Off-Label-Verordnungen in der Onkologie

Weißbach, L.; Boedefeld, Edith A.

doi:10.1007/s00103-003-0625-2

Cited by 2 publications

(4 citation statements)

References 8 publications

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“…- potential and/or evident treatment success (phase III trials) [ 11 , 12 ]. The danger of insufficient drug safety in off-label use is considered minimal if the drug has passed the legally required safety tests [ 13 ], respectively existence of publications with consensus of expected success [ 14 ].…”

Section: Discussionmentioning

confidence: 99%

“…1. Positive recommendation of the expert commission for application of an off-label drug (the Federal Minister of Health and Social Security has established an expert commission to evaluate scientifically off-label use and provide advice on such practice [ 13 ]),…”

Section: Discussionmentioning

confidence: 99%

“…In some cases, only off-label use can guarantee the legally required treatment according to the newest scientific findings. Current jurisdiction has specified the conditions for off-label use [ 13 ].…”

Section: Discussionmentioning

confidence: 99%

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Off-label use in germany - a current appraisal of gynaecologic university departments

et al. 2011

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ObjectiveThe off-label use, referring to the applicability of pharmaceutical drugs beyond the submitted and from the Federal Institute for Drugs and Medical Devices (BfArM, Bundesamt für Arzneimittel und Medizinprodukte) certified and approved administration, is the subject of controversial discussions. the application can be considered in case of severe illness - if no therapeutic alternatives are available - or it exists as a founded perspective for achieving therapeutic success.MethodsA latitudinal study for evaluating the application of off-label use supplements was performed at 43 German university and academic teaching hospitals. Five doctors at each hospital applied off-label pharmaceutical drugs and were called upon to share their personal experience to the application of those medications.Results75 (35%) questionnaires were returned out of 22 (51%) medical centres with 215 contacted physicians. Off-label use was common for 65 (91%) of the physicians. Only 9% of them obviate the application of off-label drugs. About a half of the medication is related to application in obstetrics (54%) and in most cases on an every day basis. Uterotonics were the most commonly used off-label medications (34%). The main part of information about off-label use is obtained from personal information of colleagues (66%) and personal experience (58%). 34% of physicians think that off label use is risky. Interestingly, the view about off label use of medication varies considerably among physicians from various hospitals.ConclusionsThe application of off-label pharmaceutical drugs in Germany seems to be a well established practice. More than 90% of participators of our trial use at least one medication outside the administration. This includes particularly prostaglandins, anti-hyper-tonic therapeutics and chemotherapeutics.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

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Off-label use in germany - a current appraisal of gynaecologic university departments

et al. 2011

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“…[30]. In addition, a still ongoing discussion was started [31] covering different points of view ranging from public health insurance companies [30], pharmaceutical industry [32], to federal administration [33] and legal aspects [34], which also stresses the necessity for offlabel use of pharmaceuticals, especially in oncology [35].…”

Section: Off-label Use and German Social Court Rulingsmentioning

confidence: 99%

Current Status of Financing and Reimbursement of Trastuzumab (Herceptin<sup>®</sup>) for Adjuvant and Advanced Therapy of Breast Cancer in Germany

Jacobs

2006

Breast Care

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Trastuzumab (Herceptin^®) is a monoclonal antibody treatment option for breast cancer patients costing up to 5-10 times more than state-of-the-art chemotherapy. A significantly improved outcome for defined groups of patients who are HER2/neu-positive was previously shown for advanced/metastatic breast cancer and recently also for adjuvant therapy in several large phase III trials. However, financial limitations of any health system, even in wealthy nations such as Germany, can prevent optimal treatment. The German Social Security Code requires cost-effectiveness of all medical treatment. Financing of off-label pharmaceuticals is strictly limited by law. In contrast to advanced breast cancer for which trastuzumab is licensed, in the adjuvant setting it is restricted to off-label use and could result in a massive financial loss for the health care provider. So, indication and reimbursement for innovative therapies during the interim phase between clinical trials and official approval remain difficult. In this review, the current situation in Germany and the experience with financing and reimbursement of the costs of trastuzumab in the adjuvant and advanced setting as well as the search for financial solutions are described. Dr. med. Volker R. Jacobs, MBA Oberarzt Forschung and Klinikmanagement Frauenklinik der Technischen Universität München Ismaninger Strasse 22, 81675 München, Germany Tel. +49 894140-5425, Fax -4831 E-mail volkerjacobs@hotmail.com Current Status of Financing and Reimbursement of Trastuzumab (Herceptin®) for Adjuvant and Advanced Therapy of Breast Cancer in Germany Volker R. Jacobs Frauenklinik der Technischen Universität München, Germany

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Off-Label-Verordnungen in der Onkologie

Cited by 2 publications

References 8 publications

Off-label use in germany - a current appraisal of gynaecologic university departments

Off-label use in germany - a current appraisal of gynaecologic university departments

Current Status of Financing and Reimbursement of Trastuzumab (Herceptin<sup>®</sup>) for Adjuvant and Advanced Therapy of Breast Cancer in Germany

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