@article{NoweskiWalendzikHesseletal.2013, author = {Noweski, Michael and Walendzik, Anke and Hessel, Franz and Jahn, Rebecca and Wasem, J{\"u}rgen}, title = {Zulassung und Erstattung personalisierter Arzneimittel: Zwischenbilanz des Anpassungsprozesses}, series = {Ethik in der Medizin}, volume = {25}, journal = {Ethik in der Medizin}, number = {3}, pages = {277 -- 284}, year = {2013}, abstract = {Die Arzneimittelzulassung und der Aufnahmeprozess zur Kostenerstattung sollen die Entwicklung und Vermarktung von pharmazeutischen Innovationen mit Patientennutzen nicht behindern, zugleich aber die Wirtschaftlichkeit der Arzneimittelversorgung f{\"u}r die Kostentr{\"a}ger nicht gef{\"a}hrden. Eine Anpassung der Verfahren an die Merkmale personalisierter Arzneimittel erscheint notwendig. Dabei ist allerdings zu fragen, ob eine ungerechtfertigte Privilegierung erfolgt. In den USA und in der EU werden die jeweiligen Zulassungsverfahren f{\"u}r Arzneimittel und Tests schrittweise angepasst und integriert. Zulassung und Erstattungsentscheidungen sollen koordiniert werden. Eine Privilegierung, wie bei Arzneimitteln f{\"u}r seltene Indikationen (Orphan Drugs), findet jedoch f{\"u}r personalisierte Medizin nicht statt. Es bestehen keine unzumutbaren H{\"u}rden f{\"u}r die Hersteller. Zur{\"u}ckhaltung bei der Entwicklung innovativer Produkte w{\"a}re deshalb nicht gerechtfertigt.}, language = {de} } @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{IcksChernyakBestehornetal.2010, author = {Icks, Andrea and Chernyak, Nadja and Bestehorn, Kurt and Br{\"u}ggenj{\"u}rgen, Bernd and Bruns, J. and Damm, Oliver and Dintsios, Charalabos-Markos and Dreinh{\"o}fer, Karsten E. and Gandjour, Afschin and Gerber-Grote, Andreas and Greiner, Wolfgang and Hermanek, P. and Hessel, Franz and Heymann, Romy and Huppertz, Eduard and Jacke, Christian Olaf and K{\"a}chele, H. and Kilian, R. and Klingenberger, D. and Kolominsky-Rabas, P. and Kr{\"a}mer, Heike U. and Krauth, Christian and L{\"u}ngen, M. and Neumann, T. and Porzsolt, Franz and Prenzler, A. and Pueschner, F. and Riedel, R. and R{\"u}ther, A. and Salize, H. J. and Scharnetzky, E. and Schwerd, W. and Selbmann, Hans Konrad and Siebert, H. and Stengel, Dirk and Stock, Stephanie and V{\"o}ller, Heinz and Wasem, J{\"u}rgen and Schrappe, Martin}, title = {Methoden der gesundheits{\"o}konomischen Evaluation in der Versorgungsforschung}, series = {Das Gesundheitswesen}, volume = {72}, journal = {Das Gesundheitswesen}, number = {12}, pages = {917 -- 933}, year = {2010}, abstract = {Das Deutsche Netzwerk Versorgungsforschung e. V. (DNVF e. V.) hat am 30.08.2010 getragen von den genannten im DNVF organisierten Fachgesellschaften und Organisationen, das Memorandum III „Methoden f{\"u}r die Versorgungsforschung" Teil 2 verabschiedet, das in dieser Zeitschrift publiziert wurde [Gesundheitswesen 2010; 72: 739-748]. Die vorliegende Publikation fokussiert auf die Methodik der {\"o}konomischen Evaluation der Gesundheitstechnologien bzw. Interventionen und stellt eine Vertiefung zu dem Memorandum III „Methoden f{\"u}r die Versorgungsforschung" Teil 2 dar. Zun{\"a}chst werden allgemeine methodische Standards gesundheits{\"o}konomischer Evaluationen, d. h. Studien, die die Kosten-Nutzen Relation (Wirtschaftlichkeit) von Interventionen untersuchen, kurz dargestellt. Um Versorgungsrealit{\"a}t ad{\"a}quat zu reflektieren, m{\"u}ssen zur Ermittlung der Interventionskosten und -effekte oft mehrere Datenquellen, z. B. Wirksamkeitsstudien, Register, administrative Quellen usw., verwendet werden. Daher werden f{\"u}r die gesundheits{\"o}konomischen Evaluationen im Rahmen der Versorgungsforschung potenziell geeignete Datenquellen vorgestellt, ihre Vorteile und Limitationen genannt. Anschließend wird der Weiterentwicklungsbedarf der Methodik im Hinblick auf die Datenerhebung, und -auswertung sowie die Kommunikation und Dissemination der Ergebnisse diskutiert.}, 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} } @incollection{NoweskiWalendzikHesseletal.2015, author = {Noweski, Michael and Walendzik, Anke and Hessel, Franz and Jahn, Rebecca and Wasem, J{\"u}rgen}, title = {Approval and Reimbursement of Personalised Drugs: Interim Results of the Adjustment Process}, series = {The Ethics of Personalised Medicine}, booktitle = {The Ethics of Personalised Medicine}, publisher = {Ashgate}, address = {Farnham}, publisher = {SRH Berlin University of Applied Sciences}, pages = {199 -- 209}, year = {2015}, abstract = {According to drug manufacturers, the pharmaceutical industry is suffering from an 'innovation crisis'. Nowadays, the development of new products requires significantly more investment than in the past. Most of the simple but useful chemical entities seem to have been discovered already. Moreover, many topselling drugs lose their patent protection ('patent cliff ') and, subsequently, prices and sales of the original drug are undermined by competing generics. Producers try to compensate for the loss of sales by launches of new molecular entities (Jimenez, 2012). However, the new compounds generate fewer sales. As market observers calculated, new products launched in the period from 2001 to 2005 achieved annual average sales of USD 208 million after three years. New products of the period from 2006 to 2010 reached only USD 143 million (Rockoff and Winslow, 2013). Development of a drug which yields more than a billion USD per year ('blockbuster') succeeds less often. Drugs combined with biomarker-based diagnostic tests, stratifying patients into groups characterised by different drug reactions, appear to be one way out of trouble, because a new generation of patented products seems attainable (Scollen and Phelan, 2014).}, language = {en} } @article{HesselJahnDiehmetal.2011, author = {Hessel, Franz and Jahn, Rebecca and Diehm, Curt and Lux, Gerald and Driller, Elke and Ommen, Oliver and Pfaff, Holger and Siebert, Uwe and Pittrow, David and Wasem, J{\"u}rgen and Neumann, Anja}, title = {Effect of Guideline Orientation on the Outcomes of Peripheral Arterial Disease in Primary Care}, series = {Current Medical Research and Opinion}, volume = {27}, journal = {Current Medical Research and Opinion}, number = {6}, pages = {1183 -- 1190}, year = {2011}, abstract = {Peripheral arterial disease (PAD), an established marker of premature death and cardiovascular risk in general, is highly prevalent. We analysed factors associated with poor outcomes in an observational cohort, with particular focus on the effect of guideline orientation in the management of these patients.}, language = {en} }