Budget impact analysis of gene expression tests to aid therapy decisions for breast cancer patients in Germany.

OBJECTIVES: Many women with early-stage, hormone receptor-positive breast cancer may not benefit from adjuvant chemotherapy. Gene expression tests can reduce chemotherapy over- and undertreatment by providing prognostic information on the likelihood of recurrence and, with Oncotype DX, predictive information on chemotherapy benefit. These tests are currently not reimbursed by German healthcare payers. An analysis was conducted to evaluate the budget impact of gene expression tests in Germany. MATERIALS AND METHODS: Costs of gene expression tests and medical and non-medical costs associated with treatment were assessed from healthcare payer and societal perspectives. Costs were estimated from data collected at a university hospital and were combined with decision impact data for Oncotype DX, MammaPrint, Prosigna and EndoPredict (EPclin). Changes in chemotherapy use and budget impact were evaluated over 1 year for 20,000 women. RESULTS: Chemotherapy was associated with substantial annual costs of EUR 19,003 and EUR 84,412 per therapy from the healthcare payer and societal perspective, respectively. Compared with standard care, only Oncotype DX was associated with cost savings to healthcare payers and society (EUR 5.9 million and EUR 253 million, respectively). Scenario analysis showed that both women at high clinical but low genomic risk and low clinical but high genomic risk were important contributors to costs. CONCLUSIONS: Oncotype DX was the only gene expression test that was estimated to reduce costs versus standard care in Germany. The reimbursement of Oncotype DX testing in standard clinical practice in Germany should be considered.

[Evaluation of cancer therapy from the perspective of a statutory health insurance]. / Bewertung onkologischer Therapien aus Sicht einer Kasse.

Increasing life expectancy, the introduction of costly new drugs and contributions from the health fund which do not cover overall costs, all contribute to financial problems for statutory health insurances (SHI) in oncology. Only an evidence-based approach can help to address these problems. In a first step patient-relevant benefits have to be substantiated as a necessary prerequisite for coverage of any treatment by SHIs. For products with no additional benefit compared to established forms of therapy the price will be limited by the established cost-benefit ratio. For products with additional benefits pricing is more difficult. For this situation the Institute for Quality and Efficiency in Healthcare (IQWiG) has developed general methods for the assessment of the relation of benefits to costs. Pricing based on this health economic evaluation is developed using efficiency frontier plots. However, this method is prone to manipulation and needs to be refined. Therapies without comparators, so-called soloists, cannot be priced in this way. New approaches to increase cost efficiency need to be developed in order to ensure the availability of high quality care in the future.

Geniom technology--the benchtop array facility.

Febit AG develops an integrated benchtop instrument for in situ microarrays preparation, hybridization, readout and data analysis.

Exploring nature's plasticity with a flexible probing tool, and finding new ways for its electronic distribution.

Concepts and results are described for the use of a single, but extremely flexible, probing tool to address a wide variety of genomic questions. This is achieved by transforming genomic questions into a software file that is used as the design scheme for potentially any genomic assay in a microarray format. Microarray fabrication takes place in three-dimensional microchannel reaction carriers by in situ synthesis based on spatial light modulation. This set-up allows for maximum flexibility in design and realization of genomic assays. Flexibility is achieved at the molecular, genomic and assay levels. We have applied this technology to expression profiling and genotyping experiments.

[Strained relations between federal health insurance and the public health service]. / Das Spannungsverhältnis zwischen Krankenversicherung und öffentlichem Gesundheitsdienst.

A close cooperation between all partners according to section 20 IV SGB V is basically welcome. However, in times of financial straits in public budgets, attempts have to be avoided to shift tasks and financial burdens to statutory health insurance (SHI). A series of examples shows that because of the different responsibilities-related to the insured persons on the one hand, and the general population on the other-tendencies to shift burdens to SHI are observed. However, such measures are neither adequate nor without problems (e.g. protection by vaccination). Public health service is requested to improve its epidemiological capacities and the qualification of its doctors. Furthermore, the service should be re-orient to a modern citizen-oriented service organization. Communities and provincial ("Land") governments have to provide the financial prerequisites.

[Developing social medicine competence in medical education--goals in social medicine education for the practicing physician from the viewpoint of mandatory public insurance]. / Sozialmedizinische Kompetenzvermittlung im Medizinstudium--sozialmedizinische Ausbildungsziele für den berufsfähigen Arzt aus Sicht der gesetzlichen Krankenkassen.

The social obligation of medicine is not limited to the application of technical-curative methods. It rather also encompasses prevention, rehabilitation as well as cooperation with other health professions. Furthermore, medicine is tied into a social, economical and legal framework which has a direct impact on medical practice. Training in social medicine within the medical curriculum has to address these relationships. Moreover, the interaction between the ecological, occupational and social environment and the causes of diseases and disabilities should be a central focus of the subject.

[Requirements for graduates of training courses from the viewpoint of various specialty fields]. / Anforderungsprofil der Absolventen der Aufbaustudiengänge aus der Sicht unterschiedlicher Arbeitsfelder.

By imparting competence in social medicine in the interdisciplinary course of studies "Public Health" graduates should be enabled to support social health insurance in finding adequate solutions regarding medical and economic aspects within the scope of planning and forming structures of health care. Thereby rationality in medical care can be increased so that rationing is avoided and reserves in efficiency and be mobilised.

[The concept of continuing education in medical service--competence of physicians in counseling in the field of (social) medicine, law and economics]. / Das Fortbildungskonzept der Medizinischen Dienste--ärztliche Beratungskompetenz im Spannungsfeld von (Sozial-)medizin, -recht und -ökonomie.

The paper describes the performance of continuing education programmes of the Medical Advisory Services in Germany and explains the methodical background. Elements of conceptional structure comprise basic and advanced seminars, professional und special training courses. Realizations of this training concept are described with special regard to demand, utilisation and acceptance with prospects of future.

[3 years of MDK (Health Insurance Medical Services)--current status and future trends]. / Drei jahre MDK--eine Standortbestimmung und Perspektiven für die Zukunft.

The medical service and medical supply organizations operating in Germany within the framework of compulsory sickness insurance are based on the principles of common self-administration that is monitored via contracts. The partners to these contracts develop reciprocally adequate ideas on the medical and economic structures of the medical supply system and expand their supply and negotiation strategies by discussing the structures of paid benefits and medical supply. This means there is an increasing need for a medical interpretation of the findings and of the data on the course of a disease and its treatment. The need for explaining from a medical point of view why certain contract strategies have been adopted and must be followed, is also on the increase, as is the demand for quality assurance methods that can claim to be adequate for this medical supply system. Medical Advisory Service has become more distinctive wherever compulsory sickness insurance has been making every effort to shoulder its health policy responsibilities and to make quality assurance a declared aim.