Abstracts by keywords: breast cancer
Breast cancer (BC) is the most common cancer among women in Germany, with around 69,000 new cases every year; 18,591 women died of BK in 2015 (Barnes et al., 2016). Approximately 70% of all newly diagnosed women with BK have a hormone receptor-positive tumor (HR+) who are eligible for primary adjuvant endocrine therapy (ET) with either tamoxifen (TAM) or an aromatase inhibitor (AI) (Franzoi et al., 2021) . Depending on the menopausal status, this standard therapy is taken daily for at least 5 years, significantly reduces the risk of BK recurrence and improves the overall survival of the patients (Waks & Winer, 2019, Font et al., 2022). Despite the proven effectiveness in preventing BK recurrence by 40%, approximately 50% of women take less than 80% of the prescribed dose. In addition, up to 50% of patients with BK discontinue their ET (Hadji et al., 2013; Moon et al., 2019; Peddie et al., 2021). It should be noted that both TAM and AI therapy can cause short- and long-term side effects in patients. These include hot flashes, myalgias and osteoporosis (Franzoi et al., 2021; Group et al., 2009). The occurrence of TAM- and AI-related side effects may therefore negatively impact a patient's persistence to ET. Persistence is defined as the continuation of drug use for the prescribed length of time (from initiation to discontinuation) while a patient adheres to the prescribed interval and dose of a dosing regimen (Cramer et al., 2008; Hadji et al., 2013). Recently, adherence to therapy and the persistence of ET in women with HR+ BK have been the subject of intense debate in the literature, since "non-adherence" to ET has been shown to be associated with an increased risk of disease recurrence (Font et al., 2019; Seneviratne et al ., 2015), for distant metastases (Blanchette et al., 2020; Lee et al., 2019) and for mortality (Inotai et al., 2021; Lao et al., 2019; Murphy et al., 2015). However, no study has yet investigated whether there is a connection between the health insurance company a woman has and her persistence in ET. The aim of this study was therefore to analyze persistence with TAM and AI and to show possible differences specific to health insurance companies.
28.11.2022
Medicines can only be placed on the market in Germany if they have gone through an approval procedure in accordance with Section 21 of the Medicines Act. Based on the data submitted by the applicant pharmaceutical company, the field of application (indication), the type of administration and the dosage of the drug are then determined, among other things, as part of the approval process. In principle, a drug can only be prescribed at the expense of statutory health insurance if it is used in accordance with its approval. The off-label use of a medicinal product outside the area of application approved by the national and European regulatory authorities is referred to as off-label use. Off-label use in oncology in Germany is estimated at up to 60% of patients (Ludwig 2006). However, there is currently no empirical data to support these assessments. A distinction must be made between “classic” off-label use and recognized off-label use, which enables the approval-exceeding regulation in accordance with Section 35c (1) SGB V. In 2003, an expert group was set up at the Federal Institute for Drugs and Medical Devices (BfArM), whose task is to convey the "Assessment of the current state of scientific knowledge about the off-label use of certain drugs as a recommendation" to the G-BA (G-BA press release 2014). Resolutions on recognized off-label use only become legally binding if the pharmaceutical company and the Federal Ministry of Health agree. An example of recognized off-label use in oncology is fluorouracil (5FU), approved for the treatment of advanced colorectal cancer, gastric cancer, pancreatic cancer, and advanced and/or metastatic breast cancer (BCa). According to Section 35b Paragraphs 2 and 3 SGB V, 5FU was additionally approved for the adjuvant therapy of BCa. The recognized off-label use of 5FU has also been adopted into the S3 and Onkopedia guidelines, where adjuvant treatment of patients with 5FU-containing regimens is recommended.