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Abstracts by keywords: Oncology

Strukturelle und methodische Limitationen des EU-HTA-Verfahrens für Onkologika in Deutschland

Deutschland zählt zu den bedeutendsten Arzneimittelmärkten Europas und zeichnet sich durch eine unmittelbare Erstattungsfähigkeit neu zugelassener Arzneimittel zum Zeitpunkt der Markteinführung aus. Seit Inkrafttreten des Arzneimittelmarktneuordnungsgesetzes (AMNOG) im Jahr 2011 unterliegen neue Arzneimittel einer Nutzenbewertung durch den Gemeinsamen Bundesausschuss (G-BA), welche die Grundlage für die anschließenden Preisverhandlungen bildet. Ziel dieses Systems ist es, Preisaufschläge ausschließlich […]

05.10.2026
What impact does hospital reform have on the care of cancer patients?

According to the National Cancer Plan, all cancer patients should receive high-quality care in accordance with evidence-based treatment guidelines in uniformly qualified centers. The WiZen study demonstrated significant survival benefits for all 11 cancer types examined when receiving initial treatment in a center certified by the German Cancer Society (DKG) compared to non-certified hospitals. Nevertheless, a high proportion of cancer patients are treated in non-certified hospitals. The Hospital Care Improvement Act (KHVVG) provides for a concentration of services in the field of oncological surgery; the hospital locations that collectively provide the fewest and 15% of cases with corresponding onco-surgical services for a cancer entity are to be exempt from reimbursement. We used an impact analysis based on data from Section 21 of the KHEntgG (German Hospital Care Improvement Act) for 2022 to examine the extent to which the planned concentration of services will lead to the implementation of the National Cancer Plan and the results of the WiZen study. The entities considered were breast cancer, pancreatic cancer, bronchial cancer, colon cancer, rectal cancer, gastric cancer, and esophageal cancer. Of the sites that would meet the criteria of the KHVVG, between 17.9% (breast cancer) and 85.5% (gastric cancer) are not certified according to the DKG criteria. Thus, if Section 40 of the KHG (new) is implemented, a significant proportion of patients would continue to be treated outside of certified centers, leaving corresponding quality potential untapped. Furthermore, the proposed new regulation only addresses surgical interventions per (cancer) entity—thus exempting all non-oncosurgical cancer treatments from the quality-based service concentration. Overall, to achieve the goal of hospital reform—namely, to improve the morbidity and mortality of patients with cancer—it appears significantly more effective to limit oncological care, as envisioned in the National Cancer Plan, exclusively to those facilities that meet the certification requirements of the German Cancer Society and thus demonstrably ensure guideline-compliant, evidence-based care for cancer patients. According to an analysis by the government commission, this would not significantly restrict accessibility for the population.

04.08.2024
Change in the age structure of newly diagnosed cancer patients between 2010 and 2022 in private practices

The aim of the present study was to determine the age of new cancer patients in 2010 and 2022 and to evaluate the changes in the proportion of early-onset cancers in the total number of cancer cases in private practices. This retrospective cross-sectional study included adult patients (≥18 years) with an initial cancer diagnosis in 557 private practices in Germany in 2010 or 2022 from the Disease Analyzer database (IQVIA).

02.08.2023
Potential for optimizing the care of cancer patients in the context of ASV according to § 116b SGB V ("new")

On January 1st, 2012, with the GKV-VStG, the legislator laid the foundation for the development of a new care structure, the "outpatient specialist medical care" (ASV). With the new version of § 116b SGB V (§ 116b SGB V "new"), since the beginning of 2012, not only hospitals but also contract doctors have been included in the regulations. The ASV essentially pursues two goals: Firstly, it is intended to contribute to overcoming the sectoral boundaries in the German health care system and, secondly, to achieve improved interdisciplinary coordination of diagnostics and therapy among the service providers. For the first time in the German healthcare system, the ASV is intended to open up the possibility for registered panel doctors and hospitals to work and work together across sectors under the same conditions (cf. e.g. G-BA 2015a; Klakow-Franck 2014b: 154 and 2015: 6). The introduction of the ASV was not least in the interest of panel doctors (cf. e.g. Klakow-Franck 2014b: 153), because under the existing regulations (§116b SGB V "old") they had to fear that the comparatively financially strong hospitals there is increasing competition with a correspondingly tougher competitive situation in the healthcare market. Contract doctors had also repeatedly filed lawsuits against hospital approvals under Section 116b SGB V "old" (cf. SVR 2012: 259).

31.03.2016
What effects can be expected from new oncological drugs?

When evaluating new drugs for the treatment of cancer, the endpoint survival is the main focus. Many of these new drugs can be shown to have a survival advantage compared to the previously available treatment options. However, it is often emphasized that this is usually only “two to three months” (e.g. Lauterbach 2015, Fojo et al. 2014). This additional survival time is often perceived as insufficient and complaints are also made that the time gained in this way often does not provide an adequate quality of life. Furthermore, the new active ingredients have not been sufficiently tested. The use of the usually high-priced drugs is therefore often not worth the money. Due to the high health policy importance of the assumption that new therapies only offer "two to three months" additional survival time, this study should examine whether this common assumption is in line with the facts. The basis for this is the resolutions for the evaluation of new drugs according to the Drug Market Reorganization Act (AMNOG), which all new active ingredients have had to undergo since 2011 in order to demonstrate their additional benefit compared to the so-called appropriate comparative therapy.

