@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} } @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} }