Abstracts by keywords: 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
The so-called multi-criteria decision analysis (MCEA) can be used to support complex technology assessments. Multi-criteria decision analysis procedures have their origins in decision theory or operations research and are used there to make decisions under uncertainty. They assist decision makers in evaluating a finite number of alternative health interventions using a finite number of performance criteria. In addition to conjoint analysis, the elimination and choice translating reality method (ELECTRE) and the multiattribute utility theory (MAUT) (Lootsma/Schujit 1997), the most widely used multi-criteria decision analysis tools include the Analytic Hierarchy Process (AHP).
24.01.2013
In Germany, medical care is largely financed by contributions from insured persons. This results in the normative and ethical obligation of statutory health insurance to provide the optimum level of health services with maximum benefit for the insured. It is important to reduce waste, use resources efficiently, and all results must be meaningful, especially for patients. The health insurance companies, together with the service providers and the patients, are responsible for achieving these goals and a primarily scientifically based approach (SGB V §§ 2, 12, 35b, 70). The question of what is useful is described, for example, in SGB V § 35b as “improving the state of health, shortening the duration of the illness, extending the lifespan, reducing side effects and improving the quality of life”. This maxim can be found in an identical form in the G-BA's Rules of Procedure, in the Drug Benefit Assessment Ordinance or in the IQWiG method paper for benefit assessment. The statement that the benefit assessment has to be based on “patient-relevant target values” is of particular importance. “In this context, “patient-relevant” should be understood as how a patient feels, can perceive their functions and activities or whether they survive.” (IQWiG 2011, p. 30f)