31.03.2016
“Drug development in oncology: status quo and outlook with special consideration of surrogate endpoints”

In 2011, 30 new agents were approved in the USA and 22 in Europe, including 8 and 7 for the treatment of oncological indications, respectively (1). This trend towards an increasing proportion of oncological drugs, which has already been observed for several years, is continuing in 2012, as current figures from the US Food and Drug Administration (FDA) show: one third – 13 of the 39 newly approved active substances – relate to oncological areas of application (2). Approval in oncology often takes place as part of accelerated approval procedures (“conditional marketing authorization” or “accelerated approval”) and/or as an “orphan drug” for rare diseases. The main reasons given for the significant increase in oncological active substances are: progress in the molecular-biological characterization of tumor growth, development of a large number of new "targeted" active substances, great need for more effective drug therapy options for advanced tumor diseases, demographic development, expiry of patents for blockbusters on Treatment of common diseases and a very lucrative market for oncological drugs.

24.01.2013
“Unmet Needs” – undercare and multimodal support needs of outpatient tumor patients

Against the background of the high number of cancer cases and increasing survival rates, the quality of life of oncological patients is becoming increasingly important. As patients spend shorter periods of time in inpatient facilities, care is increasingly shifting to the outpatient healthcare sector. In the areas of oncological acute medicine as well as post-treatment and rehabilitation, needs-based patient care of varying quality is established and is often integrated into the respective medical treatment concepts. Problems often arise when oncological patients are discharged from inpatient care to outpatient care (Stiel et al. 2009). Both tumor patients and their relatives as well as oncology physicians criticize deficits in the outpatient care of chronically ill tumor patients with regard to adjuvant offers (Herschbach and Mandel 2011; Mehnert et al. 2012; Chambers et al. 2012; Mitchell et al. 2012). The range of support measures available to tumor patients varies locally; in large cities it is generally easier to find a contact point than in structurally weak, mostly rural areas (Stiel et al. 2009). At the same time, comprehensive care, i.e. supporting the patient on a psychological, social and physical level, is recommended for a more favorable course of the tumor disease (Ebbinghaus et al. 2009).

24.01.2013
The development of oncological drugs prescribed on an outpatient basis in the statutory health insurance system until 2016

The expenditure of statutory health insurance on medicines for the treatment of cancer is always the focus of discussion (Neller 2013). A report prepared on behalf of the Federal Ministry of Health on the question of ensuring efficient drug supply in oncology shows that an increase in costs for statutory health insurance is to be expected in this area (Glaeske et al. 2010). The prognosis of future medical costs in the oncological field is also important internationally. Mariotto et al. (2010) considers in particular the demographically related additional costs of cancer treatment in the USA. Yabroff et al. (2011) point to the additional consideration of indirect costs as a result of cancer therapy. These are described by Featherstone et al. (2010) for a consideration of costs in the United Kingdom (UK). The demographically-related annual cost increases between 2008/2010 and 2020 are estimated in these publications at 1.0 % to 2.5 %. Global observations with a focus on the pharmaceutical market and taking new launches into account assume higher annual increases (6.9 % between 2010 and 2016) (Business Insight (2011)), which are also expected in Germany (Höer et al. 2010). The aim of the analysis currently presented is to create a current forecast for the expected development of sales and consumption of statutory health insurance (GKV) for oncological drugs dispensed on an outpatient basis until 2016.

24.01.2013
Increasing the effectiveness and efficiency of cancer drug development

The growing global burden of cancer demands a more productive and efficient process for developing new therapies. The relatively low attrition rates of molecularly targeted cancer therapies suggest that efforts to accelerate development must start with a strong foundation of data and consensus methods for identifying biomarkers associated with cancer progression and treatment response. In addition, work is needed to improve the efficiency and consistency of trials in identifying therapies that meaningfully improve outcomes. Delivering on the promise of 21st Century cancer care will require a collaborative effort that engages all stakeholders in the cancer community - researchers, product developers, regulators, and patients.

01.12.2009
A “National Cancer Plan” for Germany: Cui bono?

The “National Cancer Plan” from BMG, DKH and DKG reads like a 5-year plan to generate enormous needs, especially in the area of medication, to ensure that the increasing amounts of substances in the “oncological drug market” are supplied to a sufficiently increasing number of “consumers”. and that they are also prepared to pay the prices demanded by the product manufacturers, no matter how high, without ever being able to receive proof of benefit. A national cancer plan that serves the well-being of the individual affected and the population as a whole must pursue the opposite goal of the growth of disease and suffering: it must reduce the risk of disease, reduce the burden of disease and lead to a reduction in cancer incidence and cancer mortality through a variety of preventive measures. With such a national cancer (prevention) plan, the profit expectations of the oncological pharmaceutical market would not be fulfilled in the next 5 to 10 years. In return, the quality of life and life expectancy of the population in Germany would increase significantly. On such a central question of democracy, citizens in Germany must be asked which national cancer plan they want.

01.08.2009

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