktitle = {EACME Annual Conference, Bochum}, year = {2013}, abstract = {Keine Angabe - No details}, language = {en} } @inproceedings{Hessel2013, author = {Hessel, Franz}, title = {Developing personalized medicine drugs: incentives for pharmaceutical companies}, series = {EACME Annual Conference, Bochum}, booktitle = {EACME Annual Conference, Bochum}, year = {2013}, abstract = {Objectives: Stratification of oncology drug therapy by genetic marker diagnostics can reveal additional patient benefit but also might influence the development process of drug manufacturers. The objective of this study is to identify and describe the most important incentives for pharmaceutical companies to develop personalized medicine drugs. Methods: To describe the main factors influencing the decision making process in the development of personalized medicine drugs we designed a qualitative systemdynamic model. The main factors influencing the process and their priority ranking were determined by systematic literature search, structured expert interviews with pharmaceutical companies, test manufacturers and other key stakeholders such as regulatory bodies, reimbursement decision makers and payers. The model was build with the Consideo iModeler software package. Results: In contrast to small companies big international companies constantly look for suitable companion diagnostic tests to select subgroups of high responder. The most important key factor for market success is the extent of clinical efficacy in comparison with competitors respectively the current treatment standard. Stratification of patient populations according to treatment response or frequency of adverse events using biomarker is regarded to increase clinical efficacy of the target indication. The test performance is important due to unsolved safety issues although not regarded as crucial for the success of the drug. In contrast to other stakeholders pharmaceutical companies did not consider personalized medicine to relevantly decrease development costs or marketing efforts respectively to increase the price potential for new drugs. A low prevalence of the remaining patient population after testing is not irrelevant but it is not seen as a factor which might lead to a stop of the development of a new drug by pharmaceutical companies. Conclusions: Genetic stratification is seen as a breakthrough in cancer therapy by pharmaceutical companies and physicians. Due to the current need for improvement of approval and reimbursement processes for personalized medicine approaches in oncology especially in Europe future sales are more difficult to predict.}, language = {en} } @article{MoockHesselZiegeleretal.2010, author = {Moock, J{\"o}rn and Hessel, Franz and Ziegeler, Diana and Kubiak, Thomas and Kohlmann, Thomas}, title = {Development and Validation of the Insulin Treatment Experience Questionnaire (ITEQ)}, series = {The Patient}, volume = {3}, journal = {The Patient}, number = {1}, pages = {45 -- 58}, year = {2010}, abstract = {Objectives: To develop and psychometrically evaluate a domain-specific questionnaire to assess subtle but clinically relevant differences in treatment experiences and satisfaction over a wide range of currently available insulin therapy regimens. The study focussed on patients with type 2 diabetes mellitus and placed particular attention on the impact of different forms of insulin therapy on diabetes self-management. Methods: The development of the Insulin Treatment Experience Questionnaire (ITEQ) was conducted in three steps: (i) a qualitative phase to generate relevant items and identify relevant domains; (ii) a pilot study to reduce the number of generated items; and (iii) a validation study to assess major psychometric properties of the final ITEQ version. Results: The final version of the questionnaire comprised 28 items with the subscales 'leisure activities' (four items), 'psychological barriers' (two items), 'handling' (five items), 'diabetes control' (six items), 'dependence' (five items), 'weight control' (three items), 'sleep' (two items), and one further item assessing general treatment satisfaction. The subscales' internal consistencies (Cronbach's alpha) ranged from 0.52 to 0.83. Motivated by the homogenous structure of inter-scale-correlations (range 0.10-0.46), a summary composite score was calculated (alpha = 0.86). Construct validity showed statistically significant correlations with other scales (ITEQ vs the Problem Areas in Diabetes [PAID] questionnaire total score -0.60, ITEQ vs the Diabetes Treatment Satisfaction Questionnaire [DTSQ] total score 0.52). Conclusion: The newly developed ITEQ displayed satisfactory to good psychometric properties, thereby allowing the assessment of everyday life experience and treatment satisfaction in patients with insulin-treated type 2 diabetes. Additional research is needed to assess test-retest reliability and sensitivity to change.}, language = {en} } @article{HesselBramlageWasemetal.2010, author = {Hessel, Franz and Bramlage, Peter and Wasem, J{\"u}rgen and Mitzner, Steffen R.}, title = {Cost effectiveness of the artifical liver support system MARS in patients with acute-on-chronic liver failure}, series = {European Journal of Gastroenterology \& Hepatology}, volume = {22}, journal = {European Journal of Gastroenterology \& Hepatology}, number = {2}, pages = {213 -- 220}, year = {2010}, abstract = {For patients with an acute exacerbation of chronic liver failure (ACLF), the molecular adsorbent recirculating system (MARS) can result in a prolongation of life, but data on costs and cost-effectiveness are lacking. A health economic evaluation of a prospective controlled cohort trial in patients with ACLF not eligible for liver transplantation with 3 years follow-up and consecutive modelling of long-term costs, outcomes and cost-effectiveness was conducted. Costs were calculated from the perspective of the German health-care system. One hundred and forty-nine patients with ACLF were included of which 67 (44.9\%) were treated with MARS and 82 (55.1\%) assigned to the control group. Mean survival was 692 days in MARS-treated patients (33\% survival after 3 years) and 453 days in control patients (15\% after 3 years, logrank P = 0.022). MARS patients gained 0.66 [95\% confidence interval (CI): -0.12 to 1.46] life years (LYs), determined by the bootstrap method. The mean cost difference was 19.835 euro (95\% CI: 13.308-25.429) with 35639 euro for MARS-treated patients and 15804 euro for controls. Incremental costs per LY gained were 29.985 euro (95\% CI: 9.441-321.761) and 43.040 euro (95\% CI: 13.551-461.856) per quality-adjusted LY gained. There is an acceptable cost-effectiveness of MARS, compared with other medical technologies presently reimbursed. Randomized controlled trials with sufficient sample size are necessary before a final recommendation for MARS can be given.}, language = {en} } @article{ReinholdBrueggenjuergenSchlanderetal.2010, author = {Reinhold, Thomas and Br{\"u}ggenj{\"u}rgen, Bernd and Schlander, Michael and Rosenfeld, Stephanie and Hessel, Franz and Willich, Stefan N.}, title = {Economic analysis based on multinational studies: methods for adapting findings to national contexts}, series = {Journal of Public Health}, volume = {18}, journal = {Journal of Public Health}, number = {4}, pages = {327 -- 335}, year = {2010}, abstract = {Background: Health economic parameters are increasingly considered as variables in health care decisions, but decision makers are interested in country-specific evaluations. However, a large number of studies are performed in foreign countries or in a multinational setting, which limits the transferability to a single nation's context. Objective: The present analysis summarises several of the most common international methods for generating health economic analyses based on clinical studies from different settings. Methods: A narrative literature review was performed to identify potential reasons for limited transferability of health economic evaluation results from one country to another. Based on these results, we searched the methodological literature for analytic approaches to handle the restrictions. Additionally we describe the possibility of transferring foreign economic study results to the country of interest by matching trial data with routine data of national databases. Results: The main factors for limited transferability of health economic findings were found in country-specific differences in resource consumption and the resulting costs. These differences are affected by a number of influencing cofactors (demography, epidemiology and individual patient's factors) and the overall health care system structures (e.g. payment systems, health provider incentives). However, despite the limitations country-specific health economic assessments could be realised using the pooled/split analyses approach, some statistical approaches and modelling approaches. Conclusion: A variety of methods for identifying and adjusting country-specific differences in costs, effects and cost-effectiveness was established during the past decades. Multinational studies will continue to play a crucial role in the evaluation of cost-effectiveness at national levels. It seems likely that the growing interest in multinational studies will lead to continued developments in adaptation methods.}, language = {en} } @misc{Hessel2012, author = {Hessel, Franz}, title = {Knorpelzellentransplantation aus Sicht der Gesundheits{\"o}konomie und Versorgungsforschung}, year = {2012}, abstract = {Keine Angabe No details}, language = {de} } @article{NeumannJahnDiehmetal.2010, author = {Neumann, Anja and Jahn, Rebecca and Diehm, Curt and Driller, Elke and Hessel, Franz and Ommen, Oliver and Pfaff, Holger and Siebert, Uwe and Pittrow, David and Wasem, J{\"u}rgen}, title = {Outcomes of medical management of peripheral arterial disease in general practice: follow-up results of the PACE-PAD Study}, series = {Journal of Public Health}, volume = {18}, journal = {Journal of Public Health}, pages = {523 -- 532}, year = {2010}, abstract = {Peripheral arterial disease (PAD), a marker of elevated vascular risk, is highly prevalent in general practice. We aimed to investigate patient characteristics and outcomes of PAD patients treated according to the guidelines versus those who were not. Methods. PACE-PAD was a multicentre, cluster - randomised prospective, longitudinal cohort study of patients with PAD in primary care, who were followed-up for death or vascular events over 18 months. Guideline-orientation was assumed, if patients received anti¬coagu¬lant/antiplatelet therapy, exercise training, and (if applicable) advice for smoking cessation and therapy of diabetes mellitus, hypertension, or hypercholesterolemia, respectively. Results. The 5099 PAD patients (mean age 68.0 ± 9.0 years, 68.5\% males) who were followed-up were in Fontaine stages I, IIa, IIb, III, and IV in 22.5\%, 34.6\%, 30.1\%, 7.8\%, and 3.5\% (1.5\% not specified). Comprehensive guideline orientation was reported in 28.4\% only, however, patients in lower Fontaine stages received more often guideline-oriented therapy (I: 30.3\%; IIa: 31.6\%, IIb: 29.1\%, III: 9.8\%, IV: 18.0\%). During 18 months, 457 patients died (224 due to cerebrovascular or coronary deaths), 319 had instable angina pectoris, 116 myocardial infarction, and 140 an ischemic stroke event. In total, 24\% of patients had experienced any vascular event (19.1\% a first event). Event rates did not differ between patients treated according to guidelines, and those who were not. Conclusion. The present PAD cohort was a high-risk sample with an unexpectedly high rate of deaths and vascular events. While physicians appear to focus on the treatment of individual risk factors, rates of comprehensive PAD management in line with guideline recommendations are still suboptimal. Factors contributing to the lacking difference between outcomes in the guideline-oriented and non-guideline-oriented groups may comprise low treatment intensity or other reasons for unsatisfactory effect of treatment, misclassification of events, patient's non-compliance with therapy.}, language = {en} }